case study design sample

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Blog Graphic Design

15+ Professional Case Study Examples [Design Tips + Templates]

By Alice Corner , Jan 12, 2023

Let me ask you a question: Have you ever bought something — within the last 10 years or so — without reading its reviews or without a recommendation or prior experience of using it?

If the answer is no — or at least, rarely — you get my point.

For businesses selling consumer goods, having raving reviews is a good way to get more customers. The same thing applies to B2B and/or SaaS businesses — but for this type of business, besides regular, short reviews, having a detailed case study can help tremendously.

Case studies are an incredibly effective form of marketing that you can use to help promote your product and plan your marketing strategy effectively. You can also use it as a form of customer analysis or as a sales tool to inspire potential customers.

So what does a case study look like and how can you create one? In this article, I’m going to list over 15 marketing case study examples, case study tips, and case study templates to help you create a case study that converts.

Click to jump ahead:

• What is a Case Study?
• Marketing Case Study Examples

Sales Case Study Examples

Simple case study examples, business case study examples.

• Case Study FAQs

What is a case study?

A case study is a research method to gain a better understanding of a subject or process. Case studies involve in-depth research into a given subject, in order to understand its functionality and successes.

In the context of a business, however, case studies take customer success stories and explore how they use your product to help them achieve their business goals.

As well as being valuable marketing tools, case studies are a good way to evaluate your product as it allows you to objectively examine how others are using it.

It’s also a good way to interview your customers about why they work with you.

Related: What is a Case Study? [+6 Types of Case Studies]

What is a marketing case study?

A marketing case study is a type of marketing where you use your existing customers as an example of what your product or services can achieve. You can also create case studies of internal, successful marketing projects.

Here’s an example of a marketing case study template:

Return to Table of Contents

Marketing case study examples

Marketing case studies are incredibly useful for showing your marketing successes. Every successful marketing campaign relies on influencing a consumer’s behavior, and a great case study can be a great way to spotlight your biggest wins.

In the marketing case study examples below, a variety of designs and techniques to create impactful and effective case studies.

Show off impressive results with a bold marketing case study

Case studies are meant to show off your successes, so make sure you feature your positive results prominently. Using bold and bright colors as well as contrasting shapes, large bold fonts, and simple icons is a great way to highlight your wins.

In well-written case study examples like the one below, the big wins are highlighted on the second page with a bright orange color and are highlighted in circles.

Making the important data stand out is especially important when attracting a prospective customer with marketing case studies.

Use a simple but clear layout in your case study

Using a simple layout in your case study can be incredibly effective, like in the example of a case study below.

Keeping a clean white background, and using slim lines to help separate the sections is an easy way to format your case study.

Making the information clear helps draw attention to the important results, and it helps improve the  accessibility of the design .

Business case study examples like this would sit nicely within a larger report, with a consistent layout throughout.

Use visuals and icons to create an engaging and branded business case study

Nobody wants to read pages and pages of text — and that’s why Venngage wants to help you communicate your ideas visually.

Using icons, graphics, photos, or patterns helps create a much more engaging design. 

With this Blue Cap case study icons, colors, and impactful pattern designs have been used to create an engaging design that catches your eye.

Use a monochromatic color palette to create a professional and clean case study

Let your research shine by using a monochromatic and minimalistic color palette.

By sticking to one color, and leaving lots of blank space you can ensure your design doesn’t distract a potential customer from your case study content.

In this case study on Polygon Media, the design is simple and professional, and the layout allows the prospective customer to follow the flow of information.

The gradient effect on the left-hand column helps break up the white background and adds an interesting visual effect.

Did you know you can generate an accessible color palette with Venngage? Try our free accessible color palette generator today and create a case study that delivers and looks pleasant to the eye:

Add long term goals in your case study

When creating a case study it’s a great idea to look at both the short term and the long term goals of the company to gain the best understanding possible of the insights they provide.

Short-term goals will be what the company or person hopes to achieve in the next few months, and long-term goals are what the company hopes to achieve in the next few years.

Check out this modern pattern design example of a case study below:

In this case study example, the short and long-term goals are clearly distinguished by light blue boxes and placed side by side so that they are easy to compare.

Use a strong introductory paragraph to outline the overall strategy and goals before outlining the specific short-term and long-term goals to help with clarity.

This strategy can also be handy when creating a consulting case study.

Use data to make concrete points about your sales and successes

When conducting any sort of research stats, facts, and figures are like gold dust (aka, really valuable).

Being able to quantify your findings is important to help understand the information fully. Saying sales increased 10% is much more effective than saying sales increased.

In sales case study examples, like this one, the key data and findings can be presented with icons. This contributes to the potential customer’s better understanding of the report.

They can clearly comprehend the information and it shows that the case study has been well researched.

Use emotive, persuasive, or action based language in your marketing case study

Create a compelling case study by using emotive, persuasive and action-based language when customizing your case study template.

In this well-written case study example, we can see that phrases such as “Results that Speak Volumes” and “Drive Sales” have been used.

Using persuasive language like you would in a blog post. It helps inspire potential customers to take action now.

Keep your potential customers in mind when creating a customer case study for marketing

82% of marketers use case studies in their marketing  because it’s such an effective tool to help quickly gain customers’ trust and to showcase the potential of your product.

Why are case studies such an important tool in content marketing?

By writing a case study you’re telling potential customers that they can trust you because you’re showing them that other people do.

Not only that, but if you have a SaaS product, business case studies are a great way to show how other people are effectively using your product in their company.

In this case study, Network is demonstrating how their product has been used by Vortex Co. with great success; instantly showing other potential customers that their tool works and is worth using.

Related: 10+ Case Study Infographic Templates That Convert

Case studies are particularly effective as a sales technique.

A sales case study is like an extended customer testimonial, not only sharing opinions of your product – but showcasing the results you helped your customer achieve.

Make impactful statistics pop in your sales case study

Writing a case study doesn’t mean using text as the only medium for sharing results.

You should use icons to highlight areas of your research that are particularly interesting or relevant, like in this example of a case study:

Icons are a great way to help summarize information quickly and can act as visual cues to help draw the customer’s attention to certain areas of the page.

In some of the business case study examples above, icons are used to represent the impressive areas of growth and are presented in a way that grabs your attention.

Use high contrast shapes and colors to draw attention to key information in your sales case study

Help the key information stand out within your case study by using high contrast shapes and colors.

Use a complementary or contrasting color, or use a shape such as a rectangle or a circle for maximum impact.

This design has used dark blue rectangles to help separate the information and make it easier to read.

Coupled with icons and strong statistics, this information stands out on the page and is easily digestible and retainable for a potential customer.

Less is often more, and this is especially true when it comes to creating designs. Whilst you want to create a professional-looking, well-written and design case study – there’s no need to overcomplicate things.

These simple case study examples show that smart clean designs and informative content can be an effective way to showcase your successes.

Use colors and fonts to create a professional-looking case study

Business case studies shouldn’t be boring. In fact, they should be beautifully and professionally designed.

This means the normal rules of design apply. Use fonts, colors, and icons to create an interesting and visually appealing case study.

In this case study example, we can see how multiple fonts have been used to help differentiate between the headers and content, as well as complementary colors and eye-catching icons.

Whether you’re a B2B or B2C company, business case studies can be a powerful resource to help with your sales, marketing, and even internal departmental awareness.

Business and business management case studies should encompass strategic insights alongside anecdotal and qualitative findings, like in the business case study examples below.

Conduct a B2B case study by researching the company holistically

When it comes to writing a case study, make sure you approach the company holistically and analyze everything from their social media to their sales.

Think about every avenue your product or service has been of use to your case study company, and ask them about the impact this has had on their wider company goals.

In business case study examples like the one above, we can see that the company has been thought about holistically simply by the use of icons.

By combining social media icons with icons that show in-person communication we know that this is a well-researched and thorough case study.

This case study report example could also be used within an annual or end-of-year report.

Highlight the key takeaway from your marketing case study

To create a compelling case study, identify the key takeaways from your research. Use catchy language to sum up this information in a sentence, and present this sentence at the top of your page.

This is “at a glance” information and it allows people to gain a top-level understanding of the content immediately. 

You can use a large, bold, contrasting font to help this information stand out from the page and provide interest.

Learn  how to choose fonts  effectively with our Venngage guide and once you’ve done that.

Upload your fonts and  brand colors  to Venngage using the  My Brand Kit  tool and see them automatically applied to your designs.

The heading is the ideal place to put the most impactful information, as this is the first thing that people will read.

In this example, the stat of “Increase[d] lead quality by 90%” is used as the header. It makes customers want to read more to find out how exactly lead quality was increased by such a massive amount.

If you’re conducting an in-person interview, you could highlight a direct quote or insight provided by your interview subject.

Pick out a catchy sentence or phrase, or the key piece of information your interview subject provided and use that as a way to draw a potential customer in.

Use charts to visualize data in your business case studies

Charts are an excellent way to visualize data and to bring statistics and information to life. Charts make information easier to understand and to illustrate trends or patterns.

Making charts is even easier with Venngage.

In this consulting case study example, we can see that a chart has been used to demonstrate the difference in lead value within the Lead Elves case study.

Adding a chart here helps break up the information and add visual value to the case study. 

Using charts in your case study can also be useful if you’re creating a project management case study.

You could use a Gantt chart or a project timeline to show how you have managed the project successfully.

Use direct quotes to build trust in your marketing case study

To add an extra layer of authenticity you can include a direct quote from your customer within your case study.

According to research from Nielsen , 92% of people will trust a recommendation from a peer and 70% trust recommendations even if they’re from somebody they don’t know.

So if you have a customer or client who can’t stop singing your praises, make sure you get a direct quote from them and include it in your case study.

You can either lift part of the conversation or interview, or you can specifically request a quote. Make sure to ask for permission before using the quote.

This design uses a bright contrasting speech bubble to show that it includes a direct quote, and helps the quote stand out from the rest of the text.

This will help draw the customer’s attention directly to the quote, in turn influencing them to use your product or service.

Case Study Examples Summary

Once you have created your case study, it’s best practice to update your examples on a regular basis to include up-to-date statistics, data, and information.

You should update your business case study examples often if you are sharing them on your website.

It’s also important that your case study sits within your brand guidelines – find out how Venngage’s My Brand Kit tool can help you create consistently branded case study templates.

Case studies are important marketing tools – but they shouldn’t be the only tool in your toolbox. Content marketing is also a valuable way to earn consumer trust.

Case Study FAQ

Why should you write a case study.

Case studies are an effective marketing technique to engage potential customers and help build trust.

By producing case studies featuring your current clients or customers, you are showcasing how your tool or product can be used. You’re also showing that other people endorse your product.

In addition to being a good way to gather positive testimonials from existing customers , business case studies are good educational resources and can be shared amongst your company or team, and used as a reference for future projects.

How should you write a case study?

To create a great case study, you should think strategically. The first step, before starting your case study research, is to think about what you aim to learn or what you aim to prove.

You might be aiming to learn how a company makes sales or develops a new product. If this is the case, base your questions around this.

You can learn more about writing a case study  from our extensive guide.

Related: How to Present a Case Study like a Pro (With Examples)

Some good questions you could ask would be:

• Why do you use our tool or service?
• How often do you use our tool or service?
• What does the process of using our product look like to you?
• If our product didn’t exist, what would you be doing instead?
• What is the number one benefit you’ve found from using our tool?

You might also enjoy:

12 Essential Consulting Templates For Marketing, Planning and Branding

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Designing and Conducting Case Studies

This guide examines case studies, a form of qualitative descriptive research that is used to look at individuals, a small group of participants, or a group as a whole. Researchers collect data about participants using participant and direct observations, interviews, protocols, tests, examinations of records, and collections of writing samples. Starting with a definition of the case study, the guide moves to a brief history of this research method. Using several well documented case studies, the guide then looks at applications and methods including data collection and analysis. A discussion of ways to handle validity, reliability, and generalizability follows, with special attention to case studies as they are applied to composition studies. Finally, this guide examines the strengths and weaknesses of case studies.

Definition and Overview

Case study refers to the collection and presentation of detailed information about a particular participant or small group, frequently including the accounts of subjects themselves. A form of qualitative descriptive research, the case study looks intensely at an individual or small participant pool, drawing conclusions only about that participant or group and only in that specific context. Researchers do not focus on the discovery of a universal, generalizable truth, nor do they typically look for cause-effect relationships; instead, emphasis is placed on exploration and description.

Case studies typically examine the interplay of all variables in order to provide as complete an understanding of an event or situation as possible. This type of comprehensive understanding is arrived at through a process known as thick description, which involves an in-depth description of the entity being evaluated, the circumstances under which it is used, the characteristics of the people involved in it, and the nature of the community in which it is located. Thick description also involves interpreting the meaning of demographic and descriptive data such as cultural norms and mores, community values, ingrained attitudes, and motives.

Unlike quantitative methods of research, like the survey, which focus on the questions of who, what, where, how much, and how many, and archival analysis, which often situates the participant in some form of historical context, case studies are the preferred strategy when how or why questions are asked. Likewise, they are the preferred method when the researcher has little control over the events, and when there is a contemporary focus within a real life context. In addition, unlike more specifically directed experiments, case studies require a problem that seeks a holistic understanding of the event or situation in question using inductive logic--reasoning from specific to more general terms.

In scholarly circles, case studies are frequently discussed within the context of qualitative research and naturalistic inquiry. Case studies are often referred to interchangeably with ethnography, field study, and participant observation. The underlying philosophical assumptions in the case are similar to these types of qualitative research because each takes place in a natural setting (such as a classroom, neighborhood, or private home), and strives for a more holistic interpretation of the event or situation under study.

Unlike more statistically-based studies which search for quantifiable data, the goal of a case study is to offer new variables and questions for further research. F.H. Giddings, a sociologist in the early part of the century, compares statistical methods to the case study on the basis that the former are concerned with the distribution of a particular trait, or a small number of traits, in a population, whereas the case study is concerned with the whole variety of traits to be found in a particular instance" (Hammersley 95).

Case studies are not a new form of research; naturalistic inquiry was the primary research tool until the development of the scientific method. The fields of sociology and anthropology are credited with the primary shaping of the concept as we know it today. However, case study research has drawn from a number of other areas as well: the clinical methods of doctors; the casework technique being developed by social workers; the methods of historians and anthropologists, plus the qualitative descriptions provided by quantitative researchers like LePlay; and, in the case of Robert Park, the techniques of newspaper reporters and novelists.

Park was an ex-newspaper reporter and editor who became very influential in developing sociological case studies at the University of Chicago in the 1920s. As a newspaper professional he coined the term "scientific" or "depth" reporting: the description of local events in a way that pointed to major social trends. Park viewed the sociologist as "merely a more accurate, responsible, and scientific reporter." Park stressed the variety and value of human experience. He believed that sociology sought to arrive at natural, but fluid, laws and generalizations in regard to human nature and society. These laws weren't static laws of the kind sought by many positivists and natural law theorists, but rather, they were laws of becoming--with a constant possibility of change. Park encouraged students to get out of the library, to quit looking at papers and books, and to view the constant experiment of human experience. He writes, "Go and sit in the lounges of the luxury hotels and on the doorsteps of the flophouses; sit on the Gold Coast settees and on the slum shakedowns; sit in the Orchestra Hall and in the Star and Garter Burlesque. In short, gentlemen [sic], go get the seats of your pants dirty in real research."

But over the years, case studies have drawn their share of criticism. In fact, the method had its detractors from the start. In the 1920s, the debate between pro-qualitative and pro-quantitative became quite heated. Case studies, when compared to statistics, were considered by many to be unscientific. From the 1930's on, the rise of positivism had a growing influence on quantitative methods in sociology. People wanted static, generalizable laws in science. The sociological positivists were looking for stable laws of social phenomena. They criticized case study research because it failed to provide evidence of inter subjective agreement. Also, they condemned it because of the few number of cases studied and that the under-standardized character of their descriptions made generalization impossible. By the 1950s, quantitative methods, in the form of survey research, had become the dominant sociological approach and case study had become a minority practice.

Educational Applications

The 1950's marked the dawning of a new era in case study research, namely that of the utilization of the case study as a teaching method. "Instituted at Harvard Business School in the 1950s as a primary method of teaching, cases have since been used in classrooms and lecture halls alike, either as part of a course of study or as the main focus of the course to which other teaching material is added" (Armisted 1984). The basic purpose of instituting the case method as a teaching strategy was "to transfer much of the responsibility for learning from the teacher on to the student, whose role, as a result, shifts away from passive absorption toward active construction" (Boehrer 1990). Through careful examination and discussion of various cases, "students learn to identify actual problems, to recognize key players and their agendas, and to become aware of those aspects of the situation that contribute to the problem" (Merseth 1991). In addition, students are encouraged to "generate their own analysis of the problems under consideration, to develop their own solutions, and to practically apply their own knowledge of theory to these problems" (Boyce 1993). Along the way, students also develop "the power to analyze and to master a tangled circumstance by identifying and delineating important factors; the ability to utilize ideas, to test them against facts, and to throw them into fresh combinations" (Merseth 1991).

In addition to the practical application and testing of scholarly knowledge, case discussions can also help students prepare for real-world problems, situations and crises by providing an approximation of various professional environments (i.e. classroom, board room, courtroom, or hospital). Thus, through the examination of specific cases, students are given the opportunity to work out their own professional issues through the trials, tribulations, experiences, and research findings of others. An obvious advantage to this mode of instruction is that it allows students the exposure to settings and contexts that they might not otherwise experience. For example, a student interested in studying the effects of poverty on minority secondary student's grade point averages and S.A.T. scores could access and analyze information from schools as geographically diverse as Los Angeles, New York City, Miami, and New Mexico without ever having to leave the classroom.

The case study method also incorporates the idea that students can learn from one another "by engaging with each other and with each other's ideas, by asserting something and then having it questioned, challenged and thrown back at them so that they can reflect on what they hear, and then refine what they say" (Boehrer 1990). In summary, students can direct their own learning by formulating questions and taking responsibility for the study.

Types and Design Concerns

Researchers use multiple methods and approaches to conduct case studies.

Types of Case Studies

Under the more generalized category of case study exist several subdivisions, each of which is custom selected for use depending upon the goals and/or objectives of the investigator. These types of case study include the following:

Illustrative Case Studies These are primarily descriptive studies. They typically utilize one or two instances of an event to show what a situation is like. Illustrative case studies serve primarily to make the unfamiliar familiar and to give readers a common language about the topic in question.

Exploratory (or pilot) Case Studies These are condensed case studies performed before implementing a large scale investigation. Their basic function is to help identify questions and select types of measurement prior to the main investigation. The primary pitfall of this type of study is that initial findings may seem convincing enough to be released prematurely as conclusions.

Cumulative Case Studies These serve to aggregate information from several sites collected at different times. The idea behind these studies is the collection of past studies will allow for greater generalization without additional cost or time being expended on new, possibly repetitive studies.

Critical Instance Case Studies These examine one or more sites for either the purpose of examining a situation of unique interest with little to no interest in generalizability, or to call into question or challenge a highly generalized or universal assertion. This method is useful for answering cause and effect questions.

Identifying a Theoretical Perspective

Much of the case study's design is inherently determined for researchers, depending on the field from which they are working. In composition studies, researchers are typically working from a qualitative, descriptive standpoint. In contrast, physicists will approach their research from a more quantitative perspective. Still, in designing the study, researchers need to make explicit the questions to be explored and the theoretical perspective from which they will approach the case. The three most commonly adopted theories are listed below:

Individual Theories These focus primarily on the individual development, cognitive behavior, personality, learning and disability, and interpersonal interactions of a particular subject.

Organizational Theories These focus on bureaucracies, institutions, organizational structure and functions, or excellence in organizational performance.

Social Theories These focus on urban development, group behavior, cultural institutions, or marketplace functions.

Two examples of case studies are used consistently throughout this chapter. The first, a study produced by Berkenkotter, Huckin, and Ackerman (1988), looks at a first year graduate student's initiation into an academic writing program. The study uses participant-observer and linguistic data collecting techniques to assess the student's knowledge of appropriate discourse conventions. Using the pseudonym Nate to refer to the subject, the study sought to illuminate the particular experience rather than to generalize about the experience of fledgling academic writers collectively.

For example, in Berkenkotter, Huckin, and Ackerman's (1988) study we are told that the researchers are interested in disciplinary communities. In the first paragraph, they ask what constitutes membership in a disciplinary community and how achieving membership might affect a writer's understanding and production of texts. In the third paragraph they state that researchers must negotiate their claims "within the context of his sub specialty's accepted knowledge and methodology." In the next paragraph they ask, "How is literacy acquired? What is the process through which novices gain community membership? And what factors either aid or hinder students learning the requisite linguistic behaviors?" This introductory section ends with a paragraph in which the study's authors claim that during the course of the study, the subject, Nate, successfully makes the transition from "skilled novice" to become an initiated member of the academic discourse community and that his texts exhibit linguistic changes which indicate this transition. In the next section the authors make explicit the sociolinguistic theoretical and methodological assumptions on which the study is based (1988). Thus the reader has a good understanding of the authors' theoretical background and purpose in conducting the study even before it is explicitly stated on the fourth page of the study. "Our purpose was to examine the effects of the educational context on one graduate student's production of texts as he wrote in different courses and for different faculty members over the academic year 1984-85." The goal of the study then, was to explore the idea that writers must be initiated into a writing community, and that this initiation will change the way one writes.

The second example is Janet Emig's (1971) study of the composing process of a group of twelfth graders. In this study, Emig seeks to answer the question of what happens to the self as a result educational stimuli in terms of academic writing. The case study used methods such as protocol analysis, tape-recorded interviews, and discourse analysis.

In the case of Janet Emig's (1971) study of the composing process of eight twelfth graders, four specific hypotheses were made:

• Twelfth grade writers engage in two modes of composing: reflexive and extensive.
• These differences can be ascertained and characterized through having the writers compose aloud their composition process.
• A set of implied stylistic principles governs the writing process.
• For twelfth grade writers, extensive writing occurs chiefly as a school-sponsored activity, or reflexive, as a self-sponsored activity.

In this study, the chief distinction is between the two dominant modes of composing among older, secondary school students. The distinctions are:

• The reflexive mode, which focuses on the writer's thoughts and feelings.
• The extensive mode, which focuses on conveying a message.

Emig also outlines the specific questions which guided the research in the opening pages of her Review of Literature , preceding the report.

Designing a Case Study

After considering the different sub categories of case study and identifying a theoretical perspective, researchers can begin to design their study. Research design is the string of logic that ultimately links the data to be collected and the conclusions to be drawn to the initial questions of the study. Typically, research designs deal with at least four problems:

• What questions to study
• What data are relevant
• What data to collect
• How to analyze that data

In other words, a research design is basically a blueprint for getting from the beginning to the end of a study. The beginning is an initial set of questions to be answered, and the end is some set of conclusions about those questions.

Because case studies are conducted on topics as diverse as Anglo-Saxon Literature (Thrane 1986) and AIDS prevention (Van Vugt 1994), it is virtually impossible to outline any strict or universal method or design for conducting the case study. However, Robert K. Yin (1993) does offer five basic components of a research design:

• A study's questions.
• A study's propositions (if any).
• A study's units of analysis.
• The logic that links the data to the propositions.
• The criteria for interpreting the findings.

In addition to these five basic components, Yin also stresses the importance of clearly articulating one's theoretical perspective, determining the goals of the study, selecting one's subject(s), selecting the appropriate method(s) of collecting data, and providing some considerations to the composition of the final report.

Conducting Case Studies

To obtain as complete a picture of the participant as possible, case study researchers can employ a variety of approaches and methods. These approaches, methods, and related issues are discussed in depth in this section.

Method: Single or Multi-modal?

To obtain as complete a picture of the participant as possible, case study researchers can employ a variety of methods. Some common methods include interviews , protocol analyses, field studies, and participant-observations. Emig (1971) chose to use several methods of data collection. Her sources included conversations with the students, protocol analysis, discrete observations of actual composition, writing samples from each student, and school records (Lauer and Asher 1988).

Berkenkotter, Huckin, and Ackerman (1988) collected data by observing classrooms, conducting faculty and student interviews, collecting self reports from the subject, and by looking at the subject's written work.

A study that was criticized for using a single method model was done by Flower and Hayes (1984). In this study that explores the ways in which writers use different forms of knowing to create space, the authors used only protocol analysis to gather data. The study came under heavy fire because of their decision to use only one method.

Participant Selection

Case studies can use one participant, or a small group of participants. However, it is important that the participant pool remain relatively small. The participants can represent a diverse cross section of society, but this isn't necessary.

For example, the Berkenkotter, Huckin, and Ackerman (1988) study looked at just one participant, Nate. By contrast, in Janet Emig's (1971) study of the composition process of twelfth graders, eight participants were selected representing a diverse cross section of the community, with volunteers from an all-white upper-middle-class suburban school, an all-black inner-city school, a racially mixed lower-middle-class school, an economically and racially mixed school, and a university school.

Often, a brief "case history" is done on the participants of the study in order to provide researchers with a clearer understanding of their participants, as well as some insight as to how their own personal histories might affect the outcome of the study. For instance, in Emig's study, the investigator had access to the school records of five of the participants, and to standardized test scores for the remaining three. Also made available to the researcher was the information that three of the eight students were selected as NCTE Achievement Award winners. These personal histories can be useful in later stages of the study when data are being analyzed and conclusions drawn.

Data Collection

There are six types of data collected in case studies:

• Archival records.
• Interviews.
• Direct observation.
• Participant observation.

In the field of composition research, these six sources might be:

• A writer's drafts.
• School records of student writers.
• Transcripts of interviews with a writer.
• Transcripts of conversations between writers (and protocols).
• Videotapes and notes from direct field observations.
• Hard copies of a writer's work on computer.

Depending on whether researchers have chosen to use a single or multi-modal approach for the case study, they may choose to collect data from one or any combination of these sources.

Protocols, that is, transcriptions of participants talking aloud about what they are doing as they do it, have been particularly common in composition case studies. For example, in Emig's (1971) study, the students were asked, in four different sessions, to give oral autobiographies of their writing experiences and to compose aloud three themes in the presence of a tape recorder and the investigator.

In some studies, only one method of data collection is conducted. For example, the Flower and Hayes (1981) report on the cognitive process theory of writing depends on protocol analysis alone. However, using multiple sources of evidence to increase the reliability and validity of the data can be advantageous.

Case studies are likely to be much more convincing and accurate if they are based on several different sources of information, following a corroborating mode. This conclusion is echoed among many composition researchers. For example, in her study of predrafting processes of high and low-apprehensive writers, Cynthia Selfe (1985) argues that because "methods of indirect observation provide only an incomplete reflection of the complex set of processes involved in composing, a combination of several such methods should be used to gather data in any one study." Thus, in this study, Selfe collected her data from protocols, observations of students role playing their writing processes, audio taped interviews with the students, and videotaped observations of the students in the process of composing.

It can be said then, that cross checking data from multiple sources can help provide a multidimensional profile of composing activities in a particular setting. Sharan Merriam (1985) suggests "checking, verifying, testing, probing, and confirming collected data as you go, arguing that this process will follow in a funnel-like design resulting in less data gathering in later phases of the study along with a congruent increase in analysis checking, verifying, and confirming."

It is important to note that in case studies, as in any qualitative descriptive research, while researchers begin their studies with one or several questions driving the inquiry (which influence the key factors the researcher will be looking for during data collection), a researcher may find new key factors emerging during data collection. These might be unexpected patterns or linguistic features which become evident only during the course of the research. While not bearing directly on the researcher's guiding questions, these variables may become the basis for new questions asked at the end of the report, thus linking to the possibility of further research.

Data Analysis

As the information is collected, researchers strive to make sense of their data. Generally, researchers interpret their data in one of two ways: holistically or through coding. Holistic analysis does not attempt to break the evidence into parts, but rather to draw conclusions based on the text as a whole. Flower and Hayes (1981), for example, make inferences from entire sections of their students' protocols, rather than searching through the transcripts to look for isolatable characteristics.

However, composition researchers commonly interpret their data by coding, that is by systematically searching data to identify and/or categorize specific observable actions or characteristics. These observable actions then become the key variables in the study. Sharan Merriam (1988) suggests seven analytic frameworks for the organization and presentation of data:

• The role of participants.
• The network analysis of formal and informal exchanges among groups.
• Historical.
• Thematical.
• Ritual and symbolism.
• Critical incidents that challenge or reinforce fundamental beliefs, practices, and values.

There are two purposes of these frameworks: to look for patterns among the data and to look for patterns that give meaning to the case study.

As stated above, while most researchers begin their case studies expecting to look for particular observable characteristics, it is not unusual for key variables to emerge during data collection. Typical variables coded in case studies of writers include pauses writers make in the production of a text, the use of specific linguistic units (such as nouns or verbs), and writing processes (planning, drafting, revising, and editing). In the Berkenkotter, Huckin, and Ackerman (1988) study, for example, researchers coded the participant's texts for use of connectives, discourse demonstratives, average sentence length, off-register words, use of the first person pronoun, and the ratio of definite articles to indefinite articles.

Since coding is inherently subjective, more than one coder is usually employed. In the Berkenkotter, Huckin, and Ackerman (1988) study, for example, three rhetoricians were employed to code the participant's texts for off-register phrases. The researchers established the agreement among the coders before concluding that the participant used fewer off-register words as the graduate program progressed.

Composing the Case Study Report

In the many forms it can take, "a case study is generically a story; it presents the concrete narrative detail of actual, or at least realistic events, it has a plot, exposition, characters, and sometimes even dialogue" (Boehrer 1990). Generally, case study reports are extensively descriptive, with "the most problematic issue often referred to as being the determination of the right combination of description and analysis" (1990). Typically, authors address each step of the research process, and attempt to give the reader as much context as possible for the decisions made in the research design and for the conclusions drawn.

This contextualization usually includes a detailed explanation of the researchers' theoretical positions, of how those theories drove the inquiry or led to the guiding research questions, of the participants' backgrounds, of the processes of data collection, of the training and limitations of the coders, along with a strong attempt to make connections between the data and the conclusions evident.

Although the Berkenkotter, Huckin, and Ackerman (1988) study does not, case study reports often include the reactions of the participants to the study or to the researchers' conclusions. Because case studies tend to be exploratory, most end with implications for further study. Here researchers may identify significant variables that emerged during the research and suggest studies related to these, or the authors may suggest further general questions that their case study generated.

For example, Emig's (1971) study concludes with a section dedicated solely to the topic of implications for further research, in which she suggests several means by which this particular study could have been improved, as well as questions and ideas raised by this study which other researchers might like to address, such as: is there a correlation between a certain personality and a certain composing process profile (e.g. is there a positive correlation between ego strength and persistence in revising)?

Also included in Emig's study is a section dedicated to implications for teaching, which outlines the pedagogical ramifications of the study's findings for teachers currently involved in high school writing programs.

Sharan Merriam (1985) also offers several suggestions for alternative presentations of data:

• Prepare specialized condensations for appropriate groups.
• Replace narrative sections with a series of answers to open-ended questions.
• Present "skimmer's" summaries at beginning of each section.
• Incorporate headlines that encapsulate information from text.
• Prepare analytic summaries with supporting data appendixes.
• Present data in colorful and/or unique graphic representations.

Issues of Validity and Reliability

Once key variables have been identified, they can be analyzed. Reliability becomes a key concern at this stage, and many case study researchers go to great lengths to ensure that their interpretations of the data will be both reliable and valid. Because issues of validity and reliability are an important part of any study in the social sciences, it is important to identify some ways of dealing with results.

Multi-modal case study researchers often balance the results of their coding with data from interviews or writer's reflections upon their own work. Consequently, the researchers' conclusions become highly contextualized. For example, in a case study which looked at the time spent in different stages of the writing process, Berkenkotter concluded that her participant, Donald Murray, spent more time planning his essays than in other writing stages. The report of this case study is followed by Murray's reply, wherein he agrees with some of Berkenkotter's conclusions and disagrees with others.

As is the case with other research methodologies, issues of external validity, construct validity, and reliability need to be carefully considered.

Commentary on Case Studies

Researchers often debate the relative merits of particular methods, among them case study. In this section, we comment on two key issues. To read the commentaries, choose any of the items below:

Strengths and Weaknesses of Case Studies

Most case study advocates point out that case studies produce much more detailed information than what is available through a statistical analysis. Advocates will also hold that while statistical methods might be able to deal with situations where behavior is homogeneous and routine, case studies are needed to deal with creativity, innovation, and context. Detractors argue that case studies are difficult to generalize because of inherent subjectivity and because they are based on qualitative subjective data, generalizable only to a particular context.

Flexibility

The case study approach is a comparatively flexible method of scientific research. Because its project designs seem to emphasize exploration rather than prescription or prediction, researchers are comparatively freer to discover and address issues as they arise in their experiments. In addition, the looser format of case studies allows researchers to begin with broad questions and narrow their focus as their experiment progresses rather than attempt to predict every possible outcome before the experiment is conducted.

Emphasis on Context

By seeking to understand as much as possible about a single subject or small group of subjects, case studies specialize in "deep data," or "thick description"--information based on particular contexts that can give research results a more human face. This emphasis can help bridge the gap between abstract research and concrete practice by allowing researchers to compare their firsthand observations with the quantitative results obtained through other methods of research.

Inherent Subjectivity

"The case study has long been stereotyped as the weak sibling among social science methods," and is often criticized as being too subjective and even pseudo-scientific. Likewise, "investigators who do case studies are often regarded as having deviated from their academic disciplines, and their investigations as having insufficient precision (that is, quantification), objectivity and rigor" (Yin 1989). Opponents cite opportunities for subjectivity in the implementation, presentation, and evaluation of case study research. The approach relies on personal interpretation of data and inferences. Results may not be generalizable, are difficult to test for validity, and rarely offer a problem-solving prescription. Simply put, relying on one or a few subjects as a basis for cognitive extrapolations runs the risk of inferring too much from what might be circumstance.

High Investment

Case studies can involve learning more about the subjects being tested than most researchers would care to know--their educational background, emotional background, perceptions of themselves and their surroundings, their likes, dislikes, and so on. Because of its emphasis on "deep data," the case study is out of reach for many large-scale research projects which look at a subject pool in the tens of thousands. A budget request of $10,000 to examine 200 subjects sounds more efficient than a similar request to examine four subjects.

Ethical Considerations

Researchers conducting case studies should consider certain ethical issues. For example, many educational case studies are often financed by people who have, either directly or indirectly, power over both those being studied and those conducting the investigation (1985). This conflict of interests can hinder the credibility of the study.

The personal integrity, sensitivity, and possible prejudices and/or biases of the investigators need to be taken into consideration as well. Personal biases can creep into how the research is conducted, alternative research methods used, and the preparation of surveys and questionnaires.

A common complaint in case study research is that investigators change direction during the course of the study unaware that their original research design was inadequate for the revised investigation. Thus, the researchers leave unknown gaps and biases in the study. To avoid this, researchers should report preliminary findings so that the likelihood of bias will be reduced.

Concerns about Reliability, Validity, and Generalizability

Merriam (1985) offers several suggestions for how case study researchers might actively combat the popular attacks on the validity, reliability, and generalizability of case studies:

• Prolong the Processes of Data Gathering on Site: This will help to insure the accuracy of the findings by providing the researcher with more concrete information upon which to formulate interpretations.
• Employ the Process of "Triangulation": Use a variety of data sources as opposed to relying solely upon one avenue of observation. One example of such a data check would be what McClintock, Brannon, and Maynard (1985) refer to as a "case cluster method," that is, when a single unit within a larger case is randomly sampled, and that data treated quantitatively." For instance, in Emig's (1971) study, the case cluster method was employed, singling out the productivity of a single student named Lynn. This cluster profile included an advanced case history of the subject, specific examination and analysis of individual compositions and protocols, and extensive interview sessions. The seven remaining students were then compared with the case of Lynn, to ascertain if there are any shared, or unique dimensions to the composing process engaged in by these eight students.
• Conduct Member Checks: Initiate and maintain an active corroboration on the interpretation of data between the researcher and those who provided the data. In other words, talk to your subjects.
• Collect Referential Materials: Complement the file of materials from the actual site with additional document support. For example, Emig (1971) supports her initial propositions with historical accounts by writers such as T.S. Eliot, James Joyce, and D.H. Lawrence. Emig also cites examples of theoretical research done with regards to the creative process, as well as examples of empirical research dealing with the writing of adolescents. Specific attention is then given to the four stages description of the composing process delineated by Helmoltz, Wallas, and Cowley, as it serves as the focal point in this study.
• Engage in Peer Consultation: Prior to composing the final draft of the report, researchers should consult with colleagues in order to establish validity through pooled judgment.

Although little can be done to combat challenges concerning the generalizability of case studies, "most writers suggest that qualitative research should be judged as credible and confirmable as opposed to valid and reliable" (Merriam 1985). Likewise, it has been argued that "rather than transplanting statistical, quantitative notions of generalizability and thus finding qualitative research inadequate, it makes more sense to develop an understanding of generalization that is congruent with the basic characteristics of qualitative inquiry" (1985). After all, criticizing the case study method for being ungeneralizable is comparable to criticizing a washing machine for not being able to tell the correct time. In other words, it is unjust to criticize a method for not being able to do something which it was never originally designed to do in the first place.

Annotated Bibliography

Armisted, C. (1984). How Useful are Case Studies. Training and Development Journal, 38 (2), 75-77.

This article looks at eight types of case studies, offers pros and cons of using case studies in the classroom, and gives suggestions for successfully writing and using case studies.

Bardovi-Harlig, K. (1997). Beyond Methods: Components of Second Language Teacher Education . New York: McGraw-Hill.

A compilation of various research essays which address issues of language teacher education. Essays included are: "Non-native reading research and theory" by Lee, "The case for Psycholinguistics" by VanPatten, and "Assessment and Second Language Teaching" by Gradman and Reed.

Bartlett, L. (1989). A Question of Good Judgment; Interpretation Theory and Qualitative Enquiry Address. 70th Annual Meeting of the American Educational Research Association. San Francisco.

Bartlett selected "quasi-historical" methodology, which focuses on the "truth" found in case records, as one that will provide "good judgments" in educational inquiry. He argues that although the method is not comprehensive, it can try to connect theory with practice.

Baydere, S. et. al. (1993). Multimedia conferencing as a tool for collaborative writing: a case study in Computer Supported Collaborative Writing. New York: Springer-Verlag.

The case study by Baydere et. al. is just one of the many essays in this book found in the series "Computer Supported Cooperative Work." Denley, Witefield and May explore similar issues in their essay, "A case study in task analysis for the design of a collaborative document production system."

Berkenkotter, C., Huckin, T., N., & Ackerman J. (1988). Conventions, Conversations, and the Writer: Case Study of a Student in a Rhetoric Ph.D. Program. Research in the Teaching of English, 22, 9-44.

The authors focused on how the writing of their subject, Nate or Ackerman, changed as he became more acquainted or familiar with his field's discourse community.

Berninger, V., W., and Gans, B., M. (1986). Language Profiles in Nonspeaking Individuals of Normal Intelligence with Severe Cerebral Palsy. Augmentative and Alternative Communication, 2, 45-50.

Argues that generalizations about language abilities in patients with severe cerebral palsy (CP) should be avoided. Standardized tests of different levels of processing oral language, of processing written language, and of producing written language were administered to 3 male participants (aged 9, 16, and 40 yrs).

Bockman, J., R., and Couture, B. (1984). The Case Method in Technical Communication: Theory and Models. Texas: Association of Teachers of Technical Writing.

Examines the study and teaching of technical writing, communication of technical information, and the case method in terms of those applications.

Boehrer, J. (1990). Teaching With Cases: Learning to Question. New Directions for Teaching and Learning, 42 41-57.

This article discusses the origins of the case method, looks at the question of what is a case, gives ideas about learning in case teaching, the purposes it can serve in the classroom, the ground rules for the case discussion, including the role of the question, and new directions for case teaching.

Bowman, W. R. (1993). Evaluating JTPA Programs for Economically Disadvantaged Adults: A Case Study of Utah and General Findings . Washington: National Commission for Employment Policy.

"To encourage state-level evaluations of JTPA, the Commission and the State of Utah co-sponsored this report on the effectiveness of JTPA Title II programs for adults in Utah. The technique used is non-experimental and the comparison group was selected from registrants with Utah's Employment Security. In a step-by-step approach, the report documents how non-experimental techniques can be applied and several specific technical issues can be addressed."

Boyce, A. (1993) The Case Study Approach for Pedagogists. Annual Meeting of the American Alliance for Health, Physical Education, Recreation and Dance. (Address). Washington DC.

This paper addresses how case studies 1) bridge the gap between teaching theory and application, 2) enable students to analyze problems and develop solutions for situations that will be encountered in the real world of teaching, and 3) helps students to evaluate the feasibility of alternatives and to understand the ramifications of a particular course of action.

Carson, J. (1993) The Case Study: Ideal Home of WAC Quantitative and Qualitative Data. Annual Meeting of the Conference on College Composition and Communication. (Address). San Diego.

"Increasingly, one of the most pressing questions for WAC advocates is how to keep [WAC] programs going in the face of numerous difficulties. Case histories offer the best chance for fashioning rhetorical arguments to keep WAC programs going because they offer the opportunity to provide a coherent narrative that contextualizes all documents and data, including what is generally considered scientific data. A case study of the WAC program, . . . at Robert Morris College in Pittsburgh demonstrates the advantages of this research method. Such studies are ideal homes for both naturalistic and positivistic data as well as both quantitative and qualitative information."

---. (1991). A Cognitive Process Theory of Writing. College Composition and Communication. 32. 365-87.

No abstract available.

Cromer, R. (1994) A Case Study of Dissociations Between Language and Cognition. Constraints on Language Acquisition: Studies of Atypical Children . Hillsdale: Lawrence Erlbaum Associates, 141-153.

Crossley, M. (1983) Case Study in Comparative and International Education: An Approach to Bridging the Theory-Practice Gap. Proceedings of the 11th Annual Conference of the Australian Comparative and International Education Society. Hamilton, NZ.

Case study research, as presented here, helps bridge the theory-practice gap in comparative and international research studies of education because it focuses on the practical, day-to-day context rather than on the national arena. The paper asserts that the case study method can be valuable at all levels of research, formation, and verification of theories in education.

Daillak, R., H., and Alkin, M., C. (1982). Qualitative Studies in Context: Reflections on the CSE Studies of Evaluation Use . California: EDRS

The report shows how the Center of the Study of Evaluation (CSE) applied qualitative techniques to a study of evaluation information use in local, Los Angeles schools. It critiques the effectiveness and the limitations of using case study, evaluation, field study, and user interview survey methodologies.

Davey, L. (1991). The Application of Case Study Evaluations. ERIC/TM Digest.

This article examines six types of case studies, the type of evaluation questions that can be answered, the functions served, some design features, and some pitfalls of the method.

Deutch, C. E. (1996). A course in research ethics for graduate students. College Teaching, 44, 2, 56-60.

This article describes a one-credit discussion course in research ethics for graduate students in biology. Case studies are focused on within the four parts of the course: 1) major issues, 2 )practical issues in scholarly work, 3) ownership of research results, and 4) training and personal decisions.

DeVoss, G. (1981). Ethics in Fieldwork Research. RIE 27p. (ERIC)

This article examines four of the ethical problems that can happen when conducting case study research: acquiring permission to do research, knowing when to stop digging, the pitfalls of doing collaborative research, and preserving the integrity of the participants.

Driscoll, A. (1985). Case Study of a Research Intervention: the University of Utah’s Collaborative Approach . San Francisco: Far West Library for Educational Research Development.

Paper presented at the annual meeting of the American Association of Colleges of Teacher Education, Denver, CO, March 1985. Offers information of in-service training, specifically case studies application.

Ellram, L. M. (1996). The Use of the Case Study Method in Logistics Research. Journal of Business Logistics, 17, 2, 93.

This article discusses the increased use of case study in business research, and the lack of understanding of when and how to use case study methodology in business.

Emig, J. (1971) The Composing Processes of Twelfth Graders . Urbana: NTCE.

This case study uses observation, tape recordings, writing samples, and school records to show that writing in reflexive and extensive situations caused different lengths of discourse and different clusterings of the components of the writing process.

Feagin, J. R. (1991). A Case For the Case Study . Chapel Hill: The University of North Carolina Press.

This book discusses the nature, characteristics, and basic methodological issues of the case study as a research method.

Feldman, H., Holland, A., & Keefe, K. (1989) Language Abilities after Left Hemisphere Brain Injury: A Case Study of Twins. Topics in Early Childhood Special Education, 9, 32-47.

"Describes the language abilities of 2 twin pairs in which 1 twin (the experimental) suffered brain injury to the left cerebral hemisphere around the time of birth and1 twin (the control) did not. One pair of twins was initially assessed at age 23 mo. and the other at about 30 mo.; they were subsequently evaluated in their homes 3 times at about 6-mo intervals."

Fidel, R. (1984). The Case Study Method: A Case Study. Library and Information Science Research, 6.

The article describes the use of case study methodology to systematically develop a model of online searching behavior in which study design is flexible, subject manner determines data gathering and analyses, and procedures adapt to the study's progressive change.

Flower, L., & Hayes, J. R. (1984). Images, Plans and Prose: The Representation of Meaning in Writing. Written Communication, 1, 120-160.

Explores the ways in which writers actually use different forms of knowing to create prose.

Frey, L. R. (1992). Interpreting Communication Research: A Case Study Approach Englewood Cliffs, N.J.: Prentice Hall.

The book discusses research methodologies in the Communication field. It focuses on how case studies bridge the gap between communication research, theory, and practice.

Gilbert, V. K. (1981). The Case Study as a Research Methodology: Difficulties and Advantages of Integrating the Positivistic, Phenomenological and Grounded Theory Approaches . The Annual Meeting of the Canadian Association for the Study of Educational Administration. (Address) Halifax, NS, Can.

This study on an innovative secondary school in England shows how a "low-profile" participant-observer case study was crucial to the initial observation, the testing of hypotheses, the interpretive approach, and the grounded theory.

Gilgun, J. F. (1994). A Case for Case Studies in Social Work Research. Social Work, 39, 4, 371-381.

This article defines case study research, presents guidelines for evaluation of case studies, and shows the relevance of case studies to social work research. It also looks at issues such as evaluation and interpretations of case studies.

Glennan, S. L., Sharp-Bittner, M. A. & Tullos, D. C. (1991). Augmentative and Alternative Communication Training with a Nonspeaking Adult: Lessons from MH. Augmentative and Alternative Communication, 7, 240-7.

"A response-guided case study documented changes in a nonspeaking 36-yr-old man's ability to communicate using 3 trained augmentative communication modes. . . . Data were collected in videotaped interaction sessions between the nonspeaking adult and a series of adult speaking."

Graves, D. (1981). An Examination of the Writing Processes of Seven Year Old Children. Research in the Teaching of English, 15, 113-134.

Hamel, J. (1993). Case Study Methods . Newbury Park: Sage. .

"In a most economical fashion, Hamel provides a practical guide for producing theoretically sharp and empirically sound sociological case studies. A central idea put forth by Hamel is that case studies must "locate the global in the local" thus making the careful selection of the research site the most critical decision in the analytic process."

Karthigesu, R. (1986, July). Television as a Tool for Nation-Building in the Third World: A Post-Colonial Pattern, Using Malaysia as a Case-Study. International Television Studies Conference. (Address). London, 10-12.

"The extent to which Television Malaysia, as a national mass media organization, has been able to play a role in nation building in the post-colonial period is . . . studied in two parts: how the choice of a model of nation building determines the character of the organization; and how the character of the organization influences the output of the organization."

Kenny, R. (1984). Making the Case for the Case Study. Journal of Curriculum Studies, 16, (1), 37-51.

The article looks at how and why the case study is justified as a viable and valuable approach to educational research and program evaluation.

Knirk, F. (1991). Case Materials: Research and Practice. Performance Improvement Quarterly, 4 (1 ), 73-81.

The article addresses the effectiveness of case studies, subject areas where case studies are commonly used, recent examples of their use, and case study design considerations.

Klos, D. (1976). Students as Case Writers. Teaching of Psychology, 3.2, 63-66.

This article reviews a course in which students gather data for an original case study of another person. The task requires the students to design the study, collect the data, write the narrative, and interpret the findings.

Leftwich, A. (1981). The Politics of Case Study: Problems of Innovation in University Education. Higher Education Review, 13.2, 38-64.

The article discusses the use of case studies as a teaching method. Emphasis is on the instructional materials, interdisciplinarity, and the complex relationships within the university that help or hinder the method.

Mabrito, M. (1991, Oct.). Electronic Mail as a Vehicle for Peer Response: Conversations of High and Low Apprehensive Writers. Written Communication, 509-32.

McCarthy, S., J. (1955). The Influence of Classroom Discourse on Student Texts: The Case of Ella . East Lansing: Institute for Research on Teaching.

A look at how students of color become marginalized within traditional classroom discourse. The essay follows the struggles of one black student: Ella.

Matsuhashi, A., ed. (1987). Writing in Real Time: Modeling Production Processes Norwood, NJ: Ablex Publishing Corporation.

Investigates how writers plan to produce discourse for different purposes to report, to generalize, and to persuade, as well as how writers plan for sentence level units of language. To learn about planning, an observational measure of pause time was used" (ERIC).

Merriam, S. B. (1985). The Case Study in Educational Research: A Review of Selected Literature. Journal of Educational Thought, 19.3, 204-17.

The article examines the characteristics of, philosophical assumptions underlying the case study, the mechanics of conducting a case study, and the concerns about the reliability, validity, and generalizability of the method.

---. (1988). Case Study Research in Education: A Qualitative Approach San Francisco: Jossey Bass.

Merry, S. E., & Milner, N. eds. (1993). The Possibility of Popular Justice: A Case Study of Community Mediation in the United States . Ann Arbor: U of Michigan.

". . . this volume presents a case study of one experiment in popular justice, the San Francisco Community Boards. This program has made an explicit claim to create an alternative justice, or new justice, in the midst of a society ordered by state law. The contributors to this volume explore the history and experience of the program and compare it to other versions of popular justice in the United States, Europe, and the Third World."

Merseth, K. K. (1991). The Case for Cases in Teacher Education. RIE. 42p. (ERIC).

This monograph argues that the case method of instruction offers unique potential for revitalizing the field of teacher education.

Michaels, S. (1987). Text and Context: A New Approach to the Study of Classroom Writing. Discourse Processes, 10, 321-346.

"This paper argues for and illustrates an approach to the study of writing that integrates ethnographic analysis of classroom interaction with linguistic analysis of written texts and teacher/student conversational exchanges. The approach is illustrated through a case study of writing in a single sixth grade classroom during a single writing assignment."

Milburn, G. (1995). Deciphering a Code or Unraveling a Riddle: A Case Study in the Application of a Humanistic Metaphor to the Reporting of Social Studies Teaching. Theory and Research in Education, 13.

This citation serves as an example of how case studies document learning procedures in a senior-level economics course.

Milley, J. E. (1979). An Investigation of Case Study as an Approach to Program Evaluation. 19th Annual Forum of the Association for Institutional Research. (Address). San Diego.

The case study method merged a narrative report focusing on the evaluator as participant-observer with document review, interview, content analysis, attitude questionnaire survey, and sociogram analysis. Milley argues that case study program evaluation has great potential for widespread use.

Minnis, J. R. (1985, Sept.). Ethnography, Case Study, Grounded Theory, and Distance Education Research. Distance Education, 6.2.

This article describes and defines the strengths and weaknesses of ethnography, case study, and grounded theory.

Nunan, D. (1992). Collaborative language learning and teaching . New York: Cambridge University Press.

Included in this series of essays is Peter Sturman’s "Team Teaching: a case study from Japan" and David Nunan’s own "Toward a collaborative approach to curriculum development: a case study."

Nystrand, M., ed. (1982). What Writers Know: The Language, Process, and Structure of Written Discourse . New York: Academic Press.

Owenby, P. H. (1992). Making Case Studies Come Alive. Training, 29, (1), 43-46. (ERIC)

This article provides tips for writing more effective case studies.

---. (1981). Pausing and Planning: The Tempo of Writer Discourse Production. Research in the Teaching of English, 15 (2),113-34.

Perl, S. (1979). The Composing Processes of Unskilled College Writers. Research in the Teaching of English, 13, 317-336.

"Summarizes a study of five unskilled college writers, focusing especially on one of the five, and discusses the findings in light of current pedagogical practice and research design."

Pilcher J. and A. Coffey. eds. (1996). Gender and Qualitative Research . Brookfield: Aldershot, Hants, England.

This book provides a series of essays which look at gender identity research, qualitative research and applications of case study to questions of gendered pedagogy.

Pirie, B. S. (1993). The Case of Morty: A Four Year Study. Gifted Education International, 9 (2), 105-109.

This case study describes a boy from kindergarten through third grade with above average intelligence but difficulty in learning to read, write, and spell.

Popkewitz, T. (1993). Changing Patterns of Power: Social Regulation and Teacher Education Reform. Albany: SUNY Press.

Popkewitz edits this series of essays that address case studies on educational change and the training of teachers. The essays vary in terms of discipline and scope. Also, several authors include case studies of educational practices in countries other than the United States.

---. (1984). The Predrafting Processes of Four High- and Four Low Apprehensive Writers. Research in the Teaching of English, 18, (1), 45-64.

Rasmussen, P. (1985, March) A Case Study on the Evaluation of Research at the Technical University of Denmark. International Journal of Institutional Management in Higher Education, 9 (1).

This is an example of a case study methodology used to evaluate the chemistry and chemical engineering departments at the University of Denmark.

Roth, K. J. (1986). Curriculum Materials, Teacher Talk, and Student Learning: Case Studies in Fifth-Grade Science Teaching . East Lansing: Institute for Research on Teaching.

Roth offers case studies on elementary teachers, elementary school teaching, science studies and teaching, and verbal learning.

Selfe, C. L. (1985). An Apprehensive Writer Composes. When a Writer Can't Write: Studies in Writer's Block and Other Composing-Process Problems . (pp. 83-95). Ed. Mike Rose. NMY: Guilford.

Smith-Lewis, M., R. and Ford, A. (1987). A User's Perspective on Augmentative Communication. Augmentative and Alternative Communication, 3, 12-7.

"During a series of in-depth interviews, a 25-yr-old woman with cerebral palsy who utilized augmentative communication reflected on the effectiveness of the devices designed for her during her school career."

St. Pierre, R., G. (1980, April). Follow Through: A Case Study in Metaevaluation Research . 64th Annual Meeting of the American Educational Research Association. (Address).

The three approaches to metaevaluation are evaluation of primary evaluations, integrative meta-analysis with combined primary evaluation results, and re-analysis of the raw data from a primary evaluation.

Stahler, T., M. (1996, Feb.) Early Field Experiences: A Model That Worked. ERIC.

"This case study of a field and theory class examines a model designed to provide meaningful field experiences for preservice teachers while remaining consistent with the instructor's beliefs about the role of teacher education in preparing teachers for the classroom."

Stake, R. E. (1995). The Art of Case Study Research. Thousand Oaks: Sage Publications.

This book examines case study research in education and case study methodology.

Stiegelbauer, S. (1984) Community, Context, and Co-curriculum: Situational Factors Influencing School Improvements in a Study of High Schools. Presented at the annual meeting of the American Educational Research Association, New Orleans, LA.

Discussion of several case studies: one looking at high school environments, another examining educational innovations.

Stolovitch, H. (1990). Case Study Method. Performance And Instruction, 29, (9), 35-37.

This article describes the case study method as a form of simulation and presents guidelines for their use in professional training situations.

Thaller, E. (1994). Bibliography for the Case Method: Using Case Studies in Teacher Education. RIE. 37 p.

This bibliography presents approximately 450 citations on the use of case studies in teacher education from 1921-1993.

Thrane, T. (1986). On Delimiting the Senses of Near-Synonyms in Historical Semantics: A Case Study of Adjectives of 'Moral Sufficiency' in the Old English Andreas. Linguistics Across Historical and Geographical Boundaries: In Honor of Jacek Fisiak on the Occasion of his Fiftieth Birthday . Berlin: Mouton de Gruyter.

United Nations. (1975). Food and Agriculture Organization. Report on the FAO/UNFPA Seminar on Methodology, Research and Country: Case Studies on Population, Employment and Productivity . Rome: United Nations.

This example case study shows how the methodology can be used in a demographic and psychographic evaluation. At the same time, it discusses the formation and instigation of the case study methodology itself.

Van Vugt, J. P., ed. (1994). Aids Prevention and Services: Community Based Research . Westport: Bergin and Garvey.

"This volume has been five years in the making. In the process, some of the policy applications called for have met with limited success, such as free needle exchange programs in a limited number of American cities, providing condoms to prison inmates, and advertisements that depict same-sex couples. Rather than dating our chapters that deal with such subjects, such policy applications are verifications of the type of research demonstrated here. Furthermore, they indicate the critical need to continue community based research in the various communities threatened by acquired immuno-deficiency syndrome (AIDS) . . . "

Welch, W., ed. (1981, May). Case Study Methodology in Educational Evaluation. Proceedings of the Minnesota Evaluation Conference. Minnesota. (Address).

The four papers in these proceedings provide a comprehensive picture of the rationale, methodology, strengths, and limitations of case studies.

Williams, G. (1987). The Case Method: An Approach to Teaching and Learning in Educational Administration. RIE, 31p.

This paper examines the viability of the case method as a teaching and learning strategy in instructional systems geared toward the training of personnel of the administration of various aspects of educational systems.

Yin, R. K. (1993). Advancing Rigorous Methodologies: A Review of 'Towards Rigor in Reviews of Multivocal Literatures.' Review of Educational Research, 61, (3).

"R. T. Ogawa and B. Malen's article does not meet its own recommended standards for rigorous testing and presentation of its own conclusions. Use of the exploratory case study to analyze multivocal literatures is not supported, and the claim of grounded theory to analyze multivocal literatures may be stronger."

---. (1989). Case Study Research: Design and Methods. London: Sage Publications Inc.

This book discusses in great detail, the entire design process of the case study, including entire chapters on collecting evidence, analyzing evidence, composing the case study report, and designing single and multiple case studies.

Related Links

Consider the following list of related Web sites for more information on the topic of case study research. Note: although many of the links cover the general category of qualitative research, all have sections that address issues of case studies.

• Sage Publications on Qualitative Methodology: Search here for a comprehensive list of new books being published about "Qualitative Methodology" http://www.sagepub.co.uk/
• The International Journal of Qualitative Studies in Education: An on-line journal "to enhance the theory and practice of qualitative research in education." On-line submissions are welcome. http://www.tandf.co.uk/journals/tf/09518398.html
• Qualitative Research Resources on the Internet: From syllabi to home pages to bibliographies. All links relate somehow to qualitative research. http://www.nova.edu/ssss/QR/qualres.html

Becker, Bronwyn, Patrick Dawson, Karen Devine, Carla Hannum, Steve Hill, Jon Leydens, Debbie Matuskevich, Carol Traver, & Mike Palmquist. (2005). Case Studies. Writing@CSU . Colorado State University. https://writing.colostate.edu/guides/guide.cfm?guideid=60

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• What Is a Research Design | Types, Guide & Examples

What Is a Research Design | Types, Guide & Examples

Published on June 7, 2021 by Shona McCombes . Revised on May 31, 2023 by Pritha Bhandari.

A research design is a strategy for answering your   research question  using empirical data. Creating a research design means making decisions about:

• Your overall research objectives and approach
• Whether you’ll rely on primary research or secondary research
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research objectives and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, other interesting articles, frequently asked questions about research design.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities—start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed-methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

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Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types.

• Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships
• Descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analyzing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study—plants, animals, organizations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

• Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalize your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study , your aim is to deeply understand a specific context, not to generalize to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question .

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviors, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews .

Observation methods

Observational studies allow you to collect data unobtrusively, observing characteristics, behaviors or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what kinds of data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected—for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

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As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are high in reliability and validity.

Operationalization

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalization means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in—for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced, while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method , you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample—by mail, online, by phone, or in person?

If you’re using a probability sampling method , it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method , how will you avoid research bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organizing and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymize and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well-organized will save time when it comes to analyzing it. It can also help other researchers validate and add to your findings (high replicability ).

On its own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyze the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarize your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarize your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analyzing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

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Organizing Your Social Sciences Research Assignments

• Annotated Bibliography
• Analyzing a Scholarly Journal Article
• Group Presentations
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• Types of Structured Group Activities
• Group Project Survival Skills
• Leading a Class Discussion
• Multiple Book Review Essay
• Reviewing Collected Works
• Writing a Case Analysis Paper
• Writing a Case Study
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Reflective Paper
• Writing a Research Proposal
• Generative AI and Writing
• Acknowledgments

A case study research paper examines a person, place, event, condition, phenomenon, or other type of subject of analysis in order to extrapolate  key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study research paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or more subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.

Case Studies. Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.

How to Approach Writing a Case Study Research Paper

General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in the Organizing Your Social Sciences Research Paper writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a case study design.

However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:

• The case represents an unusual or atypical example of a research problem that requires more in-depth analysis? Cases often represent a topic that rests on the fringes of prior investigations because the case may provide new ways of understanding the research problem. For example, if the research problem is to identify strategies to improve policies that support girl's access to secondary education in predominantly Muslim nations, you could consider using Azerbaijan as a case study rather than selecting a more obvious nation in the Middle East. Doing so may reveal important new insights into recommending how governments in other predominantly Muslim nations can formulate policies that support improved access to education for girls.
• The case provides important insight or illuminate a previously hidden problem? In-depth analysis of a case can be based on the hypothesis that the case study will reveal trends or issues that have not been exposed in prior research or will reveal new and important implications for practice. For example, anecdotal evidence may suggest drug use among homeless veterans is related to their patterns of travel throughout the day. Assuming prior studies have not looked at individual travel choices as a way to study access to illicit drug use, a case study that observes a homeless veteran could reveal how issues of personal mobility choices facilitate regular access to illicit drugs. Note that it is important to conduct a thorough literature review to ensure that your assumption about the need to reveal new insights or previously hidden problems is valid and evidence-based.
• The case challenges and offers a counter-point to prevailing assumptions? Over time, research on any given topic can fall into a trap of developing assumptions based on outdated studies that are still applied to new or changing conditions or the idea that something should simply be accepted as "common sense," even though the issue has not been thoroughly tested in current practice. A case study analysis may offer an opportunity to gather evidence that challenges prevailing assumptions about a research problem and provide a new set of recommendations applied to practice that have not been tested previously. For example, perhaps there has been a long practice among scholars to apply a particular theory in explaining the relationship between two subjects of analysis. Your case could challenge this assumption by applying an innovative theoretical framework [perhaps borrowed from another discipline] to explore whether this approach offers new ways of understanding the research problem. Taking a contrarian stance is one of the most important ways that new knowledge and understanding develops from existing literature.
• The case provides an opportunity to pursue action leading to the resolution of a problem? Another way to think about choosing a case to study is to consider how the results from investigating a particular case may result in findings that reveal ways in which to resolve an existing or emerging problem. For example, studying the case of an unforeseen incident, such as a fatal accident at a railroad crossing, can reveal hidden issues that could be applied to preventative measures that contribute to reducing the chance of accidents in the future. In this example, a case study investigating the accident could lead to a better understanding of where to strategically locate additional signals at other railroad crossings so as to better warn drivers of an approaching train, particularly when visibility is hindered by heavy rain, fog, or at night.
• The case offers a new direction in future research? A case study can be used as a tool for an exploratory investigation that highlights the need for further research about the problem. A case can be used when there are few studies that help predict an outcome or that establish a clear understanding about how best to proceed in addressing a problem. For example, after conducting a thorough literature review [very important!], you discover that little research exists showing the ways in which women contribute to promoting water conservation in rural communities of east central Africa. A case study of how women contribute to saving water in a rural village of Uganda can lay the foundation for understanding the need for more thorough research that documents how women in their roles as cooks and family caregivers think about water as a valuable resource within their community. This example of a case study could also point to the need for scholars to build new theoretical frameworks around the topic [e.g., applying feminist theories of work and family to the issue of water conservation].

Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.

Structure and Writing Style

The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work.

In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.

I.  Introduction

As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:

• What is being studied? Describe the research problem and describe the subject of analysis [the case] you have chosen to address the problem. Explain how they are linked and what elements of the case will help to expand knowledge and understanding about the problem.
• Why is this topic important to investigate? Describe the significance of the research problem and state why a case study design and the subject of analysis that the paper is designed around is appropriate in addressing the problem.
• What did we know about this topic before I did this study? Provide background that helps lead the reader into the more in-depth literature review to follow. If applicable, summarize prior case study research applied to the research problem and why it fails to adequately address the problem. Describe why your case will be useful. If no prior case studies have been used to address the research problem, explain why you have selected this subject of analysis.
• How will this study advance new knowledge or new ways of understanding? Explain why your case study will be suitable in helping to expand knowledge and understanding about the research problem.

Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.

II.  Literature Review

The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and  enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:

• Place relevant works in the context of their contribution to understanding the case study being investigated . This would involve summarizing studies that have used a similar subject of analysis to investigate the research problem. If there is literature using the same or a very similar case to study, you need to explain why duplicating past research is important [e.g., conditions have changed; prior studies were conducted long ago, etc.].
• Describe the relationship each work has to the others under consideration that informs the reader why this case is applicable . Your literature review should include a description of any works that support using the case to investigate the research problem and the underlying research questions.
• Identify new ways to interpret prior research using the case study . If applicable, review any research that has examined the research problem using a different research design. Explain how your use of a case study design may reveal new knowledge or a new perspective or that can redirect research in an important new direction.
• Resolve conflicts amongst seemingly contradictory previous studies . This refers to synthesizing any literature that points to unresolved issues of concern about the research problem and describing how the subject of analysis that forms the case study can help resolve these existing contradictions.
• Point the way in fulfilling a need for additional research . Your review should examine any literature that lays a foundation for understanding why your case study design and the subject of analysis around which you have designed your study may reveal a new way of approaching the research problem or offer a perspective that points to the need for additional research.
• Expose any gaps that exist in the literature that the case study could help to fill . Summarize any literature that not only shows how your subject of analysis contributes to understanding the research problem, but how your case contributes to a new way of understanding the problem that prior research has failed to do.
• Locate your own research within the context of existing literature [very important!] . Collectively, your literature review should always place your case study within the larger domain of prior research about the problem. The overarching purpose of reviewing pertinent literature in a case study paper is to demonstrate that you have thoroughly identified and synthesized prior studies in relation to explaining the relevance of the case in addressing the research problem.

III.  Method

In this section, you explain why you selected a particular case [i.e., subject of analysis] and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that constitutes your case study.

If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; and, c) what were the consequences of the event in relation to the research problem.

If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experiences they have had that provide an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of their experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using them as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem [e.g., why is one politician in a particular local election used to show an increase in voter turnout from any other candidate running in the election]. Note that these issues apply to a specific group of people used as a case study unit of analysis [e.g., a classroom of students].

If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, historical, cultural, economic, political], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, explain why you are studying Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research suggests Echo Park has more homeless veterans].

If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut off? How might knowing the suppliers of these trucks reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.

NOTE:   The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should clearly support investigation of the research problem and linked to key findings from your literature review. Be sure to cite any studies that helped you determine that the case you chose was appropriate for examining the problem.

IV.  Discussion

The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your analysis of the case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is common to combine a description of the results with the discussion about their implications. The objectives of your discussion section should include the following:

Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.

Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.

Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.

Consider Alternative Explanations of the Findings Remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations revealed by the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research if that is how the findings can be interpreted from your case.

Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .

Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.

V.  Conclusion

As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and any need for further research.

The function of your paper's conclusion is to: 1) reiterate the main argument supported by the findings from your case study; 2) state clearly the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.

Consider the following points to help ensure your conclusion is appropriate:

• If the argument or purpose of your paper is complex, you may need to summarize these points for your reader.
• If prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the conclusion of your paper to describe your main points and explain their significance.
• Move from a detailed to a general level of consideration of the case study's findings that returns the topic to the context provided by the introduction or within a new context that emerges from your case study findings.

Note that, depending on the discipline you are writing in or the preferences of your professor, the concluding paragraph may contain your final reflections on the evidence presented as it applies to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.

Problems to Avoid

Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were engaged with social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.

Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood more in terms of managing access rather than preserving access to a scarce resource.

Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis that leave the reader questioning the results.

Case Studies. Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009;  Kratochwill,  Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education .  Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.

Writing Tip

At Least Five Misconceptions about Case Study Research

Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:

Misunderstanding 1 :  General, theoretical [context-independent] knowledge is more valuable than concrete, practical [context-dependent] knowledge. Misunderstanding 2 :  One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 :  The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 :  The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 :  It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].

While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.

Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.

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Case Study | Definition, Examples & Methods

Published on 5 May 2022 by Shona McCombes . Revised on 30 January 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organisation, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating, and understanding different aspects of a research problem .

Table of contents

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyse the case.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

• Provide new or unexpected insights into the subject
• Challenge or complicate existing assumptions and theories
• Propose practical courses of action to resolve a problem
• Open up new directions for future research

Unlike quantitative or experimental research, a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

If you find yourself aiming to simultaneously investigate and solve an issue, consider conducting action research . As its name suggests, action research conducts research and takes action at the same time, and is highly iterative and flexible. 

However, you can also choose a more common or representative case to exemplify a particular category, experience, or phenomenon.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

• Exemplify a theory by showing how it explains the case under investigation
• Expand on a theory by uncovering new concepts and ideas that need to be incorporated
• Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews, observations, and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data .

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis, with separate sections or chapters for the methods , results , and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyse its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

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Quantitative study designs: Case Studies/ Case Report/ Case Series

Quantitative study designs.

• Introduction
• Cohort Studies
• Randomised Controlled Trial
• Case Control
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Case Study / Case Report / Case Series

Some famous examples of case studies are John Martin Marlow’s case study on Phineas Gage (the man who had a railway spike through his head) and Sigmund Freud’s case studies, Little Hans and The Rat Man. Case studies are widely used in psychology to provide insight into unusual conditions.

A case study, also known as a case report, is an in depth or intensive study of a single individual or specific group, while a case series is a grouping of similar case studies / case reports together.

A case study / case report can be used in the following instances:

• where there is atypical or abnormal behaviour or development
• an unexplained outcome to treatment
• an emerging disease or condition

The stages of a Case Study / Case Report / Case Series

Which clinical questions does Case Study / Case Report / Case Series best answer?

Emerging conditions, adverse reactions to treatments, atypical / abnormal behaviour, new programs or methods of treatment – all of these can be answered with case studies /case reports / case series. They are generally descriptive studies based on qualitative data e.g. observations, interviews, questionnaires, diaries, personal notes or clinical notes.

What are the advantages and disadvantages to consider when using Case Studies/ Case Reports and Case Series ?

What are the pitfalls to look for.

One pitfall that has occurred in some case studies is where two common conditions/treatments have been linked together with no comprehensive data backing up the conclusion. A hypothetical example could be where high rates of the common cold were associated with suicide when the cohort also suffered from depression.

Critical appraisal tools 

To assist with critically appraising Case studies / Case reports / Case series there are some tools / checklists you can use.

JBI Critical Appraisal Checklist for Case Series

JBI Critical Appraisal Checklist for Case Reports

Real World Examples

Some Psychology case study / case report / case series examples

Capp, G. (2015). Our community, our schools : A case study of program design for school-based mental health services. Children & Schools, 37(4), 241–248. A pilot program to improve school based mental health services was instigated in one elementary school and one middle / high school. The case study followed the program from development through to implementation, documenting each step of the process.

Cowdrey, F. A. & Walz, L. (2015). Exposure therapy for fear of spiders in an adult with learning disabilities: A case report. British Journal of Learning Disabilities, 43(1), 75–82. One person was studied who had completed a pre- intervention and post- intervention questionnaire. From the results of this data the exposure therapy intervention was found to be effective in reducing the phobia. This case report highlighted a therapy that could be used to assist people with learning disabilities who also suffered from phobias.

Li, H. X., He, L., Zhang, C. C., Eisinger, R., Pan, Y. X., Wang, T., . . . Li, D. Y. (2019). Deep brain stimulation in post‐traumatic dystonia: A case series study. CNS Neuroscience & Therapeutics. 1-8. Five patients were included in the case series, all with the same condition. They all received deep brain stimulation but not in the same area of the brain. Baseline and last follow up visit were assessed with the same rating scale.

References and Further Reading  

Greenhalgh, T. (2014). How to read a paper: the basics of evidence-based medicine. (5th ed.). New York: Wiley.

Heale, R. & Twycross, A. (2018). What is a case study? Evidence Based Nursing, 21(1), 7-8.

Himmelfarb Health Sciences Library. (2019). Study design 101: case report. Retrieved from https://himmelfarb.gwu.edu/tutorials/studydesign101/casereports.cfm

Hoffmann T., Bennett S., Mar C. D. (2017). Evidence-based practice across the health professions. Chatswood, NSW: Elsevier.

Robinson, O. C., & McAdams, D. P. (2015). Four functional roles for case studies in emerging adulthood research. Emerging Adulthood, 3(6), 413-420.

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The case study approach

Sarah crowe.

1 Division of Primary Care, The University of Nottingham, Nottingham, UK

Kathrin Cresswell

2 Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

Ann Robertson

3 School of Health in Social Science, The University of Edinburgh, Edinburgh, UK

Anthony Avery

Aziz sheikh.

The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.

Introduction

The case study approach is particularly useful to employ when there is a need to obtain an in-depth appreciation of an issue, event or phenomenon of interest, in its natural real-life context. Our aim in writing this piece is to provide insights into when to consider employing this approach and an overview of key methodological considerations in relation to the design, planning, analysis, interpretation and reporting of case studies.

The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt. In research, the conceptually-related case study approach can be used, for example, to describe in detail a patient's episode of care, explore professional attitudes to and experiences of a new policy initiative or service development or more generally to 'investigate contemporary phenomena within its real-life context' [ 1 ]. Based on our experiences of conducting a range of case studies, we reflect on when to consider using this approach, discuss the key steps involved and illustrate, with examples, some of the practical challenges of attaining an in-depth understanding of a 'case' as an integrated whole. In keeping with previously published work, we acknowledge the importance of theory to underpin the design, selection, conduct and interpretation of case studies[ 2 ]. In so doing, we make passing reference to the different epistemological approaches used in case study research by key theoreticians and methodologists in this field of enquiry.

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables ​ Tables1, 1 , ​ ,2, 2 , ​ ,3 3 and ​ and4) 4 ) and those of others to illustrate our discussion[ 3 - 7 ].

Example of a case study investigating the reasons for differences in recruitment rates of minority ethnic people in asthma research[ 3 ]

Example of a case study investigating the process of planning and implementing a service in Primary Care Organisations[ 4 ]

Example of a case study investigating the introduction of the electronic health records[ 5 ]

Example of a case study investigating the formal and informal ways students learn about patient safety[ 6 ]

What is a case study?

A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table ​ (Table5), 5 ), the central tenet being the need to explore an event or phenomenon in depth and in its natural context. It is for this reason sometimes referred to as a "naturalistic" design; this is in contrast to an "experimental" design (such as a randomised controlled trial) in which the investigator seeks to exert control over and manipulate the variable(s) of interest.

Definitions of a case study

Stake's work has been particularly influential in defining the case study approach to scientific enquiry. He has helpfully characterised three main types of case study: intrinsic , instrumental and collective [ 8 ]. An intrinsic case study is typically undertaken to learn about a unique phenomenon. The researcher should define the uniqueness of the phenomenon, which distinguishes it from all others. In contrast, the instrumental case study uses a particular case (some of which may be better than others) to gain a broader appreciation of an issue or phenomenon. The collective case study involves studying multiple cases simultaneously or sequentially in an attempt to generate a still broader appreciation of a particular issue.

These are however not necessarily mutually exclusive categories. In the first of our examples (Table ​ (Table1), 1 ), we undertook an intrinsic case study to investigate the issue of recruitment of minority ethnic people into the specific context of asthma research studies, but it developed into a instrumental case study through seeking to understand the issue of recruitment of these marginalised populations more generally, generating a number of the findings that are potentially transferable to other disease contexts[ 3 ]. In contrast, the other three examples (see Tables ​ Tables2, 2 , ​ ,3 3 and ​ and4) 4 ) employed collective case study designs to study the introduction of workforce reconfiguration in primary care, the implementation of electronic health records into hospitals, and to understand the ways in which healthcare students learn about patient safety considerations[ 4 - 6 ]. Although our study focusing on the introduction of General Practitioners with Specialist Interests (Table ​ (Table2) 2 ) was explicitly collective in design (four contrasting primary care organisations were studied), is was also instrumental in that this particular professional group was studied as an exemplar of the more general phenomenon of workforce redesign[ 4 ].

What are case studies used for?

According to Yin, case studies can be used to explain, describe or explore events or phenomena in the everyday contexts in which they occur[ 1 ]. These can, for example, help to understand and explain causal links and pathways resulting from a new policy initiative or service development (see Tables ​ Tables2 2 and ​ and3, 3 , for example)[ 1 ]. In contrast to experimental designs, which seek to test a specific hypothesis through deliberately manipulating the environment (like, for example, in a randomised controlled trial giving a new drug to randomly selected individuals and then comparing outcomes with controls),[ 9 ] the case study approach lends itself well to capturing information on more explanatory ' how ', 'what' and ' why ' questions, such as ' how is the intervention being implemented and received on the ground?'. The case study approach can offer additional insights into what gaps exist in its delivery or why one implementation strategy might be chosen over another. This in turn can help develop or refine theory, as shown in our study of the teaching of patient safety in undergraduate curricula (Table ​ (Table4 4 )[ 6 , 10 ]. Key questions to consider when selecting the most appropriate study design are whether it is desirable or indeed possible to undertake a formal experimental investigation in which individuals and/or organisations are allocated to an intervention or control arm? Or whether the wish is to obtain a more naturalistic understanding of an issue? The former is ideally studied using a controlled experimental design, whereas the latter is more appropriately studied using a case study design.

Case studies may be approached in different ways depending on the epistemological standpoint of the researcher, that is, whether they take a critical (questioning one's own and others' assumptions), interpretivist (trying to understand individual and shared social meanings) or positivist approach (orientating towards the criteria of natural sciences, such as focusing on generalisability considerations) (Table ​ (Table6). 6 ). Whilst such a schema can be conceptually helpful, it may be appropriate to draw on more than one approach in any case study, particularly in the context of conducting health services research. Doolin has, for example, noted that in the context of undertaking interpretative case studies, researchers can usefully draw on a critical, reflective perspective which seeks to take into account the wider social and political environment that has shaped the case[ 11 ].

Example of epistemological approaches that may be used in case study research

How are case studies conducted?

Here, we focus on the main stages of research activity when planning and undertaking a case study; the crucial stages are: defining the case; selecting the case(s); collecting and analysing the data; interpreting data; and reporting the findings.

Defining the case

Carefully formulated research question(s), informed by the existing literature and a prior appreciation of the theoretical issues and setting(s), are all important in appropriately and succinctly defining the case[ 8 , 12 ]. Crucially, each case should have a pre-defined boundary which clarifies the nature and time period covered by the case study (i.e. its scope, beginning and end), the relevant social group, organisation or geographical area of interest to the investigator, the types of evidence to be collected, and the priorities for data collection and analysis (see Table ​ Table7 7 )[ 1 ]. A theory driven approach to defining the case may help generate knowledge that is potentially transferable to a range of clinical contexts and behaviours; using theory is also likely to result in a more informed appreciation of, for example, how and why interventions have succeeded or failed[ 13 ].

Example of a checklist for rating a case study proposal[ 8 ]

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table ​ (Table3), 3 ), we defined our cases as the NHS Trusts that were receiving the new technology[ 5 ]. Our focus was on how the technology was being implemented. However, if the primary research interest had been on the social and organisational dimensions of implementation, we might have defined our case differently as a grouping of healthcare professionals (e.g. doctors and/or nurses). The precise beginning and end of the case may however prove difficult to define. Pursuing this same example, when does the process of implementation and adoption of an electronic health record system really begin or end? Such judgements will inevitably be influenced by a range of factors, including the research question, theory of interest, the scope and richness of the gathered data and the resources available to the research team.

Selecting the case(s)

The decision on how to select the case(s) to study is a very important one that merits some reflection. In an intrinsic case study, the case is selected on its own merits[ 8 ]. The case is selected not because it is representative of other cases, but because of its uniqueness, which is of genuine interest to the researchers. This was, for example, the case in our study of the recruitment of minority ethnic participants into asthma research (Table ​ (Table1) 1 ) as our earlier work had demonstrated the marginalisation of minority ethnic people with asthma, despite evidence of disproportionate asthma morbidity[ 14 , 15 ]. In another example of an intrinsic case study, Hellstrom et al.[ 16 ] studied an elderly married couple living with dementia to explore how dementia had impacted on their understanding of home, their everyday life and their relationships.

For an instrumental case study, selecting a "typical" case can work well[ 8 ]. In contrast to the intrinsic case study, the particular case which is chosen is of less importance than selecting a case that allows the researcher to investigate an issue or phenomenon. For example, in order to gain an understanding of doctors' responses to health policy initiatives, Som undertook an instrumental case study interviewing clinicians who had a range of responsibilities for clinical governance in one NHS acute hospital trust[ 17 ]. Sampling a "deviant" or "atypical" case may however prove even more informative, potentially enabling the researcher to identify causal processes, generate hypotheses and develop theory.

In collective or multiple case studies, a number of cases are carefully selected. This offers the advantage of allowing comparisons to be made across several cases and/or replication. Choosing a "typical" case may enable the findings to be generalised to theory (i.e. analytical generalisation) or to test theory by replicating the findings in a second or even a third case (i.e. replication logic)[ 1 ]. Yin suggests two or three literal replications (i.e. predicting similar results) if the theory is straightforward and five or more if the theory is more subtle. However, critics might argue that selecting 'cases' in this way is insufficiently reflexive and ill-suited to the complexities of contemporary healthcare organisations.

The selected case study site(s) should allow the research team access to the group of individuals, the organisation, the processes or whatever else constitutes the chosen unit of analysis for the study. Access is therefore a central consideration; the researcher needs to come to know the case study site(s) well and to work cooperatively with them. Selected cases need to be not only interesting but also hospitable to the inquiry [ 8 ] if they are to be informative and answer the research question(s). Case study sites may also be pre-selected for the researcher, with decisions being influenced by key stakeholders. For example, our selection of case study sites in the evaluation of the implementation and adoption of electronic health record systems (see Table ​ Table3) 3 ) was heavily influenced by NHS Connecting for Health, the government agency that was responsible for overseeing the National Programme for Information Technology (NPfIT)[ 5 ]. This prominent stakeholder had already selected the NHS sites (through a competitive bidding process) to be early adopters of the electronic health record systems and had negotiated contracts that detailed the deployment timelines.

It is also important to consider in advance the likely burden and risks associated with participation for those who (or the site(s) which) comprise the case study. Of particular importance is the obligation for the researcher to think through the ethical implications of the study (e.g. the risk of inadvertently breaching anonymity or confidentiality) and to ensure that potential participants/participating sites are provided with sufficient information to make an informed choice about joining the study. The outcome of providing this information might be that the emotive burden associated with participation, or the organisational disruption associated with supporting the fieldwork, is considered so high that the individuals or sites decide against participation.

In our example of evaluating implementations of electronic health record systems, given the restricted number of early adopter sites available to us, we sought purposively to select a diverse range of implementation cases among those that were available[ 5 ]. We chose a mixture of teaching, non-teaching and Foundation Trust hospitals, and examples of each of the three electronic health record systems procured centrally by the NPfIT. At one recruited site, it quickly became apparent that access was problematic because of competing demands on that organisation. Recognising the importance of full access and co-operative working for generating rich data, the research team decided not to pursue work at that site and instead to focus on other recruited sites.

Collecting the data

In order to develop a thorough understanding of the case, the case study approach usually involves the collection of multiple sources of evidence, using a range of quantitative (e.g. questionnaires, audits and analysis of routinely collected healthcare data) and more commonly qualitative techniques (e.g. interviews, focus groups and observations). The use of multiple sources of data (data triangulation) has been advocated as a way of increasing the internal validity of a study (i.e. the extent to which the method is appropriate to answer the research question)[ 8 , 18 - 21 ]. An underlying assumption is that data collected in different ways should lead to similar conclusions, and approaching the same issue from different angles can help develop a holistic picture of the phenomenon (Table ​ (Table2 2 )[ 4 ].

Brazier and colleagues used a mixed-methods case study approach to investigate the impact of a cancer care programme[ 22 ]. Here, quantitative measures were collected with questionnaires before, and five months after, the start of the intervention which did not yield any statistically significant results. Qualitative interviews with patients however helped provide an insight into potentially beneficial process-related aspects of the programme, such as greater, perceived patient involvement in care. The authors reported how this case study approach provided a number of contextual factors likely to influence the effectiveness of the intervention and which were not likely to have been obtained from quantitative methods alone.

In collective or multiple case studies, data collection needs to be flexible enough to allow a detailed description of each individual case to be developed (e.g. the nature of different cancer care programmes), before considering the emerging similarities and differences in cross-case comparisons (e.g. to explore why one programme is more effective than another). It is important that data sources from different cases are, where possible, broadly comparable for this purpose even though they may vary in nature and depth.

Analysing, interpreting and reporting case studies

Making sense and offering a coherent interpretation of the typically disparate sources of data (whether qualitative alone or together with quantitative) is far from straightforward. Repeated reviewing and sorting of the voluminous and detail-rich data are integral to the process of analysis. In collective case studies, it is helpful to analyse data relating to the individual component cases first, before making comparisons across cases. Attention needs to be paid to variations within each case and, where relevant, the relationship between different causes, effects and outcomes[ 23 ]. Data will need to be organised and coded to allow the key issues, both derived from the literature and emerging from the dataset, to be easily retrieved at a later stage. An initial coding frame can help capture these issues and can be applied systematically to the whole dataset with the aid of a qualitative data analysis software package.

The Framework approach is a practical approach, comprising of five stages (familiarisation; identifying a thematic framework; indexing; charting; mapping and interpretation) , to managing and analysing large datasets particularly if time is limited, as was the case in our study of recruitment of South Asians into asthma research (Table ​ (Table1 1 )[ 3 , 24 ]. Theoretical frameworks may also play an important role in integrating different sources of data and examining emerging themes. For example, we drew on a socio-technical framework to help explain the connections between different elements - technology; people; and the organisational settings within which they worked - in our study of the introduction of electronic health record systems (Table ​ (Table3 3 )[ 5 ]. Our study of patient safety in undergraduate curricula drew on an evaluation-based approach to design and analysis, which emphasised the importance of the academic, organisational and practice contexts through which students learn (Table ​ (Table4 4 )[ 6 ].

Case study findings can have implications both for theory development and theory testing. They may establish, strengthen or weaken historical explanations of a case and, in certain circumstances, allow theoretical (as opposed to statistical) generalisation beyond the particular cases studied[ 12 ]. These theoretical lenses should not, however, constitute a strait-jacket and the cases should not be "forced to fit" the particular theoretical framework that is being employed.

When reporting findings, it is important to provide the reader with enough contextual information to understand the processes that were followed and how the conclusions were reached. In a collective case study, researchers may choose to present the findings from individual cases separately before amalgamating across cases. Care must be taken to ensure the anonymity of both case sites and individual participants (if agreed in advance) by allocating appropriate codes or withholding descriptors. In the example given in Table ​ Table3, 3 , we decided against providing detailed information on the NHS sites and individual participants in order to avoid the risk of inadvertent disclosure of identities[ 5 , 25 ].

What are the potential pitfalls and how can these be avoided?

The case study approach is, as with all research, not without its limitations. When investigating the formal and informal ways undergraduate students learn about patient safety (Table ​ (Table4), 4 ), for example, we rapidly accumulated a large quantity of data. The volume of data, together with the time restrictions in place, impacted on the depth of analysis that was possible within the available resources. This highlights a more general point of the importance of avoiding the temptation to collect as much data as possible; adequate time also needs to be set aside for data analysis and interpretation of what are often highly complex datasets.

Case study research has sometimes been criticised for lacking scientific rigour and providing little basis for generalisation (i.e. producing findings that may be transferable to other settings)[ 1 ]. There are several ways to address these concerns, including: the use of theoretical sampling (i.e. drawing on a particular conceptual framework); respondent validation (i.e. participants checking emerging findings and the researcher's interpretation, and providing an opinion as to whether they feel these are accurate); and transparency throughout the research process (see Table ​ Table8 8 )[ 8 , 18 - 21 , 23 , 26 ]. Transparency can be achieved by describing in detail the steps involved in case selection, data collection, the reasons for the particular methods chosen, and the researcher's background and level of involvement (i.e. being explicit about how the researcher has influenced data collection and interpretation). Seeking potential, alternative explanations, and being explicit about how interpretations and conclusions were reached, help readers to judge the trustworthiness of the case study report. Stake provides a critique checklist for a case study report (Table ​ (Table9 9 )[ 8 ].

Potential pitfalls and mitigating actions when undertaking case study research

Stake's checklist for assessing the quality of a case study report[ 8 ]

Conclusions

The case study approach allows, amongst other things, critical events, interventions, policy developments and programme-based service reforms to be studied in detail in a real-life context. It should therefore be considered when an experimental design is either inappropriate to answer the research questions posed or impossible to undertake. Considering the frequency with which implementations of innovations are now taking place in healthcare settings and how well the case study approach lends itself to in-depth, complex health service research, we believe this approach should be more widely considered by researchers. Though inherently challenging, the research case study can, if carefully conceptualised and thoughtfully undertaken and reported, yield powerful insights into many important aspects of health and healthcare delivery.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

AS conceived this article. SC, KC and AR wrote this paper with GH, AA and AS all commenting on various drafts. SC and AS are guarantors.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2288/11/100/prepub

Acknowledgements

We are grateful to the participants and colleagues who contributed to the individual case studies that we have drawn on. This work received no direct funding, but it has been informed by projects funded by Asthma UK, the NHS Service Delivery Organisation, NHS Connecting for Health Evaluation Programme, and Patient Safety Research Portfolio. We would also like to thank the expert reviewers for their insightful and constructive feedback. Our thanks are also due to Dr. Allison Worth who commented on an earlier draft of this manuscript.

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How to write a case study — examples, templates, and tools

It’s a marketer’s job to communicate the effectiveness of a product or service to potential and current customers to convince them to buy and keep business moving. One of the best methods for doing this is to share success stories that are relatable to prospects and customers based on their pain points, experiences, and overall needs.

That’s where case studies come in. Case studies are an essential part of a content marketing plan. These in-depth stories of customer experiences are some of the most effective at demonstrating the value of a product or service. Yet many marketers don’t use them, whether because of their regimented formats or the process of customer involvement and approval.

A case study is a powerful tool for showcasing your hard work and the success your customer achieved. But writing a great case study can be difficult if you’ve never done it before or if it’s been a while. This guide will show you how to write an effective case study and provide real-world examples and templates that will keep readers engaged and support your business.

In this article, you’ll learn:

What is a case study?

How to write a case study, case study templates, case study examples, case study tools.

A case study is the detailed story of a customer’s experience with a product or service that demonstrates their success and often includes measurable outcomes. Case studies are used in a range of fields and for various reasons, from business to academic research. They’re especially impactful in marketing as brands work to convince and convert consumers with relatable, real-world stories of actual customer experiences.

The best case studies tell the story of a customer’s success, including the steps they took, the results they achieved, and the support they received from a brand along the way. To write a great case study, you need to:

• Celebrate the customer and make them — not a product or service — the star of the story.
• Craft the story with specific audiences or target segments in mind so that the story of one customer will be viewed as relatable and actionable for another customer.
• Write copy that is easy to read and engaging so that readers will gain the insights and messages intended.
• Follow a standardized format that includes all of the essentials a potential customer would find interesting and useful.
• Support all of the claims for success made in the story with data in the forms of hard numbers and customer statements.

Case studies are a type of review but more in depth, aiming to show — rather than just tell — the positive experiences that customers have with a brand. Notably, 89% of consumers read reviews before deciding to buy, and 79% view case study content as part of their purchasing process. When it comes to B2B sales, 52% of buyers rank case studies as an important part of their evaluation process.

Telling a brand story through the experience of a tried-and-true customer matters. The story is relatable to potential new customers as they imagine themselves in the shoes of the company or individual featured in the case study. Showcasing previous customers can help new ones see themselves engaging with your brand in the ways that are most meaningful to them.

Besides sharing the perspective of another customer, case studies stand out from other content marketing forms because they are based on evidence. Whether pulling from client testimonials or data-driven results, case studies tend to have more impact on new business because the story contains information that is both objective (data) and subjective (customer experience) — and the brand doesn’t sound too self-promotional.

Case studies are unique in that there’s a fairly standardized format for telling a customer’s story. But that doesn’t mean there isn’t room for creativity. It’s all about making sure that teams are clear on the goals for the case study — along with strategies for supporting content and channels — and understanding how the story fits within the framework of the company’s overall marketing goals.

Here are the basic steps to writing a good case study.

1. Identify your goal

Start by defining exactly who your case study will be designed to help. Case studies are about specific instances where a company works with a customer to achieve a goal. Identify which customers are likely to have these goals, as well as other needs the story should cover to appeal to them.

The answer is often found in one of the buyer personas that have been constructed as part of your larger marketing strategy. This can include anything from new leads generated by the marketing team to long-term customers that are being pressed for cross-sell opportunities. In all of these cases, demonstrating value through a relatable customer success story can be part of the solution to conversion.

2. Choose your client or subject

Who you highlight matters. Case studies tie brands together that might otherwise not cross paths. A writer will want to ensure that the highlighted customer aligns with their own company’s brand identity and offerings. Look for a customer with positive name recognition who has had great success with a product or service and is willing to be an advocate.

The client should also match up with the identified target audience. Whichever company or individual is selected should be a reflection of other potential customers who can see themselves in similar circumstances, having the same problems and possible solutions.

Some of the most compelling case studies feature customers who:

• Switch from one product or service to another while naming competitors that missed the mark.
• Experience measurable results that are relatable to others in a specific industry.
• Represent well-known brands and recognizable names that are likely to compel action.
• Advocate for a product or service as a champion and are well-versed in its advantages.

Whoever or whatever customer is selected, marketers must ensure they have the permission of the company involved before getting started. Some brands have strict review and approval procedures for any official marketing or promotional materials that include their name. Acquiring those approvals in advance will prevent any miscommunication or wasted effort if there is an issue with their legal or compliance teams.

3. Conduct research and compile data

Substantiating the claims made in a case study — either by the marketing team or customers themselves — adds validity to the story. To do this, include data and feedback from the client that defines what success looks like. This can be anything from demonstrating return on investment (ROI) to a specific metric the customer was striving to improve. Case studies should prove how an outcome was achieved and show tangible results that indicate to the customer that your solution is the right one.

This step could also include customer interviews. Make sure that the people being interviewed are key stakeholders in the purchase decision or deployment and use of the product or service that is being highlighted. Content writers should work off a set list of questions prepared in advance. It can be helpful to share these with the interviewees beforehand so they have time to consider and craft their responses. One of the best interview tactics to keep in mind is to ask questions where yes and no are not natural answers. This way, your subject will provide more open-ended responses that produce more meaningful content.

Whether pulling from client testimonials or data-driven results, case studies tend to have more impact on new business because the story contains information that is both objective (data) and subjective (customer experience) — and the brand doesn’t sound too self-promotional.

4. Choose the right format

There are a number of different ways to format a case study. Depending on what you hope to achieve, one style will be better than another. However, there are some common elements to include, such as:

• An engaging headline
• A subject and customer introduction
• The unique challenge or challenges the customer faced
• The solution the customer used to solve the problem
• The results achieved
• Data and statistics to back up claims of success
• A strong call to action (CTA) to engage with the vendor

It’s also important to note that while case studies are traditionally written as stories, they don’t have to be in a written format. Some companies choose to get more creative with their case studies and produce multimedia content, depending on their audience and objectives. Case study formats can include traditional print stories, interactive web or social content, data-heavy infographics, professionally shot videos, podcasts, and more.

5. Write your case study

We’ll go into more detail later about how exactly to write a case study, including templates and examples. Generally speaking, though, there are a few things to keep in mind when writing your case study.

• Be clear and concise. Readers want to get to the point of the story quickly and easily, and they’ll be looking to see themselves reflected in the story right from the start.
• Provide a big picture. Always make sure to explain who the client is, their goals, and how they achieved success in a short introduction to engage the reader.
• Construct a clear narrative. Stick to the story from the perspective of the customer and what they needed to solve instead of just listing product features or benefits.
• Leverage graphics. Incorporating infographics, charts, and sidebars can be a more engaging and eye-catching way to share key statistics and data in readable ways.
• Offer the right amount of detail. Most case studies are one or two pages with clear sections that a reader can skim to find the information most important to them.
• Include data to support claims. Show real results — both facts and figures and customer quotes — to demonstrate credibility and prove the solution works.

6. Promote your story

Marketers have a number of options for distribution of a freshly minted case study. Many brands choose to publish case studies on their website and post them on social media. This can help support SEO and organic content strategies while also boosting company credibility and trust as visitors see that other businesses have used the product or service.

Marketers are always looking for quality content they can use for lead generation. Consider offering a case study as gated content behind a form on a landing page or as an offer in an email message. One great way to do this is to summarize the content and tease the full story available for download after the user takes an action.

Sales teams can also leverage case studies, so be sure they are aware that the assets exist once they’re published. Especially when it comes to larger B2B sales, companies often ask for examples of similar customer challenges that have been solved.

Case studies are a vital tool for any marketing team as they enable you to demonstrate the value of your company’s products and services to others.

Now that you’ve learned a bit about case studies and what they should include, you may be wondering how to start creating great customer story content. Here are a couple of templates you can use to structure your case study.

Template 1 — Challenge-solution-result format

• Start with an engaging title. This should be fewer than 70 characters long for SEO best practices. One of the best ways to approach the title is to include the customer’s name and a hint at the challenge they overcame in the end.
• Create an introduction. Lead with an explanation as to who the customer is, the need they had, and the opportunity they found with a specific product or solution. Writers can also suggest the success the customer experienced with the solution they chose.
• Present the challenge. This should be several paragraphs long and explain the problem the customer faced and the issues they were trying to solve. Details should tie into the company’s products and services naturally. This section needs to be the most relatable to the reader so they can picture themselves in a similar situation.
• Share the solution. Explain which product or service offered was the ideal fit for the customer and why. Feel free to delve into their experience setting up, purchasing, and onboarding the solution.
• Explain the results. Demonstrate the impact of the solution they chose by backing up their positive experience with data. Fill in with customer quotes and tangible, measurable results that show the effect of their choice.
• Ask for action. Include a CTA at the end of the case study that invites readers to reach out for more information, try a demo, or learn more — to nurture them further in the marketing pipeline. What you ask of the reader should tie directly into the goals that were established for the case study in the first place.

Template 2 — Data-driven format

• Start with an engaging title. Be sure to include a statistic or data point in the first 70 characters. Again, it’s best to include the customer’s name as part of the title.
• Create an overview. Share the customer’s background and a short version of the challenge they faced. Present the reason a particular product or service was chosen, and feel free to include quotes from the customer about their selection process.
• Present data point 1. Isolate the first metric that the customer used to define success and explain how the product or solution helped to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 2. Isolate the second metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 3. Isolate the final metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Summarize the results. Reiterate the fact that the customer was able to achieve success thanks to a specific product or service. Include quotes and statements that reflect customer satisfaction and suggest they plan to continue using the solution.
• Ask for action. Include a CTA at the end of the case study that asks readers to reach out for more information, try a demo, or learn more — to further nurture them in the marketing pipeline. Again, remember that this is where marketers can look to convert their content into action with the customer.

While templates are helpful, seeing a case study in action can also be a great way to learn. Here are some examples of how Adobe customers have experienced success.

Juniper Networks

One example is the Adobe and Juniper Networks case study , which puts the reader in the customer’s shoes. The beginning of the story quickly orients the reader so that they know exactly who the article is about and what they were trying to achieve. Solutions are outlined in a way that shows Adobe Experience Manager is the best choice and a natural fit for the customer. Along the way, quotes from the client are incorporated to help add validity to the statements. The results in the case study are conveyed with clear evidence of scale and volume using tangible data.

The story of Lenovo’s journey with Adobe is one that spans years of planning, implementation, and rollout. The Lenovo case study does a great job of consolidating all of this into a relatable journey that other enterprise organizations can see themselves taking, despite the project size. This case study also features descriptive headers and compelling visual elements that engage the reader and strengthen the content.

Tata Consulting

When it comes to using data to show customer results, this case study does an excellent job of conveying details and numbers in an easy-to-digest manner. Bullet points at the start break up the content while also helping the reader understand exactly what the case study will be about. Tata Consulting used Adobe to deliver elevated, engaging content experiences for a large telecommunications client of its own — an objective that’s relatable for a lot of companies.

Case studies are a vital tool for any marketing team as they enable you to demonstrate the value of your company’s products and services to others. They help marketers do their job and add credibility to a brand trying to promote its solutions by using the experiences and stories of real customers.

When you’re ready to get started with a case study:

• Think about a few goals you’d like to accomplish with your content.
• Make a list of successful clients that would be strong candidates for a case study.
• Reach out to the client to get their approval and conduct an interview.
• Gather the data to present an engaging and effective customer story.

Adobe can help

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Qualitative Research Designs

Case study design, using case study design in the applied doctoral experience (ade), applicability of case study design to applied problem of practice, case study design references.

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The field of qualitative research there are a number of research designs (also referred to as “traditions” or “genres”), including case study, phenomenology, narrative inquiry, action research, ethnography, grounded theory, as well as a number of critical genres including Feminist theory, indigenous research, critical race theory and cultural studies. The choice of research design is directly tied to and must be aligned with your research problem and purpose. As Bloomberg & Volpe (2019) explain:

Choice of research design is directly tied to research problem and purpose. As the researcher, you actively create the link among problem, purpose, and design through a process of reflecting on problem and purpose, focusing on researchable questions, and considering how to best address these questions. Thinking along these lines affords a research study methodological congruence (p. 38).

Case study is an in-depth exploration from multiple perspectives of a bounded social phenomenon, be this a social system such as a program, event, institution, organization, or community (Stake, 1995, 2005; Yin, 2018). Case study is employed across disciplines, including education, health care, social work, sociology, and organizational studies. The purpose is to generate understanding and deep insights to inform professional practice, policy development, and community or social action (Bloomberg 2018).

Yin (2018) and Stake (1995, 2005), two of the key proponents of case study methodology, use different terms to describe case studies. Yin categorizes case studies as exploratory or descriptive . The former is used to explore those situations in which the intervention being evaluated has no clear single set of outcomes. The latter is used to describe an intervention or phenomenon and the real-life context in which it occurred. Stake identifies case studies as intrinsic or instrumental , and he proposes that a primary distinction in designing case studies is between single and multiple (or collective) case study designs. A single case study may be an instrumental case study (research focuses on an issue or concern in one bounded case) or an intrinsic case study (the focus is on the case itself because the case presents a unique situation). A longitudinal case study design is chosen when the researcher seeks to examine the same single case at two or more different points in time or to capture trends over time. A multiple case study design is used when a researcher seeks to determine the prevalence or frequency of a particular phenomenon. This approach is useful when cases are used for purposes of a cross-case analysis in order to compare, contrast, and synthesize perspectives regarding the same issue. The focus is on the analysis of diverse cases to determine how these confirm the findings within or between cases, or call the findings into question.

Case study affords significant interaction with research participants, providing an in-depth picture of the phenomenon (Bloomberg & Volpe, 2019). Research is extensive, drawing on multiple methods of data collection, and involves multiple data sources. Triangulation is critical in attempting to obtain an in-depth understanding of the phenomenon under study and adds rigor, breadth, and depth to the study and provides corroborative evidence of the data obtained. Analysis of data can be holistic or embedded—that is, dealing with the whole or parts of the case (Yin, 2018). With multiple cases the typical analytic strategy is to provide detailed description of themes within each case (within-case analysis), followed by thematic analysis across cases (cross-case analysis), providing insights regarding how individual cases are comparable along important dimensions. Research culminates in the production of a detailed description of a setting and its participants, accompanied by an analysis of the data for themes or patterns (Stake, 1995, 2005; Yin, 2018). In addition to thick, rich description, the researcher’s interpretations, conclusions, and recommendations contribute to the reader’s overall understanding of the case study.

Analysis of findings should show that the researcher has attended to all the data, should address the most significant aspects of the case, and should demonstrate familiarity with the prevailing thinking and discourse about the topic. The goal of case study design (as with all qualitative designs) is not generalizability but rather transferability —that is, how (if at all) and in what ways understanding and knowledge can be applied in similar contexts and settings. The qualitative researcher attempts to address the issue of transferability by way of thick, rich description that will provide the basis for a case or cases to have relevance and potential application across a broader context.

Qualitative research methods ask the questions of "what" and "how" a phenomenon is understood in a real-life context (Bloomberg & Volpe, 2019). In the education field, qualitative research methods uncover educational experiences and practices because qualitative research allows the researcher to reveal new knowledge and understanding. Moreover, qualitative descriptive case studies describe, analyze and interpret events that explain the reasoning behind specific phenomena (Bloomberg, 2018). As such, case study design can be the foundation for a rigorous study within the Applied Doctoral Experience (ADE).

Case study design is an appropriate research design to consider when conceptualizing and conducting a dissertation research study that is based on an applied problem of practice with inherent real-life educational implications. Case study researchers study current, real-life cases that are in progress so that they can gather accurate information that is current. This fits well with the ADE program, as students are typically exploring a problem of practice. Because of the flexibility of the methods used, a descriptive design provides the researcher with the opportunity to choose data collection methods that are best suited to a practice-based research purpose, and can include individual interviews, focus groups, observation, surveys, and critical incident questionnaires. Methods are triangulated to contribute to the study’s trustworthiness. In selecting the set of data collection methods, it is important that the researcher carefully consider the alignment between research questions and the type of data that is needed to address these. Each data source is one piece of the “puzzle,” that contributes to the researcher’s holistic understanding of a phenomenon. The various strands of data are woven together holistically to promote a deeper understanding of the case and its application to an educationally-based problem of practice.

Research studies within the Applied Doctoral Experience (ADE) will be practical in nature and focus on problems and issues that inform educational practice.  Many of the types of studies that fall within the ADE framework are exploratory, and align with case study design. Case study design fits very well with applied problems related to educational practice, as the following set of examples illustrate:

Elementary Bilingual Education Teachers’ Self-Efficacy in Teaching English Language Learners: A Qualitative Case Study

The problem to be addressed in the proposed study is that some elementary bilingual education teachers’ beliefs about their lack of preparedness to teach the English language may negatively impact the language proficiency skills of Hispanic ELLs (Ernst-Slavit & Wenger, 2016; Fuchs et al., 2018; Hoque, 2016). The purpose of the proposed qualitative descriptive case study was to explore the perspectives and experiences of elementary bilingual education teachers regarding their perceived lack of preparedness to teach the English language and how this may impact the language proficiency of Hispanic ELLs.

Exploring Minority Teachers Experiences Pertaining to their Value in Education: A Single Case Study of Teachers in New York City

The problem is that minority K-12 teachers are underrepresented in the United States, with research indicating that school leaders and teachers in schools that are populated mainly by black students, staffed mostly by white teachers who may be unprepared to deal with biases and stereotypes that are ingrained in schools (Egalite, Kisida, & Winters, 2015; Milligan & Howley, 2015). The purpose of this qualitative exploratory single case study was to develop a clearer understanding of minority teachers’ experiences concerning the under-representation of minority K-12 teachers in urban school districts in the United States since there are so few of them.

Exploring the Impact of an Urban Teacher Residency Program on Teachers’ Cultural Intelligence: A Qualitative Case Study

The problem to be addressed by this case study is that teacher candidates often report being unprepared and ill-equipped to effectively educate culturally diverse students (Skepple, 2015; Beutel, 2018). The purpose of this study was to explore and gain an in-depth understanding of the perceived impact of an urban teacher residency program in urban Iowa on teachers’ cultural competence using the cultural intelligence (CQ) framework (Earley & Ang, 2003).

Qualitative Case Study that Explores Self-Efficacy and Mentorship on Women in Academic Administrative Leadership Roles

The problem was that female school-level administrators might be less likely to experience mentorship, thereby potentially decreasing their self-efficacy (Bing & Smith, 2019; Brown, 2020; Grant, 2021). The purpose of this case study was to determine to what extent female school-level administrators in the United States who had a mentor have a sense of self-efficacy and to examine the relationship between mentorship and self-efficacy.

Suburban Teacher and Administrator Perceptions of Culturally Responsive Teaching to Promote Connectedness in Students of Color: A Qualitative Case Study

The problem to be addressed in this study is the racial discrimination experienced by students of color in suburban schools and the resulting negative school experience (Jara & Bloomsbury, 2020; Jones, 2019; Kohli et al., 2017; Wandix-White, 2020). The purpose of this case study is to explore how culturally responsive practices can counteract systemic racism and discrimination in suburban schools thereby meeting the needs of students of color by creating positive learning experiences. 

As you can see, all of these studies were well suited to qualitative case study design. In each of these studies, the applied research problem and research purpose were clearly grounded in educational practice as well as directly aligned with qualitative case study methodology. In the Applied Doctoral Experience (ADE), you will be focused on addressing or resolving an educationally relevant research problem of practice. As such, your case study, with clear boundaries, will be one that centers on a real-life authentic problem in your field of practice that you believe is in need of resolution or improvement, and that the outcome thereof will be educationally valuable.

Bloomberg, L. D. (2018). Case study method. In B. B. Frey (Ed.), The SAGE Encyclopedia of educational research, measurement, and evaluation (pp. 237–239). SAGE. https://go.openathens.net/redirector/nu.edu?url=https%3A%2F%2Fmethods.sagepub.com%2FReference%2Fthe-sage-encyclopedia-of-educational-research-measurement-and-evaluation%2Fi4294.xml

Bloomberg, L. D. & Volpe, M. (2019). Completing your qualitative dissertation: A road map from beginning to end . (4th Ed.). SAGE.

Stake, R. E. (1995). The art of case study research. SAGE.

Stake, R. E. (2005). Qualitative case studies. In N. K. Denzin and Y. S. Lincoln (Eds.), The SAGE handbook of qualitative research (3rd ed., pp. 443–466). SAGE.

Yin, R. (2018). Case study research and applications: Designs and methods. SAGE.

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All You Wanted to Know About How to Write a Case Study

What do you study in your college? If you are a psychology, sociology, or anthropology student, we bet you might be familiar with what a case study is. This research method is used to study a certain person, group, or situation. In this guide from our dissertation writing service , you will learn how to write a case study professionally, from researching to citing sources properly. Also, we will explore different types of case studies and show you examples — so that you won’t have any other questions left.

What Is a Case Study?

A case study is a subcategory of research design which investigates problems and offers solutions. Case studies can range from academic research studies to corporate promotional tools trying to sell an idea—their scope is quite vast.

What Is the Difference Between a Research Paper and a Case Study?

While research papers turn the reader’s attention to a certain problem, case studies go even further. Case study guidelines require students to pay attention to details, examining issues closely and in-depth using different research methods. For example, case studies may be used to examine court cases if you study Law, or a patient's health history if you study Medicine. Case studies are also used in Marketing, which are thorough, empirically supported analysis of a good or service's performance. Well-designed case studies can be valuable for prospective customers as they can identify and solve the potential customers pain point.

Case studies involve a lot of storytelling – they usually examine particular cases for a person or a group of people. This method of research is very helpful, as it is very practical and can give a lot of hands-on information. Most commonly, the length of the case study is about 500-900 words, which is much less than the length of an average research paper.

The structure of a case study is very similar to storytelling. It has a protagonist or main character, which in your case is actually a problem you are trying to solve. You can use the system of 3 Acts to make it a compelling story. It should have an introduction, rising action, a climax where transformation occurs, falling action, and a solution.

Here is a rough formula for you to use in your case study:

Problem (Act I): > Solution (Act II) > Result (Act III) > Conclusion.

Types of Case Studies

The purpose of a case study is to provide detailed reports on an event, an institution, a place, future customers, or pretty much anything. There are a few common types of case study, but the type depends on the topic. The following are the most common domains where case studies are needed:

• Historical case studies are great to learn from. Historical events have a multitude of source info offering different perspectives. There are always modern parallels where these perspectives can be applied, compared, and thoroughly analyzed.
• Problem-oriented case studies are usually used for solving problems. These are often assigned as theoretical situations where you need to immerse yourself in the situation to examine it. Imagine you’re working for a startup and you’ve just noticed a significant flaw in your product’s design. Before taking it to the senior manager, you want to do a comprehensive study on the issue and provide solutions. On a greater scale, problem-oriented case studies are a vital part of relevant socio-economic discussions.
• Cumulative case studies collect information and offer comparisons. In business, case studies are often used to tell people about the value of a product.
• Critical case studies explore the causes and effects of a certain case.
• Illustrative case studies describe certain events, investigating outcomes and lessons learned.

Case Study Format

The case study format is typically made up of eight parts:

• Executive Summary. Explain what you will examine in the case study. Write an overview of the field you’re researching. Make a thesis statement and sum up the results of your observation in a maximum of 2 sentences.
• Background. Provide background information and the most relevant facts. Isolate the issues.
• Case Evaluation. Isolate the sections of the study you want to focus on. In it, explain why something is working or is not working.
• Proposed Solutions. Offer realistic ways to solve what isn’t working or how to improve its current condition. Explain why these solutions work by offering testable evidence.
• Conclusion. Summarize the main points from the case evaluations and proposed solutions. 6. Recommendations. Talk about the strategy that you should choose. Explain why this choice is the most appropriate.
• Implementation. Explain how to put the specific strategies into action.
• References. Provide all the citations.

How to Write a Case Study

Let's discover how to write a case study.

Setting Up the Research

When writing a case study, remember that research should always come first. Reading many different sources and analyzing other points of view will help you come up with more creative solutions. You can also conduct an actual interview to thoroughly investigate the customer story that you'll need for your case study. Including all of the necessary research, writing a case study may take some time. The research process involves doing the following:

• Define your objective. Explain the reason why you’re presenting your subject. Figure out where you will feature your case study; whether it is written, on video, shown as an infographic, streamed as a podcast, etc.
• Determine who will be the right candidate for your case study. Get permission, quotes, and other features that will make your case study effective. Get in touch with your candidate to see if they approve of being part of your work. Study that candidate’s situation and note down what caused it.
• Identify which various consequences could result from the situation. Follow these guidelines on how to start a case study: surf the net to find some general information you might find useful.
• Make a list of credible sources and examine them. Seek out important facts and highlight problems. Always write down your ideas and make sure to brainstorm.
• Focus on several key issues – why they exist, and how they impact your research subject. Think of several unique solutions. Draw from class discussions, readings, and personal experience. When writing a case study, focus on the best solution and explore it in depth. After having all your research in place, writing a case study will be easy. You may first want to check the rubric and criteria of your assignment for the correct case study structure.

Read Also: 'CREDIBLE SOURCES: WHAT ARE THEY?'

Although your instructor might be looking at slightly different criteria, every case study rubric essentially has the same standards. Your professor will want you to exhibit 8 different outcomes:

• Correctly identify the concepts, theories, and practices in the discipline.
• Identify the relevant theories and principles associated with the particular study.
• Evaluate legal and ethical principles and apply them to your decision-making.
• Recognize the global importance and contribution of your case.
• Construct a coherent summary and explanation of the study.
• Demonstrate analytical and critical-thinking skills.
• Explain the interrelationships between the environment and nature.
• Integrate theory and practice of the discipline within the analysis.

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Case Study Outline

Let's look at the structure of an outline based on the issue of the alcoholic addiction of 30 people.

Introduction

• Statement of the issue: Alcoholism is a disease rather than a weakness of character.
• Presentation of the problem: Alcoholism is affecting more than 14 million people in the USA, which makes it the third most common mental illness there.
• Explanation of the terms: In the past, alcoholism was commonly referred to as alcohol dependence or alcohol addiction. Alcoholism is now the more severe stage of this addiction in the disorder spectrum.
• Hypotheses: Drinking in excess can lead to the use of other drugs.
• Importance of your story: How the information you present can help people with their addictions.
• Background of the story: Include an explanation of why you chose this topic.
• Presentation of analysis and data: Describe the criteria for choosing 30 candidates, the structure of the interview, and the outcomes.
• Strong argument 1: ex. X% of candidates dealing with anxiety and depression...
• Strong argument 2: ex. X amount of people started drinking by their mid-teens.
• Strong argument 3: ex. X% of respondents’ parents had issues with alcohol.
• Concluding statement: I have researched if alcoholism is a disease and found out that…
• Recommendations: Ways and actions for preventing alcohol use.

Writing a Case Study Draft

After you’ve done your case study research and written the outline, it’s time to focus on the draft. In a draft, you have to develop and write your case study by using: the data which you collected throughout the research, interviews, and the analysis processes that were undertaken. Follow these rules for the draft:

• Your draft should contain at least 4 sections: an introduction; a body where you should include background information, an explanation of why you decided to do this case study, and a presentation of your main findings; a conclusion where you present data; and references.
• In the introduction, you should set the pace very clearly. You can even raise a question or quote someone you interviewed in the research phase. It must provide adequate background information on the topic. The background may include analyses of previous studies on your topic. Include the aim of your case here as well. Think of it as a thesis statement. The aim must describe the purpose of your work—presenting the issues that you want to tackle. Include background information, such as photos or videos you used when doing the research.
• Describe your unique research process, whether it was through interviews, observations, academic journals, etc. The next point includes providing the results of your research. Tell the audience what you found out. Why is this important, and what could be learned from it? Discuss the real implications of the problem and its significance in the world.
• Include quotes and data (such as findings, percentages, and awards). This will add a personal touch and better credibility to the case you present. Explain what results you find during your interviews in regards to the problem and how it developed. Also, write about solutions which have already been proposed by other people who have already written about this case.
• At the end of your case study, you should offer possible solutions, but don’t worry about solving them yourself.

Use Data to Illustrate Key Points in Your Case Study

Even though your case study is a story, it should be based on evidence. Use as much data as possible to illustrate your point. Without the right data, your case study may appear weak and the readers may not be able to relate to your issue as much as they should. Let's see the examples from essay writing service :

‍ With data: Alcoholism is affecting more than 14 million people in the USA, which makes it the third most common mental illness there. Without data: A lot of people suffer from alcoholism in the United States.

Try to include as many credible sources as possible. You may have terms or sources that could be hard for other cultures to understand. If this is the case, you should include them in the appendix or Notes for the Instructor or Professor.

Finalizing the Draft: Checklist

After you finish drafting your case study, polish it up by answering these ‘ask yourself’ questions and think about how to end your case study:

• Check that you follow the correct case study format, also in regards to text formatting.
• Check that your work is consistent with its referencing and citation style.
• Micro-editing — check for grammar and spelling issues.
• Macro-editing — does ‘the big picture’ come across to the reader? Is there enough raw data, such as real-life examples or personal experiences? Have you made your data collection process completely transparent? Does your analysis provide a clear conclusion, allowing for further research and practice?

Problems to avoid:

• Overgeneralization – Do not go into further research that deviates from the main problem.
• Failure to Document Limitations – Just as you have to clearly state the limitations of a general research study, you must describe the specific limitations inherent in the subject of analysis.
• Failure to Extrapolate All Possible Implications – Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings.

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How to Create a Title Page and Cite a Case Study

Let's see how to create an awesome title page.

Your title page depends on the prescribed citation format. The title page should include:

• A title that attracts some attention and describes your study
• The title should have the words “case study” in it
• The title should range between 5-9 words in length
• Your name and contact information
• Your finished paper should be only 500 to 1,500 words in length. With this type of assignment, write effectively and avoid fluff.

Here is a template for the APA and MLA format title page:

There are some cases when you need to cite someone else's study in your own one – therefore, you need to master how to cite a case study. A case study is like a research paper when it comes to citations. You can cite it like you cite a book, depending on what style you need.

Citation Example in MLA ‍ Hill, Linda, Tarun Khanna, and Emily A. Stecker. HCL Technologies. Boston: Harvard Business Publishing, 2008. Print.

Citation Example in APA ‍ Hill, L., Khanna, T., & Stecker, E. A. (2008). HCL Technologies. Boston: Harvard Business Publishing.

Citation Example in Chicago Hill, Linda, Tarun Khanna, and Emily A. Stecker. HCL Technologies.

Case Study Examples

To give you an idea of a professional case study example, we gathered and linked some below.

Eastman Kodak Case Study

Case Study Example: Audi Trains Mexican Autoworkers in Germany

To conclude, a case study is one of the best methods of getting an overview of what happened to a person, a group, or a situation in practice. It allows you to have an in-depth glance at the real-life problems that businesses, healthcare industry, criminal justice, etc. may face. This insight helps us look at such situations in a different light. This is because we see scenarios that we otherwise would not, without necessarily being there. If you need custom essays , try our research paper writing services .

Get Help Form Qualified Writers

Crafting a case study is not easy. You might want to write one of high quality, but you don’t have the time or expertise. If you’re having trouble with your case study, help with essay request - we'll help. EssayPro writers have read and written countless case studies and are experts in endless disciplines. Request essay writing, editing, or proofreading assistance from our custom case study writing service , and all of your worries will be gone.

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

Study designs are the set of methods and procedures used to collect and analyze data in a study.

Broadly speaking, there are 2 types of study designs: descriptive studies and analytical studies.

Descriptive studies

• Describes specific characteristics in a population of interest
• The most common forms are case reports and case series
• In a case report, we discuss our experience with the patient’s symptoms, signs, diagnosis, and treatment
• In a case series, several patients with similar experiences are grouped.

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

Observational studies are studies that we conduct without any intervention or experiment. In those studies, we purely observe the outcomes.  On the other hand, in experimental studies, we conduct experiments and interventions.

Observational studies

Observational studies include many subtypes. Below, I will discuss the most common designs.

Cross-sectional study:

• This design is transverse where we take a specific sample at a specific time without any follow-up
• It allows us to calculate the frequency of disease ( p revalence ) or the frequency of a risk factor
• This design is easy to conduct
• For example – if we want to know the prevalence of migraine in a population, we can conduct a cross-sectional study whereby we take a sample from the population and calculate the number of patients with migraine headaches.

Cohort study:

• We conduct this study by comparing two samples from the population: one sample with a risk factor while the other lacks this risk factor
• It shows us the risk of developing the disease in individuals with the risk factor compared to those without the risk factor ( RR = relative risk )
• Prospective : we follow the individuals in the future to know who will develop the disease
• Retrospective : we look to the past to know who developed the disease (e.g. using medical records)
• This design is the strongest among the observational studies
• For example – to find out the relative risk of developing chronic obstructive pulmonary disease (COPD) among smokers, we take a sample including smokers and non-smokers. Then, we calculate the number of individuals with COPD among both.

Case-Control Study:

• We conduct this study by comparing 2 groups: one group with the disease (cases) and another group without the disease (controls)
• This design is always retrospective
•  We aim to find out the odds of having a risk factor or an exposure if an individual has a specific disease (Odds ratio)
•  Relatively easy to conduct
• For example – we want to study the odds of being a smoker among hypertensive patients compared to normotensive ones. To do so, we choose a group of patients diagnosed with hypertension and another group that serves as the control (normal blood pressure). Then we study their smoking history to find out if there is a correlation.

Experimental Studies

• Also known as interventional studies
• Can involve animals and humans
• Pre-clinical trials involve animals
• Clinical trials are experimental studies involving humans
• In clinical trials, we study the effect of an intervention compared to another intervention or placebo. As an example, I have listed the four phases of a drug trial:

I:  We aim to assess the safety of the drug ( is it safe ? )

II: We aim to assess the efficacy of the drug ( does it work ? )

III: We want to know if this drug is better than the old treatment ( is it better ? )

IV: We follow-up to detect long-term side effects ( can it stay in the market ? )

• In randomized controlled trials, one group of participants receives the control, while the other receives the tested drug/intervention. Those studies are the best way to evaluate the efficacy of a treatment.

Finally, the figure below will help you with your understanding of different types of study designs.

References (pdf)

You may also be interested in the following blogs for further reading:

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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No Comments on An introduction to different types of study design

You are my kind of doctor. Do not lose sight of your objective.

Wow very erll explained and easy to understand

I’m Khamisu Habibu community health officer student from Abubakar Tafawa Balewa university teaching hospital Bauchi, Nigeria, I really appreciate your write up and you have make it clear for the learner. thank you

well understood,thank you so much

Well understood…thanks

Simply explained. Thank You.

Thanks a lot for this nice informative article which help me to understand different study designs that I felt difficult before

That’s lovely to hear, Mona, thank you for letting the author know how useful this was. If there are any other particular topics you think would be useful to you, and are not already on the website, please do let us know.

it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

Thanks for this information

Thanks so much for this information….I have clearly known the types of study design Thanks

That’s so good to hear, Mirembe, thank you for letting the author know.

Very helpful article!! U have simplified everything for easy understanding

I’m a health science major currently taking statistics for health care workers…this is a challenging class…thanks for the simified feedback.

That’s good to hear this has helped you. Hopefully you will find some of the other blogs useful too. If you see any topics that are missing from the website, please do let us know!

Hello. I liked your presentation, the fact that you ranked them clearly is very helpful to understand for people like me who is a novelist researcher. However, I was expecting to read much more about the Experimental studies. So please direct me if you already have or will one day. Thank you

Dear Ay. My sincere apologies for not responding to your comment sooner. You may find it useful to filter the blogs by the topic of ‘Study design and research methods’ – here is a link to that filter: https://s4be.cochrane.org/blog/topic/study-design/ This will cover more detail about experimental studies. Or have a look on our library page for further resources there – you’ll find that on the ‘Resources’ drop down from the home page.

However, if there are specific things you feel you would like to learn about experimental studies, that are missing from the website, it would be great if you could let me know too. Thank you, and best of luck. Emma

Great job Mr Hadi. I advise you to prepare and study for the Australian Medical Board Exams as soon as you finish your undergrad study in Lebanon. Good luck and hope we can meet sometime in the future. Regards ;)

You have give a good explaination of what am looking for. However, references am not sure of where to get them from.

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A well-designed cohort study can provide powerful results. This blog introduces prospective and retrospective cohort studies, discussing the advantages, disadvantages and use of these type of study designs.

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What Is a Case Study?

An in-depth study of one person, group, or event

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

Benefits and Limitations

Types of case studies, how to write a case study.

A case study is an in-depth study of one person, group, or event. In a case study, nearly every aspect of the subject's life and history is analyzed to seek patterns and causes of behavior. Case studies can be used in various fields, including psychology, medicine, education, anthropology, political science, and social work.

The purpose of a case study is to learn as much as possible about an individual or group so that the information can be generalized to many others. Unfortunately, case studies tend to be highly subjective, and it is sometimes difficult to generalize results to a larger population.

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, it is important to follow the rules of APA format .  

A case study can have both strengths and weaknesses. Researchers must consider these pros and cons before deciding if this type of study is appropriate for their needs.

One of the greatest advantages of a case study is that it allows researchers to investigate things that are often difficult to impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to collect a great deal of information
• Give researchers the chance to collect information on rare or unusual cases
• Permits researchers to develop hypotheses that can be explored in experimental research

On the negative side, a case study:

• Cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• May not be scientifically rigorous
• Can lead to bias

Researchers may choose to perform a case study if they are interested in exploring a unique or recently discovered phenomenon. The insights gained from such research can help the researchers develop additional ideas and study questions that might be explored in future studies.

However, it is important to remember that the insights gained from case studies cannot be used to determine cause and effect relationships between variables. However, case studies may be used to develop hypotheses that can then be addressed in experimental research.

Case Study Examples

There have been a number of notable case studies in the history of psychology. Much of  Freud's work and theories were developed through the use of individual case studies. Some great examples of case studies in psychology include:

• Anna O : Anna O. was a pseudonym of a woman named Bertha Pappenheim, a patient of a physician named Josef Breuer. While she was never a patient of Freud's, Freud and Breuer discussed her case extensively. The woman was experiencing symptoms of a condition that was then known as hysteria and found that talking about her problems helped relieve her symptoms. Her case played an important part in the development of talk therapy as an approach to mental health treatment.
• Phineas Gage : Phineas Gage was a railroad employee who experienced a terrible accident in which an explosion sent a metal rod through his skull, damaging important portions of his brain. Gage recovered from his accident but was left with serious changes in both personality and behavior.
• Genie : Genie was a young girl subjected to horrific abuse and isolation. The case study of Genie allowed researchers to study whether language could be taught even after critical periods for language development had been missed. Her case also served as an example of how scientific research may interfere with treatment and lead to further abuse of vulnerable individuals.

Such cases demonstrate how case research can be used to study things that researchers could not replicate in experimental settings. In Genie's case, her horrific abuse had denied her the opportunity to learn language at critical points in her development.

This is clearly not something that researchers could ethically replicate, but conducting a case study on Genie allowed researchers the chance to study phenomena that are otherwise impossible to reproduce.

There are a few different types of case studies that psychologists and other researchers might utilize:

• Collective case studies : These involve studying a group of individuals. Researchers might study a group of people in a certain setting or look at an entire community. For example, psychologists might explore how access to resources in a community has affected the collective mental well-being of those living there.
• Descriptive case studies : These involve starting with a descriptive theory. The subjects are then observed, and the information gathered is compared to the pre-existing theory.
• Explanatory case studies : These   are often used to do causal investigations. In other words, researchers are interested in looking at factors that may have caused certain things to occur.
• Exploratory case studies : These are sometimes used as a prelude to further, more in-depth research. This allows researchers to gather more information before developing their research questions and hypotheses .
• Instrumental case studies : These occur when the individual or group allows researchers to understand more than what is initially obvious to observers.
• Intrinsic case studies : This type of case study is when the researcher has a personal interest in the case. Jean Piaget's observations of his own children are good examples of how an intrinsic cast study can contribute to the development of a psychological theory.

The three main case study types often used are intrinsic, instrumental, and collective. Intrinsic case studies are useful for learning about unique cases. Instrumental case studies help look at an individual to learn more about a broader issue. A collective case study can be useful for looking at several cases simultaneously.

The type of case study that psychology researchers utilize depends on the unique characteristics of the situation as well as the case itself.

There are also different methods that can be used to conduct a case study, including prospective and retrospective case study methods.

Prospective case study methods are those in which an individual or group of people is observed in order to determine outcomes. For example, a group of individuals might be watched over an extended period of time to observe the progression of a particular disease.

Retrospective case study methods involve looking at historical information. For example, researchers might start with an outcome, such as a disease, and then work their way backward to look at information about the individual's life to determine risk factors that may have contributed to the onset of the illness.

Where to Find Data

There are a number of different sources and methods that researchers can use to gather information about an individual or group. Six major sources that have been identified by researchers are:

• Archival records : Census records, survey records, and name lists are examples of archival records.
• Direct observation : This strategy involves observing the subject, often in a natural setting . While an individual observer is sometimes used, it is more common to utilize a group of observers.
• Documents : Letters, newspaper articles, administrative records, etc., are the types of documents often used as sources.
• Interviews : Interviews are one of the most important methods for gathering information in case studies. An interview can involve structured survey questions or more open-ended questions.
• Participant observation : When the researcher serves as a participant in events and observes the actions and outcomes, it is called participant observation.
• Physical artifacts : Tools, objects, instruments, and other artifacts are often observed during a direct observation of the subject.

Section 1: A Case History

This section will have the following structure and content:

Background information : The first section of your paper will present your client's background. Include factors such as age, gender, work, health status, family mental health history, family and social relationships, drug and alcohol history, life difficulties, goals, and coping skills and weaknesses.

Description of the presenting problem : In the next section of your case study, you will describe the problem or symptoms that the client presented with.

Describe any physical, emotional, or sensory symptoms reported by the client. Thoughts, feelings, and perceptions related to the symptoms should also be noted. Any screening or diagnostic assessments that are used should also be described in detail and all scores reported.

Your diagnosis : Provide your diagnosis and give the appropriate Diagnostic and Statistical Manual code. Explain how you reached your diagnosis, how the client's symptoms fit the diagnostic criteria for the disorder(s), or any possible difficulties in reaching a diagnosis.

Section 2: Treatment Plan

This portion of the paper will address the chosen treatment for the condition. This might also include the theoretical basis for the chosen treatment or any other evidence that might exist to support why this approach was chosen.

• Cognitive behavioral approach : Explain how a cognitive behavioral therapist would approach treatment. Offer background information on cognitive behavioral therapy and describe the treatment sessions, client response, and outcome of this type of treatment. Make note of any difficulties or successes encountered by your client during treatment.
• Humanistic approach : Describe a humanistic approach that could be used to treat your client, such as client-centered therapy . Provide information on the type of treatment you chose, the client's reaction to the treatment, and the end result of this approach. Explain why the treatment was successful or unsuccessful.
• Psychoanalytic approach : Describe how a psychoanalytic therapist would view the client's problem. Provide some background on the psychoanalytic approach and cite relevant references. Explain how psychoanalytic therapy would be used to treat the client, how the client would respond to therapy, and the effectiveness of this treatment approach.
• Pharmacological approach : If treatment primarily involves the use of medications, explain which medications were used and why. Provide background on the effectiveness of these medications and how monotherapy may compare with an approach that combines medications with therapy or other treatments.

This section of a case study should also include information about the treatment goals, process, and outcomes.

When you are writing a case study, you should also include a section where you discuss the case study itself, including the strengths and limitiations of the study. You should note how the findings of your case study might support previous research. 

In your discussion section, you should also describe some of the implications of your case study. What ideas or findings might require further exploration? How might researchers go about exploring some of these questions in additional studies?

Here are a few additional pointers to keep in mind when formatting your case study:

• Never refer to the subject of your case study as "the client." Instead, their name or a pseudonym.
• Read examples of case studies to gain an idea about the style and format.
• Remember to use APA format when citing references .

A Word From Verywell

Case studies can be a useful research tool, but they need to be used wisely. In many cases, they are best utilized in situations where conducting an experiment would be difficult or impossible. They are helpful for looking at unique situations and allow researchers to gather a great deal of information about a specific individual or group of people.

If you have been directed to write a case study for a psychology course, be sure to check with your instructor for any specific guidelines that you are required to follow. If you are writing your case study for professional publication, be sure to check with the publisher for their specific guidelines for submitting a case study.

Simply Psychology. Case Study Method .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach . BMC Med Res Methodol . 2011 Jun 27;11:100. doi:10.1186/1471-2288-11-100

Gagnon, Yves-Chantal.  The Case Study as Research Method: A Practical Handbook . Canada, Chicago Review Press Incorporated DBA Independent Pub Group, 2010.

Yin, Robert K. Case Study Research and Applications: Design and Methods . United States, SAGE Publications, 2017.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

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The Family of Single-Case Experimental Designs

Single-case experimental designs (SCEDs) represent a family of research designs that use experimental methods to study the effects of treatments on outcomes. The fundamental unit of analysis is the single case—which can be an individual, clinic, or community—ideally with replications of effects within and/or between cases. These designs are flexible and cost-effective and can be used for treatment development, translational research, personalized interventions, and the study of rare diseases and disorders. This article provides a broad overview of the family of single-case experimental designs with corresponding examples, including reversal designs, multiple baseline designs, combined multiple baseline/reversal designs, and integration of single-case designs to identify optimal treatments for individuals into larger randomized controlled trials (RCTs). Personalized N-of-1 trials can be considered a subcategory of SCEDs that overlaps with reversal designs. Relevant issues for each type of design—including comparisons of treatments, design issues such as randomization and blinding, standards for designs, and statistical approaches to complement visual inspection of single-case experimental designs—are also discussed.

Keywords : single-case experimental designs, reversal designs, multiple baseline designs, personalized medicine

1. Introduction

Single-case experimental designs (SCEDs) represent a family of experimental designs to examine the relationship between one or more treatments or levels of treatment and changes in biological or behavioral outcomes. These designs originated in early experimental psychology research (Boring, 1929; Ebbinghaus, 1913; Pavlov, 1927), and were later expanded and formalized in the fields of basic and applied behavior analysis (Morgan & Morgan, 2001; Sidman, 1960). SCEDs have been extended to a number of fields, including medicine (Lillie et al., 2011; Schork, 2015), public health (Biglan et al., 2000; Duan et al., 2013), education (Horner et al., 2005), counseling psychology (Lundervold & Belwood, 2000), clinical psychology (Vlaeyen et al., 2020), health behavior (McDonald et al., 2017), and neuroscience (Soto, 2020).

SCEDs provide a framework to determine whether changes in a target behavior(s) or symptom are in fact a function of the intervention. The fundamentals of an SCED involve repeated measurement, replication of conditions (e.g., baseline and intervention conditions), and the analysis of effects with respect to each individual serving as his or her own control. This process can be useful for identifying the optimal treatment for an individual (Dallery & Raiff, 2014; Davidson et al., 2021), treating rare diseases (Abrahamyan et al., 2016), and implementing early phase translational research (Czajkowski et al., 2015). SCEDs can be referred to as ‘personalized (N-of-1) trials’ when used this way, but they also have broad applicability to a range of scientific questions. Results from SCEDs can be aggregated using meta-analytic techniques to establish generalizable methods and treatment guidelines (Shadish, 2014; Vannest et al., 2018). Figure 1 presents the main family of SCEDs, and shows how personalized (N-of-1) trials fit into these designs (Vohra et al., 2016). The figure also distinguishes between experimental and nonexperimental single-case designs. In the current article, we provide an overview of SCEDs and thus a context for the articles in this special issue focused on personalized (N-of-1) trials. Our focus is to provide the fundamentals of these designs, and more detailed treatments of data analysis (Moeyaert & Fingerhut, 2022; Schork, 2022) conduct and reporting standards (Kravitz & Duan, 2022; Porcino & Vohra, 2022), and other methodological considerations are provided in this special issue. Our hope is that this article will inspire a diverse array of students, engineers, scientists, and practitioners to further explore the utility, rigor, and flexibility of these designs.

Figure 1. The main family of single-case experimental designs and nonexperimental designs. A = Baseline, B and C refer to different treatments.

The most common approach to evaluating the effectiveness of interventions on outcomes is using randomized controlled trials (RCTs). RCTs provide an idea of the average effect of an intervention on outcomes. People do not all change at the same rate or in the same way, however; variability in both how people change and the effect of the intervention is inevitable (Fisher et al., 2018; Normand, 2016; Roustit et al., 2018). These sources of variability are conflated in a typical RCT, leading to heterogeneity of treatment effects (HTE). Research on HTE has shown variability in outcomes in RCTs, and in some studies very few people actually exhibit the benefits of that treatment (Williams, 2010). One approach in RCTs is to assess moderators of treatment response to identify individual differences that may predict response to a treatment. This approach may not limit variability in response, and substantial reduction in variability of treatment for subgroups in comparison to the group as a whole is far from assured. Even if variability is reduced, the average effect for that subgroup may not be representative of individual members of the subgroup.   

SCEDs can identify the optimal treatment for an individual person rather than the average person in a group (Dallery & Raiff, 2014; Davidson et al., 2021; Hekler et al., 2020). SCEDs are multiphase experimental designs in which a great deal of data is collected on a single person, said person serves as his or her own control (Kazdin, 2011, 2021), and the order of presentation of conditions can be randomized to enhance experimental control. That is, a person’s outcomes in one phase are compared to outcomes in another phase. In a typical study, replications are achieved within and/or across several individuals; this allows for strong inferences about causation between behavior and the treatment (or levels thereof). Achieving replications is synonymous with achieving experimental control.

We provide an overview of three experimental designs that can be adapted for personalized medicine: reversal, multiple baseline, and combined reversal and multiple baseline designs, and we discuss how SCEDs can be integrated into RCTs. These designs focus on demonstrating experimental control of the relationship between treatment and outcome. Several general principles common to all of the designs are noteworthy (Lobo et al., 2017). First, in many studies, treatment effects are compared with control conditions with a no- intervention baseline as the initial condition. To reduce threats to internal validity of the study, the order of assignment of interventions can be randomized (Kratochwill & Levin, 2010) and, when possible, the intervention and data collection can be blinded. The demonstration of experimental control across conditions or people needs to be replicated several times (three replications is the minimum) to ensure confidence of the relationship between treatment and outcome (Kratochwill et al., 2010; Kratochwill & Levin, 2015). Demonstrating stability of data within a phase or, otherwise, no trend in the direction of treatment effects prior to starting treatment is particularly important. Stability refers to the degree of variability in the data path over time (e.g., data points must fall within a 15% range of the median for a condition). Thus, phase length needs to be flexible for the sake of determining stability and trend within a phase, but a minimum of 5 data points per phase has been recommended (Kratochwill et al., 2013). The focus of the intervention’s effects is on clinically rather than statistically significant effects with the target effect prespecified and considered in interpretation of the relevance of the effect for clinical practice (Epstein et al., 2021). In addition, multiple dependent outcomes can be simultaneously measured (Epstein et al., 2021). SCEDs can be used to test whether a variable mediates the effect of a treatment on symptoms or behavior (Miočević et al., 2020; Riley & Gaynor, 2014). Visual inspection of graphical data is typically used to determine treatment effects, and statistical methods are commonly used to assist in interpretation of graphical data (Epstein et al., 2021). Furthermore, a growing number of statistical approaches can summarize treatment effects and provide effect sizes (Kazdin, 2021; Moeyaert & Fingerhut, this issue; Pustejovsky, 2019; Shadish et al., 2014). Data across many SCED trials can be aggregated to assess the generality of the treatment effects to help address for whom and under what conditions an intervention is effective (Branch & Pennypacker, 2013; Shadish, 2014; Van den Noortgate & Onghena, 2003).

2. Reversal Designs

A reversal design collects behavioral or biological outcome data in at least two phases: a baseline or no-treatment phase (labeled as ‘A’) and the experimental or treatment phase (labeled as ‘B’). The design is called a reversal design because there must be reversals or replications of phases for each individual; for example, in an ABA design, the baseline phase is replicated (Kazdin, 2011). Ideally, three replications of treatment effects are used to demonstrate experimental control (Kratochwill et al., 2010; Kratochwill & Levin, 1992). Figure 2 shows hypothetical results from an A1B1A2B2 design. The graph shows three replications of treatment effects (A1 versus B1, B1 versus A2, A2 versus B2) across four participants. Each phase was carried out until stability was evident from visual inspection of the data as well as absence of trends in the direction of the desired effect. The replication across participants increases the confidence in the effectiveness of the intervention. Extension of this design is possible by comparing multiple interventions, as well. The order of the treatments should be randomized, especially when the goal is to combine SCEDs across participants.

Figure 2. Example of a reversal design showing replications within and between subjects. A1 = First Baseline, B1 First Treatment, A2 = Return to Baseline, B2 = Return to Treatment. P1–P4 represent different hypothetical participants.

Reversal designs can be more dynamic and compare several treatments. A common approach in personalized medicine would be to compare two or more doses of or different components of the same treatment (Ward-Horner & Sturmey, 2010). For example, two drug doses could be compared using an A1B1C1B2C2 design, where A represents placebo and B and C represent the different drug doses (Guyatt et al., 1990). In the case of drug studies, the drug/placebo administration can be double blinded. A more complex design could be A1B1A2C1A3C2A4B2, which would yield multiple replications of the comparison between drug and placebo. Based on the kinetics of the drug and the need for a washout period, the design could also be A1B1C1B2C2. This would provide three demonstration of treatment effects: B1 to C1, C1 to B2, and B2 to C2. Other permutations could be planned strategically to identify the optimal dose for each individual.

Advantages of SCED reversal designs are their ability to experimentally show that a particular treatment was functionally related to a particular change in an outcome variable for that person . This is the core principle of personalized medicine: an optimal treatment for an individual can be identified (Dallery & Raiff, 2014; Davidson et al., 2021; Guyatt et al., 1990; Hekler et al., 2020; Lillie et al., 2011). These designs can work well for studying the effect of interventions on rare diseases in which collecting enough participants with similar characteristics for an RCT would be unlikely. An additional strength is the opportunity for the clinical researcher who also delivers clinical care to translate basic science findings or new findings from RCTs to their patients, who can potentially benefit (Dallery & Raiff, 2014; Hayes, 1981). Research suggests that the trickle-down of new developments and hypotheses to their support in RCTs can take more than 15 years; many important advancements in the medical and behavior sciences are likely not to be implemented rapidly enough (Riley et al., 2013). The ability to test new intervention developments using scientific principles could speed up their translation into practice.

Limitations to SCED designs, however, are worth noting. Firstly, in line with the expectation that the outcome returns to baseline levels, reversals may require removal of the treatment. If the effect is not quickly reversible, then the designs are not relevant. A washout period may be placed in-between phases if the effect is not immediately reversible; for example, a drug washout period could be planned based on the half-life of drug. Secondly, the intervention should have a relatively immediate effect on the outcome. If many weeks to months are needed for some interventions to show effects, a reversal design may not be optimal unless the investigator is willing to plan a lengthy study. Thirdly, the design depends on comparing stable data over conditions. If achieving stability due to uncontrolled sources of biological or environmental variation is not possible, a reversal design may not be appropriate to evaluate a treatment, though it may be useful to identify the sources of variability (Sidman, 1960). Finally, for a reversal to a baseline, a no-treatment phase may be inappropriate in investigating treatment effects for a very ill patient.

3. Multiple Baseline Designs

An alternative to a reversal design is the multiple baseline design, which does not require reversal of conditions to establish experimental control. There are three types of multiple baseline designs: multiple baseline across people, behaviors, and settings. The most popular is the multiple baseline across people, in which baselines are established for three or more people for the same outcome (Cushing et al., 2011; Meredith et al., 2011). Treatment is implemented after different durations of baseline across individuals. The order of treatment implementation across people can be randomized (Wen et al., 2019). Figure 3 shows an example across three individuals. In this hypothetical example, baseline data for each person are relatively stable and not decreasing, and reductions in the dependent variable are only observed after introduction of the intervention. Inclusion of one control person, who remains in baseline throughout the study and provides a control for extended monitoring, is also possible. Another variation is to collect baseline data intermittently in a ‘probe’ design, which can minimize burden associated with simultaneous and repeated measurement of outcomes (Byiers et al., 2012; Horner & Baer, 1978). If the outcomes do not change during baseline conditions and the changes only occur across participants after the treatment has been implemented—and this sequence is replicated across several people—change in the outcome may be safely attributed to the treatment. The length of the baselines still must be long enough to show stability and no trend toward improvement until the treatment is implemented.

Figure 3. Example of a multiple baseline design showing replications between subjects. P1–P3 represent different hypothetical participants.

The two other multiple baseline designs focus on individual people: the multiple baseline across settings and the multiple baseline across behaviors (Boles et al., 2008; Lane-Brown & Tate, 2010). An example of a multiple baseline across settings would be a dietary intervention implemented across meals. An intervention that targets a reduction in consumption of high–glycemic index foods, or foods with added sugar across meals, could be developed with the order of meals randomized. For example, someone may be randomized to reduce sugar-added or high–glycemic index foods for breakfast without any implementation at lunch or dinner. Implementation of the diet at lunch and then dinner would occur after different durations of baselines in these settings. An example of multiple baseline across behaviors might be to use feedback to develop a comprehensive exercise program that involves stretching, aerobic exercise, and resistance training. Feedback could target improvement in one of these randomly selected behaviors, implemented in a staggered manner.

The main limitation to a multiple baseline design is that some people (or behaviors) may be kept in baseline or control conditions for extended periods before treatment is implemented. Of course, failure to receive an effective treatment is common in RCTs for people who are randomized to control conditions, but unlike control groups in RCTs, all participants eventually receive treatment.

Finally, while the emphasis in personalized medicine is the identification of an optimal treatment plan for an individual person, situations in which multiple baselines across people prove relevant for precision medicine may arise. For example, identification of a small group of people with common characteristics—perhaps with a rare disease and for which a multiple-baseline-across-people design could be used to test an intervention more effectively than a series of personalized designs—is possible. In a similar vein, differential response to a common treatment in a multiple-baseline-across-people design can help to identify individual differences that can compromise the response to a treatment.

4. Integrating Multiple Baseline and Reversal Designs

While reversal designs can be used to compare effects of interventions, multiple baseline designs provide experimental control for testing one intervention but do not compare different interventions. One way to take advantage of the strengths of both designs is to combine them. For example, the effects of a first treatment could be studied using a multiple-baseline format and, after experimental control has been established, return to baseline prior to the commencement of a different treatment, which may be introduced in a different order. These comparisons can be made for several different interventions with the combination of both designs to demonstrate experimental control and compare effects of the interventions.

Figure 4 shows a hypothetical example of a combined approach to identify the best drug to decrease blood pressure. Baseline blood pressures are established for three people under placebo conditions before new drug X is introduced across participants in a staggered fashion to establish relative changes in blood pressure. All return to placebo after blood pressures reach stability, drug Y is introduced in a staggered sequence, participants are returned to placebo, and the most effective intervention for each individual (drug X or Y) is reintroduced to replicate the most important result: the most effective medication. This across-subjects design establishes experimental control for two different new drug interventions across three people while also establishing experimental control for five comparisons within subjects (placebo—drug X, drug Y—placebo, placebo—drug Y, drug Y—placebo, placebo—more effective drug). Though this combined design strengthens confidence beyond either reversal or multiple baseline designs, in many situations, experimental control demonstrated using a reversal design is sufficient.

Figure 4. Example of a combined reversal and multiple baseline to determine the best drug to lower blood pressure. BL = Baseline. Drug X and Drug Y represent hypothetical drugs to lower blood pressure, and Best Drug represents a reversal to the most effective drug as identified for each hypothetical participant, labeled P1–P3.

5. Other Varieties of Single-Case Experimental Designs

Other less commonly used designs within the family of SCEDs may be useful for personalized medicine. One of the most relevant may be the alternating treatment design (Barlow & Hayes, 1979; Manolov et al., 2021), in which people are exposed to baseline and one or more treatments for very brief periods without the concern about stability before changing conditions. While the treatment period may be short, many more replications of treatments—and ineffective treatments—can be identified quickly. This type of design may be relevant for drugs that have rapid effects with a short half-life and behavioral interventions that have rapid effects (Coyle & Robertson, 1998)—for example, the effects of biofeedback on heart rate (Weems, 1998). Another design is the changing criterion design, in which experimental control is demonstrated when the outcome meets certain preselected criteria that can be systematically increased or decreased over time (Hartmann & Hall, 1976). The design is especially useful when learning a new skill or when outcomes change slowly over time (Singh & Leung, 1988)—for example, gradually increasing the range of foods chosen in a previously highly selective eater (Russo et al., 2019).

6. Integrating Single-Case Experimental Designs Into Randomized Controlled Trials

SCEDs can be integrated into RCTs to compare the efficacy of treatments chosen for someone based on SCEDs versus a standardized or usual care treatment (Epstein et al., 2021; Schork & Goetz, 2017). Such innovative designs may capture the best in SCEDs and randomized controlled designs. Kravitz et al. (2018) used an RCT in which one group ( n = 108) experienced a series of reversal AB conditions, or a personalized (N-of-1) trial. The specific conditions were chosen for each patient from among eight categories of treatments to reduce chronic musculoskeletal pain (e.g., acetaminophen, any nonsteroidal anti-inflammatory drug, acetaminophen/oxycodone, tramadol). The other group ( n = 107) received usual care. The study also incorporated mobile technology to record pain-related data daily (see Dallery et al., 2013, for a discussion of technology and SCEDs). The results suggested that the N-of-1 approach was feasible and acceptable, but it did not yield statistically significant superior results in pain measures compared to the usual care group. However, as noted by Vohra and Punja (2019), the results do not indicate a flaw in the methodological approach: finding that two treatments do not differ in superiority is a finding worth knowing.

Another example of a situation where an integrated approach may be useful is selecting a diet for weight control. Many diets for weight control that vary in their macronutrient intake—such as low carb, higher fat versus low fat, and higher carb—have their proponents and favorable biological mechanisms. However, direct comparisons of these diets basically show that they achieve similar weight control with large variability in outcome. Thus, while the average person on a low-fat diet does about the same as the average person on a low-carb diet, some people on the low-carb diet do very well, while some fail. Some of the people who fail on the low-fat diet would undoubtedly do well on the low-carb diet, and some who fail on the low-fat diet would do well on the low-carb diet. Further, some would fail on both diets due to general problems in adherence.

Personalized medicine suggests that diets should be individualized to achieve the best results. SCEDs would be one way to show ‘proof of concept’ that a particular diet is better than a standard healthy diet. First, people would be randomized to experimental (including SCEDs) or control (not basing diet on SCEDs). Subject selection criteria would proceed as in any RCT. For the first 3 months, people in the experimental group would engage in individual reversal designs in which 2-week intervals of low-carb and low-fat diets would be interspersed with their usual eating, and weight loss, diet adherence, food preferences, and the reinforcing value of foods in the diet would be measured to assess biological, behavioral, and subjective changes.

Participants in the control group would experience a similar exposure to the different types of diets, but the diet to which they are assigned would be randomly chosen rather than chosen using SCED methods. In this way, they would have similar exposure to diets during the first 3 months of the study, but this experience would not impact group assignment. As with any RCT, the study would proceed with regular measures (e.g., 6, 12, 24 months) and the hypothesis that those assigned to a diet that results in better initial weight loss, and that they like and are motivated to continue, would do better than those receiving a randomly selected diet. The study could also be designed with three groups: a single-case design experimental group similar to the approach in the hypothetical study above and two control groups, one low-fat and one low-carb.

An alternative design would be to have everyone experience SCEDs for the first 3 months and then be randomized to either the optimal treatment identified during the first 3 months or an intervention randomly chosen among the interventions to be studied. This design has the advantage of randomization being after 3 months of study so that dropouts and nonadherers within the first 3 months would not be randomized in an intent-to-treat format.

The goal of either hypothesized study, or any study that attempts to incorporate SCEDs into RCTs, is that matching participants to treatments will provide superior results in comparison to providing the same treatment to everyone in a group. Two hypotheses can be generated in these types of designs: first, that the mean changes will differ between groups, and second, that the variability will differ between groups with less variability in outcome for people who have treatment selected after a single-case trial than people who have a treatment randomly selected. A reduction in variability plus mean differences in outcome should increase the effect size for people treated using individualized designs, increase power, and allow for a smaller sample size to ensure confidence about the differences observed between groups.

7. Limitations of Single-Case Experimental Designs

Single-case experimental designs have their common limitations. If a measure changes with repeated testing without intervention, it may not be useful for an SCED unless steps can be taken to mitigate such reactivity, such as more unobtrusive monitoring (Kazdin, 2021). Given that the effects of interventions are evaluated over time, systematic environmental changes or maturation could influence the relationship between a treatment and outcome and thereby obscure the effect of a treatment. However, the design logic of reversal and multiple baseline designs largely control for such influences. Since SCEDs rely on repeated measures and a detailed study of the relationship between treatment and outcome, studies that use dependent measures that cannot be sampled frequently are not candidates for SCEDs. Likewise, the failure to identify a temporal relationship between the introduction of treatment and initiation of change in the outcome can make attribution of changes to the intervention challenging. A confounding variable’s association with introduction or removal of the intervention, which may cause inappropriate decisions about the effects of the intervention, is always possible. Dropout or uncontrolled events that occur to individuals can introduce confounding variables to the SCED. These problems are not unique to SCEDs and also occur with RCTs.

8. Single-Case Experimental Designs in Early Stage Translational Research

The emphasis of a research program may be on translating basic science findings to clinical interventions. The goal may be to collect early phase translational research as a step toward a fully powered RCT—(Epstein et al., 2021). The fact that a large amount of basic science does not get translated into clinical interventions is well known (Butler, 2008; Seyhan, 2019); this served in part as the stimulus for the National Institutes of Health (NIH) to develop a network of clinical and translational science institutes in medical schools and universities throughout the United States. A common approach to early phase translational research is to implement a small, underpowered RCT to secure a ‘signal’ of a treatment effect and an effect size. This is a problematic approach to pilot research, and it is not advocated by the NIH as an approach to early phase translational research (National Center for Complementary and Integrative Health, 2020). The number of participants needed for a fully powered RCT may be substantially different from the number projected from a small-sample RCT. These small, underpowered, early phase translational studies may provide too large an estimate of an effect size, leading to an underpowered RCT. Likewise, a small-sample RCT can lead to a small effect size that can, in turn, lead to a failure to implement a potentially effective intervention (Kraemer et al., 2006). Therefore, SCEDs—especially reversal and multiple baseline designs—are evidently ideally suited to early phase translational research. This use complements the utility of SCEDs for identifying the optimal treatment for an individual or small group of individuals.

9. Conclusion

Single-case experimental designs provide flexible, rigorous, and cost-effective approaches that can be used in personalized medicine to identify the optimal treatment for an individual patient. SCEDs represent a broad array of designs, and personalized (N-of-1) designs are a prominent example, particularly in medicine. These designs can be incorporated into RCTs, and they can be integrated using meta-analysis techniques. SCEDs should become a standard part of the toolbox for clinical researchers to improve clinical care for their patients, and they can lead to the next generation of interventions that show maximal effects for individual cases as well as for early phase translational research to clinical practice.

Acknowledgments

We thank Lesleigh Stinson and Andrea Villegas for preparing the figures.

Disclosure Statement

Preparation of this special issue was supported by grants R01LM012836 from the National Library of Medicine of the National Institutes of Health and P30AG063786 from the National Institute on Aging of the National Institutes of Health. Funding to authors of this article was supported by grants U01 HL131552 from the National Heart, Lung, and Blood Institute, UH3 DK109543 from the National Institute of Diabetes, Digestive and Kidney Diseases, and RO1HD080292 and RO1HD088131 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The views expressed in this paper are those of the authors and do not represent the views of the National Institutes of Health, the U.S. Department of Health and Human Services, or any other government entity. 

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How To Write A Case Study For Your Design Portfolio

Case studies are an important part of any designer’s portfolio. Read this article to learn everything you need to know to start writing the perfect case study.

When you’re putting together your online design portfolio , design case studies are a great way to showcase your experience and skills. They also give potential clients a window into how you work.

By showing off what you can do and your design process, case studies can help you land more clients and freelance design jobs —so it can be smart to dedicate an entire section of your online portfolio website to case studies.

Getting Started

So—what is a design case study and how do they fit in your portfolio.

Let’s get some definitions out of the way first, shall we? A design case study is an example of a successful project you’ve completed. The exact case study format can vary greatly depending on your style and preferences, but typically it should outline the problem or assignment, show off your solution, and explain your approach.

One of the best ways to do that is to use a case study design that’s similar to a magazine article or long-form web article with lots of images throughout. When building your case study portfolio, create a new page for each case study. Then create a listing of all your case studies with an image and link to each of them. Now, let’s get into the nitty-gritty of creating these case studies.

Choose Your Best Projects

To make your online portfolio the best it can be , it’s good to be picky when choosing projects for case studies. Since your portfolio will often act as your first impression with potential clients, you only want it to showcase your best work.

If you have a large collection of completed projects, you may have an urge to do a ton of case studies. There’s an argument to be made in favor of that, since it’s a way to show off your extensive experience. In addition, by including a wide variety of case studies, it’s more likely that potential clients will be able to find one that closely relates to their business or upcoming project.

But don’t let your desire to have many case studies on your portfolio lead you to include projects you’re not as proud of. Keep in mind that your potential clients are probably busy people, so you shouldn’t expect them to wade through a massive list of case studies. If you include too many, you can never be sure which ones potential clients will take a look at. As a result, they may miss out on seeing some of your best work.

There’s no hard-and-fast rule for how many case studies to include. It’ll depend on the amount of experience you have, and how many of your completed projects you consider to be among your best work.

Use Your Design Expertise

When creating the case study section of your portfolio, use your designer’s eye to make everything attractive and easily digestible. One important guideline is to choose a layout that will enable you to include copy and image captions throughout.

Don’t have your portfolio up and running yet and not sure which portfolio platform is best for you? Try one that offers a free trial and a variety of cool templates that you can play around with to best showcase your design case studies.

If you don’t provide context for every image you include, it can end up looking like just a (somewhat confusing) image gallery. Case studies are more than that—they should explain everything that went into what you see in the images.

Check Out Other Case Study Examples for Inspiration

Looking at case study examples from successful designers is a great way to get ideas for making your case study portfolio more effective. Pay special attention to the case study design elements, including the layout, the number of images, and amount of copy. This will give you a better idea of how the designer keeps visitors interested in the story behind their projects.

To see some great case study examples, check out these UX designer portfolios .

Try a Case Study Template

There are plenty of resources online that offer free case study templates . These templates can be helpful, as they include questions that’ll help you ensure you’ve included all the important information.

However, most of them are not tailored to designers. These general case study templates don’t have the formatting you’ll want (i.e. the ability to include lots of images). Even the ones that are aimed at designers aren’t as effective as creating your own design. That’s why case study templates are best used as a starting point to get you thinking, or as a checklist to ensure you’ve included everything.

How to Write Case Studies

Maintain your usual tone.

You should write your case studies in the same personal, authentic (yet still professional!) tone of voice as you would when creating the About Me section of your portfolio . Don’t get bogged down in too much technical detail and jargon—that will make your case studies harder to read.

Since your case studies are part of your online portfolio, changing your usual tone can be jarring to the reader.

Instead, everything on your portfolio should have a consistent style. This will help you with creating brand identity . The result will be potential clients will be more connected to your writing and get the feeling that they’re learning what makes you unique.

Provide Some Context

Case studies are more effective when you include some information at the beginning to set the stage. This can include things like the date of the project, name of the client, and what the client does. Providing some context will make the case study more relatable to potential clients.

Also, by including the date of the project, you can highlight how your work has progressed over time. However, you don’t want to bog down this part of the case study with too much information. So it only really needs to be a sentence or two.

Explain the Client’s Expectations

Another important piece of information to include near the beginning of your case study is what the client wanted to accomplish with the project. Consider the guidelines the client provided, and what they would consider a successful outcome.

Did this project involve unique requirements? Did you tailor the design to suit the client’s brand or target audience? Did you have to balance some conflicting requirements?

Establishing the client’s expectations early on in the case study will help you later when you want to explain how you made the project a success.

Document Your Design Process

As you write your case study, you should take a look at your process from an outsider’s point of view. You already know why you made the decisions you did, so it may feel like you’re explaining the obvious. But by explaining your thought process, the case study will highlight all the consideration you put into the design project.

This can include everything from your initial plan to your inspiration, and the changes you made along the way. Basically, you should think about why you took the approach you did, and then explain it.

At this point, consider mentioning any tricks you use to make your design process more efficient . That can include how you managed your time, how you communicated with clients, and how you kept things on track.

Don’t Be Afraid to Mention Challenges

When writing a case study, it can be tempting to only explain the parts that went flawlessly. But you should consider mentioning any challenges that popped up along the way.

Was this project assigned with an extremely tight deadline? Did you have to ask the client to clarify their desired outcome? Were there revisions requested?

If you have any early drafts or drawings from the project saved, it can be a good idea to include them in the case study as well—even if they show that you initially had a very different design in mind than you ended up with. This can show your flexibility and willingness to go in new directions in order to achieve the best results.

Mentioning these challenges is another opportunity to highlight your value as a designer to potential clients. It will give you a chance to explain how you overcame those challenges and made the project a success.

Show How the Project’s Success Was Measured

Case studies are most engaging when they’re written like stories. If you followed the guidelines in this article, you started by explaining the assignment. Next, you described the process you went through when working on it. Now, conclude by going over how you know the project was a success.

This can include mentioning that all of the client’s guidelines were met, and explaining how the design ended up being used.

Check if you still have any emails or communications with the client about their satisfaction with the completed project. This can help put you in the right mindset for hyping up the results. You may even want to include a quote from the client praising your work.

Start Writing Your Case Studies ASAP

Since case studies involve explaining your process, it’s best to do them while the project is still fresh in your mind. That may sound like a pain; once you put a project to bed, you’re probably not looking forward to doing more work on it. But if you get started on your case study right away, it’s easier to remember everything that went into the design project, and why you made the choices you did.

If you’re just starting writing your case studies for projects you’ve completed in the past, don’t worry. It will just require a couple more steps, as you may need to refresh your memory a bit.

Start by taking a look at any emails or assignment documents that show what the client requested. Reviewing those guidelines will make it easier to know what to include in your case study about how you met all of the client’s expectations.

Another helpful resource is preliminary drafts, drawings, or notes you may have saved. Next, go through the completed project and remind yourself of all the work that went into achieving that final design.

Draw Potential Clients to See Your Case Studies

Having a great portfolio is the key to getting hired . By adding some case studies to your design portfolio, you’ll give potential clients insight into how you work, and the value you can offer them.

But it won’t do you any good if they don’t visit your portfolio in the first place! Luckily, there are many ways you can increase your chances. One way is to add a blog to your portfolio , as that will improve your site’s SEO and draw in visitors from search results. Another is to promote your design business using social media . If you’re looking to extend your reach further, consider investing in a Facebook ad campaign , as its likely easier and less expensive than you think.

Once clients lay eyes on all your well-written, beautifully designed case studies, the work will come roaring in!

Want to learn more about creating the perfect design portfolio? 5 Designers Reveal How to Get Clients With Your Portfolio 20 Design Portfolios You Need to See for Inspiration Study: How Does the Quality of Your Portfolio Site Influence Getting Hired?

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15+ Student Case Study Examples [ High School, Assignment, Classroom ]

Student Case Study

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Case Study Definition

Benefits and limitations of case studies, example of case study.

• Subject Focus : The case study can center on a single person, a small group of individuals, an organization, a particular event, or a broader societal issue. The choice of subject depends on the research question or the goals of the study.
• In-Depth Exploration: Case studies involve detailed data collection and analysis. Researchers collect various types of information, such as interviews, surveys, documents, observations, and other relevant sources, to build a comprehensive picture of the subject.
• Contextual Analysis: A significant aspect of a case study is the consideration of the context in which the subject operates. Understanding the background and environment is essential to interpret the findings accurately.
• Qualitative Research : Case studies often use qualitative research methods to gather and analyze data. This includes open-ended interviews, content analysis, and thematic coding.
• Rich Description: The case study report provides a rich and detailed description of the subject. It includes narratives, quotes, and empirical evidence to support the analysis.
• Analysis and Interpretation: Researchers analyze the collected data to identify patterns, themes, or trends. They may use various theoretical frameworks to interpret the information and draw conclusions.
• Real-World Application: Case studies are often used to address practical problems or real-world situations. They can be used to inform decision-making, offer solutions, or provide insights into specific issues.
• Ethical Considerations: Researchers must consider ethical principles when conducting case studies, ensuring the protection of participants’ rights and privacy.
• Findings and Recommendations: A well-structured case study typically concludes with findings, implications, and recommendations based on the analysis.

1. Choose an Interesting and Relevant Topic:

2. conduct thorough research:, 3. identify the problem or research question:, 4. introduce the case:, 5. describe the methods used:, 6. present the findings:, 7. analytical interpretation:, 8. discuss limitations:, 9. propose solutions or recommendations:, 10. write a conclusion:, 11. cite your sources:, 12. edit and proofread:, 13. format your case study:.

• Apple Inc.’s Marketing Strategy: An analysis of Apple’s marketing approach, including product design, branding, and customer loyalty.
• McDonald’s Global Expansion: A study on how McDonald’s adapted its business model for success in different international markets.
• The Case of “Little Albert”: A classic case study in psychology that examined the conditioning of fear in a young child.
• Stanford Prison Experiment: An investigation into the psychological effects of role-playing in a simulated prison environment.
• Inclusive Education in a Primary School: A case study exploring the challenges and benefits of implementing inclusive education for students with disabilities.
• Online Learning and Student Engagement: An analysis of the impact of online learning on student engagement and academic performance.
• The Tuskegee Syphilis Study: A well-known case study on the ethical issues surrounding a long-term study of untreated syphilis in African American men.
• Patient X: A Rare Medical Condition: An examination of a patient with a rare medical condition to understand its diagnosis and treatment.
• Deepwater Horizon Oil Spill: A case study of the environmental and economic impacts of the 2010 oil spill in the Gulf of Mexico.
• Deforestation in the Amazon Rainforest: An analysis of the causes, consequences, and possible solutions to deforestation in the Amazon.
• Child Welfare Services: A case study examining the challenges and interventions involved in a child welfare case.
• Substance Abuse and Rehabilitation: An analysis of the recovery journey of an individual with a substance use disorder.
• Sustainable Urban Development: A case study of a city’s efforts to promote sustainable practices in urban planning, transportation, and architecture.
• Historical Preservation of Landmarks: An exploration of the restoration and preservation of historic buildings or landmarks.
• Landmark Supreme Court Cases: In-depth analyses of important legal cases that have had a significant impact on the legal system and society.
• Intellectual Property Disputes: Case studies on legal battles involving intellectual property rights, such as patents and copyrights.
• SpaceX’s Reusable Rockets: A study of SpaceX’s development and use of reusable rocket technology.
• Failure Analysis of Bridge Structures: An investigation into the causes of structural failures in bridges and their implications.
• Enron Scandal: An examination of the accounting fraud and corporate governance issues that led to the downfall of the Enron Corporation.
• Microfinance and Poverty Alleviation: A case study on the impact of microfinance institutions on poverty reduction in developing countries.
• To deepen students’ understanding of a particular concept, theory, or topic within their field of study.
• To provide real-world context and practical applications for theoretical knowledge.
• To enhance students’ critical thinking and problem-solving abilities by analyzing complex issues or scenarios.
• To encourage students to apply their knowledge to real-life situations and develop solutions.
• To develop research skills, including data collection, data analysis , and the ability to draw meaningful conclusions from information.
• To improve analytical skills in interpreting data and making evidence-based decisions.
• To improve written and oral communication skills by requiring students to present their findings in a clear, organized, and coherent manner.
• To enhance the ability to communicate complex ideas effectively to both academic and non-academic audiences.
• To prepare students for future careers by exposing them to real-world situations and challenges they may encounter in their chosen profession.
• To develop professional skills, such as teamwork, time management, and project management.
• To prompt students to reflect on their learning and evaluate their strengths and weaknesses in research and analysis.
• To foster self-assessment and a commitment to ongoing improvement.
• To inspire creativity and innovation in finding solutions to complex problems or challenges.
• To encourage students to think outside the box and explore new approaches.

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• Study protocol
• Open access
• Published: 02 November 2023

EaveTubes for control of vector-borne diseases in Côte d’Ivoire: study protocol for a cluster randomized controlled trial

• Raphael N’Guessan 1 ,
• Serge-Brice Assi 1 ,
• Alphonsine Koffi 1 ,
• Phamien Ludovic Ahoua Alou 1 ,
• Anatole Mian 1 ,
• Nicole L. Achee 2 ,
• Benedicte Fustec 2 ,
• John P. Grieco   ORCID: orcid.org/0000-0002-2080-8598 2 ,
• Fang Liu 2 ,
• Santosh Kumar 4 ,
• Matthew Noffsinger 2 ,
• Ashley Hudson 2 ,
• Tim W. R. Möhlmann 3 &
• Marit Farenhorst 3  

Trials volume  24 , Article number:  704 ( 2023 ) Cite this article

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Vector control tools, long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS), have significantly contributed to malaria prevention efforts in sub-Saharan Africa. However, insecticide resistance has seriously hampered their efficacy in recent years and new tools are essential to further progress. In2Care® EaveTubes (ETs) are an inexpensive, new resistance-breaking vector control product under World Health Organization (WHO) evaluation informed by mosquito ecology to efficiently target malaria vectors. By installing ETs in the walls of the house at the eave level that funnel the natural airflow, mosquitoes are drawn in by the same heat and odor cues that typically attract them through open eaves. Once inside an ET, mosquitoes are exposed to insecticide-treated netting placed inside the ET. The aim of this study is to test whether ETs as stand-alone tool have an effect on the epidemiology of malaria in villages where houses have been modified with the ET intervention.

A two-armed, cluster randomized controlled trial will be conducted to evaluate the effect of ETs on clinical malaria incidence in children living in Côte d’Ivoire. Thirty-four villages will be selected based on population size and the proportion of houses suitable for modification with ETs (17 treatment arms (ETs + LLINs, 17 control arms (LLINs only)). Based on the population census, 55 households per cluster with eligible children (i.e., between the ages of 6 months to 8 years old at the start of the study) will be randomly selected for recruitment into the active detection cohorts. In the treatment arm, we will enroll eligible children who reside in ET-treated houses. The intervention and control cohorts will be followed for 4 months for baseline covariate measurements and 24 months with intervention. During case detection visits, blood samples will be taken from all febrile children and tested for malaria infection with rapid diagnostic tests (RDTs). All positive clinical malaria infections will be treated. To estimate the impact of the ET on malaria vector densities, entomological measurements (indoor sampling with CDC traps) will be conducted monthly in 20 clusters (10 ET, 10 Control) in 10 randomly selected households per cluster. To estimate the infectiousness of malaria vectors, sporozoite rates will be measured in subsets of the collected mosquito samples.

Findings will serve as an efficacy trial of ETs and will be submitted to the WHO Vector Control Advisory Group (VCAG) for assessment of public health value. Entomological outcomes will also be measured as proxies of malaria transmission to help develop guidelines for the evaluation of future In2Care® ETs products.

Trial registration

ClinicalTrials.gov NCT05736679. Registered on 10 February 2023.

Peer Review reports

Administrative information

Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers (Additional file 1 ). The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/ ).

Introduction

Background and rationale {6a}.

Control efforts in sub-Saharan Africa over the past 15 years have prevented an estimated 663 million clinical cases of malaria caused by Plasmodium falciparum [ 1 ]. Vector control, either in the form of long-lasting insecticidal nets (LLINs) or indoor residual spraying (IRS), is estimated to be responsible for 78% of those averted cases [ 2 ]. However, insecticide resistance has seriously hampered their efficacy in recent years.

Because of the impact of vector control on malaria prevalence, it is essential that existing tools are preserved and that cost-effective, environmentally friendly, and socially acceptable new tools are developed. The benefit of having new tools is two-fold: there is the ability to control mosquitoes that are not being controlled by existing interventions (e.g., insecticide-resistant mosquitoes or outdoor biting mosquitoes), and new tools provide options for managing insecticide resistance in mosquitoes, for example through “combination therapy” with two or more insecticides, analogous to using multiple drugs to combat drug resistance in parasites [ 3 ].

The local malaria vector populations in Côte d’Ivoire are highly resistant to almost all classes of insecticides used for vector control, and studies showed a high resistance ratio of local Anopheles gambiae relative to susceptible vectors when exposed to deltamethrin [ 4 ]. One recent study in the trial area showed high levels of insecticide resistance against pyrethroids in Anopheles gambiae s.s . and Anopheles coluzzii vectors. Across study villages, dose–response assays demonstrated the resistance intensity to deltamethrin was extremely high (> 1500-fold), and mortality following exposure to pyrethroid-treated bed nets was low (< 30% mortality in cone bioassays) [ 5 ].

In2Care® EaveTubes (ETs) could help meet the pressing need for new vector control tools. ETs are an inexpensive, field-ready technology, informed by mosquito ecology to efficiently target malaria vectors. ETs are a home improvement that, in addition to the physical blocking, provides a mosquito-killing effect that should lead to a community-level impact on malaria when implemented at scale. Mosquitoes that transmit malaria in sub-Saharan Africa utilize odor cues to enter homes and search for hosts to blood feed. Anophelines were shown to have a strong preference for entering traditional-style African homes through gaps between walls and the roof—i.e., the eaves of houses [ 6 , 7 , 8 , 9 ]. Closing off the eaves of such traditional-style houses with netting or curtains was shown to provide a physical barrier that can selectively prevent malaria mosquito entry into the house and, consequently, protect inhabitants from malaria [ 10 , 11 , 12 ]. In this case, it is the physical blocking of mosquito entry into the house that is the major benefit of house improvements in controlling malaria [ 12 ], but that does not assert a vector-killing impact and could lead to deflection to untreated households. Moreover, modern-style housing in Africa is showing a strong tendency towards closed eaves. ETs comprise 6-in. tubes that can be installed at eave level in traditional and modern houses, which funnel the natural airflow and lure mosquitoes in by the same heat and odor cues that typically attract them through open eaves. Once inside an ET, mosquitoes are exposed to insecticide-treated netting placed inside the ET.

In2Care® ETs have been designed with netting inserts that are covered in a coating with an electrostatic charge to hold powder formulations of insecticides. Mosquitoes contacting the static netting pick up a large dose of insecticide, overcoming insecticide resistance in the mosquito. Studies showed that pyrethroid-resistant anophelines could be effectively killed with pyrethroid-treated static netting [ 13 ] and that pyrethroid-treated ETs have high efficacy on vector and malaria incidence in an area of intense insecticide resistance [ 14 ]. Since the netting inserts are small and placed in locations that are not contacted commonly by residents (at roof level), the quantity and risk of exposure to insecticide is small. It should, therefore, be possible to use ETs as a delivery system and develop future product versions with a wide variety of insecticides that can, in future, be rotated or combined to prevent resistance as recommended by WHO.

Semi-field studies in Tanzania, Kenya, and Côte d’Ivoire demonstrated attraction of mosquitoes to the ETs and a reduction in overnight survival [ 15 , 16 , 17 ]. In a cluster randomized control trial conducted in Côte d’Ivoire between 2016 and 2019, ETs + window screenings were shown to reduce malaria case incidence by 38% [ 14 ] and by 47% in villages with > 70% coverage. The intervention provided community protection (27% less malaria in untreated houses) and significant reductions in anemia and mosquito densities. The World Health Organization Vector Control Advisory Group (WHO VCAG) confirmed the results of the trial in Côte d’Ivoire contribute substantially to the evidence base on ETs and window screening, recommended epidemiological trials with the stand-alone product, and approved the study protocol for this new trial in Côte d’Ivoire [ 18 ].

ETs were originally tested in combination with untreated window screening (“SET”), in order to block other potential entry points and funnel mosquitoes towards the ET. While window screening alone could protect individuals at the household level, it is likely to have less impact on community levels of malaria. Semi-field studies done with ETs without window screens suggest that the large impact observed in the first trial may have been primarily afforded by the ETs [ 19 ]. Window screening is difficult to standardize per house and window type, is costly, and needs frequent repairs, and is not easy to scale. Nevertheless, economic evaluations showed that SET was already similarly cost-effective to other currently used tools like IRS. However, if the intervention consisted only of ET and good epidemiological impact was still demonstrated, the cost-effectiveness would be substantially greater.

The aim of this study is to test whether ETs as stand-alone tool have an effect, not only on mosquito populations but also on the epidemiology of malaria in villages where houses have been modified with the ETs. Another trial is already ongoing in the Jinja area of Uganda: a 3-arm RCT evaluating malaria impacts of ETs versus full house screening (windows/door/gaps) and versus routine vector control (PBO bed nets). This USAID/CDC-funded “Uganda Housing Modification Study” ( https://clinicaltrials.gov/ct2/show/NCT04622241 ) installed ETs in 2000 households in 20 clusters and is monitoring the incidence of clinical malaria through passive case detection at local Health Centers during 1 year. Together, these 2 clinical trials with ETs as stand-alone tools will be submitted to the WHO VCAG to provide the evidence base for the public health impact of In2Care® ETs.

The study is being conducted in the same region of Côte d’Ivoire as the first SET trial, where insecticide resistance is widespread in the mosquito population. This is necessary to demonstrate that (pyrethroid-treated) ETs could potentially provide additional protection, even in areas where existing tools (i.e., LLINs) may be compromised by insecticide resistance. Our study is designed to test any added benefit of the ET package on top of standard control measures. By executing this trial in the same region with similar design, results of the ET intervention will be comparable with the previously achieved SET impact results.

Objectives {7}

Main research question.

This study intends to test whether ETs protect people against mosquitoes (entomological endpoints) and malaria (epidemiological endpoints) in an area where malaria transmission is driven by insecticide-resistant Anopheles gambiae mosquitoes.

The primary study objective is to assess whether ETs reduce the number of malaria infections and clinical malaria, defined by active case detection, in children between 6 months and 10 years of age, compared to children living in communities without ETs, in an area where there is universal coverage of LLINs (1 LLIN for every 2 people) and pyrethroid resistance is high.

Secondary objectives include:

To determine how ETs impact the rate of anemia (moderate anemia defined as 7–9.9 g/dL hemoglobin; severe anemia as < 7 g/dL hemoglobin)

To assess how ETs impact Entomological Inoculation Rates (EIR) computed as the product of the anopheline vector density and the sporozoite rate, compared with LLINs alone

To assess the cost-effectiveness of the ETs intervention

To assess the user acceptance of the ETs intervention

Trial design {8}

The trial design is a 2-armed cluster randomized control trial (cRCT) with 17 clusters (villages) per arm for evaluating the protective efficacy of the SR intervention. Clusters are the unit of replication in this design, and they will be randomly allocated to one of the two arms. Both the replication and randomization in our design are essential to distinguish the effect of ETs from other village-level variation in malaria incidence.

Villages that have not participated in the previous SET cRCT, and villages that received standard pyrethroid-only LLINs (Permanet 2.0) from the National Malaria Control Program (NMCP) distribution campaign in May 2021 will be enrolled. We will exclude villages being treated by IRS and/or new generation bed net campaigns.

The control arm of this cRCT will include 17 villages with universal coverage of LLINs (defined as 1 LLIN for every 2 people) and no ETs. The 17 villages in the treatment arm will receive universal coverage of LLINs plus ETs. For those households assessed to not have met thresholds of universal coverage, topping up of LLINs will be conducted as needed.

Methods: participants, interventions, and outcomes

Study setting {9}.

The study is being conducted in the Béoumi district in the Gbêkê region in central Côte d’Ivoire where there is year-round malaria transmission with a peak during the wet season (May–October). This is the same region of Côte d’Ivoire as the first trial, where on average malaria incidence was 2–3 malaria cases/child/year and insecticide resistance is widespread in the mosquito population. This is necessary to demonstrate that (pyrethroid-treated) ETs could potentially provide additional protection, even in areas where existing tools (i.e., LLINs) may be compromised by insecticide resistance. Our study is designed to test any added benefit of the ET package on top of standard control measures. By executing this trial in the same region with similar design, results of the ET intervention will be comparable with the previously achieved SET impact results.

Eligibility criteria {10}

Village-level inclusion criteria:

 ≥ 80% of households (HHs) must be suitable for ET installation.

 ≥ 70% of HHs willing to have ETs installed.

No participation in the previous screening + ETs cRCT.

Received standard pyrethroid-only LLINs (Permanet 2.0).

100–300 HHs per village.

 ≥ 2 km away from another village.

Village-level exclusion criteria:

 < 80% of HHs suitable for ET installation

 < 70% of HHs willing to have ETs installed

Villages being treated by IRS and/or new generation bed net campaigns

Participation in previous Screening + ET cRCT

 < 100 and > 300 households per village

 < 2 km from another village

Household-level inclusion criteria:

HHs must be suitable for ET installation

Provision of consent from heads of HH

Household-level exclusion criteria:

HH not suitable for ET installation (e.g., houses with poor quality thatch roofing or very large eaves or wall gaps, houses in substantial disrepair, unfinished houses under construction, poorly constructed houses)

No provision of consent from heads of HH

Individual-level inclusion criteria:

Children aged ≥ 6 months to < 8 years old at the time of enrollment (so all participants are under 10 years old for the duration of clinical follow-up).

Provision of written, informed consent by parents/caregivers.

Children must reside in villages enrolled in the study and in ETs-treated HHs.

Hemoglobin at baseline of > 7 mg/dL.

Individual-level exclusion criteria:

Children aged < 6 months or ≥ 8 years old at the time of enrollment

No provision of written, informed consent by parents/caregivers for child participation

Expected to be non-resident during a significant part of the transmission season

Hemoglobin at baseline of ≤ 7 mg/dL, have a known chronic disease, or have signs of clinical decompensation

Participation in another clinical trial investigating a drug, vaccine, medical device, or procedure

Who will take informed consent? {26a}

The study subjects may understand French, and/or Baoulé, and/or Malinke. The consent forms will be translated from English into French and then from French into Baoulé, or Malinke by members of the team. These two local languages are only oral; they are not written. The translated version will be on a vocal recording. The consent team of trained, study personnel will be trained to provide the same translation of the survey in Baoulé and Malinke.

The consent process for participation in the active infection detection cohort will occur at the subjects’ home. After the recruitment material and screening questions have been presented to the parents, if the child meets the screening criteria, a team member will show the consent form to the parent. The team member presenting the consent form will be fluent in both French and Baoulé or Malinke. If the parent feels uncomfortable reading the form in French, the team member will help the parent by reading the form to the parent and/or providing an oral translation of the form in Baoulé or Malinke. The local (Ivorian) researchers do not typically provide compensation for participating in epidemiological studies. We will follow these customs and not provide compensation for participating.

The consent process for ETs’ installation in households will take place at the residents’ homes in the 17 selected intervention villages. Once the house is deemed eligible for ETs’ installation, a team member will present the consent form to the head of household. The team member presenting the consent form will be fluent in both French and Baoulé or Malinke. If the head of household feels uncomfortable reading the form in French, the team member will help by providing an oral translation of the form in Baoulé or Malinke.

The consent process for entomological monitoring in households will take place at the participants’ homes. randomly selected each month in the same way as described above for the ETs’ installation consents.

The informed consent form will be provided on paper. The team member will read the recruitment information and the screening questions in both French and Baoulé or Malinke. If the participant meets the screening criteria, the consent form will be read and at the bottom of the page, the participants will be asked to sign the form, which will serve as their agreement to participate. A witness will also be asked to sign the form.

Participants are free to withdraw from the study at any time and they will be informed of this right during the informed consent process.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Not applicable. No ancillary studies will be conducted with participant data.

Interventions

Explanation for the choice of comparators {6b}.

According to the WHO VCAG’s guidelines for vector control field trial design, studies should always have a control arm from which data is collected simultaneously with data collection from an intervention arm [ 17 ]. The control arm of this cRCT will include villages with universal coverage of pyrethroid-treated LLINs and no ETs.

The cRCT study design will not withhold standard-of-care for clinical management of malaria. Study participants will also not be instructed to avoid alternative vector control tools (e.g., coils, topicals, insecticide-treated nets).

Intervention description {11a}

In2Care® ETs comprise 15-cm diameter, 10–20 cm long ventilation tubes with removable netting inserts that are placed in the wall at eave level under the roof of houses where they attract malaria mosquitoes at night, block them from entering the house, and contaminate them with a lethal dose of insecticide. In2Care® ET netting inserts have an electrostatically charged coating treated with bio-actives in powder form, which kills insecticide-resistant mosquitoes through high active ingredient (AI) dose transfer. ETs represent a novel way of delivering an insecticidal AI. In principle, any AI that kills a mosquito or otherwise reduces its ability to transmit malaria parasites could be used, subject to satisfying the appropriate safety requirements and operational factors such as persistence. As such, the specific nature of the AI is not central to the technology or the cRCT.

For the purpose of the trial, we will use a commercially available 5% dustable powder formulation of the pyrethroid insecticide deltamethrin (K-Othrine 50WP, Bayer). This formulation was shown to be effective and persistent against resistant anophelines in Côte d’Ivoire and is used in ET product registrations.

ETs’ installations will be carried out by trained local builders under the day-to-day supervision of the local Principal Investigator (PI) and senior field staff. The aim is to achieve on average a > 70% ET coverage in the intervention clusters. Eligible households in the intervention clusters will receive on average 8–10 ETs per house. The ET intervention consists of five elements:

House modification: In houses with concrete/hard brick walls and closed eaves, we will drill 16-cm diameter holes (to fit the tubes) approximately 20 cm below the roof at 1.5–2-m intervals into the outer walls of rooms occupied in evening/at night (bedrooms and living rooms but not storage rooms). Per room, 2 ETs will be placed at minimum in opposite walls to maximize airflow. Where possible, ETs will be fitted in eave openings or behind air vents to avoid the need for drilling. The remaining open eave spaces or gaps in the walls will be sealed with brick, cement, or plaster. Houses with large open eaves (> 40 cm) will not be eligible and are excluded.

ETs’ installation: PVC tubes of 10–20-cm length and 15-cm diameter will be installed behind air vents, in eave gaps, or in the drilled holes and fixated with cement. These installed tubes will be fitted with untreated ET netting inserts immediately after placement to avoid mosquito entry.

Insecticide treatment: After all cluster ET installations are complete, untreated inserts will be replaced with insecticide-treated netting inserts. This will be done within a 2-week timeframe to ensure a simultaneous start in all intervention clusters. Deltamethrin powder will be applied locally with custom-built closed-system applicators, similar to the first SET cRCT.

Maintenance: The condition of the ET intervention will be monitored through village “walk-throughs” every 4 months. Any damage to ETs or walls will be recorded and repaired.

Insecticide retreatment. A random sample of 15 inserts in total will be collected from 5 randomly selected HHs in ET clusters to monitor the persistence of the insecticide on a bi-monthly basis using bioassays with local, field-collected (pyrethroid-resistant) mosquitoes. All inserts in the intervention households will be replaced with freshly treated inserts if bioassay mortality falls below 70%. Retrieved used ET inserts will be washed, dried, and retreated for the next servicing round.

Criteria for discontinuing or modifying allocated interventions {11b}

A study participant will be discontinued from participation in the study if:

Withdrawal of consent by subject or parent of cohort subject.

Cohort subject is non-resident for a significant portion of the malaria transmission season.

Cohort subject is not available for follow-up visits (i.e., lost to follow-up).

Subject experiences any clinically significant adverse events (AEs), laboratory abnormalities, or other medical conditions or situations such that continued participation in the study would not be in the best interest of the subject. This includes events that are not related to malaria or the ET intervention.

Development of any exclusion criteria.

The reason for participant’s premature termination will be documented on the appropriate page of the data collection forms and specified which of the following possible reasons were responsible for the study’s premature termination:

Serious adverse event (SAE); any events that are life-threatening or result in death, events that result in hospitalization or prolongation of existing hospitalization, events that result in persistent or significant debilitation or incapacity.

Participant’s consent withdrawal.

Lost to follow-up: A “lost to follow-up” is any participant who completed all protocol-specific procedures up to the administration of the investigational product or intervention, but was then lost during the study period to any further follow-up, with no safety information and no endpoint data.

Any other reason requiring a premature termination of the participant.

All study participants are free to withdraw from the study at any time without giving a reason. If a subject voluntarily withdraws or is withdrawn by the Principal Investigator (PI) during the study, data from their follow-up until that date will be used towards incidence analyses. A 20% LTFU was included in the sample size calculations, so there will be no new children recruited as replacement for follow-up during the study.

Strategies to improve adherence to interventions {11c}

The status of the intervention (damage to ETs) and general condition of all houses will be monitored by quarterly village walk-throughs by project staff in both study arms. In addition, a designated member of the study team will be available for householders to report ET-related construction problems and get them fixed during the trial.

The persistence of the chemical insecticide used on the inserts will be monitored bimonthly by taking a sample of inserts from the treated villages to the lab (these will be replaced with fresh inserts) and exposing mosquitoes to them in a controlled bioassay. We will use F1 adult female anopheline mosquitoes reared from field-collected eggs in WHO cone tests with a 3-min exposure and mortality monitored 1 day post-exposure. Mortality will be compared against equivalent mosquitoes (wild-type resistant) exposed to untreated “control” inserts. Inserts will be replaced once the mortality post-exposure falls below 70% (from previous results, we expect this to be every 10–12 months).

During ET insert retreatment rounds, the number and quality of the retrieved inserts will be monitored as an indicator of product quality and intervention adherence.

Relevant concomitant care permitted or prohibited during the trial {11d}

While the standard-of-care for clinical management of malaria and vector control interventions (e.g., LLINs, IRS) will not be withheld in either the study arm, these interventions will be monitored and recorded throughout the trial. At baseline, children enrolled into the cohorts will be provided a 3-day course of standard, first-line antimalarials (Coartem® or ASAQ Winthrop®, both Artemisinin combination therapies (ACTs) recommended by the NMCP in Côte d’Ivoire) to clear any malaria parasite infections as well as a new LLIN. In addition, subjects will be provided treatment for malaria infection throughout the follow-up period. Lastly, participants will be encouraged to continue LLIN use and not instructed to avoid alternative vector control tools (e.g., coils, topicals, aerosol sprays, repellents) which will allow for an estimation of the ET effect assuming all other measures are still occurring for malaria prevention, essentially providing insight on an additive benefit above that provided by currently recommended WHO malaria preventive measures.

Provisions for post-trial care {30}

Not applicable—the study will not provide post-trial care.

Outcomes {12}

The primary outcome measure is the incidence rate of malaria infection as measured by active infection and clinical malaria case detection in cohorts of 55 children (between 6 months and 10 years old) per cluster, 17 clusters per arm on a biweekly basis in peak transmission season and monthly basis in low transmission season. [Time Frame: 24 months].

Secondary outcome measures include:

Clinical malaria incidence measured in children between 6 months and 10 years old living in the study cohorts using passive case detection via the existing community health workers and health centers. [Time Frame: 24 months]

Malaria parasitemia measured in children between 6 months and 10 years old in the cohorts of 55 children. [Time Frame: 24 months]

Prevalence of moderate (defined as 7–9.9 g/dL hemoglobin) to severe anemia (< 7 g/dL hemoglobin) measured in children under 5 years of age in the cohorts of 55 children four times: at the start and end of the rainy season (April and November respectively) of Year 1 and Year 2. [Time Frame: 24 months]

Mean numbers of female malaria mosquitoes ( An. gambiae s.l., Anopheles funestus s.l. ) captured in study houses measured by CDC light traps in 20 clusters, 10 houses per cluster on a monthly basis. [Time Frame: 24 months]

Malaria parasite sporozoite rate assessed in 10% of all anophelines captured by CDC light trap. [Time Frame: 24 months]

Entomological inoculation rates measured in each study arm as the product of the anopheline vector density and sporozoite rate. [Time Frame: 24 months]

Other pre-specified outcome measures include:

Cost modeling will assess the cost-effectiveness of EaveTubes compared to the previously applied Screening + EaveTubes intervention, and compared to other vector control interventions such as long-lasting insecticide nets and indoor residual spray. [Time Frame: 24 months]

Assessments of willingness to participate and adoption of EaveTubes at the end of the study period through questionnaires and willing-to-pay surveys. [Time Frame: 24 months]

Participant timeline {13}

The duration of the current study is 2 years and 9 months. The first 6 months are for set up and baseline. The cRCT proper runs for 2 years with an additional 3 months for primary data analysis.

The epidemiological monitoring will require 1 to 2 visits per month, depending on the time of year (1 visit per month from November until April, and 2 visits during the peak season from May until October). The epidemiological monitoring visits are expected to last approximately 30 min, with an additional 30 min twice a year for anemia and respiratory testing.

The entomological monitoring will require 3 nights (6 pm–8 am) per house each month. ET installations will require approximately 3 months for an estimated 3000 households in 17 village clusters. Retreatment of netting inserts takes approx. 10 min per house and is done from the outside of the house.

Sample size {14}

The number of villages for the cRCT is estimated at 17 per treatment arm based on the power analysis which is detailed in the Statistical Analysis Plan.

The sample size determination on the required number of households per cluster for testing the primary hypothesis on PE is based on the hazard rate comparison in the proportional hazards regression model. With the following specifications: power = 80%, 2-sided type-I error rate = 5%.

True PE/Minimum effect size = 35%

Baseline first-time malaria infection hazard rate = 1.5 cases of falciparum malaria per person-year (conservative estimate based on control arm data from first SET cRCT)

Coefficient of variation (k) = 40% (based on first SET cRCT)

Loss to follow-up (LTFU) rate = 20%

Monitoring = 2 years to capture 2 peak transmission seasons

One interim analysis for efficacy and non-binding futility with the O’Brien-Fleming error spending function when 50% information is collected

With 17 clusters per treatment, 55 children (aged 0.5 to 10 years old) from 55 different households per cluster are expected to yield 1315 independent first-time malaria events with a 24-month follow-up period to yield 80% power in testing the primary hypothesis on PE. Since the sample size already factors in a 20% LTFU rate, there is no need for replacement subjects.

Recruitment {15}

Local workers will be recruited from the trial village to enhance community engagement and study participation. Community sensitization procedures will include meetings with village leaders and inhabitants to introduce the study and each of its components.

Assignment of interventions: allocation

Sequence generation {16a}.

The unit of randomization for the intervention and control will be a village cluster. For baseline, recruitment of participants for enrollment will be based on random HH selection following census and mapping of the study area. The study statistician will analyze baseline data to inform potential stratification criteria, i.e., baseline malaria incidence levels and/or adult entomological endpoints. Following stratification (as needed), allocation of individual villages to trial arms will be conducted using randomization. One of the eligible randomization allocations will be selected at a public ceremony in the presence of community leaders.

Concealment mechanism {16b}

Cluster allocation was randomly conducted using a lottery mechanism whereby pieces of paper will be marked ET and Control, placed in a basket, mixed, and then a randomly selected child will be asked to draw from the marked papers. Each drawn paper must correspond to a given village, until they are all listed out. This event will be a public ceremony in the presence of community leaders and the Ministry of Health.

Implementation {16c}

The study statistician will use a random number generator to generate the allocation sequence and assign clusters to treatment or control arms. Trained study staff will enroll participants to study clusters.

Assignment of interventions: blinding

Who will be blinded {17a}.

Given the nature of the intervention, it is impossible to conduct this study in a fully blinded manner but those parts of the data collection that can be blinded will be. Observer bias will be reduced where feasible. All laboratory work will be blinded. Mosquito collector bias will be reduced by using standard CDC light traps which do not rely on the ability of the fieldworker to collect specimens. Trap catches will not be examined and analyzed by those who collected them but by different technicians who will not know the trap location. We will use codes to identify any clinical samples. Electronic records will not carry the name of the research participants, only an alphanumeric code. Primary analysis by the project statistician will be conducted on blinded data (e.g., arms designated as treatment A and B or something similar).

Procedure for unblinding if needed {17b}

Datasets will only be unblinded once they have been locked.

Data collection and management

Plans for assessment and collection of outcomes {18a}.

The pre-trial “ramp up phase” will be used to recruit and train local staff, and obtain ethical approval for the trial. During ramp up, forty candidate villages will be identified based on size (100–300 households) and proximity to Bouaké, Côte d’Ivoire, i.e., within a 50-km radius of Béoumi town in the Béoumi district of the Gbêkê region. We will select 34 of the 40 candidate villages based on ET suitability (no/small wall gaps, solid roof, no/small open eaves) and indications of participatory willingness based on meetings with the community leaders.

In each of the 34 trial villages, project personnel will meet with the authorities in each community (“chef du village”) to obtain permission to talk to the village residents about the trial. Village outreach will begin with town hall meetings to explain the trial and the possibility of a village being assigned to the treatment or the control arm, to outline all trial activities that will take place in the villages, and to answer any questions from the audience. A few days after the town hall meeting, the chef du village will be contacted to find out whether the community agrees to participate in the trial.

During ramp-up, a Population Census will be conducted in all the villages. Householders will be asked for information about their households (#, age, gender of family members in their HH) and given a new bed net if they have fewer than 2 per HH so that universal coverage is guaranteed in both trial arms. HH owners will be asked a short series of questions regarding their use of vector control tools, the availability of health care in the village, and markers of socio-economic status (house quality and availability of goods). For each HH, we will record the number of structures/dwellings, their construction (wall type, roof type, open eaves, wall gaps), number of windows, and number of doors. Following the local customs and local health ministry procedures in Côte d’Ivoire, each household (which typically does not have addresses) will be assigned a letter-number code that will be written in chalk on the door-jam of the house. During these activities, every eligible child in the village (between the ages of 6 months and 8 years old) will be assigned a unique identifier and their parents given a card with that unique identifier.

Community health workers will receive refresher training from a clinician before the onset of the trial baseline period.

Baseline (includes intervention installation)

Based on the Population Census data, 55 children in each village will be randomly selected for active monitoring of malaria infection. Informed consent will be obtained, and these children will be given ID cards for presentation to study nurses and health workers.

The baseline prevalence of malaria infection in the cohorts will be measured by taking blood samples from all children and confirming parasite infection using rapid diagnostic tests (RDTs). At the end of the baseline period, at the onset of the clinical phase, the entire study cohort will be cleared of malaria parasites, regardless of infection status, using a standard dose of first-line antimalarials.

Baseline entomological sampling will be done in all clusters in both arms, in 10 randomly selected HH per cluster. Once informed consent is obtained indoor mosquito collections will be done using CDC light trap collections during 3 consecutive nights per house. Subsets of 10% of baseline collected anophelines will be identified at species level and tested for sporozoites to quantify the baseline EIR in each trial arm.

Once census and baseline prevalence data have been obtained, randomization will be done to allocate the selected villages to the trial arms which will potentially be stratified by epidemiological, environmental, and/or demographic factors if it is necessary. At the end of the randomization process, there will be 17 villages in the control arm and 17 in the treatment arm. In the 17 treatment arm villages, heads of households that are suitable for ET installation will be offered the option of having ETs installed.

Following randomization, trial personnel will go door-to-door in the 17 selected intervention villages to obtain consent from the owners of eligible (ET suitable) houses for the installation of ETs. ET installation will start in parallel: commencing in village clusters as soon as > 50% consent in that particular village has been obtained. It is estimated that 3-month installation time is needed for the 17 ET clusters. There is an expectation of > 70% of HHs with ET installation in the intervention clusters, with 8–10 ETs per house on average. Standard Operational Manuals (developed from the first SET cRCT) will be used. It is estimated that 4-month installation time is needed for the 17 ET clusters.

At the start of the clinical follow-up period, the clean ET netting inserts will be replaced with the deltamethrin-treated ET inserts in all treatment clusters. This is estimated to take 2–3 weeks’ time.

Clinical follow-up will run for 2 years to cover two high transmission seasons (typically associated with the rains, May–October) and the remaining lower transmission periods.

Epidemiological monitoring

The incidence of malaria infection and clinical malaria will be determined by active case detection in febrile children in the study cohorts. Clinical monitoring and treatment will be performed by trained nurses from the Institut Pierre Richet, who will collaborate with the community health workers present in the trial villages. On the first visit, in the trial baseline period, parasite prevalence will be measured in all cohort children by RDT (SD Bioline Malaria Ag P.f/Pan; Standard Diagnostics; Seoul, South Korea). Immediately following this initial blood sampling, every child will be treated with a 3-day course of standard, first-line antimalarials (Coartem® or ASAQ Winthrop®, both ACTs recommended by the NMCP in Côte d’Ivoire) to clear any malaria parasite infections.

Children enrolled in the active detection cohort will be visited every 2 weeks during the peak malaria transmission season (May–October) and monthly during the rest of the year when transmission rates are low (November–April). At each visit, the clinical team will record the axillary temperature of each child. If the child is febrile or has a history of fever in the past 48 h or the parents report that their child was sick, the child receives a physical examination and a record will be made of symptoms. A finger prick blood sample will be taken from all febrile children. RDTs will be used to detect Plasmodium infection.

Children who are RDT-positive and are diagnosed with uncomplicated malaria by the study nurse will be treated immediately with first-line antimalarials for 3 days. This is the standard procedure for diagnosing and treating malaria in Côte d’Ivoire. Because it is a malaria-endemic region, only symptomatic children are typically treated. ACT treatment for malaria will be provided free of charge through the NMCP system. The community health worker who normally provides diagnostic and treatment in the village will be responsible for monitoring the child until he or she is cured. If the child exhibits any symptoms of severe illness, he or she will be sent immediately to the closest health clinic for treatment. Children who have been treated for malaria will be considered not at risk for 2 weeks following treatment and there will be no data collection for these individuals during this time. Nurses and community health workers will capture history of travel away from the household to flag any cases that might be a result of infection while traveling outside the village.

Clinical malaria incidence will also be monitored continuously by passive case detection using the existing clinical system: Community Health Workers and local health facilities. Any enrolled child between 6 months and 10 years old will be counted whenever they are brought to a community health worker or local health clinic with a body temperature of ≥ 37.5 °C. These data are planned to be provided weekly to ET Trial personnel.

Twice a year (at the beginning and end of the peak transmission season), all cohort children of 5 years of age or younger will have a blood sample taken for immediate measurement of anemia. Blood samples will be checked for hemoglobin levels using a spectrophotometer (Hemocue Hb diagnostic system).

Entomological evaluations

Deltamethrin will be the AI deployed in ET. In addition, the standard pyrethroid-only net distributed in the study area is PermaNet 2.0, which contains deltamethrin. Long-term efficacy of the insecticide-treated ETs will be evaluated using periodic WHO cone bioassays to validate continued impact against resistant wild-type mosquitoes.

We will assess the impact of ETs on entomological measures of malaria transmission by measuring the density of Anopheles mosquitoes indoors on a monthly basis: in 20 clusters (10 ET, 10 control) in 10 randomly selected households per cluster. Per trial arm, 10 new clusters will be selected each month so that all study villages will be sampled bimonthly, as recommended by the WHO VCAG. In the 10 selected treatment clusters, we will select only ET-treated households. Mosquitoes will be captured indoors overnight using miniature CDC light traps placed next to a sleeper under an LLIN for 3 consecutive nights. These traps will be placed inside the house by Vector Control Product Evaluation Centre/Institut Pierre Richet (VCPEC-IPR) entomology technicians at 6 pm in the evening and collected by the technicians at 8 am the following morning. Mosquitoes will be sorted by Household ID and date of collection. Indoor temperature and relative humidity will be recorded in enrolled HHs during entomological sampling using data logging devices.

A subset of 10% of all caught mosquitoes will be identified by microscopy and the numbers of An. gambiae s.l. and other species recorded. In subsets of 10% of all caught anophelines, we will type to species level using PCR. Results will be used to estimate mean vector density and species composition per trial arm. For the An. gambiae and An. funestus samples in these subsets, we will assess the presence of sporozoites using CSP-ELISA. Sporozoite prevalence will be measured from a random sample of up to 60 anopheline females per cluster per sampling night.

We will estimate the EIR in each study arm (i . e. , mean number of sporozoite infective per bites per cluster per month) where we assume that a mosquito caught indoors and actively searching is able to bite the host.

Intervention quality monitoring

Integrity of the intervention (e.g., damage to the ET inserts) in the treatment villages and general house condition in all villages will be monitored by quarterly village walk-throughs every 4 months by project staff in both study arms. In addition, a designated member of the study team will be available for householders to report ET-related construction problems and get them fixed during the trial.

A combination of standardized paper-based or digital forms (under Android tablets) will be used. VCPEC-IPR and University of Notre Dame (UND)/Center for Research Computing (CRC) will work together to develop the quantitative forms to be uploaded on Android tablets. Entered data (entomological and epidemiological) will be automatically assessed for quality using established quality control rules, then reviewed, and appended to the data already present. Data forms can be made available upon request submitted to UND.

End of trial

The final clinical survey of the child cohort will take place at the end of the 24-month follow-up. The final light trap collection will take place at about the same time.

At the end of the trial, HH owners will be offered to have the ETs blocked with a closed insert or plastic cap to block the tubes. However, we intend to liaise with stakeholders throughout the trial to gage interest in providing continued retreatment for ET inserts after the trial, as is now taking place in Côte d’Ivoire.

Sub-studies

The sub-studies described in this section are not part of the WHO-approved clinical study design as they are secondary endpoints and not part of the primary evaluation of public health impact of the intervention.

We will conduct an assessment of key user acceptance indicators and cost-effectiveness of the ETs intervention vis-a-vis other alternative technologies or practices available. These sub-studies will be critical for successful scaling of the product, as they will help identify the most socially acceptable and sustainable way of achieving and maintaining high coverage of ETs. User acceptance does not always translate into adoption unless the intervention is found to be affordable and more cost-effective compared to other available options for malaria protection. In this regard, cost-effectiveness analyses are planned in this study.

Cost-effectiveness studies

A Global Health Economist within UND’s Keough School of Global Affairs will conduct an economic evaluation to estimate the costs and cost-effectiveness of the ETs intervention. The cost analysis will take the gold-standard, societal perspective which includes both provider and community costs. Implementation costs will be carefully monitored during ETs installation and maintenance activities. Data on incremental costs of the ETs product, house modifications during install, and their sources will be collected from project expenditure records. Household costs will be collected at cohort enrolment shortly after intervention installation, and the unit costs (cost per house and person) will be calculated. This cost study will demonstrate the costs of using ETs as a stand-alone tool compared to the previously combined intervention of SET.

The cost-effectiveness analysis will have the primary endpoint of cost per disability-adjusted life years (DALYs) averted by ETs. Incremental cost per DALY averted for ETs (Intervention arm) relative to LLINs alone (control arm) will be calculated using the epidemiological data collected during the trial. Cost-effectiveness ratios will be presented as point estimates and ranges (using the confidence intervals (CIs) on the epidemiological data and reflecting any uncertainty in costs) and interpreted against a range of willingness to pay thresholds and in relation to the cost-effectiveness of other malaria control interventions.

Cost modeling will assess the cost-effectiveness of ETs compared to the previously applied SET intervention, and compared to standard vector control interventions such as LLINs and IRS. The potential cost-effectiveness of ETs at scale over time will be simulated to facilitate comparison with other malaria control interventions and cost-effectiveness benchmarks. We will measure the cost of ETs’ implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness to incentivize potential procurers.

User acceptance studies

Social scientists from the Institut Pierre Richet will use quantitative methods to assess ETs’ adoption, adherence, and acceptability among study participants. Combined, endpoints from these assessments will inform potential bottlenecks to product access, uptake, and implementation post-trial.

Ethnographic data will be collected during the baseline population census to inform socio-economic status of households and participants. Adoption will be assessed using indicators of informed consent rates and ETs coverage rates in the trial. Adherence will be assessed via quality control monitoring of ETs’ integrity during the trial. User acceptance will be measured based on inhabitants’ willingness to pay and continue using ETs after the trial through an endline survey.

To design potential strategies for scale-up, we will identify and engage with key local, national, and international level stakeholders, involving them in discussions and creating a driving team to identify mechanisms for expansion and institutionalization while acting as advocates for the innovation.

Plans to promote participant retention and complete follow-up {18b}

Participant retention strategies include fostering relationships with participants, provision of community health worker and nurse contact information for easy communication to alleviate concerns, and periodic generation of retention rates to evaluate strategies.

Data management {19}

UND will achieve a systems approach to protocol adherence, implementation, data gathering, and sharing by installing a program monitoring plan (i.e., data gathering, training oversight, overall program progress) that will support rigorous data collection for policy recommendation. The UND CCRC will host the data server and will be responsible for data management, data form processing, and provision of support for training in-country collaborators’ data entry personnel.

Hardcopies of study and study-related documents (e.g., protocols, raw data, documentation, and final reports generated during a study, as well as chemical usage sheets) will be stored at VCPEC-IPR in a locked filing cabinet under the supervision of a designated archivist. Electronic data will be stored on UND servers with restricted access.

After study files have been held in the VCPEC-IPR for 5 years, the archivist will contact the sponsor to determine their future storage requirements. At the request of the Sponsor, it will either continue to be kept at VCPEC-IPR, sent to the Sponsor for storage, or destroyed. All hardcopies of documents will be destroyed by shredding and data on disks will be wiped, and the disks broken prior to disposal in the VCPEC-IPR waste.

Confidentiality {27}

Study subjects will be identified only by their study identification number and any electronic database will only contain their study identification number. Personal identifiers will be removed from the transcripts of interviews and discussions with participants being identified only through a study identification number. Thus, all data will be anonymized on data entry. The UND CRC databases will be password-protected and accessible only to authorized personnel. All hardcopy documents will be securely stored in locked filing cabinets and accessible only to authorized personnel.

The PI will maintain appropriate medical and research records for this study in compliance with the principles of good clinical practice and regulatory and institutional requirements for the protection of confidentiality of participants.

The authorized representatives of the sponsor, the ethics committee(s), or regulatory bodies may inspect all documents and records required to be maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) for the participants in this study. The clinical study site will permit access to such records.

Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Not applicable. Study has no planned future uses for the biological specimens.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}.

The baseline characteristics of the enrolled subjects, households, and clusters will be summarized by treatment arm (control arm, LLIN and intervention arm, ET + LLIN). Specifically, we will examine subject age and gender at the individual level, wall type and roof type, house open eaves, number of windows, number of doors at the household levels, and cluster population and baseline prevalence rate at the cluster level.

In the following analysis that involves malaria incidence, a child will not be considered at risk for malaria for 2 weeks after any treatment for malaria.

Protective efficacy (PE) against clinical malaria infection will be determined by comparing hazard rates of malaria clinical cases between the two treatment arms based on an intention to treat (ITT) analysis. The primary hypothesis on PE against overall malaria case incidence will be tested by comparing the hazard rates of the overall malaria case incidence between the control and ET in the ITT population using a proportional hazards model. The model will include relevant individual-level, household-level, and cluster-level baseline covariates, treatment assignment, and follow-up visits and random effects to account for correlations among the subjects within the same cluster and among multiple infections within the same individual. The hazard ratio \(\beta\) between ET and control will be estimated, along with a 95% confidence interval. The null hypothesis of PE = 0% is equivalent to \(\beta =0\) , which will be tested by the Wald’s test \(z=\widehat{\beta }/s\) , where \(s\) is the estimated standard error of \(\widehat{\beta }\) . There will be one formal interim analysis to test the primary hypothesis. The decision boundaries are calculated for either stopping for futility or stop for efficacy using the O’Brien-Fleming error spending function [ 8 , 9 , 10 ], with a 2-sided Type I error rate of 0.05, Type-II error rate of 0.2; baseline incidence rate of 1.5 per person-year, and between-cluster CV of 40%. The interim analysis will occur when 658 events (50% information) are collected. Assuming a baseline incidence rate of 1.5 per person-year, the interim analysis is estimated to occur around the end of Year 1 of the intervention follow-up. Due to the formal interim look at the data which costs a certain amount of type-I error rate and type-II error rates, the final critical value is different from what would be for a study without the interim look.

If the z-score of the log(hazard ratio) from the comparison between ETs and control at the interim look is >  − 0.7288 then the study can stop for futility (if z -score > 2.7965, the trial would stop for definitive harmful effects of ETs though the chance this would occur is close to 0 if not 0), the study can stop for futility. Since we adopt the non-binding futility boundary the study can continue to collect more data even if we cross the futility boundary at the interim look, there will be no inflation of type I error. In other words, the trial does not need to stop to accept the null hypothesis when the test statistic falls in the futility region at the interim stage. If the interim z-score <  − 2.7965 then the study can stop for efficacy. The study may also continue even if the efficacy boundary is crossed at the interim look, and there will be no inflation of type I error as efficacy is already established at the interim. If the interim z-score falls within (− 2.7965, − 0.7288), the study continues.

If the interim results do not cross either the futility or efficacy boundaries, the z -score from the final analysis upon the completion of the study will be compared with − 1.9744. If the z -score <  − 1.9744, we reject the null hypothesis, claiming ETs reduce the malaria hazard rate compared to control at the significance level of 5%; if the z -score > 1.9744, we fail to reject the null hypothesis, claiming ETs do not reduce the malaria hazard rate compared to control in Cote d’Ivoire. If the interim results cross either the futility or efficacy boundaries, the final analysis is only conducted for estimation purposes, as the futility or efficacy of ETs is already established at the interim.

PE of ETs against malaria infections (both with clinical symptoms and asymptomatic)

A similar proportional hazard model used for analyzing the primary endpoint above will be applied. The malaria hazard ratio between ET and control will be estimated, along with 95% CI.

PE analysis without baseline covariates

A PE analysis of clinical malaria infection will be also performed by removing all the baseline covariates from the proportional hazards presented above and keeping the treatment arm as the only covariate in the proportional hazard model. The hazard ratio between ET and control will be provided, along with a 2-sided 95% CIs. A similar analysis will be performed for clinical and asymptomatic malaria infections combined.

The first study on ET [ 14 ] suggests ET has a protective effect against anemia. In this study, an in-depth health examination of the recruited children for malaria follow-up will be conducted at the beginning and the end of the transmission season in both Year 1 and Year 2 to monitor severe anemia. A mixed-effects logistic regression will be used to compare ETs and control in the anemia proportion. The model has anemia status (Y or N) as the outcome; a similar set of covariates as in the proportional hazards model in the primary endpoint analysis is used, with two additional terms of time (baseline, Year 1, Year 2) and time-by-treatment interaction, along with random effects to count for correlations among the subjects within the same cluster and among multiple anemia episode within the same subject, used. The regression coefficient associated with treatment arm quantifies the ratio between the ET and control arms on the odds of getting anemia, which will be estimated, along with a 95% confidence interval.

Effect of ETs on malaria prevalence

Malaria prevalence data will be collected at baseline and at the end of Year 1 and Year 2. A mixed-effects logistic regression as used in the anemia analysis above will be used to compare ETs and control on malaria prevalence over time, with the outcome anemia status being replaced malaria status (Y or N).

Incidence rate

The malaria incidence rate is defined as the ratio of the number of new malaria cases during the follow-up period vs the sum of the time at risk (in year) across the individuals within the same cluster. The incidence rates per person-year during the whole intervention follow-up will be calculated by cluster in the ET and the control arms respectively. Summary statistics of the cluster-level incidence rate will be provided by treatment arm; the incidence ratio between the two arms will be also calculated.

Effects of ETs on entomology

The endpoints in the entomological analysis include anopheline density collected by light-trap, anopheline sporozoite rate, and anopheline EIR.

We will report the frequency and proportion of each anopheline mosquito Genus and species collected using a light trap for each cluster and by treatment arm. The time profile plots of overall anopheline density will be obtained at the baseline and during the intervention period. An appropriate statistical model for anopheline density will be identified after examining the distributional characteristics of the density data, which are likely to follow (zero-inflated) Poisson distribution or (zero-inflated) negative binomial distribution if there is over-dispersion. The covariates in the models will include fixed effects of treatment, time, cluster population size, number of houses in a cluster, and a random effect for cluster. The ratio between ET and control in anopheline density will be estimated along with a 95% CI; the %reduction in anopheline density by ET is given by (1 − density ratio) × 100%.

The analysis for sporozoite rate will be similar to that for analyzing mosquito density If the data on sporozoite positivity are highly unbalanced in the sense that the marginal distribution of the variable (e.g., 99% negative sporozoite), then the model might lead to unstable estimates or the model might not even converge. The ratio between ET and control in sporozoite rate will be estimated along with a 95% CI; the %reduction in sporozoite rate by ET is given by (1 − sporozoite rate ratio) × 100%. In such cases, only summary statistics will be provided. EIR is the product of the anopheline vector density and the sporozoite rate and its analysis is similar to what’s used for analyzing sporozoite rate. Summary statistics will be provided on sporozoite rate and EIR at baseline and per year during the intervention period by treatment group.

Analysis of the relationship between malaria hazard rate and entomological endpoints

To explore the relationship between the malaria hazard rate and the entomological endpoints, a similar model as the proportional hazards regression model used to address the primary objective on the malaria infection will be applied to the clusters from which the entomological data are collected, with similar random effects specification. For the covariates in the model, in addition to those used for analyzing the primary endpoint, we will also include a covariate that captures the entomological information; whether it is a linear or non-linear term will be informed by the exploratory data analysis of the relationship between the cluster-level incidence rate and each of the entomological endpoints (e.g., indoor mosquito density and sporozoite positivity rate if there is enough data). The regression coefficient associated with the entomological covariate quantifies how the entomological covariate affects the malaria hazard rate.

Safety assessment

Mean, minimum and maximum frequency, and percentage of AEs and SAEs across clusters among enrolled subjects will be summarized by treatment arm. The AE/SAEs summary will be provided for both clinical diagnosis and symptoms. In addition, they will be labeled as Probable, Possible, Plausible (such as dermal events, oral events, Inhalation events), or Unlikely (eye Irritation, headache) due to ETs.

Interim analyses {21b}

A formal interim analysis during the intervention period will be conducted to test the primary hypothesis as outlined above. The interim analysis will be performed by an independent statistician on the DSMB, and the interim outcome report will be shared only with In2Care and VCAG, not with UND or Cote d’Ivoire investigators to mitigate unintentional bias in data collection in the remaining period of the study after the interim analysis. The final decision to stop should always rest with the DSMC, not the investigators, or the funder.

Methods for additional analyses (e.g., subgroup analyses) {20b}

The analysis outlined in the primary and secondary analysis will be based on the intent-to-treat (ITT) dataset. The study will also examine the per-protocol (PP) dataset. If the PP dataset differs significantly from the ITT dataset for a particular analysis, the analysis will also be performed in the PP dataset.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

Significant effort will be made to avoid having missing values on outcome (malaria infection status and visit dates, and entomological endpoints). When missing values occur for an outcome for reasons not related to the outcome, reasons for missingness and the missing fraction by treatment arm and cluster will be reported. Per protocol, the subjects are screened actively on the malaria status (the outcome) every 4 weeks.

If a subject misses one or more scheduled visits due to reasons not related to the ETs product or the outcome, the subject will have missing values on the outcome that can be regarded as ignorable missingness (MAR or MCAR [ 11 ]).

If a subject drops out study due to reasons unrelated to the ETs product and/or malaria infection, then the missing observations from the subject can be regarded as ignorable missingness (MAR or MCAR [ 11 ]).

In both cases, all the available data from the subject will be included in the primary and secondary analysis, without employing any specific missing data analysis techniques, due to the ignorability of the missing mechanisms [ 11 ].

Missing baseline covariates (individual-level, household-level, and cluster-level) that are a part of the regression models for the outcome of interest will be imputed using simple hot-deck imputation methods if the missing fraction for the covariate is < 5%. If the missing fraction for a covariable is ≥ 5%, appropriate multiple imputation approaches will be applied. If ≥ 50% of the subjects have missing values on a covariate (due to missing at random or missing completely at random), that covariate will be excluded in the model.

Plans to give access to the full protocol, participant-level data, and statistical code {31c}

The SAP and analytic code will be made open access. Data and supporting information will be made available 12 months following the completion of data analysis and will remain open access in the public domain.

Oversight and monitoring

Composition of the coordinating center and trial steering committee {5d}.

In2Care will serve as the lead organization for this program and will assume the overall responsibility for management, oversight, and administration for the program. The coordinating personnel at UND will include the Lead PI, Co-Investigators, Program Manager, and Finance Manager. UND will communicate on a day-to-day basis with In2Care and VCPEC-IPR. VCPEC-IPR will be responsible for running the cRCT on a day-to-day basis which includes but will not be limited to conducting a baseline survey, deploying ETs, entomological monitoring, and subject follow-up. Representatives from VCPEC-IPR and UND will all serve on the data management team to oversee the development and implementation of data collection, recording, and cleaning.

A Trial Steering Committee (TSC) will be established. Members on the committee will have the clinical, epidemiological, and statistical expertise to monitor study progress and safety of participants, and the committee will have access to the study data. SOPs will be developed, adhering to Good Clinical Practice and Good Field Entomology Practice.

Composition of the data monitoring committee, its role, and reporting structure {21a}

The trial will not consist of a data monitoring committee as the TSC will serve in this capacity. In addition, routine data monitoring and management for Quality Assurance and Quality Control will be conducted in partnership between UND and VCPEC-IPR data management teams.

Adverse event reporting and harms {22}

Safety oversight will be carried out by the TSC. Children of the study cohorts will have access to the current standard of care. Serious adverse events (SAEs), whether attributed or not to ETs or LLINs, will be recorded throughout the trial. The host institution medical expert (Dr. Serge Assi) and his clinical team will be responsible for recording, reporting, and managing SAEs, including follow-up, in accordance with national guidelines. A summary table of all SAE will be provided at regular intervals to the TSC.

Frequency and plans for auditing trial conduct {23}

The Chief Investigator will permit study-related monitoring, audits, and inspections by the study sponsor, IRB, TSC, and government regulatory bodies, of all study-related documents (e.g., source documents, regulatory documents, data collection instruments, study data, etc.). The investigator will ensure the capability for inspections of applicable study-related facilities (e.g., pharmacy, diagnostic laboratory, etc.).

Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}

All amendments to the protocol will be documented. Substantial amendments will require a report and approval by the TSC and/or the ethical review boards.

Dissemination plans {31a}

Dissemination of results includes submission to WHO VCAG, workshop with study partners, on-site meetings in Cote de Ivoire, and presentations at scientific meetings and/or peer-reviewed publications.

Control efforts in sub-Saharan Africa over the past 15 years have prevented millions of clinical cases of malaria caused by Plasmodium falciparum [ 1 ]. Vector control tools, LLINs and IRS, are estimated to be responsible for a majority of those averted cases [ 2 ]; however, insecticide resistance has seriously hampered their efficacy in recent years. Because of the impact of vector control on malaria transmission, new tools which are cost-effective, environmentally friendly, and socially acceptable need to be developed to complement the existing arsenal.

In2Care® ETs could help meet the pressing need for new vector control tools. ETs are an inexpensive, field-ready technology, informed by mosquito ecology to efficiently target and kill malaria vectors. In a previous cRCT conducted in Côte d’Ivoire, ETs + window screenings were shown to reduce malaria case incidence by 38% and by 47% in villages with > 70% coverage [ 14 ]. The objective of the current trial is to further demonstrate the epidemiological and entomological impact of ETs and generate additional data required by WHO to assess public health value.

Trial status

Protocol version 4.0 from July 17, 2022. The study has currently completed the baseline prevalence survey (as of June 22, 2023), whereby participants were recruited, screened, and enrolled for confirming parasite infections using RDTs. Baseline data analyses are ongoing to verify underlying assumptions of malaria prevalence and coefficient of variation. Recruitment, screening, and enrolment of subjects for follow-up with intervention are scheduled to commence in August 2023.

Availability of data and materials {29}

The statistical analysis plan and analytic code will be made open access. The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain. Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations

Artemisinin combination therapies

Adverse event

Active ingredient

Center for Research Computing

Cluster randomized control trial

Confidence interval

Disability-adjusted life year

Entomological Inoculation Rate

Identification

Indoor residual spray

Vector Control Product Evaluation Centre/Institut Pierre Richet

Intention to treat

Long-lasting insecticide net

Loss to follow-up

Missing at random

Missing completely at random

National Malaria Control Program

National Institute of Public Health of Côte d'Ivoire

Protective efficacy

Principal investigator

Rapid diagnostic test

Serious adverse event

Statistical Analysis Plan

Screening + EaveTubes

Trial Steering Committee

University of Notre Dame

Vector Control Advisory Group

World Health Organization

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Acknowledgements

We thank our trial steering committee, the field staff, and the community health workers involved in the trial, the district health officials, and all the trial participants.

This trial has received financial support from the Fund for Innovation in Development (Grant no. AFD CCII9O8 OIM), USAID Development Innovation Ventures (Grant no. 7200AA21FA00042), and the Achmea Foundation (Agreement 19 Dec 2022). Funders have no role in the design of the study and collection, analysis, and interpretation of data and in the writing of the manuscript.

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Vector Control Product Evaluation Centre/Institut Pierre Richet, Bouaké, Côte d’Ivoire

Raphael N’Guessan, Serge-Brice Assi, Alphonsine Koffi, Phamien Ludovic Ahoua Alou & Anatole Mian

University of Notre Dame, Notre Dame, IN, USA

Nicole L. Achee, Benedicte Fustec, John P. Grieco, Fang Liu, Matthew Noffsinger & Ashley Hudson

In2Care BV, Wageningen, Netherlands

Tim W. R. Möhlmann & Marit Farenhorst

Keough School of Global Affairs, University of Notre Dame, Notre Dame, IN, USA

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Contributions

RN, SA, AK, AAP, NLA, JPG, BF, FL, PK, TM, and MF contributed to the development of this protocol. FL developed the statistical analyses plan and is responsible for conducting data analyses. SK will be responsible for economic evaluations. AM and MN will be responsible for data management. RN, SA, AK, AAP, and PK will be responsible for trial implementation, data collection, and sample analysis. AH drafted the manuscript. All authors reviewed and approved the final version of this manuscript.

Corresponding author

Correspondence to John P. Grieco .

Ethics declarations

Ethics approval and consent to participate {24}.

Protocol approved by the National Ethics Committee of Life Sciences and Health (CNESVS) US DPT of HHS (110–22/MSHPCMU/CNESVS-kp) and UND IRB (22–10-7454). Informed consent to participate will be obtained from all participants.

Consent for publication {32}

Manuscript will not include any details, images, or videos relating to an individual person. Model consent form will be provided upon request to Sponsor ([email protected]).

Competing interests {28}

MF and TM are remunerated by and hold shares in In2Care BV. The other authors declare that they have no competing interests.

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N’Guessan, R., Assi, SB., Koffi, A. et al. EaveTubes for control of vector-borne diseases in Côte d’Ivoire: study protocol for a cluster randomized controlled trial. Trials 24 , 704 (2023). https://doi.org/10.1186/s13063-023-07639-9

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DOI : https://doi.org/10.1186/s13063-023-07639-9

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Study of active design strategies to enhance physical activity in university educational buildings: a case study at King Abdulaziz University

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Saudi Arabia is taking significant steps to improve urban lifestyles by implementing the Quality-of-Life Program, which focuses on increasing public participation in physical activities. Studies have shown a link between physical inactivity and poor health. A large percentage of the adult population does not meet the World Health Organization's physical activity recommendations due to many reasons, including the lack of active design strategies in the built environment. This research aims to measure the extent to which active design strategies are applied in university buildings at King Abdulaziz University in Saudi Arabia and suggest recommendations for university educational buildings in KSA. A comparative analysis of systems for evaluating the application of active design strategies was conducted, and The Movement Checklist in WELL Building Standard was used as a tool to evaluate educational buildings. Additionally, a questionnaire and interviews were used to identify the awareness of the study sample of the importance of physical activity and to discover appropriate active design strategies for them. The findings of this research will help to inform the development of active design strategies that can be applied to university educational buildings in KSA and will contribute to achieving the objectives of the National Transformation Program's Quality-of-Life Program.

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1 Introduction

In the Kingdom of Saudi Arabia, the Quality-of-Life Program was launched in 2018 as part of the country's Vision 2030 initiative to improve the quality of life for Saudi residents. The program aims to develop the environment and provide the necessary options to enhance participation in activities that improve the quality of life. One of the main objectives of the program is to promote sports activities in the community, with a commitment to reaching 40% of individuals engaging in sports and physical activities on a weekly basis by 2030 [ 1 ], in line with the third Sustainable Development Goal (SDG) to ensure good health and well-being.

The World Health Organization recommends that adults between the ages of 18 and 64 engage in at least 150 min of moderate physical activity per week, 75 min of vigorous physical activity per week, or an equivalent combination of moderate and vigorous activity. To maximize health benefits, adults should increase their amount of moderate physical activity to 300 min per week, or equivalent, and should do muscle-strengthening activities targeting major muscle groups on two or more days of the week [ 2 ].

The study by Hudson et al. confirmed the beneficial health effects of physical activity and the dangers of sedentary lifestyles [ 3 ]. Screen time was identified as one of the biggest contributors to idle time today. Stamatakis et al. found that prolonged periods of sitting were associated with a higher risk of mortality, and this risk was limited to those who did not meet physical activity recommendations. Increasing physical activity was identified as an important strategy for preventing cardiovascular disease and premature mortality in a physically inactive population [ 4 ].

Several studies have reported numerous public health benefits associated with physical activity, which have been widely discussed, such as improved quality of life, sleep, and cognitive function over a lifetime, these benefits include reduced risk of dementia, excessive weight gain, and cancer Additionally, physical activity can reduce the risk of gestational diabetes and fall-related injuries in adults [ 5 , 6 ]. Overall, the dangers of inactive behavior vary between physical and psychological health risks. Therefore, it is important to recognize the significance of physical activity in reducing the risks associated with sedentary lifestyles.

Despite widespread awareness of the importance of physical activity, the latest global estimates show that 1.4 billion adults (27.5% of the world's adult population) are not engaging in the recommended level of physical activity. This highlights the need for greater awareness and action to promote physical activity worldwide. In Saudi Arabia, the General Authority for Statistics estimates for 2021 showed that 70.3% of the population does not meet the recommendations of the World Health Organization. This is due to several reasons, including transportation patterns, increased use of technology, and difficulty in accessing safe and appropriate programs and places for physical activity [ 7 , 8 , 9 ]. As a result, many diseases associated with a lack of movement and a low level of physical activity have emerged in Saudi society, especially among university youth.

Several studies have been conducted to identify the attitudes of Saudi university students toward physical activity and the barriers to it. Jifri studied the attitudes of King Abdulaziz University students towards physical activity and found that there is a need to spread health and cultural awareness about the importance of physical activity and its impact on health. Additionally, the study recommended the need to develop and strengthen the attitudes of students towards physical activity through periodic newsletters, educational lectures, and more activities and sports gatherings [ 10 ].

Samara et al. found that there was a decrease in the self-efficacy of physical activity among female Saudi university students in Riyadh, although these students showed awareness of the benefits of physical activity on health and well-being. The lack of facilities and encouragement was identified as barriers to physical activity [ 11 ]. The study by Al-Drees et al. aimed to identify physical activity habits and examine their association with the average cumulative grades of students in the Faculty of Medicine at King Saud University in Riyadh. The study showed positive associations between physical activity habits and high academic achievement [ 12 ]. This highlights the need to establish educational programs on physical activity and public health to reinforce the importance of physical activity among the Saudi population.

The study by Al-Muhazaa aimed to explore the motivations and obstacles to physical activity as a healthy lifestyle among female students at King Saud University. The results showed that the students were motivated by factors such as maintaining weight, health, youth, and good appearance, and viewed physical activity as a hobby. The recommendations included providing healthy food in the university sports club, advertising competitions and activities, providing nutritionists, and carrying out campaigns to raise awareness about physical activity. Banners should also be placed at elevators to emphasize the importance of physical activity [ 13 ].

Sayyds et al. study revealed that the most important factors that impede the success of physical and sports activities among males in the universities of the Kingdom of Saudi Arabia are a lack of energy, motivation, self-confidence, and time, while females face a lack of social support and resources [ 14 ]. This highlights the need for more research to realize the potential in this field in the Kingdom of Saudi Arabia and achieve the goals of Vision 2030.

Several studies have addressed the obstacles that hinder the practice of physical activity in universities. The study by Hu et al. indicated that Chinese university employees are more likely to work extra hours than usual. Although they intend to exercise, the feeling of a lack of time remains a constant barrier to physical activity [ 15 ], as confirmed by the Oster et al. study. Public health measures associated with the COVID-19 pandemic have further exacerbated the issue, leading to reduced opportunities for physical activity for college students. Despite the hardships posed by the pandemic, finding motivating ways to be physically active can lead to positive outcomes for students, such as improved physical and mental health, as well as opportunities to reconnect with people and places [ 16 ].

A study by Golubev et al. concluded that the average duration of time spent by students at the university ranges between 6–8 h per day, and they take about 2–4 h every day to prepare for classes. The study also found that a third of the undergraduate students suffer from some chronic diseases and lack awareness of the indicators that reflect the state of human health. Yet, 95.7% of the students interviewed agreed with the opinion that a person should live a healthy life [ 17 ]. Another study by Kolokoltsev & Jagiello evaluated the weekly physical activity level of fourth-year students at the Technical University of Russia. They found that 23.4% of the students had low levels of physical activity and motor skills, indicating a tendency of young students to lack movement, which is a sign of the risk of developing chronic diseases in the body [ 18 ].

From the evidence presented, users of university buildings have low levels of physical activity, and there are obstacles preventing them from engaging in physical activity, such as a lack of time. To address this issue, several studies have been conducted to motivate and increase physical activity on university campuses. Additionally, research has suggested the need to develop a positive attitude towards physical activity in Saudi universities. However, most of the studies related to Saudi universities have only focused on raising awareness of the importance of physical activity without addressing the application of active design strategies related to the built environment and designing buildings to promote physical activity. This highlights the importance of further research in this area, as well as the need to explore the potential of active design strategies to create an environment that encourages physical activity and promotes healthy lifestyles. Additionally, it is important to consider the cultural context of Saudi universities when designing buildings to ensure that the strategies are effective and appropriate.

1.1 The role of the built environment in promoting physical activity

Caspersen et al. suggest that physical activity can be divided into different categories, such as light, moderate, or heavy intensity, voluntary or compulsory, and weekday or weekend activities. These subdivisions should be mutually exclusive and should add up to the total caloric expenditure caused by physical activity [ 19 ].

Powell et al. discuss various intervention strategies that have been effective in increasing physical activity (see Fig.  1 ), including those aimed at individuals, community settings, and programs delivered through a range of information and communication technology channels. Elements of the built environment are also associated with increased physical activity. Some interventions have small effect sizes, but others, such as telephone-assisted advice, mobile phone interventions, and sedentary behavior worksite interventions, have produced medium to large effect sizes [ 6 ].

Targeting social and environmental factors to promote physical activity and reduce sedentary behavior, as adapted from Powell et al.'s study [ 6 ]

This research focuses on community-level, multicomponent university-based interventions aimed at increasing students' physical activity throughout the school day. These interventions include physical environment and policy interventions integrated into neighborhoods and the built environment in which people live, work, and play [ 2 , 6 , 20 ]. The importance of environments and policies in influencing public health outcomes is well-documented [ 21 ]. Changes in these factors can have a profound and lasting impact on entire societies, making them a key focus for public health initiatives. By understanding the effects of environmental and policy changes, public health professionals can develop effective strategies to improve population health.

The importance of the built environment in promoting physical activity has been widely studied. For example, Engelen et al. found that moving to a health-promoting building reduced sedentary behavior and improved physical activity, workplace perceptions, and workplace productivity [ 22 ]. Similarly, Tannis et al. found that many minority and low-income families live in neighborhoods that are not designed to support physical activity and healthy eating, leading to higher rates of chronic diseases. This study suggests that active design strategies should be adopted in affordable housing to promote healthier lifestyles and physical activity [ 23 ]. Kolokoltsev & Jagiello's study recommended the use of innovative methods to increase students’ motivation for self-motor activity. The results of the study indicated an increase in students’ physical activity after completing training in the physical education program at the university due to students’ increased motivation for motor activity [ 18 ].

The built environment is not limited to physical structures and infrastructure that are visible. It also comprises the social, economic, and cultural aspects of the places we inhabit. The built environment has the potential to influence how people interact with each other, how they access resources, and how they experience their surroundings. Furthermore, it can shape people's perceptions of their environment and how they utilize it. By comprehending the intricacies of the built environment, we can create places that are more equitable, sustainable, and enjoyable for everyone [ 24 ].

1.2 Active design elements & strategies

Most studies of physical activity conducted by public health and behavioral scientists traditionally focused on recreational or leisure-time physical activity. However, in the late 1990s, public health professionals began to recognize the importance of physical activity in other aspects of life, such as transportation, work, and home activities. This shift in focus led to the development of the concept of “Active Living,” which encompasses all forms of physical activity, including exercise, recreational activities, home and occupational activities, and active transportation [ 25 ]. This broader concept has enabled researchers, policymakers, and practitioners to better understand the role of physical activity in promoting health and well-being. For example, transportation planners, urban planners, and designers have been researching how to design cities so that people can walk and cycle more [ 26 ]. This shift in terminology from exercise to physical activity to active living symbolizes the evolution in how physical activity is conceived, the disciplines involved, and the conceptual models used to guide research, policy, and practice [ 21 ].

The phrase "active design" first appeared in the Active Design Guidelines, a guide published by the City of New York in 2010, to create healthy buildings, streets, and urban spaces based on the latest academic research and industry best practices [ 27 ]. Active design is an evidence-based approach that uses architecture and urban planning to promote physical activity and make healthy foods more accessible and attractive. It has been recognized by various sustainable and green building rating systems [ 28 ], and is one of the strategies for the built environment to improve health outcomes. Engelen et al. noted that active design considers how features of the built environment can support daily physical activity, such as the inclusion of central staircases, light and attractive walkways, communal areas, and toilets adjacent to central areas that can increase physical activity [ 22 ].

Numerous studies have highlighted the importance of the built environment in promoting the health and well-being of users [ 29 ]. Organizing spaces in work environments, such as restrooms, cafeterias, and meeting rooms, within walking distance of individual workplaces can help establish routine walks for users at least once or twice a day [ 30 ]. To further encourage physical activity, these spaces should be located in central, visible locations in the building, with good views of the activity spaces from the movement paths within the building. This will help increase awareness of these spaces and their use, as exercise is more attractive when it is in places with views of nature and human activities [ 31 ].

New strategies, such as motivation, which make use of play elements to simulate desirable behaviors, have been added as fun and innovative ways to encourage healthy behaviors, such as climbing stairs, in both public and private spaces. This can create movement opportunities throughout the day. Study-based guidelines, such as the Active Design Guidelines, suggest that staircases should be close to key entry points and physically present and visible prior to elevators [ 27 ]. Escalators should be avoided unless the influx of large numbers of people makes it necessary for pedestrian safety. In transport facilities such as train stations, research indicates that escalator use is reduced by 50 percent when a second escalator is provided [ 32 ]. Additionally, buildings with escalators have been found to have the lowest rates of stair use [ 33 ].

Engelen et al. found that motivational and instructional posters for reinforcing the use of stairs showed small or no effects. The future of interventions promoting the use of stairs in occupational settings may require more interactive or personalized intervention methods. Posters promoting the use of stairs may be a thing of the past, and this should be factored into future workplace health promotion efforts to increase physical activity. New and interactive approaches using new media are recommended [ 34 ]. However, in a recent study conducted by Ly & Irwin to examine the effect of a multicomponent poster-based intervention to promote climbing stairs in a library on a Canadian university campus, observers counted the number of subjects who used stairs or elevators for 28 days, either in the absence or presence of a poster-based intervention. Chi-Square tests were used to compare stair versus elevator use before, during, and after the poster-based intervention. The frequency of using stairs on weekdays was significantly higher during the intervention and follow-up periods. This study provides evidence that a multicomponent poster-based intervention can lead to increased use of stairs [ 35 ].

Studies conducted from a public health perspective have focused on reducing sitting time in the work environment, where, along with rapid advances in technology, office work increasingly involves computer work [ 36 ]. An ideal ergonomic setup is necessary for the tasks assigned to that space, with movement encouraged through a variety of active interventions and design methods such as adjustable furniture [ 37 , 38 ]. Therefore, many studies aimed at reducing sitting time in the workplace used active workstations. These desks include treadmills or treadmills that are installed under the desk and height-adjustable workstations, which enable office workers to stand or walk while working on the usual computer and other office work tasks. Laboratory and field studies using these workstations have indicated a range of positive benefits, including reduced sitting time in the workplace [ 39 ]. At least 25% of workstations can be adjusted by the user to work in a sitting or standing position through the use of manually or electrically height-adjustable worktops that provide users with the ability to customize the height of the workstation in both sitting and standing positions, as well as supplemental health solutions (e.g., stands) that allow all or part of a work surface, monitor, and primary input devices (e.g., keyboard and mouse) to be raised or lowered to different heights [ 40 , 41 ]. Additionally, studies have shown that the use of active workstations can lead to improved physical and mental health outcomes, such as increased energy levels, improved concentration, and reduced stress levels [ 37 , 38 ].

Natural lighting within the building provides an attractive sensory experience along the walking paths, and well-lit staircases encourage people to use them while providing lighting levels within the staircase area that are compatible with its purpose as a public space of interest in the building. To achieve this, the following strategies should be incorporated: incorporating natural lighting into the staircase area, providing lighting levels that are 75 percent equal to those of adjacent walkways, with at least 108 lx lit inside the staircase, and meeting the minimum building code lighting levels of 22 lx on the walking deck, primarily intended for emergency exit. To further encourage the use of stairs, visual cues should be used to draw attention to them, such as highlighting the stairs with accent lighting or painting them in a bright color. Additionally, the elevator should be avoided as a daily use option, with signage and other visual cues that direct people to the stairs. By implementing these strategies, the building can create a safe and inviting environment that encourages people to use the stairs [ 27 ]. Illumination levels of at least 215 lx should be in use, and windows or skylights should be included to allow natural light in, as well as natural design elements such as plants, water, and landscapes. To further enhance the environment, the use of light-colored walls and ceilings can help to reflect the natural light, creating a brighter and more inviting atmosphere [ 42 ].

According to behavioral psychologists, color has a profound effect on a person's mind and body. The effect produced by colors also depends on their brightness, hue, and location. For example, cool and light colors are bright and relaxing; they are soothing and encourage relaxation. On the other hand, colors that stimulate activity are red, orange, blue, green, purple, and neon colors [ 43 ].

Research has shown that improved ventilation and thermal comfort can have a positive effect on physical activity. Van Kasteren et al. indicated that changes in the way thermal comfort is managed through office building HVAC systems can enhance physical behavior at work. Furthermore, developments in building management systems and sensors make it possible to capture data not only on temperature but also on thermal comfort metrics such as humidity, air velocity, and air quality. This helps to understand more about the effects of thermal comfort on physical activity at work and its impacts on productivity [ 44 ].

The thermal sensation and comfort of the human body can be drastically altered due to changes in environmental conditions or activities within a building, such as in a fitness center. If the indoor thermal environment is set to an unsuitable level or is slightly warmer, the heat generated by exercise can become intensified, leading to increased sweating and fatigue, and ultimately reducing comfort. This unfavorable environment can cause users to expend more physical energy when performing high-intensity exercises, resulting in a decrease in performance [ 45 ].

After conducting a comprehensive review of existing studies on active design strategies to enhance physical activity in university educational buildings, we classified the strategies into eight distinct active design elements. Firstly, "Spaces Provision" includes organizing spaces, circulation, and providing space for physical activity. The second element, "Vertical Transportation," encompasses stairs, elevators, and escalators. The third element, "Office Furniture," includes workstations and supplemental health solutions. The fourth element, "Lighting," involves natural lighting and artificial lighting levels. The fifth element, "Guidance, Direction & Motivation," includes indicator plates, fun theory, and educational programs. The sixth element, "Aesthetics," encompasses colors, finishes, and natural views. The seventh element, "Ventilation & Thermal Comfort," addresses air quality and thermal comfort. Finally, the eighth element, "Facilities & Utilities," includes shower facilities, wardrobes, drinking fountains, and vending machines to provide healthy snacks. Each of these elements has been found to have a positive impact on physical activity levels in university educational buildings. The elements are illustrated in Fig.  2 .

Elements of active design strategies to enhance physical activity. The researchers concluded this after conducting a comprehensive review of existing studies

1.3 Active design evaluation systems

Several global and local building evaluation and assessment systems have been developed to assess the extent to which active design standards and strategies are applied. This paper discusses the most prominent building assessment systems in chronological order, starting from the oldest to the most recent. These global assessment systems include Leadership in Energy and Environmental Design (LEEDv4), Active Design Guidelines, Fitwel Certification Standard, and WELL Building Standard. Additionally, a local building assessment system, Mostadam Green Building Rating System, is also discussed. Furthermore, the paper presents the elements of active design strategies that promote physical activity in each system.

LEED is a green building certification program that was created in 1994 to encourage sustainable practices. The certification is based on a point system where projects must meet requirements and earn points. LEED promotes green building practices that reduce negative impacts while lowering operating costs. It is available for all building types and phases and ensures the highest standards of sustainability and environmental responsibility. LEED certification is available for all building types and all building phases, including new construction: building design and construction (BD + C), interior design and construction (ID + C), building operations and maintenance (O + M), Neighborhood Development (ND), Homes, and Cities. By utilizing LEED standards, construction projects can ensure that they meet the highest standards of sustainability and environmental responsibility [ 46 ].

Garland et al. investigated the effect of active design strategies on physical activity among adults living in two affordable housing developments. The first building incorporates LEED Innovation in Design (ID) Credit by including active design features, and the participants living in this building had higher levels of physical activity [ 47 ].

LEED certification provides a framework for building owners and architects to incorporate active design features into their projects. The rating system considers several factors related to active design, such as access to public transportation, bike storage, showers, and changing rooms for employees who bike or walk to work.

1.4 Active Design Guidelines

In 2010, the Active Design Guidelines Handbook was published in partnership with several New York City agencies, including the Department of Health and the Department of Design and Construction [ 28 ]. This guide is used as a tool to increase physical activity in the design and construction of neighborhoods, streets, and buildings. It addresses building components such as secure bike parking and storage, well-lit stairwells, outdoor fitness equipment, recreational spaces, and parks to encourage physical activity. The guide also includes a wide range of strategies aimed at encouraging collaboration between different designs in promoting health through design. It helps teachers of architecture, planning, and design who seek to incorporate key health-promoting design factors into student projects and curricula [ 27 ].

1.5 WELL building standard

The International Well Building Institute (IWBI) released version 1.0 of the WELL Building Standard in October 2014, which is the world's first standard to focus on promoting human health and well-being through the built environment [ 48 ]. It is a certification program that helps buildings become more sustainable and energy-efficient by providing a comprehensive assessment of the building's performance and guidance on how to improve it. The program is administered by IWBI and Green Business Certification Inc. (GBCI) and covers ten core concepts of health while referencing current standards and best practice guidelines. The program is designed to reduce environmental impact, save money, and improve the health and comfort of occupants [ 49 ].

Alfonsin et al. conducted a study to compare the WELL Building Standard™ (WELL™) with active design and strategies in the workplace and to suggest which strategies should be prioritized for office construction projects. The study also suggested that future research should focus on the potential health benefits of active building design and operations strategies for other building types, such as schools, airports, and other places where people spend a lot of time [ 50 ]. Luo et al. found that the WELL Building Standard v2 had a positive impact on the energy performance and indoor environment of office buildings, resulting in an average reduction of 8.3% in energy consumption and an average improvement of 8.2% in air quality [ 51 ].

1.6 Fitwel certification standard

Fitwel, which was launched in early 2017, has seen rapid adoption of its certification standard in workplaces and residential buildings [ 52 ]. Fitwel is a certification system created by the U.S. Centers for Disease Control and Prevention and the U.S. General Services Administration to promote health and well-being in buildings. It is based on evidence-based strategies that address seven categories of health and provides a scoring system to measure the effectiveness of the implemented strategies. The Center for Active Design was selected as the licensed operator of Fitwel to expand it to the global market [ 53 ]. The Fitwel standard is faster, more affordable, open, and automated, making it an ideal option for individuals who may not have the financial resources or energy for a full WELL certification process but still need to create progressively healthy workspaces [ 54 ].

1.7 Mostadam green building rating system

Mostadam is a green building rating system that was developed by the Ministry of Housing in the Kingdom of Saudi Arabia and is operated by The Sustainable Building Company. It was released in 2019 and helps to promote sustainability in the built environment. The system is designed to increase energy efficiency, encourage the use of renewable energy, increase water efficiency and the use of recycled water, and raise public awareness of sustainability. Additionally, the system provides a range of incentives and rewards for those who meet the criteria set out in the guide. These include financial incentives, such as tax credits, as well as recognition and awards for those who demonstrate excellence in sustainability [ 55 ].

1.8 Comparing the elements of active design strategies to enhance physical activity in evaluation system categories

As mentioned earlier, eight elements have been identified after a comprehensive review of existing studies. These elements are Spaces Provision, Vertical Transportation, Office Furniture, Lighting, Guidance, Direction & Motivation, Aesthetics, Ventilation & Thermal Comfort, and Facilities & Utilities. In this section, a comparison is made between the categories of evaluation systems based on their inclusion of these elements.

The LEED standard addresses eight main evaluation categories, namely: “Location and Transportation”, “Sustainable Sites”, “Water Efficiency”, “Energy and Atmosphere”, “Materials and Resources”, “Indoor Environmental Quality”, “Innovation”, and “Regional Priority”. Each of these categories has a checklist of items, and for each item, there are several criteria that must be met to achieve LEED certification. This model provides a good starting point for promoting physical activity through active design elements, but it is not sufficient on its own. It is missing these elements: (Space Provision), (Vertical Transportation), (Office Furniture), (Guidance, Direction & Motivation).

Active Design Guidelines can be divided into five distinct categories, namely: “Site Design”, “Building Design", “Outdoor Spaces”, “Community Engagement”, and “Technology”. Each of these categories provides a comprehensive set of guidelines to promote physical activity and healthy living in the built environment. Site Design focuses on the layout of the site, including the placement of buildings, streets, and other features. Building Design focuses on the design of the building itself, including the use of natural light, ventilation, and other features that promote physical activity. Outdoor Spaces focuses on the design of outdoor spaces, such as parks, trails, and other recreational areas. Community Engagement focuses on the involvement of the community in the design process, including public input and feedback. Finally, Technology focuses on the use of technology to promote physical activity, such as the use of sensors and other tracking devices.

It has been found that the categories of "Site Design," "Outdoor Spaces," "Community Engagement," and "Technology" are not very specific to interior spaces and buildings. Additionally, the category of "Building Design" is missing two important elements: (Office Furniture) and (Ventilation & Thermal Comfort).

The WELL Building Standard v2 pilot program is designed to address ten key concepts from the main evaluation categories, including “Air”, “Water”, “Nourishment”, “Light”, “Movement”, “Thermal Comfort”, “Sound”, “Materials”, “Mind”, and “Community”. Each concept is evaluated based on a set of performance requirements that is designed to improve occupant health and well-being. The program also provides guidance on how to implement the requirements and offers resources to help building owners and operators achieve certification.

The category of "Movement" concept includes all elements of active design that enhance physical activity, except for one element: (Ventilation & Thermal Comfort), which is covered in the category of "Air" concept. This makes the category of "Movement" concept the most comprehensive evaluation model for active design elements that stimulate physical activity.

The Fitwel Certification Standard addresses 12 major health-promoting assessment categories, including "Location," "Building Access," "Outdoor Spaces," "Entrances and Ground Floor," "Stairs," "Indoor Environments," "Workspaces and Dwellings," "Shared Spaces," "Water Supply," "Prepared Food Areas," "Vending Machines and Snack Bars," and "Emergency Preparedness." It has been found that these categories support all elements of active design that promote physical activity, but they are not comprehensive enough to cover all aspects of element promotion. Each category supports only three elements or fewer. For example, in the "Location" category, only the (Spaces Provision) element was covered. In the "Building Access" category, only (Spaces Provision) and (Facilities & Utilities) were covered, as were the rest of the categories.

The Mostadam System Guide consists of three classification systems: "Mostadam for Residential Buildings", "Mostadam for Communities", and "Mostadam for Commercial Buildings". Each classification system has two categories: "Design + Construction" and "Operations + Existing". Each category has a guide that explains its components, applicability, standard methodology, and details of its conditions. These categories support the provision of requirements for the following elements of active design that enhance physical activity: (Spaces Provision), (Lighting), (Aesthetics), (Ventilation and Thermal Comfort), (Facilities & Utilities). However, the elements of (Vertical Transportation), (office furniture), (Guidance, Direction & Motivation) are not covered in the Guide.

Based on the foregoing, a comparative analysis of building rating systems for evaluating the application of active design strategies has been conducted. It appears that the standards that focus on active design strategies, which enhance physical activity, have recently emerged, indicating an increased awareness and interest in supporting the improvement of a healthy lifestyle. However, there is still a lack of concern by local standards for evaluating the application of active design strategies that enhance physical activity in buildings, such as in the "Mostadam system." Therefore, to ensure that active design strategies are properly implemented, local standards should be updated to include specific criteria for evaluating the application of active design strategies. Additionally, more research should be conducted to identify the most effective active design strategies and to determine how they can be best implemented in different contexts.

The comparison of the existing evaluation forms revealed that none of them cover all the elements of active design strategies that enhance physical activity. Table 1 summarizes these comparison results. The "Well-Certification-v2-Scorecard-q2-2021" form, specifically the "Movement" Checklist, was the most comprehensive, covering most of the elements of active design strategies that promote physical activity in a more accurate and detailed manner, and including the interior spaces in the buildings. However, this model lacks the (Ventilation and Thermal Comfort) element. Therefore, there is a need to develop an evaluation form that addresses all elements of active design strategies to promote physical activity. Such a form should provide a comprehensive picture of the strategies, both for external and internal spaces, and should be able to accurately assess the application of active design strategies.

2 Methodology

The aim of this research is to measure the extent to which active design strategies are applied in educational buildings at King Abdulaziz University (KAU) in Jeddah, Saudi Arabia, in order to reach recommendations that can be applied to educational buildings in Saudi Arabia's universities to increase physical activity and reduce sedentary behavior among university users. Studies have indicated that college students regularly spend a lot of time at the university, and college is a stage in which they begin to make independent decisions about their future, which can include adopting an active lifestyle [ 56 ]. The research contributes to increasing the knowledge and awareness of designers, specialists, and those in charge of buildings in the university educational environment of the design aspects that must be considered to influence the user's health behaviors related to physical activity. In addition to the applied value that helps ensure enjoying healthy lifestyles and well-being, which is in line with the third Sustainable Development Goal, good health and well-being, and the achievement of the Quality-of-Life Program in Saudi Vision 2030 to improve lifestyle by promoting sports and physical activities in society. Based on this, the research objectives are as follows:

Increasing awareness of the main aspects of active design that stimulate physical activity in university educational buildings.

Investigating the extent to which international standards of active design can be applied in university educational buildings.

Proposing recommendations and active design strategies for policymakers to promote physical activity in the building.

In order to achieve those objectives, a mixed-methods approach will be used, combining both quantitative and qualitative methods (see Fig.  3 ). The qualitative methods will include a comparative analysis of building rating systems to evaluate the application of active design strategies. Additionally, a case study analysis was conducted for educational buildings in KAU to evaluate the application of active design strategies using the Movement Checklist in the WELL Building Standard.

Illustration of the flow diagram on research methodology conduction

Additionally, the research includes interviews with university staff and decision-makers to identify the main challenges and obstacles that prevent the application of active design strategies in university educational buildings. The quantitative methods will include a survey of university students and staff to find out how aware the study sample is of the importance of physical activity and to discover appropriate active design strategies for them.

With all this data at hand, the researchers will suggest recommendations that can be applied to educational buildings in Saudi Arabia's universities, which will foster physical activity and reduce sedentary behavior among university users.

The study was conducted on the employees, faculty members, administrators, and students of King Abdulaziz University in Jeddah, Saudi Arabia. The study was limited to the University buildings and was carried out during the academic year 2021–2022.

3 Buildings evaluation: case studies

In this section, a case study analysis has been conducted on two educational buildings located at King Abdulaziz University (KAU) in Jeddah, Saudi Arabia, to investigate the extent to which international standards of active design can be applied in university educational buildings. The method used for selecting the buildings under study, the evaluation mechanism used, and the evaluation results will be discussed in detail, providing an in-depth analysis of the findings.

3.1 Building selection

King Abdulaziz University (KAU) has numerous buildings, ranging from educational, administrative, and research centers. Two buildings have been selected for the study, both located in the female section of KAU. The first building is Building 41 (Al-Batoul Building) (Number 41), and the second building is Building 7 (Faculty of Science) (Number 7), as illustrated in Fig.  4 .

Building 41 & Building 7 in King Abdulaziz University, Jeddah

The case studies were selected based on the following parameters:

A university building at King Abdulaziz University, based on Jifri's study (2014), recommended the need to develop and strengthen KAU students' attitudes towards physical activity [ 10 ]. Both buildings, 41 and 7, are multi-functional and service buildings.

Contains a main staircase at the entrance of the main building.

Contains different types of classrooms, lecture halls, and offices.

It has multiple activities and functions.

It consists of several floors, so there are stairs.

Ease of access for the researcher.

Building 41 consists of three floors, and there is a common elevator area between Building 41 and the adjacent building. The ground floor (Fig.  5 ) contains the laboratories of the Department of Clothing and Textiles and the Department of Food and Nutrition, while the first floor (Fig.  6 ) contains laboratories and classrooms for the Department of Clothing and Textiles and the Department of Food and Nutrition. The second floor (Fig.  7 ) contains laboratories, classrooms, and workshops (42). The number of female students is 900, the number of offices for faculty members and technicians is 5, and the number of laboratories, classrooms, and workshops is 42 (Source: Faculty of Human Sciences and Design at KAU, 2022). Figure  8 illustrates some of the facilities in Building 41 that meet the specified parameters.

Ground Floor Plan of Building 41 in KAU. (Source:KAU Vice Presidency for Projects)

First Floor Plan of Building 41 in KAU. (Source: KAU Vice Presidency for Projects)

Second Floor Plan of Building 41 in KAU. (Source: KAU Vice Presidency for Projects)

a Grand Staircase leading to the entrance of the South Facade of the Main Building; b Building 41 is a multi-purpose facility that contains offices, classrooms, and other amenities; c there is a walking path located opposite the north facade of the building; d the area of elevators and stairways is adjacent to Building 41

Building 7 consists of three floors. The ground floor (Fig.  9 ) contains the biology and physics department laboratories, computer laboratories, classrooms, offices, and open areas. The first floor (Fig.  10 ) contains the biology, physics, and chemistry department laboratories, computer laboratories, classrooms, offices, and a cafeteria. The second floor (Fig.  11 ) contains laboratories, a chapel, a library, meeting rooms, classrooms, offices, and a cafeteria. Figure  12 illustrates some of the facilities in Building 7 that meet the specified parameters.

Ground Floor Plan of Building 7 in KAU. (Source:KAU Vice Presidency for Projects)

First Floor Plan of Building 7 in KAU. (Source:KAU Vice Presidency for Projects)

Second Floor Plan of Building 7 in KAU. (Source: KAU Vice Presidency for Projects)

a Grand Staircase in Building 7. b Building 7 is a multi-purpose facility that contains offices, classrooms, and other amenities. c There is a walking path situated opposite the east facade of the building. d The Elevators in Building 7

3.2 Evaluation criteria

In the previous section, the comparative analysis of building rating systems for evaluating the application of active design strategies revealed that the "Well-Certification-v2-Scorecard-q2-2021" form, specifically the (Movement) Checklist, was the most comprehensive. It covers most of the elements of active design strategies that promote physical activity in a more accurate and detailed manner, including the interior spaces in the buildings. Accordingly, the evaluation criteria are based on the Movement Feature Requirements in the Well-Certification-v2-Scorecard-q2-2021, which promote physical activity through environmental design, policies, and programs.

The Movement Feature is a part of the “Well-Certification-v2-Scorecard-q2-2021” and comprises 11 features that focus on promoting physical activity and movement in buildings and communities. These features cover a wide range of aspects related to promoting physical activity, from ergonomic workstation design to site planning and selection, physical activity opportunities, and self-monitoring. In the first feature, (V01: Active Buildings and Communities), achieving at least one point in one of the following features is necessary to fulfill Feature V01: Circulation Network (V03), Facilities for Active Occupants (V04), Site Planning and Selection (V05), Physical Activity Spaces and Equipment (V08). The second feature, (V02: Ergonomic Workstation Design), focuses on designing workstations that promote good posture. Workstations should be designed to consider adjustable features, support for the natural curvature of the spine, and proper placement of computer equipment. The (V03: Circulation Network) feature promotes movement and physical activity by designing an aesthetic staircase that not only looks great but also makes it easy and appealing to take the stairs instead of the elevator. Additionally, point-of-decision signage is strategically placed throughout the space to remind people to make active choices, while visible stairs make it clear that taking the stairs is a viable option. (V04: Facilities for Active Occupants) focuses on providing cycling infrastructure, showers, lockers, and changing facilities. The (V05: Site Planning and Selection) feature focuses on selecting sites that encourage physical activity on pedestrian-friendly streets and the accessibility of mass transit systems. The (V06: Physical Activity Opportunities) feature provides no-cost physical activity opportunities appropriate for the project population, programmed by a qualified physical activity professional, either in-person or virtually. The (V07: Active Furnishings) feature focuses on selecting active workstations that encourage physical activity, such as the treadmill desk, bicycle desk, and stepper machine. The (V08: Physical Activity Spaces and Equipment) feature encourages building owners and managers to provide at least one facility for physical activity in each indoor and outdoor space. The (V09: Physical Activity Promotion) feature focuses on promoting physical activity through marketing and education. The (V10: Self-Monitoring) feature encourages building owners and managers to provide tools and resources to help occupants monitor their physical activity levels. Finally, the (V11: β Ergonomics Programming) feature focuses on designing programs that promote good ergonomics and physical activity. By incorporating these features, building owners and managers can help create environments that encourage people to be more active and improve overall health and well-being [ 57 ].

3.3 Building evaluation results & discussion

The checklist in 'Well-Certification-v2-Scorecard-q2-2021' was used to evaluate the building under study, calculating the number of points it earned by applying active design strategies that promote physical activity. These results were obtained by examining the requirements for the 'Movement' feature in 'Well-Certification-v2-Scorecard-q2-2021'.

It appears in Table 2 that the evaluation results of Building 41, based on the requirements of the Movement checklist form in “Well-Certification-v2-Scorecard-q2-2021”, show that the building achieved 5 points out of the 21 required points, with a rate of 24%. This indicates that the building lacks many active design requirements, at a rate of 76%.

Building 41 met the first feature requirements (V01: Active Buildings and Communities) by achieving points in the following features: Circulation Network (V03), Site Planning and Selection (V05), and Physical Activity Spaces and Equipment (V08). However, it did not meet the requirements of the second feature (V02: Ergonomic Workstation Design) in providing workstations that promote good posture. In the third feature (V03: Circulation Network), the building did not meet the requirements for (V03.1 Design Aesthetic Staircases) or (V03.2 Integrate Point-of-Decision Signage), but it earned a point for achieving the (V03.3 Promote Visible Stairs) requirement. This is because the stairs are open to regular occupants and are located visibly before the elevators. The building did not meet the requirements of the feature (V04: Facilities for Active Occupants) in providing cycling infrastructure, showers, lockers, and changing facilities. In the feature (V05: Site Planning and Selection), the building met the requirements of (V05.1 Select Sites with Pedestrian-friendly Streets), but it did not meet the requirements of (V05.2 Select Sites with Access to Mass Transit). The building did not meet the requirements of the feature (V06: Physical Activity Opportunities) in offering physical activity opportunities. The building did not meet the requirements of the feature (V07: Active Furnishings) in providing active workstations. In the feature (V08: Physical Activity Spaces and Equipment), the building did not meet the requirements for (V08.1 Provide Indoor Activity Spaces), but it earned a point for achieving the (V08.2 Provide Outdoor Physical Activity Space) requirement by providing green space (walking trail). The building did not meet the requirements of the feature (V09: Physical Activity Promotion) in offering physical activity incentives. The building did not meet the requirements of the feature (V10: Self-Monitoring) in providing self-monitoring tools. The building did not meet the requirements of the feature (V11: β Ergonomics Programming) in providing programs that promote good ergonomics and physical activity.

Table 3 shows the evaluation results of Building 7 based on the requirements of the Movement checklist form in "Well-Certification-v2-Scorecard-q2-2021". The building achieved 6 points out of the required 21 points, with a rate of 28%. This indicates that the building lacks many active design requirements, at a rate of 72%.

Building 7 met the first feature requirements (V01: Active Buildings and Communities) by achieving points in the following features: Circulation Network (V03), Site Planning and Selection (V05), and Physical Activity Spaces and Equipment (V08). However, it did not meet the requirements of the second feature (V02: Ergonomic Workstation Design) in providing workstations that promote good posture. In the third feature (V03: Circulation Network), the building got a point for achieving (V03.1 Design Aesthetic Staircases) requirements, which implies that the design and appearance of the staircase meet certain aesthetic standards and are visually appealing. However, it did not meet the requirements for (V03.2 Integrate Point-of-Decision Signage), which refers to the placement of signs or indicators at key decision points in the staircase to help people navigate and find their way around the building. It did get a point for achieving (V03.3 Promote Visible Stairs) requirements, which means that the staircase is clearly visible and easy to access. The building did not meet the requirements of the feature (V04: Facilities for Active Occupants) in providing cycling infrastructure, showers, and changing facilities. The only available facility was lockers, which are not sufficient for people who choose to cycle or run to work. In the feature (V05: Site Planning and Selection), the building met the requirements of (V05.1 Select Sites with Pedestrian-friendly Streets), but it did not meet the requirements of (V05.2 Select Sites with Access to Mass Transit). The building did not meet the requirements of the feature (V06: Physical Activity Opportunities) in offering physical activity opportunities. It also did not meet the requirements of the feature (V07: Active Furnishings) in providing active workstations. In the feature (V08: Physical Activity Spaces and Equipment), the building did not meet the requirements for (V08.1 Provide Indoor Activity Spaces), but it got a point for achieving the (V08.2 Provide Outdoor Physical Activity Space) requirements by providing green spaces (park, walking trail). The building did not meet the requirements of the feature (V09: Physical Activity Promotion) in offering Physical Activity Incentives. It also did not meet the requirements of the feature (V10: Self-Monitoring) in providing self-monitoring tools. Lastly, the building did not meet the requirements of the feature (V11: β Ergonomics Programming) in providing programs that promote good ergonomics and physical activity.

These building evaluation results confirm the findings of studies [ 2 , 7 ] that the difficulty of accessing safe and appropriate programs and places for physical activity is one of the reasons why many adults are not meeting the global physical activity recommendations set by the World Health Organization. Moreover, these results are in line with the studies of [ 11 , 14 ], which suggest that the most important obstacle is the lack of designated areas available for physical activity and that the most important factors that impede the success of physical and sports activities in the universities of the Kingdom of Saudi Arabia are the lack of energy, motivation, self-confidence, time, social support, and resources. The results of the building assessment in this study are consistent with the results of the questionnaire, which will be discussed in the next section, examining the causes of low levels of physical activity in the study sample. This further highlights the need for more active design requirements to promote physical activity and improve the health of the population, which confirms the results of the studies [ 50 , 51 ].

4 Study on the awareness of the importance of physical activity and appropriate active design strategies for the study sample

The questionnaire was used as a study tool, which aims to understand the awareness of King Abdulaziz University (KAU) employees, administrators, male and female students of the importance of physical activity on the life of the individual and society, and to discover appropriate active design strategies for them. Additionally, the questionnaire was used to identify some of the obstacles that impede the practice of physical activity in the university. In order to achieve this aim and analyze the collected data, several appropriate statistical methods were used using the Statistical Package for Social Sciences (SPSS v.28). The following statistical metrics were calculated: 1- Analyze the questionnaire using frequencies and percentages to identify the personal and functional characteristics of the study sample and determine the responses of its members towards the paragraphs of the axes included in the study tool. 2—Illustrations and diagrams. 3—Arithmetic means and standard deviations to know the general trend of the paragraphs and axes of the questionnaire. 4—Pearson and Spearman correlation test to calculate the relationships between the variables of the study.

The questionnaire was designed to assess the level of physical activity of the participants, their awareness of the importance of physical activity, and their focus on choosing active design strategies. It consisted of three main sections:

Level of physical activity.

Awareness of the importance of physical activity.

Selecting Active Design Strategies.

The results of the questionnaire will be used to develop strategies to promote physical activity among the university's employees, administrators, and students.

4.1 Study sample

The Stephen Thompson equation was used to calculate the sample size, which was determined by the size of the community (N = 113,000), the standard score corresponding to the significance level 0.95 (z = 1.96), the percentage error (d = 0.05), and the ratio of property and neutral availability (p = 0.50). Based on this, the sample size was determined to be of 383 individuals chosen using the random sampling method available in the second semester of the university season 1442–1443 AH.

4.2 Questionnaire arbitrating

To ensure that the axes of the questionnaire are suitable for its intended purpose, it was presented to experienced and specialized arbitrators for review. The arbitrators were asked to evaluate the questionnaire, assess its axes, and incorporate any feedback they had. This process of arbitration will help to ensure that the questionnaire is effective and meets its intended objectives.

4.3 Stability and validity

To ensure the stability and validity of the study tool (questionnaire), the data was encoded and then converted into the SPSS program. The stability coefficients of the study tool were then calculated and presented in Table 4 . The results of the stability coefficients indicate that the study tool is reliable and valid.

In Table 4 the general stability coefficient of the study sections is high, reaching (0.855) for the total of the thirty-three questionnaire elements, while the stability of the axes ranged between 0.870 as a minimum and 0.869 as a maximum, indicating that the questionnaire has a high degree of stability and can be relied upon. The Cronbach's alpha coefficient was used to measure the stability of the study tool, and the results of the analysis showed that the questionnaire is highly reliable. According to the Natley scale, a minimum of 0.70 is required for stability [ 58 , pp. 264–265]. Additionally, the amount of honesty in the questionnaire is equal to 0.94 and ranges between 0.931–0.933, which indicates a high level of honesty in the sample of the pilot study. This suggests that the questionnaire is a valid and reliable tool for measuring the desired outcomes of the study.

4.4 Questionnaire results & discussion

The study sample comprised of 384 participants, exceeding the required sample size of 383 by 1.

4.4.1 First section analysis: level of physical activity

Figure  13 shows the results of the first axis (level of physical activity), and it was the highest percentage of the (Activity type that you typically do while in the university building (most of the time)) was (Attending theoretical lectures) with a rate of 62.8%, followed by (Working in the office) with a rate of 15.6%, followed by (Other) with a rate of 11.5%, followed by (Working on a specialized machine or device) with a rate of 6.5%, followed by (Drawing / Design on paper) with a rate of 3.6%.

Results of the first axis (level of physical activity), a Activity type that you typically do while in the university building (most of the time); b Evaluating your weekly physical activity; c The most significant challenge that is preventing you from engaging in physical activity; b Evaluating your weekly physical activity

Also, the largest percentage for (Evaluating your weekly physical activity) was (Irregular) with a rate of 29.7%, followed by (medium activity) with a rate of 23.7%, followed by (low activity) with a rate of 21.4%, followed by (no physical activity) with a rate of 21.4%. Its rate was 18.8%, while the lowest rate was (high activity) at 6.5%. This corresponds to the findings of the study [ 11 ] which showed that there is a decrease in the self-efficacy of physical activity for female Saudi university students. This is further supported by the findings of a study [ 18 ] which revealed that young students tend to lack movement and the level of evaluation of weekly physical activity for students, resulting in 23.4% of students having low levels of physical activity and motor skills, which is a sign of chronic disease risk in the body.

(The most significant challenge that is preventing you from engaging in physical activity) was found to be (Lack of time), with a rate of 39.6%, confirming the findings of Hu et al. [ 15 ] that this remains a permanent obstacle. This was followed by (Lack of a designated space for activity) (29.9%), (There being no obstacle) (12.2%), the (Lack of services such as shower rooms) (10.4%), and (Other) factors (7.8%). These results are consistent with Sayyds et. al, study [ 14 ] which found that the most important factors impeding the success of physical and sports activities in the universities of the Kingdom of Saudi Arabia are lack of energy, motivation, self-confidence, time, social support and resources.

The highest percentage of chronic diseases was (Not having a chronic disease), with a rate of 76.6%, followed by (Overweight) with a rate of 13.5%, (Other) with a rate of 6.3%, and (Diabetes or stress) with a rate of 3.4%. The lowest percentage was (heart disease) with a rate of 0.3%. This indicates that most university users are not suffering from any chronic diseases, but there is still a significant number of users who are overweight or suffering from other chronic diseases, this is consistent with the studies [ 2 , 6 , 20 ] which all indicate the health risks associated with sedentary behavior.

Based on the foregoing, physical activity levels are irregular and generally low for a large percentage of university educational buildings users. To address this issue, active design strategies should be implemented to enhance physical activity and reduce the challenges that prevent physical activity, such as the feeling of lack of time. By incorporating physical activity into the work or study environment, users can easily incorporate physical activity into their daily routine. This will not only improve physical activity levels, but also promote overall health and wellbeing.

4.4.2 Second section analysis: awareness of the importance of physical activity

The analysis of the opinions of the study sample members in the second and third sections was conducted by calculating the frequencies, percentages, arithmetic means, standard deviations, and the score of the means according to the five-point Likert scale. The lowest response (1) indicated not agreeing at all, and the highest response (5) indicated completely agreeing [ 59 ]. Furthermore, the results were analyzed using descriptive statistics to gain a better understanding of the data. To further analyze the data, the paragraphs were arranged in descending order according to the arithmetic means with the lowest value of the standard deviation. This allowed for a more comprehensive analysis of the data.

Figure  14 shows that the total score for the second axis (awareness of the importance of physical activity) got an arithmetic average of (4.34) out of (5) scores with a standard deviation of (0.760), which corresponds to a degree (strongly agree) according to the five-point Likert scale where the arithmetic mean is located In the period (from 4.20 to 5), where (4) of the paragraphs got an arithmetic average of (strongly agree) and (1) paragraph got an arithmetic average of (agreed). This indicates that the study sample had a very high level of awareness of the importance of physical activity on the life of the individual and society.

Results of the second axis (Awareness of the importance of physical activity)

Despite this high awareness, the levels of physical activity were irregular and generally low for a large percentage of the users of university educational buildings, which is in line with the findings of studies [ 2 , 7 ] regarding global estimates. The World Health Organization has confirmed that adults between the ages of 18 and 64 should do at least 150 min of moderate physical activity over the course of a week, or vigorous-intensity physical activity for 75 min over the course of a week.

However, the last paragraph (I know in advance that the World Health Organization recommends that adults aged 18–64 years should engage in moderate physical activity for at least 150 min per week, or vigorous physical activity for 75 min per week) got an arithmetic mean (3.49) out of (5) and a standard deviation (1.147), which corresponds to a five-point Likert scale (OK). This suggests that the study sample may not be meeting the recommended levels of physical activity.

4.4.3 Third section analysis: selecting active design strategies

The analysis of the opinions of the study sample members on the third section (selecting active design strategies) which consists of eight elements, namely (Spaces Provision, Vertical Transportation, Lighting, Ventilation & Thermal Comfort, Aesthetic, Guidance, Direction & Motivation, Office Furniture, Facilities & Utilities) was conducted by calculating the frequencies, percentages, arithmetic means, standard deviations, the score of the means according to the five-point Likert scale, and the descending order of the paragraphs according to the arithmetic means with the lowest value of the standard deviation. Additionally, the analysis was conducted to identify the most important active design strategies that should be taken into consideration when designing a university educational building in KSA.

Figure  15 shows that the strategies that have priority for application based on the desire of users are in the following order: The element (Ventilation & Thermal Comfort) came in the first place, the second came the element (Spaces Provision), and then the third came to the element (Facilities & Utilities). The element (Aesthetic) came in the fourth place, then the element (Office Furniture) came in the fifth place, then the element (Lighting) came in the sixth place, and the element (Vertical Transportation) came in the seventh place, while the element (Guidance, Direction & Motivation) came in the last place. Ventilation & Thermal Comfort ranked first can be explained by the importance of providing thermal comfort, whether natural or mechanical, which is of great importance in reducing the extreme temperature and providing a sense of comfort for the population, which contributes to increasing physiological comfort because of being affected by climate factors such as heat, humidity, and sunlight, which must be considered in the design of active places. to create a pleasant and healthy environment for the users.

Results of the Third axis (Selecting Active Design Strategies)

The survey concluded that users of university buildings have inadequate levels of physical activity, with attending theoretical lectures being the most common activity. Lack of time was the most significant challenge preventing physical activity, and a significant number of participants were overweight or suffering from chronic diseases. The study recommends incorporating physical activity into the work or study environment by implementing active design strategies. The study sample had a high degree of awareness of the significance of physical activity, but the levels of physical activity were generally low. The most important active design strategies for users were ventilation and thermal comfort, providing spaces, utilities, and services. The study emphasizes the importance of considering climate factors in designing active spaces to create a healthy and pleasant environment for the users.

5 The interview

The interview was conducted to confirm the validity of the results of the case study analysis of Building 41 and7, which were based on the requirements of the movement checklist in 'Well-Certification-v2-Scorecard-q2-2021', and to identify the obstacles of applying active design strategies to promote physical activity in KAU educational buildings. The interview consisted of two main questions:

Are active design strategies that enhance physical activity applied in university buildings? If the answer is yes, why were the strategies implemented in the university buildings? Are there requirements from the university, work requests, or did the designer include them later? What are the benefits of these strategies? If the answer is no, what are the obstacles? Is it a lack of awareness and knowledge or high costs?

Will active design strategies that enhance physical activity be included in the future? If the answer is yes, what is the mechanism? Are there future plans? What are the expected benefits of these strategies? If the answer is no, what are the obstacles? What are the potential solutions to overcome these obstacles?

5.1 Interview results & discussion

Interviews were conducted with two members of the Vice Presidency for Projects at KAU, and they were asked questions with an expansion of the request for answers. The interview results revealed that the main obstacles to applying active design strategies that stimulate physical activity in university buildings at KAU are:

The novelty of the topic amongst decision makers and designers.

Lack of awareness, culture, and indicative signs

Lack of mandatory instructions and requirements

Culture of dress and uniform

The local hot climate

The officials confirmed the lack of application of active design strategies in the educational university buildings, which supports the results of the evaluation of Building 41 and 7. They highlighted the need to spread the culture of active design and the importance of physical activity, and the need to adopt the strategies as a policy while providing guidance and advertisements promoting them, to be adopted as design requirements under the item (health requirements) that cannot be bypassed. This is in line with two studies [ 10 , 18 ] that highlight the significance of boosting students' motivation for physical activity and raising awareness about the health benefits of physical activity.

The members of the University Vice Presidency for Projects also explained that the lack of a variety of means of transportation caused the scarcity of using bicycles or providing parking for them in buildings, and that the local hot climate, local dress code, and society’s view are also among the reasons that prevent the use of bicycles. This is confirmed by studies [ 2 , 7 ] that the difficulty of accessing safe and appropriate programs and places for physical activity is one of the reasons why the adult population does not meet the global recommendations of the World Health Organization regarding physical activity, and confirms what was stated in the [ 11 , 14 ] that the most important obstacle is the lack of designated areas available for physical activity and that the most important factors that impede the success of physical and sports activities in the KSA are the lack of energy, motivation, self-confidence, time, social support and resources.

They added that although there is a trend towards occupational health, physical activity is not available in educational buildings due to the aforementioned reasons. They also highlighted a number of strategies that can be provided easily and without great financial cost, such as: Directions and guiding signs that show the dangers of sitting for long periods and the benefits of climbing stairs, standing in the office and walking in the corridors, and that the guiding signs are considered among the strategies that have priority for application. They also emphasized the importance of taking into account the culture of traditional dress and uniforms, which may be obstacles to the implementation of some strategies, as well as taking into account working times, work needs and community culture when implementing strategies. The results of this interview also support and explain the results of the previously mentioned questionnaire on the reasons for the low levels of physical activity in the study sample, in addition to confirming the results of the evaluation of the building under study.

6 Recommendations

The study has uncovered some crucial findings that point toward the need for active design strategies in university buildings to promote physical activity and reduce the risk of chronic diseases. The Key findings are summarized as follows:

Lack of application of active design strategies: The study revealed a significant lack of active design strategies in university buildings.

Low levels of physical activity: Despite a high degree of awareness about the importance of physical activity, the levels of physical activity among university building users were generally low

Need for policy adoption: Strategies to promote active design should be adopted as policy requirements to ensure that they are implemented and promoted effectively.

Based on these findings, the following actions are recommended to promote physical activity and active design strategies at both community and built environment levels. The recommendations followed the effective intervention strategies proposed by Powell et al. [ 6 ], focusing on interventions aimed at community settings and elements of the built environment and policy levels:

Community level:

Developing educational programs and campaigns to increase awareness of the required level of physical activity approved by the World Health Organization.

Encouraging universities to provide incentives for students, faculty, and staff to use active design strategies, such as providing discounts for students who use stairs instead of elevators.

Built environment and policy level:

Developing educational programs and campaigns to increase awareness of the importance of applying active design strategies related to the built environment and designing university educational buildings in a way that contributes to the practice of physical activity to avoid physical inactivity and chronic diseases and to increase the intellectual and practical efficiency of its users

Developing local assessment systems to ensure that the implementation of active design strategies related to the built environment is appropriately evaluated for the culture and climate of the Kingdom of Saudi Arabia.

Establishing partnerships with local organizations and stakeholders to promote physical activity and active design strategies related to the built environment

Evaluating the effectiveness of the strategies implemented to promote physical activity and active design strategies related to the built environment

Apply appropriate and easily implementable active design strategies such as signboards, attractive walkways, and staircases

Developing a comprehensive plan for the implementation of active design strategies in university educational buildings in the Kingdom of Saudi Arabia in accordance with international standards. This plan should include the development of a budget, the selection of materials, the selection of contractors, and the implementation of strategies

7 Conclusion

In conclusion, this study has shed light on the alarming lack of active design strategies in university buildings and the low levels of physical activity among university building users. The study emphasizes the necessity of adopting policies that promote active design strategies to ensure their effective implementation and improve physical activity levels. The study recommends community-level and built environment-level actions, such as developing educational programs, establishing partnerships, and evaluating the effectiveness of the implemented strategies. The strengths of the study include the considerable amount of information gathered on the application of active design strategies to enhance physical activity in university buildings in Saudi Arabia. The study has identified the elements of active design strategies that can be applied to university buildings to increase physical activity and reduce sedentary behavior among university users. The research has also provided recommendations to raise awareness of the importance of physical activity and apply active design strategies available in international standards. However, the main limitation of the study is the small sample size, which does not represent all university buildings or users in Saudi Arabia. Overall, this study highlights the importance of promoting physical activity and active design strategies in university buildings to improve health and well-being.

Availability of data and materials

The data and materials used in this study are available upon request from the corresponding author. Restrictions may apply to the availability of these data and materials due to ethical or privacy considerations. The data used in this study is available upon request from the authors, subject to compliance with ethical and legal requirements.

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Acknowledgements

In this particular case, it is crucial to acknowledge the Faculty of Human Sciences and Design at KAU, as well as Eng. Basem M. Ali in KAU Vice Presidency for Projects, for providing the much-needed data and architectural plans for the buildings under study. Without their support, the research would have been difficult to carry out, let alone complete. Furthermore, it is essential to acknowledge the questionnaire validators, including Dr. Noorh Albadi, Head of the Interior and Furniture Design Department at KAU, Dr. Donia M. Bettaieb from the Department of Interior and Furniture Design at KAU, and Dr. Mostafa Sabbagh from the Department of Architecture at KAU. These individuals played a vital role in the research process and provided valuable insights that helped shape the study's outcome.

The authors declare that no funds were received for this research. All costs associated with the study were covered by the authors themselves.

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Rawan Mahfoudh and Noura Ghabra have contributed to the interpretation of the results and approved the final version of the manuscript.

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Department of Interior and Furniture Design, King Abdulaziz, University, Abdullah Sulayman St, 21589, Jeddah, Makkah, Saudi Arabia

Rawan Mahfoudh & Noura Ghabra

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Rawan Mahfoudh conceptualized and designed the study, collected and analyzed the data, and wrote the manuscript. Dr. Noura Ghabra supervised the study, provided guidance and input during the design and analysis stages, and critically reviewed and revised the manuscript.

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Correspondence to Rawan Mahfoudh .

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Mahfoudh, R., Ghabra, N. Study of active design strategies to enhance physical activity in university educational buildings: a case study at King Abdulaziz University. J. Umm Al-Qura Univ. Eng.Archit. (2023). https://doi.org/10.1007/s43995-023-00033-1

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Received : 12 June 2023

Accepted : 03 October 2023

Published : 31 October 2023

DOI : https://doi.org/10.1007/s43995-023-00033-1

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