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• What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, 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 analyze the case, other interesting articles.

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

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

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.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

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

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

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.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

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 analyze 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.

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

• Normal distribution
• Degrees of freedom
• Null hypothesis
• Discourse analysis
• Control groups
• Mixed methods research
• Non-probability sampling
• Quantitative research
• Ecological validity

Research bias

• Rosenthal effect
• Implicit bias
• Cognitive bias
• Selection bias
• Negativity bias
• Status quo bias

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation.

It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied. Case studies typically involve multiple sources of data, including interviews, observations, documents, and artifacts, which are analyzed using various techniques, such as content analysis, thematic analysis, and grounded theory. The findings of a case study are often used to develop theories, inform policy or practice, or generate new research questions.

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

A single-case study is an in-depth analysis of a single case. This type of case study is useful when the researcher wants to understand a specific phenomenon in detail.

For Example , A researcher might conduct a single-case study on a particular individual to understand their experiences with a particular health condition or a specific organization to explore their management practices. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a single-case study are often used to generate new research questions, develop theories, or inform policy or practice.

Multiple-Case Study

A multiple-case study involves the analysis of several cases that are similar in nature. This type of case study is useful when the researcher wants to identify similarities and differences between the cases.

For Example, a researcher might conduct a multiple-case study on several companies to explore the factors that contribute to their success or failure. The researcher collects data from each case, compares and contrasts the findings, and uses various techniques to analyze the data, such as comparative analysis or pattern-matching. The findings of a multiple-case study can be used to develop theories, inform policy or practice, or generate new research questions.

Exploratory Case Study

An exploratory case study is used to explore a new or understudied phenomenon. This type of case study is useful when the researcher wants to generate hypotheses or theories about the phenomenon.

For Example, a researcher might conduct an exploratory case study on a new technology to understand its potential impact on society. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as grounded theory or content analysis. The findings of an exploratory case study can be used to generate new research questions, develop theories, or inform policy or practice.

Descriptive Case Study

A descriptive case study is used to describe a particular phenomenon in detail. This type of case study is useful when the researcher wants to provide a comprehensive account of the phenomenon.

For Example, a researcher might conduct a descriptive case study on a particular community to understand its social and economic characteristics. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a descriptive case study can be used to inform policy or practice or generate new research questions.

Instrumental Case Study

An instrumental case study is used to understand a particular phenomenon that is instrumental in achieving a particular goal. This type of case study is useful when the researcher wants to understand the role of the phenomenon in achieving the goal.

For Example, a researcher might conduct an instrumental case study on a particular policy to understand its impact on achieving a particular goal, such as reducing poverty. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of an instrumental case study can be used to inform policy or practice or generate new research questions.

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

Interviews involve asking questions to individuals who have knowledge or experience relevant to the case study. Interviews can be structured (where the same questions are asked to all participants) or unstructured (where the interviewer follows up on the responses with further questions). Interviews can be conducted in person, over the phone, or through video conferencing.

Observations

Observations involve watching and recording the behavior and activities of individuals or groups relevant to the case study. Observations can be participant (where the researcher actively participates in the activities) or non-participant (where the researcher observes from a distance). Observations can be recorded using notes, audio or video recordings, or photographs.

Documents can be used as a source of information for case studies. Documents can include reports, memos, emails, letters, and other written materials related to the case study. Documents can be collected from the case study participants or from public sources.

Surveys involve asking a set of questions to a sample of individuals relevant to the case study. Surveys can be administered in person, over the phone, through mail or email, or online. Surveys can be used to gather information on attitudes, opinions, or behaviors related to the case study.

Artifacts are physical objects relevant to the case study. Artifacts can include tools, equipment, products, or other objects that provide insights into the case study phenomenon.

How to conduct Case Study Research

Conducting a case study research involves several steps that need to be followed to ensure the quality and rigor of the study. Here are the steps to conduct case study research:

• Define the research questions: The first step in conducting a case study research is to define the research questions. The research questions should be specific, measurable, and relevant to the case study phenomenon under investigation.
• Select the case: The next step is to select the case or cases to be studied. The case should be relevant to the research questions and should provide rich and diverse data that can be used to answer the research questions.
• Collect data: Data can be collected using various methods, such as interviews, observations, documents, surveys, and artifacts. The data collection method should be selected based on the research questions and the nature of the case study phenomenon.
• Analyze the data: The data collected from the case study should be analyzed using various techniques, such as content analysis, thematic analysis, or grounded theory. The analysis should be guided by the research questions and should aim to provide insights and conclusions relevant to the research questions.
• Draw conclusions: The conclusions drawn from the case study should be based on the data analysis and should be relevant to the research questions. The conclusions should be supported by evidence and should be clearly stated.
• Validate the findings: The findings of the case study should be validated by reviewing the data and the analysis with participants or other experts in the field. This helps to ensure the validity and reliability of the findings.
• Write the report: The final step is to write the report of the case study research. The report should provide a clear description of the case study phenomenon, the research questions, the data collection methods, the data analysis, the findings, and the conclusions. The report should be written in a clear and concise manner and should follow the guidelines for academic writing.

Examples of Case Study

Here are some examples of case study research:

• The Hawthorne Studies : Conducted between 1924 and 1932, the Hawthorne Studies were a series of case studies conducted by Elton Mayo and his colleagues to examine the impact of work environment on employee productivity. The studies were conducted at the Hawthorne Works plant of the Western Electric Company in Chicago and included interviews, observations, and experiments.
• The Stanford Prison Experiment: Conducted in 1971, the Stanford Prison Experiment was a case study conducted by Philip Zimbardo to examine the psychological effects of power and authority. The study involved simulating a prison environment and assigning participants to the role of guards or prisoners. The study was controversial due to the ethical issues it raised.
• The Challenger Disaster: The Challenger Disaster was a case study conducted to examine the causes of the Space Shuttle Challenger explosion in 1986. The study included interviews, observations, and analysis of data to identify the technical, organizational, and cultural factors that contributed to the disaster.
• The Enron Scandal: The Enron Scandal was a case study conducted to examine the causes of the Enron Corporation’s bankruptcy in 2001. The study included interviews, analysis of financial data, and review of documents to identify the accounting practices, corporate culture, and ethical issues that led to the company’s downfall.
• The Fukushima Nuclear Disaster : The Fukushima Nuclear Disaster was a case study conducted to examine the causes of the nuclear accident that occurred at the Fukushima Daiichi Nuclear Power Plant in Japan in 2011. The study included interviews, analysis of data, and review of documents to identify the technical, organizational, and cultural factors that contributed to the disaster.

Application of Case Study

Case studies have a wide range of applications across various fields and industries. Here are some examples:

Business and Management

Case studies are widely used in business and management to examine real-life situations and develop problem-solving skills. Case studies can help students and professionals to develop a deep understanding of business concepts, theories, and best practices.

Case studies are used in healthcare to examine patient care, treatment options, and outcomes. Case studies can help healthcare professionals to develop critical thinking skills, diagnose complex medical conditions, and develop effective treatment plans.

Case studies are used in education to examine teaching and learning practices. Case studies can help educators to develop effective teaching strategies, evaluate student progress, and identify areas for improvement.

Social Sciences

Case studies are widely used in social sciences to examine human behavior, social phenomena, and cultural practices. Case studies can help researchers to develop theories, test hypotheses, and gain insights into complex social issues.

Law and Ethics

Case studies are used in law and ethics to examine legal and ethical dilemmas. Case studies can help lawyers, policymakers, and ethical professionals to develop critical thinking skills, analyze complex cases, and make informed decisions.

Purpose of Case Study

The purpose of a case study is to provide a detailed analysis of a specific phenomenon, issue, or problem in its real-life context. A case study is a qualitative research method that involves the in-depth exploration and analysis of a particular case, which can be an individual, group, organization, event, or community.

The primary purpose of a case study is to generate a comprehensive and nuanced understanding of the case, including its history, context, and dynamics. Case studies can help researchers to identify and examine the underlying factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and detailed understanding of the case, which can inform future research, practice, or policy.

Case studies can also serve other purposes, including:

• Illustrating a theory or concept: Case studies can be used to illustrate and explain theoretical concepts and frameworks, providing concrete examples of how they can be applied in real-life situations.
• Developing hypotheses: Case studies can help to generate hypotheses about the causal relationships between different factors and outcomes, which can be tested through further research.
• Providing insight into complex issues: Case studies can provide insights into complex and multifaceted issues, which may be difficult to understand through other research methods.
• Informing practice or policy: Case studies can be used to inform practice or policy by identifying best practices, lessons learned, or areas for improvement.

Advantages of Case Study Research

There are several advantages of case study research, including:

• In-depth exploration: Case study research allows for a detailed exploration and analysis of a specific phenomenon, issue, or problem in its real-life context. This can provide a comprehensive understanding of the case and its dynamics, which may not be possible through other research methods.
• Rich data: Case study research can generate rich and detailed data, including qualitative data such as interviews, observations, and documents. This can provide a nuanced understanding of the case and its complexity.
• Holistic perspective: Case study research allows for a holistic perspective of the case, taking into account the various factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and comprehensive understanding of the case.
• Theory development: Case study research can help to develop and refine theories and concepts by providing empirical evidence and concrete examples of how they can be applied in real-life situations.
• Practical application: Case study research can inform practice or policy by identifying best practices, lessons learned, or areas for improvement.
• Contextualization: Case study research takes into account the specific context in which the case is situated, which can help to understand how the case is influenced by the social, cultural, and historical factors of its environment.

Limitations of Case Study Research

There are several limitations of case study research, including:

• Limited generalizability : Case studies are typically focused on a single case or a small number of cases, which limits the generalizability of the findings. The unique characteristics of the case may not be applicable to other contexts or populations, which may limit the external validity of the research.
• Biased sampling: Case studies may rely on purposive or convenience sampling, which can introduce bias into the sample selection process. This may limit the representativeness of the sample and the generalizability of the findings.
• Subjectivity: Case studies rely on the interpretation of the researcher, which can introduce subjectivity into the analysis. The researcher’s own biases, assumptions, and perspectives may influence the findings, which may limit the objectivity of the research.
• Limited control: Case studies are typically conducted in naturalistic settings, which limits the control that the researcher has over the environment and the variables being studied. This may limit the ability to establish causal relationships between variables.
• Time-consuming: Case studies can be time-consuming to conduct, as they typically involve a detailed exploration and analysis of a specific case. This may limit the feasibility of conducting multiple case studies or conducting case studies in a timely manner.
• Resource-intensive: Case studies may require significant resources, including time, funding, and expertise. This may limit the ability of researchers to conduct case studies in resource-constrained settings.

About the author

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Researcher, Academic Writer, Web developer

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What is case study research?

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8 February 2023

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Suppose a company receives a spike in the number of customer complaints, or medical experts discover an outbreak of illness affecting children but are not quite sure of the reason. In both cases, carrying out a case study could be the best way to get answers.

Organization

Case studies can be carried out across different disciplines, including education, medicine, sociology, and business.

Most case studies employ qualitative methods, but quantitative methods can also be used. Researchers can then describe, compare, evaluate, and identify patterns or cause-and-effect relationships between the various variables under study. They can then use this knowledge to decide what action to take. 

Another thing to note is that case studies are generally singular in their focus. This means they narrow focus to a particular area, making them highly subjective. You cannot always generalize the results of a case study and apply them to a larger population. However, they are valuable tools to illustrate a principle or develop a thesis.

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• What are the different types of case study designs?

Researchers can choose from a variety of case study designs. The design they choose is dependent on what questions they need to answer, the context of the research environment, how much data they already have, and what resources are available.

Here are the common types of case study design:

Explanatory

An explanatory case study is an initial explanation of the how or why that is behind something. This design is commonly used when studying a real-life phenomenon or event. Once the organization understands the reasons behind a phenomenon, it can then make changes to enhance or eliminate the variables causing it. 

Here is an example: How is co-teaching implemented in elementary schools? The title for a case study of this subject could be “Case Study of the Implementation of Co-Teaching in Elementary Schools.”

Descriptive

An illustrative or descriptive case study helps researchers shed light on an unfamiliar object or subject after a period of time. The case study provides an in-depth review of the issue at hand and adds real-world examples in the area the researcher wants the audience to understand. 

The researcher makes no inferences or causal statements about the object or subject under review. This type of design is often used to understand cultural shifts.

Here is an example: How did people cope with the 2004 Indian Ocean Tsunami? This case study could be titled "A Case Study of the 2004 Indian Ocean Tsunami and its Effect on the Indonesian Population."

Exploratory

Exploratory research is also called a pilot case study. It is usually the first step within a larger research project, often relying on questionnaires and surveys . Researchers use exploratory research to help narrow down their focus, define parameters, draft a specific research question , and/or identify variables in a larger study. This research design usually covers a wider area than others, and focuses on the ‘what’ and ‘who’ of a topic.

Here is an example: How do nutrition and socialization in early childhood affect learning in children? The title of the exploratory study may be “Case Study of the Effects of Nutrition and Socialization on Learning in Early Childhood.”

An intrinsic case study is specifically designed to look at a unique and special phenomenon. At the start of the study, the researcher defines the phenomenon and the uniqueness that differentiates it from others. 

In this case, researchers do not attempt to generalize, compare, or challenge the existing assumptions. Instead, they explore the unique variables to enhance understanding. Here is an example: “Case Study of Volcanic Lightning.”

This design can also be identified as a cumulative case study. It uses information from past studies or observations of groups of people in certain settings as the foundation of the new study. Given that it takes multiple areas into account, it allows for greater generalization than a single case study. 

The researchers also get an in-depth look at a particular subject from different viewpoints.  Here is an example: “Case Study of how PTSD affected Vietnam and Gulf War Veterans Differently Due to Advances in Military Technology.”

Critical instance

A critical case study incorporates both explanatory and intrinsic study designs. It does not have predetermined purposes beyond an investigation of the said subject. It can be used for a deeper explanation of the cause-and-effect relationship. It can also be used to question a common assumption or myth. 

The findings can then be used further to generalize whether they would also apply in a different environment.  Here is an example: “What Effect Does Prolonged Use of Social Media Have on the Mind of American Youth?”

Instrumental

Instrumental research attempts to achieve goals beyond understanding the object at hand. Researchers explore a larger subject through different, separate studies and use the findings to understand its relationship to another subject. This type of design also provides insight into an issue or helps refine a theory. 

For example, you may want to determine if violent behavior in children predisposes them to crime later in life. The focus is on the relationship between children and violent behavior, and why certain children do become violent. Here is an example: “Violence Breeds Violence: Childhood Exposure and Participation in Adult Crime.”

Evaluation case study design is employed to research the effects of a program, policy, or intervention, and assess its effectiveness and impact on future decision-making. 

For example, you might want to see whether children learn times tables quicker through an educational game on their iPad versus a more teacher-led intervention. Here is an example: “An Investigation of the Impact of an iPad Multiplication Game for Primary School Children.” 

• When do you use case studies?

Case studies are ideal when you want to gain a contextual, concrete, or in-depth understanding of a particular subject. It helps you understand the characteristics, implications, and meanings of the subject.

They are also an excellent choice for those writing a thesis or dissertation, as they help keep the project focused on a particular area when resources or time may be too limited to cover a wider one. You may have to conduct several case studies to explore different aspects of the subject in question and understand the problem.

• What are the steps to follow when conducting a case study?

1. Select a case

Once you identify the problem at hand and come up with questions, identify the case you will focus on. The study can provide insights into the subject at hand, challenge existing assumptions, propose a course of action, and/or open up new areas for further research.

2. Create a theoretical framework

While you will be focusing on a specific detail, the case study design you choose should be linked to existing knowledge on the topic. This prevents it from becoming an isolated description and allows for enhancing the existing information. 

It may expand the current theory by bringing up new ideas or concepts, challenge established assumptions, or exemplify a theory by exploring how it answers the problem at hand. A theoretical framework starts with a literature review of the sources relevant to the topic in focus. This helps in identifying key concepts to guide analysis and interpretation.

3. Collect the data

Case studies are frequently supplemented with qualitative data such as observations, interviews, and a review of both primary and secondary sources such as official records, news articles, and photographs. There may also be quantitative data —this data assists in understanding the case thoroughly.

4. Analyze your case

The results of the research depend on the research design. Most case studies are structured with chapters or topic headings for easy explanation and presentation. Others may be written as narratives to allow researchers to explore various angles of the topic and analyze its meanings and implications.

In all areas, always give a detailed contextual understanding of the case and connect it to the existing theory and literature before discussing how it fits into your problem area.

• What are some case study examples?

What are the best approaches for introducing our product into the Kenyan market?

How does the change in marketing strategy aid in increasing the sales volumes of product Y?

How can teachers enhance student participation in classrooms?

How does poverty affect literacy levels in children?

Case study topics

Case study of product marketing strategies in the Kenyan market

Case study of the effects of a marketing strategy change on product Y sales volumes

Case study of X school teachers that encourage active student participation in the classroom

Case study of the effects of poverty on literacy levels in children

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What is a Case Study in Research? Definition, Methods, and Examples

Case study methodology offers researchers an exciting opportunity to explore intricate phenomena within specific contexts using a wide range of data sources and collection methods. It is highly pertinent in health and social sciences, environmental studies, social work, education, and business studies. Its diverse applications, such as advancing theory, program evaluation, and intervention development, make it an invaluable tool for driving meaningful research and fostering positive change.[ 1]  

Table of Contents

What is a Case Study?  

A case study method involves a detailed examination of a single subject, such as an individual, group, organization, event, or community, to explore and understand complex issues in real-life contexts. By focusing on one specific case, researchers can gain a deep understanding of the factors and dynamics at play, understanding their complex relationships, which might be missed in broader, more quantitative studies.  

When to do a Case Study?  

A case study design is useful when you want to explore a phenomenon in-depth and in its natural context. Here are some examples of when to use a case study :[ 2]  

• Exploratory Research: When you want to explore a new topic or phenomenon, a case study can help you understand the subject deeply. For example , a researcher studying a newly discovered plant species might use a case study to document its characteristics and behavior.  
• Descriptive Research: If you want to describe a complex phenomenon or process, a case study can provide a detailed and comprehensive description. For instance, a case study design   could describe the experiences of a group of individuals living with a rare disease.  
• Explanatory Research: When you want to understand why a particular phenomenon occurs, a case study can help you identify causal relationships. A case study design could investigate the reasons behind the success or failure of a particular business strategy.  
• Theory Building: Case studies can also be used to develop or refine theories. By systematically analyzing a series of cases, researchers can identify patterns and relationships that can contribute to developing new theories or refining existing ones.  
• Critical Instance: Sometimes, a single case can be used to study a rare or unusual phenomenon, but it is important for theoretical or practical reasons. For example , the case of Phineas Gage, a man who survived a severe brain injury, has been widely studied to understand the relationship between the brain and behavior.  
• Comparative Analysis: Case studies can also compare different cases or contexts. A case study example involves comparing the implementation of a particular policy in different countries to understand its effectiveness and identifying best practices.  

How to Create a Case Study – Step by Step  

Step 1: select a case  .

Careful case selection ensures relevance, insight, and meaningful contribution to existing knowledge in your field. Here’s how you can choose a case study design :[ 3]  

• Define Your Objectives: Clarify the purpose of your case study and what you hope to achieve. Do you want to provide new insights, challenge existing theories, propose solutions to a problem, or explore new research directions?  
• Consider Unusual or Outlying Cases: Focus on unusual, neglected, or outlying cases that can provide unique insights.  
• Choose a Representative Case: Alternatively, select a common or representative case to exemplify a particular category, experience, or phenomenon.   
• Avoid Bias: Ensure your selection process is unbiased using random or criteria-based selection.  
• Be Clear and Specific: Clearly define the boundaries of your study design , including the scope, timeframe, and key stakeholders.   
• Ethical Considerations: Consider ethical issues, such as confidentiality and informed consent.  

Step 2: Build a Theoretical Framework  

To ensure your case study has a solid academic foundation, it’s important to build a theoretical framework:   

• Conduct a Literature Review: Identify key concepts and theories relevant to your case study .  
• Establish Connections with Theory: Connect your case study with existing theories in the field.  
• Guide Your Analysis and Interpretation: Use your theoretical framework to guide your analysis, ensuring your findings are grounded in established theories and concepts.   

Step 3: Collect Your Data  

To conduct a comprehensive case study , you can use various research methods. These include interviews, observations, primary and secondary sources analysis, surveys, and a mixed methods approach. The aim is to gather rich and diverse data to enable a detailed analysis of your case study .  

Step 4: Describe and Analyze the Case  

How you report your findings will depend on the type of research you’re conducting. Here are two approaches:   

• Structured Approach: Follows a scientific paper format, making it easier for readers to follow your argument.  
• Narrative Approach: A more exploratory style aiming to analyze meanings and implications.  

Regardless of the approach you choose, it’s important to include the following elements in your case study :   

• Contextual Details: Provide background information about the case, including relevant historical, cultural, and social factors that may have influenced the outcome.  
• Literature and Theory: Connect your case study to existing literature and theory in the field. Discuss how your findings contribute to or challenge existing knowledge.  
• Wider Patterns or Debates: Consider how your case study fits into wider patterns or debates within the field. Discuss any implications your findings may have for future research or practice.  

What Are the Benefits of a Case Study   

Case studies offer a range of benefits , making them a powerful tool in research.  

1. In-Depth Analysis  

• Comprehensive Understanding: Case studies allow researchers to thoroughly explore a subject, understanding the complexities and nuances involved.  
• Rich Data: They offer rich qualitative and sometimes quantitative data, capturing the intricacies of real-life contexts.  

2. Contextual Insight  

• Real-World Application: Case studies provide insights into real-world applications, making the findings highly relevant and practical.  
• Context-Specific: They highlight how various factors interact within a specific context, offering a detailed picture of the situation.  

3. Flexibility  

• Methodological Diversity: Case studies can use various data collection methods, including interviews, observations, document analysis, and surveys.  
• Adaptability: Researchers can adapt the case study approach to fit the specific needs and circumstances of the research.  

4. Practical Solutions  

• Actionable Insights: The detailed findings from case studies can inform practical solutions and recommendations for practitioners and policymakers.  
• Problem-Solving: They help understand the root causes of problems and devise effective strategies to address them.  

5. Unique Cases  

• Rare Phenomena: Case studies are particularly valuable for studying rare or unique cases that other research methods may not capture.  
• Detailed Documentation: They document and preserve detailed information about specific instances that might otherwise be overlooked.  

What Are the Limitations of a Case Study   

While case studies offer valuable insights and a detailed understanding of complex issues, they have several limitations .  

1. Limited Generalizability  

• Specific Context: Case studies often focus on a single case or a small number of cases, which may limit the generalization of findings to broader populations or different contexts.  
• Unique Situations: The unique characteristics of the case may not be representative of other situations, reducing the applicability of the results.  

2. Subjectivity  

• Researcher Bias: The researcher’s perspectives and interpretations can influence the analysis and conclusions, potentially introducing bias.  
• Participant Bias: Participants’ responses and behaviors may be influenced by their awareness of being studied, known as the Hawthorne effect.  

3. Time-Consuming  

• Data Collection and Analysis: Gathering detailed, in-depth data requires significant time and effort, making case studies more time-consuming than other research methods.  
• Longitudinal Studies: If the case study observes changes over time, it can become even more prolonged.  

4. Resource Intensive  

• Financial and Human Resources: Conducting comprehensive case studies may require significant financial investment and human resources, including trained researchers and participant access.  
• Access to Data: Accessing relevant and reliable data sources can be challenging, particularly in sensitive or proprietary contexts.  

5. Replication Difficulties  

• Unique Contexts: A case study’s specific and detailed context makes it difficult to replicate the study exactly, limiting the ability to validate findings through repetition.  
• Variability: Differences in contexts, researchers, and methodologies can lead to variations in findings, complicating efforts to achieve consistent results.  

By acknowledging and addressing these limitations , researchers can enhance the rigor and reliability of their case study findings.  

Key Takeaways  

Case studies are valuable in research because they provide an in-depth, contextual analysis of a single subject, event, or organization. They allow researchers to explore complex issues in real-world settings, capturing detailed qualitative and quantitative data. This method is useful for generating insights, developing theories, and offering practical solutions to problems. They are versatile, applicable in diverse fields such as business, education, and health, and can complement other research methods by providing rich, contextual evidence. However, their findings may have limited generalizability due to the focus on a specific case.  

Frequently Asked Questions  

Q: What is a case study in research?  

A case study in research is an impactful tool for gaining a deep understanding of complex issues within their real-life context. It combines various data collection methods and provides rich, detailed insights that can inform theory development and practical applications.  

Q: What are the advantages of using case studies in research?  

Case studies are a powerful research method, offering advantages such as in-depth analysis, contextual insights, flexibility, rich data, and the ability to handle complex issues. They are particularly valuable for exploring new areas, generating hypotheses, and providing detailed, illustrative examples that can inform theory and practice.  

Q: Can case studies be used in quantitative research?  

While case studies are predominantly associated with qualitative research, they can effectively incorporate quantitative methods to provide a more comprehensive analysis. A mixed-methods approach leverages qualitative and quantitative research strengths, offering a powerful tool for exploring complex issues in a real-world context. For example , a new medical treatment case study can incorporate quantitative clinical outcomes (e.g., patient recovery rates and dosage levels) along with qualitative patient interviews.  

Q: What are the key components of a case study?  

A case study typically includes several key components:   

• Introductio n, which provides an overview and sets the context by presenting the problem statement and research objectives;  
• Literature review , which connects the study to existing theories and prior research;  
• Methodology , which details the case study design , data collection methods, and analysis techniques;   
• Findings , which present the data and results, including descriptions, patterns, and themes;   
• Discussion and conclusion , which interpret the findings, discuss their implications, and offer conclusions, practical applications, limitations, and suggestions for future research.  

Together, these components ensure a comprehensive, systematic, and insightful exploration of the case.  

References  

• de Vries, K. (2020). Case study methodology. In  Critical qualitative health research  (pp. 41-52). Routledge.  
• Fidel, R. (1984). The case study method: A case study.  Library and Information Science Research ,  6 (3), 273-288.  
• Thomas, G. (2021). How to do your case study.  How to do your case study , 1-320.  

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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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The Ultimate Guide to Qualitative Research - Part 1: The Basics

• Introduction and overview
• What is qualitative research?
• What is qualitative data?
• Examples of qualitative data
• Qualitative vs. quantitative research
• Mixed methods
• Qualitative research preparation
• Theoretical perspective
• Theoretical framework
• Literature reviews

Research question

• Conceptual framework
• Conceptual vs. theoretical framework

Data collection

• Qualitative research methods
• Focus groups
• Observational research

What is a case study?

Applications for case study research, what is a good case study, process of case study design, benefits and limitations of case studies.

• Ethnographical research
• Ethical considerations
• Confidentiality and privacy
• Power dynamics
• Reflexivity

Case studies

Case studies are essential to qualitative research , offering a lens through which researchers can investigate complex phenomena within their real-life contexts. This chapter explores the concept, purpose, applications, examples, and types of case studies and provides guidance on how to conduct case study research effectively.

Whereas quantitative methods look at phenomena at scale, case study research looks at a concept or phenomenon in considerable detail. While analyzing a single case can help understand one perspective regarding the object of research inquiry, analyzing multiple cases can help obtain a more holistic sense of the topic or issue. Let's provide a basic definition of a case study, then explore its characteristics and role in the qualitative research process.

Definition of a case study

A case study in qualitative research is a strategy of inquiry that involves an in-depth investigation of a phenomenon within its real-world context. It provides researchers with the opportunity to acquire an in-depth understanding of intricate details that might not be as apparent or accessible through other methods of research. The specific case or cases being studied can be a single person, group, or organization – demarcating what constitutes a relevant case worth studying depends on the researcher and their research question .

Among qualitative research methods , a case study relies on multiple sources of evidence, such as documents, artifacts, interviews , or observations , to present a complete and nuanced understanding of the phenomenon under investigation. The objective is to illuminate the readers' understanding of the phenomenon beyond its abstract statistical or theoretical explanations.

Characteristics of case studies

Case studies typically possess a number of distinct characteristics that set them apart from other research methods. These characteristics include a focus on holistic description and explanation, flexibility in the design and data collection methods, reliance on multiple sources of evidence, and emphasis on the context in which the phenomenon occurs.

Furthermore, case studies can often involve a longitudinal examination of the case, meaning they study the case over a period of time. These characteristics allow case studies to yield comprehensive, in-depth, and richly contextualized insights about the phenomenon of interest.

The role of case studies in research

Case studies hold a unique position in the broader landscape of research methods aimed at theory development. They are instrumental when the primary research interest is to gain an intensive, detailed understanding of a phenomenon in its real-life context.

In addition, case studies can serve different purposes within research - they can be used for exploratory, descriptive, or explanatory purposes, depending on the research question and objectives. This flexibility and depth make case studies a valuable tool in the toolkit of qualitative researchers.

Remember, a well-conducted case study can offer a rich, insightful contribution to both academic and practical knowledge through theory development or theory verification, thus enhancing our understanding of complex phenomena in their real-world contexts.

What is the purpose of a case study?

Case study research aims for a more comprehensive understanding of phenomena, requiring various research methods to gather information for qualitative analysis . Ultimately, a case study can allow the researcher to gain insight into a particular object of inquiry and develop a theoretical framework relevant to the research inquiry.

Why use case studies in qualitative research?

Using case studies as a research strategy depends mainly on the nature of the research question and the researcher's access to the data.

Conducting case study research provides a level of detail and contextual richness that other research methods might not offer. They are beneficial when there's a need to understand complex social phenomena within their natural contexts.

The explanatory, exploratory, and descriptive roles of case studies

Case studies can take on various roles depending on the research objectives. They can be exploratory when the research aims to discover new phenomena or define new research questions; they are descriptive when the objective is to depict a phenomenon within its context in a detailed manner; and they can be explanatory if the goal is to understand specific relationships within the studied context. Thus, the versatility of case studies allows researchers to approach their topic from different angles, offering multiple ways to uncover and interpret the data .

The impact of case studies on knowledge development

Case studies play a significant role in knowledge development across various disciplines. Analysis of cases provides an avenue for researchers to explore phenomena within their context based on the collected data.

This can result in the production of rich, practical insights that can be instrumental in both theory-building and practice. Case studies allow researchers to delve into the intricacies and complexities of real-life situations, uncovering insights that might otherwise remain hidden.

Types of case studies

In qualitative research , a case study is not a one-size-fits-all approach. Depending on the nature of the research question and the specific objectives of the study, researchers might choose to use different types of case studies. These types differ in their focus, methodology, and the level of detail they provide about the phenomenon under investigation.

Understanding these types is crucial for selecting the most appropriate approach for your research project and effectively achieving your research goals. Let's briefly look at the main types of case studies.

Exploratory case studies

Exploratory case studies are typically conducted to develop a theory or framework around an understudied phenomenon. They can also serve as a precursor to a larger-scale research project. Exploratory case studies are useful when a researcher wants to identify the key issues or questions which can spur more extensive study or be used to develop propositions for further research. These case studies are characterized by flexibility, allowing researchers to explore various aspects of a phenomenon as they emerge, which can also form the foundation for subsequent studies.

Descriptive case studies

Descriptive case studies aim to provide a complete and accurate representation of a phenomenon or event within its context. These case studies are often based on an established theoretical framework, which guides how data is collected and analyzed. The researcher is concerned with describing the phenomenon in detail, as it occurs naturally, without trying to influence or manipulate it.

Explanatory case studies

Explanatory case studies are focused on explanation - they seek to clarify how or why certain phenomena occur. Often used in complex, real-life situations, they can be particularly valuable in clarifying causal relationships among concepts and understanding the interplay between different factors within a specific context.

Intrinsic, instrumental, and collective case studies

These three categories of case studies focus on the nature and purpose of the study. An intrinsic case study is conducted when a researcher has an inherent interest in the case itself. Instrumental case studies are employed when the case is used to provide insight into a particular issue or phenomenon. A collective case study, on the other hand, involves studying multiple cases simultaneously to investigate some general phenomena.

Each type of case study serves a different purpose and has its own strengths and challenges. The selection of the type should be guided by the research question and objectives, as well as the context and constraints of the research.

The flexibility, depth, and contextual richness offered by case studies make this approach an excellent research method for various fields of study. They enable researchers to investigate real-world phenomena within their specific contexts, capturing nuances that other research methods might miss. Across numerous fields, case studies provide valuable insights into complex issues.

Critical information systems research

Case studies provide a detailed understanding of the role and impact of information systems in different contexts. They offer a platform to explore how information systems are designed, implemented, and used and how they interact with various social, economic, and political factors. Case studies in this field often focus on examining the intricate relationship between technology, organizational processes, and user behavior, helping to uncover insights that can inform better system design and implementation.

Health research

Health research is another field where case studies are highly valuable. They offer a way to explore patient experiences, healthcare delivery processes, and the impact of various interventions in a real-world context.

Case studies can provide a deep understanding of a patient's journey, giving insights into the intricacies of disease progression, treatment effects, and the psychosocial aspects of health and illness.

Asthma research studies

Specifically within medical research, studies on asthma often employ case studies to explore the individual and environmental factors that influence asthma development, management, and outcomes. A case study can provide rich, detailed data about individual patients' experiences, from the triggers and symptoms they experience to the effectiveness of various management strategies. This can be crucial for developing patient-centered asthma care approaches.

Other fields

Apart from the fields mentioned, case studies are also extensively used in business and management research, education research, and political sciences, among many others. They provide an opportunity to delve into the intricacies of real-world situations, allowing for a comprehensive understanding of various phenomena.

Case studies, with their depth and contextual focus, offer unique insights across these varied fields. They allow researchers to illuminate the complexities of real-life situations, contributing to both theory and practice.

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Understanding the key elements of case study design is crucial for conducting rigorous and impactful case study research. A well-structured design guides the researcher through the process, ensuring that the study is methodologically sound and its findings are reliable and valid. The main elements of case study design include the research question , propositions, units of analysis, and the logic linking the data to the propositions.

The research question is the foundation of any research study. A good research question guides the direction of the study and informs the selection of the case, the methods of collecting data, and the analysis techniques. A well-formulated research question in case study research is typically clear, focused, and complex enough to merit further detailed examination of the relevant case(s).

Propositions

Propositions, though not necessary in every case study, provide a direction by stating what we might expect to find in the data collected. They guide how data is collected and analyzed by helping researchers focus on specific aspects of the case. They are particularly important in explanatory case studies, which seek to understand the relationships among concepts within the studied phenomenon.

Units of analysis

The unit of analysis refers to the case, or the main entity or entities that are being analyzed in the study. In case study research, the unit of analysis can be an individual, a group, an organization, a decision, an event, or even a time period. It's crucial to clearly define the unit of analysis, as it shapes the qualitative data analysis process by allowing the researcher to analyze a particular case and synthesize analysis across multiple case studies to draw conclusions.

Argumentation

This refers to the inferential model that allows researchers to draw conclusions from the data. The researcher needs to ensure that there is a clear link between the data, the propositions (if any), and the conclusions drawn. This argumentation is what enables the researcher to make valid and credible inferences about the phenomenon under study.

Understanding and carefully considering these elements in the design phase of a case study can significantly enhance the quality of the research. It can help ensure that the study is methodologically sound and its findings contribute meaningful insights about the case.

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Conducting a case study involves several steps, from defining the research question and selecting the case to collecting and analyzing data . This section outlines these key stages, providing a practical guide on how to conduct case study research.

Defining the research question

The first step in case study research is defining a clear, focused research question. This question should guide the entire research process, from case selection to analysis. It's crucial to ensure that the research question is suitable for a case study approach. Typically, such questions are exploratory or descriptive in nature and focus on understanding a phenomenon within its real-life context.

Selecting and defining the case

The selection of the case should be based on the research question and the objectives of the study. It involves choosing a unique example or a set of examples that provide rich, in-depth data about the phenomenon under investigation. After selecting the case, it's crucial to define it clearly, setting the boundaries of the case, including the time period and the specific context.

Previous research can help guide the case study design. When considering a case study, an example of a case could be taken from previous case study research and used to define cases in a new research inquiry. Considering recently published examples can help understand how to select and define cases effectively.

Developing a detailed case study protocol

A case study protocol outlines the procedures and general rules to be followed during the case study. This includes the data collection methods to be used, the sources of data, and the procedures for analysis. Having a detailed case study protocol ensures consistency and reliability in the study.

The protocol should also consider how to work with the people involved in the research context to grant the research team access to collecting data. As mentioned in previous sections of this guide, establishing rapport is an essential component of qualitative research as it shapes the overall potential for collecting and analyzing data.

Collecting data

Gathering data in case study research often involves multiple sources of evidence, including documents, archival records, interviews, observations, and physical artifacts. This allows for a comprehensive understanding of the case. The process for gathering data should be systematic and carefully documented to ensure the reliability and validity of the study.

Analyzing and interpreting data

The next step is analyzing the data. This involves organizing the data , categorizing it into themes or patterns , and interpreting these patterns to answer the research question. The analysis might also involve comparing the findings with prior research or theoretical propositions.

Writing the case study report

The final step is writing the case study report . This should provide a detailed description of the case, the data, the analysis process, and the findings. The report should be clear, organized, and carefully written to ensure that the reader can understand the case and the conclusions drawn from it.

Each of these steps is crucial in ensuring that the case study research is rigorous, reliable, and provides valuable insights about the case.

The type, depth, and quality of data in your study can significantly influence the validity and utility of the study. In case study research, data is usually collected from multiple sources to provide a comprehensive and nuanced understanding of the case. This section will outline the various methods of collecting data used in case study research and discuss considerations for ensuring the quality of the data.

Interviews are a common method of gathering data in case study research. They can provide rich, in-depth data about the perspectives, experiences, and interpretations of the individuals involved in the case. Interviews can be structured , semi-structured , or unstructured , depending on the research question and the degree of flexibility needed.

Observations

Observations involve the researcher observing the case in its natural setting, providing first-hand information about the case and its context. Observations can provide data that might not be revealed in interviews or documents, such as non-verbal cues or contextual information.

Documents and artifacts

Documents and archival records provide a valuable source of data in case study research. They can include reports, letters, memos, meeting minutes, email correspondence, and various public and private documents related to the case.

These records can provide historical context, corroborate evidence from other sources, and offer insights into the case that might not be apparent from interviews or observations.

Physical artifacts refer to any physical evidence related to the case, such as tools, products, or physical environments. These artifacts can provide tangible insights into the case, complementing the data gathered from other sources.

Ensuring the quality of data collection

Determining the quality of data in case study research requires careful planning and execution. It's crucial to ensure that the data is reliable, accurate, and relevant to the research question. This involves selecting appropriate methods of collecting data, properly training interviewers or observers, and systematically recording and storing the data. It also includes considering ethical issues related to collecting and handling data, such as obtaining informed consent and ensuring the privacy and confidentiality of the participants.

Data analysis

Analyzing case study research involves making sense of the rich, detailed data to answer the research question. This process can be challenging due to the volume and complexity of case study data. However, a systematic and rigorous approach to analysis can ensure that the findings are credible and meaningful. This section outlines the main steps and considerations in analyzing data in case study research.

Organizing the data

The first step in the analysis is organizing the data. This involves sorting the data into manageable sections, often according to the data source or the theme. This step can also involve transcribing interviews, digitizing physical artifacts, or organizing observational data.

Categorizing and coding the data

Once the data is organized, the next step is to categorize or code the data. This involves identifying common themes, patterns, or concepts in the data and assigning codes to relevant data segments. Coding can be done manually or with the help of software tools, and in either case, qualitative analysis software can greatly facilitate the entire coding process. Coding helps to reduce the data to a set of themes or categories that can be more easily analyzed.

Identifying patterns and themes

After coding the data, the researcher looks for patterns or themes in the coded data. This involves comparing and contrasting the codes and looking for relationships or patterns among them. The identified patterns and themes should help answer the research question.

Interpreting the data

Once patterns and themes have been identified, the next step is to interpret these findings. This involves explaining what the patterns or themes mean in the context of the research question and the case. This interpretation should be grounded in the data, but it can also involve drawing on theoretical concepts or prior research.

Verification of the data

The last step in the analysis is verification. This involves checking the accuracy and consistency of the analysis process and confirming that the findings are supported by the data. This can involve re-checking the original data, checking the consistency of codes, or seeking feedback from research participants or peers.

Like any research method , case study research has its strengths and limitations. Researchers must be aware of these, as they can influence the design, conduct, and interpretation of the study.

Understanding the strengths and limitations of case study research can also guide researchers in deciding whether this approach is suitable for their research question . This section outlines some of the key strengths and limitations of case study research.

Benefits include the following:

• Rich, detailed data: One of the main strengths of case study research is that it can generate rich, detailed data about the case. This can provide a deep understanding of the case and its context, which can be valuable in exploring complex phenomena.
• Flexibility: Case study research is flexible in terms of design , data collection , and analysis . A sufficient degree of flexibility allows the researcher to adapt the study according to the case and the emerging findings.
• Real-world context: Case study research involves studying the case in its real-world context, which can provide valuable insights into the interplay between the case and its context.
• Multiple sources of evidence: Case study research often involves collecting data from multiple sources , which can enhance the robustness and validity of the findings.

On the other hand, researchers should consider the following limitations:

• Generalizability: A common criticism of case study research is that its findings might not be generalizable to other cases due to the specificity and uniqueness of each case.
• Time and resource intensive: Case study research can be time and resource intensive due to the depth of the investigation and the amount of collected data.
• Complexity of analysis: The rich, detailed data generated in case study research can make analyzing the data challenging.
• Subjectivity: Given the nature of case study research, there may be a higher degree of subjectivity in interpreting the data , so researchers need to reflect on this and transparently convey to audiences how the research was conducted.

Being aware of these strengths and limitations can help researchers design and conduct case study research effectively and interpret and report the findings appropriately.

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Writing a Case Study

What is a case study?

A Case study is: 

• An in-depth research design that primarily uses a qualitative methodology but sometimes​​ includes quantitative methodology.
• Used to examine an identifiable problem confirmed through research.
• Used to investigate an individual, group of people, organization, or event.
• Used to mostly answer "how" and "why" questions.

What are the different types of case studies?

Note: These are the primary case studies. As you continue to research and learn

about case studies you will begin to find a robust list of different types. 

Who are your case study participants?

What is triangulation ? 

Validity and credibility are an essential part of the case study. Therefore, the researcher should include triangulation to ensure trustworthiness while accurately reflecting what the researcher seeks to investigate.

How to write a Case Study?

When developing a case study, there are different ways you could present the information, but remember to include the five parts for your case study.

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• Case Study | Definition, Examples & Methods

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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What Is a Case Study?

Weighing the pros and cons of this method of research

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

• Pros and Cons

What Types of Case Studies Are Out There?

Where do you find data for a case study, how do i write a psychology 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 many different fields, including psychology, medicine, education, anthropology, political science, and social work.

The point 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, we got you—here are some rules of APA format to reference.  

At a Glance

A case study, or an in-depth study of a person, group, or event, can be a useful research tool when used wisely. In many cases, case studies are best used in situations where it would be difficult or impossible for you to conduct an experiment. They are helpful for looking at unique situations and allow researchers to gather a lot of˜ information about a specific individual or group of people. However, it's important to be cautious of any bias we draw from them as they are highly subjective.

What Are the Benefits and Limitations of Case Studies?

A case study can have its 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 or impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to capture information on the 'how,' 'what,' and 'why,' of something that's implemented
• Gives researchers the chance to collect information on why one strategy might be chosen over another
• Permits researchers to develop hypotheses that can be explored in experimental research

On the other hand, a case study can have some drawbacks:

• It cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• It may not be scientifically rigorous
• It can lead to bias

Researchers may choose to perform a case study if they want to explore a unique or recently discovered phenomenon. Through their insights, researchers develop additional ideas and study questions that might be explored in future studies.

It's important to remember that the insights 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 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 learning was possible, even after missing critical periods for language development. 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 denied her the opportunity to learn a language at critical points in her development.

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

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

• 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 who live 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 case 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 use depends on the unique characteristics of the situation and the case itself.

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.

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 you need to follow. If you are writing your case study for a professional publication, check with the publisher for their specific guidelines for submitting a case study.

Here is a general outline of what should be included in a case study.

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?

Need More Tips?

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, use 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 .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach .  BMC Med Res Methodol . 2011;11:100.

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."

• Open access
• Published: 27 June 2011

The case study approach

• Sarah Crowe 1 ,
• Kathrin Cresswell 2 ,
• Ann Robertson 2 ,
• Guro Huby 3 ,
• Anthony Avery 1 &
• Aziz Sheikh 2  

BMC Medical Research Methodology volume  11 , Article number:  100 ( 2011 ) Cite this article

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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.

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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 1 , 2 , 3 and 4 ) and those of others to illustrate our discussion[ 3 – 7 ].

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 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.

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 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 2 , 3 and 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 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 2 and 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 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 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 ].

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 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 ].

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table 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 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 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 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 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 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 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 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 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 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 9 )[ 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.

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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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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.

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• Roberta Heale 1 ,
• Alison Twycross 2
• 1 School of Nursing , Laurentian University , Sudbury , Ontario , Canada
• 2 School of Health and Social Care , London South Bank University , London , UK
• Correspondence to Dr Roberta Heale, School of Nursing, Laurentian University, Sudbury, ON P3E2C6, Canada; rheale{at}laurentian.ca

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What is it?

Case study is a research methodology, typically seen in social and life sciences. There is no one definition of case study research. 1 However, very simply… ‘a case study can be defined as an intensive study about a person, a group of people or a unit, which is aimed to generalize over several units’. 1 A case study has also been described as an intensive, systematic investigation of a single individual, group, community or some other unit in which the researcher examines in-depth data relating to several variables. 2

Often there are several similar cases to consider such as educational or social service programmes that are delivered from a number of locations. Although similar, they are complex and have unique features. In these circumstances, the evaluation of several, similar cases will provide a better answer to a research question than if only one case is examined, hence the multiple-case study. Stake asserts that the cases are grouped and viewed as one entity, called the quintain . 6  ‘We study what is similar and different about the cases to understand the quintain better’. 6

The steps when using case study methodology are the same as for other types of research. 6 The first step is defining the single case or identifying a group of similar cases that can then be incorporated into a multiple-case study. A search to determine what is known about the case(s) is typically conducted. This may include a review of the literature, grey literature, media, reports and more, which serves to establish a basic understanding of the cases and informs the development of research questions. Data in case studies are often, but not exclusively, qualitative in nature. In multiple-case studies, analysis within cases and across cases is conducted. Themes arise from the analyses and assertions about the cases as a whole, or the quintain, emerge. 6

Benefits and limitations of case studies

If a researcher wants to study a specific phenomenon arising from a particular entity, then a single-case study is warranted and will allow for a in-depth understanding of the single phenomenon and, as discussed above, would involve collecting several different types of data. This is illustrated in example 1 below.

Using a multiple-case research study allows for a more in-depth understanding of the cases as a unit, through comparison of similarities and differences of the individual cases embedded within the quintain. Evidence arising from multiple-case studies is often stronger and more reliable than from single-case research. Multiple-case studies allow for more comprehensive exploration of research questions and theory development. 6

Despite the advantages of case studies, there are limitations. The sheer volume of data is difficult to organise and data analysis and integration strategies need to be carefully thought through. There is also sometimes a temptation to veer away from the research focus. 2 Reporting of findings from multiple-case research studies is also challenging at times, 1 particularly in relation to the word limits for some journal papers.

Examples of case studies

Example 1: nurses’ paediatric pain management practices.

One of the authors of this paper (AT) has used a case study approach to explore nurses’ paediatric pain management practices. This involved collecting several datasets:

Observational data to gain a picture about actual pain management practices.

Questionnaire data about nurses’ knowledge about paediatric pain management practices and how well they felt they managed pain in children.

Questionnaire data about how critical nurses perceived pain management tasks to be.

These datasets were analysed separately and then compared 7–9 and demonstrated that nurses’ level of theoretical did not impact on the quality of their pain management practices. 7 Nor did individual nurse’s perceptions of how critical a task was effect the likelihood of them carrying out this task in practice. 8 There was also a difference in self-reported and observed practices 9 ; actual (observed) practices did not confirm to best practice guidelines, whereas self-reported practices tended to.

Example 2: quality of care for complex patients at Nurse Practitioner-Led Clinics (NPLCs)

The other author of this paper (RH) has conducted a multiple-case study to determine the quality of care for patients with complex clinical presentations in NPLCs in Ontario, Canada. 10 Five NPLCs served as individual cases that, together, represented the quatrain. Three types of data were collected including:

Review of documentation related to the NPLC model (media, annual reports, research articles, grey literature and regulatory legislation).

Interviews with nurse practitioners (NPs) practising at the five NPLCs to determine their perceptions of the impact of the NPLC model on the quality of care provided to patients with multimorbidity.

Chart audits conducted at the five NPLCs to determine the extent to which evidence-based guidelines were followed for patients with diabetes and at least one other chronic condition.

The three sources of data collected from the five NPLCs were analysed and themes arose related to the quality of care for complex patients at NPLCs. The multiple-case study confirmed that nurse practitioners are the primary care providers at the NPLCs, and this positively impacts the quality of care for patients with multimorbidity. Healthcare policy, such as lack of an increase in salary for NPs for 10 years, has resulted in issues in recruitment and retention of NPs at NPLCs. This, along with insufficient resources in the communities where NPLCs are located and high patient vulnerability at NPLCs, have a negative impact on the quality of care. 10

These examples illustrate how collecting data about a single case or multiple cases helps us to better understand the phenomenon in question. Case study methodology serves to provide a framework for evaluation and analysis of complex issues. It shines a light on the holistic nature of nursing practice and offers a perspective that informs improved patient care.

• Gustafsson J
• Calanzaro M
• Sandelowski M

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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

Quantitative study designs.

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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 creation process

Types of case studies, benefits and limitations.

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case study , detailed description and assessment of a specific situation in the real world created for the purpose of deriving generalizations and other insights from it. A case study can be about an individual, a group of people, an organization, or an event, among other subjects.

By focusing on a specific subject in its natural setting, a case study can help improve understanding of the broader features and processes at work. Case studies are a research method used in multiple fields, including business, criminology , education , medicine and other forms of health care, anthropology , political science , psychology , and social work . Data in case studies can be both qualitative and quantitative. Unlike experiments, where researchers control and manipulate situations, case studies are considered to be “naturalistic” because subjects are studied in their natural context . ( See also natural experiment .)

The creation of a case study typically involves the following steps:

• The research question to be studied is defined, informed by existing literature and previous research. Researchers should clearly define the scope of the case, and they should compile a list of evidence to be collected as well as identify the nature of insights that they expect to gain from the case study.
• Once the case is identified, the research team is given access to the individual, organization, or situation being studied. Individuals are informed of risks associated with participation and must provide their consent , which may involve signing confidentiality or anonymity agreements.
• Researchers then collect evidence using multiple methods, which may include qualitative techniques, such as interviews, focus groups , and direct observations, as well as quantitative methods, such as surveys, questionnaires, and data audits. The collection procedures need to be well defined to ensure the relevance and accuracy of the evidence.
• The collected evidence is analyzed to come up with insights. Each data source must be reviewed carefully by itself and in the larger context of the case study so as to ensure continued relevance. At the same time, care must be taken not to force the analysis to fit (potentially preconceived) conclusions. While the eventual case study may serve as the basis for generalizations, these generalizations must be made cautiously to ensure that specific nuances are not lost in the averages.
• Finally, the case study is packaged for larger groups and publication. At this stage some information may be withheld, as in business case studies, to allow readers to draw their own conclusions. In scientific fields, the completed case study needs to be a coherent whole, with all findings and statistical relationships clearly documented.

Case studies have been used as a research method across multiple fields. They are particularly popular in the fields of law, business, and employee training; they typically focus on a problem that an individual or organization is facing. The situation is presented in considerable detail, often with supporting data, to discussion participants, who are asked to make recommendations that will solve the stated problem. The business case study as a method of instruction was made popular in the 1920s by instructors at Harvard Business School who adapted an approach used at Harvard Law School in which real-world cases were used in classroom discussions. Other business and law schools started compiling case studies as teaching aids for students. In a business school case study, students are not provided with the complete list of facts pertaining to the topic and are thus forced to discuss and compare their perspectives with those of their peers to recommend solutions.

In criminology , case studies typically focus on the lives of an individual or a group of individuals. These studies can provide particularly valuable insight into the personalities and motives of individual criminals, but they may suffer from a lack of objectivity on the part of the researchers (typically because of the researchers’ biases when working with people with a criminal history), and their findings may be difficult to generalize.

In sociology , the case-study method was developed by Frédéric Le Play in France during the 19th century. This approach involves a field worker staying with a family for a period of time, gathering data on the family members’ attitudes and interactions and on their income, expenditures, and physical possessions. Similar approaches have been used in anthropology . Such studies can sometimes continue for many years.

Case studies provide insight into situations that involve a specific entity or set of circumstances. They can be beneficial in helping to explain the causal relationships between quantitative indicators in a field of study, such as what drives a company’s market share. By introducing real-world examples, they also plunge the reader into an actual, concrete situation and make the concepts real rather than theoretical. They also help people study rare situations that they might not otherwise experience.

Because case studies are in a “naturalistic” environment , they are limited in terms of research design: researchers lack control over what they are studying, which means that the results often cannot be reproduced. Also, care must be taken to stay within the bounds of the research question on which the case study is focusing. Other limitations to case studies revolve around the data collected. It may be difficult, for instance, for researchers to organize the large volume of data that can emerge from the study, and their analysis of the data must be carefully thought through to produce scientifically valid insights. The research methodology used to generate these insights is as important as the insights themselves, for the latter need to be seen in the proper context. Taken out of context, they may lead to erroneous conclusions. Like all scientific studies, case studies need to be approached objectively; personal bias or opinion may skew the research methods as well as the results. ( See also confirmation bias .)

Business case studies in particular have been criticized for approaching a problem or situation from a narrow perspective. Students are expected to come up with solutions for a problem based on the data provided. However, in real life, the situation is typically reversed: business managers face a problem and must then look for data to help them solve it.

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What the Case Study Method Really Teaches

• Nitin Nohria

Seven meta-skills that stick even if the cases fade from memory.

It’s been 100 years since Harvard Business School began using the case study method. Beyond teaching specific subject matter, the case study method excels in instilling meta-skills in students. This article explains the importance of seven such skills: preparation, discernment, bias recognition, judgement, collaboration, curiosity, and self-confidence.

During my decade as dean of Harvard Business School, I spent hundreds of hours talking with our alumni. To enliven these conversations, I relied on a favorite question: “What was the most important thing you learned from your time in our MBA program?”

• Nitin Nohria is the George F. Baker Jr. and Distinguished Service University Professor. He served as the 10th dean of Harvard Business School, from 2010 to 2020.

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5 Benefits of Learning Through the Case Study Method

• 28 Nov 2023

While several factors make HBS Online unique —including a global Community and real-world outcomes —active learning through the case study method rises to the top.

In a 2023 City Square Associates survey, 74 percent of HBS Online learners who also took a course from another provider said HBS Online’s case method and real-world examples were better by comparison.

Here’s a primer on the case method, five benefits you could gain, and how to experience it for yourself.

Access your free e-book today.

What Is the Harvard Business School Case Study Method?

The case study method , or case method , is a learning technique in which you’re presented with a real-world business challenge and asked how you’d solve it. After working through it yourself and with peers, you’re told how the scenario played out.

HBS pioneered the case method in 1922. Shortly before, in 1921, the first case was written.

“How do you go into an ambiguous situation and get to the bottom of it?” says HBS Professor Jan Rivkin, former senior associate dean and chair of HBS's master of business administration (MBA) program, in a video about the case method . “That skill—the skill of figuring out a course of inquiry to choose a course of action—that skill is as relevant today as it was in 1921.”

Originally developed for the in-person MBA classroom, HBS Online adapted the case method into an engaging, interactive online learning experience in 2014.

In HBS Online courses , you learn about each case from the business professional who experienced it. After reviewing their videos, you’re prompted to take their perspective and explain how you’d handle their situation.

You then get to read peers’ responses, “star” them, and comment to further the discussion. Afterward, you learn how the professional handled it and their key takeaways.

Learn more about HBS Online's approach to the case method in the video below, and subscribe to our YouTube channel for more.

HBS Online’s adaptation of the case method incorporates the famed HBS “cold call,” in which you’re called on at random to make a decision without time to prepare.

“Learning came to life!” said Sheneka Balogun , chief administration officer and chief of staff at LeMoyne-Owen College, of her experience taking the Credential of Readiness (CORe) program . “The videos from the professors, the interactive cold calls where you were randomly selected to participate, and the case studies that enhanced and often captured the essence of objectives and learning goals were all embedded in each module. This made learning fun, engaging, and student-friendly.”

If you’re considering taking a course that leverages the case study method, here are five benefits you could experience.

5 Benefits of Learning Through Case Studies

1. take new perspectives.

The case method prompts you to consider a scenario from another person’s perspective. To work through the situation and come up with a solution, you must consider their circumstances, limitations, risk tolerance, stakeholders, resources, and potential consequences to assess how to respond.

Taking on new perspectives not only can help you navigate your own challenges but also others’. Putting yourself in someone else’s situation to understand their motivations and needs can go a long way when collaborating with stakeholders.

2. Hone Your Decision-Making Skills

Another skill you can build is the ability to make decisions effectively . The case study method forces you to use limited information to decide how to handle a problem—just like in the real world.

Throughout your career, you’ll need to make difficult decisions with incomplete or imperfect information—and sometimes, you won’t feel qualified to do so. Learning through the case method allows you to practice this skill in a low-stakes environment. When facing a real challenge, you’ll be better prepared to think quickly, collaborate with others, and present and defend your solution.

3. Become More Open-Minded

As you collaborate with peers on responses, it becomes clear that not everyone solves problems the same way. Exposing yourself to various approaches and perspectives can help you become a more open-minded professional.

When you’re part of a diverse group of learners from around the world, your experiences, cultures, and backgrounds contribute to a range of opinions on each case.

On the HBS Online course platform, you’re prompted to view and comment on others’ responses, and discussion is encouraged. This practice of considering others’ perspectives can make you more receptive in your career.

“You’d be surprised at how much you can learn from your peers,” said Ratnaditya Jonnalagadda , a software engineer who took CORe.

In addition to interacting with peers in the course platform, Jonnalagadda was part of the HBS Online Community , where he networked with other professionals and continued discussions sparked by course content.

“You get to understand your peers better, and students share examples of businesses implementing a concept from a module you just learned,” Jonnalagadda said. “It’s a very good way to cement the concepts in one's mind.”

4. Enhance Your Curiosity

One byproduct of taking on different perspectives is that it enables you to picture yourself in various roles, industries, and business functions.

“Each case offers an opportunity for students to see what resonates with them, what excites them, what bores them, which role they could imagine inhabiting in their careers,” says former HBS Dean Nitin Nohria in the Harvard Business Review . “Cases stimulate curiosity about the range of opportunities in the world and the many ways that students can make a difference as leaders.”

Through the case method, you can “try on” roles you may not have considered and feel more prepared to change or advance your career .

5. Build Your Self-Confidence

Finally, learning through the case study method can build your confidence. Each time you assume a business leader’s perspective, aim to solve a new challenge, and express and defend your opinions and decisions to peers, you prepare to do the same in your career.

According to a 2022 City Square Associates survey , 84 percent of HBS Online learners report feeling more confident making business decisions after taking a course.

“Self-confidence is difficult to teach or coach, but the case study method seems to instill it in people,” Nohria says in the Harvard Business Review . “There may well be other ways of learning these meta-skills, such as the repeated experience gained through practice or guidance from a gifted coach. However, under the direction of a masterful teacher, the case method can engage students and help them develop powerful meta-skills like no other form of teaching.”

How to Experience the Case Study Method

If the case method seems like a good fit for your learning style, experience it for yourself by taking an HBS Online course. Offerings span eight subject areas, including:

• Business essentials
• Leadership and management
• Entrepreneurship and innovation
• Digital transformation
• Finance and accounting
• Business in society

No matter which course or credential program you choose, you’ll examine case studies from real business professionals, work through their challenges alongside peers, and gain valuable insights to apply to your career.

Are you interested in discovering how HBS Online can help advance your career? Explore our course catalog and download our free guide —complete with interactive workbook sections—to determine if online learning is right for you and which course to take.

About the Author

• Case Studies

Case Study Basics

What is a case study *.

A case study is a snapshot of an organization or an industry wrestling with a dilemma, written to serve a set of pedagogical objectives. Whether raw or cooked , what distinguishes a pedagogical case study from other writing is that it centers on one or more dilemmas. Rather than take in information passively, a case study invites readers to engage the material in the case to solve the problems presented. Whatever the case structure, the best classroom cases all have these attributes: (1)The case discusses issues that allow for a number of different courses of action – the issues discussed are not “no-brainers,” (2) the case makes the management issues as compelling as possible by providing rich background and detail, and (3) the case invites the creative use of analytical management tools.

Case studies are immensely useful as teaching tools and sources of research ideas. They build a reservoir of subject knowledge and help students develop analytical skills. For the faculty, cases provide unparalleled insights into the continually evolving world of management and may inspire further theoretical inquiry.

There are many case formats. A traditional case study presents a management issue or issues calling for resolution and action. It generally breaks off at a decision point with the manager weighing a number of different options. It puts the student in the decision-maker’s shoes and allows the student to understand the stakes involved. In other instances, a case study is more of a forensic exercise. The operations and history of a company or an industry will be presented without reference to a specific dilemma. The instructor will then ask students to comment on how the organization operates, to look for the key success factors, critical relationships, and underlying sources of value. A written case will pre-package appropriate material for students, while an online case may provide a wider variety of topics in a less linear manner.

Choosing Participants for a Case Study

Many organizations cooperate in case studies out of a desire to contribute to management education. They understand the need for management school professors and students to keep current with practice.

Organizations also cooperate in order to gain exposure in management school classrooms. The increased visibility and knowledge about an organization’s operations and culture can lead to subsidiary benefits such as improved recruiting.

Finally, organizations participate because reading a case about their operations and decision making written by a neutral observer can generate useful insights. A case study preserves a moment in time and chronicles an otherwise hidden history. Managers who visit the classroom to view the case discussion generally find the experience invigorating.

The Final Product

Cases are usually written as narratives that take the reader through the events leading to the decision point, including relevant information on the historical, competitive, legal, technical, and political environment facing the organization. A written case study generally runs from 5,000 to 10,000 words of text supplemented with numerous pages of data exhibits. An online raw case may have less original text, but will require students to extract information from multiple original documents, videos of company leaders discussing the challenges, photographs, and links to articles and websites.

The first time a case is taught represents something of a test run. As students react to the material, plan to revise the case to include additional information or to delete data that does not appear useful. If the organization’s managers attend the class, their responses to student comments and questions may suggest some case revisions as well.

The sponsoring professor will generally write a “teaching note” to give other instructors advice on how to structure classroom discussion and useful bits of analysis that can be included to explicate the issues highlighted in the case study.

Finally, one case may inspire another. Either during the case writing process or after a case is done, a second “B” case might be useful to write that outlines what the organization did or that outlines new challenges faced by the organization after the timeframe of the initial case study.

* Portions of this note are adapted from E. Raymond Corey, “Writing Cases and Teaching Notes,” Harvard Business School case 399-077, with updates to reflect Yale School of Management practices for traditional and raw cases.

Redirect Notice

Nih definition of clinical trial case studies.

The case studies provided below are designed to help you identify whether your study would be considered by NIH to be a clinical trial. Expect the case studies and related guidance to evolve over the upcoming year. For continuity and ease of reference, case studies will retain their original numbering and will not be renumbered if cases are revised or removed.

The simplified case studies apply the following four questions to determine whether NIH would consider the research study to be a clinical trial:

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according to the NIH definition.

General Case Studies

The study involves the recruitment of research participants who are randomized to receive one of two approved drugs. It is designed to compare the effects of the drugs on the blood level of a protein.

• Does the study involve human participants? Yes, the study involves human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, one of two drugs.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the drugs on the level of the protein in the participants’ blood.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a protein, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition Y to receive a drug that has been approved for another indication. It is designed to measure the drug’s effects on the level of a biomarker associated with the severity of condition Y.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the approved drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the drug’s effect on the level of the biomarker.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a biomarker, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition X to receive investigational compound A. It is designed to assess the pharmacokinetic properties of compound A.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, compound A.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how the body interacts with compound A
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, pharmacokinetic properties, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess safety and determine the maximum tolerated dose of the drug.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to assess safety and determine the maximum tolerated dose of the investigational drug.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, safety and maximum tolerated dose, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive a chronic disease management program. It is designed to assess usability and to determine the maximum tolerated dose of the chronic disease program (e.g., how many in-person and telemedicine visits with adequate adherence).

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the chronic disease management program.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine the maximum tolerated dose of the program to obtain adequate adherence.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, tolerable intensity and adequate adherence of the intervention, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive either an investigational drug or a placebo. It is designed to evaluate the efficacy of the investigational drug to relieve disease symptoms.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the participants’ symptoms.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, relief of symptoms, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess whether there is a change in disease progression compared to baseline. There is no concurrent control used in this study.

• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the subject’s disease progression.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, disease progression, is a health-related outcome.

The study involves the recruitment of research participants with disease X to test an investigational in vitro diagnostic device (IVD). It is designed to evaluate the ability of the device to measure the level of an antibody in blood.

• Are the participants prospectively assigned to an intervention? No, in this context the IVD would not be considered an intervention. The IVD is being used to test its ability to measure antibody levels, but not to test its effects on any health-related biomedical or behavioral outcomes. 

The study involves the recruitment of research participants with disease X to be evaluated with an investigational in vitro diagnostic device (IVD). The study is designed to evaluate how knowledge of certain antibody levels impacts clinical management of disease.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, measurement of an antibody level, with the idea that knowledge of that antibody level might affect clinical management.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how knowledge of the level of an antibody might inform treatment.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being measured, how blood antibody levels inform treatment, is a health-related outcome.

The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation.

• Does the study involve human participants? Yes, the healthy volunteers are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, different durations of sleep deprivation followed by a blood draw.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of different durations of sleep deprivation on stress hormone levels.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, stress hormone levels, is a health-related biomedical outcome.

The study involves the analysis of de-identified, stored blood samples and de-identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

• Does the study involve human participants? No, the study does not involve human participants because only de-identified samples and information are used.

The study involves the analysis of identifiable, stored blood samples and identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

• Does the study involve human participants? Yes, patients are human participants because the blood and information are identifiable.
• Are the participants prospectively assigned to an intervention? No, secondary research with biospecimens or health information is not a clinical trial.

The study involves the recruitment of a healthy volunteers whose blood is drawn for genomic analysis. It is designed to identify the prevalence of a genetic mutation in the cohort and evaluate potential association between the presence of the mutation and the risk of developing a genetic disorder.

• Are the participants prospectively assigned to an intervention? No, sample collection (blood draw) is not an intervention in this context.

Physicians report that some patients being treated with drug A for disease X are also experiencing some improvement in a second condition, condition Y. The study involves the recruitment of research participants who have disease X and condition Y and are being treated with drug A. The participants are surveyed to ascertain whether they are experiencing an improvement in condition Y.

• Are the participants prospectively assigned to an intervention? No, participants are not prospectively assigned to receive an intervention as they are receiving drugs as part of their clinical care. The surveys are being used for measurement, not to modify a biomedical or behavioral outcome.

The study involves the recruitment of patients with disease X who are receiving one of three standard therapies as part of their clinical care. It is designed to assess the relative effectiveness of the three therapies by monitoring survival rates using medical records over a few years.

• Are the participants prospectively assigned to an intervention? No, there is no intervention. The therapies are prescribed as part of clinical care; they are not prospectively assigned for the purpose of the study. The study is observational.

The study involves the recruitment of research participants with disease X vs. healthy controls and comparing these participants on a range of health processes and outcomes including genomics, biospecimens, self-report measures, etc. to explore differences that may be relevant to the development of disease X.

• Are the participants prospectively assigned to an intervention? No, the measures needed to assess the outcomes are not interventions in this context, as the study is not intended to determine whether the measures modify a health-related biomedical or behavioral outcome.

The study involves the recruitment of healthy volunteers for a respiratory challenge study; participants are randomized to receive different combinations of allergens. The study evaluates the severity and mechanism of the immune response to different combinations of allergens introduced via inhalation.

• Does the study involve human participants? Yes, healthy volunteers are human participants.
• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to randomly selected combinations of allergens.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of different combinations of allergens on the immune response in healthy individuals.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates the severity and mechanism of the immune reaction to allergens, which are health-related biomedical outcomes.

The study involves the recruitment of research participants with Alzheimer’s disease (AD) to evaluate the effects of an investigational drug on memory, and retention and recall of information.

• Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive the investigational drug.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the drug on participants’ memory.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates memory, and retention and recall of information in the context of AD.

The study involves the recruitment of individuals to receive a new behavioral intervention for sedentary behavior. It is designed to measure the effect of the intervention on hypothesized differential mediators of behavior change.

• Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive a behavioral intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the intervetion on mediators of behavior change.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, mediators of behavior change, are behavioral outcomes relevant to health.

The study involves the recruitment of patients with disease X to be evaluated with a new visual acuity task. It is designed to evaluate the ability of the new task to measure visual acuity as compared with the gold standard Snellen Test

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, the new visual acuity test.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the study is designed to evaluate the ability of the new visual acuity test to measure visual acuity as compared to the gold standard Snellen Test, but not to modify visual acuity.

The study involves the recruitment of research participants with CHF who were hospitalized before or after implementation of the Medicare incentives to reduce re-hospitalizations. Morbidity, mortality, and quality of life of these participants are evaluated to compare the effects of these Medicare incentives on these outcomes.

• Are the participants prospectively assigned to an intervention? No, the intervention (incentives to reduce re-hospitalization) were assigned by Medicare, not by the research study.

The study involves the recruitment of healthcare providers to assess the extent to which being provided with genomic sequence information about their patients informs their treatment of those patients towards improved outcomes.

• Does the study involve human participants? Yes, both the physicians and the patients are human participants.
• Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to receive genomic sequence information, which is the intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on the treatment they provide to their patients.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the extent to which providing specific information to physicians informs the treatment of patients, is a health-related outcome.

The study involves the recruitment of research participants with a behavioral condition to receive either an investigational behavioral intervention or a behavioral intervention in clinical use. It is designed to evaluate the effectiveness of the investigational intervention compared to the intervention in clinical use in reducing the severity of the obsessive compulsive disorder.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, either the investigational intervention or an intervention in clinical use.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate whether the investigational intervention is as effective as the standard intervention, at changing behavior.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the interventions’ effectiveness in reducing the severity of the condition, is a health-related behavioral outcome.

The study involves the recruitment of physicians who will be randomly assigned to use a new app or an existing app, which cues directed interviewing techniques. The study is designed to determine whether the new app is better than the existing app at assisting physicians in identifying families in need of social service support. The number of community service referrals will be measured.

• Does the study involve human participants? Yes, both the physicians and the families are human participants.
• Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to use one of two apps, which are the interventions.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on social service support referral for families.
• Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the number of referrals, is a health-related outcome.

The study involves the recruitment of parents to participate in focus groups to discuss topics related to parental self-efficacy and positive parenting behaviors. It is designed to gather information needed to develop an intervention to promote parental self-efficacy and positive parenting behaviors.

• Does the study involve human participants? Yes, the parents are human participants.
• Are the participants prospectively assigned to an intervention? No, a focus group is not an intervention.

The study involves the recruitment of healthy volunteers to test a new behavioral intervention. It is designed to evaluate the effect of a meditation intervention on adherence to exercise regimens and quality of life to inform the design of a subsequent, fully-powered trial.

• Does the study involve human participants? Yes, study participants are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to a behavioral intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the intervention on adherence, and quality of life.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, adherence and quality of life are health-related outcomes.

A study will test the feasibility a mobile phone app designed to increase physical activity. A group of sedentary individuals will use the app for a week while their interactions with the app are monitored. The number of interactions with the app will be measured, as well as any software issues. Participants will also complete a survey indicating their satisfaction with and willingness to use the app, as well as any feedback for improvement. The app’s effect on physical activity, weight, or cardiovascular fitness will not be evaluated.

• Does the study involve human participants? Yes, sedentary individuals will be enrolled.
• Are the participants prospectively assigned to an intervention? The participants will interact with the app for a week.
• Is the study designed to evaluate the effect of the intervention on the participants? No. While the participants’ interactions are monitored (steps or heart rate may be recorded in this process), the study is NOT measuring the effect of using the app ON the participant. The study is only measuring the usability and acceptability of the app, and testing for bugs in the software. The effect on physical activity is NOT being measured.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A

The study involves the recruitment of healthy family members of patients hospitalized for disease X to test two CPR training strategies. Participants will receive one of two training strategies. The outcome is improved CPR skills retention.

• Does the study involve human participants? Yes, family members of patients are human participants.
• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to one of two CPR educational strategies.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of educational strategies on CPR skills.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, retention of CPR skills is a health-related behavioral outcome.

The study involves the recruitment of research participants in three different communities (clusters) to test three CPR training strategies. The rate of out-of- hospital cardiac arrest survival will be compared.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive one of three types of CPR training, which is the intervention.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of different CPR training strategies on patient survival rates post cardiac arrest.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, out-of-hospital cardiac arrest survival is a health-related outcome.

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. The accuracy of the two food monitoring methods in measuring energy intake will be assessed.

• Does the study involve human participants? Yes, children are human participants.
• Are the participants prospectively assigned to an intervention? No, in this context the monitoring methods would not be considered an intervention. The study is designed to test the accuracy of two monitoring methods, but not to test the effect on any health-related biomedical or behavioral outcomes. 

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. Changes to eating behavior will be assessed.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to two food monitoring methods.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether using the monitoring methods changes eating behavior.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, eating behavior is a health-related outcome.

A study involves the recruitment of children at two schools to monitor eating behavior. Children’s food choices will be monitored using a remote food photography method. Food consumption and the accuracy of food monitoring methods will be assessed.

• Does the study involve human participants? Yes, the children participating in this study are human participants.
• Are the participants prospectively assigned to an intervention? No, not in this context. The study involves observing and measuring eating behavior, but not modifying it. This is an observational study.

A study involves the recruitment of children at two schools to evaluate their preferences for graphics and colors used in healthy food advertisements. Children will be presented with multiple health advertisements and their preferences for graphics and colors will be assessed.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to see different advertisements.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the advertisements.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? No, preferences are not health-related biomedical or behavioral outcomes.

The study involves ambulatory patients who have new-onset stable angina and who are recruited from community practices. They are randomized to undergo CT angiography or an exercise stress test of the doctor’s choice. To keep the trial pragmatic, the investigators do not prescribe a protocol for how physicians should respond to test results. The study is designed to determine whether the initial test (CT angiography or stress test) affects long-term rates of premature death, stroke, or myocardial infarctions.

• Are the participants prospectively assigned to an intervention? Yes, the participants are randomized to undergo CT angiography or an exercise stress test.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether the initial test done affects long-term rates of certain clinical events.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, premature death, stroke, and myocardial infarction are health-related biomedical outcomes.

The study involves patients who present with stable angina to community practices. As part of their routine care some of their physicians refer them for CT angiography, while others refer them for exercise stress tests. The study is designed to see whether or not there's an association between the type of test that is chosen and long-term risk of death, stroke, or myocardial infarction.

• Are the participants prospectively assigned to an intervention? No, the intervention is not prospectively assigned by the investigators. Rather, the intervention, in this case diagnostic study, occurs as part of routine clinical care.

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

• Does the study involve human participants? Yes.
• Are the participants prospectively assigned to an intervention? No, not in this context.  Antipsychotic medications are given as part of clinical care, not as part of a prospective, approved research protocol.  

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. As part of the research protocol, all participants will be prescribed the same dose of the antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

• Are the participants prospectively assigned to an intervention? Yes, although participants are all receiving antipsychotic medication as part of their standard medical care, the dose of the antipsychotic medication is determined by the research protocol, rather than individual clinical need.
• Is the study designed to evaluate the effect of the intervention on the participants?  Yes, the study is designed to evaluate the effect of a dose of antipsychotic medication on brain function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, brain function measured by imaging is a health-related outcome.

The study involves recruitment of healthy volunteers who will wear a thermal compression device around their legs. This pilot study is designed to examine preliminary performance and safety of a thermal compression device worn during surgery. Investigators will measure core temperature, comfort, and presence of skin injury in 15-minute intervals.

• Are the participants prospectively assigned to an intervention? Yes, participants are assigned to wear a thermal compression device.
• Is the study designed to evaluate the effect of the intervention on the participants?  Yes, the study is designed to evaluate the effect of the thermal compression device on participant core temperature, comfort, and presence of skin injury.
• Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, participant core temperature, comfort, and presence of skin injury are health-related biomedical outcomes.

The study involves collection of data on hospitalizations for various acute illnesses among people who live close to a border between two states that have recently implemented different laws related to public health (e.g. smoking regulations, soda taxes). The investigators want to take advantage of this “natural experiment” to assess the health impact of the laws.

• Does the study involve human participants?  Yes, the study involves human participants.
• Are the participants prospectively assigned to an intervention?  No, the interventions were assigned by state laws and state of residence, not by the research study.

The study involves recruitment of healthy volunteers to engage in working memory tasks while undergoing transcranial magnetic stimulation (TMS) to induce competing local neuronal activity. The study is measuring task performance to investigate the neural underpinnings of working memory storage and processing.

• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive TMS stimulation protocols during a working memory task.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of local TMS stimulation on working memory performance and oscillatory brain activity in healthy individuals.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates working memory processes, which are health-related biomedical outcomes.

The study involves recruitment of healthy volunteers to engage in a social valuation task while dopamine tone in the brain is manipulated using tolcapone, an FDA-approved medication. The study aims to understand the role of dopamine in social decision-making and to search for neural correlates of this valuation using fMRI.

• Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive tolcapone during a social valuation task.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of modulating dopamine tone on social decision-making. Although this study uses an FDA-approved drug to modulate dopamine tone, the goal of this intervention is to understand the role of dopamine in a fundamental phenomenon (social valuation), and not to study the mechanism of action of the drug or its clinical effects.

The career development candidate proposes to independently lead a study to test a new drug A on patients with disease X. Patients will be randomized to a test and control group, with the test group receiving one dose of drug A per week for 12 months and controls receiving placebo. To assess presence, number, and type of any polyps, a colonoscopy will be performed. To assess biomarkers of precancerous lesions, colon mucosal biopsies will be collected. Complete blood count will be measured, and plasma will be stored for potential biomarker evaluation.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drug A or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drug A and placebo on the presence and type of polyps.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the presence and type of polyps, is a health-related biomedical outcome.

Ancillary Study to Case Study #42a: Some types of drug A being evaluated in Case Study #42a have been reported to impact renal function. An internal medicine fellow performs an ancillary study where stored plasma from Case Study #42a will be evaluated for multiple biomarkers of renal function.

• Does the study involve human participants? Yes, patients are human participants because the plasma and information are identifiable.
• Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention occurs as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that is not an independent clinical trial.

Ancillary Study to Case Study #42a: An internal medicine fellow designs an independent ancillary trial where a subset of patients from the parent trial in Case Study #42a will also receive drug B, based on the assumption that a two-drug combination will work significantly better than a single drug at both improving renal function and reducing polyps. The test subjects will be evaluated for renal function via plasma clearance rates at 6 and 12 months after initiation of drugs A and B.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drugs A and B.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drugs A and B on renal function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, renal function, is a health-related biomedical outcome.

A group of healthy young adults will perform a Go/No-Go task while undergoing fMRI scans. The purpose of the study is to characterize the pattern of neural activation in the frontal cortex during response inhibition, and the ability of the participant to correctly withhold a response on no-go

• Does the study involve human participants? Yes, healthy young adults will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a Go/No-Go task, which involves different levels of inhibitory control.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the Go/No-Go task on neural activation in the frontal cortex. The study will measure inhibitory control and the neural systems being engaged. In this study, the Go/No-Go task is the independent variable, and behavioral performance and the associated fMRI activations are the dependent variables.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the neural correlates of inhibitory control and behavioral performance are health-related biomedical outcomes.

A group of adolescents will participate in a longitudinal study examining changes in executive function over the course of a normal school year. Color naming performance on the standard version of the Stroop test will be obtained. All measures will be compared at multiple time points during the school year to examine changes in executive function. The purpose is to observe changes in executive function and to observe if differences exist in the Stroop effect over the course of the school year for these adolescents.

• Does the study involve human participants? Yes, adolescents will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? No, there is no intervention in this study and no independent variable manipulated. The adolescents are not prospectively assigned to an intervention, but instead the investigator will examine variables of interest (including the Stroop test) over time. The Stroop effect is used as a measurement of point-in-time data.
• Is the study designed to evaluate the effect of the intervention on the participants? No, there is no intervention. Performance on the Stroop test is a well-established measure of executive function and the test is not providing an independent variable of interest here. It is not being used to manipulate the participants or their environment. The purpose is simply to obtain a measure of executive function in adolescents over the course of the school year.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A. No effect of an intervention is being evaluated.

A group of participants with social anxiety will perform an experimentally manipulated Stroop test. In this variant of the Stroop test, the stimuli presented are varied to include emotional and neutral facial expressions presented in different colors. Participants are instructed to name the colors of the faces presented, with the expectation that they will be slower to name the color of the emotional face than the neutral face. The purpose of the study is to examine the degree to which participants with social anxiety will be slower to process emotional faces than neutral faces.

• Does the study involve human participants? Yes, participants with social anxiety will be enrolled in this study.
• Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a modified Stroop test using different colored emotional/neutral faces to explore emotional processing in people with social anxiety. Note that the independent variable is the presentation of emotional vs neutral faces.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of emotional valence (i.e. emotional faces) on participant response time to name the color. The purpose is to determine whether the response time to emotional faces is exaggerated for people with social anxiety as compared to neutral faces. Note that the response time to name the colors is the dependent variable in this study.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the processing of emotional information is a health-related biomedical outcome.

The study involves healthy volunteers and compares temporal SNR obtained with a new fMRI pulse sequence with that from another sequence.

• Are the participants prospectively assigned to an intervention? No, in this context the different pulse sequences would not be considered an intervention. The pulse sequences are not being used to modify any biomedical or behavioral outcome; rather the investigator is comparing performance characteristics of the two pulse sequences.

The study is designed to demonstrate that a new imaging technology (e.g. MRI, PET, ultrasound technologies, or image processing algorithm) is equivalent to, or has better sensitivity/specificity than a standard of care imaging technology. Aim one will use the new imaging technology and the gold standard in ten healthy volunteers. Aim Two will use the new imaging technology and the gold standard before and after a standard care procedure in ten patients. In both aims the performance of the new technology will be compared to the gold standard. No clinical care decisions will be made based on the use of the device in this study.

• Does the study involve human participants? YES. Aim one will study ten healthy volunteers, and aim two will study ten patient volunteers.
• Are the participants prospectively assigned to an intervention? Yes, participants will be prospectively assigned to be evaluated with a new imaging technology and the gold standard technology.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the study is not measuring the effect of the technologies ON the human subjects. The study is determining if the new technology is equivalent or better than the gold standard technology. No effect on the participant is being measured.

Institute or Center specific Case Studies

An investigator proposes to add secondary outcomes to an already funded clinical trial of a nutritional intervention. The trial is supported by other funding, but the investigator is interested in obtaining NIH funding for studying oral health outcomes. Participants in the existing trial would be assessed for oral health outcomes at baseline and at additional time points during a multi-week dietary intervention. The oral health outcomes would include measures of gingivitis and responses to oral health related quality of life questionnaires. Oral fluids would be collected for analysis of inflammatory markers and microbiome components.

• Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention (and the administration of the intervention) occur as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that leverages an already existing clinical trial.

The goal of the project is to use functional neuroimaging to distinguish patients with temporomandibular disorders (TMD) who experience TMD pain through centralized pain processes from those with TMD related to peripheral pain. Pain processing in a study cohort of TMD patients and healthy controls will be measured through functional magnetic resonance neuroimaging (fMRI) following transient stimulation of pain pathways through multimodal automated quantitative sensory testing (MAST QST). TMD patients will receive study questionnaires to better correlate the extent to which TMD pain centralization influences TMD prognosis and response to standard of care peripherally targeted treatment (prescribed by physicians, independently of the study).

• Are the participants prospectively assigned to an intervention? No, not in this context. The transient stimulation of pain pathways and the fMRI are being performed to measure and describe brain activity, but not to modify it.

An investigator proposes to perform a study of induced gingivitis in healthy humans, to study microbial colonization and inflammation under conditions of health and disease. During a 3-week gingivitis induction period, each study participant will use a stent to cover the teeth in one quadrant during teeth brushing. A contralateral uncovered quadrant will be exposed to the individual's usual oral hygiene procedures, to serve as a control. Standard clinical assessments for gingivitis will be made and biospecimens will be collected at the point of maximal induced gingivitis, and again after normal oral hygiene is resumed. Biospecimens will be assessed for microbial composition and levels of inflammation-associated chemokines.

• Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, abstaining from normal oral hygiene for a portion of the mouth, to induce gingivitis.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the induced gingivitis on microbial composition and levels of inflammatory chemokines in oral samples.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the microbial composition and chemokine levels in oral samples are health-related biomedical outcomes.

The study will enroll older adults with hearing loss, comparing the effectiveness of enhanced hearing health care (HHC) to usual HHC. In addition to routine hearing-aid consultation and fitting, participants randomized to enhanced HCC will be provided patient-centered information and education about a full range of hearing assistive technologies and services. Study outcomes include the utilization of technology or services, quality of life, communication abilities, and cognitive function.

• Does the study involve human participants? Yes, the study enrolls older adults with hearing loss.
• Are the participants prospectively assigned to an intervention? Yes, participants are randomized to receive enhanced HCC or usual HCC interventions.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study will evaluate enhanced HCC’s effectiveness in modifying participant behavior and biomedical outcomes.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, rate of technology/service utilization is a behavioral outcome and quality of life, communications, and cognition are biomedical outcomes that may be impacted by the interventions.

The study involves the recruitment of obese individuals who will undergo a muscle biopsy before and after either exercise training or diet-induced weight loss. Sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species and mitochondrial function will be measured. Levels will be correlated with insulin sensitivity.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to either exercise training or a diet.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the interventions on muscle metabolism.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, muscle metabolism/signaling is a health-related outcome.

The study involves the recruitment of participants with type 2 diabetes who will undergo a muscle biopsy before and after a fast to measure acetylation on lysine 23 of the mitochondrial solute carrier adenine nucleotide translocase 1 (ANT1). Levels will be related to rates of fat oxidation.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to undergo a fast.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the fast on molecular parameters of metabolism.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, metabolism is a health-related outcome.

Insulin-resistant and insulin-sensitive nondiabetic adults who have a parent with type 2 diabetes will be followed over time to understand the role of mitochondrial dysfunction in the development of diabetes. Oral glucose tolerance tests will be performed annually to measure insulin sensitivity and glycemic status. Participants will also undergo a brief bout of exercise, and mitochondrial ATP synthesis rates will be measured by assessing the rate of recovery of phosphocreatine in the leg muscle, using 31P magnetic resonance spectroscopy.

• Are the participants prospectively assigned to an intervention? No, the participants are not assigned to an intervention; the OGTT and 31P MRS are measures.

Participants with chronic kidney disease will be recruited to receive one of two drug agents. After 6 weeks of therapy, subjects will undergo vascular function testing and have measures of oxidative stress evaluated in their plasma and urine. Results of the function testing and the oxidative stress biomarkers will be related to drug treatment.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive two different drugs.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function is a health-related outcome.

Participants with Autosomal Dominant Polycystic Kidney Disease will be recruited to receive an oral curcumin therapy or placebo and the participants will undergo vascular function testing, renal imaging to assess kidney size, and assessment of oxidative stress biomarkers in urine and plasma after an ascorbic acid challenge. Changes in these outcomes will be related to oral therapy.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive medication or placebo.
• Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function and kidney size.
• Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function and kidney size are health-related outcomes.

Kidney transplant recipients will be recruited to undergo an experimental imaging procedure at several timepoints up to 4 months post-transplantation. Output from the images will be related to pathological assessments of the transplant as well as clinical measures of renal function.

• Are the participants prospectively assigned to an intervention? No, the participants are not assigned to receive an intervention. They undergo transplantation as part of their routine clinical care. The imaging procedure is a measure and not an intervention.

The study proposes the development of a novel probe to assess clearance of a nutritional metabolite in a given disease state. The probe is a GMP grade, deuterated, intravenously administered tracer and clearance is assessed by mass spectrometry analysis of serial blood draws. Participants will either receive a micronutrient supplement or will receive no supplementation. The clearance rate of the probe will be compared in the two groups, to understand the performance of the probe.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive either a micronutrient supplement or nothing.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention is being used to assess the performance of the probe and is not looking at an effect on the participant.

In order to assess the contribution of ingested glycolate to oxalate production, healthy participants will be recruited to a study involving the consumption of a controlled diet for three days, followed by an infusion of 13C2-glycolate. Blood and urine will be collected during the subsequent 24 hours to assess the amount of labeled glycolate in plasma and urine oxalate.

• Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive a controlled diet for three days.
• Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention (controlled diet) is being used to minimize exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion. The study will not be evaluating the effect of the diet on the participants.
• Decision Tool: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?
• NIH Definition of a Clinical Trial

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Office of the Assistant Secretary for Planning and Evaluation

Case Studies in Supporting Prevention through Human Services Program Integration

The Office of the Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services has been working with researchers, human services agency leaders, and persons with lived experience to visualize, describe, and document models of prevention within human services. To support this goal, ASPE sponsored the Case Studies in Supporting Prevention through Human Services Program Integration project to explore innovative prevention approaches that integrate human services, including preventing child welfare involvement, promoting housing stability and preventing homelessness for youth and families, and increasing the use of economic supports such as Temporary Assistance for Needy Families (TANF).

This brief summarizes case study findings from nine sites across the U.S. that integrate human services with a prevention lens. It includes how case study sites integrated services; what helped and challenged sites during the ongoing implementation of their integrated prevention initiatives; and ideas and strategies for improving implementation to sustain programs and services in the future. Key themes throughout this brief include:

• Human services integration can reduce burden on individuals and families seeking services by reducing duplicative eligibility determinations, enrollment processes, service provision, and communication between individuals or families and staff. It enables service providers to support individuals and families participating in services before they are in crisis and may improve efficiency.
• Case study sites simplified access and met families’ immediate needs by offering services at a centralized location and by using a no-wrong-door approach. They also offered stabilization supports, integrated case management, and used navigation approaches.
• Many sites embraced partnerships with community partners throughout the design and implementation of their initiatives, which helped sites center community values in initiative design and build trust with community members.
• Sites shared strategies to address funding and staffing challenges, such as proactive communication with partners and braiding funding at the administrative level. They also used data to assess and improve implementation and outcomes.

Available Reports:

• Prevention Through Human Services Integration Brief

Related Products:

• Prevention Through Integration: Whole Person Services Brief  
• Prevention Through Integration: Child Welfare Brief