case studies as a research methodology

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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.

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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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McCombes, S. (2023, November 20). What Is a Case Study? | Definition, Examples & Methods. Scribbr. Retrieved April 12, 2024, from https://www.scribbr.com/methodology/case-study/

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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.

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• Knowledge Base
• Methodology
• 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.

Prevent plagiarism, run a free check.

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.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the ‘Cite this Scribbr article’ button to automatically add the citation to our free Reference Generator.

McCombes, S. (2023, January 30). Case Study | Definition, Examples & Methods. Scribbr. Retrieved 9 April 2024, from https://www.scribbr.co.uk/research-methods/case-studies/

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Shona McCombes

Other students also liked, correlational research | guide, design & examples, a quick guide to experimental design | 5 steps & examples, descriptive research design | definition, methods & examples.

What is case study research?

Last updated

8 February 2023

Reviewed by

Cathy Heath

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.

Analyze case study research

Dovetail streamlines case study research to help you uncover and share actionable insights

• 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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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.

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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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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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On This Page:

Case studies are in-depth investigations of a person, group, event, or community. Typically, data is gathered from various sources using several methods (e.g., observations & interviews).

The case study research method originated in clinical medicine (the case history, i.e., the patient’s personal history). In psychology, case studies are often confined to the study of a particular individual.

The information is mainly biographical and relates to events in the individual’s past (i.e., retrospective), as well as to significant events that are currently occurring in his or her everyday life.

The case study is not a research method, but researchers select methods of data collection and analysis that will generate material suitable for case studies.

Freud (1909a, 1909b) conducted very detailed investigations into the private lives of his patients in an attempt to both understand and help them overcome their illnesses.

This makes it clear that the case study is a method that should only be used by a psychologist, therapist, or psychiatrist, i.e., someone with a professional qualification.

There is an ethical issue of competence. Only someone qualified to diagnose and treat a person can conduct a formal case study relating to atypical (i.e., abnormal) behavior or atypical development.

 Famous Case Studies

• Anna O – One of the most famous case studies, documenting psychoanalyst Josef Breuer’s treatment of “Anna O” (real name Bertha Pappenheim) for hysteria in the late 1800s using early psychoanalytic theory.
• Little Hans – A child psychoanalysis case study published by Sigmund Freud in 1909 analyzing his five-year-old patient Herbert Graf’s house phobia as related to the Oedipus complex.
• Bruce/Brenda – Gender identity case of the boy (Bruce) whose botched circumcision led psychologist John Money to advise gender reassignment and raise him as a girl (Brenda) in the 1960s.
• Genie Wiley – Linguistics/psychological development case of the victim of extreme isolation abuse who was studied in 1970s California for effects of early language deprivation on acquiring speech later in life.
• Phineas Gage – One of the most famous neuropsychology case studies analyzes personality changes in railroad worker Phineas Gage after an 1848 brain injury involving a tamping iron piercing his skull.

Clinical Case Studies

• Studying the effectiveness of psychotherapy approaches with an individual patient
• Assessing and treating mental illnesses like depression, anxiety disorders, PTSD
• Neuropsychological cases investigating brain injuries or disorders

Child Psychology Case Studies

• Studying psychological development from birth through adolescence
• Cases of learning disabilities, autism spectrum disorders, ADHD
• Effects of trauma, abuse, deprivation on development

Types of Case Studies

• Explanatory case studies : Used to explore causation in order to find underlying principles. Helpful for doing qualitative analysis to explain presumed causal links.
• Exploratory case studies : Used to explore situations where an intervention being evaluated has no clear set of outcomes. It helps define questions and hypotheses for future research.
• Descriptive case studies : Describe an intervention or phenomenon and the real-life context in which it occurred. It is helpful for illustrating certain topics within an evaluation.
• Multiple-case studies : Used to explore differences between cases and replicate findings across cases. Helpful for comparing and contrasting specific cases.
• Intrinsic : Used to gain a better understanding of a particular case. Helpful for capturing the complexity of a single case.
• Collective : Used to explore a general phenomenon using multiple case studies. Helpful for jointly studying a group of cases in order to inquire into the phenomenon.

Where Do You Find Data for a Case Study?

There are several places to find data for a case study. The key is to gather data from multiple sources to get a complete picture of the case and corroborate facts or findings through triangulation of evidence. Most of this information is likely qualitative (i.e., verbal description rather than measurement), but the psychologist might also collect numerical data.

1. Primary sources

• Interviews – Interviewing key people related to the case to get their perspectives and insights. The interview is an extremely effective procedure for obtaining information about an individual, and it may be used to collect comments from the person’s friends, parents, employer, workmates, and others who have a good knowledge of the person, as well as to obtain facts from the person him or herself.
• Observations – Observing behaviors, interactions, processes, etc., related to the case as they unfold in real-time.
• Documents & Records – Reviewing private documents, diaries, public records, correspondence, meeting minutes, etc., relevant to the case.

2. Secondary sources

• News/Media – News coverage of events related to the case study.
• Academic articles – Journal articles, dissertations etc. that discuss the case.
• Government reports – Official data and records related to the case context.
• Books/films – Books, documentaries or films discussing the case.

3. Archival records

Searching historical archives, museum collections and databases to find relevant documents, visual/audio records related to the case history and context.

Public archives like newspapers, organizational records, photographic collections could all include potentially relevant pieces of information to shed light on attitudes, cultural perspectives, common practices and historical contexts related to psychology.

4. Organizational records

Organizational records offer the advantage of often having large datasets collected over time that can reveal or confirm psychological insights.

Of course, privacy and ethical concerns regarding confidential data must be navigated carefully.

However, with proper protocols, organizational records can provide invaluable context and empirical depth to qualitative case studies exploring the intersection of psychology and organizations.

• Organizational/industrial psychology research : Organizational records like employee surveys, turnover/retention data, policies, incident reports etc. may provide insight into topics like job satisfaction, workplace culture and dynamics, leadership issues, employee behaviors etc.
• Clinical psychology : Therapists/hospitals may grant access to anonymized medical records to study aspects like assessments, diagnoses, treatment plans etc. This could shed light on clinical practices.
• School psychology : Studies could utilize anonymized student records like test scores, grades, disciplinary issues, and counseling referrals to study child development, learning barriers, effectiveness of support programs, and more.

How do I Write a Case Study in Psychology?

Follow specified case study guidelines provided by a journal or your psychology tutor. General components of clinical case studies include: background, symptoms, assessments, diagnosis, treatment, and outcomes. Interpreting the information means the researcher decides what to include or leave out. A good case study should always clarify which information is the factual description and which is an inference or the researcher’s opinion.

1. Introduction

• Provide background on the case context and why it is of interest, presenting background information like demographics, relevant history, and presenting problem.
• Compare briefly to similar published cases if applicable. Clearly state the focus/importance of the case.

2. Case Presentation

• Describe the presenting problem in detail, including symptoms, duration,and impact on daily life.
• Include client demographics like age and gender, information about social relationships, and mental health history.
• Describe all physical, emotional, and/or sensory symptoms reported by the client.
• Use patient quotes to describe the initial complaint verbatim. Follow with full-sentence summaries of relevant history details gathered, including key components that led to a working diagnosis.
• Summarize clinical exam results, namely orthopedic/neurological tests, imaging, lab tests, etc. Note actual results rather than subjective conclusions. Provide images if clearly reproducible/anonymized.
• Clearly state the working diagnosis or clinical impression before transitioning to management.

3. Management and Outcome

• Indicate the total duration of care and number of treatments given over what timeframe. Use specific names/descriptions for any therapies/interventions applied.
• Present the results of the intervention,including any quantitative or qualitative data collected.
• For outcomes, utilize visual analog scales for pain, medication usage logs, etc., if possible. Include patient self-reports of improvement/worsening of symptoms. Note the reason for discharge/end of care.

4. Discussion

• Analyze the case, exploring contributing factors, limitations of the study, and connections to existing research.
• Analyze the effectiveness of the intervention,considering factors like participant adherence, limitations of the study, and potential alternative explanations for the results.
• Identify any questions raised in the case analysis and relate insights to established theories and current research if applicable. Avoid definitive claims about physiological explanations.
• Offer clinical implications, and suggest future research directions.

5. Additional Items

• Thank specific assistants for writing support only. No patient acknowledgments.
• References should directly support any key claims or quotes included.
• Use tables/figures/images only if substantially informative. Include permissions and legends/explanatory notes.
• Provides detailed (rich qualitative) information.
• Provides insight for further research.
• Permitting investigation of otherwise impractical (or unethical) situations.

Case studies allow a researcher to investigate a topic in far more detail than might be possible if they were trying to deal with a large number of research participants (nomothetic approach) with the aim of ‘averaging’.

Because of their in-depth, multi-sided approach, case studies often shed light on aspects of human thinking and behavior that would be unethical or impractical to study in other ways.

Research that only looks into the measurable aspects of human behavior is not likely to give us insights into the subjective dimension of experience, which is important to psychoanalytic and humanistic psychologists.

Case studies are often used in exploratory research. They can help us generate new ideas (that might be tested by other methods). They are an important way of illustrating theories and can help show how different aspects of a person’s life are related to each other.

The method is, therefore, important for psychologists who adopt a holistic point of view (i.e., humanistic psychologists ).

Limitations

• Lacking scientific rigor and providing little basis for generalization of results to the wider population.
• Researchers’ own subjective feelings may influence the case study (researcher bias).
• Difficult to replicate.
• Time-consuming and expensive.
• The volume of data, together with the time restrictions in place, impacted the depth of analysis that was possible within the available resources.

Because a case study deals with only one person/event/group, we can never be sure if the case study investigated is representative of the wider body of “similar” instances. This means the conclusions drawn from a particular case may not be transferable to other settings.

Because case studies are based on the analysis of qualitative (i.e., descriptive) data , a lot depends on the psychologist’s interpretation of the information she has acquired.

This means that there is a lot of scope for Anna O , and it could be that the subjective opinions of the psychologist intrude in the assessment of what the data means.

For example, Freud has been criticized for producing case studies in which the information was sometimes distorted to fit particular behavioral theories (e.g., Little Hans ).

This is also true of Money’s interpretation of the Bruce/Brenda case study (Diamond, 1997) when he ignored evidence that went against his theory.

Breuer, J., & Freud, S. (1895).  Studies on hysteria . Standard Edition 2: London.

Curtiss, S. (1981). Genie: The case of a modern wild child .

Diamond, M., & Sigmundson, K. (1997). Sex Reassignment at Birth: Long-term Review and Clinical Implications. Archives of Pediatrics & Adolescent Medicine , 151(3), 298-304

Freud, S. (1909a). Analysis of a phobia of a five year old boy. In The Pelican Freud Library (1977), Vol 8, Case Histories 1, pages 169-306

Freud, S. (1909b). Bemerkungen über einen Fall von Zwangsneurose (Der “Rattenmann”). Jb. psychoanal. psychopathol. Forsch ., I, p. 357-421; GW, VII, p. 379-463; Notes upon a case of obsessional neurosis, SE , 10: 151-318.

Harlow J. M. (1848). Passage of an iron rod through the head.  Boston Medical and Surgical Journal, 39 , 389–393.

Harlow, J. M. (1868).  Recovery from the Passage of an Iron Bar through the Head .  Publications of the Massachusetts Medical Society. 2  (3), 327-347.

Money, J., & Ehrhardt, A. A. (1972).  Man & Woman, Boy & Girl : The Differentiation and Dimorphism of Gender Identity from Conception to Maturity. Baltimore, Maryland: Johns Hopkins University Press.

Money, J., & Tucker, P. (1975). Sexual signatures: On being a man or a woman.

Further Information

• Case Study Approach
• Case Study Method
• Enhancing the Quality of Case Studies in Health Services Research
• “We do things together” A case study of “couplehood” in dementia
• Using mixed methods for evaluating an integrative approach to cancer care: a case study

The Case Study as Research Method: A Practical Handbook

Qualitative Research in Accounting & Management

ISSN : 1176-6093

Article publication date: 21 June 2011

Scapens, R.W. (2011), "The Case Study as Research Method: A Practical Handbook", Qualitative Research in Accounting & Management , Vol. 8 No. 2, pp. 201-204. https://doi.org/10.1108/11766091111137582

Emerald Group Publishing Limited

Copyright © 2011, Emerald Group Publishing Limited

This book aims to provide case‐study researchers with a step‐by‐step practical guide to “help them conduct the study with the required degree of rigour” (p. xi).

It seeks to “demonstrate that the case study is indeed a scientific method” (p. 104) and to show “the usefulness of the case method as one tool in the researcher's methodological arsenal” (p. 105). The individual chapters cover the various stages in conducting case‐study research, and each chapter sets out a number of practical steps which have to be taken by the researcher. The following are the eight stages/chapters and, in brackets, the number of steps in each stages:

Assessing appropriateness and usefulness (4).

Ensuring accuracy of results (21).

Preparation (6).

Selecting cases (4).

Collecting data (7).

Analyzing data (4).

Interpreting data (3).

Reporting results (4).

It is particularly noticeable that ensuring accuracy of results has by far the largest number of number of steps – 21 steps compared to seven or fewer steps in the other stages. This reflects Gagnon's concern to demonstrate the scientific rigour of case‐study research. In the forward, he explains that the book draws on his experience in conducting his own PhD research, which was closely supervised by three professors, one of whom was inclined towards quantitative research. Consequently, his research was underpinned by the principles and philosophy of quantitative research. This is clearly reflected in the approach taken in this book, which seeks to show that case‐study research is just as rigorous and scientific as quantitative research, and it can produce an objective and accurate representation of the observed reality.

There is no discussion of the methodological issues relating to the use of case‐study research methods. This is acknowledged in the forward, although Gagnon refers to them as philosophical or epistemological issues (p. xii), as he tends to use the terms methodology and method interchangeably – as is common in quantitative research. Although he starts (step 1.1) by trying to distance case and other qualitative research from the work of positivists, arguing that society is socially constructed, he nevertheless sees social reality as objective and independent of the researcher. So for Gagnon, the aim of case research is to accurately reflect that reality. At various points in the book the notion of interpretation is used – evidence is interpreted and the (objective) case findings have to be interpreted.

So although there is a distancing from positivist research (p. 1), the approach taken in this book retains an objective view of the social reality which is being researched; a view which is rather different to the subjective view of reality taken by many interpretive case researchers. This distinction between an objective and a subjective view of the social reality being researched – and especially its use in contrasting positivist and interpretive research – has its origins the taxonomy of Burrell and Morgan (1979) . Although there have been various developments in the so‐called “objective‐subjective debate”, and recently some discussion in relation to management accounting research ( Kakkuri‐Knuuttila et al. , 2008 ; Ahrens, 2008 ), this debate is not mentioned in the book. Nevertheless, it is clear that Gagnon is firmly in the objective camp. In a recent paper, Johnson et al. (2006, p. 138) provide a more contemporary classification of the different types of qualitative research. In their terms, the approach taken in this book could be described as neo‐empiricist – an approach which they characterise as “qualitative positivists”.

The approach taken in this handbook leaves case studies open to the criticisms that they are a small sample, and consequently difficult to generalise, and to arguments that case studies are most appropriate for exploratory research which can subsequently be generalised though quantitative research. Gagnon explains that this was the approach he used after completing his thesis (p. xi). The handbook only seems to recognise two types of case studies, namely exploratory and raw empirical case studies – the latter being used where “the researcher is interested in a subject without having formed any preconceived ideas about it” (p. 15) – which has echoes of Glaser and Strauss (1967) . However, limiting case studies to these two types ignores other potential types; in particular, explanatory case studies which are where interpretive case‐study research can make important contributions ( Ryan et al. , 2002 ).

This limited approach to case studies comes through in the practical steps which are recommended in the handbook, and especially in the discussion of reliability and validity. The suggested steps seem to be designed to keep very close to the notions of reliability and validity used in quantitative research. There is no mention of the recent discussion of “validity” in interpretive accounting research, which emphasises the importance of authenticity and credibility and their implications for writing up qualitative and case‐study research ( Lukka and Modell, 2010 ). Although the final stage of Gagnon's handbook makes some very general comments about reporting the results, it does not mention, for example, Baxter and Chua's (2008) paper in QRAM which discusses the importance of demonstrating authenticity, credibility and transferability in writing qualitative research.

Despite Gagnon's emphasis on traditional notions of reliability and validity the handbook provides some useful practical advice for all case‐study researchers. For example, case‐study research needs a very good research design; case‐study researchers must work hard to gain access to and acceptance in the research settings; a clear strategy is needed for data collection; the case researcher should create field notes (in a field notebook, or otherwise) to record all the thoughts, ideas, observations, etc. that would not otherwise be collected; and the vast amount of data that case‐study research can generate needs to be carefully managed. Furthermore, because of what Gagnon calls the “risk of mortality” (p. 54) (i.e. the risk that access to a research site may be lost – for instance, if the organisation goes bankrupt) it is crucial for some additional site(s) to be selected at the outset to ensure that the planned research can be completed. This is what I call “insurance cases” when talking to my own PhD students. Interestingly, Gagnon recognises the ethical issues involved in doing case studies – something which is not always mentioned by the more objectivist type of case‐study researchers. He emphasises that it is crucial to honour confidentiality agreements, to ensure data are stored securely and that commitments are met and promises kept.

There is an interesting discussion of the advantages and disadvantages of using computer methods in analysing data (in stage 6). However, the discussion of coding appears to be heavily influenced by grounded theory, and is clearly concerned with producing an accurate reflection of an objective reality. In addition, Gagnon's depiction of case analysis is overly focussed on content analysis – possibly because it is a quantitative type of technique. There is no reference to the other approaches available to qualitative researchers. For example, there is no mention of the various visualisation techniques set out in Miles and Huberman (1994) .

To summarise, Gagnon's book is particularly useful for case‐study researchers who see the reality they are researching as objective and researcher independent. However, this is a sub‐set of case‐study researchers. Although some of the practical guidance offered is relevant for other types of case‐study researchers, those who see multiple realities in the social actors and/or recognise the subjectivity of the research process might have difficulty with some of the steps in this handbook. Gagnon's aim to show that the case study is a scientific method, gives the handbook a focus on traditional (quantitatively inspired) notions rigour and validity, and a tendency to ignore (or at least marginalise) other types of case study research. For example, the focus on exploratory cases, which need to be supplemented by broad based quantitative research, overlooks the real potential of case study research which lies in explanatory cases. Furthermore, Gagnon is rather worried about participant research, as the researcher may play a role which is “not consistent with scientific method” (p. 42), and which may introduce researcher bias and thereby damage “the impartiality of the study” (p. 53). Leaving aside the philosophical question about whether any social science research, including quantitative research, can be impartial, this stance could severely limit the potential of case‐study research and it would rule out both the early work on the sociology of mass production and the recent calls for interventionist research. Clearly, there could be a problem where a researcher is trying to sell consulting services, but there is a long tradition of social researchers working within organisations that they are studying. Furthermore, if interpretive research is to be relevant for practice, researchers may have to work with organisations to introduce new ideas and new ways of analysing problems. Gagnon would seem to want to avoid all such research – as it would not be “impartial”.

Consequently, although there is some good practical advice for case study researchers in this handbook, some of the recommendations have to be treated cautiously, as it is a book which sees case‐study research in a very specific way. As mentioned earlier, in the Forward Gagnon explicitly recognises that the book does not take a position on the methodological debates surrounding the use of case studies as a research method, and he says that “The reader should therefore use and judge this handbook with these considerations in mind” (p. xii). This is very good advice – caveat emptor .

Ahrens , T. ( 2008 ), “ A comment on Marja‐Liisa Kakkuri‐Knuuttila ”, Accounting, Organizations and Society , Vol. 33 Nos 2/3 , pp. 291 ‐ 7 , Kari Lukka and Jaakko Kuorikoski.

Baxter , J. and Chua , W.F. ( 2008 ), “ The field researcher as author‐writer ”, Qualitative Research in Accounting & Management , Vol. 5 No. 2 , pp. 101 ‐ 21 .

Burrell , G. and Morgan , G. ( 1979 ), Sociological Paradigms and Organizational Analysis , Heinneman , London .

Glaser , B.G. and Strauss , A.L. ( 1967 ), The Discovery of Grounded Theory: Strategies for Qualitative Research , Aldine , New York, NY .

Johnson , P. , Buehring , A. , Cassell , C. and Symon , G. ( 2006 ), “ Evaluating qualitative management research: towards a contingent critieriology ”, International Journal of Management Reviews , Vol. 8 No. 3 , pp. 131 ‐ 56 .

Kakkuri‐Knuuttila , M.‐L. , Lukka , K. and Kuorikoski , J. ( 2008 ), “ Straddling between paradigms: a naturalistic philosophical case study on interpretive research in management accounting ”, Accounting, Organizations and Society , Vol. 33 Nos 2/3 , pp. 267 ‐ 91 .

Lukka , K. and Modell , S. ( 2010 ), “ Validation in interpretive management accounting research ”, Accounting, Organizations and Society , Vol. 35 , pp. 462 ‐ 77 .

Miles , M.B. and Huberman , A.M. ( 1994 ), Qualitative Data Analysis: A Source Book of New Methods , 2nd ed. , Sage , London .

Ryan , R.J. , Scapens , R.W. and Theobald , M. ( 2002 ), Research Methods and Methodology in Finance and Accounting , 2nd ed. , Thomson Learning , London .

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Questions & More Information

Answers to the most commonly asked questions here

Case Studies

Case studies are a popular research method in business area. Case studies aim to analyze specific issues within the boundaries of a specific environment, situation or organization.

According to its design, case studies in business research can be divided into three categories: explanatory, descriptive and exploratory.

Explanatory case studies aim to answer ‘how’ or ’why’ questions with little control on behalf of researcher over occurrence of events. This type of case studies focus on phenomena within the contexts of real-life situations. Example: “An investigation into the reasons of the global financial and economic crisis of 2008 – 2010.”

Descriptive case studies aim to analyze the sequence of interpersonal events after a certain amount of time has passed. Studies in business research belonging to this category usually describe culture or sub-culture, and they attempt to discover the key phenomena. Example: “Impact of increasing levels of multiculturalism on marketing practices: A case study of McDonald’s Indonesia.”

Exploratory case studies aim to find answers to the questions of ‘what’ or ‘who’. Exploratory case study data collection method is often accompanied by additional data collection method(s) such as interviews, questionnaires, experiments etc. Example: “A study into differences of leadership practices between private and public sector organizations in Atlanta, USA.”

Advantages of case study method include data collection and analysis within the context of phenomenon, integration of qualitative and quantitative data in data analysis, and the ability to capture complexities of real-life situations so that the phenomenon can be studied in greater levels of depth. Case studies do have certain disadvantages that may include lack of rigor, challenges associated with data analysis and very little basis for generalizations of findings and conclusions.

John Dudovskiy

• Open access
• Published: 12 April 2024

Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey

• Kas Woudstra 1 , 2 ,
• Marcia Tummers 1 ,
• Catharina J. M. Klijn 3 ,
• Lotte Sondag 3 ,
• Floris Schreuder 3 ,
• Rob Reuzel 1 &
• Maroeska Rovers 2  

BMC Health Services Research volume  24 , Article number:  462 ( 2024 ) Cite this article

Metrics details

Stakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders’ views, needs, and values. Methods for these engagements have however not been compared to analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, interaction, and time-investment.

We compared focus groups, interviews, and an online survey in a case-study on minimally invasive endoscopy-guided surgery for patients with intracerebral haemorrhage. The focus groups and interviews featured two rounds, one explorative focussing on individual perspectives, and one interactive focussing on the exchange of perspectives between participants. The comparison between methods was made in terms of number and content of themes, how participants interact, and hours invested by all researchers.

The focus groups generated 34 themes, the interviews 58, and the survey 42. Various improvements for the assessment of the surgical procedure were only discussed in the interviews. In focus groups, participants were inclined to emphasise agreement and support, whereas the interviews consisted of questions and answers. The total time investment for researchers of focus groups was 95 h, of interviews 315 h, and survey 81 h.

Conclusions

Within the context of medical device evaluation, interviews appeared to be the most appropriate method for understanding stakeholder views since they provide a scope and depth of information that is not generated by other methods. Focus groups were useful to rapidly bring views together. Surveys enabled a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.

Peer Review reports

Medical devices form an intricate part of the healthcare system. Novel medical devices like robots, nano-technologies, and e-health platforms carry the promise of improving healthcare systems [ 1 ]. As medical devices become more pervasive and complex, it is essential to develop and apply these technologies so that they solve the most pressing medical problems in global healthcare systems. Multiple guidelines and regulations exist that stimulate a practice of medical device research and development that is aimed at solving critical health problems [ 2 , 3 , 4 ]. In these documents, one of the recommendations is to actively involve a diverse selection of stakeholders in the research and development process of medical devices. This should lead to better informed decisions during evaluation: aligning devices with the views, needs, and values of stakeholders like medical professionals or patients. This, in turn, can optimise the use of resources spent on research, development, implementation, or use [ 5 ].

There are several methods for stakeholder involvement but these have not been compared against the background of their suitability for medical device evaluation purposes. Studying methods within this context is important, because there are some typical requirements in medical device evaluation. Methods should yield relevant information for research or development choices, preferably foster agreement among stakeholders regarding the future development and implementation of the medical device, and be feasible in terms of resources. By relevant information we mean: any information that helps to understand what features a device should have or how research into a device should be conducted to meet the needs and values of stakeholders. This could involve effectiveness, functionalities, ease of use, affordability, or possible spill overs. By analysing stakeholder needs and practices and making consequent design changes, medical devices can become more valuable [ 6 , 7 ]. Fostering agreement is important to ensure that a device is sufficiently endorsed to make implementation successful. This requires interaction between stakeholders to find common ground [ 8 ]. In entrepreneurial settings where resources are limited and the life-cycle of medical devices is relatively short, development trajectories generally cannot be too long and costly [ 9 ]. Participatory methods can—on the other hand – give insights into development, evaluation, and implementation issues that can occur, and therefore possibly save costs. Due to these unique conditions, it is important to specifically analyse participatory methods in the context of medical device evaluation or development. Some general comparisons of interviews, focus groups, and surveys exist terms of effect on outcomes exist, but these comparisons are not directly applicable to medical devices, nor are they compared all three together [ 10 , 11 , 12 ].

Interviews and focus groups are the most often-used methods in participatory research of medical devices and therefore we compare these in this study [ 13 ]. Surveys are chosen because they are also used in qualitative research and because they methodologically differ on various aspects from interviews and focus groups [ 13 ]. Qualitative surveys offer open text boxes and therefore researchers cannot ask follow-up questions, and there is no direct interaction between researchers and participants. Therefore, we aimed to investigate how focus groups, interviews, and a survey compare in terms of the number of relevant themes they provide, interaction between stakeholders, and time-investment, when conducted in the context of the evaluation of a medical device.

Comparison in one clinical case

We simultaneously employed and compared three participatory methods: focus groups, interviews, and a survey, in an empirical case-study on minimally-invasive endoscopy-guided surgery for patients with intracerebral haemorrhage (ICH). ICH is the deadliest stroke subtype, with a 30-day case fatality of 40%, and of the patients surviving many live with severe disability [ 14 ]. To improve outcome of patients with ICH, an innovative endoscopic device has been developed that has the potential of removing the haemorrhage by minimally-invasive surgery. A systematic review and meta-analysis of randomised trials investigating surgical treatment of ICH showed that minimally-invasive surgery was associated with a reduction in mortality and an increase in good functional outcome, particularly when performed early after symptom onset [ 15 ]. The Dutch Intracerebral haemorrhage Surgery Trial (DIST) pilot study (NCT03608423) has recently demonstrated in 40 patients with ICH that minimally-invasive endoscopy-guided surgery within 8 h of symptom onset using the novel endoscopy-guided approach was feasible, safe, and technically effective for hematoma removal (Sondag, personal communication). At the time of our research, members of our team (CK, LS, FS) were preparing a phase 3 randomised clinical trial to evaluate effectiveness on functional outcome using early minimally-invasive endoscopy-guided surgery in patients with ICH (NCT05460793). Against this background we employed focus groups, interviews, and a survey to elicit [ 1 ] views of stakeholders on the new endoscopic device and (2) the quality of the (received) hospital care for ICH-patients.

Selection procedure participants

We selected participants who are involved in hospital care for ICH and involved in the use of the new endoscopic device. Three stakeholder groups were identified: patients and relatives, healthcare professionals (HCPs), and policy experts. The number of participants that were determined for each method was guided by the concept of information power, which helps to establish how many participants are needed to acquire a reliable dataset [ 16 ]. Patients, relatives, and HCPs were approached by KW, LS and FS. LS and FS had a physician–patient relationship with the invited patients and relatives, or knew patients and relatives because they had participated in a previous studies related to ICH. HCPs were approached via the network of the neurologists involved in this research (CK, LS, FS), which spans over various ICH care institutions across the Netherlands. Policy experts were approached through networks of CK and MR. In the initial invitations, participants were assigned at random to one of the three methods. Participants that were invited for one method were not allowed to participate in other methods, so there were no cross-overs between methods. Subsequently, all potential participants were contacted via e-mail or by phone. After expressing their willingness to participate, they received an information letter and an informed consent form. In these documents, the aim, conditions, practical details, advantages, and disadvantages of participation were explained. All participants were given two weeks to consider participation, and the conditions of participation were again discussed or presented before each interview, focus group, or survey started. All participants gave written or verbal consent on audio tapes. The local certified ethics committee approved the research protocol.

Data collection method 1: focus groups

We organised five 45-min focus groups, all planned on one evening. The first three focus groups were homogeneous: one for patients, one for HCPs, and one for policy experts. These three focus groups were conducted simultaneously. In these sessions, patients and relatives, HCPs, and policy experts convened in their own groups to discuss their views on the intervention with the new endoscopic device and the quality of hospital care. The participants were first placed in homogeneous groups to familiarize and become comfortable with people with a comparable perspective and make participants at ease. They were also placed in these groups to mirror the first round of interviews that was not primarily aimed at interaction but at constructing the different views of participants. The last two focus groups were also planned simultaneously, fifteen minutes after the first three focus groups. In these focus groups the patients and relatives, HCPs, and policy experts who participated in the first round of focus groups were mixed into two heterogeneous groups to discuss findings from the earlier homogeneous focus groups and to discuss how the different perspectives could be brought together. A number of four to twelve participants per focus groups is advised in literature, so we aimed to include six persons in the homogeneous focus groups, and nine persons in the ensuing heterogenous focus groups [ 17 ]. A minimum number of participants for qualitative research has been proposed of 12, so we aimed to include a higher number than that and tried to include a number that was comparable to the interviews [ 18 ]. Each focus group was led by one moderator, who probed for more in-depth answers if needed, and ensured that every participant was able to participate. All moderators were experienced in moderating group discussions and not in any way involved in ICH-care. Two moderators who participated in the first round moderated the second round. We used semi-structured focus groups protocols (see Appendix 1 ). All focus groups were audio-recorded and transcribed verbally. The audio tapes and transcripts were stored in accordance with European data safety requirements [ 19 ]. Due to the COVID-19 pandemic, the focus groups were organised online via a video call platform. The literature on online or ‘synchronous’ focus groups and interviews indicates that there can be some methodological specificalities to online data collection. It might improve the representation of certain groups, e.g. geographically dispersed people and people with disabilities, and it might be easier to generate richer data on sensitive topics. However, visual ques are harder to read [ 20 , 21 , 22 ]. Altogether, online focus groups might therefore be a useful way of data collection, especially for patients with ICH that encounter many mobility issues and social obstacles.

Data collection method 2: interviews

For the interviews, we used fourth-generation evaluation methodology with some minor modifications [ 23 , 24 , 25 ]. All participants were interviewed twice: in the first round they were asked to share their views on the new endoscopic device and the quality of hospital care, and in the second round they were invited to respond to rival claims of other participants. We aimed to include a number that was comparable to the focus groups and above the minimum number of 12 participants that has been proposed [ 18 ]. All interviews were conducted by KW (3 years of interviewing experience). For both interview rounds, a semi-structured interview protocol was used (see Appendix 2 ). All opinions were processed and presented to other participants anonymously. Due to the COVID-19 pandemic, all interviews were taken via a video call platform, or by phone. As described above, online or synchronous data collection has distinctive features and might be a valuable method of data collection. All interviews were audio recorded and transcribed. The audio tapes and transcripts were stored in accordance with European data safety requirements [ 19 ].

Data collection method 3: qualitative survey

The survey started with information about the study, then asked questions about characteristics of the person filling out the survey, including age, gender, education level, profession, and subsequently questions about improvements in the hospital treatment for ICH and the minimally invasive intervention with the new device. Patients and HCPs were asked to list unmet needs of patients and relevant outcome measures. The questions were closed, answer categories limited, but always followed by an opportunity to provide additional information in an open text field. We invited 78 participants, above the number of participants that proposed as a minimum in qualitative research (which is 12) and above the number of participants that is proposed for qualitative surveys (which is 25 to 50) [ 18 , 26 ]. The survey was conducted via Castor, a digital survey platform. The data were stored in accordance with European data safety requirements [ 19 ].

Units of comparison

The three methods were compared on three outcomes: the number of themes, interaction, and the time-investment of the methods, which are described below.

Number and type of themes

The analysis of the number and type of themes was supported by Atlas.ti software (V.9) and performed by one author (KW) to increase consistency. Following the six steps of thematic analysis by Braun and Clarke [ 27 ], the analysis started with reading and coding the transcripts and survey answers. In later phases these codes were arranged and grouped into themes. This process was discussed with MT and RR to check the credibility of the codes and the themes to ensure consistency and minimise a possible bias. We compared the number of themes provided by each method, and determined what themes were constructed in only one of the methods. Counting themes may not be a conventional approach in qualitative research. However, we aim to provide insight into the breadth and thus comprehensiveness of information collected. Because the coding method was consistent along the three methods, we believe counting themes is an adequate unit of comparison.

Interaction

To assess interaction, we performed three analyses to determine: (i) what themes were addressed by multiple stakeholder groups, (ii) which participants interact with each other, and (iii) how participants interact. All these analyses were performed after the data were collected, and supported by Atlas.ti software (V.9). For the first analysis, we calculated the percentage of the themes that was addressed by two or three stakeholder groups in each data-collection method. For example, if both HCPs and policy experts addressed theme X, this theme was marked as ‘shared’, and consequently the percentage of shared themes of the total amount of themes could be calculated. For this comparison, all methods were taken into account, even though participants did not directly interact in surveys. For the other two analyses, we examined how participants interact. To this aim, we adapted coding schemes by Morgan & Hoffman [ 28 ] and Keyton [ 29 ], which can be applied on verbatim transcripts to code how people react. Our main aims for this analysis were to identify how extensive topics were addressed, and to identify whether stakeholders could reach forms of agreement while interacting. The codes as described by Morgan & Hoffman [ 28 ] were most applicable for these aims so we have used their code book, whereas Keyton [ 29 ] more concisely describes how different turns in an interaction can be coded, so we have adapted her coding process. The main change in the coding book that we made, is that we distinguished who interact from the ways how people interact, which was not clearly incorporated in Morgan & Hofmann’s code book (see Appendix 3 ). We coded who the speaker is and to whom this speaker addresses the message, which will be referred to as turn . When a moderator asked a question to participants, or vice versa, this is coded as a ‘moderator-participant’ turn, and when participants ask and answer questions to each other, these are coded as ‘turn between participants’. When a moderator presented views of other participants, and when participants reacted, these were separately coded as a ‘turn between moderator and participant where moderator presents view of others’. Besides turns we also coded how participants interact in the conversation, using the codes ‘question’, ‘answer’, ‘expansion: sharing new aspect of previous topic’, and ‘agreement’, which will be referred to as acts . Acts are mutually exclusive, but multiple acts could be assigned to one turn in a conversation and vice versa, for example when a participant gives an answer to a moderator and directly poses a question the moderator. KW performed the coding process. These analyses were discussed in-depth with MT and RR, to ensure consistency and minimise a possible bias.

Time-investment

We have operationalised time-investment as the absolute number of hours that all the involved researchers and moderators spent on preparing and performing data-collection and analysing the data. We chose not to analyse the investment from the perspective of the participants, because in this paper aims to compare participatory methods from the perspective of the person or organisation conducting them. Time-investment was based on the researchers’ (KW) agenda, supplemented by sources in the literature, to establish the average time that is needed to transcribe a one-hour audio-tape [ 30 , 31 ]. Because the focus groups and interviews were conducted online, travelling time for researchers and moderators was not taken into account. The calculation of time-investment is set out in detail in Appendix 4 .

Researcher characteristics and reflexivity

The research team partially consists of researchers developing qualitative evaluation methods (KW, MT, MR, RR), and partially of neurologists (CK, FS, LS). There was a doctor-patient relationship between FS and some of the participants. RR is an expert on interactive interviews.

Participants

We invited 24 persons for the focus groups of whom 18 participated, 23 for the interviews of whom 17 participated, and 79 for the survey of whom 43 participated (see Table  1 ). In the focus groups, we had equal numbers of patients or relatives, HCPs, and policy makers: 6 participants in each group. The 17 participants in the interviews were patients ( n  = 7 and n  = 3 in round 1 and 2), HCPs ( n  = 8 and n  = 6 in round 1 and 2), and policy makers ( n  = 2 in both rounds). In the survey, we included 21 patients, 18 HCPs, and 4 policy makers. See Appendix 5 for an overview of the types and number of enrolled participants per data-collection methods that is completed with the total number of invited participants. The majority of interviews lasted an hour, but the duration varied from 30 to 90 min. All focus groups lasted 45 min.

The number of themes varied between the different methods (see Fig.  1 ). In the explorative round 31 themes were constructed. In the interactive round 19 themes were constructed and 16 of these were also discussed in the first round, so 34 themes were constructed in all focus groups. The first interview round generated 58 themes, the second 40, and all themes in the second round of interviews had already been discussed in the first round. The survey generated 42 unique themes. An overview of all the themes generated can be found in Appendix 6 .

Number of themes constructed in three data collection methods

All methods generated themes about research improvements for the innovation and care experiences in the hospital but there were some unique themes that specifically came up in one of the methods and not in the others. In the focus groups, four themes were constructed that were not generated in the other methods, two of which related to communication between HCPs and patients and relatives. In the interviews 19 themes were generated, that addressed various aspects of the assessment of the new treatment, such as the characteristics of the study population that ideally should undergo the new treatment in a subsequent research phase, and the informed consent procedure of that research phase. In the survey, 9 unique themes were present, ranging from ‘trust in HCPs’ to ‘outcome measure: feasibility’.

Percentage of themes that is addressed by multiple groups of stakeholders

Figure 2 shows that some themes were addressed by multiple stakeholder groups, whereas other themes were mentioned by one stakeholder group only. In the first explorative round of the focus groups, 16 percent of the themes was addressed by two or three stakeholder groups. In the second interactive round the percentage of themes addressed by multiple groups was 35 percent. In the first round of interviews the percentage of themes addressed by multiple groups was 25 percent in the first round and 58 percent in the second round. In the survey, 21 percent of the themes was addressed by multiple stakeholder groups, and these shared themes are all based on the numeric answers. None of the open-text box answers led to themes that were addressed by multiple stakeholders.

Percentage of themes addressed by multiple stakeholder groups in three data collection methods in round 1 (exploration) and round 2 (reaction)

Which participants interact with each other: turns

Figure 3 depicts which participants interacted with each other. In the first round of the focus group the moderators and participants primarily interacted, whereas in the second interactive round, participants more often interacted directly with each other. In the first interview round, 98% of the turns consisted of direct interaction between participants and the moderator and 2% of the turns consisted of interactions about other participants’ perspectives. In interview round 2, 20% of the turns consisted of direct interaction, and 80% percent of the turns entailed other participants’ opinions. The total number of turns in focus groups round one is 89, in round two 115. The total number of turns in interview round one is 1472 and in round two 894.

Which participants interact with each other: presented as percentage of total number of interactions

How participants interact: acts

Figure 4 presents how participants and moderators interacted in each of the rounds in the focus groups and interviews. In the first round of the focus groups, 93% of the acts consisted of questions, follow-up questions, answers, and expansions on topics, whereas concrete expressions of agreement (18 percent) and support (8 percent) were more prevalent in the second round. In interview round one, 99% of the acts consisted of questions, follow-up questions, answers, and expansions upon previous answers. In round two this was 98%.

Form of interaction as percentage of total number of interactions

Figure 5 provides insight in the time-investment of each of the methods, operationalised as the number of hours that needs to be worked by all researchers. The preparation, data-collection, and analysis of the focus groups took 26, 15, and 54 h within in an overall time span of seven months. Of these 54 h of analysis, 19 consisted of transcribing interviews. The recruitment of participants for the interviews and setting a date took a preparation time that spanned over 5 months. The interviews took 26 h, 45 and 244 h for preparation, data-collection and analysis in a time span of 5 months and 10 months for the first and second round. Of these 244 h of analysis, 140 were dedicated to transcribing. The survey took 57 h to prepare and was completed over the course of nine months, as all questions had to be carefully integrated, checked, and piloted using a digital survey platform.

Accumulative number of hours worked by researchers

Summary main findings

This comparison of focus groups, interviews and a survey in an empirical case study on minimally-invasive endoscopy-guided surgery in patients with ICH showed considerable differences in themes, interaction, and time-investment. In the focus groups relatively few themes were discussed, in the survey slightly more themes occurred, and in the interviews the largest number of themes was constructed. Many improvements for the assessment of the minimally invasive procedure were only discussed in the interviews, such as in- and exclusion criteria for the randomised clinical trial. We assume this is due to the extended time that can be dedicated to data collection, so that more detailed topics can be discussed in-depth. In other respects, there were no clear patterns of topics that occurred in specific methods. In terms of interaction, the focus groups where characterised by relatively much agreement and support. In the interviews agreement and support were seldomly expressed: nearly only questions and answers occurred. In terms of time-investment, the survey required the lowest total time investment: a total of 81 h, followed by focus groups with 96 h, and interviews required the highest time investment with a total of 315 h. There were no significant differences in time investment between the two rounds, neither for the focus groups nor for the interviews. The time allocated for preparation, data collection, and analysis was proportional to the number of interviews and focus groups conducted in each round.

Taking these results together, we can conclude that interviews generated the most useful data within the clinical case because they generated the highest number of relevant themes. They did however require a high-time investment. Focus groups appeared to be a technique that can better be employed to generate agreement and support instead of generating many relevant themes. Surveys do not generate the most comprehensive overview of themes, but can be useful if researchers want to map themes in a quick way without asking follow-up questions. It is important to be aware that we analysed these differences in the context of medical device evaluation, where the aim of participatory methods is to inform the research or development process, rather than merely describing stakeholder views.

Comparison literature

Our results are in agreement with other studies that show that focus groups generate fewer themes compared to interviews, and that focus groups are relatively time efficient [ 32 , 33 , 34 ]. Other studies, however, report that focus groups and interviews generate a comparable large number of themes, whereas our results clearly show that interviews generate more themes [ 10 , 35 , 36 , 37 ]. The discrepancy might be explained by the large number of focus groups that were held and the number of participants that participated in these latter studies. Namey et al. [ 35 ] for example assigned 310 participants to 40 focus groups and 40 participants to interviews. Because these authors include such high numbers in focus groups, they also state that focus groups require a lower time-investment. Based on our findings and the findings in the literature, we can assume that with equal inclusion numbers, focus groups take less time at the expense of generating less data.

Strengths and limitations

The major strength of our study is that we compared three participatory methods in one single empirical case study on the development and evaluation of a medical device. With rigorous control of many contextual and methodological factors we can conclude that the differences in the three outcomes of this study are mainly caused by the characteristics of the data collection methods. Another strength is that we have embedded the comparison in an actual participatory assessment of an innovative minimally-invasive surgical treatment, increasing the ecological validity of the results. Patients and their relatives were involved, they interacted with different physicians and policy makers, and the findings were used in later assessments of the new procedure. Therefore, the results of this study are representative for interactions between these groups. The insights have also informed subsequent quantitative studies on the surgical treatment. Albeit our study is focussed on medical device evaluation, it also has consequences for comparisons of qualitative methods in a broader perspective, because we have adopted conventional focus group, interview and survey methodologies. Our results can therefore be compared with those from related studies outside the domain of medical device evaluation. Finally, we performed an analysis of interaction. The analysis of interaction is rarely done, probably because it is laborious. However, this analysis is crucial because interaction between participants and between participants and moderator(s) is one of the primary aims of focus groups and interviews. By showing who interacts with whom and how, we offer insights in the processes of these methods, which can be of use in the selection of one of these methods by others.

Some limitations should also be addressed. First, there are still some variations in the three research designs that could have influenced the outcomes. Different moderators and stakeholders were involved in each method, and their specific characteristics could have affected the results. Using different moderators and participants was a considerate choice, however, since the use of the same moderator or participants in all methods would have influenced the outcomes, as they would have taken their experiences from one activity to the other. Second, a substantial proportion of themes was found in only two or one of the methods, which indicates that none of the methods generated a complete set of data. This implies that the concept of information power might not have been the most suitable technique to determine the number of participants. Saturation might be a better point to close the data collection phase, especially when a diverse range of participants is included, such as in this study. Third, in the survey a relatively low number of participants were enrolled. The data may therefore not be representative of surveys with higher inclusion numbers. Yet, the survey in this study was constructed for qualitative research aims and not intended to produce quantitatively significant results. Fourth, the data of all three methods were collected digitally, because the data-collection was performed during the COVID-19 pandemic. Therefore, the results may not be directly applicable to face-to-face interactions. As work is increasingly being digitalised and organised remotely, it is likely that in the future qualitative data more often are being collected by means of video consulting applications.

Implications

Our results help researchers and innovators to choose a method that is most suitable for their research aim, both in- and outside the domain of medical device evaluation. First we will place the methodological findings in the clinical context in which we worked. Next, we will discuss contextual factors that are relevant for medical device evaluation in general.

As described in the methods section, three methods were compared against the background of the design of a phase 3 randomised clinical trial to evaluate early minimally-invasive endoscopy-guided surgery in patients with ICH (NCT05460793). The clinical results of our research were used to inform different aspects of this randomised clinical trial, such as the selection of relevant outcome variables and the process of acquiring informed consent in this acute intervention trial. The results were also used to see how hospital care for ICH could be improved in general. All methods generated relevant insights in the context of this study, but interviews generated the most comprehensive body of relevant results for the trial and were thus most useful in the specific clinical context.

As described, there are some implications that are relevant for all types of researchers or innovators that want to employ participatory methods. Elucidating needs of stakeholders might especially be relevant in early development stages since they can be translated in the further development and evaluation of a device. It is thus relevant to have a comprehensive, in-depth assessment of these needs and interviews appear to be most appropriate for that aim. If in later stages more specific development issues need to be resolved, stakeholders could be brought together in a small focus group to make a joint decision. Since financial investments are required for participatory evaluations, the question arises whether the benefits live up to these investments. In the literature, stakeholder involvement is generally considered to be beneficial, but an important caveat is that low budgets and small-scale involvements can lead to flawed stakeholder representation and reproducing existing power differences [ 38 ]. We strongly recommend to invest in participatory development and evaluation as this is likely to be highly beneficial, because the perspectives of stakeholders are embedded in the innovation process.

Furthermore, we posit the existence of overarching methodological implications pertinent to participatory research at large, and delineate some considerations. The body of results generated by focus groups was not as comprehensive as in the interviews. This is possibly due to the social dynamic that is at play between participants and the limited time that each individual speaker is talking, which makes expansive questioning by a moderator on all relevant topics hard to realize. This implies that for comprehensively answering a research question, focus groups are not the most suitable method. Nevertheless, topics can be discussed and resolved relatively quickly in a focus group if the participants are more or less on the same page, which implies that focus groups can be a useful decision-making technique. Interviews can best be used for in-depth analyses of different perspectives, to generate much data, and therefore comprehensively answer a research question. Researchers or innovators may shorten the time-investment of interviews by speeding up the analysis, for example by not transcribing full interviews but writing summaries directly after an interview. Surveys might be suitable if researchers or innovators want to carry out a fast exploration of themes, and do not require interaction or an in-depth explication of topics. Qualitative surveys lack the option for inductive questioning, so they are not suitable if researchers want to apply an open research design. Methods presented in this paper could also be combined, or integrated in a stepwise manner in a research of development process. A researcher might first use a survey to explore multiple stakeholders’ wishes, and subsequently arrange a round of interactive focus groups when fast and definite decision needs to be made. An evaluation trajectory of medical devices is hard to plan in advance and unforeseen issues might arise, and these issues might demand specific participatory methods.

Focus groups, interviews, and surveys have clear methodological differences and provide different results within the context of medical device evaluation. Focus groups can best be used to bring views together, but do not enable a comprehensive analysis. Interviews enable an in-depth analysis of stakeholder views and can best be used to comprehensively answer an explorative research question, but are time-intensive. Surveys can be used for a rapid exploration of perspectives. Researchers should account for these methodological differences and select the method that serves their research aim.

Availability of data and materials

No data are available. All relevant data are presented in this study.

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Acknowledgements

We wish to express our gratitude to Leon Bijlmakers and Anke Oerlemans for their valuable help in guiding the focus groups.

This work was sponsored by a Vici fund by the Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie (ZonMw) (grant number 91818617). CK and LS are supported by the Netherlands Cardiovascular Research Initiative, which is supported by the Dutch Heart Foundation, CVON2015-01: CONTRAST and the support of the Brain Foundation Netherlands (HA2015.01.06). CK is supported by ZonMw (ASPASIA grant, 015008048). FS is supported by the Dutch Heart Foundation (senior clinical scientist grant, T2019T060).

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KW, RR, MR, MT contributed to the conception and design. KW, CK, LS, RR and MT contributed to the acquisition, analysis and interpretation of data. KW, RR, MR, MT, CK, LS and FS have been drafting the manuscript. MR has obtained funding.

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Woudstra, K., Tummers, M., Klijn, C.J.M. et al. Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey. BMC Health Serv Res 24 , 462 (2024). https://doi.org/10.1186/s12913-024-10887-3

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International development work involves external partners bringing expertise, resources, and management for local interventions in LMICs, but there is often a gap in understandings of relevant local shared values. There is a widespread need to better design interventions which accommodate relevant elements of local culture, as emphasised by recent discussions in global health research regarding neo-colonialism. One recent innovation is the concept of producing ‘cultural protocols’ to precede and guide community engagement or intervention design, but without suggestions for generating them. This study explores and demonstrates the potential of an approach taken from another field, named WeValue InSitu , to generate local culturally-informed protocols. WeValue InSitu engages stakeholder groups in meaning-making processes which ‘crystallize’ their envelope of local shared values, making them communicable to outsiders.

Our research context is understanding and reducing child stunting, including developing interventions, carried out at the Senegal and Indonesia sites of the UKRI GCRF Action Against Stunting Hub. Each national research team involves eight health disciplines from micro-nutrition to epigenetics, and extensive collection of samples and questionnaires. Local culturally-informed protocols would be generally valuable to pre-inform engagement and intervention designs. Here we explore generating them by immediately following the group WeValue InSitu crystallization process with specialised focus group discussions exploring: what local life practices potentially have significant influence on the environments affecting child stunting, and which cultural elements do they highlight as relevant. The discussions will be framed by the shared values, and reveal linkages to them. In this study, stakeholder groups like fathers, mothers, teachers, market traders, administrators, farmers and health workers were recruited, totalling 83 participants across 20 groups. Themes found relevant for a culturally-informed protocol for locally-acceptable food interventions included: specific gender roles; social hierarchies; health service access challenges; traditional beliefs around malnutrition; and attitudes to accepting outside help. The concept of a grounded culturally-informed protocol, and the use of WeValue InSitu to generate it, has thus been demonstrated here. Future work to scope out the advantages and limitations compared to deductive culture studies, and to using other formative research methods would now be useful.

Peer Review reports

Although progress has been made towards the SDG of ‘Zero Hunger by 2025’, the global rates of malnutrition and stunting are still high [ 1 ]. Over the past 20 years, researchers have implemented interventions to reduce undernutrition, specifically focussing on the first 1000 days of life, from conception to 24 months [ 2 ]. However, due to both differing determinants between countries [ 3 , 4 ] as well as varying contextual factors, it is clear that no single fixed approach or combination of approaches can be relied on when implementing stunting interventions [ 5 , 6 , 7 ]. Furthermore, when external researchers design interventions for local areas in Low- and Middle-Income Countries (LMICs) they can often overlook relevant local cultural factors that consequently act as barriers to intervention uptake and reduce their effectiveness, such as geographical factors and the levels of migration in certain populations [ 8 , 9 ], or social norms or perceptions relating to accepting outside help, and power dynamics related to gender [ 10 , 11 , 12 ]. The inclusion of cultural level factors in behaviour change interventions has been proposed as a requirement for effective interventions [ 13 ]. However, despite the breadth of literature highlighting the negative impacts from failing to do this, the lack of integration or even regard of local culture remains a persistent problem in Global Health Research [ 14 ], possibly hindering progress towards the SDGs. Thus, there is a need for approaches to integrate local cultural elements into intervention design.

This lack of understanding of relevant local culture, social norms and shared values also has ethical implications. The field of Global Health Ethics was predominantly developed in the Global North, in High Income Countries (HICs), embedding values common in those countries such as the prominence of individual autonomy [ 15 , 16 ]. Researchers from HICs carrying out research in LMICs may wrongly assume that values held in the Global North are universal [ 14 ] and disregard some local values, such as those related to family and collective decision making, which are core to many communities in LMICs. It is therefore important for outside researchers to have an understanding of relevant local values, culture and social norms before conducting research in LMICs so as not to impose values that do not align with local culture and inadvertently cause harm or offence [ 16 , 17 ]. The importance of this is compounded by the colonial history that is often present in relationships between research communities in HICs and LMICs, and the fact that the majority of the funding and leading institutions are still located in the Global North [ 18 , 19 ]. Thus, conscious steps must be taken to avoid neo-colonialism in Global Health Research [ 20 ]. From a health-equity perspective, it is essential to ensure that those in vulnerable communities are not hindered from involvement in interventions to improve nutrition. Encouraging uptake by such communities could be provided if salient local shared values, norms and culture were taken into account [ 21 ].

In a recent paper, Memon et al., (2021) highlight the usefulness of first creating a cultural protocol that can precede and guide subsequent stages of community engagement or intervention design to ensure that salient local values are known to external researchers coming into the community [ 16 ]. We adopt the use of the concept of a cultural protocol, referring to locally-generated guidance about key values, norms, behaviours and customs relevant to working with the local community. However, we prefer the term, ‘culturally-informed protocol’ since this relates to only cultural elements deemed salient by the researchers, and locally, rather than any comprehensive notion of culture, nor extending beyond the research context.

Memon et al. (2021), point out links between the creation of such a protocol and existing codes of practice that have already been created for some cultures such as the Te Ara Tika, a Guideline for Māori Research Ethics [ 22 ]. Currently, research and interventions in Global Health can be informed by a stage of formative research involving one-to-one interviews, focus groups or direct observations, which can sometimes be ethnographic in nature such as within Focussed Ethnographic Studies or Rapid Assessment Procedures [ 23 , 24 , 25 ]. Although these methods can be effective to inform intervention designs, they have disadvantages like: can take long periods to complete [ 26 ], can be resource intensive [ 26 ] and can lack cultural acceptability [ 27 ]. These limitations may account for the frequent neglect of their use generally, highlighted by Aubel and Chibanda (2022) [ 14 ]. Additionally, none of these methods work towards making explicit local values, or towards the creation of a culturally-informed protocol. In brief, the literature suggests a need to develop alternative methods of Formative Research for understanding locally relevant cultural elements, that are less time-consuming and can generate data that is more easily translatable to intervention design. In addition, these approaches must be applicable in different cultures. Additionally, the protocols produced must be actionable and practical not only for guiding interactions between research teams but also for guiding the initial stages of intervention design.

The work presented here aims to address several of these needs. It includes an exploration of the usefulness of the WeValue InSitu ( WVIS ) approach because that has previously been shown, in environmental management domains, to offer a way to gather in-depth values-based perspectives from a target population [ 28 , 29 ] It was first created through action research, and co-designed to enable civil society organisations to better understand and measure the values-based aspects of their work [ 30 ]. The core WeValue InSitu process (detailed in Table 1 ) involves the crystallization of shared values, with a facilitator guiding a group of participants with shared experiences, through cycles of tacit meaning-making (using a stage of photo-elicitation and triggering) [ 31 ], until they can articulate more explicitly their shared values, in concise and precise statements. These statements are then linked together in a framework by the participants. In an example case in Nigeria, the results of the WVIS approach hinted at the creation of a culturally-informed protocol through an analysis of the shared values frameworks to find cultural themes for the creation of an indicator tool that was used to evaluate several development scenarios based on their social acceptability [ 29 ].

Furthermore, it has been found that if a group of WVIS participants take part in a specialised focus group discussion (FGD), named Perspectives EXploration (PEX:FGD) immediately afterward the main workshop, then they easily and articulately express their perspectives on the topics raised for discussion - and with allusions to the shared values they had crystallised just prior. In an example from Shanghai, the PEX:FGDs focussed on eliciting perspectives on climate change, which were shown to be closely linked with the cultural themes existing within the shared values frameworks produced immediately prior [ 32 ]. In that case, the PEX:FGDs allowed the cultural themes generated during the main WVIS workshop to be linked more closely to the research question. Those results suggested that the WVIS plus PEX:FGD approach could be used to create a specialised culturally-informed protocol for improved intervention design.

In the study presented here, the WVIS approach was explored for the purpose of creating culturally-informed protocols to inform the planning of interventions within two localities of the UKRI GCRF Action Against Stunting Hub [ 33 ]. The work was carried out in two parts. Firstly, the WVIS main workshop was used to elicit cultural themes within the target communities, indicating key elements to consider to ensure ethical engagement. Secondly, the PEX focus group discussions focussed on life practices related to stunting which we explored for the purpose of tailoring the culturally-informed protocols to the specific purpose of improving the design of an example intervention. The Action Against Stunting Hub works across three sites where stunting is highly prevalent but via different determinants: East Lombok in Indonesia (estimated 36% of under-fives stunted), Kaffrine in Senegal (estimated 16% of under-fives stunted) and Hyderabad in India (estimated 48% of under-fives stunted) [ 34 ]. We propose that, the information about local shared values in a given site could be used to inform the design of several interventions, but for our specific exploration the focus here is a proposed ‘egg intervention’, in which pregnant women would be provided with an egg three times per week as supplement to their diet. This study proposes that identifying shared values within a community, alongside information about local life practices, provides critical cultural information on the potential acceptability and uptake of this intervention which can be used to generate culturally-informed protocols consisting of recommendations for improved intervention design.

In this paper we aim to explore the use of the WVIS approach to create culturally-informed protocols to guide engagement and inform the design of localised egg interventions to alleviate stunting in East Lombok, Indonesia and Kaffrine, Senegal. We do this by analysing data about local shared values that are crystallized using the WeValue InSitu ( WVIS ) process to provide clear articulation of local values, followed by an analysis of life practices discussed during PEX:FGD to tailor the culturally-informed protocols for the specific intervention design.

Study setting

This research was exploratory rather than explanatory in nature. The emphasis was on demonstrating the usefulness of the WeValue InSitu ( WVIS ) approach to develop culturally-informed protocols of practical use in intervention design, in different cultural sites. This study was set within a broader shared-values workstream within the UKRI GCRF Action Against Stunting Hub project [ 33 ]. The Hub project, which was co-designed and co-researched by researchers from UK, Indonesia, Senegal and India, involves cohorts of 500 women and their babies in each site through pregnancy to 24 months old, using cross-disciplinary studies across gut health, nutrition, food systems, micro-nutrition, home environment, WASH, epigenetics and child development to develop a typology of stunting. Alongside these health studies are studies of the shared values of the communities, obtained via the WVIS approach described here, to understand the cultural contexts of that diverse health data. In this study the data from East Lombok, Indonesia and Kaffrine, Senegal were used: India’s data were not yet ready, and these two countries were deemed sufficient for this exploratory investigation.

The WVIS approach

The WVIS approach is a grounded scaffolding process which facilitates groups of people to make explicit their shared values in their own vocabulary and within their own frames (details in Fig. 1 and activities in Table 1 ). The first stage of the WVIS is Contextualisation, whereby the group identifies themselves and set the context of their shared experiences, for example, as ‘mothers in East Lombok, Indonesia’. Subsequently, there is a stage of Photo Elicitation, in which the group are first asked to consider what is important, meaningful or worthwhile to them about their context (e.g., ‘being mothers in East Lombok, Indonesia’) and then asked to choose photos from a localised set that they can use as props to help describe their answer to the group [ 29 ]. After this, a localised Trigger List is used. This Trigger List consists of 109 values statements that act as prompts for the group. Examples of these values statements are included below but all the statements begin with “it is important to me/us that…”. The group are asked to choose which statements within the trigger list resonate with them, and those are taken forward for group intersubjective discussion. After a topic of their shared values has been explored, the group begin to articulate and write down their own unique statements of them. These also all begin with “It is important to me/us that…”. After discussing all pressing topics, the group links the written statements on the table into a unique Framework, and one member provides a narrative to communicate it to ‘outsiders’. The WVIS provides a lens of each group’s local shared values, and it is through this lens that they view the topics in the focus group discussions which immediately follow, termed Perspectives EXplorations (PEX:FGDs).

Schematic of the macro-level activities carried out during the WeValue InSitu ( WVIS ) main workshop session

This results in very grounded perspectives being offered, of a different nature to those obtained in questionnaires or using external frameworks [ 31 ]. The specific PEX:FGD topics are chosen as pertinent to stunting contextual issues, including eating habits, food systems and environments, early educational environments, and perceptions of stunting. The local researchers ensured that all topics were handled sensitively, with none that could cause distress to the participants. The data for this study were collected over 2 weeks within December 2019–January 2020 in workshops in East Lombok, Indonesia, and 2 weeks within December 2020 in Kaffrine, Senegal.

The PEX:FGDs were kept open-ended so that participants could dictate the direction of the discussion, which allowed for topics that may not have been pre-considered by the facilitators to arise. Sessions were facilitated by local indigenous researchers, guided in process by researchers more experienced in the approach, and were carried out in the local languages, Bahasa in East Lombok, Indonesia and French or Wolof in Kaffrine, Senegal.

Development of localised WVIS materials

Important to the WVIS approach is the development of localised materials (Table 1 ). The main trigger list has been found applicable in globalised places where English is the first language, but otherwise the trigger lists are locally generated in the local language, incorporating local vocabulary and ways of thinking. To generate these, 5–8 specific interviews are taken with local community members, by indigenous university researchers, eliciting local phrases and ways of thinking. This is a necessary step because shared tacit values cannot be easily accessed without using local language. Examples of localised Trigger Statements produced this way are given below: (they all start with: “It is important to me/us that…”):

…there is solidarity and mutual aid between the people

…I can still be in communication with my children, even if far away

…husbands are responsible for the care of their wives and family

…the town council fulfils its responsibility to meet our needs

…people are not afraid of hard, and even manual work

Study participants

The group participants targeted for recruitment, were selected by local country Hub co-researchers to meet two sets of requirements. For suitability for the WVIS approach they should be between 3 and 12 in number; belong to naturally existing groups that have some history of shared experiences; are over 18 years old; do not include members holding significantly more power than others; and speak the same native language. For suitability in the PEX:FGD to offer life practices with relevance to the research topic of stunting, the groups were chosen to represent stakeholders with connections to the food or learning environment of children (which the Action Against Stunting Hub refer to as the Whole Child approach) [ 33 ]. The university researchers specialising in shared values from the UK, and Senegal and Indonesia respectively, discussed together which stakeholder groups might be appropriate to recruit. The local researchers made the final decisions. Each group was taken through both a WVIS workshop and the immediately-subsequent PEX:FGD.

Data collection and analysis

Standard data output from the WeValue session includes i) the jointly-negotiated bespoke Statements of shared values, linked together in their unique Framework, and ii) an oral recording of a descriptive Narrative of it, given by the group. These were digitized to produce a single presentation for each group as in Fig. 2 . It represents the synthesised culmination of the crystallisation process: a portrait of what was ‘important’ to each stakeholder group. Separately, statements from the group about the authenticity/ownership of the statements are collected.

An illustrative example of one digitized Shared Values Framework and accompanying Narrative from a teacher’s group in East Lombok, Indonesia. The “…” refers to each statement being preceded by “It is important to us that…”

When these Frameworks of ‘Statements of Shared Values’ are viewed across all the groups from one locality (Locality Shared Values Statements), they provide portraits of ‘what is important’ to people living there, often in intimate detail and language. They can be used to communicate to ‘outsiders’ what the general cultural shared values are. In this work the researchers thematically coded them using Charmaz constructionist grounded theory coding [ 35 ] to find broad Major Cultural Themes within each separate locality.

The second area of data collection was in the post- WVIS event: the PEX:FGD for each group. A translator/interpreter provided a running commentary during these discussions, which was audio recorded and then transcribed. The specific topics raised for each group to discuss varied depending on their local expertise. This required completely separate workstreams of coding of the dataset with respect to each topic. This was carried out independently by two researchers: one from UK (using NVivo software (Release 1.3.1)) and one from the local country, who resolved any small differences. All the transcripts were then collated and inductively, interpretively analysed to draw out insights that should be relayed back to the Action Against Stunting Hub teams as contextual material.

The extracts of discussion which were identified as relevant within a particular Hub theme (e.g. hygiene) were then meta-ethnographically synthesised [ 36 ] into ‘Hub Theme Statements’ on each topic, which became the core data for later communication and interrogation by other researchers within the Action Against Stunting Hub. These statements are interpretations of participants’ intended meanings, and links from each of them to data quotes were maintained, enabling future interpretations to refer to them for consistency checks between received and intended meaning.

In this investigation, those Hub Theme Statements (derived from PEX:FGD transcripts) were then deductively coded with respect to any topics with potential implications of the egg intervention. Literature regarding barriers and facilitators to nutrition interventions indicated the following topics could be relevant: attitudes to accepting help; community interactions; cooking and eating habits; traditional beliefs about malnutrition; sharing; social hierarchies [ 12 , 37 , 38 ] to which we added anything related to pregnancy or eggs. This analysis produced our Egg Intervention Themes from the data.

The Major Cultural Themes and Egg Intervention Themes were then used to create a set of culture-based recommendations and intervention specific recommendations respectively for each locality. These recommendations were then combined to form specialized culturally-informed protocols for the egg intervention in each locality: East Lombok, Indonesia and Kaffrine, Senegal. The process is displayed schematically in Fig.  3 .

Schematic representation of the method of production of the culturally-informed protocol for each locality

The preparation of the localised WVIS materials at each site took 6 hours of interview field work, and 40 person hours for analysis. The 10 workshops and data summaries were concluded within 10 workdays by two people (80 person hours). The analysis of the PEX:FGD data took a further 80 person hours. Thus, the total research time was approximately 200 person hours.

The stakeholder group types are summarised in Table 2 . The data is presented in three parts. Firstly, the Major Cultural Themes found in East Lombok, Indonesia and in Kaffrine, Senegal are described – the ones most heavily emphasised by participants. Then, the Egg Intervention Themes and finally, the combined set of Recommendations to comprise a culturally-informed protocol for intervention design for each location. Quotations are labelled INDO or SEN for East Lombok, Indonesia and Kaffrine, Senegal, respectively.

Major cultural themes from frameworks and narratives

These were derived from the Locality Shared Values Statements produced in the WVIS .

East Lombok, Indonesia

Religious values.

Islamic values were crucially important for participants from East Lombok, Indonesia and to their way of life. Through living by the Quran, participating in Islamic community practices, and teaching Islamic values to their children, participants felt they develop their spirituality and guarantee a better afterlife for themselves and their children. Participants stated the Quran tells them to breastfeed their children for 2 years, so they do. Despite no explicit religious official curriculum in Kindergarten, the teachers stated that it was important to incorporate religious teaching.

“East Lombok people always uphold the religious values of all aspects of social life.”

“It is important for me to still teach religious values even though they are not clearly stated in the curriculum.” – Workshop 1 INDO (teachers).

“In Quran for instance, we are told to breastfeed our kids for 2 years. We can even learn about that ” – Workshop 3 INDO (mothers).

Related to this was the importance of teaching manners to children and preventing them from saying harsh words. Teachers stated that it was important to create a happy environment for the children and to ensure that they are polite and well-behaved. Similarly, mothers emphasised the need to teach their children good religious values to ensure they will be polite and helpful to their elders.

“Children don’t speak harsh words.”

“My children can help me like what I did to my parents”.

– Workshop 8 INDO (mothers).

Togetherness within families and the community

The Locality Shared Values Frameworks stressed the importance of togetherness, both within family and community. Comments mentioned it being important that people rely heavily on their family and come together in times of need to support each other and provide motivation. This was also important more broadly, in that people in society should support each other, and that children grow up to contribute to society. This was also reflected in comments around roles within the family. Despite women being primary care givers, and men working to finance the family, participants stated that they follow a process of consultation to make decisions, and when facing hardships.

“that we have the sense of kinship throughout our society”.

“We have togetherness as mothers”.

“For the family side, whatever happens we need to be able to be united as a whole family. We need to have the [sense of] forgiveness for the sake of the children” – Workshop 2 INDO (mothers).

Attitudes about extra-marital pregnancy

In East Lombok, Indonesia, it was essential to both mothers and fathers that pregnancy happened within a marriage, this was to ensure that the honour of the family was upheld and that the lineage of the child was clear. The potential danger to health that early pregnancies can cause was also acknowledged.

“If they don’t listen to parents’ advice, there will be the possibility of pre-marital pregnancy happening, which will affect the family [so much].

The affect is going to be ruining the good name, honour and family dignity. When the children [are] born outside [of] marriage, she or he will have many difficulties like getting a birth certificate [and] having a hard time when registering to school or family” - Workshop 4 INDO (mothers).

“ To make sure that our children avoid getting married at a very young age and moreover [avoid] having free sex so that they will not get pregnant before the marriage” - Workshop 9 INDO (fathers).

Kaffrine, Senegal

The Major Cultural Themes which emerged from the Kaffrine data are described below. As these are grounded themes, they are different than those seen in East Lombok, Indonesia.

Access to healthcare

A recurring theme amongst the groups in Kaffrine were aspirations of affordable and easy-to-access healthcare. Community health workers stated the importance of encouraging women to give birth in hospitals and spoke of the importance of preventing early pregnancy which result from early marriages. Giving birth in hospitals was also a concern for Public Office Administrators who highlighted that this leads to subsequent issues with registering children for school. Mothers and fathers stated the importance of being able to afford health insurance and access healthcare so that they could take care of themselves.

“That the women give birth in the hospital” – Workshop 11 SEN (CHWS).

“To have affordable health insurance ” – Workshop 10 SEN (mothers).

“To have access to health care ” – Workshop 3 SEN (fathers).

“It is important that women give birth in the hospital in order to be able to have a certificate that allows us to establish the civil status” – Workshop 9 SEN (administrators).

Additionally, Community health workers spoke of their aspiration to have enough supplements to provide to their community so as to avoid frustration at the lack of supply, and mothers spoke of their desire to be provided with supplements.

“To have dietary supplements in large quantities to give them to all those who need them, so as not to create frustration” – Workshop 11 SEN (CHWS).

Another aspect of access to healthcare, was mistrust between fathers and community health workers. Community health workers explained that sometimes men can blame them when things go wrong in a pregnancy or consider their ideas to be too progressive. Thus, to these community health workers the quality of endurance was very important.

“Endurance (Sometimes men can accuse us of influencing their wives when they have difficulties in conceiving)” – Workshop 5 SEN (CHWs).

Another recurring theme was the importance of having secure employment and a means to support themselves; that there were also jobs available for young people, and that women had opportunities to make money to help support the family. This included preventing early marriages so girls could stay in school. Having jobs was stated as essential for survival and important to enable being useful to the community and society.

“To have more means of survival (subsistence) to be able to feed our families”.

“To have a regular and permanent job”.

“We assure a good training and education for our children so that they will become useful to us and the community”.

“ Our women should have access to activities that will support us and lessen our burden” – Workshop 3 SEN (fathers).

It was considered very important to have a religious education and respect for religious elders. Moreover, living by, and teaching, religious values such as being hard working, humble and offering mutual aid to others, was significant for people in Kaffrine.

“Have an education in the Islamic Culture (Education that aligns with the culture of Islam)”.

“Respect toward religious leaders” – Workshop 3 SEN (fathers).

“ To organize religious discussions to develop our knowledge about Islam ” - Workshop 10 SEN (mothers).

“ Have belief and be prayerful and give good counselling to people ” - Workshop 4 SEN (grandmothers).

Egg intervention themes from each country from perspectives EXplorations focus group discussion data

Below are results of analyses of comments made during the PEX:FGDs in East Lombok, Indonesia and Kaffrine, Senegal. The following codes were used deductively: attitudes to accepting outside help, traditional gender roles, food sharing, traditional beliefs, social hierarchies and understanding of stunting and Other. These topics were spoken about during open discussion and were not the subject of direct questions. For example, topics relating to traditional gender roles came up in East Lombok, during conversations around the daily routine. Thus, in order to more accurately reflect the intended meaning of the participants, these were labelled food practices, under the “Other” theme. If any of the themes were not present in the discussion, they are not shown below.

Attitudes to accepting outside help

Few mentions were made that focussed on participants attitudes to accepting outside help, but participants were sure that they would not make changes to their menus based on the advice of outside experts. Additionally, teachers mentioned that they are used to accepting help from local organisations that could to help them to identify under-developed children.

“ We don’t believe that [the outsiders are] going to change our eating habits or our various menus ” – Workshop 3 INDO (Mothers).

Traditional gender roles

In East Lombok, mothers spoke about how their husbands go to work and then provide them with daily money to buy the food for the day. However, this was discussed in relation to why food is bought daily and is thus discussed below in the topics Other – Food practices.

Food sharing

In East Lombok, Indonesia, in times when they have extra food, they share it with neighbours, in the hope that when they face times of hardship, their neighbours will share with them. Within the household, they mentioned sharing food from their plate with infants and encouraging children to share. Some mothers mentioned the importance of weekly meetings with other mothers to share food and sharing food during celebrations.

“ Sometimes we share our food with our family. So, when we cook extra food, we will probably send over the food to our neighbour, to our families. So, sometimes, with the hope that when we don’t have anything to eat, our neighbour will pay for it and will [share with] us.” – Workshop 3 INDO (Mothers).

“Even they serve food for the kids who come along to the house. So, they teach the kids to share with their friends. They provide some food. So, whenever they play [at their] house, they will [eat] the same.” – Workshop 2 INDO (Mothers).

Understanding of stunting

The teachers in East Lombok were aware of child stunting through Children’s Development Cards provided by local healthcare organizations. They stated that they recognise children with nutrition problems as having no patience period, no expression, no energy for activities and less desire to socialise and play with other children. The teachers said that stunted children do not develop the same as other children and are not as independent as children who are the proper height and weight for their development. They also stated that they recognise stunted children by their posture, pale faces and bloated stomachs. They explained how they usually use the same teaching methods for stunting children, but will sometimes allow them to do some activities, like singing, later, once the other children are leaving.

“ They have no patience period, don’t have any energy to do any of the activities. No expression, only sitting down and not mingling around with the kids. They are different way to learn. They are much slower than the other kids .” – Workshop 1 INDO (teachers).

“ When they are passive in singing, they will do it later when everyone else is leaving, they just do it [by] themselves ” – Workshop 1 INDO (teachers).

Specific views on eggs

In East Lombok, Indonesia, there were no superstitions or traditional beliefs around the consumption of eggs. When asked specifically on their views of eggs, and if they would like to be provided with eggs, women in East Lombok said that they would be happy to accept eggs. They also mentioned that eggs were a food they commonly eat, feed to children and use for convenience. Eggs were considered healthy and were common in their house.

“ We choose eggs instead. If we don’t have time, we just probably do some omelettes or sunny side up. So, it happens, actually when we get up late, we don’t have much time to be able to escort our kids to the school, then we fry the eggs or cook the instant noodles. And it happens to all mothers. So, if my kids are being cranky, that’s what happens, I’m not going to cook proper meals so, probably just eggs and instant noodles.” – Workshop 3 INDO (Mothers).

Other important topics – food practices

Some detailed themes about food practices were heard in East Lombok, Indonesia. The women were responsible for buying and preparing the food, which they purchased daily mainly due to the cost (their husbands were paid daily and so provided them with a daily allowance) and lack of storage facilities. They also bought from mobile vendors who came to the street, because they could buy very small amounts and get occasional credit. The mother decided the menu for the family and cooked once per day in the morning: the family then took from this dish throughout the day. Mothers always washed their fruits and vegetables and tried to include protein in their meals when funds allowed: either meat, eggs, tofu or tempeh.

“ One meal a day. They [the mothers] cook one time and they [the children] can eat it all day long. Yes, they can take it all day long. They find that they like [to take the food], because they tend to feel hungry.” – Workshop 6 INDO (Mothers).

“ They shop every day because they don’t have any storage in their house and the other factor is because the husband has a daily wage. They don’t have monthly wage. In the morning, the husband gives the ladies the money and the ladies go to the shop for the food. ” – Workshop 4 INDO (Mothers).

In Kaffrine, the following themes emerged relating to an egg intervention: they were different in content and emphasis to Lombok and contained uniquely local cultural emphases.

Mothers were welcoming of eggs as a supplement to improve their health during pregnancy and acknowledged the importance of good nutrition during pregnancy. However, they also mentioned that their husbands can sometimes be resistant to accepting outside help and provided an example of a vaccination programme in which fathers were hesitant to participate. However, participants stated that the Government should be the source of assistance to them (but currently was not perceived to be so).

“But if these eggs are brought by external bodies, we will hesitate to take it. For example, concerning vaccination some fathers hesitate to vaccinate their children even if they are locals who are doing it. So, educating the fathers to accept this is really a challenge” – Workshop 11 SEN (CHWs).

Some traditional gender roles were found to be strong. The participants emphasised that men are considered the head of the household, as expected in Islam, with the mother as primary caregiver for children. This is reflected in the comments from participants regarding the importance of Islam and living their religious values. The men thus made the family decisions and would need to be informed and agree to any family participation in any intervention – regardless of the education level of the mother. The paternal grandmother also played a very important role in the family and may also make decisions for the family in the place of the father. Community Health Workers emphasised that educating paternal grandmothers was essential to improve access to healthcare for women.

“There are people who are not flexible with their wives and need to be informed. Sometimes the mother-in-law can decide the place of the husband. But still, the husband’s [permission] is still necessary.” – Workshop 1 SEN (CHWs).

“[We recommend] communication with mothers-in-law and the community. Raise awareness through information, emphasizing the well-being of women and children.” – Workshop 1 SEN (CHWs).

“The [grand]mothers take care of the children so that the daughters in-law will take care of them in return So it’s very bad for a daughter in law not to take care of her mother in-law. Society does not like people who distance themselves from children.” – Workshop 4 SEN (grandmothers).

Social hierarchies

In addition to hierarchies relating to gender/position in the family such as grandmothers have decision making power, there was some mention of social hierarchies in Kaffrine, Senegal. For example, during times of food stress it was said that political groups distribute food and elected officials who choose the neighbourhoods in which the food will be distributed. Neighbourhood leaders then decide to whom the food is distributed, meaning there is a feeling that some people are being left out.

“ It’s political groups that come to distribute food or for political purposes…organizations that often come to distribute food aid, but in general it is always subject to a selection on the part of elected officials, in particular the neighbourhood leaders, who select the people they like and who leave the others ” – Workshop 11 SEN (CHWs).

Participants explained that during mealtimes, the family will share food from one large plate from which the father will eat first as a sign of respect and courtesy. Sometimes, children would also eat in their neighbour’s house to encourage them to eat.

“ Yes, it happens that we use that strategy so that children can eat. Note that children like to imitate so that’s why we [send them to the neighbour’s house]” – Workshop 11 SEN (CHWs)”.

Traditional beliefs about malnutrition

In Kaffrine, Senegal, some participants spoke of traditional beliefs relating to malnutrition, which are believed by fewer people these days. For example, uncovered food might attract bad spirits, and any person who eats it will become ill. There were a number of food taboos spoken of which were thought to have negative consequences for the baby, for example watermelon and grilled meat which were though to lead to birth complications and bleeding. Furthermore, cold water was thought to negatively impact the baby. Groups spoke of a tradition known as “bathie” in which traditional healers wash stunted children with smoke.

“ There are traditional practices called (Bathie) which are practiced by traditional healers. Parents are flexible about the practice of Bathie ” – Workshop 1 SEN (CHWs).

Causes of malnutrition and stunting were thought to be a lack of a balanced diet, lack of vitamin A, disease, intestinal worms, poor hygiene, socio-cultural issues such as non-compliance with food taboos, non-compliance with exclusive breastfeeding and close pregnancies. Malnutrition was also thought by some to be hereditary. Numerous signs of malnutrition were well known amongst the groups in Kaffrine. For example, signs of malnutrition were thought to be a big bloated belly, diarrhoea, oedema of the feet, anaemia, small limbs and hair loss as well as other symptoms such as red hair and a pale complexion. Despite this, malnutrition was thought to be hard to identify in Kaffrine as not all children will visit health centres, but mothers do try to take their babies heights and weights monthly. The groups were aware of the effect of poverty on the likelihood of stunting as impoverished parents cannot afford food. Furthermore, the groups mentioned that there is some stigma towards stunted children, and they can face mockery from other children although most local people feel pity and compassion towards them. Malnourished children are referred to as Khiibon or Lonpogne in the local language of Wolof.

“ It is poverty that is at the root of malnutrition, because parents do not have enough money [and] will have difficulty feeding their families well, so it is the situation of poverty that is the first explanatory factor of malnutrition here in Kaffrine” – Workshop 9 SEN (administrators).

“It can happen that some children are the victim of jokes for example of mockery from children of their same age, but not from adults and older ” – Workshop 9 SEN (administrators).

Pregnancy beliefs

In Kaffrine, Senegal, there were concerns around close pregnancies, and pregnancies in women who were too young, and for home births. Within the communities there was a stigma around close pregnancies, which prevented them from attending antenatal appointments. Similarly, there were superstitions around revealing early pregnancies, which again delayed attendance at health centres.

Groups acknowledged the role of good nutrition, and mentioned some forbidden foods such as salty foods, watermelon and grilled meat (which sometimes related back to a traditional belief that negative impacts would be felt in the pregnancy such as birth complications and bleeding). Similarly, drinking cold water was thought to negatively affect the baby. Beneficial foods mentioned included vegetables and meat, during pregnancy.

“ Often when a woman has close pregnancies, she can be ashamed, and this particularly delays the time of consultation” – Workshop 5 SEN (CHWs).

“Yes, there are things that are prohibited for pregnant women like salty foods” – Workshop 11 SEN (CHWs).

In Kaffrine, Senegal, some participants spoke of a traditional belief that if a pregnant woman consumes eggs then her baby might be overweight, or have problems learning how to talk. Despite this, mothers in Kaffrine said that they would be happy to accept eggs as a supplement, although if supplements are provided that require preparation (such as powdered supplements), they would be less likely to accept them.

“These restrictions are traditional, and more women no longer believe that eggs will cause a problem to the child. But if these eggs are brought by external bodies, we will hesitate to take it.” – Workshop 11 SEN (CHWs).

“They don’t eat eggs before the child starts speaking (the child only eats eggs when he starts talking). This is because it’s very heavy and can cause bloating and may also lead to intestinal problems.” – Workshop 4 SEN (grandmothers).

Other important topics – access to health services

For the participants in Kaffrine, Senegal, accessing health services was problematic, particularly for pre- and post-natal appointments, which faced frequent delays. Some women had access due to poor roads and chose to give birth at home. Access issues were further compounded by poverty and social factors, as procedures in hospitals can be costly, and women with close pregnancies (soon after an earlier one) can feel shame from society and hide their pregnancy.

“Women really have problems of lack of finances. There are social services in the hospital; but those services rarely attend to women without finances. Even when a child dies at birth they will require money to do the necessary procedure ” – Workshop 11 SEN (CHWs).

Creation of the culturally-informed protocols

Recommendations that comprise a culturally-informed protocol for intervention design in each locality are given in Table 3 .

The Major Cultural Themes, and specific Egg Intervention Themes drawn out from only 9–11 carefully planned group sessions in each country provided a rich set of recommendations towards a culturally-informed protocol for the localised design of a proposed Egg Intervention for both East Lombok, Indonesia and Kaffrine, Senegal. A culturally-informed protocol designed in this way comprises cultural insights which are worthy of consideration in local intervention design and should guide future stages of engagement and provide a platform from which good rapport and trust can be built between researchers and the community [ 16 ]. For example, in Kaffrine, Senegal, the early involvement of husbands and grandmothers is crucial, which reflects values around shared decision making within families that are noted to be more prevalent in LMICs, in contrast to individualistic values in HICs [ 16 , 39 ]. Similarly, due to strong religious values in both East Lombok, Indonesia and Kaffrine, Senegal, partnerships with Islamic leaders is likely to improve engagement. Past studies show the crucial role that religious leaders can play in determining social acceptability of interventions, particularly around taboo topics such as birth spacing [ 40 ].

The WVIS plus PEX:FGD method demonstrated here produced both broad cultural themes from shared values, which were in a concise and easy-to-understand format which could be readily communicated with the wider Action Against Stunting Hub, as well as life practices relevant to stunting in Kaffrine, Senegal and in East Lombok, Indonesia. Discussions of shared values during the WVIS main workshop provided useful cultural background within each community. PEX:FGD discussion uncovered numerous cultural factors within local life practices that could influence on the Egg Intervention engagement and acceptability. Combining themes from the WVIS workshop and PEX:FGDs allowed for specific recommendations to be made towards a culturally-informed protocol for the design of an Egg Intervention that included both broad cultural themes and specific Intervention insights (Table 3 ). For example, in Kaffrine, Senegal, to know that the husband’s authoritative family decision-making for health care (specific) is rooted in Islamic foundations (wider cultural) points to an Intervention Recommendation within the protocol, involving consultations with Islamic Leaders to lead community awareness targeting fathers. Similarly, in East Lombok, Indonesia the (specific) behaviour of breastfeeding for 2 years was underpinned by (wider cultural) shared values of living in Islam. This understanding of local values could prevent the imposition of culturally misaligned values, which Bernal and Adames (2017) caution against [ 17 ].

There are a number of interesting overlaps between values seen in the WVIS Frameworks and Narratives and the categories of Schwartz (1992) and The World Values Survey (2023) [ 41 , 42 ]. For example, in both Kaffrine, Senegal and East Lombok, Indonesia, strong religious values were found, and the groups spoke of the importance of practicing their religion with daily habits. This would align with traditional and conservation values [ 41 , 43 ]. Furthermore, in Kaffrine, Senegal participants often mentioned the importance of mutual aid within the community, and similar values of togetherness and respect in the community were found in East Lombok, Indonesia. These would seem to align with traditional, survival and conservation values [ 41 , 43 ]. However, the values mentioned by the groups in the WVIS workshops are far more specific, and it is possible that through asking what is most worthwhile, valuable and meaningful about their context, the participants are able to prioritise which aspects of their values are most salient to their daily lives. Grounded shared values such as these are generally neglected in Global Health Research, and values predominant in the Global North are often assumed to be universal [ 14 ]. Thus, by excluding the use of a predefined external framework, we minimized the risk of imposing our own ideas of values in the community, and increased the relevance, significance and local validity of the elicited information [ 28 ].

Participatory methods of engagement are an essential step in conducting Global Health Research but there is currently a paucity of specific guidance for implementing participatory methods in vulnerable communities [ 16 , 44 ]. In addition, there is acknowledgement in the literature that it is necessary to come into communities in LMICs without assumptions about their held values, and to use bottom-up participatory approaches to better understand local values [ 14 , 16 ]. The WVIS plus PEX:FGD methodology highlighted here exemplifies a method that is replicable in multiple country contexts [ 28 , 32 ] and can be used to crystallize local In Situ Shared Values which can be easily communicated to external researchers. Coupled with the specialised FGD (PEX:FGD), values-based perceptions of specific topics (in this case stunting) can be elicited leading to the creation of specific Culture-based recommendations. This therefore takes steps to answer the call by Memon and colleagues (2021) for the creation of cultural protocols ahead of conducting research in order to foster ethical research relationships [ 16 ]. We believe that the potential usefulness of the WVIS approach to guide engagement and inform intervention design is effectively demonstrated in this study and WVIS offers a method of making explicit local values in a novel and valuable way.

However, we acknowledge that our approach has several limitations. It has relied heavily on the local university researchers to debate and decide which participant stakeholder groups should be chosen, and although they did this in the context of the Whole Child approach, it would have been advantageous to have involved cultural researchers with a deeper understanding of cultural structures, to ensure sufficient opportunities for key cultural elements to emerge. This would have in particular strengthened the intervention design derived from the PEX:FGD data. For example, we retrospectively realised that our study could have been improved if grandmothers had been engaged in East Lombok. Understanding this limitation leads to suggestion for further work: to specifically investigate the overlap of this approach with disciplinary studies of culture, where social interactions and structures are taken into account via formal frameworks.

There are more minor limitations to note. For example, the WVIS approach can only be led by a trained and experienced facilitator: not all researchers can do this. A training programme is currently under development that could be made more widely available through online videos and a Handbook. Secondly, although the groups recruited do not need to be representative of the local population, the number recruited should be increased until theoretical saturation is achieved of the themes which emerge, which was not carried out in this study as we focussed on demonstrating the feasibility of the tool. Thirdly, there is a limit to the number of topics that can be explored in the PEX:FGDs within the timeframe of one focus group (depending on the stamina of the participants), and so if a wider range of topics need formative research, then more workshops are needed. Lastly, this work took place in a large, highly collaborative project involving expert researchers from local countries as well as international experts in WVIS : other teams may not have these resources. However, local researchers who train in WVIS could lead on their own (and in this Hub project such training was available).

The need for better understanding, acknowledgement and integration of local culture and shared values is increasing as the field of Global Health Research develops. This study demonstrates that the WVIS plus PEX:FGD shared values approach provides an efficient approach to contextualise and localise interventions, through eliciting and making communicable shared values and local life practices which can be used towards the formation of a culturally-informed protocols. Were this method to be used for intervention design in future, it is possible that more focus should be given to existing social structures and support systems and a greater variety of stakeholders should be engaged. This study thus contributes to the literature on methods to culturally adapt interventions. This could have significant implications for improving the uptake of nutrition interventions to reduce malnutrition through improved social acceptability, which could help progression towards the goal of Zero Hunger set within the SDGs. The transferability and generalisability of the WVIS plus PEX:FGD approach should now be investigated further in more diverse cultures and for providing formative research information for a wider range of research themes. Future studies could also focus on establishing its scaling and pragmatic usefulness as a route to conceptualising mechanisms of social acceptability, for example a mechanism may be that in communities with strong traditional religious values, social hierarchies involving religious leaders and fathers exist and their buy-in to the intervention is crucial to its social acceptability. Studies could also focus on the comparison or combination of WVIS plus PEX:FGD with other qualitative methods used for intervention design and implementation.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request [email protected], Orcid number 0000–0002–1811-4597. These include deidentified Frameworks of Shared Values and Accompanying Narrative from each Group; deidentified Hub Insight Statements of relevant themes.

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Acknowledgements

We thank the Hub PI, Claire Heffernan, for feedback on a late draft of the manuscript.

The Action Against Stunting Hub is funded by the Medical Research Council through the UK Research and Innovation (UKRI) Global Challenges Research Fund (GCRF), Grant No.: MR/S01313X/1.

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Annabel J. Chapman, Mahsa Firoozmand & Marie K. Harder

Department of Environmental Science and Engineering, Fudan University, Shanghai, People’s Republic of China

Chike C. Ebido, Rahel Neh Tening, Yanyan Huang & Marie K. Harder

Department of Zoology and Environmental Biology, University of Nigeria, Nsukka, Nigeria

Chike C. Ebido

Preventive Medicine and Public Health, Université Cheikh Anta Diop (UCAD), Dakar, Senegal

Ndèye Marème Sougou

Faculty of Psychology, Universitas Islam Negeri Syarif Hidayatullah, Jakarta, Indonesia

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Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEO RECFON) Universitas Indonesia, Jakarta, Indonesia

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Contributions

MKH formulated the initial research question and study design. AJC developed the specific research question. Data collection in Senegal involved CCE, NMS, AHD, FBD, RNT, CEHAN and JM. Data collection in Indonesia involved RA, RK, YH and MKH. Cultural interpretation in Senegal Involved AHD, FBD, NMS, RNT and JM. Analysis involved AJC and MF. AJC and MKH wrote the paper.

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Correspondence to Marie K. Harder .

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Chapman, A.J., Ebido, C.C., Tening, R.N. et al. Creating culturally-informed protocols for a stunting intervention using a situated values-based approach ( WeValue InSitu ): a double case study in Indonesia and Senegal. BMC Public Health 24 , 987 (2024). https://doi.org/10.1186/s12889-024-18485-y

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DOI : https://doi.org/10.1186/s12889-024-18485-y

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Continuing to enhance the quality of case study methodology in health services research

Shannon l. sibbald.

1 Faculty of Health Sciences, Western University, London, Ontario, Canada.

2 Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

3 The Schulich Interfaculty Program in Public Health, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.

Stefan Paciocco

Meghan fournie, rachelle van asseldonk, tiffany scurr.

Case study methodology has grown in popularity within Health Services Research (HSR). However, its use and merit as a methodology are frequently criticized due to its flexible approach and inconsistent application. Nevertheless, case study methodology is well suited to HSR because it can track and examine complex relationships, contexts, and systems as they evolve. Applied appropriately, it can help generate information on how multiple forms of knowledge come together to inform decision-making within healthcare contexts. In this article, we aim to demystify case study methodology by outlining its philosophical underpinnings and three foundational approaches. We provide literature-based guidance to decision-makers, policy-makers, and health leaders on how to engage in and critically appraise case study design. We advocate that researchers work in collaboration with health leaders to detail their research process with an aim of strengthening the validity and integrity of case study for its continued and advanced use in HSR.

Introduction

The popularity of case study research methodology in Health Services Research (HSR) has grown over the past 40 years. 1 This may be attributed to a shift towards the use of implementation research and a newfound appreciation of contextual factors affecting the uptake of evidence-based interventions within diverse settings. 2 Incorporating context-specific information on the delivery and implementation of programs can increase the likelihood of success. 3 , 4 Case study methodology is particularly well suited for implementation research in health services because it can provide insight into the nuances of diverse contexts. 5 , 6 In 1999, Yin 7 published a paper on how to enhance the quality of case study in HSR, which was foundational for the emergence of case study in this field. Yin 7 maintains case study is an appropriate methodology in HSR because health systems are constantly evolving, and the multiple affiliations and diverse motivations are difficult to track and understand with traditional linear methodologies.

Despite its increased popularity, there is debate whether a case study is a methodology (ie, a principle or process that guides research) or a method (ie, a tool to answer research questions). Some criticize case study for its high level of flexibility, perceiving it as less rigorous, and maintain that it generates inadequate results. 8 Others have noted issues with quality and consistency in how case studies are conducted and reported. 9 Reporting is often varied and inconsistent, using a mix of approaches such as case reports, case findings, and/or case study. Authors sometimes use incongruent methods of data collection and analysis or use the case study as a default when other methodologies do not fit. 9 , 10 Despite these criticisms, case study methodology is becoming more common as a viable approach for HSR. 11 An abundance of articles and textbooks are available to guide researchers through case study research, including field-specific resources for business, 12 , 13 nursing, 14 and family medicine. 15 However, there remains confusion and a lack of clarity on the key tenets of case study methodology.

Several common philosophical underpinnings have contributed to the development of case study research 1 which has led to different approaches to planning, data collection, and analysis. This presents challenges in assessing quality and rigour for researchers conducting case studies and stakeholders reading results.

This article discusses the various approaches and philosophical underpinnings to case study methodology. Our goal is to explain it in a way that provides guidance for decision-makers, policy-makers, and health leaders on how to understand, critically appraise, and engage in case study research and design, as such guidance is largely absent in the literature. This article is by no means exhaustive or authoritative. Instead, we aim to provide guidance and encourage dialogue around case study methodology, facilitating critical thinking around the variety of approaches and ways quality and rigour can be bolstered for its use within HSR.

Purpose of case study methodology

Case study methodology is often used to develop an in-depth, holistic understanding of a specific phenomenon within a specified context. 11 It focuses on studying one or multiple cases over time and uses an in-depth analysis of multiple information sources. 16 , 17 It is ideal for situations including, but not limited to, exploring under-researched and real-life phenomena, 18 especially when the contexts are complex and the researcher has little control over the phenomena. 19 , 20 Case studies can be useful when researchers want to understand how interventions are implemented in different contexts, and how context shapes the phenomenon of interest.

In addition to demonstrating coherency with the type of questions case study is suited to answer, there are four key tenets to case study methodologies: (1) be transparent in the paradigmatic and theoretical perspectives influencing study design; (2) clearly define the case and phenomenon of interest; (3) clearly define and justify the type of case study design; and (4) use multiple data collection sources and analysis methods to present the findings in ways that are consistent with the methodology and the study’s paradigmatic base. 9 , 16 The goal is to appropriately match the methods to empirical questions and issues and not to universally advocate any single approach for all problems. 21

Approaches to case study methodology

Three authors propose distinct foundational approaches to case study methodology positioned within different paradigms: Yin, 19 , 22 Stake, 5 , 23 and Merriam 24 , 25 ( Table 1 ). Yin is strongly post-positivist whereas Stake and Merriam are grounded in a constructivist paradigm. Researchers should locate their research within a paradigm that explains the philosophies guiding their research 26 and adhere to the underlying paradigmatic assumptions and key tenets of the appropriate author’s methodology. This will enhance the consistency and coherency of the methods and findings. However, researchers often do not report their paradigmatic position, nor do they adhere to one approach. 9 Although deliberately blending methodologies may be defensible and methodologically appropriate, more often it is done in an ad hoc and haphazard way, without consideration for limitations.

Cross-analysis of three case study approaches, adapted from Yazan 2015

The post-positive paradigm postulates there is one reality that can be objectively described and understood by “bracketing” oneself from the research to remove prejudice or bias. 27 Yin focuses on general explanation and prediction, emphasizing the formulation of propositions, akin to hypothesis testing. This approach is best suited for structured and objective data collection 9 , 11 and is often used for mixed-method studies.

Constructivism assumes that the phenomenon of interest is constructed and influenced by local contexts, including the interaction between researchers, individuals, and their environment. 27 It acknowledges multiple interpretations of reality 24 constructed within the context by the researcher and participants which are unlikely to be replicated, should either change. 5 , 20 Stake and Merriam’s constructivist approaches emphasize a story-like rendering of a problem and an iterative process of constructing the case study. 7 This stance values researcher reflexivity and transparency, 28 acknowledging how researchers’ experiences and disciplinary lenses influence their assumptions and beliefs about the nature of the phenomenon and development of the findings.

Defining a case

A key tenet of case study methodology often underemphasized in literature is the importance of defining the case and phenomenon. Researches should clearly describe the case with sufficient detail to allow readers to fully understand the setting and context and determine applicability. Trying to answer a question that is too broad often leads to an unclear definition of the case and phenomenon. 20 Cases should therefore be bound by time and place to ensure rigor and feasibility. 6

Yin 22 defines a case as “a contemporary phenomenon within its real-life context,” (p13) which may contain a single unit of analysis, including individuals, programs, corporations, or clinics 29 (holistic), or be broken into sub-units of analysis, such as projects, meetings, roles, or locations within the case (embedded). 30 Merriam 24 and Stake 5 similarly define a case as a single unit studied within a bounded system. Stake 5 , 23 suggests bounding cases by contexts and experiences where the phenomenon of interest can be a program, process, or experience. However, the line between the case and phenomenon can become muddy. For guidance, Stake 5 , 23 describes the case as the noun or entity and the phenomenon of interest as the verb, functioning, or activity of the case.

Designing the case study approach

Yin’s approach to a case study is rooted in a formal proposition or theory which guides the case and is used to test the outcome. 1 Stake 5 advocates for a flexible design and explicitly states that data collection and analysis may commence at any point. Merriam’s 24 approach blends both Yin and Stake’s, allowing the necessary flexibility in data collection and analysis to meet the needs.

Yin 30 proposed three types of case study approaches—descriptive, explanatory, and exploratory. Each can be designed around single or multiple cases, creating six basic case study methodologies. Descriptive studies provide a rich description of the phenomenon within its context, which can be helpful in developing theories. To test a theory or determine cause and effect relationships, researchers can use an explanatory design. An exploratory model is typically used in the pilot-test phase to develop propositions (eg, Sibbald et al. 31 used this approach to explore interprofessional network complexity). Despite having distinct characteristics, the boundaries between case study types are flexible with significant overlap. 30 Each has five key components: (1) research question; (2) proposition; (3) unit of analysis; (4) logical linking that connects the theory with proposition; and (5) criteria for analyzing findings.

Contrary to Yin, Stake 5 believes the research process cannot be planned in its entirety because research evolves as it is performed. Consequently, researchers can adjust the design of their methods even after data collection has begun. Stake 5 classifies case studies into three categories: intrinsic, instrumental, and collective/multiple. Intrinsic case studies focus on gaining a better understanding of the case. These are often undertaken when the researcher has an interest in a specific case. Instrumental case study is used when the case itself is not of the utmost importance, and the issue or phenomenon (ie, the research question) being explored becomes the focus instead (eg, Paciocco 32 used an instrumental case study to evaluate the implementation of a chronic disease management program). 5 Collective designs are rooted in an instrumental case study and include multiple cases to gain an in-depth understanding of the complexity and particularity of a phenomenon across diverse contexts. 5 , 23 In collective designs, studying similarities and differences between the cases allows the phenomenon to be understood more intimately (for examples of this in the field, see van Zelm et al. 33 and Burrows et al. 34 In addition, Sibbald et al. 35 present an example where a cross-case analysis method is used to compare instrumental cases).

Merriam’s approach is flexible (similar to Stake) as well as stepwise and linear (similar to Yin). She advocates for conducting a literature review before designing the study to better understand the theoretical underpinnings. 24 , 25 Unlike Stake or Yin, Merriam proposes a step-by-step guide for researchers to design a case study. These steps include performing a literature review, creating a theoretical framework, identifying the problem, creating and refining the research question(s), and selecting a study sample that fits the question(s). 24 , 25 , 36

Data collection and analysis

Using multiple data collection methods is a key characteristic of all case study methodology; it enhances the credibility of the findings by allowing different facets and views of the phenomenon to be explored. 23 Common methods include interviews, focus groups, observation, and document analysis. 5 , 37 By seeking patterns within and across data sources, a thick description of the case can be generated to support a greater understanding and interpretation of the whole phenomenon. 5 , 17 , 20 , 23 This technique is called triangulation and is used to explore cases with greater accuracy. 5 Although Stake 5 maintains case study is most often used in qualitative research, Yin 17 supports a mix of both quantitative and qualitative methods to triangulate data. This deliberate convergence of data sources (or mixed methods) allows researchers to find greater depth in their analysis and develop converging lines of inquiry. For example, case studies evaluating interventions commonly use qualitative interviews to describe the implementation process, barriers, and facilitators paired with a quantitative survey of comparative outcomes and effectiveness. 33 , 38 , 39

Yin 30 describes analysis as dependent on the chosen approach, whether it be (1) deductive and rely on theoretical propositions; (2) inductive and analyze data from the “ground up”; (3) organized to create a case description; or (4) used to examine plausible rival explanations. According to Yin’s 40 approach to descriptive case studies, carefully considering theory development is an important part of study design. “Theory” refers to field-relevant propositions, commonly agreed upon assumptions, or fully developed theories. 40 Stake 5 advocates for using the researcher’s intuition and impression to guide analysis through a categorical aggregation and direct interpretation. Merriam 24 uses six different methods to guide the “process of making meaning” (p178) : (1) ethnographic analysis; (2) narrative analysis; (3) phenomenological analysis; (4) constant comparative method; (5) content analysis; and (6) analytic induction.

Drawing upon a theoretical or conceptual framework to inform analysis improves the quality of case study and avoids the risk of description without meaning. 18 Using Stake’s 5 approach, researchers rely on protocols and previous knowledge to help make sense of new ideas; theory can guide the research and assist researchers in understanding how new information fits into existing knowledge.

Practical applications of case study research

Columbia University has recently demonstrated how case studies can help train future health leaders. 41 Case studies encompass components of systems thinking—considering connections and interactions between components of a system, alongside the implications and consequences of those relationships—to equip health leaders with tools to tackle global health issues. 41 Greenwood 42 evaluated Indigenous peoples’ relationship with the healthcare system in British Columbia and used a case study to challenge and educate health leaders across the country to enhance culturally sensitive health service environments.

An important but often omitted step in case study research is an assessment of quality and rigour. We recommend using a framework or set of criteria to assess the rigour of the qualitative research. Suitable resources include Caelli et al., 43 Houghten et al., 44 Ravenek and Rudman, 45 and Tracy. 46

New directions in case study

Although “pragmatic” case studies (ie, utilizing practical and applicable methods) have existed within psychotherapy for some time, 47 , 48 only recently has the applicability of pragmatism as an underlying paradigmatic perspective been considered in HSR. 49 This is marked by uptake of pragmatism in Randomized Control Trials, recognizing that “gold standard” testing conditions do not reflect the reality of clinical settings 50 , 51 nor do a handful of epistemologically guided methodologies suit every research inquiry.

Pragmatism positions the research question as the basis for methodological choices, rather than a theory or epistemology, allowing researchers to pursue the most practical approach to understanding a problem or discovering an actionable solution. 52 Mixed methods are commonly used to create a deeper understanding of the case through converging qualitative and quantitative data. 52 Pragmatic case study is suited to HSR because its flexibility throughout the research process accommodates complexity, ever-changing systems, and disruptions to research plans. 49 , 50 Much like case study, pragmatism has been criticized for its flexibility and use when other approaches are seemingly ill-fit. 53 , 54 Similarly, authors argue that this results from a lack of investigation and proper application rather than a reflection of validity, legitimizing the need for more exploration and conversation among researchers and practitioners. 55

Although occasionally misunderstood as a less rigourous research methodology, 8 case study research is highly flexible and allows for contextual nuances. 5 , 6 Its use is valuable when the researcher desires a thorough understanding of a phenomenon or case bound by context. 11 If needed, multiple similar cases can be studied simultaneously, or one case within another. 16 , 17 There are currently three main approaches to case study, 5 , 17 , 24 each with their own definitions of a case, ontological and epistemological paradigms, methodologies, and data collection and analysis procedures. 37

Individuals’ experiences within health systems are influenced heavily by contextual factors, participant experience, and intricate relationships between different organizations and actors. 55 Case study research is well suited for HSR because it can track and examine these complex relationships and systems as they evolve over time. 6 , 7 It is important that researchers and health leaders using this methodology understand its key tenets and how to conduct a proper case study. Although there are many examples of case study in action, they are often under-reported and, when reported, not rigorously conducted. 9 Thus, decision-makers and health leaders should use these examples with caution. The proper reporting of case studies is necessary to bolster their credibility in HSR literature and provide readers sufficient information to critically assess the methodology. We also call on health leaders who frequently use case studies 56 – 58 to report them in the primary research literature.

The purpose of this article is to advocate for the continued and advanced use of case study in HSR and to provide literature-based guidance for decision-makers, policy-makers, and health leaders on how to engage in, read, and interpret findings from case study research. As health systems progress and evolve, the application of case study research will continue to increase as researchers and health leaders aim to capture the inherent complexities, nuances, and contextual factors. 7

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Case report article, case report: iatrogenic tattoos caused by skin marking pen in a postoperative patient.

• 1 Department of Burn and Plastic Surgery, West China Hospital, Sichuan University, Chengdu, China
• 2 Department of Dermatology, West China Fourth Hospital, Sichuan University, Chengdu, China

In this report, a female patient suffering from pigment retention caused by a skin marking pen was elucidated. The patient underwent blepharoplasty 6 months ago and presented with blue-black linear marks at the upper eyelid incision 2 weeks after surgery. Under dermoscopy, scattered pigments were observed to accumulate in the epidermis of the upper eyelid. The patient was diagnosed with iatrogenic tattoo by a surgical marking pen. We chose surgical excision of the skin with the pigmentation. Previous studies have established that the risk of bacterial contamination, contact dermatitis, and allergies may increase with the surgical marking pens, while pigment retention has not yet been mentioned yet. Here, we present a case with a pigment retention in the incision. The selection of the surgical labelling methods and the management of the pigmentation were also addressed. According to our clinical findings, the risk of pigment retention by marking pens needs to be mentioned in the patient’s informed consent. Therefore, the practitioner should ensure that the ink is cleaned by the end of each invasive procedure.

Introduction

In dermatosurgery, oil-based surgical marking pens are involved in preoperative marking to define the surgical area. Optimally, the marker should withstand disinfectants and surgery wash without leaving a permanent stain on the skin. Increasing persistence and visibility, however, also increases the risk of colorant residue. Previous complications related to marking pens were mainly bacterial contamination, contact dermatitis, and allergies. No relevant literature has yet been reported on pigment residue. In our clinical practice, however, we have confirmed the possibility of oil-based markers leading to an iatrogenic tattoo at the time of surgery or injection.

Case presentation

A 47-year-old female patient presented to the outpatient clinic with blue-black linear marks on the upper eyelid ( Figure 1A ). She had a blepharoplasty surgery 6 months prior. Two weeks after surgery, she found a blue-black linear mark on the bilateral upper eyelid. Conservative treatment was taken to monitor the changes in the marks. One month later, part of the pigmentation had faded, leaving some scattered pigments in linear arrangements around the incision.

Figure 1 . (A) Photograph taken 6 months after surgery showed an inhomogeneous blue-black pigment in the double eyelid incision. (B) The evaluation with a dermoscopy showed the exogenous blue-black pigments in the skin. (C) Histology of the upper eyelid skin tattooed with blue-black ink (H&E stain, magnification 20×). (D) Pigment particles are presented in the basal layer of the squamous epithelium (arrows), visible at 40× magnification. (E) Highly refractive brown pigment granules (triangle arrows) and chromophages (asterism) could be seen scattered in the superficial dermis and the perivascular area, visible at 40× magnification.

On physical examination, the marks were approximately 7 mm from the supraciliary line hidden in the upper eyelid crease. The patient had no dermatitis over the pigment or keloid hyperplasia, hyperpigmentation, or depigmented changes in the surgical site involvement. On palpation, no foreign body was detected in the upper eyelid. Under dermoscopy, scattered pigments were observed to accumulate in the skin ( Figure 1B ).

The diagnosis of exogenous pigment residue was suspected, given her surgical history, physical examination, and dermatology examination. We speculated that the origin of the pigmentation was a surgical marker used in preoperative preparation. Our teams chose surgical removal of bilateral upper eyelid marks. The postoperative histological examination of the skin tissue confirmed that brown pigments accumulated in the squamous epithelium and the connective tissue ( Figure 1C ).

In preoperative preparation, marking pens are used to define the surgical field, design surgical incisions, mark landmarks, and others. Optimally, the markers should withstand disinfectants and surgical scrubbing without leaving a permanent stain on the skin. For visibility, the marker ink contains water-insoluble pigments that the body cannot degrade. Which means that increasing persistence and visibility also increases the risk of colorant residue.

Preoperative skin marking is an essential safety practice to prevent serious reportable events (SPE), as defined by the National Quality Forum (NQF) ( 1 ). However, unintended retention of a foreign object, including marking pen pigments in a patient after surgery or other invasive procedures, is also classified as an SRE. Previous studies have established that the risk of bacterial contamination, contact dermatitis, and allergies may increase with surgical marking pens ( 2 – 5 ). The terminology in the literature needs to be more consistent, and we refer to this complication as iatrogenic tattoo by marking pen.

The requirements for a skin marking pen are visibility and durability on the skin. Although oil-based pens are common, convenient, and inexpensive, the ink may contain carcinogenic substances such as crystal violet and xylene ( 6 ). Since conventional skin markers contain harmful substances, organic colorants have become increasingly used in skin marking. Studies on water-based ink have shown superior durability compared to the conventional oil-based pen ( 5 ). Moreover, Goto et al. ( 7 ) reported an organic-based marker using Inkbox ® (Inkbox, Toronto, Canada) with a duration of 16 days compared to 4 days for an oil-based pen. However, although the organic-based markers do not contain carcinogenic substances, some patients have experienced severe contact allergies or been provoked to granulomatous reactions ( 5 , 8 ). The labeling approach differs with respect to skin types and the purpose of the labeling. For areas with hair growth, marking pens are more suitable than stickers. Similarly, marking pens are more suitable for marking the surgical field and incisions. Therefore, a balance should be struck between safety and effectiveness when choosing a proper marker.

Our patient’s presentation was colorant retention in the epidermis layer of the upper eyelids. In such patients with a sense of cosmetic issues, removing colorants needs to be addressed. The techniques listed in the published work include dermabrasion, cryotherapy, laser, and surgical excision ( 3 ). Dermabrasion and cryotherapy completely remove the epidermis to induce re-epithelialization, which is technique-dependent and time-consuming, with potential complications, including pigment changes, hypertrophic scarring, and infection. The introduction of newer therapies, such as lasers, allowed for precise determination of percent surface area and clinical recovery time and efficacy, providing more significant clinical outcomes. However, such procedures can hardly achieve removal effectiveness with a single treatment. Moreover, the safety of using lasers in the periorbital area is yet to be discussed. As aesthetics is the primary endpoint, surgical excision seems to be the preferable option for this patient.

In conclusion, according to this case report the marking pen may lead to iatrogenic tattoos. Physicians should inform patients of the risk of pigment residue before invasive procedures and avoid any pigment retention by the end of the procedure.

Data availability statement

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Ethics statement

The studies involving human participant was reviewed and approved by the Medical Ethics Committee of West China Hospital of Sichuan University. All procedures performed in this study involving the human participant were in accordance with the 1964 Helsinki declaration. Written informed consent to participate in this study was provided by the participant. Written informed consent was obtained from the participant for the publication of any potentially identifiable images or data included in this article.

Author contributions

HZ: Visualization, Writing – original draft, Writing – review & editing. XW: Conceptualization, Writing – original draft, Writing – review & editing. YY: Data curation, Writing – original draft, Writing – review & editing. CC: Supervision, Validation, Writing – original draft, Writing – review & editing.

The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

1. Namburi, N, and Lee, LS. National Quality Forum In: StatPearls . Treasure Island, FL: StatPearls Publishing (2023).

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4. Huff, ML, Jacobs, AM, Huang, E, and Miles, MG. Surgical marking pen contamination: writing a postoperative infection into your preoperative plan. Cureus . (2023) 15:e40007. doi: 10.7759/cureus.40007

5. Nakayama, S, Hirose, M, Kaneshige, S, Nakamura, K, Matsuo, Y, and Monzen, H. Development and evaluation of a novel water-based pigment marker for radiation therapy skin marking. Radiol Phys Technol . (2023) 16:543–51. doi: 10.1007/s12194-023-00743-0

6. Canada, H Important safety information. Available at: https://recalls-rappels.canada.ca/en/alert-recall/health-canada-warns-canadians-potential-cancer-risk-associated-gentian-violet . (Accessed June 12, 2019).

7. Goto, M, Oshiro, Y, Tamaki, Y, Ishida, T, Kato, Y, Shinoda, K, et al. A novel method for skin marking in radiotherapy: first clinical use of temporary organic tattoo seal. J Radiat Res . (2022) 63:314–8. doi: 10.1093/jrr/rrab126

8. Bircher, AJ, Sigg, R, Scherer Hofmeier, K, Schlegel, U, and Hauri, U. Allergic contact dermatitis caused by a new temporary blue-black tattoo dye—sensitization to genipin from jagua ( Genipa americana L.) fruit extract. Contact Derm . (2017) 77:374–8. doi: 10.1111/cod.12844

Keywords: surgical complication, pigmentation and colour, dermatosurgery, tattoo, iatrogenic accident

Citation: Zhao H, Wu X, Yu Y and Cao C (2024) Case report: Iatrogenic tattoos caused by skin marking pen in a postoperative patient. Front. Med . 11:1387773. doi: 10.3389/fmed.2024.1387773

Received: 18 February 2024; Accepted: 25 March 2024; Published: 11 April 2024.

Reviewed by:

Copyright © 2024 Zhao, Wu, Yu and Cao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Chang Cao, [email protected]

† These authors have contributed equally to this work and share first authorship

‡ Guarantor of the clinical content of this submission

Nevada Today

Researchers develop innovative method of teaching self-help skills to preschoolers who are deafblind, study demonstrate the effectiveness of system of least prompts (slp) as part of an intervention.

MaryAnn Demchak, Ph.D., BCBA-D, supporting Jill Grattan, Ph.D., as she successfully defended her dissertation for her doctoral degree.

A groundbreaking approach to teaching essential self-help skills to preschoolers who are deafblind has been developed by researchers. Led by MaryAnn Demchak, Ph.D., BCBA-D. , professor of special education at the University of Nevada, Reno, and Jill Grattan, Ph.D. this innovative method employs the System of Least Prompts (SLP) .

“Very little research occurs with students who have severe, multiple disabilities that include deafblindness,” Demchak said. “This study extends prior research to this population and provides teachers and other practitioners with effective educational strategies.”

In their study, the researchers focused on teaching three crucial self-help skills – hand washing, hand drying and entry routines – to preschoolers aged 3 to 5 with vision and hearing impairments, along with multiple disabilities. Remarkably, 75% of the participants showed increased independence in mastering these targeted skills.

Self-help skills play a pivotal role in daily life, impacting health and shaping social acceptance. However, until now, research in this area for deafblind preschoolers with multiple disabilities has been limited.

The findings of this study demonstrate the effectiveness of SLP as part of an intervention package in teaching self-help skills to young children with multiple disabilities, including deafblindness. Although the mastery criterion wasn't universally achieved, the significant increase in independence among 75% of the participants is noteworthy.

“Interacting with the students and seeing their progress as a result of systematic teaching using SLP was very rewarding,” Grattan said.

Preschoolers with multiple disabilities, including deafblindness, often require extensive support in their daily activities. Therefore, any progress toward independence, even with some level of support or modification, is significant. Educators working with this population can now rely on evidence from this study to inform their teaching strategies, particularly emphasizing the effectiveness of SLP.

Jill Grattan, who earned her doctoral degree in Education: Special Education and Disability Studies from the University of Nevada, Reno, has collaborated with Demchak on various research studies focusing on individuals with disabilities.

“It is a privilege to collaborate with current and former doctoral students to make contributions to the field of severe, multiple disabilities, including the area of deafblindness,” Demchak said.

This study offers valuable insights, demonstrating that self-help skills can be effectively taught to deafblind preschoolers. This not only promises to foster healthy habits and well-being but also lays the foundation for future independence, ultimately enhancing the quality of life for both the children and their caregivers.

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