case study method can be used for

• Privacy Policy

Buy Me a Coffee

Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

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

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

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

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

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

Multiple-Case Study

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

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

Exploratory Case Study

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

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

Descriptive Case Study

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

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

Instrumental Case Study

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

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

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

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

Observations

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

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

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

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

How to conduct Case Study Research

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

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

Examples of Case Study

Here are some examples of case study research:

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

Application of Case Study

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

Business and Management

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

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

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

Social Sciences

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

Law and Ethics

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

Purpose of Case Study

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

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

Case studies can also serve other purposes, including:

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

Advantages of Case Study Research

There are several advantages of case study research, including:

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

Limitations of Case Study Research

There are several limitations of case study research, including:

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

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

You may also like

Questionnaire – Definition, Types, and Examples

Observational Research – Methods and Guide

Quantitative Research – Methods, Types and...

Qualitative Research Methods

Explanatory Research – Types, Methods, Guide

Survey Research – Types, Methods, Examples

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base

Methodology

• 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.

Receive feedback on language, structure, and formatting

Professional editors proofread and edit your paper by focusing on:

• Academic style
• Vague sentences
• Style consistency

See an example

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Research bias

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

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 Citation Generator.

McCombes, S. (2023, November 20). What Is a Case Study? | Definition, Examples & Methods. Scribbr. Retrieved April 2, 2024, from https://www.scribbr.com/methodology/case-study/

Is this article helpful?

Shona McCombes

Other students also liked, primary vs. secondary sources | difference & examples, what is a theoretical framework | guide to organizing, what is action research | definition & examples, unlimited academic ai-proofreading.

✔ Document error-free in 5minutes ✔ Unlimited document corrections ✔ Specialized in correcting academic texts

• Open access
• Published: 27 June 2011

The case study approach

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

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

762k Accesses

1026 Citations

37 Altmetric

Metrics details

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.

Peer Review reports

Introduction

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

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

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables 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.

Yin RK: Case study research, design and method. 2009, London: Sage Publications Ltd., 4

Google Scholar  

Keen J, Packwood T: Qualitative research; case study evaluation. BMJ. 1995, 311: 444-446.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Sheikh A, Halani L, Bhopal R, Netuveli G, Partridge M, Car J, et al: Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma. PLoS Med. 2009, 6 (10): 1-11.

Article   Google Scholar  

Pinnock H, Huby G, Powell A, Kielmann T, Price D, Williams S, et al: The process of planning, development and implementation of a General Practitioner with a Special Interest service in Primary Care Organisations in England and Wales: a comparative prospective case study. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R&D (NCCSDO). 2008, [ http://www.sdo.nihr.ac.uk/files/project/99-final-report.pdf ]

Robertson A, Cresswell K, Takian A, Petrakaki D, Crowe S, Cornford T, et al: Prospective evaluation of the implementation and adoption of NHS Connecting for Health's national electronic health record in secondary care in England: interim findings. BMJ. 2010, 41: c4564-

Pearson P, Steven A, Howe A, Sheikh A, Ashcroft D, Smith P, the Patient Safety Education Study Group: Learning about patient safety: organisational context and culture in the education of healthcare professionals. J Health Serv Res Policy. 2010, 15: 4-10. 10.1258/jhsrp.2009.009052.

Article   PubMed   Google Scholar  

van Harten WH, Casparie TF, Fisscher OA: The evaluation of the introduction of a quality management system: a process-oriented case study in a large rehabilitation hospital. Health Policy. 2002, 60 (1): 17-37. 10.1016/S0168-8510(01)00187-7.

Stake RE: The art of case study research. 1995, London: Sage Publications Ltd.

Sheikh A, Smeeth L, Ashcroft R: Randomised controlled trials in primary care: scope and application. Br J Gen Pract. 2002, 52 (482): 746-51.

PubMed   PubMed Central   Google Scholar  

King G, Keohane R, Verba S: Designing Social Inquiry. 1996, Princeton: Princeton University Press

Doolin B: Information technology as disciplinary technology: being critical in interpretative research on information systems. Journal of Information Technology. 1998, 13: 301-311. 10.1057/jit.1998.8.

George AL, Bennett A: Case studies and theory development in the social sciences. 2005, Cambridge, MA: MIT Press

Eccles M, the Improved Clinical Effectiveness through Behavioural Research Group (ICEBeRG): Designing theoretically-informed implementation interventions. Implementation Science. 2006, 1: 1-8. 10.1186/1748-5908-1-1.

Article   PubMed Central   Google Scholar  

Netuveli G, Hurwitz B, Levy M, Fletcher M, Barnes G, Durham SR, Sheikh A: Ethnic variations in UK asthma frequency, morbidity, and health-service use: a systematic review and meta-analysis. Lancet. 2005, 365 (9456): 312-7.

Sheikh A, Panesar SS, Lasserson T, Netuveli G: Recruitment of ethnic minorities to asthma studies. Thorax. 2004, 59 (7): 634-

CAS   PubMed   PubMed Central   Google Scholar  

Hellström I, Nolan M, Lundh U: 'We do things together': A case study of 'couplehood' in dementia. Dementia. 2005, 4: 7-22. 10.1177/1471301205049188.

Som CV: Nothing seems to have changed, nothing seems to be changing and perhaps nothing will change in the NHS: doctors' response to clinical governance. International Journal of Public Sector Management. 2005, 18: 463-477. 10.1108/09513550510608903.

Lincoln Y, Guba E: Naturalistic inquiry. 1985, Newbury Park: Sage Publications

Barbour RS: Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?. BMJ. 2001, 322: 1115-1117. 10.1136/bmj.322.7294.1115.

Mays N, Pope C: Qualitative research in health care: Assessing quality in qualitative research. BMJ. 2000, 320: 50-52. 10.1136/bmj.320.7226.50.

Mason J: Qualitative researching. 2002, London: Sage

Brazier A, Cooke K, Moravan V: Using Mixed Methods for Evaluating an Integrative Approach to Cancer Care: A Case Study. Integr Cancer Ther. 2008, 7: 5-17. 10.1177/1534735407313395.

Miles MB, Huberman M: Qualitative data analysis: an expanded sourcebook. 1994, CA: Sage Publications Inc., 2

Pope C, Ziebland S, Mays N: Analysing qualitative data. Qualitative research in health care. BMJ. 2000, 320: 114-116. 10.1136/bmj.320.7227.114.

Cresswell KM, Worth A, Sheikh A: Actor-Network Theory and its role in understanding the implementation of information technology developments in healthcare. BMC Med Inform Decis Mak. 2010, 10 (1): 67-10.1186/1472-6947-10-67.

Article   PubMed   PubMed Central   Google Scholar  

Malterud K: Qualitative research: standards, challenges, and guidelines. Lancet. 2001, 358: 483-488. 10.1016/S0140-6736(01)05627-6.

Article   CAS   PubMed   Google Scholar  

Yin R: Case study research: design and methods. 1994, Thousand Oaks, CA: Sage Publishing, 2

Yin R: Enhancing the quality of case studies in health services research. Health Serv Res. 1999, 34: 1209-1224.

Green J, Thorogood N: Qualitative methods for health research. 2009, Los Angeles: Sage, 2

Howcroft D, Trauth E: Handbook of Critical Information Systems Research, Theory and Application. 2005, Cheltenham, UK: Northampton, MA, USA: Edward Elgar

Book   Google Scholar  

Blakie N: Approaches to Social Enquiry. 1993, Cambridge: Polity Press

Doolin B: Power and resistance in the implementation of a medical management information system. Info Systems J. 2004, 14: 343-362. 10.1111/j.1365-2575.2004.00176.x.

Bloomfield BP, Best A: Management consultants: systems development, power and the translation of problems. Sociological Review. 1992, 40: 533-560.

Shanks G, Parr A: Positivist, single case study research in information systems: A critical analysis. Proceedings of the European Conference on Information Systems. 2003, Naples

Pre-publication history

The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2288/11/100/prepub

Download references

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.

Author information

Authors and affiliations.

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

Sarah Crowe & Anthony Avery

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

Kathrin Cresswell, Ann Robertson & Aziz Sheikh

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

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Sarah Crowe .

Additional information

Competing interests.

The authors declare that they have no competing interests.

Authors' contributions

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

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and permissions

About this article

Cite this article.

Crowe, S., Cresswell, K., Robertson, A. et al. The case study approach. BMC Med Res Methodol 11 , 100 (2011). https://doi.org/10.1186/1471-2288-11-100

Download citation

Received : 29 November 2010

Accepted : 27 June 2011

Published : 27 June 2011

DOI : https://doi.org/10.1186/1471-2288-11-100

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Case Study Approach
• Electronic Health Record System
• Case Study Design
• Case Study Site
• Case Study Report

BMC Medical Research Methodology

ISSN: 1471-2288

• General enquiries: [email protected]

Case Study Research: Methods and Designs

Case study research is a type of qualitative research design. It’s often used in the social sciences because it involves…

Case study research is a type of qualitative research design. It’s often used in the social sciences because it involves observing subjects, or cases, in their natural setting, with minimal interference from the researcher.

In the case study method , researchers pose a specific question about an individual or group to test their theories or hypothesis. This can be done by gathering data from interviews with key informants.

Here’s what you need to know about case study research design .

What Is The Case Study Method?

Main approaches to data collection, case study research methods, how case studies are used, case study model.

Case study research is a great way to understand the nuances of a matter that can get lost in quantitative research methods. A case study is distinct from other qualitative studies in the following ways:

• It’s interested in the effect of a set of circumstances on an individual or group.
• It begins with a specific question about one or more cases.
• It focuses on individual accounts and experiences.

Here are the primary features of case study research:

• Case study research methods typically involve the researcher asking a few questions of one person or a small number of people—known as respondents—to test one hypothesis.
• Case study in research methodology may apply triangulation to collect data, in which the researcher uses several sources, including documents and field data. This is then analyzed and interpreted to form a hypothesis that can be tested through further research or validated by other researchers.
• The case study method requires clear concepts and theories to guide its methods. A well-defined research question is crucial when conducting a case study because the results of the study depend on it. The best approach to answering a research question is to challenge the existing theories, hypotheses or assumptions.
• Concepts are defined using objective language with no reference to preconceived notions that individuals might have about them. The researcher sets out to discover by asking specific questions on how people think or perceive things in their given situation.

They commonly use the case study method in business, management, psychology, sociology, political science and other related fields.

A fundamental requirement of qualitative research is recording observations that provide an understanding of reality. When it comes to the case study method, there are two major approaches that can be used to collect data: document review and fieldwork.

A case study in research methodology also includes literature review, the process by which the researcher collects all data available through historical documents. These might include books, newspapers, journals, videos, photographs and other written material. The researcher may also record information using video cameras to capture events as they occur. The researcher can also go through materials produced by people involved in the case study to gain an insight into their lives and experiences.

Field research involves participating in interviews and observations directly. Observation can be done during telephone interviews, events or public meetings, visits to homes or workplaces, or by shadowing someone for a period of time. The researcher can conduct one-on-one interviews with individuals or group interviews where several people are interviewed at once.

Let’s look now at case study methodology.

The case study method can be divided into three stages: formulation of objectives; collection of data; and analysis and interpretation. The researcher first makes a judgment about what should be studied based on their knowledge. Next, they gather data through observations and interviews. Here are some of the common case study research methods:

One of the most basic methods is the survey. Respondents are asked to complete a questionnaire with open-ended and predetermined questions. It usually takes place through face-to-face interviews, mailed questionnaires or telephone interviews. It can even be done by an online survey.

2. Semi-structured Interview

For case study research a more complex method is the semi-structured interview. This involves the researcher learning about the topic by listening to what others have to say. This usually occurs through one-on-one interviews with the sample. Semi-structured interviews allow for greater flexibility and can obtain information that structured questionnaires can’t.

3. Focus Group Interview

Another method is the focus group interview, where the researcher asks a few people to take part in an open-ended discussion on certain themes or topics. The typical group size is 5–15 people. This method allows researchers to delve deeper into people’s opinions, views and experiences.

4. Participant Observation

Participant observation is another method that involves the researcher gaining insight into an experience by joining in and taking part in normal events. The people involved don’t always know they’re being studied, but the researcher observes and records what happens through field notes.

Case study research design can use one or several of these methods depending on the context.

Case studies are widely used in the social sciences. To understand the impact of socio-economic forces, interpersonal dynamics and other human conditions, sometimes there’s no other way than to study one case at a time and look for patterns and data afterward.

It’s for the same reasons that case studies are used in business. Here are a few uses:

• Case studies can be used as tools to educate and give examples of situations and problems that might occur and how they were resolved. They can also be used for strategy development and implementation.
• Case studies can evaluate the success of a program or project. They can help teams improve their collaboration by identifying areas that need improvements, such as team dynamics, communication, roles and responsibilities and leadership styles.
• Case studies can explore how people’s experiences affect the working environment. Because the study involves observing and analyzing concrete details of life, they can inform theories on how an individual or group interacts with their environment.
• Case studies can evaluate the sustainability of businesses. They’re useful for social, environmental and economic impact studies because they look at all aspects of a business or organization. This gives researchers a holistic view of the dynamics within an organization.
• We can use case studies to identify problems in organizations or businesses. They can help spot problems that are invisible to customers, investors, managers and employees.
• Case studies are used in education to show students how real-world issues or events can be sorted out. This enables students to identify and deal with similar situations in their lives.

And that’s not all. Case studies are incredibly versatile, which is why they’re used so widely.

Human beings are complex and they interact with each other in their everyday life in various ways. The researcher observes a case and tries to find out how the patterns of behavior are created, including their causal relations. Case studies help understand one or more specific events that have been observed. Here are some common methods:

1. Illustrative case study

This is where the researcher observes a group of people doing something. Studying an event or phenomenon this way can show cause-and-effect relationships between various variables.

2. Cumulative case study

A cumulative case study is one that involves observing the same set of phenomena over a period. Cumulative case studies can be very helpful in understanding processes, which are things that happen over time. For example, if there are behavioral changes in people who move from one place to another, the researcher might want to know why these changes occurred.

3. Exploratory case study

An exploratory case study collects information that will answer a question. It can help researchers better understand social, economic, political or other social phenomena.

There are several other ways to categorize case studies. They may be chronological case studies, where a researcher observes events over time. In the comparative case study, the researcher compares one or more groups of people, places, or things to draw conclusions about them. In an intervention case study, the researcher intervenes to change the behavior of the subjects. The study method depends on the needs of the research team.

Deciding how to analyze the information at our disposal is an important part of effective management. An understanding of the case study model can help. With Harappa’s Thinking Critically course, managers and young professionals receive input and training on how to level up their analytic skills. Knowledge of frameworks, reading real-life examples and lived wisdom of faculty come together to create a dynamic and exciting course that helps teams leap to the next level.

Explore Harappa Diaries to learn more about topics such as Objectives Of Research , What are Qualitative Research Methods , How To Make A Problem Statement and How To Improve your Cognitive Skills to upgrade your knowledge and skills.

Organizing Your Social Sciences Research Assignments

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

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

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

How to Approach Writing a Case Study Research Paper

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

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

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

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

Structure and Writing Style

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

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

I.  Introduction

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

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

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

II.  Literature Review

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

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

III.  Method

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

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

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

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

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

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

IV.  Discussion

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

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

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

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

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

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

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

V.  Conclusion

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

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

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

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

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

Problems to Avoid

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

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

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

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

Writing Tip

At Least Five Misconceptions about Case Study Research

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

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

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

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

• << Previous: Writing a Case Analysis Paper
• Next: Writing a Field Report >>
• Last Updated: Mar 6, 2024 1:00 PM
• URL: https://libguides.usc.edu/writingguide/assignments

Research Writing and Analysis

• NVivo Group and Study Sessions
• SPSS This link opens in a new window
• Statistical Analysis Group sessions
• Using Qualtrics
• Dissertation and Data Analysis Group Sessions
• Research Process Flow Chart
• Research Alignment This link opens in a new window
• Step 1: Seek Out Evidence
• Step 2: Explain
• Step 3: The Big Picture
• Step 4: Own It
• Step 5: Illustrate
• Annotated Bibliography
• Literature Review This link opens in a new window
• Systematic Reviews & Meta-Analyses
• How to Synthesize and Analyze
• Synthesis and Analysis Practice
• Synthesis and Analysis Group Sessions
• Problem Statement
• Purpose Statement
• Quantitative Research Questions
• Qualitative Research Questions
• Trustworthiness of Qualitative Data
• Analysis and Coding Example- Qualitative Data
• Thematic Data Analysis in Qualitative Design
• Dissertation to Journal Article This link opens in a new window
• International Journal of Online Graduate Education (IJOGE) This link opens in a new window
• Journal of Research in Innovative Teaching & Learning (JRIT&L) This link opens in a new window

Writing a Case Study

What is a case study?

A Case study is: 

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

What are the different types of case studies?

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

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

Who are your case study participants?

What is triangulation ? 

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

How to write a Case Study?

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

Was this resource helpful?

• << Previous: Thematic Data Analysis in Qualitative Design
• Next: Journal Article Reporting Standards (JARS) >>
• Last Updated: Apr 1, 2024 6:03 PM
• URL: https://resources.nu.edu/researchtools

• SUGGESTED TOPICS
• The Magazine
• Newsletters
• Managing Yourself
• Managing Teams
• Work-life Balance
• The Big Idea
• Data & Visuals
• Reading Lists
• Case Selections
• HBR Learning
• Topic Feeds
• Account Settings
• Email Preferences

What the Case Study Method Really Teaches

• Nitin Nohria

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

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

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

• Nitin Nohria is the George F. Baker Jr. Professor at Harvard Business School and the former dean of HBS.

Partner Center

What is the Case Study Method?

Overview Dropdown up

Overview dropdown down, celebrating 100 years of the case method at hbs.

The 2021-2022 academic year marks the 100-year anniversary of the introduction of the case method at Harvard Business School. Today, the HBS case method is employed in the HBS MBA program, in Executive Education programs, and in dozens of other business schools around the world. As Dean Srikant Datar's says, the case method has withstood the test of time.

Case Discussion Preparation Details Expand All Collapse All

In self-reflection in self-reflection dropdown down, in a small group setting in a small group setting dropdown down, in the classroom in the classroom dropdown down, beyond the classroom beyond the classroom dropdown down, how the case method creates value dropdown up, how the case method creates value dropdown down, in self-reflection, in a small group setting, in the classroom, beyond the classroom.

How Cases Unfold In the Classroom

How cases unfold in the classroom dropdown up, how cases unfold in the classroom dropdown down, preparation guidelines expand all collapse all, read the professor's assignment or discussion questions read the professor's assignment or discussion questions dropdown down, read the first few paragraphs and then skim the case read the first few paragraphs and then skim the case dropdown down, reread the case, underline text, and make margin notes reread the case, underline text, and make margin notes dropdown down, note the key problems on a pad of paper and go through the case again note the key problems on a pad of paper and go through the case again dropdown down, how to prepare for case discussions dropdown up, how to prepare for case discussions dropdown down, read the professor's assignment or discussion questions, read the first few paragraphs and then skim the case, reread the case, underline text, and make margin notes, note the key problems on a pad of paper and go through the case again, case study best practices expand all collapse all, prepare prepare dropdown down, discuss discuss dropdown down, participate participate dropdown down, relate relate dropdown down, apply apply dropdown down, note note dropdown down, understand understand dropdown down, case study best practices dropdown up, case study best practices dropdown down, participate, what can i expect on the first day dropdown down.

Most programs begin with registration, followed by an opening session and a dinner. If your travel plans necessitate late arrival, please be sure to notify us so that alternate registration arrangements can be made for you. Please note the following about registration:

HBS campus programs – Registration takes place in the Chao Center.

India programs – Registration takes place outside the classroom.

Other off-campus programs – Registration takes place in the designated facility.

What happens in class if nobody talks? Dropdown down

Professors are here to push everyone to learn, but not to embarrass anyone. If the class is quiet, they'll often ask a participant with experience in the industry in which the case is set to speak first. This is done well in advance so that person can come to class prepared to share. Trust the process. The more open you are, the more willing you’ll be to engage, and the more alive the classroom will become.

Does everyone take part in "role-playing"? Dropdown down

Professors often encourage participants to take opposing sides and then debate the issues, often taking the perspective of the case protagonists or key decision makers in the case.

View Frequently Asked Questions

Subscribe to Our Emails

• Bipolar Disorder
• Therapy Center
• When To See a Therapist
• Types of Therapy
• Best Online Therapy
• Best Couples Therapy
• Best Family Therapy
• Managing Stress
• Sleep and Dreaming
• Understanding Emotions
• Self-Improvement
• Healthy Relationships
• Student Resources
• Personality Types
• Guided Meditations
• Verywell Mind Insights
• 2023 Verywell Mind 25
• Mental Health in the Classroom
• Editorial Process
• Meet Our Review Board
• Crisis Support

What Is a Case Study?

Weighing the pros and cons of this method of research

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

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

• Pros and Cons

What Types of Case Studies Are Out There?

Where do you find data for a case study, how do i write a psychology case study.

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

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

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, we got you—here are some rules of APA format to reference.  

At a Glance

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

What Are the Benefits and Limitations of Case Studies?

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

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

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

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

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

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

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

Case Study Examples

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

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

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

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

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

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

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

The type of case study that psychology researchers use depends on the unique characteristics of the situation and the case itself.

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

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

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

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

Section 1: A Case History

This section will have the following structure and content:

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

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

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

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

Section 2: Treatment Plan

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

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

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

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

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

Need More Tips?

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

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

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

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

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

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

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

Human-generated content, empowered by AI.

FREE eBook: Establish Authorship & Build Authority Online

When and How to Use a Case Study for Research

May 17, 2021 (Updated: May 4, 2023)

Quick Navigation

What Is Case Study Research?

Types of case studies, when should you use a case study, case study benefits, case study limitations, how to write a case study.

Imagine your company receives a string of negative reviews online. You notice a few common themes among the complaints, but you still aren’t quite sure what went wrong. Or suppose an old blog post suddenly went viral, and you’d like to know why and how to do it again. In both of these situations, a case study could be the best way to find answers.

A case study is a process whereby researchers examine a specific subject in a thorough, detailed way. The subject of a case study could be an individual, a group, a community, a business, an organization, an event, or a phenomenon. Regardless of the type of subject, case studies are in-depth investigations designed to identify patterns and cause-and-effect relationships. Case studies are often used by researchers in the field of psychology , medicine, business, social work, anthropology, education, or political science.

Because they are singular in their focus and often rely on qualitative data, case studies tend to be highly subjective. The results of a single case study cannot always be generalized and applied to the larger population. However, case studies can be valuable tools for developing a thesis or illustrating a principle. They can help researchers understand, describe, compare, and evaluate different aspects of an issue or question.

Image via Flickr by plings

Case studies can be classified according to their purpose or their subject. For instance, a case study can focus on any of the following:

• A person:  Some case studies focus on one particular person. Often, the subject will be an individual with some rare characteristic or experience.
• A group:  Group case studies could look at a family, a group of coworkers, or a friend group. It could be people thrown together by circumstance or who share some bond or relationship. A group case study could even focus on an entire community of people.
• An organization:  An organizational case study could focus on a business, a nonprofit, an institution, or any other formal entity. The study could look at the people in the organization, the processes they use, or an incident at the organization.
• A location:  An event case study focuses on a specific area. It could be used to study environmental and population changes or to examine how people use the location.
• An event:  Event case studies can be used to cover anything from a natural disaster to a political scandal. Often, these case studies are conducted retrospectively, as an investigation into a past event.

In addition to different types of subjects, case studies often have different designs or purposes. Here are a few of the most common types of case studies:

• Explanatory:  An explanatory case study tries to explain the why or how behind something. This type of case study works well when studying an event or phenomenon, like an airplane crash or unexpected power outage.
• Descriptive:  A descriptive, or illustrative, case study is designed to shed light on an unfamiliar subject. Case studies like this provide in-depth, real-world examples of whatever the researcher wants to help the audience understand. For instance, a descriptive case study could focus on the experience of a mother with postpartum depression or on a young adult who has aged out of the foster care system.
• Exploratory:  An exploratory case study, or pilot case study, often serves as the first step in a larger research project. Researchers may use a case study to help them narrow their focus, draft a specific research question, and guide the parameters of a formal, large-scale study.
• Intrinsic:  An intrinsic case study has no goal beyond a deeper understanding of its subject. In this type of study, researchers are not trying to make generalized conclusions, challenge existing assumptions, or make any compare-and-contrast connections. The most interesting thing about the study is the subject itself.
• Critical Instance:  A critical instance case study is similar to an explanatory or intrinsic study. Like an intrinsic study, it may have no predetermined purpose beyond investigating the subject. Like an explanatory study, it may be used to explain a cause-and-effect relationship. A critical instance case study may also be used to call into question a commonly held assumption or popular theory.
• Instrumental:  An instrumental case study is the opposite of an intrinsic study because it serves a purpose beyond understanding the immediate subject. In this type of study, researchers explore a larger question through an individual case or cases. For instance, researchers could use a handful of case studies to investigate the relationship between social media use and happiness.
• Cumulative:  A cumulative, or collective, case study uses information from several past studies as the basis for a new study. Because it takes into account multiple case studies, a cumulative study allows for greater generalization than a single case study. It can also be a more time- and cost-effective option since it makes use of existing research.

Case studies are often used in the exploratory phase of research to gather qualitative data. They can also be used to create, support, or refute a hypothesis and guide future research. For instance, a marketing professional might conduct a case study to discover why a viral ad campaign was so successful . They can then take any lessons they glean from the case study and apply them to future marketing efforts. A psychologist could use a case study to form a theory about the best way to treat a specific disorder. That theory could then be tested later through a large-scale controlled study.

Case studies are a good way to explore a real-world topic in-depth, illustrate a point, discuss the implications or meaning of an event, or compare the experiences of different individuals. A trainer may use a case study to bring to life what would otherwise be an abstract series of recommended action steps or to spark a conversation about how to respond in a specific scenario. Similarly, professors can use case studies to highlight key concepts from a lecture and pose questions to test students’ understanding of the material.

In some situations, case studies are the only way to compile quantitative data in an ethical manner. For instance, many of the recommendations that doctors make regarding what is or is not safe during pregnancy are based on case studies. It wouldn’t be ethical to conduct a controlled study that exposes pregnant women to potentially harmful substances, so doctors rely on the anecdotal evidence provided by case studies to find correlations and draw their conclusions.

Case studies can also be used to gather data that would be otherwise impossible or impractical to obtain. Students often use case studies for their thesis or dissertation when they lack the time or resources to conduct large-scale research. Zoologists might use existing case studies to determine the success rate of reintroducing rehabilitated animals into the wild. A historian could use case studies to explore the strategies used by dictators to gain and maintain power.

Image via Flickr by calebmmartin

Case studies can be used on their own or as a complement to other research methods, depending on the situation. The examples above are just a few instances where case studies can be useful. Case studies also work well for the following:

Providing Insight Through Qualitative Data

Case studies generally provide more qualitative data as opposed to quantitative data , and that makes them an invaluable tool for gathering insight into complex topics. Psychologists, for instance, use case studies to better understand human behavior. Crafting theories on the motives behind human actions would be difficult with quantitative data alone. The information gleaned through case studies may be subjective, but so is much of what makes us human. As individuals, we each have a unique blend of emotions, attitudes, opinions, motivations, and behaviors. Objective quantitative data is rarely the best way to identify and explain these nuances.

By their very nature, case studies allow more more intensive, in-depth study than other research methods. Rather than aiming for a large sample size, case studies follow a single subject. Often case studies are conducted over a longer period of time, and the narrow focus allows researchers to gather more detail than would be possible in a study of thousands of people. The information gleaned may not be representative of the broader population, but it does provide richer insight into the subject than other research methods.

Identifying Avenues for Future Research

Case studies are often used as the first step in a larger research project. The results of a case study cannot necessarily be generalized, but they can help researchers narrow their focus. For instance, researchers in the medical field might conduct a case study on a patient who survived an injury that typically proves fatal.

Over the course of the study, researchers may identify two or three ways in which this patient’s situation differed from others they have seen. Perhaps they identify something unique in the patient’s DNA or lifestyle choices or in the steps doctors took to treat the injury. Letting that information guide them, researchers could use other methods to deepen their understanding of those factors and perhaps develop new treatments or preventative recommendations.

Case studies can also be used in the fields of social work, politics, and anthropology to draw attention to a widespread problem and spur more research. A detailed narrative about one person’s experience will inspire more compassion than an academic paper filled with quantitative data. Stories often have a greater impact than statistics.

Challenging, Testing, or Developing Theories

Case studies can be particularly useful in the process of forming and testing theories. A case study may lead researchers to form a new theory or call into a question an existing one. They are an invaluable tool for identifying exceptions to a rule or disproving conventional wisdom.

For instance, a medical professional may write a case study about a patient who exhibited atypical symptoms to assert that the list of symptoms for a condition should be expanded. A psychologist could use a case study to determine whether the new treatment they devised for depression is effective, or to demonstrate that existing treatment methods are flawed. As the result of a case study, a marketing professional could suggest that consumers values have changed and that marketing best practices should be updated accordingly.

Enabling the Study of Unique Subjects

Some subjects would be impossible, impractical, or unethical to study through other research methods. This is true in the case of extremely rare phenomenon, many aspects of human behavior, and even some medical conditions.

Suppose a medical professional would like to gather more information about multiple-birth pregnancies with four or more fetuses. More information would be helpful because we have less information about them, but the reason we have less information is because they are so rare. Conducting case studies of a few women who are currently pregnant with multiples or have given birth to multiples in the past may be the only practical way to research them.

Case studies can also be used to gain insight into historical events and natural phenomenon — things we are not able to repeat at will. Case studies have also been used to study subjects such as a feral child , child prodigies, rare psychological conditions, crisis response, and more.

Helping People Better Understand Nuanced Concepts

Educators incorporate case studies into their lectures for a reason. Walking students through a detailed case study can make the abstract seem more real and draw out the nuances of a concept. Case studies can facilitate engaging discussions, spark thoughtful questions, and give students a chance to apply what they have learned to real-world situations.

Outside the classroom, case studies can be used to illustrate complex ideas. For instance, a well-constructed case study can highlight the unintended consequences of a new piece of legislation or demonstrate that depression does not always manifest in an obvious way. Case studies can help readers and listeners understand and care about an issue that does not directly affect them.

Despite their benefits, case studies do come with a few limitations. Compared to other research methods, case studies are often at a disadvantage in terms of the following:

Replicability

In most cases, scientists strive to create experiments that can be repeated by others. That way, other scientists can perform their own research and compare their results to those of the initial study. Assuming these other scientists achieve similar results, the replicability of the experiment lends credibility to the findings and theories of the original researchers.

One limitation of case studies is that they are often difficult, if not impossible, to replicate. Although this fact does not diminish the value of case studies, it does demonstrate that case studies are not a good fit for every research problem — at least, not on their own. Additional research would have to be performed to corroborate the results and prove or disprove any generalized theories generated by a case study.

Generalization

Generalization is another area in which case studies cannot match other research methods. A case study can help us challenge existing theories and form new ones, but its results cannot necessarily be generalized. The data we gather from a case study is only valid for that specific subject, and we cannot assume that our conclusions apply to the broader population.

Researchers or readers can attempt to apply the principles from a particular case to similar situations or incorporate the results into a more comprehensive theory. However, a case study by itself can only prove the existence of certain possibilities and exceptions, not a general rule.

Reliability

The reliability of case studies may be called into question for two reasons. The first objection centers on the fallibility of human memory and the question of whether subjects are being honest. Many case studies rely on subjects to self-report biographical details, their state of mind, their thoughts and feelings, or their behaviors.

The second issue is the Hawthorne effect, which refers to the tendency of individuals to modify their behavior when they know they are being observed. This effect makes it nearly impossible for researchers to ensure that the observations and conclusions of their case study are reliable.

Researcher Bias

Researcher bias is another potential issue with case studies. The results of a case study are by nature subjective and qualitative rather than objective and qualitative, and any findings rely heavily on the observations and narrative provided by the researcher. Even the best researchers are still human, and no matter how hard they try to remain objective, they will not be able to keep their findings completely free of bias.

Researchers may have biases they are not even aware of. A researcher may over-identify with the subject and lose the benefit of a dispassionate outside perspective. If the researcher already has an opinion on the subject, they may subconsciously overlook or discount facts that contradict their pre-existing assumptions. Researcher bias can affect what the researcher observes and records, as well as how they interpret and apply their observations.

Case studies can be time-consuming and expensive to conduct. Crafting a thorough case study can be a lengthy project due to the intensive, detailed nature of this type of research. Plus, once the information has been gathered, it must be interpreted. Between the observation and analysis, a case study could take months or even years to complete. Researchers will need to be heavily involved in every step of the process, putting in a lot of time, energy, focus, and effort to ensure that the case study is as informative as possible.

Now that you understand the benefits, limitations, and types of case studies, you can follow these steps to write your own:

• Determine your objective.  Write out your research problem, question, or goal. If you aren’t sure, ask yourself questions like, “What am I trying to accomplish? What do I need to know? What will success look like?” Be clear and specific. Your answers will help you choose the right type of case study for your needs.
• Review the research.  Before delving into your case study, take some time to review the research that is already available. The information you gather during this preliminary research can help guide your efforts.
• Choose a subject.  Decide what or who the subject of your case study will be. For instance, if you are conducting a case study to find out how businesses have been affected by new CDC guidelines, you will need to choose a specific restaurant or retailer. In some cases, you may need to draft a release form for the subject to sign so that you will be able to publish your study.
• Gather information.  Case studies about a person, organization, or group may rely on questionnaires or interviews to gather information. If you are studying an event, you might use a combination of academic research and witness interviews. In some cases, you will record your own observations as part of the study.
• Write a report.  Most case studies culminate in a written report, similar to a research paper. Most case studies include five sections : an introduction, a literature review, an explanation of your methods, a discussion of your findings and the implications, followed by a conclusion.
• Publish your findings.  Once you’ve written your case study, consider the most engaging way to present your findings. A well-written research article is a good place to start, but going a step further will maximize the impact of your research. For instance, you could design an infographic to highlight key findings or commission an animated video to turn your case study into a visual narrative.

Whether research is your primary occupation or only an incidental part of your job, you can benefit from a solid understanding of what case studies are, how they work, and when to use them. Use the information and steps above to design and write a case study that will provide the answers you’re looking for.

CopyPress writer

More from the author:

Quick Navigation What Does a Content Manager Do? Who Does a Content Manager Report To? Are Content Managers Paid...

In our digital age, it’s important to know the best ways to reach your target audience and boost your...

The best content marketing conferences offer the chance to learn more about the industry and provide networking opportunities with...

RECENT ARTICLES

Read More About Measurement

27 Nov 2023

31 Oct 2023

23 May 2023

• Columbia University in the City of New York
• Office of Teaching, Learning, and Innovation
• University Policies
• Columbia Online
• Academic Calendar
• Resources and Technology
• Resources and Guides

Case Method Teaching and Learning

What is the case method? How can the case method be used to engage learners? What are some strategies for getting started? This guide helps instructors answer these questions by providing an overview of the case method while highlighting learner-centered and digitally-enhanced approaches to teaching with the case method. The guide also offers tips to instructors as they get started with the case method and additional references and resources.

On this page:

What is case method teaching.

• Case Method at Columbia

Why use the Case Method?

Case method teaching approaches, how do i get started.

• Additional Resources

The CTL is here to help!

For support with implementing a case method approach in your course, email [email protected] to schedule your 1-1 consultation .

Cite this resource: Columbia Center for Teaching and Learning (2019). Case Method Teaching and Learning. Columbia University. Retrieved from [today’s date] from https://ctl.columbia.edu/resources-and-technology/resources/case-method/  

Case method 1 teaching is an active form of instruction that focuses on a case and involves students learning by doing 2 3 . Cases are real or invented stories 4  that include “an educational message” or recount events, problems, dilemmas, theoretical or conceptual issue that requires analysis and/or decision-making.

Case-based teaching simulates real world situations and asks students to actively grapple with complex problems 5 6 This method of instruction is used across disciplines to promote learning, and is common in law, business, medicine, among other fields. See Table 1 below for a few types of cases and the learning they promote.

Table 1: Types of cases and the learning they promote.

For a more complete list, see Case Types & Teaching Methods: A Classification Scheme from the National Center for Case Study Teaching in Science.

Back to Top

Case Method Teaching and Learning at Columbia

The case method is actively used in classrooms across Columbia, at the Morningside campus in the School of International and Public Affairs (SIPA), the School of Business, Arts and Sciences, among others, and at Columbia University Irving Medical campus.

Faculty Spotlight:

Professor Mary Ann Price on Using Case Study Method to Place Pre-Med Students in Real-Life Scenarios

Read more  

Professor De Pinho on Using the Case Method in the Mailman Core

Case method teaching has been found to improve student learning, to increase students’ perception of learning gains, and to meet learning objectives 8 9 . Faculty have noted the instructional benefits of cases including greater student engagement in their learning 10 , deeper student understanding of concepts, stronger critical thinking skills, and an ability to make connections across content areas and view an issue from multiple perspectives 11 . 

Through case-based learning, students are the ones asking questions about the case, doing the problem-solving, interacting with and learning from their peers, “unpacking” the case, analyzing the case, and summarizing the case. They learn how to work with limited information and ambiguity, think in professional or disciplinary ways, and ask themselves “what would I do if I were in this specific situation?”

The case method bridges theory to practice, and promotes the development of skills including: communication, active listening, critical thinking, decision-making, and metacognitive skills 12 , as students apply course content knowledge, reflect on what they know and their approach to analyzing, and make sense of a case. 

Though the case method has historical roots as an instructor-centered approach that uses the Socratic dialogue and cold-calling, it is possible to take a more learner-centered approach in which students take on roles and tasks traditionally left to the instructor. 

Cases are often used as “vehicles for classroom discussion” 13 . Students should be encouraged to take ownership of their learning from a case. Discussion-based approaches engage students in thinking and communicating about a case. Instructors can set up a case activity in which students are the ones doing the work of “asking questions, summarizing content, generating hypotheses, proposing theories, or offering critical analyses” 14 . 

The role of the instructor is to share a case or ask students to share or create a case to use in class, set expectations, provide instructions, and assign students roles in the discussion. Student roles in a case discussion can include: 

• discussion “starters” get the conversation started with a question or posing the questions that their peers came up with; 
• facilitators listen actively, validate the contributions of peers, ask follow-up questions, draw connections, refocus the conversation as needed; 
• recorders take-notes of the main points of the discussion, record on the board, upload to CourseWorks, or type and project on the screen; and 
• discussion “wrappers” lead a summary of the main points of the discussion. 

Prior to the case discussion, instructors can model case analysis and the types of questions students should ask, co-create discussion guidelines with students, and ask for students to submit discussion questions. During the discussion, the instructor can keep time, intervene as necessary (however the students should be doing the talking), and pause the discussion for a debrief and to ask students to reflect on what and how they learned from the case activity. 

Note: case discussions can be enhanced using technology. Live discussions can occur via video-conferencing (e.g., using Zoom ) or asynchronous discussions can occur using the Discussions tool in CourseWorks (Canvas) .

Table 2 includes a few interactive case method approaches. Regardless of the approach selected, it is important to create a learning environment in which students feel comfortable participating in a case activity and learning from one another. See below for tips on supporting student in how to learn from a case in the “getting started” section and how to create a supportive learning environment in the Guide for Inclusive Teaching at Columbia . 

Table 2. Strategies for Engaging Students in Case-Based Learning

Approaches to case teaching should be informed by course learning objectives, and can be adapted for small, large, hybrid, and online classes. Instructional technology can be used in various ways to deliver, facilitate, and assess the case method. For instance, an online module can be created in CourseWorks (Canvas) to structure the delivery of the case, allow students to work at their own pace, engage all learners, even those reluctant to speak up in class, and assess understanding of a case and student learning. Modules can include text, embedded media (e.g., using Panopto or Mediathread ) curated by the instructor, online discussion, and assessments. Students can be asked to read a case and/or watch a short video, respond to quiz questions and receive immediate feedback, post questions to a discussion, and share resources. 

For more information about options for incorporating educational technology to your course, please contact your Learning Designer .

To ensure that students are learning from the case approach, ask them to pause and reflect on what and how they learned from the case. Time to reflect  builds your students’ metacognition, and when these reflections are collected they provides you with insights about the effectiveness of your approach in promoting student learning.

Well designed case-based learning experiences: 1) motivate student involvement, 2) have students doing the work, 3) help students develop knowledge and skills, and 4) have students learning from each other.  

Designing a case-based learning experience should center around the learning objectives for a course. The following points focus on intentional design. 

Identify learning objectives, determine scope, and anticipate challenges. 

• Why use the case method in your course? How will it promote student learning differently than other approaches? 
• What are the learning objectives that need to be met by the case method? What knowledge should students apply and skills should they practice? 
• What is the scope of the case? (a brief activity in a single class session to a semester-long case-based course; if new to case method, start small with a single case). 
• What challenges do you anticipate (e.g., student preparation and prior experiences with case learning, discomfort with discussion, peer-to-peer learning, managing discussion) and how will you plan for these in your design? 
• If you are asking students to use transferable skills for the case method (e.g., teamwork, digital literacy) make them explicit. 

Determine how you will know if the learning objectives were met and develop a plan for evaluating the effectiveness of the case method to inform future case teaching. 

• What assessments and criteria will you use to evaluate student work or participation in case discussion? 
• How will you evaluate the effectiveness of the case method? What feedback will you collect from students? 
• How might you leverage technology for assessment purposes? For example, could you quiz students about the case online before class, accept assignment submissions online, use audience response systems (e.g., PollEverywhere) for formative assessment during class? 

Select an existing case, create your own, or encourage students to bring course-relevant cases, and prepare for its delivery

• Where will the case method fit into the course learning sequence? 
• Is the case at the appropriate level of complexity? Is it inclusive, culturally relevant, and relatable to students? 
• What materials and preparation will be needed to present the case to students? (e.g., readings, audiovisual materials, set up a module in CourseWorks). 

Plan for the case discussion and an active role for students

• What will your role be in facilitating case-based learning? How will you model case analysis for your students? (e.g., present a short case and demo your approach and the process of case learning) (Davis, 2009). 
• What discussion guidelines will you use that include your students’ input? 
• How will you encourage students to ask and answer questions, summarize their work, take notes, and debrief the case? 
• If students will be working in groups, how will groups form? What size will the groups be? What instructions will they be given? How will you ensure that everyone participates? What will they need to submit? Can technology be leveraged for any of these areas? 
• Have you considered students of varied cognitive and physical abilities and how they might participate in the activities/discussions, including those that involve technology? 

Student preparation and expectations

• How will you communicate about the case method approach to your students? When will you articulate the purpose of case-based learning and expectations of student engagement? What information about case-based learning and expectations will be included in the syllabus?
• What preparation and/or assignment(s) will students complete in order to learn from the case? (e.g., read the case prior to class, watch a case video prior to class, post to a CourseWorks discussion, submit a brief memo, complete a short writing assignment to check students’ understanding of a case, take on a specific role, prepare to present a critique during in-class discussion).

Andersen, E. and Schiano, B. (2014). Teaching with Cases: A Practical Guide . Harvard Business Press. 

Bonney, K. M. (2015). Case Study Teaching Method Improves Student Performance and Perceptions of Learning Gains†. Journal of Microbiology & Biology Education , 16 (1), 21–28. https://doi.org/10.1128/jmbe.v16i1.846

Davis, B.G. (2009). Chapter 24: Case Studies. In Tools for Teaching. Second Edition. Jossey-Bass. 

Garvin, D.A. (2003). Making the Case: Professional Education for the world of practice. Harvard Magazine. September-October 2003, Volume 106, Number 1, 56-107.

Golich, V.L. (2000). The ABCs of Case Teaching. International Studies Perspectives. 1, 11-29. 

Golich, V.L.; Boyer, M; Franko, P.; and Lamy, S. (2000). The ABCs of Case Teaching. Pew Case Studies in International Affairs. Institute for the Study of Diplomacy. 

Heath, J. (2015). Teaching & Writing Cases: A Practical Guide. The Case Center, UK. 

Herreid, C.F. (2011). Case Study Teaching. New Directions for Teaching and Learning. No. 128, Winder 2011, 31 – 40. 

Herreid, C.F. (2007). Start with a Story: The Case Study Method of Teaching College Science . National Science Teachers Association. Available as an ebook through Columbia Libraries. 

Herreid, C.F. (2006). “Clicker” Cases: Introducing Case Study Teaching Into Large Classrooms. Journal of College Science Teaching. Oct 2006, 36(2). https://search.proquest.com/docview/200323718?pq-origsite=gscholar  

Krain, M. (2016). Putting the Learning in Case Learning? The Effects of Case-Based Approaches on Student Knowledge, Attitudes, and Engagement. Journal on Excellence in College Teaching. 27(2), 131-153. 

Lundberg, K.O. (Ed.). (2011). Our Digital Future: Boardrooms and Newsrooms. Knight Case Studies Initiative. 

Popil, I. (2011). Promotion of critical thinking by using case studies as teaching method. Nurse Education Today, 31(2), 204–207. https://doi.org/10.1016/j.nedt.2010.06.002

Schiano, B. and Andersen, E. (2017). Teaching with Cases Online . Harvard Business Publishing. 

Thistlethwaite, JE; Davies, D.; Ekeocha, S.; Kidd, J.M.; MacDougall, C.; Matthews, P.; Purkis, J.; Clay D. (2012). The effectiveness of case-based learning in health professional education: A BEME systematic review . Medical Teacher. 2012; 34(6): e421-44. 

Yadav, A.; Lundeberg, M.; DeSchryver, M.; Dirkin, K.; Schiller, N.A.; Maier, K. and Herreid, C.F. (2007). Teaching Science with Case Studies: A National Survey of Faculty Perceptions of the Benefits and Challenges of Using Cases. Journal of College Science Teaching; Sept/Oct 2007; 37(1). 

Weimer, M. (2013). Learner-Centered Teaching: Five Key Changes to Practice. Second Edition. Jossey-Bass.

Additional resources 

Teaching with Cases , Harvard Kennedy School of Government. 

Features “what is a teaching case?” video that defines a teaching case, and provides documents to help students prepare for case learning, Common case teaching challenges and solutions, tips for teaching with cases. 

Promoting excellence and innovation in case method teaching: Teaching by the Case Method , Christensen Center for Teaching & Learning. Harvard Business School. 

National Center for Case Study Teaching in Science . University of Buffalo. 

A collection of peer-reviewed STEM cases to teach scientific concepts and content, promote process skills and critical thinking. The Center welcomes case submissions. Case classification scheme of case types and teaching methods:

• Different types of cases: analysis case, dilemma/decision case, directed case, interrupted case, clicker case, a flipped case, a laboratory case. 
• Different types of teaching methods: problem-based learning, discussion, debate, intimate debate, public hearing, trial, jigsaw, role-play. 

Columbia Resources

Resources available to support your use of case method: The University hosts a number of case collections including: the Case Consortium (a collection of free cases in the fields of journalism, public policy, public health, and other disciplines that include teaching and learning resources; SIPA’s Picker Case Collection (audiovisual case studies on public sector innovation, filmed around the world and involving SIPA student teams in producing the cases); and Columbia Business School CaseWorks , which develops teaching cases and materials for use in Columbia Business School classrooms.

Center for Teaching and Learning

The Center for Teaching and Learning (CTL) offers a variety of programs and services for instructors at Columbia. The CTL can provide customized support as you plan to use the case method approach through implementation. Schedule a one-on-one consultation. 

Office of the Provost

The Hybrid Learning Course Redesign grant program from the Office of the Provost provides support for faculty who are developing innovative and technology-enhanced pedagogy and learning strategies in the classroom. In addition to funding, faculty awardees receive support from CTL staff as they redesign, deliver, and evaluate their hybrid courses.

The Start Small! Mini-Grant provides support to faculty who are interested in experimenting with one new pedagogical strategy or tool. Faculty awardees receive funds and CTL support for a one-semester period.

Explore our teaching resources.

• Blended Learning
• Contemplative Pedagogy
• Inclusive Teaching Guide
• FAQ for Teaching Assistants
• Metacognition

CTL resources and technology for you.

• Overview of all CTL Resources and Technology
• The origins of this method can be traced to Harvard University where in 1870 the Law School began using cases to teach students how to think like lawyers using real court decisions. This was followed by the Business School in 1920 (Garvin, 2003). These professional schools recognized that lecture mode of instruction was insufficient to teach critical professional skills, and that active learning would better prepare learners for their professional lives. ↩
• Golich, V.L. (2000). The ABCs of Case Teaching. International Studies Perspectives. 1, 11-29. ↩
• Herreid, C.F. (2007). Start with a Story: The Case Study Method of Teaching College Science . National Science Teachers Association. Available as an ebook through Columbia Libraries. ↩
• Davis, B.G. (2009). Chapter 24: Case Studies. In Tools for Teaching. Second Edition. Jossey-Bass. ↩
• Andersen, E. and Schiano, B. (2014). Teaching with Cases: A Practical Guide . Harvard Business Press. ↩
• Lundberg, K.O. (Ed.). (2011). Our Digital Future: Boardrooms and Newsrooms. Knight Case Studies Initiative. ↩
• Heath, J. (2015). Teaching & Writing Cases: A Practical Guide. The Case Center, UK. ↩
• Bonney, K. M. (2015). Case Study Teaching Method Improves Student Performance and Perceptions of Learning Gains†. Journal of Microbiology & Biology Education , 16 (1), 21–28. https://doi.org/10.1128/jmbe.v16i1.846 ↩
• Krain, M. (2016). Putting the Learning in Case Learning? The Effects of Case-Based Approaches on Student Knowledge, Attitudes, and Engagement. Journal on Excellence in College Teaching. 27(2), 131-153. ↩
• Thistlethwaite, JE; Davies, D.; Ekeocha, S.; Kidd, J.M.; MacDougall, C.; Matthews, P.; Purkis, J.; Clay D. (2012). The effectiveness of case-based learning in health professional education: A BEME systematic review . Medical Teacher. 2012; 34(6): e421-44. ↩
• Yadav, A.; Lundeberg, M.; DeSchryver, M.; Dirkin, K.; Schiller, N.A.; Maier, K. and Herreid, C.F. (2007). Teaching Science with Case Studies: A National Survey of Faculty Perceptions of the Benefits and Challenges of Using Cases. Journal of College Science Teaching; Sept/Oct 2007; 37(1). ↩
• Popil, I. (2011). Promotion of critical thinking by using case studies as teaching method. Nurse Education Today, 31(2), 204–207. https://doi.org/10.1016/j.nedt.2010.06.002 ↩
• Weimer, M. (2013). Learner-Centered Teaching: Five Key Changes to Practice. Second Edition. Jossey-Bass. ↩
• Herreid, C.F. (2006). “Clicker” Cases: Introducing Case Study Teaching Into Large Classrooms. Journal of College Science Teaching. Oct 2006, 36(2). https://search.proquest.com/docview/200323718?pq-origsite=gscholar ↩

This website uses cookies to identify users, improve the user experience and requires cookies to work. By continuing to use this website, you consent to Columbia University's use of cookies and similar technologies, in accordance with the Columbia University Website Cookie Notice .

Scientists are using underwater speakers to help restore degraded coral reefs: Study

Corals rely on rich soundscapes to thrive, researchers have discovered.

Researchers have discovered a new method that could encourage the restoration of degraded coral reef populations, which have been declining around the world due to record-high marine temperatures.

The sounds of a healthy reef could be used to encourage coral larvae to recolonize damaged or degraded reefs, according to a study published in the journal Royal Society Open Science on Tuesday. Underwater speakers that play the sounds of a healthy reef, such as fish calls, were found to help coral larvae settle at rates up to seven times higher.

Researchers at the Woods Hole Oceanographic Institution have been recording underwater sounds from coral reefs in the Caribbean for close to a decade, Nadège Aoki, a marine biologist at the Woods Hole Oceanographic Institution in Massachusetts and author of the paper, told ABC News. During that time, they observed that healthier reefs tended to have more diverse fish assemblages as well as more complex soundscapes.

Fish make sounds by strumming on their swim bladder and crunching and scraping on corals, Aoki said. Other sounds of the reef could include the crackling of snapping shrimp, according to the researchers.

"They have a sound environment that is distinctive and gives kind of an acoustic signature to the reef," Aoki said.

MORE: 'Strikingly warm' ocean heat wave off Florida coasts could decimate corals, other marine life, experts say

In their first days of life, coral larvae make a permanent decision of where they will settle and metamorphose into adults -- swimming or drifting with the currents in an effort to seek the right conditions to settle. The sounds of the reef are important settlement cues, the paper found.

Corals are immobile as adults, so the larval stage is their only opportunity to select a good habitat.

The researchers collected larvae from adult colonies of the mustard hill coral species off the coast of the U.S. Virgin Islands and re-placed them on three reefs along the southern coast of St. John -- one of which was healthy and the other two labeled as relatively degraded, with sparse coral and few fish.

The larvae were placed on the reefs' little cups in order to create a controlled environment at distances of one, five, 10 and 30 meters from the solar-powered speakers, which played the sounds of a healthy reef recorded about 10 years earlier, according to the paper.

MORE: Installation underway of 15 acres of 3D-printed artificial reefs in coastal North Carolina

After collecting the cups, the researchers found that the larvae that were placed near underwater speakers settled at a rate of about twice as much, Aoki said.

"This effect decreased as you got farther away from the speaker," she added. "Low-frequency sound appears to have an impact on their settlement behavior as well."

The experiment, sponsored by the Vere and Oceankind Foundations and the National Science Foundation, was conducted twice in the summer of 2022.

The oval-shaped larvae, about the size of a grain of rice, are covered in ciliary hairs, leading the scientists to believe they are sensing the sound waves through the epidermis, Aoki said, adding that the exact mechanism in which the corals are potentially hearing by is not yet known.

MORE: Hawaii's coral reefs are in peril. What researchers are doing to restore coral ecosystems and preserve biodiversity

The researchers embarked on the study in response to the "alarming" rates at which coral reefs are declining, Aoki said. The results of the study suggests that acoustic enrichment could be a new method to restore coral reefs, the researcher said.

Aoki believes that the method can be used in nurseries both on land and off the coast to restore coral reef populations. In addition, underwater speakers have the ability to broadcast to a large area, she said.

Reef populations off the coast of Florida and in the Caribbean experienced a large bleaching event over the summer due to record-breaking marine heatwaves. Reef populations will need all the help they can get to recover from climate change-induced stressors, Aoki said.

"We're observing thermal heating and bleaching events happening at more regular frequencies than they have in the past, and that makes it very difficult for reefs to have sufficient time to recover and grow back in between these disruptive events," she said.

Related Topics

• Climate Change
• Environment

Top Stories

Why April's total solar eclipse will be a historic event in the US

• Apr 2, 5:30 AM

Trump secures $175 million bond in New York civil fraud case

• Apr 1, 10:44 PM

Migrants flown to Martha's Vineyard by Florida Gov. Ron DeSantis can sue charter flight company

• Apr 1, 8:16 PM

Tulsi Gabbard turned down RFK Jr.'s offer to be his running mate, she says

Angie Harmon says delivery person shot and killed family dog: 'Beyond devastated'

Abc news live.

24/7 coverage of breaking news and live events

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

• View all journals
• My Account Login
• Explore content
• About the journal
• Publish with us
• Sign up for alerts
• Open access
• Published: 02 April 2024

Maternal hybrid immunity and risk of infant COVID-19 hospitalizations: national case-control study in Israel

• Joshua Guedalia   ORCID: orcid.org/0000-0002-3458-7896 1   na1 ,
• Michal Lipschuetz   ORCID: orcid.org/0000-0002-7370-0417 2 , 3 , 4   na1 ,
• Adva Cahen-Peretz 2 ,
• Sarah M. Cohen   ORCID: orcid.org/0000-0001-6359-3729 2 ,
• Yishai Sompolinsky 2 ,
• Galit Shefer 5 ,
• Eli Melul 5 ,
• Zivanit Ergaz-Shaltiel 6 ,
• Debra Goldman-Wohl 2 ,
• Simcha Yagel 2 ,
• Ronit Calderon-Margalit 1   na2 &
• Ofer Beharier   ORCID: orcid.org/0000-0001-5317-4512 2 , 4   na2  

Nature Communications volume  15 , Article number:  2846 ( 2024 ) Cite this article

Metrics details

• Epidemiology
• Viral infection

Hybrid immunity, acquired through vaccination followed or preceded by a COVID-19 infection, elicits robust antibody augmentation. We hypothesize that maternal hybrid immunity will provide greater infant protection than other forms of COVID-19 immunity in the first 6 months of life. We conducted a case-control study in Israel, enrolling 661 infants up to 6 months of age, hospitalized with COVID-19 (cases) and 59,460 age-matched non-hospitalized infants (controls) between August 24, 2021, and March 15, 2022. Infants were grouped by maternal immunity status at delivery: Naïve (never vaccinated or tested positive, reference group), Hybrid-immunity (vaccinated and tested positive), Natural-immunity (tested positive before or during the study period), Full-vaccination (two-shot regimen plus 1 booster), and Partial-vaccination (less than full three shot regimen). Applying Cox proportional hazards models to estimate the hazard ratios, which was then converted to percent vaccine effectiveness, and using the Naïve group as the reference, maternal hybrid-immunity provided the highest protection (84% [95% CI 75-90]), followed by full-vaccination (66% [95% CI 56-74]), natural-immunity (56% [95% CI 39-68]), and partial-vaccination (29% [95% CI 15-41]). Maternal hybrid-immunity was associated with a reduced risk of infant hospitalization for Covid-19, as compared to natural-immunity, regardless of exposure timing or sequence. These findings emphasize the benefits of vaccinating previously infected individuals during pregnancy to reduce COVID-19 hospitalizations in early infancy.

Introduction

Infants are at increased risk for serious COVID-19 disease with hospitalization for acute respiratory failure as compared with older children 1 , 2 , 3 . In the US, hospitalization rates among infants aged <6 months were approximately five times higher during the peak week of Omicron predominance compared to the Delta predominance period 3 . While messenger RNA (mRNA) vaccines (BNT162b2-Pfizer and mRNA-1273 Moderna) were authorized for children as young as 6 months 3 , 4 , prevention of infection and illness for younger infants remains an issue of significant concern.

Maternal anti-SARS-CoV-2 antibodies play a critical role in maternal antiviral immunity 5 . Moreover, maternal immunoglobulin G (IgG) antibodies cross the placental barrier, providing the first line of defense for neonatal humoral immunity. Previous studies have demonstrated the effectiveness of maternal immunization in preventing pertussis and influenza infections in infants 6 , 7 , 8 . Moreover, a 2023 study demonstrated the use of RSVperF vaccine during pregnancy to limit infant illnesses 9 . We and others have previously described the significant role of a third maternal mRNA vaccine dose during pregnancy in reducing the risk for mother 10 and infant hospitalizations due to COVID-19 11 . These findings fit with previous reports by Halasa et al. that showed an association between maternal vaccination with the second dose of mRNA vaccine and reduced risks of COVID-19-related hospitalizations, and critical disease among infants younger than six months 12 . These data support the notion that anti-SARS-CoV-2 vaccine-mediated immunity has a significant clinical impact for both mother and offspring. Nevertheless, the role of vaccination following SARS-CoV-2 infection remains to be elucidated.

The dynamics of anti-SARS-CoV-2 antibody levels following infection during pregnancy were described by us and others 5 , 13 . Similar to what was described in the general population, we found waning of anti-SARS-CoV-2 antibody levels in those infected with SARS-CoV-2 either before or during pregnancy 13 . We further showed that hybrid immunity, i.e., immunity conferred by the combination of infection and vaccination, elicits higher levels of neutralizing antibodies in both maternal and umbilical cord blood, detected at delivery, when compared with recovered unimmunized pregnant women 13 . These results are consistent with data obtained in non-pregnant populations, showing that hybrid immunity reinforced protection against reinfection 14 , 15 .

The clinical significance of maternal hybrid immunity in COVID-19 protection, both in mothers and their offspring, is unclear. Moreover, how hybrid immunity compares with natural immunity (i.e., immunity acquired by previous infection alone), remains an open fundamental question. Addressing these knowledge gaps is imperative, particularly considering the suboptimal vaccination response observed in previously infected pregnant women.

We therefore aimed to estimate the effectiveness of maternal hybrid immunity during pregnancy against COVID-19-related hospital admissions for infants in their first six months of life. To do so, we compared subgroups of infants categorized by maternal immunity-conferring events and analyzed real-world national-level data obtained in Israel during the periods of Delta and Omicron variant circulation.

Participants

Characteristics of infant cases and controls are shown in Table  1, in addition to participants characteristics by maternal immunity group. Study participants included 661 infants that were admitted to hospital due to COVID-19 up to age of 180 days (case infants, age distribution of the cases, Supplementary Fig.  1 ), and 59,460 that were not hospitalized (control infants), (see Fig.  1 - study flow chart and Supplementary fig.  2 ). Cases and controls were similar in most characteristics; however, primiparity was more common among the cases than controls (33.9% vs. 28.3%, respectively) and grandmultiparity was less common (11.6% vs. 15.3%, respectively). Mothers of cases had more tests for SARS-COV-2 than controls ≥5 documented tests: 46.0% vs. 36.9%, respectively). Cases and controls were grouped by mother’s immunity status at the time of delivery: Naïve (reference group), Natural immunity, Hybrid immunity, Partial vaccination, or Full vaccination (3 doses).

The flow chart shows the case-control comparison groups investigated during the study period. Created with BioRender.com.

Maternal characteristics were analyzed according to immunity status sub-groups. Mothers with hybrid immunity were older compared to mothers in the natural immunity and naïve groups, with 71.6% of them aged >27 years, as opposed to 64.1% and 60.5% in the latter groups, respectively. Additionally, they underwent SARS-CoV-2 testing more frequently, with 48.0% of them having undergone ≥5 tests, as compared to 40.5% and 20.3% in the natural immunity and naïve groups, respectively (Table  1 ).

A total of 20 of the 661 case infants (3.0%) were born to mothers with hybrid immunity, 46 (7.0%) to mothers with natural immunity, 95 (14.4%) to mothers with full vaccination, 272 (41.1%) partial vaccination, and 228 (34.5%) to naïve mothers. In comparison, the control group comprised 59,460 infants distributed as follows: 5832 (9.8%) hybrid immunity, 5430 (9.2%) natural immunity, 12,212 (20.5%) full vaccination, 21,287 (35.8%) partial vaccination, and 14,699 (24.7%) born to naïve mothers. Maternal post-partum vaccination could impact the risk of COVID-19 infection among infants 16 , 17 ; we therefore analyzed the frequency of post-partum vaccination among all subgroups and found similar rates (ranging from 7 to 10%). The distribution of the study population by maternal immunity status for case and control infants, over the study period, is illustrated in Supplementary fig.  3 .

Clinical severity of COVID-19 hospitalization among cases

As shown in Table  1, of the 661 infants hospitalized due to COVID-19, 33 (5.0%) were admitted to the pediatric critical care units (PICU), with no significant difference in PICU admission rates among maternal immunization groups (ANOVA, p  = 0.852). The overall median length of stay of COVID-19 hospitalization for all cases was 2 days (IQR 1–3)). There were no significant differences in mean length of stay between infants of mothers in the hybrid immunity group and all other groups (ANOVA, 2.30 ± 1.3 days, p  = 1.000). However, infants born to mothers in the full vaccination group experienced a shorter median length of stay of 2 (IQR 1–2) days (Kruskal–Wallis, p  = 0.008) than those born to mothers in the naïve group, with a mean of 2.43 ( ± 1.8) (ANOVA, p  = 0.009, Bonferroni post-hoc correction). No deaths were recorded among the infants hospitalized for COVID-19.

Maternal mediated immunity estimated effectiveness

Using Cox proportional hazards models to estimate the hazard ratios (HR), we compared the effectiveness of maternal hybrid, natural, and vaccine-induced (full and partial) immunity, with naïve mothers as reference group, against COVID-19-associated hospitalization of infants below six months of age. Our results demonstrated that maternal hybrid immunity conferred the greatest protection at 84% (95% CI: 75–90), followed by full vaccination at 66% (95% CI: 56–74), natural immunity at 56% (95% CI: 39–68), and partial vaccination at 29% (95% CI: 15–41; Fig.  2 ). Hybrid immunity effectiveness differed (84% vs. 66%, 56%, and 29%) significantly from all other groups ( p  < 0.005, p  < 0.001, and p  < 0.001, respectively). In a sensitivity analysis including infants who were considered non-eligible as cases (i.e., tested positive for COVID-19, but hospitalized for reasons unrelated to COVID-19), similar overall trends were observed (Supplementary Table  2 ).

Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) for COVID-19 hospitalizations in the various groups of maternal immunity status, compared to the maternal naïve group. Models were adjusted for maternal age, gestational age at delivery, parity, and neonatal sex; multifetal gestation, birthweight, and number of maternal documented SARS-CoV-2 tests during pregnancy. Maternal Immunization effectiveness was calculated as (1−adjusted hazard ratio) × 100. Similar analysis was performed when stratified by COVID-19 variants. The delta-predominant period was defined as 24 August 2021 to 1 December 2021. The omicron-predominant period was defined as 15 December 2021 to 15 March 2022. Case infants, n  = 661; Control infants, n  = 59,460. Boxes and error bars represent the median and 95% CI. Dotted line shows no effect point. Subgroups are indicated by color: Hybrid, red; Natural immunity, green; Full vaccination (3–4 doses), orange; Partial vaccination: 1–2 doses, navy blue.

We performed separate analyses of infant hospitalizations during the Delta and Omicron variant surges. During the Delta variant surge 173 infants were admitted, whereas 486 infants were admitted during the Omicron surge, a 2.8-fold increase. These cases were matched with 15,570 and 43,710 controls, respectively. An additional two cases that were admitted during the washout period between the two waves were included in the overall study group, but not in variant-specific analyses. We were unable to estimate the effectiveness of hybrid and full vaccination immunity against Delta-associated hospitalization, as no infants born to mothers with these immunity statuses were hospitalized during that timeframe. This finding highlights the considerable protective impact of hybrid and full vaccination during the Delta surge. Our analysis indicated that natural immunity effectiveness reached 75% (95% CI: 45–88%) and partial vaccination effectiveness was 49% (95% CI: 29–63%) during the Delta period. During the Omicron surge, maternal hybrid, natural, and full vaccination immunity exhibited effectiveness rates of 81% (95% CI: 70–88%), 48% (95% CI: 25–64%), and 64% (95% CI: 52–73%), respectively, as compared to the naïve reference group, while partial vaccination did not confer significant protection during this period (Fig.  2 ).

Hybrid and natural immunity effectiveness

Our findings show that maternal hybrid immunity improves infant protection when compared to natural. To further elucidate the potential advantages of hybrid-mediated immunity over natural immunity, we sought to assess the impact of maternal infection timing on infant protection (i.e., first infection was before or during pregnancy; Fig.  3 , whole study group, and Supplementary fig.  4A, B for Delta and Omicron periods). The effectiveness trend of hybrid immunity was higher than natural immunity for all measured time points.

Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) for COVID-19 hospitalizations in the Hybrid and Natural groups of maternal immunity status, compared to the maternal naïve group, stratified by maternal infection timing. Infection before pregnancy is defined as the last infection that occurred before conception of pregnancy. Infection before 20 weeks refers to the last documented infection that occurred during the first 20 weeks of gestation, while infection after 20 weeks refers to the last documented infection that occurred during the last 20 weeks of gestation. Models were adjusted for maternal age, gestational age at delivery, parity, and neonatal sex; multifetal gestation, birthweight, and number of maternal documented SARS-CoV-2 tests during pregnancy. Maternal Immunization effectiveness was calculated as (1−adjusted hazard ratio) × 100. Case infants, n  = 661; Control infants, n  = 59,460. Boxes and error bars represent the median and 95% CI. Dotted line shows no effect point. Subgroups are indicated by color: Hybrid, red; Natural immunity, green. (Delta and Omicron waves were analyzed separately; results are shown in Supplementary fig.  4A, B ).

Our analysis revealed that the protective effects of hybrid immunity remained comparable for different sequences of hybrid exposure, as shown in Supplementary fig.  5 , infection before vaccination (80%, 95% CI: 65–89%) or infection after vaccination (88%, 95% CI: 75–95%). Analysis of hybrid effectiveness based on timing of the last immune stimulation (vaccination or infection), revealed modest differences in protection. Those born to mothers whose last stimulation occurred in the first 20 weeks of gestation had a slightly lower protection rate of 78% (95% CI 51–90%), while those who received their last stimulation after 20 weeks of gestation had a protection rate of 86% (95% CI 74–92%). These rates resemble those found among the small subgroup of infants ( n  = 342, 2 hospitalized) that were born to mothers whose last stimulation took place before pregnancy 74% (95% CI [−6]–94%) and those whose last stimulation took place during pregnancy ( n  = 5510, 18 hospitalized) 84% (95% CI 74–90%, respectively) (Supplementary fig.  5 ).

For infants born to mothers with a prior SARS-CoV2 infection, we noted that immune-mediated protection correlated with the number of administered booster doses. Specifically, natural immunity (achieved without vaccination) was found to be effective at a rate of 56% (95% CI 39–68%); hybrid immunity, which ensues following a single vaccine dose, was estimated to be 78% (95% CI 62–87%); and hybrid immunity bolstered by two or more vaccine doses exhibited effectiveness rate of 92% (95% CI 79–97%; Fig.  4 ).

Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) for COVID-19 hospitalizations according to the number of maternal vaccinations; no vaccination (Natural immunity group); one vaccination (Hybrid group with one vaccination) and ≥2 vaccinations (Hybrid group with two or more vaccination), compared to the maternal naïve group. Models were adjusted for maternal age, gestational age at delivery, parity, and neonatal sex; multifetal gestation, birthweight, and number of maternal documented SARS-CoV-2 tests during pregnancy. Maternal Immunization effectiveness was calculated as (1−adjusted hazard ratio) × 100. Case infants, n  = 661; Control infants, n  = 59,460. Boxes and error bars represent the median and 95% CI. Dotted line shows no effect point.

In this study, we found that maternal hybrid immunity provides heightened protection against infant COVID-19 hospitalization during the first six months of life, as compared to natural immunity. Our analyses show that hybrid immunity effectiveness reached 84% (95% CI, 75–90%) throughout the study period, whereas natural immunity effectiveness was 56% (95% CI, 39–68%). These results emphasize the significance of immunizing women who have recovered from COVID-19 infection during pregnancy to confer robust protection against early infant COVID-19 illness. Infant hospitalizations for COVID-19 were in general brief in all maternal immunity subgroups, and admission to the pediatric ICU was rare. We studied the effect of maternal hybrid immunity on infant COVID-19 hospitalizations, rather than infant SARS-CoV2 infections. Recorded infection rates may be biased by varying testing frequencies among different population groups, particularly among unvaccinated individuals. In Israel, while not consistently implemented across all healthcare facilities, routine SARS-CoV-2 testing of infants presenting with upper respiratory infection symptoms was widely established as a standard procedure in most hospitals during the study period. Given the unbiased approach to testing, and the fact that COVID-19 hospitalization better reflects significant disease burden, we analyzed the data accordingly.

This study concentrated on the indirect benefits of maternal hybrid immunity for unvaccinated newborns. Our findings augment the growing body of evidence underscoring the considerable protective effects of maternal vaccination during pregnancy on early infant COVID-19 disease. Prior research has primarily focused on vaccinating pregnant women who have not been previously exposed to the virus. A Norwegian study published in 2022 linked maternal vaccination with a reduced risk of infant infection during the first four months of life 18 , while a U.S. study associated pregnancy vaccination with a decreased risk of infant hospitalizations and critical disease up to six months of age 12 . Our 2023 study, summarizing data from Israel, demonstrated the significant impact of maternal third booster dose in limiting infant COVID-19 hospitalization 11 . However, clinical data on the durability and benefits of maternal hybrid immunization remain limited. Information on this type of protection stems from studies investigating maternal and newborn protective antibody levels, which indicate high levels of SARS-CoV-2-specific immunoglobulins in maternal blood, cord blood, and milk after vaccinating recovered pregnant women, compared to recovered non-vaccinated pregnant women 13 , 19 , 20 . Our study further expands current knowledge with substantial clinical data, illustrating how maternal hybrid immunity translates to early infant protection. Importantly, we demonstrate that hybrid immunization offers greater protection than all other maternal immunization status groups.

Despite significant differences in infant hospitalization rates based on maternal immunity, we observed similar hospitalization durations across all groups, regardless of maternal immunization status. We postulate that the uniformity in stay length may be due to a shared clinical presentation, primarily fever in infants, which necessitates brief hospital stays. However, it is important to note that we lack data regarding the prevalence of fever.

Two studies from 2021 demonstrated that administering the SARS-CoV-2 vaccine during the late second or early third trimester of pregnancy results in increased antibody levels in umbilical cord blood 21 , 22 , and a reduced risk of infant COVID-19 morbidity, compared to earlier gestation vaccination 4 , 12 . Our previous research supports these findings, revealing that vaccination during the third trimester leads to elevated anti-COVID-19 antibodies in cord blood compared to the first trimester 13 . Our findings align with this observation, indicating that when immune stimulation occurs after 20 weeks of gestation, the level of protection appears to be higher compared to stimulation during the first 20 weeks. However, the difference in protection was somewhat reduced compared to previous reports on vaccination alone 4 , 12 . It is worth noting that the number of infants born to mothers who were last stimulated before pregnancy was limited in our data, which restricts our ability to accurately predict the true protective effect for infants in that particular group.

Intriguingly, protection resulting from immune stimulation before pregnancy was more robust than that conferred during the first 20 weeks of gestation. This suggests that the durability of immunity acquired through early pregnancy immunization may differ from that obtained pre-pregnancy. Further investigations should focus on these disparities, striving to better understand their origins.

Hybrid-mediated immunity resulted in robust infant protection regardless of the sequence of stimulations (i.e., vaccination before infection or vice-versa). Additionally, our findings suggest that the effectiveness of hybrid-mediated immunity acquired from one vaccine dose is lower than that obtained after two or more doses. Overall these new data provide novel insights into daily clinical questions relevant for patients and families, obstetricians, and healthcare policy. As COVID-19 spread continues, we predict that future guidelines will adopt recommendations for routine SARS-CoV-2 booster vaccination before pregnancy, or during the third trimester 23 , aiming to reduce early infant morbidity, similar to recommendations for pertussis and influenza prevention 24 , 25 , 26 .

In our analysis, we focus on two key waves of SARS-CoV-2 variants: Delta and Omicron. While Omicron variants have become more prevalent, examining the Delta wave is crucial to understanding the evolving dynamics of the pandemic. This comparison highlights differences between the waves which can be crucial for understanding the importance of updating vaccines to match the currently circulating strains and boosting immunity to overcome waning. However, hybrid immunization enhances protection for both waves.

Our national data reveals a 2.8-fold increase in hospitalization rates among infants aged less than six months during the peak week of Omicron predominance compared to the period of Delta predominance. These results are consistent with CDC reports, which documented a five-fold increase in hospitalization rates when comparing these periods 3 . The observed differences could be due to higher infant infection rates, decreased protection from vaccines and natural immunity, or increased virulence of variants in infants. Our study did not examine the causes underlying these differences: further research is needed to understand these key factors.

Our study has several strengths. We used population-based databases covering the entire Israeli population with high data completeness. In Israel, a substantial proportion of the convalescent pregnant population received the COVID-19 vaccine during pregnancy, providing a large cohort for analysis. The mandatory reporting of information to the Israeli national registries, as described in the Methods section, limited the potential for selection bias and provided detailed data on clinical and sociodemographic factors. However, data did not include disease symptoms, constraining any evaluation of severity.

Our investigation presents certain limitations. As a real-world observational study, participants opted for vaccination at different times, making it difficult to account for potential disparities in asymptomatic (and unrecorded) infections, household exposures, health-seeking, behaviors, or risk aversion among individuals.

While we made efforts to adjust for multiple potential confounding factors, the absence of data on critical variables such as breastfeeding practices, enrollment in daycare centers, and other family or behavioral variables could have influenced the observed outcomes. Additionally, during the study period, changes in testing eligibility occurred, and data on home rapid antigen test results were unavailable. These limitations underscore the complexities of real-world observational research, emphasizing the need for future investigations that incorporate a more comprehensive dataset and account for these variables.

Maternal vaccination during pregnancy offers infant protection through two primary mechanisms: (a) the transfer of protective antibodies via the placenta and breast milk, and (b) a reduction in the infant’s exposure to infectious agents due to a better-protected mother (resulting in decreased vector susceptibility and infectiousness) 27 , 28 , 29 . While it is crucial to comprehensively understand the relative contribution of each protective factor, the necessary data for such determination was not available in this study, highlighting the need for further investigation in future research.

In summary, this real-world assessment revealed that maternal hybrid immunization was associated with a reduced risk of infant hospitalization due to COVID-19 compared to natural immunity via infection alone. Our results show that effectiveness of hybrid immunity remains robust regardless of the timing of stimulation during pregnancy. Our findings supply crucial evidence to reinforce current recommendations advocating for COVID-19 vaccination of previously infected individuals during pregnancy to mitigate substantial illness in early infancy.

Study design, setting, and populations

We conducted a nationwide population-based case-control study in Israel, a country with roughly 9.5 million inhabitants and 190,000 births every year. In Israel, SARS-CoV-2 vaccinations began on 20 December 2020 (1st dose), with the second dose first available from 10 January 2021. At the start of the vaccination drive, groups considered high risk (the elderly, chronic disease patients and health care workers). By this time, pregnant women were considered high risk and were recommended to present for vaccination. The third (“booster”) dose rollout began on 30 July 2021. Vaccination of recovered individuals became available to the general population on 24 August 2021. On 15 March 2022, the public policy regarding testing and COVID-19 restrictions was changed. The cases comprised infants who were six months of age or younger during the study period, i.e., who were born between 27 February 2021 and 15 March 2022 and hospitalized due to COVID-19 during the study period. Cases were age matched to non-hospitalized infants (See Flow Chart, Supplementary data- Fig.  1 ). We excluded infants who were born before 23 weeks of gestation, had a birthweight of <500 grams, missing birthweight, or were hospitalized due to COVID-19 prior to 24 August 2021.

Case infants were defined as those with documented hospitalization due to COVID-19. We collected data on admission and discharge dates and outcomes for all hospitalizations associated with ICD-9 code 07984 (COVID-19 infection) in infants aged 0–180 days. A pediatric expert (Z.E.S.), blinded to preliminary data collection, examined the medical records of infants diagnosed with COVID-19 during their hospital stay, determining whether the primary reason for hospitalization was indeed COVID-19-related. Data on infants who were considered non-eligible as cases (tested positive for COVID-19, but hospitalized for reasons unrelated to COVID-19) are summarized in Supplementary Table  1 .

For every case infant, approximately 90 infants were individually matched, based on birthdate (±3 days). Control infants were randomly selected from the birthdate-appropriate population of infants who were not hospitalized for COVID-19 (656 cases had full matching of 90 controls, while 5 cases had 84 matching controls). This approach accounts for both age and timing of exposure to COVID-19 which affect infant morbidity and hospitalization risk. A calendarial distribution of the study cases and controls matching is illustrated in Supplementary fig.  2 .

Immunity status

To evaluate the effectiveness of maternal immunity-conferring events against COVID-19 hospitalization, infants were categorized into five groups based on their mothers’ immunity status at the time of delivery: Naïve (i.e., no documentation of SARS-CoV-2 infection or vaccination, Reference Group), natural immunity (i.e., documented positive SARS-CoV-2 test without vaccination), hybrid immunity (i.e., the combination of natural immunity and vaccination with mRNA COVID-19 vaccine), partial vaccination (i.e., vaccination with one or two doses of mRNA COVID-19 vaccine and no infection), and full vaccination (i.e., vaccination with three or four doses of mRNA COVID-19 vaccine and no infection). The mRNA vaccines were BNT162b2-Pfizer and mRNA-1273 Moderna. During the study period, the original monoclonal mRNA vaccine was used; bivalent vaccines were not yet available. Included in the analyses are 5 women who received non-mRNA vaccination.

Data source and organization

Data were retrieved from TIMNA, a national research infrastructure for big data established by the Israel Ministry of Health (MOH) to facilitate large-scale health research. The MOH maintains a COVID-19 registry, which compiles information on all laboratory-based SARS-CoV-2 diagnostic tests, vaccinations, and confirmed cases. Our study analyzed integrated participant-level data provided by the MOH from three main sources: the National Birth Registry, the COVID-19 Registry, and the National Inpatient Registry, which encompasses all diagnoses of hospitalized patients in Israel.

Statistical analysis

Descriptive statistics of the study population (cases vs. controls) were presented as proportions or means, as appropriate. Differences between groups were calculated using χ 2 , and ANOVA with post hoc Bonferroni analysis as appropriate; length-of-stay was analyzed with Kruskal–Wallis test. In this matched case-control study, data analyses employed stratified Cox regressions, where each case and its controls accounted for one stratum, yielding weighted HR which is an estimate for the odds ratios in conditional logistic regressions. Models were adjusted for maternal age, gestational age at delivery, parity, and neonatal sex; multifetal gestation, birthweight categories (<2500, 2500–3999, ≥4000) and number of maternal documented SARS-CoV-2 tests categories during pregnancy (0–1, 2–4, ≥5). We further analyzed these associations by dominant-variant period, having separate models for the Delta (24 August 2021–1 December 2021) and Omicron (15 December 2021–15 March 2022) periods, and excluding the washout period between the variants (2 December 2021–14 December 2021). Maternal mediated immunity effectiveness was estimated as a percentage, defined as (1−HR) × 100; 95% CI were calculated similarly, for the entire study period and for the Delta and Omicron periods separately.

We conducted additional analyses stratified by timing of immunity conferring events (i.e., infection or vaccination before or during pregnancy). Among infants of the hybrid group, we also evaluated the association between the sequence of immunity-conferring events (infection before or after vaccination), timing of last stimulation (i.e., vaccination or infection) for three different time groups: before pregnancy, during pregnancy up to 20 weeks of gestation, and during pregnancy ≥20 weeks of gestation). For infants born to mothers with previous infections we estimated the association between the number of vaccine doses (i.e., none vs. one vs. two or more) and infant COVID-19 hospitalizations. We compared the effectiveness of each maternal immunity subgroup to the Naïve (reference) group by Cox proportional hazard modeling. In order to evaluate the effectiveness of each type of maternal immunity compared to the others, i.e. Hybrid vs. Natural immunity, the HRs of the maternal immunity groups were compared using p-values derived from z-scores according to the following equation (Equation 1):

Where (0) represents the regression coefficient and its standard error for the hybrid immunity, and (x) represents these parameters in any other immunity group used for the comparison.

Python version 3.7.3 and lifelines 0.24.14 were used for Cox models. IBM-SPSS for Windows, version 29 (IBM Corp., Armonk, N.Y., USA), was used for descriptive and univariate analyses. A two-sided p -value ≤ 0.05 was considered to indicate statistical significance in all analyses. A p -value ≤ 0.05 was considered to indicate statistical significance in all analyses. The study protocol was approved by the Hadassah Medical Organization’s Institutional Review Board (Helsinki Committee approval #0593-21, 5 September 2021). The committee granted exemption from informed consent, based on preserving the participants’ anonymity.

Reporting summary

Further information on research design is available in the  Nature Portfolio Reporting Summary linked to this article.

Data availability

The data that support the findings of this study are available from the authors but due to national and organizational data privacy regulations, individual-level data such as those used for this study cannot be shared openly. Restrictions apply to the availability of these data, which were used under license from the Israel Ministry of Health for the current study, and so are not publicly available. Data are, however, available from the ministry upon request and with permission from the Israel Ministry of Health https://govextra.gov.il/ministry-of-health/big-data-research/home/ .

Code availability

The modeling in this paper used Python version 3.7.3 and lifelines 0.24.1, which are freely available.

Cui, X. et al. A systematic review and meta-analysis of children with coronavirus disease 2019 (COVID-19). J. Med. Virol. 93 , 1057–1069 (2021).

Article   CAS   PubMed   Google Scholar  

Hobbs, C. V. et al. Frequency, characteristics and complications of COVID-19 in hospitalized infants. Pediatr. Infect. Dis. J. 41 , e81–e86 (2022).

Article   PubMed   Google Scholar  

Marks, K. J. et al. Hospitalization of infants and children aged 0–4 years with laboratory-confirmed COVID-19—COVID-NET, 14 states, March 2020–February 2022. Morbid. Mortal. Wkly Rep. 71 , 429 (2022).

Article   CAS   Google Scholar  

Jorgensen, S. C. J. et al. Maternal mRNA covid-19 vaccination during pregnancy and delta or omicron infection or hospital admission in infants: test negative design study. BMJ 380 , e074035 (2023).

Villar, J. et al. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study. Lancet 401 , 447–457 (2023).

Article   PubMed   PubMed Central   Google Scholar  

Switzer, C., D’Heilly, C. & Macina, D. Immunological and clinical benefits of maternal immunization against pertussis: a systematic review. Infect. Dis. Ther. 8 , 499–541 (2019).

Schlaudecker, E. P. et al. IgA and neutralizing antibodies to influenza a virus in human milk: a randomized trial of antenatal influenza immunization. PLoS ONE 8 , e70867 (2013).

Article   ADS   CAS   PubMed   PubMed Central   Google Scholar  

Blencowe, H., Lawn, J., Vandelaer, J., Roper, M. & Cousens, S. Tetanus toxoid immunization to reduce mortality from neonatal tetanus. Int. J. Epidemiol. 39 , i102–i109 (2010).

Kampmann, B. et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N. Engl. J. Med. 388 , 1451–1464 (2023).

Guedalia, J. et al. Effectiveness of a third BNT162b2 mRNA COVID-19 vaccination during pregnancy: a national observational study in Israel. Nat. Commun. 13 , 6961 (2022).

Lipschuetz, M. et al. Maternal third dose of BNT162b2 mRNA vaccine and risk of infant COVID-19 hospitalization. Nat. Med . 29 , 1155–1163 (2023).

Halasa, N. B. et al. Maternal vaccination and risk of hospitalization for Covid-19 among infants. N. Engl. J. Med. 387 , 109–119 (2022).

Nevo, L. et al. Boosting maternal and neonatal humoral immunity following SARS-CoV-2 infection using a single messenger RNA vaccine dose. Am. J. Obstet. Gynecol. 227 , 486.e1–486.e10 (2022).

Bobrovitz, N. et al. Protective effectiveness of previous SARS-CoV-2 infection and hybrid immunity against the omicron variant and severe disease: a systematic review and meta-regression. Lancet Infect. Dis. 23 , 556–567 (2023).

Article   CAS   PubMed   PubMed Central   Google Scholar  

Powell, A. A. et al. Protection against symptomatic infection with delta (B.1.617.2) and omicron (B.1.1.529) BA.1 and BA.2 SARS-CoV-2 variants after previous infection and vaccination in adolescents in England, August, 2021-March, 2022: a national, observational, test-negative, case-control study. Lancet Infect. Dis. 23 , 435–444 (2023).

Szczygioł, P. et al. Antibodies in the breastmilk of COVID-19 recovered women. BMC Pregnancy Childbirth 22 , 635 (2022).

Juncker, H. G. et al. Comparing the human milk antibody response after vaccination with four COVID-19 vaccines: a prospective, longitudinal cohort study in the Netherlands. EClinicalMedicine 47 , 101393 (2022).

Carlsen, E. O. et al. Association of COVID-19 vaccination during pregnancy with incidence of SARS-CoV-2 infection in infants. JAMA Intern. Med. 226 , 177–186 (2022).

Google Scholar  

Kugelman, N. et al. Third trimester messenger RNA COVID-19 booster vaccination upsurge maternal and neonatal SARS-CoV-2 immunoglobulin G antibody levels at birth. Eur. J. Obstet. Gynecol. Reprod. Biol. 274 , 148–154 (2022).

Longueira, Y. et al. SARS-CoV-2-Specific IgG and IgA response in maternal blood and breastmilk of vaccinated naive and convalescent lactating participants. Front. Immunol. 13 , 909995 (2022).

Mithal, L. B., Otero, S., Shanes, E. D., Goldstein, J. A. & Miller, E. S. Cord blood antibodies following maternal coronavirus disease 2019 vaccination during pregnancy. Am. J. Obstet. Gynecol. 225 , 192–194 (2021).

Beharier, O. et al. Efficient maternal to neonatal transfer of antibodies against SARS-CoV-2 and BNT162b2 mRNA COVID-19 vaccine. J. Clin. Invest. 131 , e150319 (2021).

Rottenstreich, A. et al. Kinetics of maternally derived anti–severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in infants in relation to the timing of antenatal vaccination. Clin. Infect. Dis. 76 , e274–e279 (2022).

Cuningham, W. et al. Optimal timing of influenza vaccine during pregnancy: a systematic review and meta-analysis. Influenza Other Respir. Viruses 13 , 438–452 (2019).

Skoff, T. H. et al. Impact of the US maternal tetanus, diphtheria, and acellular pertussis vaccination program on preventing pertussis in infants <2 months of age: a case-control evaluation. Clin. Infect. Dis. 65 , 1977–1983 (2017).

Nunes, M. C. & Madhi, S. A. Influenza vaccination during pregnancy for prevention of influenza confirmed illness in the infants: a systematic review and meta-analysis. Hum. Vaccin. Immunother. 14 , 758–766 (2018).

Prunas, O. et al. Vaccination with BNT162b2 reduces transmission of SARS-CoV-2 to household contacts in Israel. Science 375 , 1151–1154 (2022).

Article   ADS   CAS   PubMed   Google Scholar  

VanderWeele, T. J. & Tchetgen Tchetgen, E. J. Bounding the infectiousness effect in vaccine trials. Epidemiology 22 , 686–693 (2011).

Richterman A., Meyerowitz E. A., Cevik M. Indirect protection by reducing transmission: ending the pandemic with severe acute respiratory syndrome coronavirus 2 vaccination. Open Forum Infect. Dis. 9 , ofab259 (2022).

Download references

Acknowledgements

This study was supported by The Magda and Richard Hoffman Center for Human Placental Research (M.L.; S.M.C.; D.W.; and O.B.) and the “Ofek” Program of the Hadassah Medical Center (O.B.). The Jerusalem Center for Personalized Computational Medicine provided post-doctoral support (J.G.).

Author information

These authors contributed equally: Joshua Guedalia, Michal Lipschuetz.

These authors jointly supervised this work: Ronit Calderon-Margalit, Ofer Beharier.

Authors and Affiliations

Braun School of Public Health, Hadassah Medical Center, Faculty of Medicine of the Hebrew University of Jerusalem, Jerusalem, Israel

Joshua Guedalia & Ronit Calderon-Margalit

Obstetrics & Gynecology Division, Hadassah Medical Center, Faculty of Medicine of the Hebrew University of Jerusalem, Jerusalem, Israel

Michal Lipschuetz, Adva Cahen-Peretz, Sarah M. Cohen, Yishai Sompolinsky, Debra Goldman-Wohl, Simcha Yagel & Ofer Beharier

Henrietta Szold Hadassah Hebrew University School of Nursing in the Faculty of Medicine Jerusalem, Jerusalem, Israel

Michal Lipschuetz

The Jerusalem Center for Personalized Computational Medicine Jerusalem, Jerusalem, Israel

Michal Lipschuetz & Ofer Beharier

TIMNA-Israel Ministry of Health’s Big Data Platform, Israel Ministry of Health, Jerusalem, Israel

Galit Shefer & Eli Melul

Neonatology Department Hadassah Medical Center, Faculty of Medicine of the Hebrew University of Jerusalem, Jerusalem, Israel

Zivanit Ergaz-Shaltiel

You can also search for this author in PubMed   Google Scholar

Contributions

J.G., M.L., Y.S., E.M., A.C.P. and O.B. saw the original data, collected it and analyzed it. J.G., M.L., O.B., R.C.M., G.S. and S.Y. conceived and designed the study. Z.E.S. reviewed the neonatal data and outcomes. J.G., M.L., O.B., R.C.M., S.M.C., Y.S., D.G.-W., A.C.P. and S.Y. wrote the manuscript. All authors critically reviewed the manuscript and decided to proceed with publication. R.C.M., S.Y. and O.B. supervised the study process. O.B. vouches for the data and analysis. E.M. and G.S. combined, anonymized, and QC of the MOH data.

Corresponding authors

Correspondence to Michal Lipschuetz or Ofer Beharier .

Ethics declarations

Competing interests.

The authors declare no competing interests.

Peer review

Peer review information.

Nature Communications thanks Thiago Cerqueira-Silva and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. A peer review file is available.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Supplementary information, peer review file, reporting summary, rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ .

Reprints and permissions

About this article

Cite this article.

Guedalia, J., Lipschuetz, M., Cahen-Peretz, A. et al. Maternal hybrid immunity and risk of infant COVID-19 hospitalizations: national case-control study in Israel. Nat Commun 15 , 2846 (2024). https://doi.org/10.1038/s41467-024-46694-x

Download citation

Received : 21 July 2023

Accepted : 05 March 2024

Published : 02 April 2024

DOI : https://doi.org/10.1038/s41467-024-46694-x

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

By submitting a comment you agree to abide by our Terms and Community Guidelines . If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate.

Quick links

• Explore articles by subject
• Guide to authors
• Editorial policies

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

• - Google Chrome

Intended for healthcare professionals

• Access provided by Google Indexer
• My email alerts
• BMA member login
• Username * Password * Forgot your log in details? Need to activate BMA Member Log In Log in via OpenAthens Log in via your institution

Search form

• Advanced search
• Search responses
• Search blogs
• Use of progestogens...

Use of progestogens and the risk of intracranial meningioma: national case-control study

• Related content
• Peer review

This article has a correction. Please see:

• Use of progestogens and the risk of intracranial meningioma: national case-control study - March 28, 2024
• Noémie Roland , general practitioner and epidemiologist 1 ,
• Anke Neumann , senior statistician 1 ,
• Léa Hoisnard , epidemiologist 2 ,
• Lise Duranteau , endocrinologist and gynaecologist 3 ,
• Sébastien Froelich , professor of neurosurgery 4 ,
• Mahmoud Zureik , professor of epidemiology and head of department 1 5 ,
• Alain Weill , senior epidemiologist and deputy director 1
• 1 EPI-PHARE Scientific Interest Group, French National Agency for Medicines and Health Products Safety, French National Health Insurance, Saint-Denis, France
• 2 EpiDermE Epidemiology in Dermatology and Evaluation of Therapeutics, EA7379, Paris Est Créteil University UPEC, Créteil, France
• 3 Department of Medical Gynaecology, Bicêtre Hospital, Assistance Publique-Hôpitaux de Paris, Paris Saclay University, 94270, Le Kremlin-Bicêtre, France
• 4 Department of Neurosurgery, Lariboisière University Hospital, Paris-Cité University, Assistance Publique-Hôpitaux de Paris, Paris, France
• 5 University Versailles St-Quentin-en-Yvelines, Montigny le Bretonneux, France
• Correspondence to: N Roland noemie.roland{at}assurance-maladie.fr (@NoemieRoland11 @EPIPHARE on X)
• Accepted 22 February 2024

Objective To assess the risk of intracranial meningioma associated with the use of selected progestogens.

Design National case-control study.

Setting French National Health Data System (ie, Système National des Données de Santé ).

Participants Of 108 366 women overall, 18 061 women living in France who had intracranial surgery for meningioma between 1 January 2009 and 31 December 2018 (restricted inclusion periods for intrauterine systems) were deemed to be in the case group. Each case was matched to five controls for year of birth and area of residence (90 305 controls).

Main outcome measures Selected progestogens were used: progesterone, hydroxyprogesterone, dydrogesterone, medrogestone, medroxyprogesterone acetate, promegestone, dienogest, and intrauterine levonorgestrel. For each progestogen, use was defined by at least one dispensation within the year before the index date (within three years for 13.5 mg levonorgestrel intrauterine systems and five years for 52 mg). Conditional logistic regression was used to calculate odds ratio for each progestogen meningioma association.

Results Mean age was 57.6 years (standard deviation 12.8). Analyses showed excess risk of meningioma with use of medrogestone (42 exposed cases/18 061 cases (0.2%) v 79 exposed controls/90 305 controls (0.1%), odds ratio 3.49 (95% confidence interval 2.38 to 5.10)), medroxyprogesterone acetate (injectable, 9/18 061 (0.05%) v 11/90 305 (0.01%), 5.55 (2.27 to 13.56)), and promegestone (83/18 061 (0.5%) v 225/90 305 (0.2 %), 2.39 (1.85 to 3.09)). This excess risk was driven by prolonged use (≥one year). Results showed no excess risk of intracranial meningioma for progesterone, dydrogesterone, or levonorgestrel intrauterine systems. No conclusions could be drawn concerning dienogest or hydroxyprogesterone because of the small number of individuals who received these drugs. A highly increased risk of meningioma was observed for cyproterone acetate (891/18 061 (4.9%) v 256/90 305 (0.3%), odds ratio 19.21 (95% confidence interval 16.61 to 22.22)), nomegestrol acetate (925/18 061 (5.1%) v 1121/90 305 (1.2%), 4.93 (4.50 to 5.41)), and chlormadinone acetate (628/18 061 (3.5%) v 946/90 305 (1.0%), 3.87 (3.48 to 4.30)), which were used as positive controls for use.

Conclusions Prolonged use of medrogestone, medroxyprogesterone acetate, and promegestone was found to increase the risk of intracranial meningioma. The increased risk associated with the use of injectable medroxyprogesterone acetate, a widely used contraceptive, and the safety of levonorgestrel intrauterine systems are important new findings.

Introduction

Meningiomas account for 40% of primary tumours of the central nervous system. 1 2 The incidence of meningioma in the United States is 9.5 per 100 000 person years. 2 Meningiomas are mostly slow growing, histologically benign tumours but can nevertheless compress adjacent brain tissue and thus patients may require surgical decompression. 3 The incidence of meningiomas increases with age, rising sharply after the age of 65 years. Conversely, meningiomas are rare before the age of 35. Other recognised risk factors for meningioma are being female, intracranial exposure to ionising radiation, neurofibromatosis type 2 2 , and, as shown only recently, prolonged use (≥one year) to high doses of three potent progestogens: cyproterone acetate, 4 5 chlormadinone acetate, 4 and nomegestrol acetate. 4

The link between female sexual hormones, in particular progesterone, and intracranial meningioma is biologically plausible. 6 Progesterone receptors are present in more than 60% of meningiomas 7 and the volume of these tumours has been observed to increase during pregnancy and to decrease post partum. 8 However, previous pregnancy does not appear to be an unequivocal risk factor for meningioma. 9 Studies have also shown a link, albeit a weak one, between breast cancer and meningiomas. 10

No significant association between exogenous female hormones and risk of meningioma has been shown to date for hormonal contraceptives (either combined or progestogen only pills). 11 12 Additionally, data for hormone replacement treatment for menopause are contradictory. Several studies have shown a slight excess risk of meningioma associated with the use of hormone replacement treatment for menopause, 11 13 whereas others have reported no deleterious effects of these molecules. 14 By contrast, the excess risk of meningioma observed with the use of high doses of cyproterone acetate among cis women, men, and trans women has been shown to be very high 5 15 16 and somewhat lower, but still substantial, for chlormadinone acetate and nomegestrol acetate. 4 Discontinuation of each of these three progestogens generally leads to a reduction in meningioma volume, 17 18 which avoids the need for surgery and its associated risk of complications for most patients.

Whether progestogens other than these three oral progestogens at high doses have a similar effect depending on their route of administration is still unknown. Our study aimed to assess the real-life risk of intracranial meningioma associated with the use of progestogens from an extensive list (progesterone, hydroxyprogesterone, dydrogesterone, medrogestone, medroxyprogesterone acetate, promegestone, dienogest, and levonorgestrel intrauterine systems) with different routes of administration (oral, percutaneous, intravaginal, intramuscular, and intrauterine). Although some of the progestogens studied are used in France (promegestone) or in only a few countries (medrogestone), others are widely used worldwide in various doses and for various indications (progesterone, levonorgestrel, hydroxyprogesterone, medroxyprogesterone) (supplementary table A). Certain progestogens may also be risky at some doses when used over a long period of time, but not at lower doses or when used for a short period of time. Our secondary objectives were to describe the characteristics of the women who were in the cases group (age, grade, and anatomical location of the meningiomas) and to approximate the number of surgically treated meningiomas attributable to the use of the concerned progestogens.

Study design and data source

This observational population based study used data derived from the French national health data system ( Système National des Données de Santé (SNDS)). Given the analysis of multiple exposure situations (different exposure definitions and lookback periods) in our study, we opted for a case-control design rather than a cohort study, thus including long term users of the considered medications. 19

The SNDS database contains information on all health spending reimbursements for over 99% of the population residing in France and is linked to the French hospital discharge database. 20 SNDS is currently one of the largest healthcare databases in the world and is widely used in pharmacoepidemiological studies. 4 5 21 22 23 24

Definition of cases and selection of controls

The eligible cases in this study were women residing in France of all ages who underwent surgery for intracranial meningioma between 1 January 2009, and 31 December 2018. For each case, the start date of the corresponding admission to hospital marked the index date. Women with a pregnancy beginning in the two years before the index date were excluded from the study (pregnancies were defined as those that had resulted in childbirth or medical termination of the pregnancy after 22 weeks of amenorrhoea).

Surgery for intracranial meningioma was defined by the simultaneous combination of the following diagnoses and procedures recorded for the same hospital stay: a meningeal tumour (codes D32, D42, or C70 according to the 10 th revision of the International Classification of Diseases (ICD-10)) coded as the main diagnosis of the admission to hospital and an intracranial surgery act (supplementary table B). These codes have already been used in our previous studies. 4 5

Five women in the control group were randomly matched to each woman in the case group for the year of birth and area of residence (“ département ”, a French geographical subdivision, n=101). Matching was based on the risk set sampling approach. 25 The traceability of the controls in the SNDS was ensured by selecting only women who had had at least one service reimbursed in the calendar year before the index date and the two to three calendar years preceding the index date. This criterion was also applied to the selection of cases.

For analyses relating to intrauterine systems, subsets of these cases and the matched controls were considered to ensure sufficiently long lookback periods. For the hormonal intrauterine systems containing 52 mg levonorgestrel and copper intrauterine devices, the cases and controls from the years 2011 to 2018 were retained. For the hormonal intrauterine systems containing 13.5 mg levonorgestrel, the inclusion period was restricted to 2017 to 2018 (start of commercialisation in France in 2013).

Definition of exposure

Exposure to the progestogen of interest was defined according to WHO’s anatomical, therapeutic, and chemical (ATC) classification. The list included progesterone (oral and intravaginal: 100, 200 mg (ATC code G03DA04); percutaneous: 25 mg per bar (G03DA04)), dydrogesterone (10 mg, or in association with oestrogen: 5 or 10 mg (G03DB01, G03FA14, G03FB08)), hydroxyprogesterone (500 mg (G03DA03)), medrogestone (5 mg (G03DB03)), promegestone (0.125, 0.25, or 0.5 mg (G03DB07)), medroxyprogesterone acetate (injectable contraceptive, 150 mg/3 mL (G03AC06, L02AB02 partially)), dienogest (in association with oestrogen, 2 mg (G03FA15)), levonorgestrel (52 mg intrauterine systems (G02BA03); 13.5 mg intrauterine systems (G02BA03)) (supplementary tables C and D). As drospirenone, which is a spironolactone derivative, is not reimbursed in France, we were unable to access data concerning its use. We therefore chose to study the use of spironolactone (25, 50, and 75 mg), even though its indications may be very different. The code used to identify spironolactone was C03DA01. The indications for these various progestogens in France are available in table 1 .

Main indications (marked as x), in France, for the progestogens under study

• View inline

For oral, intravaginal, percutaneous, or intramuscular progestogens, exposure was defined as at least one dispensation of the progestogen of interest in the 365 days before the index date. For intrauterine progestogens, a dispensation was sought within three years before the index date for levonorgestrel 13.5 mg (as the duration of efficacy of this intrauterine system is three years before any change or withdrawal of the device) and within five years before the index date for levonorgestrel 52 mg intrauterine systems (duration of contraceptive efficacy of five to six years according to current recommendations during the study period).

Exposure was described by three modes for each progestogen as follows: 1) exposure to the progestogen concerned, 2) exposure during the three years preceding the index date to at least one of the three high dose progestogens known to increase the risk of meningioma (ie, chlormadinone acetate, nomegestrol acetate, and cyproterone acetate), and 3) absence of exposure to the progestogen considered or to the three high dose progestogens (the reference for the analyses).

Definition of covariates

The description of sociodemographic and medical characteristics included age, area of residence, existence of neurofibromatosis type 2 (ICD-10 code Q85.1), and, for cases only, the year of surgery, anatomical site (anterior, middle, or posterior base of the skull, convexity, falx and tentorium, others; supplementary table C), and grade of severity of the meningioma (according to WHO’s classification 1 : benign, malignant, or atypical, supplementary table E).

Adjuvant radiotherapy was also sought from three months before the index date to six months after (supplementary table F). Additionally, all causes mortality at two and five years after the index date was assessed in cases, as well as the use of antiepileptic drugs in the third year after the index date (supplementary table G).

Statistical analysis

Logistic regression models conditioned on matched pairs were used to estimate odds ratios and their 95% confidence intervals (CIs) for the association between exposure to the progestogens of interest and meningioma (odds ratio of exposure relative to non-exposure). Additionally, the effect of history of neurofibromatosis type 2 on the risk of meningioma was estimated, as well as the effect of chlormadinone acetate, nomegestrol acetate, and cyproterone acetate exposure, all serving as positive controls for exposure to validate our results. In parallel, exposure to a copper intrauterine device was used as a negative control for exposure (codes in supplementary table H).

The risk of meningioma associated with progestogen use was also estimated for each oral, percutaneous, intravaginal, and intramuscular progestogen according to the duration of use: short term (at least one dispensation in the year before the index date but no dispensation in the second year before the index date) and prolonged use (at least one dispensation in the year before the index date and at least one dispensation in the second year before the index date).

The population attributable fraction was approximated from the odds ratio obtained for each progestogen. The formula used was as follows: population attributable fraction=p c (1-1/odds ratio), where p c is the prevalence of the use of the progestogen concerned (isolated exposure) among the cases. 26 Lastly, sensitivity analyses were performed. Analyses were stratified for age (<35 years, 35-44 years, 45-54 years, 55-64 years, and ≥65 years) and for the location and grade of severity of the tumours whenever a positive association was found between exposure to the considered progestogen and meningioma surgery.

Data were analysed using SAS software version 9.4 (SAS Institute Inc). A P value of less than 0.05 was considered statistically significant (two tailed tests).

The present study was authorised by decree 2016–1871 on 26 December 2016. 27 As an authorised permanent user of the SNDS, the author’s team was exempt from approval from the institutional review board. This work was declared, before implementation, on the register of studies of the EPI-PHARE Scientific Interest Group with register reference T-2023-01-437.

Patient and public involvement

The list of progestogens of interest (supplementary table B) was drawn up in consultation with a temporary scientific advisory board comprised of representatives of the French National Agency for Medicines and Health Products Safety, patient organisations, and healthcare professionals (neurosurgery, endocrinology, gynaecology, and general medicine).

Description of cases and controls

In total, 108 366 women were included in the study during the inclusion period of 2009 to 2018, consisting of 18 061 women in the case group were matched with 90 305 in the control group ( fig 1 ).

Flowchart for the analyses of oral, percutaneous, intravaginal, and intramuscular progestogens. Index date is defined as the date of hospital admission

• Download figure
• Open in new tab
• Download powerpoint

Among them, 15 162 cases and 75 810 controls were retained for the analyses of intrauterine systems and copper intrauterine devices using 52 mg of levonorgestrel (restricted inclusion period: 2011 to 2018) (supplementary figure A) and 4048 cases and their 20 240 controls for the analysis of intrauterine systems of 13.5 mg of levonorgestrel (2017-18) (supplementary figure B). Descriptions of cases and controls for the analyses of intrauterine devices are detailed in supplementary I and J.

The mean age of all women was 57.6 years (standard deviation 12.8 years). The most highly represented age groups were 45-54 (26.7%), 55-64 (26.4%), and 65-74 (21.5%) years ( table 2 ).

Description of the cases and controls (overall inclusion period 2009-18). Data are number of individuals (percentage), unless otherwise specified

The number of cases steadily increased from 1329 in 2009 to 2069 in 2018. Meningiomas requiring surgery were most frequently located at the base of the skull (a total of 10 046/18 061 cases (55.6%); anterior skull base: 3979/18 061 (22.0%), middle: 3911/18 061 (21.7%), posterior: 2156/18 061 (11.9%)), followed by the convexity (6468/18 061 (35.8%)). Concerning tumour grade, most meningioma cases were benign (16 662/18 061, 92.3%) and 1047/18 061 (5.8%) were classified as atypical and 352/18 061 (1.9%) as malignant. Among cases, 28.8% (5202/18 061) of women used antiepileptic drugs three years after the index date of surgery. Mortality was also higher among cases than controls: 502 cases/18 061 (2.8%) died within two years ( v 1.2% of controls) and 951/18 061 (5.3%) within five years ( v 3.4% of controls). Mortality was higher for the cases with malignant tumours, 12.5% of whom died within two years and 20.7% within five.

The comparison of the cases and controls in the subsets used to analyse hormonal intrauterine systems is included the supplementary data (supplementary tables I and J).

Progestogens (others than intrauterine)

Exposure among cases.

Among the 18 061 women admitted to hospital for meningioma surgery between 2009 and 2018, 329 (1.8%) had used oral or intravaginal progesterone, 90 (0.5%) percutaneous progesterone, zero hydroxyprogesterone, 156 (0.9%) dydrogesterone, 42 (0.2%) medrogestone, nine (<0.1%) medroxyprogesterone acetate, 83 (0.5%) promegestone, three (<0.1%) dienogest, and 264 (1.5%) spironolactone ( table 3 , supplementary figure C). These numbers excluded 2999 women who had been exposed to cyproterone acetate, nomegestrol acetate, or chlormadinone acetate, or a combination, within the previous three years (among these 2999 women, 68 had also been exposed to oral progesterone, 47 to percutaneous progesterone, 0 to hydroxyprogesterone, 43 to dydrogesterone, 10 to medrogestone, 0 to medroxyprogesterone acetate, 17 to promegestone, 1 to dienogest, and 56 to spironolactone). The median cumulative doses of progestogens for cases and exposed controls are shown in supplementary table K.

Associations between use of oral, percutaneous, intravaginal, and intramuscular progestogen and risk of surgically treated intracranial meningioma. Data are number of individuals (percentage), unless otherwise specified

Effect on meningioma risk

No significant association with an increased risk of intracranial meningioma surgery was noted with exposure to oral or intravaginal progesterone (odds ratio of 0.88 (95% CI 0.78 to 0.99)) or percutaneous progesterone (1.11 (0.89 to 1.40)), dydrogesterone (0.96 (0.81 to 1.14)), or spironolactone (0.95 (0.84 to 1.09)) ( table 3 , supplementary figure C). Exposure to dienogest was rare, with only 14 women who were exposed (3/18 061 among cases and 11/90 305 among controls) and, consequently, the estimated odds ratio had a very large confidence interval (1.48 (0.41 to 5.35)). Additionally, we could not assess the odds ratio concerning hydroxyprogesterone because no exposed cases were found ( fig 2 ).

Associations between various progestogens and risk of intracranial meningioma requiring surgery (case control design, 2009-18). Odds ratio in logarithmic scale. CI=confidential interval; LNG=levonorgestrel; SNDS=French National Health Data System ( Système National des Données de Santé ). *LNG had different denominators due to restricted inclusion periods (10/4048 cases, 48/20 240 controls; 566/15 162 cases, 3888/75 810 controls)

By contrast, an excess risk of meningioma was associated with the use of medrogestone (3.49 (2.38 to 5.10)), medroxyprogesterone acetate (5.55 (2.27 to 13.56)), and promegestone (2.39 (1.85 to 3.09)). As expected, an excess risk of meningioma for women with positive control exposure neurofibromatosis type 2 (18.93 (10.50 to 34.11)), as well as those exposed to chlormadinone acetate (3.87 (3.48 to 4.30)), nomegestrol acetate (4.93 (4.50 to 5.41)), and cyproterone acetate (19.21 (16.61 to 22.22)) was also noted ( fig 2 ).

The duration of exposure to medrogestone, medroxyprogesterone acetate, promegestone, chlormadinone, nomegestrol, and cyproterone acetate for exposed cases and controls is presented in supplementary table L. The results show that three quarters of the women in the cases group who had been exposed for more than a year had been exposed for more than three years. As for medrogestone, medroxyprogesterone acetate, and promegestone, the excess risk associated with prolonged use was higher than that measured for short term and prolonged exposure combined. Specifically, prolonged use of promegestone had an odds ratio of 2.74 (2.04 to 3.67) (versus 2.39 for all durations of exposure) and short term use an odds ratio of 1.62 (0.95 to 2.76). For prolonged use of medrogestone, the odds ratio was 4.08 (2.72 to 6.10) (versus 3.49 for all durations of exposure combined), and for medroxyprogesterone acetate, the odds ratio was 5.62 (2.19 to 14.42). No significant association was reported for either short or prolonged periods of use for any of the other progestogens studied.

Meningiomas before age 45 years were rare in cases of exposure to medrogestone (n=3/42), medroxyprogesterone acetate (n=3/9), or promegestone (n=10/83), and only one (medroxyprogesterone) was observed before the age of 35.

Concerning medrogestone, the most frequent locations of meningiomas in exposed cases were the base of the skull (n=21/42; 13 in the middle) and the convexity (n=19/42) (supplementary tables M, N and O). The excess risk of meningioma for the middle of the base of the skull was particularly high (odds ratio 8.30 (95% CI 3.70 to 18.63)). Additionally, the estimated excess risk among women aged 45-54 years was slightly higher than that in the main analysis (4.53 (2.73 to 7.53) v 3.49 (2.38 to 5.10)).

In women in the cases group who were exposed to promegestone, meningiomas were preferentially located at the front of the base of the skull (n=25/83), the convexity (n=25/83), and the middle of the base of the skull (n=22/83). The excess risk of meningioma linked to promegestone use was slightly higher in the group who were older than 65 years (odds ratio 3.21 (95% CI 1.39 to 7.43)) and for meningiomas located at the front or middle of the base of the skull (3.15 (1.95 to 5.10) and 3.03 (1.82 to 5.02), respectively).

We found no malignant grade tumours among cases exposed to medrogestone, medroxyprogesterone acetate, or promegestone (for information, the same analyses were carried out for chlormadinone acetate, nomegestrol acetate, and cyproterone acetate in supplementary table N).

Levonorgestrel intrauterine systems

In total, 566/15 162 users of hormonal levonorgestrel 52 mg were among the cases with meningioma surgery between 2011 and 2018 (3.7%) ( table 3 ). For the intrauterine systems with 13.5 mg of levonorgestrel, 10 of 4048 users were reported among the cases from 2017 and 2018 (0.2% of all cases). Again, women who had been exposed to cyproterone acetate, nomegestrol acetate, or cyproterone acetate, or a combination, within the previous three years were not counted (among them, 95 were exposed to the intrauterine systems of 52 mg levonorgestrel and three to intrauterine systems of 13.5 mg levonorgestrel).

No excess risk of meningioma was reported with the use of hormonal intrauterine systems containing 52 mg (odds ratio 0.94 (95% CI 0.86 to 1.04)) or 13.5 mg (1.39 (0.70 to 2.77)) of levonorgestrel ( fig 2).

Exposure to copper intrauterine devices, used as a negative control for exposure in this study, had an odds ratio of 1.13 (1.01 to 1.25).

Attributable cases

The population attributable fractions, which are relative to the observed overall number of surgically treated intracranial meningiomas, were 0.17% for exposure to medrogestone, 0.04% for medroxyprogesterone acetate, and 0.27% for promegestone. For comparison, they were calculated as 2.58% for chlormadinone acetate, 4.08% for nomegestrol acetate, and 4.68% for cyproterone acetate. The numbers for the attributable cases are presented in supplementary figure D.

Principal findings

Although the risk of meningioma was already known for three progestogens, this study is the first to assess the risk associated with progestogens that are much more widely used for multiple indications, such as contraception.

This population based study shows an association between the prolonged use of medrogestone (5 mg), medroxyprogesterone acetate injection (150 mg), and promegestone (0.125, 0.25, 0.5 mg) and a risk of intracranial meningioma requiring surgery. No such risk was reported for less than one year of use of these progestogens. However, we found no excess risk of meningioma with the use of progesterone (25, 100, 200 mg; oral, intravaginal, percutaneous), dydrogesterone (10 mg, combined with oestrogen: 5, 10 mg), or spironolactone (25, 50, 75 mg), neither with short term nor prolonged use, and with the use of levonorgestrel intrauterine systems (13.5, 52 mg). A small number of women were exposed to dienogest (2 mg, in association with oestrogen) and hydroxyprogesterone (500 mg), therefore we cannot draw any conclusions concerning the association between use of these progestogens and the risk of meningioma.

No malignant meningiomas were noted for women exposed to medrogestone, medroxyprogesterone acetate, or promegestone. Moreover, the number of cases of surgically treated intracranial meningioma attributable to use of these progestogens was much lower than the number of cases attributable to the intake of chlormadinone acetate, nomegestrol acetate, and, in particular, cyproterone acetate. This finding is explained by both a lower excess risk of meningioma (for medrogestone and promegestone) and lower rates of use in France (particularly low for medroxyprogesterone acetate, with less than 5000 women exposed each quarter during the inclusion period of the study of 2009-18).

Specific considerations on meningiomas

Meningioma is a predominantly benign tumour. Between 2011 and 2015, 80.5% of the meningiomas diagnosed in the United States were grade 1, 17.7% grade 2, and 1.7% grade 3. 1 Even in the absence of malignancy, meningiomas can cause potentially disabling symptoms. In such cases, first line treatment is surgery, even for the oldest patients, entailing a risk of complications and morbidity. 28 29

Age is an important factor both for the indication of progestogens and for considering intracranial surgery. In our study, the mean age of women in the cases group was 57.6 years. Medrogestone, medroxyprogesterone acetate, and promegestone can be used both by women of childbearing age and by premenopausal and postmenopausal women. In our study, only one user of these progestogens who had undergone meningioma surgery was younger than 35 years (medroxyprogesterone).

Postoperative complications are not uncommon for meningioma surgery. Depending on the exact location of meningiomas, the surgical risk varies but surgery may have severe neurological consequences due to the immediate proximity of highly functional cortical area and critical neurovascular structures. Cognitive function tends to improve after surgery for meningioma, 30 31 but several studies have suggested a potential for postoperative anxiety and depression and a high intake of antidepressants and sedatives in the medium term, 32 33 although other studies have reported conflicting findings for depression. 34 Seizures are also a possible short term complication of surgery, 35 leading to a need to take antiepileptic drugs in the years following the operation. In our study, almost three in 10 women (28.8% of cases) were using antiepileptic drugs three years after the operation, which was consistent with previously published findings. 36 Additionally, results showed that progestin related meningiomas tend to occur more frequently at the skull base and that surgery for lesions in this location is much more challenging. The recent evidence supporting stabilisation or regression of meningiomas after stopping chlormadinone acetate, nomegestrol acetate, and cyproterone acetate has reduced the surgical indications for these patients, thus avoiding potential complications. 17 18 A recent report showed that although the tissue portion of the meningioma most often regresses in size, the hyperostosis associated with meningiomas further increases, which may require surgical intervention, not for oncological purposes but only for decompression of the structures nerves and relief of symptoms. 37

Use of the studied progestogens in France and worldwide

Medrogestone is indicated in France for the treatment of menstrual cycle disorders and luteal insufficiency (eg, dysmenorrhea, functional menorrhagia or fibroid-related menorrhagia, premenstrual syndrome, and irregular cycles), endometriosis, mastodynia, and hormone replacement therapy for menopause. In the United States, medrogestone has never been approved by the US Food and Drug Administration. Outside of France, this molecule is also used in Germany, in combination with oestrogen (0.3 mg/5 mg, 0.6 mg/2 mg, 0.6 mg/5 mg). 38 The use of medrogestone increased significantly in France in 2019, notably as a result of postponements in the prescription of chlormadinone acetate, nomegestrol acetate, and cyproterone acetate, following the French and European recommendations to reduce the risk of meningioma attributable to these progestogens in 2018 and 2019. 39 40 As therapeutic alternatives have not shown an increased risk of meningioma, switching from products that notoriously increase this risk to medrogestone should be reconsidered.

Worldwide, in 2019, 3.9% of women of childbearing age were using injectable contraception (medroxyprogesterone), that is, 74 million users, but figures vary widely between world regions (from 1.8% in high income countries to 8.7% in low income countries). 41 This method of contraception is the most widely used in Indonesia (13 million women), 42 Ethiopia (4.6 million women), and South Africa (3.6 million women). 41 In the USA, medroxyprogesterone acetate is used in more than 2 million prescriptions in 2020 and more than one of five sexually active American women report having used injected medroxyprogesterone acetate (150 mg/3 mL) in their lifetime. 43 44 Injectable contraceptives are much less widely used in Europe (3.1% of women of childbearing age in the UK and 0.2% in France 41 ). Our results support preliminary findings from studies of meningioma cases exposed to chronic use of medroxyprogesterone acetate or cases of high dose administration. 45 46 47 48 49 In particular, our results show similarities with those of a retrospective review of 25 patients diagnosed with meningioma who had a history of chronic medroxyprogesterone acetate use and were treated at the University of Pittsburgh Medical Center between 2014 and 2021 concerning the characteristics of cases exposed to medroxyprogesterone acetate (women (mean age of 46 years) with meningiomas commonly located at the base of the skull). 48 In addition, medroxyprogesterone acetate used as an injected contraceptive is known to be prescribed to specific populations, especially people with mental illnesses. 50 The protection of these vulnerable populations from additional drug risks is particularly important. Depot medroxyprogesterone acetate (150 mg) is registered for use as a form of birth control in more than 100 countries worldwide. 41 In countries that have high numbers of people using medroxyprogesterone acetate, the number of meningiomas attributable to this progestogen may be potentially high. Furthermore, medroxyprogesterone (non-acetate) is also used orally, at lower doses, in some countries other than France (notably in the US), for which no data exists on a risk of meningioma so far.

Promegestone was only available in France (not marketed in any other country) and was withdrawn from the market in 2020. This drug was indicated for the relief of premenopausal symptoms and hormone replacement therapy for menopause. With the discontinuation of its marketing, some users could have switched to medrogestone in 2020, a molecule also implicated in the risk of meningioma in our results. Clinicians therefore must remain vigilant because meningioma risk could last beyond market withdrawal and a potential switch to another progestogen.

The FDA defines a therapeutic class as “all products (…) assumed to be closely related in chemical structure, pharmacology, therapeutic activity, and adverse reactions”. 51 52 Various subtypes of progestogens exist depending on the molecule from which the progestogen is derived (ie, progesterone, testosterone, and spironolactone) (supplementary table B). 53 Their chemical structures and pharmacological properties differ according to this classification, which explains why no class effect is reported for certain benefits and risks associated with their use (eg, breast cancer and cardiovascular risk). 54 55 56 57 Progestogens have distinct affinities for different target organ steroid receptors, which may vary even within a subclass, determining their activity.

Our study suggests that 17-OH-hydroprogesterone and 19-norprogesterone derivatives, both progesterone derivatives, have a class effect on meningioma risk. Four of five progestogens belonging to the 17-OH-hydroprogesterone group have shown an increase in the risk of meningioma (supplementary table R). However, the fact that we found different sizes of risk appears to be more a question of duration and cumulative dose than that of belonging to a progestogen class. We could not draw any conclusions about hydroxyprogesterone (due to a lack of power), the fifth progestogen in the subclass, but its main indication (assisted reproductive technology) corresponded to fewer women exposed and very short exposure (approximately 15 days), which could explain why this drug differs from the others. Finally, to date, at the doses considered in the study, no excess risk of meningioma associated with testosterone derivatives has been shown. However, the risk of meningioma associated with the use of these derivatives at other doses and in other regimens needs to be investigated.

Strengths and limitations

To our knowledge, this study of meningioma risk is the first to expand the list of progestogens of interest beyond chlormadinone acetate, nomegestrol acetate, and cyproterone acetate, detailing the risk associated with each progestogen, with different modes of administration. This study was conducted on a national scale for women of all ages for both the cases and their controls. The SNDS database allowed the use of exhaustive real-world data from over a period of 12 years (2006-18; postoperative information was searched even up to 2022), thus preventing recall bias.

The exclusion of women with a pregnancy beginning in the two years preceding the index date ensured that estimates of the risks associated with progestogen use were reliable. Pregnancy is a unique state, affecting exposure to progestogens (of endogenous or exogenous origin), the likelihood of a meningioma appearing or increasing in volume, 9 58 59 and the likelihood of admission to hospital for surgery (possibly with a lower surgery rate, depending on the symptoms, maternal and foetal health, and tumour characteristics). 59

Another potentially important confounding factor, use of chlormadinone acetate, nomegestrol acetate, or cyproterone acetate, was considered in the analyses by modelling exposure to each progestogen of interest with a separate mode of prior or simultaneous exposure to these drugs. Furthermore, the results obtained for the negative and positive control exposure, including exposure to chlormadinone acetate, nomegestrol acetate, and cyproterone acetate, support the appropriateness of the method chosen for this study.

However, this study also had several limitations. As a result of the scarcity of historical data in the SNDS (which began in 2006, and did not have information for some reimbursement schemes during the first few years), we have only three years of lookback period for the oldest meningioma cases (2009-06), and 12 years for the most recent. The SNDS does not provide information on non-reimbursed drugs, which obliged us to study dienogest in association with oestrogen rather than dienogest alone. Further studies will therefore be necessary. Similarly, we were unable to study other progestogens, such as norgestimate, gestodene, and norethisterone, contained in non-reimbursed products (supplementary table B). Conversely, desogestrel is available and reimbursed in France. Its dosage is much lower and, thus, we chose not to study the drug. Further study to assess a dose-response association in the event of prolonged use would be needed. The progestogen implants (etonogestrel) are also rarely used in France, and concern young women, for whom the risk of meningioma is probably very low. 60 61 We have also not studied the risk associated with the use of hormonal intrauterine systems containing 19.5 mg levonorgestrel because its marketing in France was too recent (2018). However, any excess risk associated with the use of the levonorgestrel 19.5 mg intrauterine systems is unlikely because this dose of levonorgestrel is lower than that of the levonorgestrel 52 mg intrauterine systems, for which we observed no risk.

Moreover, the SNDS does not provide information on all the clinical details and medical indications for which progestogens are prescribed. These missing data mean assessing the risk-benefit ratio of prescriptions is not possible, which could be favourable in the absence of an effective alternative, for example, in the case of relief of endometriosis symptoms. We only have some indirect idea of the indication, depending on the age of the user, and the molecule used (progesterone is not indicated for endometriosis, for example, and dydrogesterone is indicated for endometriosis but is rarely used in this indication). Nevertheless, a risk-benefit assessment was not the aim of our study and will require further studies using other sources of data for product efficacy. Furthermore, no evidence suggests that an increase in meningioma risk depends on the medical indication for the progestogen prescription. In the study of Weill and colleagues in 2021, the excess risk of meningioma associated with the use of cyproterone acetate was equivalent for men and women, who, nevertheless, use cyproterone acetate for radically different indications. 5

In this study, only admission to hospital for meningioma surgery was used as the outcome of interest. However, meningiomas can also be treated with radiotherapy (in rare cases) or simply monitored. Therefore, this study is highly likely to have underestimated the prevalence of meningiomas attributable to the use of progestogens by limiting itself solely to symptomatic tumours that require surgery. However, using admission to hospital for surgery as the outcome ensured diagnostic specificity and thus limited classification bias. The SNDS does not specify the histological characteristics of the meningiomas or the isolated or multiple nature of the tumour, both of which are important criteria in determining severity and the choice of appropriate treatment. Nevertheless, for the cases selected for this study, WHO’s severity grade of the meningioma is coded via the main diagnosis, which is entered according to the ICD-10 code at the end of the hospital stay after a reading of the pathology report. As such, we had indirect information about the histology of the tumours.

Our study has several confounding factors. The two main risk factors identified for meningioma, in addition to age (which was considered in this study) and being female (only women were included in this study), are genetic predisposition, attributed, in particular, to hereditary mutations of the neurofibromatosis type 2 gene, and medical or environmental exposure to high doses of ionising radiation. Radiotherapy for brain cancer (especially during childhood) is probably the most important of the possible medical reasons for intracranial radiation exposure, but only a small proportion of individuals in the general population had cerebral radiotherapy or a malignant brain tumour during childhood.

The progestogens investigated in our study that did not result in an increase to risk of meningioma should be considered under the specific conditions of use in France. These results may not be generalised to the use of these progestogens for other indications, increased doses, or increased duration of use. Similarly, the use of one or more of these progestogens might increase the meningioma risk, when the patient had previously received another type of progestogen.

Prescribers need to be aware of previous progestogen use of any kind and any changes in type of progestogen prescribed that may have occurred and should consider the cumulative dose of progestogens for each patient. The list of progestogens we studied is wide ranging, covering a variety of indications (summarised in table 1 ) for women of all ages (childbearing, premenopausal, and menopausal). As in hormone replacement therapy for menopause, progestogens can be easily substituted for each other, and thus progesterone appears to be the safest alternative. For endometriosis, however, therapeutic alternatives are much more limited, and each indication must be discussed on the basis of the personal benefit to risk ratio. If a high risk progestogen is to be continued, clinical and radiological monitoring and compliance with recommendations are essential.

Finally, we did not estimate the effect of concomitant oestrogen use on the risk of meningioma. In a previous report, having a concomitant oestrogen prescription was weakly but significantly associated with meningioma risk, with an age adjusted hazard ratio of 1.6 (95% CI 1.1 to 2.4) for use of cyproterone acetate. In our previous studies, the simultaneous prescription of oestrogen with chlormadinone acetate (hazard ratio 0.8 (0.5 to 1.3)) and nomegestrol acetate (1.0 (0.7 to 1.7)) was not significantly associated with a risk of meningioma. 28 62 In addition, in these two studies, which were cohort studies of women initiating treatment with the progestogen considered, the proportion of women with a simultaneous prescription of oestrogen at the initiation of progestogen treatment was relatively low (6.8%, and 5.0%, respectively per study).

Conclusions

Prolonged use of medrogestone, medroxyprogesterone acetate, and promegestone was found to be associated with an increased risk of meningioma. Future studies should further clarify the association between the duration of use and risk for the progestogens studied, and extend the discussion of meningioma risk to dienogest and hydroxyprogesterone. Finally, no excess risk of meningioma was associated with the use of progesterone, dydrogesterone, or spironolactone, or the hormonal intrauterine systems used worldwide, regardless of the dose of levonorgestrel they contained.

Further studies are also needed to assess the meningioma risk with the use of medroxyprogesterone acetate, which, in this study, was considered at a dose of 150 mg and corresponded to a second line injectable contraceptive that is rarely used in France. Studies from countries with a broader use of this product, which, furthermore, is often administered to vulnerable populations, are urgently needed to gain a better understanding of its dose-response association.

What is already known on this topic

Known risk factors for intracranial meningioma include age, female sex, neurofibromatosis type 2, exposure to ionising radiation, and use of high dose progestogens: nomegestrol, chlormadinone, and cyproterone acetate

Many other progestogens are widely used for multiple indications for which the risk of meningioma associated with their use has not been estimated individually

What this study adds

Prolonged use of medrogestone (5 mg, oral), medroxyprogesterone acetate (150 mg, injectable), and promegestone (0.125/0.5 mg, oral) was found to be associated with an excess risk of intracranial meningioma

In countries for which the use of medroxyprogesterone acetate for birth control is frequent (74 million users worldwide), the number of attributable meningiomas may be potentially high

The results for oral, intravaginal, and percutaneous progesterone, as well as dydrogesterone and levonorgestrel intrauterine systems, are reassuring, supporting the absence of excess meningioma risk

Ethics statements

Ethical approval.

The present study was authorised by decree 2016–1871 on December 26, 2016. 27 As a permanent user of the SNDS, the author’s team was exempt from approval from the institutional review board. This work was declared, before implementation, on the register of studies of the EPI-PHARE Scientific Interest Group requiring use of the SNDS (register reference: EP-0437).

Data availability statement

Under the terms of the SNDS data use agreement, the complete study data cannot be shared with other investigators ( https://www.snds.gouv.fr ). However, the authors try to share publication related data as much as possible: algorithms and other additional information are provided in the supplemental data; aggregated data can be supplied upon request by contacting the corresponding author at noemie.roland{at}assurance-maladie.fr .

Acknowledgments

We thank Bérangère Baricault and Pauline Dayani for their help in responding to the reviewers, and Sylvie Fontanel and Emmanuelle Mignaton for reviewing the manuscript. We also thank Alex Edelman and Associates for proofreading the English version.

Contributors: AW had the idea for the study. NR, AN, LH, and AW conceived and planned the study. NR and AN drafted the manuscript. AN and LH performed the data management. AN, LH, and NR performed the statistical analyses. AW and MZ ensured project and study management. All authors approved the final manuscript. The corresponding author (NR) attests that all listed authors meet the authorship criteria and that no others meeting the criteria have been omitted. AW is the guarantor.

Funding: This research was funded by the French National Health Insurance Fund (Cnam) and the French National Agency for Medicines and Health Products Safety (ANSM) via the Health Product Epidemiology Scientific Interest Group (ANSM-Cnam EPI-PHARE Scientific Interest Group). NR, AN, and AW are employees of the French National Health Insurance Fund, MZ is an employee of the French National Agency for Medicines and Health Products Safety. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support from French National Health Insurance Fund (Cnam) and the Health Product Epidemiology Scientific Interest Group (ANSM-Cnam EPI-PHARE Scientific Interest Group) for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.

Transparency: The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported, that no important aspects of the study have been omitted, and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.

Dissemination to participants and related patient and public communities: The results were presented for the first time on 12 June 2023, at a meeting organised by the French National Agency for Medicines and Health Products Safety to invited patient association representatives, gynaecologists, endocrinologists, neurosurgeons, and general practitioners. The report on this study (in French) was than published on 26 June 2023, on the EPI-PHARE, ANSM (Agence nationale de sécurité du médicament et des produits de santé), and Cnam (Caisse nationale de l’assurance maladie) websites and was sent to the European Medicine Agency.

Provenance and peer review: Not commissioned; externally peer reviewed.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

• Ostrom QT ,
• Kruchko C ,
• Barnholtz-Sloan JS
• Kshettry VR ,
• Al-Mefty O ,
• Barnett GH ,
• Hoisnard L ,
• Laanani M ,
• Passeri T ,
• Mariniello G ,
• Guadagno E ,
• Barbato M ,
• Corvino S ,
• Del Basso De Caro M
• Baxter DS ,
• Rosenfeld JV ,
• Mathiesen T
• Casabella AM ,
• Urakov TM ,
• Pettersson-Segerlind J ,
• Mathiesen T ,
• Elmi-Terander A ,
• Degeneffe A ,
• De Maertelaer V ,
• De Witte O ,
• Michaud DS ,
• Schlehofer B ,
• Lemaire I ,
• Raffin Sanson ML
• Benson VS ,
• Kirichek O ,
• Korhonen K ,
• Raitanen J ,
• Haapasalo H ,
• Salminen T ,
• Wiepjes CM ,
• de Blok CJM ,
• Mikkelsen AP ,
• Greiber IK ,
• Scheller NM ,
• Lidegaard Ø
• Bernat AL ,
• Voormolen EHJ ,
• Champagne PO ,
• Pottegård A
• Lassalle R ,
• Billioti de Gage S ,
• Desplas D ,
• Baricault B ,
• Jabagi MJ ,
• Bertrand M ,
• Lassalle M ,
• Dray-Spira R
• Mansournia MA ,
• Hernán MA ,
• Greenland S
• ↵ JORF. Décret no 2016-1871 du 26 décembre 2016 relatif au traitement de données à caractère personnel dénommé “ système national des données de santé”» 2016-1871, JORF n°0301. 26 December 2016. https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000033702840
• Goldbrunner R ,
• Stavrinou P ,
• Jenkinson MD ,
• Lorenzetti M ,
• Franca RA ,
• Esposito F ,
• Gehring K ,
• Rutten GJM ,
• Sitskoorn MM
• Ruhland JM ,
• Wiestler B ,
• van der Vossen S ,
• Schepers VPM ,
• Berkelbach van der Sprenkel JW ,
• Visser-Meily JMA ,
• Skoglund T ,
• Neumann A ,
• Florea SM ,
• Abbritti R ,
• Gelbe Liste Online
• Duranteau L ,
• United Nations
• Maharani A ,
• Sujarwoto S ,
• ClinCalc DrugStats Database
• Daniels K ,
• Hensiek AE ,
• Kellerman AJ ,
• Wahyuhadi J ,
• Heryani D ,
• Malueka RG ,
• Hartanto RA ,
• Setyawan NH ,
• Abou-Al-Shaar H ,
• Wrigley R ,
• Mallela AN ,
• Zenonos GA ,
• Pozzati E ,
• Zucchelli M ,
• Schiavina M ,
• Contini P ,
• Foschini MP
• McCloskey LR ,
• Wisner KL ,
• Cattan MK ,
• Betcher HK ,
• ↵ The Food and Drug Administration (FDA). Federal register. 2008. Guidance for industry on diabetes mellitus-evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. https://www.federalregister.gov/documents/2008/12/19/E8-30086/guidance-for-industry-on-diabetes-mellitus-evaluating-cardiovascular-risk-in-new-antidiabetic
• Furberg CD ,
• Herrington DM ,
• Schindler AE ,
• Campagnoli C ,
• Druckmann R ,
• Sitruk-Ware R ,
• Stanczyk FZ ,
• Hapgood JP ,
• Mishell DR Jr .
• Palacios S ,
• Hipolito Rodrigues MA ,
• Carbone L ,
• Le Guen M ,
• Rouzaud-Cornabas M ,
• Health Barometer group 2016

• Study Protocol
• Open access
• Published: 26 March 2024

The effect of a midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: a mixed-methods protocol

• Fatemeh Razavinia   ORCID: orcid.org/0000-0002-6827-509X 1 , 2 ,
• Parvin Abedi   ORCID: orcid.org/0000-0002-6980-0693 3 ,
• Mina Iravani   ORCID: orcid.org/0000-0002-8854-1738 4 ,
• Eesa Mohammadi   ORCID: orcid.org/0000-0001-6169-9829 5 ,
• Bahman Cheraghian   ORCID: orcid.org/0000-0001-5446-6998 6 ,
• Shayesteh Jahanfar   ORCID: orcid.org/0000-0001-6149-1067 7 &
• Mahin Najafian   ORCID: orcid.org/0000-0002-6649-3931 8  

BMC Medical Education volume  24 , Article number:  338 ( 2024 ) Cite this article

97 Accesses

Metrics details

The midwifery continuity of care model is one of the care models that have not been evaluated well in some countries including Iran. We aimed to assess the effect of a program based on this model on the clinical competence of midwifery students and delivery outcomes in Ahvaz, Iran.

This sequential embedded mixed-methods study will include a quantitative and a qualitative phase. In the first stage, based on the Iranian midwifery curriculum and review of seminal midwifery texts, a questionnaire will be developed to assess midwifery students’ clinical competence. Then, in the second stage, the quantitative phase (randomized clinical trial) will be conducted to see the effect of continuity of care provided by students on maternal and neonatal outcomes. In the third stage, a qualitative study (conventional content analysis) will be carried out to investigate the students’ and mothers’ perception of continuity of care. Finally, the results of the quantitative and qualitative phases will be integrated.

According to the nature of the study, the findings of this research can be effectively used in providing conventional midwifery services in public centers and in midwifery education.

Trial registration

This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1401.460). Also, the study protocol was registered in the Iranian Registry for Randomized Controlled Trials (IRCT20221227056938N1).

Peer Review reports

Providing quality services to pregnant women has been recommended to all countries to achieve the Millennium Development Goals (MDGs) (Goals 3, 4 and 5) [ 1 ]. There are different care methods to maintain maternal and neonatal health during pregnancy and postpartum [ 1 ]. One of these care models is continuity of care that can be provided by a midwife or an obstetrician.

Midwifery continuity of care is a relationship-based care provided by a midwife who can be supported by one to three more midwives. They provide planned care for a woman during pregnancy, labor, birth, and the early postpartum period up to 6 weeks after delivery [ 2 ].

Continuity of midwifery care has become a global effort to enable women to have access to high-quality maternity care and delivery services [ 3 ]. As a result, many service providers today are transitioning to a continuous care model [ 4 ], and they have considered continuous care to be necessary for realizing women's rights [ 5 ]. Also, continuous midwifery care is known as the gold standard in maternity care to achieve excellent results for women [ 5 , 6 ]. In order to strengthen midwifery services to achieve global health goals in 2015, the World Health Organization (WHO) proposed a midwife-led continuous care model [ 7 ].

Countries use different midwifery care models. In Iran, for example, primary health services that are specific to pregnant mothers are provided in public health centers by midwives working in the network system and in compliance with the level of services and the referral system [ 8 ].

In general, midwifery continuous care not only has an important impact on a wide range of health and clinical outcomes for mothers and neonates but also brings about economic consequences for the health system [ 2 , 9 ]. This care model is useful for healthcare professionals as well [ 10 ], and it has improved the job satisfaction of midwives [ 11 ]. The midwife is the main guide in planning, organizing and providing care to a woman from the beginning of pregnancy to the postpartum period [ 12 ]. In 2011, in order to increase job motivation and satisfaction, promote retention of the midwifery workforce [ 13 ], and alleviate the shortage of workforce at the international level [ 14 ], the Nursing and Midwifery Advisory Center recommended using midwifery students (at the bedside and to perform midwifery work) to overcome this problem.

Providing high quality care requires enhancing the clinical competence of the professionals [ 4 ]. There is a close relationship between the concept of patient care quality and clinical competence. Therefore, clinical competence is of unique importance in midwifery practice [ 15 ]. As a result, in order to achieve quality patient care, midwifery professionals need to train students to become workforce with clinical competence in order to provide quality care in the health system. WHO defined clinical competence as a level of performance that demonstrates the effective application of knowledge, skills, and judgment [ 16 ].

A previous study showed that clinical competence of midwives plays an important role in managing the process of providing care, achieving care goals, and improving the quality of midwifery services [ 17 ]. In other words, the graduates of this field must have an acceptable level of clinical and professional skills in performing midwifery duties so that the health of mothers, children, and ultimately the community can be improved.

In Iran, prenatal care and the care during labor, delivery and postpartum are not continuous, and a new health provider may take the responsibility of care at any stage. This fragmented care may negatively affect the pregnancy outcomes and increase the rate of cesarean section [ 18 ]. Furthermore, the results of some studies in Iran indicate that the clinical competence obtained by midwifery students is far from optimal and that they do not acquire the necessary skills and abilities at the end of their studies [ 19 ]. Farrokhi et al. showed that the performance quality of 70% of midwives is average, and only 18.5% of them have good quality performance [ 20 ]. Several factors play a role in acquiring, maintaining and improving clinical competence [ 21 ]. There are a number of solutions that can increase the clinical competence of midwifery students, and one is the use of different care models such as the continuity of care model. The continuity of care model allows students to develop their midwifery knowledge, skills, and values individually [ 22 ]. Despite the strong foundation of midwifery in Iran, midwifery care models have not yet been tested. Some studies have reported that the quality of services provided during pregnancy, delivery and after delivery in Iran is poor to moderate. Also, these studies emphasize the necessity of a paradigm shift for better quality care and greater satisfaction of mothers, and they consider lack of continuity of care as the reason for the increase in unnecessary cesarean sections [ 23 , 24 , 25 ]. Moreover, the lack of qualified and experienced workforce has led to low quality health services, including midwifery care, and an increase in the economic burden of health. In Iran, no study has yet been conducted to investigate the effect of the midwifery continuity of care model on the students’ clinical competence and pregnancy outcomes. Given the importance of this topic, using a mixed-methods study design, we aimed to assess the effect of a midwifery continuity of care program on the clinical competence of midwifery students and pregnancy outcomes in Ahvaz, Iran.

Specific objectives

To determine the effect of midwifery continuity of care program on the clinical competence of midwifery students.

To determine the effect of a midwifery continuity of care program provided by midwifery students on pregnancy outcomes.

To explain the perception of midwifery students and mothers about the use of the midwifery continuity of care program provided by midwifery students.

Methods/design

Study design.

This sequential embedded mixed-methods study will include a quantitative phase and a qualitative one. A mixed (embedded) experimental design involves the collection and analysis of quantitative and qualitative data by the researcher and the integration of the information into an experimental study or intervention trial. This design adds qualitative data to an experiment or intervention to integrate the personal experience of research participants. Therefore, the qualitative data are converted into a secondary source of data embedded before and after the test. Qualitative data is added to the experiment in differrent ways, including: before the experiment, during the experiment, or after the experiment [ 26 , 27 ]. Embedded mixed-methods studies that are qualitative followed by quantitative are used to understand the rationale for the results and receive feedback from participants (to confirm and support the findings of the quantitative studies) [ 27 ]. In the first stage of this study, a questionnaire for assessing midwifery students’ clinical competence will be created based on the midwifery curriculum of Iran and a review of seminal texts of midwifery. Then, the effect of continuity of care provided by midwifery students on maternal and neonatal outcomes will be assessed in a randomized clinical trial. In the third stage, a qualitative study will be carried out to investigate the perception of students and mothers. Finally, the results of the quantitative and qualitative phases will be integrated (Fig.  1 ).

Sequential and embedded mixed-methods design

First stage: questionnaire development

This questionnaire will be developed based on midwifery curriculum and a comprehensive and systematic search (with no time limit) in English and Persian databases (Web of Science, Embase, Scopus, ProQuest, Google scholar, Magiran, SID).

Tool design

There are four steps in tool development:

Choosing a conceptual model to show aspects of clinical competence in the measurement process

Explaining the purpose of the tool

Designing the route map

Developing the tool (use of methods, classification of objects, rules and procedures for scoring tools) [ 28 ].

Answer to the objects

A 1 to 4-point Likert scale will be used for scoring [ 29 ].

Content validity

To ensure the selection of the most important and correct content (necessity of the case), the content validity will be assessed. Also, to ensure that the instrument items are designed in the best way to measure the content, the content validity index will be calculated [ 30 ].

Reliability

Reliability will be evaluated using internal consistency (Cronbach's alpha coefficient ≥ 0.7) and stability (test-re-test ≥ 0.74) by piloting the questionnaire on 20 midwifery students [ 31 ].

Second stage: quantitative phase

A randomized controlled clinical trial will be conducted in this phase of research to examine the effect of the continuous care program of midwifery students on their clinical competence and pregnancy outcomes.

Sample size

According to the study objective and previous study results [ 32 ] with α = 0.01, β = 0.1, p 1  = 0.51 and p 2  = 0.021, the sample size will be n  = 23. Considering a 20% dropout rate, the final sample size will be 58 women (29 women in each group).

Data collection

This phase of the randomized clinical trial will be conducted with the participation of 58 undergraduate midwifery students at their 7th and 8th semesters. The students will be divided randomly to intervention (continuous care) and control (routine care) groups providing care to 58 pregnant women in six health centers and two hospitals (Sina and Razi) in Ahvaz city, southwest of Iran.

The study will begin after receiving the approval of the Ethics Committee of Ahvaz University of Medical Sciences and registering the study in the Iranian Registry for Randomized Clinical Trials. Inclusion criteria will be willingness to participate in the study.

Randomization

To implement the intervention, the students will be divided into two intervention (providing continuous care for pregnant women) and control (providing standard care for pregnant women) groups. Allocating students will be done using permuted block randomization technique with a block size of four and an allocation ratio of 1:1. Five blocks of 4 pieces and 3 blocks of 3 pieces will be extracted randomly using WIN PEPI software. In each block of 4, 2 students will be in control and 2 will be in intervention group. Also, in each block of 3 students, 1 student will be in control and 2 will be in intervention group, and the arrangement of each person is random. To prevent contamination, first the control group will provide routine care, and then the intervention group will conduct continuity of care for pregnant women. Mothers are randomly selected based on the hospital where they will give birth. As a result, Razi Hospital will be the control group and Sina Hospital will be the intervention group.

Intervention

Women who meet the inclusion criteria will be recruited in the study using a non-probability convenience sampling method. Women in the intervention group will be included in the study after their first pregnancy visit (6–10 weeks of gestation) and will receive continuous care by midwifery students. Women in the control group will receive the usual and routine care, and will be included in the study at the time of delivery. They will have a gestational age of more than 37 weeks based on the inclusion criteria of the study. Their delivery will be performed by midwifery students who will follow them up until six weeks after delivery.

At first, the necessary training will be given by the lead researcher (FR) to the students in orientation sessions held for both groups separately. In the intervention group, each midwifery student as the main midwife will be responsible for taking care of two or three pregnant women and will be the back-up midwife for two other pregnant women (under the supervision of other students). The lead researcher will create a group in WhatsApp with the participation of students in the intervention group, and they can communicate with each other and the researcher. Also, the midwifery students will be directly and indirectly under the supervision of a qualified person (lead researcher). Another WhatsApp group will be created for the women of the intervention and control groups (to facilitate communication between the researcher and the women). Two midwifery students will be introduced to each pregnant woman in the intervention group (as a main midwife and a backup midwife). If the main midwife is not available, the woman will be in contact with the backup midwife. The backup student will meet the woman at least once and will be introduced to her.

Instruments

All students and pregnant women participating in this study will complete a demographic questionnaire. A checklist will be provided for collecting data during prenatal care, labor, and delivery.

Also, the midwifery students will complete the clinical competency questionnaire at the beginning and end of the study.

Care will be provided and recorded by the main student according to the pregnancy care protocol. Also, danger signs will be taught to the students according to the national protocol, and emergencies will be handled by the midwifery student under the supervision of the lead researcher. Admission to hospital will be arranged by the student, and all information will be recorded. Pregnancy, labour and delivery, postpartum, and newborn checklist will be completed. Students will complete a demographic and obstetric questionnaire that includes questions about age, education, occupation, gravidity, parity, abortions, live and dead children, last contraceptive method, intended and unintended pregnancies, last menstrual period (LMP), gestational age, date of birth, body mass index (BMI), previous pregnancy and childbirth records, high-risk behavior of the mother and father, current history of special care, test and ultrasound results, and participation in childbirth preparation class. Also, the following data will be recorded in the labor and delivery and post-partum checklist: checking the conditions of labor according to the partograph, length of labor, need for induction and the method used type of delivery, examination of perineal trauma, postpartum bleeding, and examination of the condition of the mother up to 6 weeks after delivery. In addition, the amount of bleeding will be checked visually and by measuring the level of hemoglobin and hematocrit. Apgar score of the newborn will be recorded (in infant checklist) in minutes 1 and 5. Also, the newborn’s hospitalization status, breastfeeding and anthropometric indices will be recorded.

The students in the intervention group will start prenatal care < 20 weeks of gestation. At least five round of prenatal care will be provided by each student according to national guidelines for each pregnant woman. Pregnant women can communicate with their in-charge students in non-emergency cases from 8:00 a.m. to 23:00 p.m. and in emergency cases 24 h a day, all days a week. All reports will be recorded by the students. During labor and delivery, the student and the lead researcher will be present at the mother's bedside. In case of natural vaginal delivery (NVD), delivery will be done by a student midwife under the supervision of the researcher. In case of cesarean delivery (CS), a student will be present at the patient's bedside. Postpartum care will be provided by midwifery students in both groups (intervention and control). Each student will be at the mother's bedside for two hours after delivery. The conditions of labor, delivery, and the neonate will be recorded by the student in the relevant form. Also, the mother will be followed up by telephone for up to 6 weeks after delivery (postpartum). The clinical competency questionnaire will be completed by students before and after the intervention.

Inclusion criteria

Inclusion criteria for midwifery students will be: studying at the seventh and eighth semester and willingness to participate in the study.

Inclusion criteria for service recipients (pregnant women) will be: age 18 – 40 years, Iranian nationality, singleton pregnancy, low risk pregnancy, and gestational age < 20 wks.

Exclusion criteria

Exclusion criteria will be: history of psychiatric disorders, previous caesarean section, use of alcohol and tobacco, or having a disease that requires prenatal care by a specialist.

Primary outcome

Clinical competence of midwifery students.

Secondary outcome

Mode of delivery, length of labor stages, the need to induction, postpartum bleeding first and fifth minute Apgar score, admission of neonate to the neonatal intensive care unit, breastfeeding initiation, and exclusive breastfeeding up to 6 weeks postpartum.

Data analysis

Statistical analyses will be done using SPSS version 26.0 (SPSS, Inc., Chicago, IL, USA). The independent t-test and Chi-square tests will be used for continuous data and categorical data, respectively. ANCOVA test will be used to eliminate the influence of confounding variables. The effect size will be calculated. A 95% confidence interval (CI) and p values will be reported. P -values less than 0.5 will be considered statistically significant.

Third step of research: qualitative study

This phase will be a qualitative study using conventional content analysis.

Purposeful sampling will be used in this study [ 33 ]. Sampling will continue until data saturation [ 34 ], i.e., no new information or data about a class or relationships between classes is revealed.

This phase of the study is a conventional qualitative content analysis [ 35 ] aimed at examining the perceptions of midwifery students and mothers receiving continuous care. The researcher will conduct in-depth, semi-structured interviews with open-ended questions with students and mothers in the group of the continuous care program. All interviews will be done by the lead researcher who is qualified in qualitative research method. The interview will start with a general and open question such as: “Please tell me about your experiences or feelings about participating in the continuous midwifery care program. How did you feel about participating in this program?” Then, in-depth exploratory questions will be asked based on their answers (e.g., what do you mean? Why? Can you elaborate on that? Can you give me an example so I can understand what you mean?). All interviews will be recorded with the participants' consent. Paralinguistic features, such as mood and features of the participants, including tone of voice, facial expressions, and their posture, will be recorded by the researcher during the interview [ 35 ].

The data will be analyzed based on Granheim and Lundman's 2004 content analysis approach [ 36 ].

Interviews will be transcribed at the end of each interview. Data analysis begins with a careful study of all data so that the researcher can immerse herself in the data and gain an overview. Interviews will be transcribed verbatim. Key concepts will be highlighted and codes will be extracted. Then the first interpretations will be made and analyzed. Labels emerge for codes that represent more than one key concept and are usually taken directly from the text and become the initial coding map. Then the codes are placed in the category based on their similarity. Then, definitions will be created for each category, subcategory and code. When reporting findings, examples of each code and data category will be provided [ 35 ].

Inclusion criteria for midwifery students will be: studying at the seventh or eighth semester, willingness to participate in the study.

Inclusion criteria for service recipients (pregnant women) will be: receiving continuous care provided by the student, willingness to participate in the study, and being able to communicate.

The qualitative study and interview data will be analyzed based on the content analysis approach of Granheim and Lundman 2004 [ 36 ] as follows:

Reading and re-reading the interviews after completion of each interview

Selection of the unit of analysis

Determination of semantic units

Classification

Extraction of information content

In the first step, the data is converted into text format. As soon as possible after the interview, the interview will be typed verbatim. Then the whole text will be read several times to get a general understanding of the content of interview. Each meaning unit will be converted into condensed meaning units and then coded. The Codes will be classified into subcategories and categories based on their common characteristics. Finally, the content of the categories will be revealed, taking into account their hidden meaning [ 36 ].

Trustworthiness

Five criteria of will be used to increase data trustworthiness according to Lincoln & Guba [ 37 ]. These include: 1. Credibility, 2. Dependability, 3. Confirmability, 4. Transferability, 5. Authenticity.

Credibility of the data will be ensured by continuous engagement of the researchers with the subject, member checks, and external checks. Dependability will be ensured by relying on the insight of external observers. In order to increase the confirmability, data will be accurately recorded and reported. Also, transferability will be ensured by presenting the research process accurately, clearly and purposefully, which includes purposive sampling and presenting the research results to a number of people with the same profile of the participants who did not participate in the research. Finally, authenticity will be guaranteed by continuous reflection on information, long-term presence of the researcher, interview recording, writing, and reporting of findings.

Combining qualitative and quantitative phases

Data combination will be done using data integration strategies. The integration or combination of data starts from quantitative data analysis. Then qualitative data is collected by interview. In fact, the qualitative study is a secondary source of embedded data in the collection of experimental test data (continuous care) after the quantitative study. In this research, in order to understand the results of the RCT, the views of the participants will be unified in order to get a correct understanding of the intervention (implementation of the continuity of care model by the students) from the mothers' and students' point of view (Fig.  2 ).

Study diagram

Study status

The development of the evaluation tools was made. Also, sampling the quantitative phase of the study and the basic of the program are in process (Table 1 ).

This is the first mixed-methods study to be conducted in Iran investigating the effect of a midwifery continuity of care program on clinical competence of midwifery students and pregnancy outcomes. According to the recommendations of the WHO, midwifery continuity of care should be adopted in order to increase the quality of pregnancy care as well as the satisfaction of pregnant women and service providers [ 7 ]. Contrary to the recommendation of WHO, the continuous care program is neither implemented in Iran's health system nor included in the midwifery curriculum. The results of this study can help health planners and policy makers to implement high quality midwifery care program based on global recommendations.

The study has several strengths. The use of a mixed-methods study design (combination of quantitative and qualitative approaches) in contrast to the separate use of quantitative and qualitative studies provides a better understanding of the research questions [ 38 ]. In embedded design, one type of data collection (quantitative or qualitative) plays a supporting and essential role for another type. As a result, the embedded mixed-methods technique in the qualitative phase after designing the intervention will be used to receive feedback from the participants to confirm and support the findings of quantitative phase [ 39 ]. Also, interviews with mothers and midwifery students in the intervention group can reflect their positive and negative experiences of this program. Considering that Iran's healthcare system lacks continuous midwifery care, the findings of this research can be effectively used in providing conventional midwifery services in public centers and in midwifery education.

Considering that this care model will be implemented for the first time in Iran's midwifery education and healthcare system, there may be two possible limitations in this study: lack of infrastructure and interference with other educational programs.

Availability of data and materials

All the data that will be obtained will be published in the next article after the implementation of the study.

Abbreviations

Body mass index

Cesarean section

Last menstrual period

Millennium Development Goals

Natural vaginal delivery

World Health Organization

Bagheri A, Simbar M, Samimi M, Nahidi F, Majd HA. Exploring the concept of continuous midwifery-led care and its dimensions in the prenatal, perinatal, and postnatal periods in Iran (Kashan). Midwifery. 2017;51:44–52.

Article   Google Scholar  

Cummins A, Coddington R, Fox D, Symon A. Exploring the qualities of midwifery-led continuity of care in Australia (MiLCCA) using the quality maternal and newborn care framework. Women Birth. 2020;33(2):125–34.

Choudhary S, Jelly P, Mahala P. Models of maternity care: a continuity of midwifery care. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2666–70.

Bradford BF, Wilson AN, Portela A, McConville F, Fernandez Turienzo C, Homer CS. Midwifery continuity of care: a scoping review of where, how, by whom and for whom? PLOS Global Public Health. 2022;2(10):e0000935.

Lettink A, Chaibekava K, Smits L, Langenveld J, van de Laar R, Peeters B, et al. CCT: continuous care trial-a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands. BMC Pregnancy Childbirth. 2020;20(1):1–6.

Chaibekava KV, Scheenen AJ, Lettink A, Smits LJ, Langenveld J, Van De Laar R, et al. Continuous care during labor by maternity care assistants in the Netherlands vs care-as-usual: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023;5(11):101168.

Michel-Schuldt M, McFadden A, Renfrew M, Homer C. The provision of midwife-led care in low-and middle-income countries: an integrative review. Midwifery. 2020;84:102659.

Khosravi S, Babaey F, Abedi P, Kalahroodi ZM, Hajimirzaie SS. Strategies to improve the quality of midwifery care and developing midwife-centered care in Iran: analyzing the attitudes of midwifery experts. BMC Pregnancy Childbirth. 2022;22(1):40.

Donnellan Fernandez R, Scarf V, Devane D, Healey A. Is Midwifery Continuity of Care Cost Effective? Midwifery Continuity of Care. Elsevier; 2019.  p. 137–56.

Aune I, Tysland T, Amalie VS. Norwegian midwives’ experiences of relational continuity of midwifery care in the primary healthcare service: a qualitative descriptive study. Nordic J Nurs Res. 2021;41(1):5–13.

Hanley A, Davis D, Kurz E. Job satisfaction and sustainability of midwives working in caseload models of care: an integrative literature review. Women Birth. 2022;35(4):e397–407.

Grylka-Baeschlin S, Iglesias C, Erdin R, Pehlke-Milde J. Evaluation of a midwifery network to guarantee outpatient postpartum care: a mixed methods study. BMC Health Serv Res. 2020;20:1–12.

Evans J, Taylor J, Browne J, Ferguson S, Atchan M, Maher P, et al. The future in their hands: graduating student midwives’ plans, job satisfaction and the desire to work in midwifery continuity of care. Women Birth. 2020;33(1):e59–66.

Carter J, Sidebotham M, Dietsch E. Prepared and motivated to work in midwifery continuity of care? A descriptive analysis of midwifery students’ perspectives. Women Birth. 2022;35(2):160–71.

Inoue N, Nakao Y, Yoshidome A. Development and validity of an intrapartum self-assessment scale aimed at instilling midwife-led care competencies used at freestanding midwifery units. Int J Environ Res Public Health. 2023;20(3):1859.

Vázquez-Sánchez C, Gigirey L, editors. Design of a scoring rubric for the assessment of clinical competencies in the subject of optometry IV of the degree of optics and optometry-USC. INTED2023 Proceedings. Valencia: IATED; 2023. p. 2224–30. https://doi.org/10.21125/inted.2023.0613 .

Kubota S, Ando M, Murray J, Khambounheuang S, Theppanya K, Nanthavong P, et al. A regulatory gap analysis of midwifery to deliver essential reproductive, maternal, newborn, child and adolescent health services in Lao People’s Democratic Republic. Lancet Reg Health West Pac. 2024;43:1–10. https://doi.org/10.1016/j.lanwpc.2023.100959 .

Pazandeh F, Moridi M, Safari K. Labouring women perspectives on mistreatment during childbirth: a qualitative study. Nursing Ethics. 2023;30(4):513–25. https://doi.org/10.1177/09697330231158732 .

Abbasi A, Bazghaleh M, FadaeeAghdam N, Basirinezhad MH, Tanhan A, Montazeri R, et al. Efficacy of simulated video on test anxiety in objective structured clinical examination among nursing and midwifery students: a quasi-experimental study. Nurs Open. 2023;10(1):165–71.

Farokhi F. Quality assessment of midwives performance in prenatal cares in urban health centers in Mashhad, Iran. Payesh (Health Monitor). 2008;7(3):0.

Google Scholar  

Moradali MR, Hajian S, Majd HA, Rahbar M, Entezarmahdi R. Job Satisfaction and its Related Factors in Midwives Working in the Health Services System in Iran: A Systematic Review. J Midwifery Reprod Health. 2023;11(2):3650–63. https://doi.org/10.22038/jmrh.2023.64824.1890 .

Hainsworth N, Cummins A, Newnham E, Foureur M. Learning through relationships: the transformative learning experience of midwifery continuity of care for students: a qualitative study. Women Birth. 2023;36(4):385–92.

Lazar J. Exploring the experiences of midwives facilitating group antenatal care: City, University of London; 2023.

Adelson P, Fleet J-A, McKellar L. Evaluation of a regional midwifery caseload model of care integrated across five birthing sites in South Australia: women’s experiences and birth outcomes. Women Birth. 2023;36(1):80–8.

Prussing E, Browne G, Dowse E, Hartz D, Cummins A. Implementing midwifery continuity of care models in regional Australia: a constructivist grounded theory study. Women Birth. 2023;36(1):99–107.

Pintubatu J. keterampilan proses sains pada pembelajaran ipas berorientasi outdoor learning siswa SMK Negeri 1 Lolak. Charm Sains: Jurnal Pendidikan Fisika. 2023;4(1):7–12.

Creswell JW. Controversies in mixed methods research. Sage Handbook Qual Res. 2011;4(1):269–84.

Kristensen SB, Clausen A, Skjødt MK, Søndergaard J, Abrahamsen B, Möller S, et al. An enhanced version of FREM (Fracture Risk Evaluation Model) using national administrative health data: analysis protocol for development and validation of a multivariable prediction model. Diagn Progn Res. 2023;7(1):19.

Alabi AT, Jelili MO. Clarifying likert scale misconceptions for improved application in urban studies. Qual Quant. 2023;57(2):1337–50.

Roopashree MR. A pragmatic approach for the calculation content validity indices: a study on validation of training tool for pre and post-test questionnaire for the health care sector. QAI J Healthc Qual Patient Saf. 2023;4(1):17–23.

Martyushev NV, Malozyomov BV, Sorokova SN, Efremenkov EA, Valuev DV, Qi M. Review models and methods for determining and predicting the reliability of technical systems and transport. Mathematics. 2023;11(15):3317.

Hildingsson I, Karlström A, Haines H, Johansson M. Swedish women’s interest in models of midwifery care–Time to consider the system? A prospective longitudinal survey. Sex Reprod Healthc. 2016;7:27–32.

Creswell JW, Creswell JD. Research design: Qualitative, quantitative, and mixed methods approaches. 3rd ed. SAGE Publications Inc.; 2017.

Obilor EI. Convenience and purposive sampling techniques: are they the same. Int J Innov Soc Sci Educ Res. 2023;11(1):1–7.

Serafini F, Reid SF. Multimodal content analysis: expanding analytical approaches to content analysis. Vis Commun. 2023;22(4):623–49.

Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105–12.

Lincoln YS, Guba EG. Naturalistic inquiry. SAGE Publications; 1985.

Matović N, Ovesni K. Interaction of quantitative and qualitative methodology in mixed methods research: integration and/or combination. Int J Social Res Methodol. 2023;26(1):51–65.

Creswell JW, Clark VLP. Designing and conducting mixed methods research. SAGE Publication, Inc; 2017.

Download references

The study was funded by Ahvaz Jundishapur University of Medical Sciences.

Author information

Authors and affiliations.

Midwifery Department, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Fatemeh Razavinia

Midwifery Department, Menopause Andropause Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Midwifery Department, Menopause Andropause Research Center, Ahvaz Jundisahpur University of Medical Sciences, Golestan BLvd, Ahvaz, Iran

Parvin Abedi

Reproductive Health Promotion Research Center, Midwifery Department, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Mina Iravani

Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

Eesa Mohammadi

Alimentary Tract Research Center, Clinical Sciences Research Institute, Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Bahman Cheraghian

MPH Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, USA

Shayesteh Jahanfar

Department of Obstetrics and Gynecology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Mahin Najafian

You can also search for this author in PubMed   Google Scholar

Contributions

FR, PA, MI, EM, BCh, ShJ and MN conceptualized the study. FR will collect the data. FR drafted the protocol. PA revised the manuscript. The authors read and approved the final manuscript.

Corresponding author

Correspondence to Parvin Abedi .

Ethics declarations

Ethics approval and consent to participate.

This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1401.460). Also, the study protocol was registered in the Iranian Registry for Randomized Controlled Trials (IRCT20221227056938N1). Informed consent will be obtained from all participants. The study’s findings will be shared via the publishing of peer-reviewed articles, talks at scientific conferences and meetings with related teams.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Razavinia, F., Abedi, P., Iravani, M. et al. The effect of a midwifery continuity of care program on clinical competence of midwifery students and delivery outcomes: a mixed-methods protocol. BMC Med Educ 24 , 338 (2024). https://doi.org/10.1186/s12909-024-05321-5

Download citation

Received : 28 October 2023

Accepted : 15 March 2024

Published : 26 March 2024

DOI : https://doi.org/10.1186/s12909-024-05321-5

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Continuity of care
• Clinical competence
• Mixed-methods
• Midwifery students
• Pregnancy outcomes

BMC Medical Education

ISSN: 1472-6920

• Submission enquiries: [email protected]
• General enquiries: [email protected]

Advertisement

Supported by

Use of Abortion Pills Has Risen Significantly Post Roe, Research Shows

By Pam Belluck

Pam Belluck has been reporting about reproductive health for over a decade.

• Share full article

On the eve of oral arguments in a Supreme Court case that could affect future access to abortion pills, new research shows the fast-growing use of medication abortion nationally and the many ways women have obtained access to the method since Roe v. Wade was overturned in June 2022.

The Details

A study, published on Monday in the medical journal JAMA , found that the number of abortions using pills obtained outside the formal health system soared in the six months after the national right to abortion was overturned. Another report, published last week by the Guttmacher Institute , a research organization that supports abortion rights, found that medication abortions now account for nearly two-thirds of all abortions provided by the country’s formal health system, which includes clinics and telemedicine abortion services.

The JAMA study evaluated data from overseas telemedicine organizations, online vendors and networks of community volunteers that generally obtain pills from outside the United States. Before Roe was overturned, these avenues provided abortion pills to about 1,400 women per month, but in the six months afterward, the average jumped to 5,900 per month, the study reported.

Overall, the study found that while abortions in the formal health care system declined by about 32,000 from July through December 2022, much of that decline was offset by about 26,000 medication abortions from pills provided by sources outside the formal health system.

“We see what we see elsewhere in the world in the U.S. — that when anti-abortion laws go into effect, oftentimes outside of the formal health care setting is where people look, and the locus of care gets shifted,” said Dr. Abigail Aiken, who is an associate professor at the University of Texas at Austin and the lead author of the JAMA study.

The co-authors were a statistics professor at the university; the founder of Aid Access, a Europe-based organization that helped pioneer telemedicine abortion in the United States; and a leader of Plan C, an organization that provides consumers with information about medication abortion. Before publication, the study went through the rigorous peer review process required by a major medical journal.

The telemedicine organizations in the study evaluated prospective patients using written medical questionnaires, issued prescriptions from doctors who were typically in Europe and had pills shipped from pharmacies in India, generally charging about $100. Community networks typically asked for some information about the pregnancy and either delivered or mailed pills with detailed instructions, often for free.

Online vendors, which supplied a small percentage of the pills in the study and charged between $39 and $470, generally did not ask for women’s medical history and shipped the pills with the least detailed instructions. Vendors in the study were vetted by Plan C and found to be providing genuine abortion pills, Dr. Aiken said.

The Guttmacher report, focusing on the formal health care system, included data from clinics and telemedicine abortion services within the United States that provided abortion to patients who lived in or traveled to states with legal abortion between January and December 2023.

It found that pills accounted for 63 percent of those abortions, up from 53 percent in 2020. The total number of abortions in the report was over a million for the first time in more than a decade.

Why This Matters

Overall, the new reports suggest how rapidly the provision of abortion has adjusted amid post-Roe abortion bans in 14 states and tight restrictions in others.

The numbers may be an undercount and do not reflect the most recent shift: shield laws in six states allowing abortion providers to prescribe and mail pills to tens of thousands of women in states with bans without requiring them to travel. Since last summer, for example, Aid Access has stopped shipping medication from overseas and operating outside the formal health system; it is instead mailing pills to states with bans from within the United States with the protection of shield laws.

What’s Next

In the case that will be argued before the Supreme Court on Tuesday, the plaintiffs, who oppose abortion, are suing the Food and Drug Administration, seeking to block or drastically limit the availability of mifepristone, the first pill in the two-drug medication abortion regimen.

The JAMA study suggests that such a ruling could prompt more women to use avenues outside the formal American health care system, such as pills from other countries.

“There’s so many unknowns about what will happen with the decision,” Dr. Aiken said.

She added: “It’s possible that a decision by the Supreme Court in favor of the plaintiffs could have a knock-on effect where more people are looking to access outside the formal health care setting, either because they’re worried that access is going away or they’re having more trouble accessing the medications.”

Pam Belluck is a health and science reporter, covering a range of subjects, including reproductive health, long Covid, brain science, neurological disorders, mental health and genetics. More about Pam Belluck

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• J Med Libr Assoc
• v.107(1); 2019 Jan

Distinguishing case study as a research method from case reports as a publication type

The purpose of this editorial is to distinguish between case reports and case studies. In health, case reports are familiar ways of sharing events or efforts of intervening with single patients with previously unreported features. As a qualitative methodology, case study research encompasses a great deal more complexity than a typical case report and often incorporates multiple streams of data combined in creative ways. The depth and richness of case study description helps readers understand the case and whether findings might be applicable beyond that setting.

Single-institution descriptive reports of library activities are often labeled by their authors as “case studies.” By contrast, in health care, single patient retrospective descriptions are published as “case reports.” Both case reports and case studies are valuable to readers and provide a publication opportunity for authors. A previous editorial by Akers and Amos about improving case studies addresses issues that are more common to case reports; for example, not having a review of the literature or being anecdotal, not generalizable, and prone to various types of bias such as positive outcome bias [ 1 ]. However, case study research as a qualitative methodology is pursued for different purposes than generalizability. The authors’ purpose in this editorial is to clearly distinguish between case reports and case studies. We believe that this will assist authors in describing and designating the methodological approach of their publications and help readers appreciate the rigor of well-executed case study research.

Case reports often provide a first exploration of a phenomenon or an opportunity for a first publication by a trainee in the health professions. In health care, case reports are familiar ways of sharing events or efforts of intervening with single patients with previously unreported features. Another type of study categorized as a case report is an “N of 1” study or single-subject clinical trial, which considers an individual patient as the sole unit of observation in a study investigating the efficacy or side effect profiles of different interventions. Entire journals have evolved to publish case reports, which often rely on template structures with limited contextualization or discussion of previous cases. Examples that are indexed in MEDLINE include the American Journal of Case Reports , BMJ Case Reports, Journal of Medical Case Reports, and Journal of Radiology Case Reports . Similar publications appear in veterinary medicine and are indexed in CAB Abstracts, such as Case Reports in Veterinary Medicine and Veterinary Record Case Reports .

As a qualitative methodology, however, case study research encompasses a great deal more complexity than a typical case report and often incorporates multiple streams of data combined in creative ways. Distinctions include the investigator’s definitions and delimitations of the case being studied, the clarity of the role of the investigator, the rigor of gathering and combining evidence about the case, and the contextualization of the findings. Delimitation is a term from qualitative research about setting boundaries to scope the research in a useful way rather than describing the narrow scope as a limitation, as often appears in a discussion section. The depth and richness of description helps readers understand the situation and whether findings from the case are applicable to their settings.

CASE STUDY AS A RESEARCH METHODOLOGY

Case study as a qualitative methodology is an exploration of a time- and space-bound phenomenon. As qualitative research, case studies require much more from their authors who are acting as instruments within the inquiry process. In the case study methodology, a variety of methodological approaches may be employed to explain the complexity of the problem being studied [ 2 , 3 ].

Leading authors diverge in their definitions of case study, but a qualitative research text introduces case study as follows:

Case study research is defined as a qualitative approach in which the investigator explores a real-life, contemporary bounded system (a case) or multiple bound systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information, and reports a case description and case themes. The unit of analysis in the case study might be multiple cases (a multisite study) or a single case (a within-site case study). [ 4 ]

Methodologists writing core texts on case study research include Yin [ 5 ], Stake [ 6 ], and Merriam [ 7 ]. The approaches of these three methodologists have been compared by Yazan, who focused on six areas of methodology: epistemology (beliefs about ways of knowing), definition of cases, design of case studies, and gathering, analysis, and validation of data [ 8 ]. For Yin, case study is a method of empirical inquiry appropriate to determining the “how and why” of phenomena and contributes to understanding phenomena in a holistic and real-life context [ 5 ]. Stake defines a case study as a “well-bounded, specific, complex, and functioning thing” [ 6 ], while Merriam views “the case as a thing, a single entity, a unit around which there are boundaries” [ 7 ].

Case studies are ways to explain, describe, or explore phenomena. Comments from a quantitative perspective about case studies lacking rigor and generalizability fail to consider the purpose of the case study and how what is learned from a case study is put into practice. Rigor in case studies comes from the research design and its components, which Yin outlines as (a) the study’s questions, (b) the study’s propositions, (c) the unit of analysis, (d) the logic linking the data to propositions, and (e) the criteria for interpreting the findings [ 5 ]. Case studies should also provide multiple sources of data, a case study database, and a clear chain of evidence among the questions asked, the data collected, and the conclusions drawn [ 5 ].

Sources of evidence for case studies include interviews, documentation, archival records, direct observations, participant-observation, and physical artifacts. One of the most important sources for data in qualitative case study research is the interview [ 2 , 3 ]. In addition to interviews, documents and archival records can be gathered to corroborate and enhance the findings of the study. To understand the phenomenon or the conditions that created it, direct observations can serve as another source of evidence and can be conducted throughout the study. These can include the use of formal and informal protocols as a participant inside the case or an external or passive observer outside of the case [ 5 ]. Lastly, physical artifacts can be observed and collected as a form of evidence. With these multiple potential sources of evidence, the study methodology includes gathering data, sense-making, and triangulating multiple streams of data. Figure 1 shows an example in which data used for the case started with a pilot study to provide additional context to guide more in-depth data collection and analysis with participants.

Key sources of data for a sample case study

VARIATIONS ON CASE STUDY METHODOLOGY

Case study methodology is evolving and regularly reinterpreted. Comparative or multiple case studies are used as a tool for synthesizing information across time and space to research the impact of policy and practice in various fields of social research [ 9 ]. Because case study research is in-depth and intensive, there have been efforts to simplify the method or select useful components of cases for focused analysis. Micro-case study is a term that is occasionally used to describe research on micro-level cases [ 10 ]. These are cases that occur in a brief time frame, occur in a confined setting, and are simple and straightforward in nature. A micro-level case describes a clear problem of interest. Reporting is very brief and about specific points. The lack of complexity in the case description makes obvious the “lesson” that is inherent in the case; although no definitive “solution” is necessarily forthcoming, making the case useful for discussion. A micro-case write-up can be distinguished from a case report by its focus on briefly reporting specific features of a case or cases to analyze or learn from those features.

DATABASE INDEXING OF CASE REPORTS AND CASE STUDIES

Disciplines such as education, psychology, sociology, political science, and social work regularly publish rich case studies that are relevant to particular areas of health librarianship. Case reports and case studies have been defined as publication types or subject terms by several databases that are relevant to librarian authors: MEDLINE, PsycINFO, CINAHL, and ERIC. Library, Information Science & Technology Abstracts (LISTA) does not have a subject term or publication type related to cases, despite many being included in the database. Whereas “Case Reports” are the main term used by MEDLINE’s Medical Subject Headings (MeSH) and PsycINFO’s thesaurus, CINAHL and ERIC use “Case Studies.”

Case reports in MEDLINE and PsycINFO focus on clinical case documentation. In MeSH, “Case Reports” as a publication type is specific to “clinical presentations that may be followed by evaluative studies that eventually lead to a diagnosis” [ 11 ]. “Case Histories,” “Case Studies,” and “Case Study” are all entry terms mapping to “Case Reports”; however, guidance to indexers suggests that “Case Reports” should not be applied to institutional case reports and refers to the heading “Organizational Case Studies,” which is defined as “descriptions and evaluations of specific health care organizations” [ 12 ].

PsycINFO’s subject term “Case Report” is “used in records discussing issues involved in the process of conducting exploratory studies of single or multiple clinical cases.” The Methodology index offers clinical and non-clinical entries. “Clinical Case Study” is defined as “case reports that include disorder, diagnosis, and clinical treatment for individuals with mental or medical illnesses,” whereas “Non-clinical Case Study” is a “document consisting of non-clinical or organizational case examples of the concepts being researched or studied. The setting is always non-clinical and does not include treatment-related environments” [ 13 ].

Both CINAHL and ERIC acknowledge the depth of analysis in case study methodology. The CINAHL scope note for the thesaurus term “Case Studies” distinguishes between the document and the methodology, though both use the same term: “a review of a particular condition, disease, or administrative problem. Also, a research method that involves an in-depth analysis of an individual, group, institution, or other social unit. For material that contains a case study, search for document type: case study.” The ERIC scope note for the thesaurus term “Case Studies” is simple: “detailed analyses, usually focusing on a particular problem of an individual, group, or organization” [ 14 ].

PUBLICATION OF CASE STUDY RESEARCH IN LIBRARIANSHIP

We call your attention to a few examples published as case studies in health sciences librarianship to consider how their characteristics fit with the preceding definitions of case reports or case study research. All present some characteristics of case study research, but their treatment of the research questions, richness of description, and analytic strategies vary in depth and, therefore, diverge at some level from the qualitative case study research approach. This divergence, particularly in richness of description and analysis, may have been constrained by the publication requirements.

As one example, a case study by Janke and Rush documented a time- and context-bound collaboration involving a librarian and a nursing faculty member [ 15 ]. Three objectives were stated: (1) describing their experience of working together on an interprofessional research team, (2) evaluating the value of the librarian role from librarian and faculty member perspectives, and (3) relating findings to existing literature. Elements that signal the qualitative nature of this case study are that the authors were the research participants and their use of the term “evaluation” is reflection on their experience. This reads like a case study that could have been enriched by including other types of data gathered from others engaging with this team to broaden the understanding of the collaboration.

As another example, the description of the academic context is one of the most salient components of the case study written by Clairoux et al., which had the objectives of (1) describing the library instruction offered and learning assessments used at a single health sciences library and (2) discussing the positive outcomes of instruction in that setting [ 16 ]. The authors focus on sharing what the institution has done more than explaining why this institution is an exemplar to explore a focused question or understand the phenomenon of library instruction. However, like a case study, the analysis brings together several streams of data including course attendance, online material page views, and some discussion of results from surveys. This paper reads somewhat in between an institutional case report and a case study.

The final example is a single author reporting on a personal experience of creating and executing the role of research informationist for a National Institutes of Health (NIH)–funded research team [ 17 ]. There is a thoughtful review of the informationist literature and detailed descriptions of the institutional context and the process of gaining access to and participating in the new role. However, the motivating question in the abstract does not seem to be fully addressed through analysis from either the reflective perspective of the author as the research participant or consideration of other streams of data from those involved in the informationist experience. The publication reads more like a case report about this informationist’s experience than a case study that explores the research informationist experience through the selection of this case.

All of these publications are well written and useful for their intended audiences, but in general, they are much shorter and much less rich in depth than case studies published in social sciences research. It may be that the authors have been constrained by word counts or page limits. For example, the submission category for Case Studies in the Journal of the Medical Library Association (JMLA) limited them to 3,000 words and defined them as “articles describing the process of developing, implementing, and evaluating a new service, program, or initiative, typically in a single institution or through a single collaborative effort” [ 18 ]. This definition’s focus on novelty and description sounds much more like the definition of case report than the in-depth, detailed investigation of a time- and space-bound problem that is often examined through case study research.

Problem-focused or question-driven case study research would benefit from the space provided for Original Investigations that employ any type of quantitative or qualitative method of analysis. One of the best examples in the JMLA of an in-depth multiple case study that was authored by a librarian who published the findings from her doctoral dissertation represented all the elements of a case study. In eight pages, she provided a theoretical basis for the research question, a pilot study, and a multiple case design, including integrated data from interviews and focus groups [ 19 ].

We have distinguished between case reports and case studies primarily to assist librarians who are new to research and critical appraisal of case study methodology to recognize the features that authors use to describe and designate the methodological approaches of their publications. For researchers who are new to case research methodology and are interested in learning more, Hancock and Algozzine provide a guide [ 20 ].

We hope that JMLA readers appreciate the rigor of well-executed case study research. We believe that distinguishing between descriptive case reports and analytic case studies in the journal’s submission categories will allow the depth of case study methodology to increase. We also hope that authors feel encouraged to pursue submitting relevant case studies or case reports for future publication.

Editor’s note: In response to this invited editorial, the Journal of the Medical Library Association will consider manuscripts employing rigorous qualitative case study methodology to be Original Investigations (fewer than 5,000 words), whereas manuscripts describing the process of developing, implementing, and assessing a new service, program, or initiative—typically in a single institution or through a single collaborative effort—will be considered to be Case Reports (formerly known as Case Studies; fewer than 3,000 words).

• Do Not Sell My Personal Info

•  ⋅ 
• Content Marketing

35 Content Marketing Statistics You Should Know

Stay informed with the latest content marketing statistics. Discover how optimized content can elevate your digital marketing efforts.

Content continues to sit atop the list of priorities in most marketing strategies, and there is plenty of evidence to support the reasoning.

Simply put, content marketing is crucial to any digital marketing strategy, whether running a small local business or a large multinational corporation.

After all, content in its many and evolving forms is indisputably the very lifeblood upon which the web and social media are based.

Modern SEO has effectively become optimized content marketing for all intents and purposes.

This is when Google demands and rewards businesses that create content demonstrating experience, expertise, authoritativeness, and trustworthiness (E-E-A-T) for their customers – content that answers all of the questions consumers may have about their services, products, or business in general.

Content marketing involves creating and sharing helpful, relevant, entertaining, and consistent content in various text, image, video, and audio-based formats to the plethora of traditional and online channels available to modern marketers.

The primary focus should be on attracting and retaining a clearly defined audience, with the ultimate goal of driving profitable customer action.

Different types of content can and should be created for each stage of a customer’s journey .

Some content, like blogs or how-to videos, are informative or educational. Meanwhile, other content, like promotional campaign landing pages , gets to the point of enticing prospective customers to buy.

But with so much content being produced and shared every day, it’s important to stay updated on the latest trends and best practices in content marketing to keep pace and understand what strategies may be most effective.

Never has this been more true than in 2024, when we’re in the midst of a content revolution led by generative AI , which some feel represents both an opportunity and a threat to marketers.

To help you keep up, here are 35 content marketing statistics I think you should know:

Content Marketing Usage

How many businesses are leveraging content marketing, and how are they planning to find success?

• According to the Content Marketing Institute (CMI), 73% of B2B marketers, and 70% of B2C marketers use content marketing as part of their overall marketing strategy.
• 97% of marketers surveyed by Semrush achieved success with their content marketing in 2023.
• A B2B Content Marketing Study conducted by CMI found that 40% of B2B marketers have a documented content marketing strategy; 33% have a strategy, but it’s not documented, and 27% have no strategy.
• Half of the surveyed marketers by CMI said they outsource at least one content marketing activity.

Content Marketing Strategy

What strategies are content marketers using or finding to be most effective?

• 83% of marketers believe it’s more effective to create higher quality content less often. (Source: Hubspot)
• In a 2022 Statista Research Study of marketers worldwide, 62% of respondents emphasized the importance of being “always on” for their customers, while 23% viewed content-led communications as the most effective method for personalized targeting efforts.
• With the increased focus on AI-generated search engine results, 31% of B2B marketers say they are sharpening their focus on user intent/answering questions, 27% are creating more thought leadership content, and 22% are creating more conversational content. (Source: CMI)

Types Of Content

Content marketing was synonymous with posting blogs, but the web and content have evolved into audio, video, interactive, and meta formats.

Here are a few stats on how the various types of content are trending and performing.

• Short-form video content, like TikTok and Instagram Reel, is the No. 1 content marketing format, offering the highest return on investment (ROI).
• 43% of marketers reported that original graphics (like infographics and illustrations) were the most effective type of visual content. (Source: Venngage)
• 72% of B2C marketers expected their organization to invest in video marketing in 2022. (Source: Content Marketing Institute – CMI)
• The State of Content Marketing: 2023 Global Report by Semrush reveals that articles containing at least one video tend to attract 70% more organic traffic than those without.
• Interactive content generates 52.6% more engagement compared to static content. On average, buyers spend 8.5 minutes viewing static content items and 13 minutes on interactive content items. (Source: Mediafly)

Content Creation

Creating helpful, unique, engaging content can be one of a marketer’s greatest challenges. However, innovative marketers are looking at generative AI as a tool to help ideate, create, edit, and analyze content quicker and more cost-effectively.

Here are some stats around content creation and just how quickly AI is changing the game.

• Generative AI reached over 100 million users just two months after ChatGPT’s launch. (Source: Search Engine Journal)
• A recent Ahrefs poll found that almost 80% of respondents had already adopted AI tools in their content marketing strategies.
• Marketers who are using AI said it helps most with brainstorming new topics ( 51%) , researching headlines and keywords (45%), and writing drafts (45%). (Source: CMI)
• Further, marketers polled by Hubspot said they save 2.5 hours per day using AI for content.

Content Distribution

It is not simply enough to create and publish content.

For a content strategy to be successful, it must include distributing content via the channels frequented by a business’s target audience.

• Facebook is still the dominant social channel for content distribution, but video-centric channels like YouTube, TikTok, and Instagram are growing the fastest .  (Source: Hubspot)
• B2B marketers reported to CMI that LinkedIn was the most common and top-performing organic social media distribution channel at 84% by a healthy margin. All other channels came in under 30%.
• 80% of B2B marketers who use paid distribution use paid social media advertising. (Source: CMI)

Content Consumption

Once content reaches an audience, it’s important to understand how an audience consumes the content or takes action as a result.

• A 2023 Content Preferences Study by Demand Gen reveals that 62% of B2B buyers prefer practical content like case studies to inform their purchasing decisions, citing “a need for valid sources.”
• The same study also found that buyers tend to rely heavily on content when researching potential business solutions, with 46% reporting that they increased the amount of content they consumed during this time.
• In a recent post, blogger Ryan Robinson reports the average reader spends 37 seconds reading a blog.
• DemandGen’s survey participants also said they rely most on demos ( 62% ) and user reviews (55%) to gain valuable insights into how a solution will meet their needs.

Content Marketing Performance

One of the primary reasons content marketing has taken off is its ability to be measured, optimized, and tied to a return on investment.

• B2C marketers reported to CMI that the top three goals content marketing helps them to achieve are creating brand awareness, building trust, and educating their target audience.
• 87% of B2B marketers surveyed use content marketing successfully to generate leads.
• 56% of marketers who leverage blogging say it’s an effective tactic, and 10% say it generates the greatest return on investment (ROI).
• 94% of marketers said personalization boosts sales.

Content Marketing Budgets

Budget changes and the willingness to invest in specific marketing strategies are good indicators of how popular and effective these strategies are at a macro level.

The following stats certainly seem to indicate marketers have bought into the value of content.

• 61% of B2C marketers said their 2022 content marketing budget would exceed their 2021 budget.
• 22% of B2B marketers said they spent 50% or more of their total marketing budget on content marketing. Furthermore, 43% saw their content marketing budgets grow from 2020 to 2021, and 66% expected them to grow again in 2022.

Content Challenges

All forms of marketing come with challenges related to time, resources, expertise, and competition.

Recognizing and addressing these challenges head-on with well-thought-out strategies is the best way to overcome them and realize success.

• Top 3 content challenges included “attracting quality leads with content” ( 45% ), “creating more content faster” (38%), and “generating content ideas” (35%). (Source: Semrush’s The State of Content Marketing: 2023 Global Report)
• 44% of marketers polled for CMI’s 2022 B2B report highlighted the challenge of creating the right content for multi-level roles as their top concern. This replaced internal communication as the top challenge from the previous year.
• Changes to SEO/search algorithms ( 64% ), changes to social media algorithms (53%), and data management/analytics (48%) are also among the top concerns for B2C marketers.
• 47% of people are seeking downtime from internet-enabled devices due to digital fatigue.
• While generative AI has noted benefits, it also presents challenges for some marketers who fear it may replace them. In Hubspot’s study, 23% said they felt we should avoid using generative AI.
• Another challenge with AI is how quickly it has come onto the scene without giving organizations time to provide training or to create policies and procedures for its appropriate and legal use. According to CMI, when asked if their organizations have guidelines for using generative AI tools, 31% of marketers said yes, 61% said no, and 8% were unsure.

Time To Get Started

As you can clearly see and perhaps have already realized, content marketing can be a highly effective and cost-efficient way to generate leads, build brand awareness, and drive sales. Content, in its many formats, powers virtually all online interactions.

Generative AI is effectively helping to solve some of the time and resource challenges by acting as a turbo-powered marketing assistant, while also raising a few procedural concerns.

However, the demand for content remains strong.

Those willing to put in the work of building a documented content strategy and executing it – by producing, optimizing, distributing, and monitoring high-value, relevant, customer-centric content, with the help of AI or not – can reap significant business rewards.

More resources:

• 6 Ways To Humanize Your Content In The AI Era
• Interactive Content: 10 Types To Engage Your Audience
• B2B Lead Generation: Create Content That Converts

Featured Image: Deemak Daksina/Shutterstock 

Jeff has been helping organizations manage, measure and optimize their Web presences for over 20 years. He has deep knowledge ...

Subscribe To Our Newsletter.

Conquer your day with daily search marketing news.