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  • Published: 27 June 2011

The case study approach

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

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

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

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Introduction

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

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

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

What is a case study?

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

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

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

What are case studies used for?

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

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

How are case studies conducted?

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

Defining the case

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

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

Selecting the case(s)

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

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

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

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

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

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

Collecting the data

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

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

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

Analysing, interpreting and reporting case studies

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

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

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

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

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

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

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

Conclusions

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

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Acknowledgements

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

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

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

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

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

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

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

Table of contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Research bias

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

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What Is a Case Study?

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

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

clinical or case study method

Cara Lustik is a fact-checker and copywriter.

clinical or case study method

Verywell / Colleen Tighe

Benefits and Limitations

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

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

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

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

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

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

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

On the negative side, a case study:

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

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

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

Case Study Examples

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

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

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

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

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

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

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

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

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

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

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

Where to Find Data

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

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

Section 1: A Case History

This section will have the following structure and content:

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

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

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

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

Section 2: Treatment Plan

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

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

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

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

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

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

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

A Word From Verywell

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

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

Simply Psychology. Case Study Method .

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

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

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

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

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Case Study Research Method in Psychology

Saul Mcleod, PhD

Educator, Researcher

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, Ph.D., is a qualified psychology teacher with over 18 years experience of working in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

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

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

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

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

Case studies are widely used in psychology, and amongst the best known were the ones carried out by Sigmund Freud, including Anna O and Little Hans .

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

Even today, case histories are one of the main methods of investigation in abnormal psychology and psychiatry.

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

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

The procedure used in a case study means that the researcher provides a description of the behavior. This comes from interviews and other sources, such as observation.

The client also reports detail of events from his or her point of view. The researcher then writes up the information from both sources above as the case study and interprets the information.

The research may also continue for an extended period of time, so processes and developments can be studied as they happen.

Amongst the sources of data the psychologist is likely to turn to when carrying out a case study are observations of a person’s daily routine, unstructured interviews with the participant herself (and with people who know her), diaries, personal notes (e.g., letters, photographs, notes) or official document (e.g., case notes, clinical notes, appraisal reports).

The case study method often involves simply observing what happens to or reconstructing ‘the case history’ of a single participant or group of individuals (such as a school class or a specific social group), i.e., the idiographic approach .

The interview is also an extremely effective procedure for obtaining information about an individual, and it may be used to collect comments from the person’s friends, parents, employer, workmates, and others who have a good knowledge of the person, as well as to obtain facts from the person him or herself.

Most of this information is likely to be qualitative (i.e., verbal description rather than measurement), but the psychologist might collect numerical data as well.

The data collected can be analyzed using different theories (e.g., grounded theory, interpretative phenomenological analysis, text interpretation, e.g., thematic coding).

All the approaches mentioned here use preconceived categories in the analysis, and they are ideographic in their approach, i.e., they focus on the individual case without reference to a comparison group.

Interpreting the information means the researcher decides what to include or leave out. A good case study should always clarify which information is the factual description and which is an inference or the researcher’s opinion.

  • Provides detailed (rich qualitative) information.
  • Provides insight for further research.
  • Permitting investigation of otherwise impractical (or unethical) situations.

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

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

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

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

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

Limitations

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

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

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

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

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

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

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

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

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

Further Information

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

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Focused review article, clinical case studies in psychoanalytic and psychodynamic treatment.

clinical or case study method

  • Centre for Psychoanalytic Studies, University of Essex, Colchester, UK

This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases.

Introduction

Psychoanalysis has always been, according to its inventor, both a research endeavor and a therapeutic endeavor. Furthermore it is clear from Freud's autobiography that he prioritized the research aspect; he did not become a doctor because he wished to cure people in ill health ( Freud, 2001 [1925] ). His invention of the psychoanalytic approach to therapy, involving the patient lying down and associating freely, served a research purpose as much as a therapeutic purpose. Through free association, he would be able to gain unique insight in the human mind. Next, he had to find a format to report on his findings, and this would be the case study. The case study method already existed in medicine ( Forrester, 2016 ), but Freud adjusted it considerably. Case studies in medical settings were more like case files, in which the patient was described or reduced to a number of medical categories: the patient became a case of some particular ailment ( Forrester, 2016 ). In Freud's hands, the case study developed into Kranken Geschichten in which the current pathology of the patient is related to the whole of his life, sometimes even over generations.

Although Freud's case studies have demonstrably provided data for generations of research by analysts ( Midgley, 2006a ) and various scholars ( Pletsch, 1982 ; Sealey, 2011 ; Damousi et al., 2015 ), the method of the case study has become very controversial. According to Midgley (2006b) , objections against the case study method can be grouped into three arguments. First there is the data problem: case studies provide no objective clinical data ( Widlöcher, 1994 ), they only report on what went right and disregard any confusion or mistakes ( Spence, 2001 ). Second, there is the data analysis problem: the way in which the observations of the case study are analyzed lack validity; case studies confirm what we already know ( Spence, 2001 ). Some go even so far to say that they are purely subjective: Michels calls case studies the “crystallization of the analyst's countertransference” ( Michels, 2000 , p. 373). Thirdly, there is the generalizability problem: it is not possible to gain generalizable insight from case studies. Reading, writing and presenting case studies has been described as being a group ritual to affirm analysts in their professional identity, rather than a research method ( Widlöcher, 1994 ).

These criticisms stand in contrast to the respect gained by the case study method in the last two decades. Since the 1990s there has been an increasing number of psychoanalytic and psychodynamic clinical case study and empirical case studies being published in scientific journals ( Desmet et al., 2013 ; Cornelis et al., in press ). It has also been signaled that the case study method is being revived more broadly in the social sciences. In the most recent, fifth edition of his seminal book on case study research, Yinn (2014) includes a figure showing the steady increase of the frequency with which the term “case study research” appears in published books in the period from 1980 to 2008.

KEY CONCEPT 1. Clinical case study A clinical case study is a narrative report by the therapist of what happened during a therapy together with the therapist's interpretations of what happened. It is possible that certain (semi)-structured assessment instruments, such as a questionnaire or a diagnostic interview are included in clinical case studies, yet it is still the therapist that uses these, interprets and discusses them.

KEY CONCEPT 2. Empirical case studies In an empirical case study data are gathered from different sources (e.g., self-report, observation,…) and there is a research team involved in the analyses of the data. This study can take place either in a naturalistic setting (systematic case study) or in a controlled experimental environment (single-case experiment).

In addition to the controversy about the case study method, psychoanalysis has developed into a fragmented discipline. The different psychoanalytic schools share Freud's idea of the unconscious mind, but they focus on different aspects in his theoretical work. Some of the schools still operate under the wings of the International Psychoanalytic Association, while others have established their own global association. Each school is linked to one or several key psychoanalysts who have developed their own version of psychoanalysis. Each psychoanalytic school has a different set of theories but there are also differences in the training of new psychoanalysts and in the therapeutic techniques that are applied by its proponents.

Based on this heterogeneity of perspectives in psychoanalysis, a research group around the Single Case Archive investigated the current status of case study research in psychoanalysis ( Willemsen et al., 2015a ). They were particularly interested to know more about the output and methodology of case studies within the different psychoanalytic schools.

KEY CONCEPT 3. Single case archive The Single Case Archive is an online archive of published clinical and empirical case studies in the field of psychotherapy ( http://www.singlecasearchive.com ). The objective of this archive is to facilitate the study of case studies for research, clinical, and teaching purposes. The online search engine allows the identification of sets of cases in function of specific clinical or research questions.

Our Survey Among Case Study Authors About their Psychoanalytic School

In order to investigate and compare case studies from different psychoanalytic schools, we first had to find a way of identifying to which school the case studies belonged. This is very difficult to judge straightforwardly on the basis of the published case study: the fact that someone cites Winnicott or makes transference interpretations doesn't place him or her firmly within a particular psychoanalytic school. The best approach was to ask the authors themselves. Therefore, we contacted all case study authors included in the Single Case Archive (since the time of our original study in 2013, the archive has expanded). We sent emails and letters in different languages to 445 authors and received 200 replies (45% response rate). We asked them the following question: “ At the time you were working on this specific case, to which psychoanalytic school(s) did you feel most attached? ” Each author was given 10 options: (1) Self Psychology (1.a Theory of Heinz Kohut, 1.b Post-Kohutian Theories, 1.c Intersubjective psychoanalysis), (2) Relational psychoanalysis, (3) Interpersonal psychoanalysis, (4) Object relational psychoanalysis (4.a Theory of Melanie Klein, 4.b Theory of Donald W. Winnicott, 4.c Theory of Wilfred R. Bion, 4.d Theory of Otto F. Kernberg), (5) Ego psychology (or) “Classic psychoanalysis” (5.a Theories of Sigmund Freud, 5.b Ego psychology, 5.c Post-Ego psychology), (6) Lacanian psychoanalysis, (7) Jungian psychoanalysis, (8) National Psychological Association for Psychoanalysis (NPAP) related theory, (9) Modern psychoanalysis related to the Boston or New York Graduate School of Psychoanalysis (BGSP/NYGSP), (10) Other. Respondents could indicate one or more options.

Analysis of the responses indicated that the two oldest schools in psychoanalysis, Object-relations psychoanalysis and Ego psychology, dominate the field in relation to case studies that are published in scientific journals. More than three quarters of all case study authors (77%) reported these schools of thought to be the ones with which they considered themselves most affiliated. Three more recent schools were also well-represented among case studies: Self Psychology, Relational Psychoanalysis, and Interpersonal Psychoanalysis. Lacanian Psychoanalysis, Jungian Psychoanalysis, NPAP related Theory and Modern Psychoanalysis related to the BGSP/NYGSP were only rarely mentioned by case study authors as their school of thought. This does not mean that clinicians or researchers within these latter schools do not write any case studies. It only means that they publish few case studies in the scientific journals included in ISI-ranked journals indexed in Web of Science. But they might have their own journals in which they publish clinical material.

Our survey demonstrated that the majority of case study authors (59%) feel attached to more than one psychoanalytic school. This was in fact one of the surprising findings in our study. It seems that theoretical pluralism is more rule than exception among case study authors. There were some differences between the psychoanalytic schools though in terms of pluralism. Case study authors who feel attached to Self Psychology and Interpersonal Psychoanalysis are the most pluralistic: 92 and 86%, respectively also affiliate with one or more other psychoanalytic schools. Case study authors who feel attached to Object Relations Psychoanalysis are the “purest” group: only 69% of them affiliate with one or more other psychoanalytic schools.

KEY CONCEPT 4. Theoretical pluralism A situation in which several, potentially contradicting, theories coexist. It is sometimes interpreted as a sign of the immaturity of a science, under the assumption that a mature science should arrive at one single coherent truth. Others see theoretical pluralism as unavoidable for any applied discipline, as each theory can highlight only part of reality.

Psychoanalytic Pluralism and the Case Study Method

We were not really surprised to find that Object Relations psychoanalysis and Ego psychology were the most dominant schools in the field of psychoanalytic case studies, as they are very present in European, Latin-American and North-American psychoanalytic institutes. We were more surprised to find such a high degree of pluralism among these case study authors, given the fact that disputes between analysts from different schools can be quite ardent ( Green, 2005 ; Summers, 2008 ). Others have compared the situation of psychoanalytic schools with the Tower of Babel ( Steiner, 1994 ).

It has been argued that the case study method contributes to the degree of theoretical pluralism within psychoanalysis. The reason for this is situated in the reasoning style at the basis of case study research ( Chiesa, 2010 ; Fonagy, 2015 ). The author of a psychoanalytic case study makes a number of observations about the patient within the context of the treatment, and then moves to a conclusion about the patient's psychodynamics in general. The conclusion he or she arrives at inductively gains its “truth value” from the number and quality of observations it is based on. This style of reasoning in case study research is very similar to how clinicians reason in general. Clinicians look for patterns within patients and across patients. If they make similar observations in different patients, or if other psychoanalysts make similar observations in their patients, the weight of the conclusion becomes greater and greater. The problem with this reasoning style is that one can never arrive at definite conclusions: even if a conclusion is based on a large number of observations, it is always possible that the next observation disconfirms the conclusion. Therefore, it could be said, it is impossible to attain “true” knowledge.

The above argument is basically similar to objections against any kind of qualitative research. To this, we argue with Rustin (2003) that there is not one science and no hierarchy of research methods. Each method comes with strengths and weaknesses, and what one gains in terms of control and certainty in a conventional experimental setup is lost in terms of external validity and clinical applicability. Numerous researchers have pleaded for the case study approach as one method among a whole range of research methods in the field of psychoanalysis ( Rustin, 2003 ; Luyten et al., 2006 ; Midgley, 2006b ; Colombo and Michels, 2007 ; Vanheule, 2009 ; Hinshelwood, 2013 ). Leuzinger-Bohleber makes a distinction between clinical research and extra-clinical research ( Leuzinger-Bohleber, 2015 ). Clinical research is the idiographic type of research conducted by a psychoanalyst who is working with a patient. Unconscious phantasies and conflicts are symbolized and put into words at different levels of abstraction. This understanding then molds the perception of the analyst in subsequent clinical situations; even though the basic psychoanalytic attitude of “not knowing” is maintained. The clinical case study is clinical research par excellence . Extra-clinical research consists in the application of different methodologies developed in the natural and human sciences, to the study of the unconscious mind. Leuzinger-Bohleber refers to empirical psychotherapy research, experimental research, literature, cultural studies, etc. We believe that the clinical case study method should step up and claim its place in psychoanalytic research, although we agree that the method should be developed further. This paper and a number of others such as Midgley (2006b) should facilitate this methodological improvement. The clinical research method is very well-suited to address any research question related to the description of phenomena and sequences in psychotherapy (e.g., manifestation and evolution of symptoms and therapeutic relationship over time). It is not suitable for questions related to causality and outcome.

We also want to point out that there is a new evolution in the field of psychotherapy case study research, which consists in the development of methodologies for meta-studies of clinical case studies ( Iwakabe and Gazzola, 2009 ). The evolution builds on the broader tendency in the field of qualitative research to work toward integration or synthesis of qualitative findings ( Finfgeld, 2003 ; Zimmer, 2006 ). The first studies which use this methodology have been published recently: Widdowson (2016) developed a treatment manual for depression, Rabinovich (2016) studied the integration of behavioral and psychoanalytic treatment interventions, and Willemsen et al. (2015b) investigated patterns of transference in perversion. The rich variety of research aims demonstrates the potential of these meta-studies of case studies.

KEY CONCEPT 5. Meta-studies of clinical case studies A meta-study of clinical case studies is a research approach in which findings from cases are aggregated and more general patterns in psychotherapeutic processes are described. Several methodologies for meta-studies have been described, including cross-case analysis of raw data, meta-analysis, meta-synthesis, case comparisons, and review studies in general.

Lack of Basic Information in Psychoanalytic Case Studies

The second research question of our study ( Willemsen et al., 2015a ) concerned the methodological, patient, therapist, and treatment characteristics of published psychoanalytic case studies. All studies included in the Single Case Archive are screened by means of a coding sheet for basic information, the Inventory of Basic Information in Single Cases (IBISC). The IBISC was designed to assess the presence of basic information on patient (e.g., age, gender, reasons to consult), therapist (e.g., age, gender, level of experience), treatment (e.g., duration, frequency, outcome), and the methodology (e.g., therapy notes or audio recoding of sessions). The IBISC coding revealed that a lot of basic information is simply missing in psychoanalytic case studies ( Desmet et al., 2013 ). Patient information is fairly well-reported, but information about therapist, treatment and methodology are often totally absent. Training and years of experience are not mentioned in 84 and 94% of the cases, respectively. The setting of the treatment is not mentioned in 61% of the case studies. In 80% of the cases, it was not mentioned whether the writing of the case studies was on the basis of therapy notes, or audiotapes. In 91% of the cases, it was not mentioned whether informed consent was obtained.

Using variables on which we had more comprehensive information, we compared basic information of case studies from different psychoanalytic schools. This gave us a more detailed insight in the type of case studies that have been generated within each psychoanalytic school, and into the difference between these schools in terms of the kind of case study they generate. We found only minimal differences. Case studies in Relational Psychoanalysis stand out because they involve older patients and longer treatments. Case studies in Interpersonal Psychoanalysis tend to involve young, female patients and male therapists. Case study authors from both these schools tend to report on intensive psychoanalysis in terms of session frequency. But for the rest, it seems that the publication of case studies throughout the different psychoanalytic schools has intensified quite recently.

Guidelines for Writing Clinical Case Studies

One of the main problems in using psychoanalytic case studies for research purposes is the enormous variability in quality of reporting and inconsistency in the provision of basic information about the case. This prevents the reader from contextualizing the case study and it obstructs the comparison of one case study with another. There have been attempts to provide guidelines for the writing of case studies, especially in the context of analytic training within the American Psychoanalytic Association ( Klumpner and Frank, 1991 ; Bernstein, 2008 ). However, these guidelines were never enforced for case study authors by the editors from the main psychoanalytic journals. Therefore, the impact of these guidelines on the field of case study research has remained limited.

Here at the end of our focused review, we would like to provide guidelines for future case study authors. Our guidelines are based on the literature and on our experience with reading, writing, and doing research with clinical case studies. We will include fragments of existing case studies to clarify our guidelines. These guidelines do not provide a structure or framework for the case study; they set out basic principles about what should be included in a case study.

Basic Information

First of all, we think that a clinical case study needs to contain basic information about the patient, the therapist, the treatment, and the research method. In relation to the patient , it is relevant to report on gender, age (or an age range in which to situate the patient), and ethnicity or cultural background. The reader needs to know these characteristics in order to orientate themselves as to who the patient is and what brings them to therapy. In relation to the therapist , it is important to provide information about professional training, level of professional experience, and theoretical orientation. Tuckett (2008) emphasizes the importance for clinicians to be explicit about the theory they are using and about their way of practicing. It is not sufficient to state membership of a particular group or school, because most groups have a wide range of different ways of practicing. In relation to the treatment itself, it is important to be explicit about the kind of setting, the duration of treatment, the frequency of sessions, and details about separate sequences in the treatment (diagnostic phase, follow-up etc.). These are essential features to share, especially at a time when public sector mental health treatment is being subjected to tight time restrictions and particular ways of practising are favored over others. For example short-term psychotherapies are being implemented in public services for social and economic reasons. While case studies carried out in the public sector can give us information on those short-term therapies, private practice can offer details about the patient's progress on a long-term basis. Moreover, it is important to report whether the treatment is completed. To our astonishment, there are a considerable number of published case studies on therapies that were not finished ( Desmet et al., 2013 ). As Freud (2001 [1909] , p. 132) already advised, it is best to wait till completion of the treatment before one starts to work on a case study. Finally, in relation to the research method , it is crucial to mention which type of data were collected (therapy notes taken after each session, audio-recordings, questionnaires, etc.), whether informed consent was given, and in what way the treatment was supervised. Clinicians who would like to have help with checking whether they included all necessary basic information case use the Inventory for Basic Information in Single Cases (IBISC), which is freely available on http://www.singlecasearchive.com/resources .

Motivation to Select a Particular Patient

First of all, it is crucial to know what the motivation for writing about a particular case comes from. Some of the following questions should be kept in mind and made explicit from the beginning of the case presentation. Why is it interesting to look at this case? What is it about this case or the psychotherapist's work that can contribute to the already existing knowledge or technique?

“This treatment resulted in the amelioration of his [obsessive-compulsive] symptoms, which remained stable eight years after treatment ended. Because the standard of care in such cases has become largely behavioral and pharmacological, I will discuss some questions about our current understanding of obsessive-compulsive phenomena that are raised by this case, and some of the factors that likely contributed to the success of psychoanalytic treatment for this child ( McGehee, 2005 , p. 213–214).”

This quotation refers to a case that has been selected on the basis of its successful outcome. The author is then interested to find out what made this case successful.

Informed Consent and Disguise

As regulations on privacy and ethics are becoming tighter, psychotherapists find themselves with a real problem in deciding what is publishable and what is not. Winship (2007) points out that there is a potential negative effect of research overregulation as clinicians may be discouraged from reporting ordinary and everyday findings from their clinical practice. But he also offers very good guidelines for approaching the issue of informed consent. A good practice is asking for consent either at the start of the treatment or after completion of the treatment: preferably not during treatment. It is inadvisable to complete the case study before the treatment has ended. It is also advisable that the process of negotiating consent with the patient is reported in the case study.

“To be sure that Belle's anonymity was preserved, I contacted her while writing this book and told her it would not be published without her complete approval. To do this, I asked if she would review every word of every draft. She has ( Stoller, 1986 , p. 217).”

In relation to disguise, one has to strike a balance between thin and thick disguise. Gabbard (2000) suggests different useful approaches to disguising the identity of the patient.

Patient Background and Context of Referral or Self-Referral

It is important to include relevant facts about the patient's childhood, family history, siblings, any trauma or losses and relationship history (social and romantic) and the current context of the patient's life (family, working, financial). The context of referral is also key to understanding how and why the patient has come to therapy. Was the patient encouraged to come or had wanted to come? Has there been a recent crisis which prompted the intervention or an on-going problem which the patient had wanted to address for some time?

“Michael was one of the youngest children in his family of origin. He had older brothers and sisters who had been received into care before his birth. His parents separated before he was born. There had been some history of violence between them and Michael was received into care on a place of safety order when he was an infant because his mother had been unable to show consistent care toward him ( Lykins Trevatt, 1999 , p. 267).”

Patient's Narrative, Therapist's Observations, and Interpretations

A case study should contain detailed accounts of key moments or central topics, such as a literal transcription of an interaction between patient and therapist, the narration of a dream, a detailed account of associations, etc. This will increase the fidelity of the case studied, especially when both patient's and therapist's speech are reported as carefully as possible.

“Martha spoke in a high-pitched voice which sounded even more tense than usual. She explained that her best friend's mum had shouted at her for being so withdrawn; this made her angry and left her feeling that she wanted to leave their home for good. I told Martha that she often tried to undo her bad feelings by acting quickly on her instincts, as she did not feel able to hold her feelings in her mind and bring them to her therapy to think about with me. Martha nodded but it was not clear whether she could really think about what I just said to her. She then said that she was being held in the hospital until a new foster placement could be found. “In the meantime,” she said in a pleased tone, “I have to be under constant supervision” ( Della Rosa, 2015 , p. 168).”

In this example, observations of nonverbal behavior and tonality are also included, which helps to render a lively picture of the interaction.

Interpretative Heuristics

In which frame of reference is the writer operating? It is important to know what theories are guiding the therapist's thinking and what strategies he employs in order to deal with the clinical situation he is encountering. Tuckett (1993) writes about the importance of knowing what “explanatory model” is used by the therapist in order to make sense of the patient and to relate his own thinking to a wider public for the purpose of research. This idea is also supported by Colombo and Michels (2007) who believe that making theoretical orientations as explicit as possible would make the case studies intelligible and more easily employed by the research community. This can be done by the therapists explaining why they have interpreted a particular situation in the way they have. For example, Kegerreis in her paper on time and lateness (2013) stresses throughout how she is working within the object-relations framework and looking out for the patient's use of projective mechanisms.

“She was 10 minutes late. Smiling rather smugly to herself she told me that the wood supplied for her new floor had been wrongly cut. The suppliers were supposed to come and collect it and hadn't done so, so she had told them she was going to sell it to a friend, and they are now all anxious and in a hurry to get it.

I said she now feels as if she has become more powerful, able to get a response. She agrees, grinning more, telling me she does have friends who would want it, that it was not just a ploy.

She said she had found it easier to get up today but was still late. I wondered if she had a sense of what the lateness was about. She said it was trying to fit too much in. She had been held up by discussing the disposal of rubble with her neighbors.

I said I thought there was a link here with the story about the wood. In that she had turned the situation around. She had something that just didn't work, had a need for something, but it was turned around into something that was the suppliers' problem. They were made to feel the urgency and the need. Maybe when she is late here she is turning it around, so it is me who is to be uncertain and waiting, not her waiting for her time to come.

We maybe learn here something of her early object relationships, in which being in need is felt to be unbearable, might lead to an awful awareness of lack and therefore has to be exported into someone else. One could go further and surmise that in her early experience she felt teased and exploited by the person who has the power to withhold what you need ( Kegerreis, 2013 , p. 458).”

There can be no doubt reading this extract about the theoretical framework which is being used by the therapist.

Reflexivity and Counter-Transference

A good case study contains a high degree of reflexivity, whereby the therapist is able to show his feelings and reactions to the patient's communication in the session and an ability to think about it later with hindsight, by himself or in supervision. This reflexivity needs to show the pattern of the therapist's thinking and how this is related to his school of thought and to his counter-transferential experiences. How has the counter-transference been dealt with in a professional context? One can also consider whether the treatment has been influenced by supervision or discussion with colleagues.

“Recently for a period of a few days I found I was doing bad work. I made mistakes in respect of each one of my patients. The difficulty was in myself and it was partly personal but chiefly associated with a climax that I had reached in my relation to one particular psychotic (research) patient. The difficulty cleared up when I had what is sometimes called a ‘healing’ dream. […] Whatever other interpretations might be made in respect of this dream the result of my having dreamed it and remembered it was that I was able to take up this analysis again and even to heal the harm done to it by my irritability which had its origin in a reactive anxiety of a quality that was appropriate to my contact with a patient with no body ( Winnicott, 1949 , p. 70).”

Leaving Room for Interpretation

A case study is the therapist's perspective on what happened. A case study becomes richer if the author can acknowledge aspects of the story that remain unclear to him. This means that not every bit of reported clinical material should be interpreted and fitted within the framework of the research. There should be some loose ends. Britton and Steiner (1994) refer to the use of interpretations where there is no room for doubt as “soul murder.” A level of uncertainty and confusion make a case study scientifically fruitful ( Colombo and Michels, 2007 ). The writer can include with hindsight what he thinks he has not considered during the treatment and what he thinks could have changed the course for the treatment if he had been aware or included other aspects. This can be seen as an encouragement to continue to be curious and maintain an open research mind.

Answering the Research Question, and Comparison with Other Cases

As in any research report, the author has to answer the research question and relate the findings to the existing literature. Of particular interest is the comparison with other similar cases. Through comparing, aggregating, and contrasting case studies, one can discover to what degree and under what conditions, the findings are valid. In other words, the comparison of cases is the start of a process of generalization of knowledge.

“Although based on a single case study, the results of my research appear to concur with the few case studies already in the field. In reviewing the literature on adolescent bereavement, it was the case studies that had particular resonance with my own work, and offered some of the most illuminating accounts of adolescent bereavement. Of special significance was Laufer's (1966) case study that described the narcissistic identifications of ‘Michael’, a patient whose mother had died in adolescence. Both Laufer's research and my own were conducted using the clinical setting as a basis and so are reflective of day-to-day psychotherapy practice ( Keenan, 2014 , p. 33).”

As Yinn (2014) has argued for the social sciences, the case study method is the method of choice when one wants to study a phenomenon in context, especially when the boundaries between the phenomenon and the context are fussy. We are convinced that the same is true for case study methodology in the fields of psychoanalysis and psychotherapy. The current focused review has positioned the research method within these fields, and has given a number of guidelines for future case study researchers. The authors are fully aware that giving guidelines is a very tricky business, because while it can channel and stimulate research efforts it can as well-limit creativity and originality in research. Moreover, guidelines for good research change over time and have to be negotiated over and over again in the literature. A similar dilemma is often pondered when it comes to qualitative research ( Tracy, 2010 ). However, our first impetus for providing these guidelines is pedagogical. The three authors of this piece are experienced psychotherapists who also work in academia. A lot of our students are interested in doing case study research with their own patients, but they struggle with the methodology. Our second impetus is to improve the scientific credibility of the case study method. Our guidelines for what to include in the written account of a case study, should contribute to the improvement of the quality of the case study literature. The next step in the field of case study research is to increase the accessibility of case studies for researchers, students and practitioners, and to develop methods for comparing or synthesizing case studies. As we have described above, efforts in that direction are being undertaken within the context of the Single Case Archive.

Author Contributions

JW has written paragraphs 1–4; ER and JW have written paragraph 5 together; SK has contributed to paragraph 5 and revised the whole manuscript.

Conflict of Interest Statement

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

Author Biography

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Keywords: clinical case study, methodology, psychotherapy research, psychoanalysis, psychoanalytic schools, theoretical pluralism, review

Citation: Willemsen J, Della Rosa E and Kegerreis S (2017) Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment. Front. Psychol . 8:108. doi: 10.3389/fpsyg.2017.00108

Received: 29 November 2016; Accepted: 16 January 2017; Published: 02 February 2017.

Reviewed by:

Copyright © 2017 Willemsen, Della Rosa and Kegerreis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: [email protected]

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  • Policy & Compliance
  • Clinical Trials

NIH Definition of Clinical Trial Case Studies

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

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

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

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

See this page for more information about the NIH definition of a clinical trial.

General Case Studies

Institute or center specific case studies.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive either a micronutrient supplement or nothing.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention is being used to assess the performance of the probe and is not looking at an effect on the participant.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive a controlled diet for three days.
  • Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention (controlled diet) is being used to minimize exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion. The study will not be evaluating the effect of the diet on the participants.

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Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment

Affiliation.

  • 1 Centre for Psychoanalytic Studies, University of Essex Colchester, UK.
  • PMID: 28210235
  • PMCID: PMC5288375
  • DOI: 10.3389/fpsyg.2017.00108

This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases.

Keywords: clinical case study; methodology; psychoanalysis; psychoanalytic schools; psychotherapy research; review; theoretical pluralism.

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8+ Clinical Case Study Templates and Examples [Download Now]

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Clinical Case Study Templates And Examples

8+ clinical case study templates and examples, 1. case study analysis template, 2. clinical case study template, 3. clinical case study sample, 4. medical case study example, 5. psychological case study example, 6. sample clinical case study, 7. medical case study guide, 8. student medical case study, 9. clinical case study article.

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Teaching with Case Studies to Develop Clinical Reasoning

By Ann Horigan 

  • Owen, M.I. (2017). A case study scavenger hunt for senior nursing students. Journal of Nursing Education, 56(3), 191. doi: 10.3928/01484834-20170222-13.  Describes the use of a case study and simulation used with a group of senior nursing students in a synthesis seminar. The purpose of the exercise in this course was to provide students with a standardized method of analyzing and synthesizing content from previous courses to help prepare them for the RN licensure exam.  Good example of using a case study with low fidelity simulation and demonstrates that students benefit from this type of exercise. However, this was done in a sim lab setting in small groups of students and does not delve into issues of using case studies in a didactic setting to establish and further clinical reasoning.
  • Peery, A. (2015). Use of the unfolding case study in teaching nurse educator master of science in nursing students. Journal of Nursing Education, 54(3), 180. doi: 10.3928/01484834-20150217-11 . Course for nurse educator MSN students done in an online format which uses an unfolding case study to work through challenging issues that a nurse educator is likely to encounter. Unfolding cases promote inquiry among students and should be believable and relevant to the class. Four steps to developing an unfolding case study are discussed. Students found the exercise useful and made them aware of situations they otherwise may not have been aware of in education. It is a dynamic and engaging method for teaching and preparing for real-life scenarios. This article is helpful as it notes the steps in devising an unfolding case study and the benefits of using this type of exercise. It would be more helpful if this had been set up as a formal inquiry with specific measures of application and synthesis pre and post. As it is, it describes an experience and innovative method which is helpful.
  • Kaylor, S. and Strickland, H. (2015). Unfolding case studies as a formative teaching methodology for novice nursing students.  Journal of Nursing Education, 54(2), 106-110. doi:10.3928/01484834-20150120-06. Describes a way in which unfolding case studies can be used to teach undergraduate nursing, novice students evidence based practice information rather than the case study acting as a summative evaluation of knowledge. Unfolding case studies develop over time and are unpredictable to the learner. If well done, promotes experiential education and imagination. Students picture themselves as part of the scenario. Enables students to practice making decisions and evaluating the effects of those decisions in a non-threatening environment. When this is done in small groups, students are developing decision making, communication, clinical judgment and problem solving. Helps students connect dots between theory and practice. Authors recommend that this is not the only method of active learning used throughout the semester and should be used several times but not exhaustively.  Excellent article that presents a unique active learning method with benefits, barriers, lessons learned. Would be interesting to see what students thought of it as a learning method.
  • Dudas, K. (2012). Podcast and unfolding case study to promote active learning. Journal of Nursing Education, 51(8), 476. DOI:10.3928/01484834-20120719-02. Describes the use of a pre-class podcast used to give information for an unfolding case study on a patient with a neuromuscular disorder completed in class. Information from the podcast was reviewed at the beginning of class and then students were given the unfolding case study. Class reconvened and answers to the case study reviewed. Students reported feeling actively involved in learning and that clinical decision making skills improved. Students wanted these more frequently in the course. Authors state that while unfolding case studies are time consuming to prepare, the benefits from active learning outweigh the time needed.
  • Utterback, V., Davenport, D. Gallegos, B. & Boyd, E. (2012). The critical difference assignment: An innovative instructional method. Journal of Nursing Education, 51(1), 42-45. DOI:10.3928/01484834-20111116-03. Describes an assignment called the Critical Difference assignment where two case studies are given to students who must use reasoning to differentiate between the 2 cases. The cases have similar patient presentations but have differing and unknown underlying pathophysiologies. Students must compare and contrast symptoms, lab results, diagnostic studies to come to an understanding of the critical difference between the 2 cases and then develop a plan of care for each case based on the similarities and differences in the cases. These studies are called companion case studies and are purposely constructed so that students must discriminate between 2 similarly presenting patient problems. The outcomes from this type of learning are that the learner can learn by themselves, learn with others, share information, and make decisions. This mirrors the ability to work with others in the clinical setting. Excellent example of how to move students thinking to the next level. Again, would be interesting to see what students thought of experience as well as any objective measures of how this has helped initiate clinical judgment or improve abilities in clinical judgment.
  • Priddy, K. & Crow, M. (2011). Clinical imagination: Dynamic cast studies using an attribute listing matrix. Journal of Nursing Education, 50(10), 591-594. DOI:10.3928/01484834-20110630-03. Describes how to develop and use a matrix for choosing elements of a case study so that they are randomly generated and students have differing elements with different outcomes. It allows for more opportunities to role model and richer discussion. The number of choices on the matrix can be based on the context and the problem at hand. This can be done based on developmental level of students and where they are in the nursing curriculum. It describes the steps of how to implement this in class in detail which is very helpful. The variety of options possible gives opportunity for great discussion and generation of nursing knowledge. Great example of what can be done in smaller groups as formative or summative evaluation. Would be difficult to do in a large lecture course. Again, no objective measures of how this has pushed students to think and engage.
  • Bennett, C., Kennedy, S. & Donato, A. (2011). Preparing NP’s for primary care: Unraveling complexity with unfolding cases. Journal of Nursing Education, 50(6), 328-331. doi:10.3928/01484834-20110228-05. Describes the use of Backward Design (identifying desired results, identifying evidence of learning and developing teaching methods) to design a course for nurse practitioners in a behavioral health therapeutics course. Faculty developed cases that included an initial patient encounter and follow up encounter which were video taped with actors and complications of treatment or new problems were added at follow up visits. In the final step of Backward Design, creating teaching methods, the authors used Zull’s model of learning as brain change, which encourage innovative strategies to teach in context. There is an emphasis on reflection and iterative knowledge development. The authors found that students’ iterative thought processes advanced as they were able to practice as independent clinicians in a safe and collaborative environment. Course evaluations were done based on university requirements and therefore did not evaluate this method specifically, but they state that written feedback was overwhelmingly positive. Would be nice to see objective measures of advancement of clinical thinking, maybe samples of how grades improved over the semester or how pass rates on certification exams improved.
  • Beyer, D. (2011). Reverse case study: To think like a nurse. Journal of Nursing Education, 50(1), 48-50.  doi:10.3928/01484834-20101029-06. Describes combining two active learning strategies, case studies and concept mapping into a reverse case study to promote critical thinking and problem solving. The article outlines a process for creating a reverse case study to be used in small groups. They are given a blank concept map with elements of the nursing process and patient history on it, but with no specific information other than a list of medications. Students work backward from that point to devise a list of anticipated medical problems the patient probably experiences and the care for these problems. The complexity of the cases can be manipulated by the number and type of medications. Groups then present their cases and priorities. This is a unique twist on the traditional case study. It could be done at every level of nursing education and development. A lab or discussion course would probably be best, not a class of 100+ students.
  • Tanner, C. (2009). The case for cases: A pedagogy for developing habits of thought. Journal of Nursing Education, 48(6), 299-300.  An editorial that argues that the use of case based learning as a method that supports experiential thinking, clinical judgment and encourages students to “think like a nurse”. No information on actual work done in classroom.
  • Sandstom, S. (2006). Use of case studies to teach diabetes and other chronic illnesses to nursing students. Journal of Nursing Education, 45(6), 229-232. Case studies increase learning by “placing” them in a situation where they must use or apply knowledge learned in the classroom. They are in a real world situation with decisions to make. The use of the example case study is done in the laboratory setting about diabetes as students are learning to draw up insulin and monitor blood glucose. Discusses 2 other assignments related to diabetes content that students are assigned. The article lacks depth about how the case studies are developed and why. No objective findings of student evaluation or learning other than the author’s recitation of what has been said in lab.
  • Schlenker, E. & Kerber, C. (2006). The CARE case study method for teaching community health nursing. Journal of Nursing Education, 45(4), 144. Stands for Case study, Application, Research, Evaluation. Goal of this method is to facilitate understanding of theoretical content, foster interaction between faculty and students and knowledge sharing, give opportunities to apply knowledge in the classroom. Case studies are developed based on current topics in community health nursing and introduced during class time. Students work in small groups to answer clinical questions. The authors state that this has been well received by students who are motivated and excited to come to class and have done the prep work. There is no description of how the case studies are generated other than by choosing current topics in community health nursing, there is also no further discussion of how this method is used but a generic description. More detail would be helpful.
  • Loving, G. & Siow, P. (2005). Use of an online case study template in nursing education. Journal of Nursing Education, 44(8), 387-388. The authors created a template to be used in online nursing courses that was based on interactivity and feedback for faculty to use in the design of case studies. It is a set of online forms that allows faculty to enter information. Students also work through this case study and click on multiple choice answers where feedback is given. This isn’t particularly helpful information. It doesn’t inform how the body of the case should be created, the elements, whether they should unfold and how or how the students interface with the case study in detail. 
  • Tarcinale, M. (1987). The case study as a vicarious learning technique. Journal of Nursing Education, 26(8), 340-341. Discusses vicarious learning or learning through imagination, which I think now 30 years later would be experiential, or situational learning. The learner will use information from previous experiences to help solve current situational problems. Components of a case study are discussed (very helpful and one of only a few articles that do this). The placement of the case study in class depends on what it would be used for. Helpful information, but I think that the case study method has evolved quite a bit over time to include the reverse and unfolding case studies. However this is a good summary of how a basic case study can be used to bring abstract concepts to more concrete understanding.
  • Page, J., Kowlowitz, V. & Alden, K. (2010). Development of a scripted unfolding case study focusing on delirium in older adults. The Journal of Continuing Education in Nursing, 41(5), 225-230. DOI:10.3928/00220124-20100423-05. The article begins by talking about how simulation is an important piece of practice based learning and that continuing education for nurses should incorporate more of it. The article then goes on to describe how to develop an unfolding case study. (might be splitting hairs, but case studies and simulation are not the same, many times simulation will use a case study, but sometimes it doesn’t. And not all uses of case studies are simulation. They don’t do a good job of connecting the two in the article) The steps for developing a case study for use are outlined as well as how to review it before implementing it. The authors present data on evaluation of the case by nurses who were involved in the continuing education. This is good information, detailed in the description of how the case can be developed, presented and evaluated.
  • Jones, D. & Sheridan, M., (1999). A case study approach: Developing critical thinking skills in novice pediatric nurses. The Journal of Continuing Education in Nursing, 30(2), 75-78. Key component of nursing is problem solving, but not all nurses are good at it. The use of case studies promotes problem solving and critical thinking. They can be done with real or hypothetical situations. Provides an opportunity to enact in decision making when a real clinical situation isn’t available. In novice pediatric nurses, case studies reinforce what was learned in school but also introduce them to unique situations in family focused nursing. The article goes on to describe that case studies should include certain elements and gives and example. The article does not present data on how case studies have improved novice nurses comfort level or competence in working with families and children or if novice nurses found them useful during an orientation period.
  • Smallheer, B. (2016). Reverse case study: A new perspective on an existing teaching strategy. Nurse Educator, 41(1), 7-8. DOI: 10.1097/NNE.0000000000000186. Traditional case studies can be limited to utilizing the lower portion of Blooms taxonomy, remembering, understanding, applying.  The reverse case study can engage students in higher parts of taxonomy: analyzing evaluating and creating. Students actually develop the scenario which means they must analyze and evaluate material in creating the materials and data for the case study. The article gives an example of a graded reverse case study done in a nursing pharmacology class. During the session, faculty observed collaboration, team work, prioritization and critical thinking. This type of case study refocuses students from being task oriented to being thinkers and planners. Would be an excellent process for lab or seminar group, clinical post conference group. May be difficult to do in a large class without splitting into groups. Again, wonder if there are any objective measures regarding student outcomes.
  • Porter-Wenzlaff, L. (2013). Unfolding multicourse case study: Developing students administrative competencies. Nurse Educator, 38(6), 241-245. DOI: 10.1097/01.NNE.0000435263.15495.9f. The articles describes an unfolding case study that is done over 2 semesters in 2 courses. This is done in 2 graduate level nurse executive courses that are leveled. Students work in teams as the nurse executive of a fictional facility and must work through administrative complexities such as physician relations, resource allocation etc. Students are to do individual pieces of projects and come together and use the work in the larger objective. The projects progress across semesters and ideally students teams are the same as semesters change. The author recognized that students felt over whelmed and unprepared for this learning (and probably would have no matter the format) but found ways to help them work through by validating their concerns, having help available and that learning is an ongoing process. This paper does a great job of reporting anecdotal feedback from students, although it acknowledges there were no formal pre and post measures of implementation of this case study format.
  • Harrison, E., (2012). How to develop well written case studies: The essential elements. Nurse Educator, 37(2), 67-70. DOI: 10.1097/NNE.0b013e3182461ba2. Briefly discusses the history of the use of case studies as educational tool in nursing. Suggests that case studies, much like narratives, should have a setting, characters, plot and elements of style that come together to create a mystery, a puzzle to be solved by the information given and knowing what additional information is needed. Students identify important data from that data that may be superfluous or not essential to the case. This is a unique way to describe a case study and how to create elements that nurses may forget, or not emphasize in their creation of case studies. Would be helpful to know if this paradigm has been used by others and if they found it effective.
  • Henning, J.E., Nielsen, L.E. & Hauschildt, J.A. (2006). Implementing case study methodology in critical care nursing: a discourse analysis. Nurse Educator, 31(4):153-8. Describes a change in content delivery technique based on student feedback that lectures were boring and they wanted to experience more patient scenarios. Case study approach was adopted to increase interaction between teacher and students. Used method by Stepien et al. to analyze the case.  A model for discussion was then used with the case method which uses 3 types of discussion, 1. Frame the discussion where interest is generated and background information is given. 2. Conceptual discussion – teacher guides students in grasping concept 3. Application discussions where students discuss newly acquired knowledge is discussed as applied to scenarios. Using this method required that the teacher learn a new way to talk with or to students; had to learn how to elicit information from students and respond to them.  Student participation increased significantly with each addition of the next level of discussion where the teacher adjusted their questioning/cuing of students to elicit more response. They found that students spoke 2x as much as professor and both students and teacher seemed to become more comfortable with their new role as discussions went on. Very helpful in describing a way in which a classroom discussion can take place, one that elicits student participation and lets students guide the learning and morphs into a review discussion where the teacher makes sure that students understand the material accurately and use their discussion to apply newly acquired material.
  • Ciesielka, D. (2003). Clues for clinicians: a case study approach to educating the renaissance nurse. Nurse Educator, 28(1), 3-4. Describes a way to integrate the humanities into a rigorous graduate curriculum already packed with science in order to prepare nurses to be able to work with patients of all cultures and social status. Developed Clues for Clinicians and used in the first clinical reasoning/clinical judgment course in nurse practitioner program. Instead of deriving cases from standard everyday clinical practice, cases were developed based on historical accounts. Faculty guided students in problem solving and students found themselves discussing the medical issue while also investigating a part of medical history.. Feedback was unanimously positive. I’m not convinced that this infuses humanities to the extent that the authors think it does, but it does keep interest and encourages student participation and reasoning as well as gives students something memorable to hang the information on. 
  • Dowd, S.B. & Davidhizar, R. (1999). Using case studies to teach clinical problem-solving. Nurse Educator, 24(5), 42-6. Discusses advantages of using case studies to as well as preparation for faculty. Lists ways to prepare the case studies and how case studies can be solved.  Case studies connect theory to practice. They require preparation on the part of faculty and flexibility in allowing students to solve the case.
  • Summary of findings: Most studies lack any data regarding student performance in clinical reasoning or judgment pre/post implementation of this method. While there is evidence that students find this method useful and engaging, no study presents findings that demonstrate that the case study method does what it’s purported to do. Studies discuss the preparation that must go into the case study development, that there are different ways of using the case study method (traditional, unfolding, reverse) and that students find them beneficial as well as how thinking is transformed to reach higher levels of Blooms Taxonomy. Almost all studies discuss case studies used in small groups or large classes broken into groups. None discuss how to lead a large class through a case and if/how this can engage students as well as improve their clinical reasoning. Only one articles discusses the use of an ongoing case that continues to the next semester, and this is for graduate students who are at a very different level of processing information than undergraduate students.

case study method in psychology

Case Study Method In Psychology: Meaning, Pros, and Cons

Page Contents

What is Case Study Method?

The case study method is the in-depth study of any event, person, or problem in a given situation. It strives to get out the root causes of a given spot. Also, referred to as case history or clinical method.

The case study is one of the oldest research methods used particularly to reveal depths for the diagnosis and treatment of behavior disorders in psychology . The psychologist Sigmund Freud, constructed his theory of personality from case studies. Jean Piaget, the most influential observer of children formulated many cognitive theories on children from case studies.

The case study involves making observations for a particular period of time to find the cause and development of a particular behavior pattern. The case record includes information on family background, home life, neighborhood activities, experience at school, health, past life, and so on.

This method is based on the idea that the more we know about individuals, the better we will be able to understand and help them. While using case study the investor uses, tests, checklists, questionnaires, interviews, etc. It can be done at home, school, or work situations.

For example, A child who is problematic at school may be referred to a guidance clinic, where a detailed case history is compiled using all the possible diagnostic testing with personality inventories, intelligence test, psychoanalytic procedures, etc. so that it will be helpful in understanding the child’s problems to provide him with a remedial plan.

The case study method may also be based on a longitudinal study. A longitudinal study follows a study over an extended period of time, with the measurement at periodic intervals. The researchers have to choose one that suits them the best while doing research.

Advantages and Disadvantages of Case Study Method

Advantages:.

  • It is very beneficial to know about the social behavioral pattern of the individual in-depth. It provides the perception of inner strivings, tensions, and motivations into one’s life directly.
  • It enables the researchers to trace out the relationship of an individual’s inner self with social forces and surroundings for careful historical analysis of the past life.
  • The case study method is quite useful for diagnosis, therapy, and other practical case problems.

Disadvantages/Limitations

  • In the case of history, the information usually comes from parents, teachers, and other associations of the individual being studied, the subjectivity of the researcher may hamper the report that is needed.
  • The danger of false generalizations is always there because no set of rules are followed in the collection of the information and only a few units are studied.
  • It consumes more time, effort, and money to go through studying the behavior.
  • The case study method can be used in a limited sphere, it is not possible to use for a big number.

Despite its limitations, the case study method is a widely used systematic field research technique in social sciences these days. A wide range of private experiences, informal factors, and personal feelings can not experiment directly. In such cases, the case history method proves to be a valuable technique. It proves more useful in the diagnosis and treatment of problem children, neurotics, socially and emotionally maladjusted persons, delinquents, criminals, etc.

Child psychology uses this method to study juvenile delinquency. Similarly, anthropologists, historians, management technicians, novelists, etc. also have used this method extensively. Its use is increasing day by day.

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Home » Pros and Cons » 12 Case Study Method Advantages and Disadvantages

12 Case Study Method Advantages and Disadvantages

A case study is an investigation into an individual circumstance. The investigation may be of a single person, business, event, or group. The investigation involves collecting in-depth data about the individual entity through the use of several collection methods. Interviews and observation are two of the most common forms of data collection used.

The case study method was originally developed in the field of clinical medicine. It has expanded since to other industries to examine key results, either positive or negative, that were received through a specific set of decisions. This allows for the topic to be researched with great detail, allowing others to glean knowledge from the information presented.

Here are the advantages and disadvantages of using the case study method.

List of the Advantages of the Case Study Method

1. it turns client observations into useable data..

Case studies offer verifiable data from direct observations of the individual entity involved. These observations provide information about input processes. It can show the path taken which led to specific results being generated. Those observations make it possible for others, in similar circumstances, to potentially replicate the results discovered by the case study method.

2. It turns opinion into fact.

Case studies provide facts to study because you’re looking at data which was generated in real-time. It is a way for researchers to turn their opinions into information that can be verified as fact because there is a proven path of positive or negative development. Singling out a specific incident also provides in-depth details about the path of development, which gives it extra credibility to the outside observer.

3. It is relevant to all parties involved.

Case studies that are chosen well will be relevant to everyone who is participating in the process. Because there is such a high level of relevance involved, researchers are able to stay actively engaged in the data collection process. Participants are able to further their knowledge growth because there is interest in the outcome of the case study. Most importantly, the case study method essentially forces people to make a decision about the question being studied, then defend their position through the use of facts.

4. It uses a number of different research methodologies.

The case study method involves more than just interviews and direct observation. Case histories from a records database can be used with this method. Questionnaires can be distributed to participants in the entity being studies. Individuals who have kept diaries and journals about the entity being studied can be included. Even certain experimental tasks, such as a memory test, can be part of this research process.

5. It can be done remotely.

Researchers do not need to be present at a specific location or facility to utilize the case study method. Research can be obtained over the phone, through email, and other forms of remote communication. Even interviews can be conducted over the phone. That means this method is good for formative research that is exploratory in nature, even if it must be completed from a remote location.

6. It is inexpensive.

Compared to other methods of research, the case study method is rather inexpensive. The costs associated with this method involve accessing data, which can often be done for free. Even when there are in-person interviews or other on-site duties involved, the costs of reviewing the data are minimal.

7. It is very accessible to readers.

The case study method puts data into a usable format for those who read the data and note its outcome. Although there may be perspectives of the researcher included in the outcome, the goal of this method is to help the reader be able to identify specific concepts to which they also relate. That allows them to discover unusual features within the data, examine outliers that may be present, or draw conclusions from their own experiences.

List of the Disadvantages of the Case Study Method

1. it can have influence factors within the data..

Every person has their own unconscious bias. Although the case study method is designed to limit the influence of this bias by collecting fact-based data, it is the collector of the data who gets to define what is a “fact” and what is not. That means the real-time data being collected may be based on the results the researcher wants to see from the entity instead. By controlling how facts are collected, a research can control the results this method generates.

2. It takes longer to analyze the data.

The information collection process through the case study method takes much longer to collect than other research options. That is because there is an enormous amount of data which must be sifted through. It’s not just the researchers who can influence the outcome in this type of research method. Participants can also influence outcomes by given inaccurate or incomplete answers to questions they are asked. Researchers must verify the information presented to ensure its accuracy, and that takes time to complete.

3. It can be an inefficient process.

Case study methods require the participation of the individuals or entities involved for it to be a successful process. That means the skills of the researcher will help to determine the quality of information that is being received. Some participants may be quiet, unwilling to answer even basic questions about what is being studied. Others may be overly talkative, exploring tangents which have nothing to do with the case study at all. If researchers are unsure of how to manage this process, then incomplete data is often collected.

4. It requires a small sample size to be effective.

The case study method requires a small sample size for it to yield an effective amount of data to be analyzed. If there are different demographics involved with the entity, or there are different needs which must be examined, then the case study method becomes very inefficient.

5. It is a labor-intensive method of data collection.

The case study method requires researchers to have a high level of language skills to be successful with data collection. Researchers must be personally involved in every aspect of collecting the data as well. From reviewing files or entries personally to conducting personal interviews, the concepts and themes of this process are heavily reliant on the amount of work each researcher is willing to put into things.

These case study method advantages and disadvantages offer a look at the effectiveness of this research option. With the right skill set, it can be used as an effective tool to gather rich, detailed information about specific entities. Without the right skill set, the case study method becomes inefficient and inaccurate.

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Blended teaching mode based on small private online course and case-based learning in analgesia and sedation education in China: a comparison with an offline mode

  • Longxiang Su 2 ,
  • Ran Lou 3 ,
  • Ying Liu 4 ,
  • Hua Zhang 5 &

on behalf of the Chinese Analgesia and Sedation Education and Research (CASER) group

BMC Medical Education volume  24 , Article number:  28 ( 2024 ) Cite this article

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Standardized training for pain, agitation-sedation, and delirium (PAD) management is urgently needed for Chinese intensivists’ continuing education. Since 2020, because of the COVID-19 pandemic, the Chinese Analgesia and Sedation Education and Research (CASER) group has used an online blended teaching mode based on a small private online course (SPOC) and case-based learning (CBL). This study evaluated whether an online blended teaching mode has similar effects on PAD management training when an offline mode cannot be used.

Materials and methods

Since 2020, the CASER group has provided offline training and online SPOC&CBL training three times each, targeting intensivists and ICU nurses in China. All participants were divided into an offline group and SPOC&CBL group. A final examination was offered in each training session to assess the students' mastery of professional knowledge. Teachers’ and students’ perceptions regarding the online SPOC&CBL mode were evaluated through questionnaires.

Of all participants ( n  = 117), 106 completed all examinations and questionnaires. Most participants were aged 31–40 years (53, 50.0%), had an academic degree (60, 56.6%), and worked in a tertiary hospital (100, 94.34%). We assessed the learning effect on participants from two aspects: theory and clinical practice. There was no significant difference between the SPOC&CBL and offline groups in terms of theoretical, case analysis, and total scores ( p  > 0.05). In terms of the participants’ perceptions regarding the SPOC&CBL mode, 91.5% considered the online mode to be a useful and accessible alternative to improve knowledge and skills. A total of 95.7% of the participants believed that they could interact well with group members, and 87.2% believed that they had a good degree of participation. Of these participants, 76.6% believed that they had received valuable learning resources. All instructors believed that the SPOC&CBL mode was more flexible than the offline mode in terms of teaching time and location, and they were all willing to carry out training with the SPOC&CBL mode.

Compared to the offline mode, the SPOC&CBL mode can also enhance participants’ knowledge and skills and meets their expectations. Therefore, an online mode can be considered a potential method in PAD management education in China.

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Introduction

Pain, agitation-sedation and delirium (PAD) management is an integral part of intensive care [ 1 , 2 ]. However, inappropriate PAD management, such as analgesia or sedation that is too deep or too light or undetected delirium, may have serious adverse effects on patient prognosis [ 3 , 4 ]. Therefore, comprehensively mastering theoretical knowledge of PAD management and using it proficiently in clinical practice is an important part of optimizing treatment. To promote PAD management training, the Chinese Analgesia and Sedation Education and Research (CASER) group was formed with the support of the Chinese Association of Critical Care Physicians (CACCP). In 2020, the CASER team carried out several offline training sessions that achieved good results and improved the medical staff's theoretical knowledge and clinical capability of PAD management.

In the second half of 2020, because of the COVID-19 pandemic, the CASER group had to change the mode from offline to online training. Small private online courses (SPOCs) are a popular teaching method in education. In SPOCs, the number of participants is limited, and the participants must meet certain criteria so that the content of the course can be more accurate, which can effectively help students supplement the knowledge that needs to be improved [ 5 ]. However, SPOCs are not popular in medical education because clinical scenario simulation training is difficult to carry out in online mode. Fortunately, the experience of the CASER group in offline training modes showed that the ability to apply PAD management theory in actual clinical work can be improved by discussing and analysing actual cases. Moreover, to understand students' concerns about the online training mode, we conducted a prequestionnaire with our previous students. The results showed that more than 85% of the participants believed that engagement and interactivity are areas that need improvement in online trainings. Therefore, the CASER group has used a blended teaching mode based on a SPOC and case-based learning (CBL) in PAD management training. CBL consists of the analysis of medical records with the aim of duplicating the actual clinical scenario and prompting students to identify and develop new areas of learning, which can be very effective in promoting students to combine theory with clinical practice and improve their clinical problem-solving abilities [ 6 , 7 ]. Moreover, some activities have been optimized to promote interaction. In this study, we conducted tests and questionnaires for instructors and students to compare the effects of the SPOC&CBL and offline teaching modes on PAD management training.

Design of courses

The project management team consisted of clinicians, medical teachers, statisticians, pedagogists, and a graphic designer. The teaching team consisted of four critical care medicine instructors who are also intensivists with more than 15 years of teaching experience and clinical work experience. The project management team was responsible for 1) building the overall training structure, including training objectives (improving the theoretical knowledge and clinical practice ability in PAD management) and specific content (principles of analgesia and sedation treatment, drug selection, assessment scales, etc.), understanding the participants’ needs, and evaluating the effectiveness of the training; and 2) organizing the members of the teaching team to conduct training and prepare centralized lessons in the SPOC&CBL teaching mode. The teaching team was responsible for making course-related multimedia materials, collecting and arranging course-related literature and materials, organizing clinical cases, and teaching during each training session.

For offline courses, we recruited students from different hospitals to complete face-to-face courses at a specific time and place. First, the teacher explained the course content. Then, the students were divided into several groups, and the groups discussed 10 actual clinical cases. After the discussion, an examination was conducted. The number of people in each course was limited to 30.

The SPOC&CBL courses include the following aspects. Before the training, the project management team collected information from the registered students, including their major, education level, seniority, medical institution and position, and conducted a basic assessment of the students to ensure that they met the criteria for participating in the course. In the theoretical knowledge review and learning section, the online live broadcast platform was used, and the teaching team conducted training in various ways, such as by using PowerPoint slides, multimedia materials, and reference materials. Afterwards, in the discussion and clinical practice part, the students were divided into several groups, with five to six participants per group. A simulation scene was set up based on 10 classic cases, and the groups discussed the cases. The instructors guided the students in applying theoretical knowledge to practical clinical scenarios during the discussion. Finally, the instructors summarized the instruction through the live broadcast platform, provided feedback on the performance of each group, instructed the participants to review the material after class, and assessed the professional theoretical knowledge and clinical application capability of the participants by tests.

The training objectives and content were similar in the offline and SPOC&CBL training modes. To enhance interaction in the online SPOC&CBL mode, we asked the teachers to interact with each student. In the discussion, every student was required to make a speech. For the final certificate, the students who participated in the discussion and actively asked questions were graded separately, and the students with high scores received an A-level certificate.

Participants and study setting

Since 2020, the CASER group has held PAD management training regularly. The training class included physicians and nurses working in intensive care units (ICUs) nationwide as participants, and no more than 20 trainees were recruited for each session. In the first half of 2020, three offline teaching sessions were held, and three online SPOC&CBL training sessions were held from the second half of 2020 to April 2022.

Evaluating the effect of each teaching mode

The students took the exams after completing the courses. The test included six theoretical questions about analgesia, sedation and consciousness assessment and six questions on clinical case analysis. The two groups of students complete the same test paper for the postclass test. In addition, the students were taught by the same teachers, who also completed the grading and interpretation of the test paper. Therefore, the course content and test paper difficulty were identical between the two groups of students.

From July to October 2022, electronic questionnaires were delivered to six instructors and all the participants to evaluate their perceptions of the SPOC&CBL blended teaching mode and the teaching effect. The questionnaire for instructors consisted of items regarding the purpose, significance, sponsoring organization (CACCP), ethics statement and perception of the training effect of the SPOC&CBL mode. The questionnaire for participants consisted of three parts: 1. a preface, which explained the purpose, significance, sponsoring organization, and ethics statement; 2. a general information section, including items on the sex, age, educational level, professional and technical title, working department, and number of years of working experience of the participants; and 3. a section on the participants’ perceptions of the training effect of the SPOC&CBL mode.

The questionnaire was organized and completed by the expert group according to the purpose of this research. The members of the expert group included six doctors (with more than 15 years of work experience) from comprehensive ICUs in different provinces, two nurses and one medical statistician. The pilot testing of the questionnaire was completed by 12 trainees who participated in the training, and various data were collected, including the layout, structure, attractiveness, question setting, respondent tolerance, and respondent understanding of the questions. SPSS software 22.0 was used for content validity analysis, and the Cronbach’s alpha value was 0.793, indicating that the questionnaire was effective.

Statistical analysis

SPSS software (version 22.0) was used to analyse the data. Categorical variables are expressed as percentages and were compared by the chi-square test or Fisher’s exact test. Continuous data are reported as medians with interquartile ranges and were compared using the unpaired Mann‒Whitney U test. Statistical significance was set at p  < 0.05.

Characteristics of the participants

Questionnaires were delivered to all 117 trainees who participated in the training. A total of 106 valid questionnaires from trainees were returned. Among the 106 participants, there were 54 males (50.94%) and 52 females (49.06%). Most participants were aged 31–40 years (53, 50.0%). There were 94 physicians (88.68%) and 12 nurses (11.32%). Most participants had master’s degrees (60, 56.6%). There were at most 55 (51.89%) participants with intermediate titles (attending physician), 30 with senior titles (leading a medical team, 28.3%), and at least 21 with junior titles (resident physician, 19.81%). Most of the participants worked in tertiary hospitals (100, 94.34%). There were 72 (67.92%) participants who worked in general ICUs and 34 (32.08%) participants who worked in specialized ICUs. In terms of the number of working years, 18 (16.98%) participants had worked for less than 5 years, 29 (27.36%) had worked for 5–10 years, and 59 (55.66%) had worked for more than 10 years. The 106 participants were divided into groups according to the different teaching methods, and there was no significant difference in the basic characteristics between the two groups (Table 1 ).

Perception of teachers regarding the SPOC&CBL mode

The results of questionnaires from six instructors showed that all six were willing to carry out online courses, and two of them preferred the SPOC&CBL mode to the offline mode (Fig.  1 a). In terms of the advantages of the SPOC&CBL mode, all instructors believed that it was more flexible than the offline course mode in terms of teaching time and location. Three instructors believed that the SPOC&CBL mode provided students with a more engaging and interactive scenario. Four instructors believed that the online mode was more conducive to stimulating students to learn actively (Fig.  1 b). Two instructors believed that the preclass preparation required more work and took longer in the SPOC&CBL mode than in the offline mode (Fig.  1 c).

figure 1

Perception of teachers regarding the SPOC&CBL mode. SPOC, small private online course. CBL, case-based learning

The influence of the SPOC&CBL mode on the test scores of participants

According to the content and focus of the training, we assessed the learning effect on the participants from two aspects: theory and clinical practice. The theoretical part and the clinical part each consisted of 50 points, with a total score of 100 points. The results showed that there was no significant difference between the SPOC&CBL group and the offline group in terms of theoretical, case analysis, and total scores ( p  > 0.05) (Table 2 ).

Perceptions of students regarding the SPOC&CBL mode

In addition to understanding the learning effect on the students through objective tests, we also studied the perceptions of the participants through the questionnaires. In terms of the participants’ acceptance of the online course, the results showed that 72 (67.92%) students preferred the online mode or both the online and offline modes (Fig.  2 a).

figure 2

Perceptions of students regarding the SPOC&CBL mode. SPOC, small private online course. CBL, case-based learning

In terms of learning benefits, 93.3% of the offline group believed that they had benefited in terms of theoretical knowledge, case application or both. A total of 91.5% of the participants in the SPOC&CBL group believed that they had benefited in terms of theoretical knowledge, case application, or both (Fig.  2 b).

We investigated the opinions of the participants in the SPOC&CBL group regarding the advantages and disadvantages of the online mode. In terms of advantages, 95.7% of the participants believed that they could interact well with group members during the course, and 87.2% believed that they had a good degree of participation in the class. A total of 97.9% of the participants thought that the learning initiative was well stimulated, and 76.6% believed that they had received valuable learning resources throughout the course. A total of 86.8% of the participants believed that the clinical case simulation scenario was sufficient. Flexibility of time and location and the low cost of courses were also advantages recognized by almost all participants. In terms of disadvantages, 44.7% of the participants thought that it took more time and energy to participate in training with the SPOC&CBL mode (Fig.  2 c).

The results of this study showed that the blended SPOC&CBL mode is effective in PAD management training in China compared with the offline mode. According to the analysis of the participants' objective test scores and subjective perceptions, the instructional effectiveness of the SPOC&CBL mode was similar to that of the offline mode. Moreover, for the new blended teaching mode, instructors and participants had a good degree of acceptance. The characteristics of a more flexible time and place and lower costs for the online mode made it easier for participants from all over the country to participate in the training. It also allowed the CASER group to promote PAD management training in China in an orderly and in-depth manner in the context of the COVID-19 pandemic.

PAD management for critically ill patients has been recognized for more than 10 years in China. Judging from the increasing number of reports and discussions in conferences regarding critical illness, the importance of PAD management is recognized by intensivists in China [ 8 , 9 , 10 ]. However, there are still many deficiencies in the mastery of specific theoretical knowledge and clinical practice [ 11 , 12 , 13 ]. Exploring different teaching forms, improving teaching effectiveness, and conducting consistent training on PAD management for intensivists across the country are the core content of the CASER group's work. We have achieved good results with previous offline trainings, and the majority of participants benefit from the trainings. However, with the expansion of the training program, we also realize that the training mode still needs further development. PAD management training is not included in the medical undergraduate and graduate education curriculum but forms part of the continuing education content for critical medicine. The organization of offline teaching modes is obviously not as convenient and feasible as that of online teaching modes. In addition, the COVID-19 pandemic has an unprecedented impact on global public health and affected the medical education sector [ 14 ]. Therefore, in later training, we switched from the offline training mode to the online training mode.

Online modes are not as popular in Chinese medical education as in education in other fields. There are many practical clinical operations in medical training that are difficult to conduct with online modes. However, in PAD management training, discussing and analysing actual clinical cases can promote participants' ability to translate theoretical PAD knowledge into clinical treatment. Moreover, our preliminary research on offline training found that most of the intensivists in China had a clear understanding of the concept of PAD management, but the actual application in clinical cases was not ideal. Therefore, in our PAD management training, clinical practice was the focus of training. We used an online CBL mode in this study. Based on typical clinical cases, participants participated in group discussions to explore the optimal PAD management plan, which was conducive to their ability to solve clinical practical problems [ 15 , 16 ].

PAD management training includes much content, and there are many levels of difficulty in the course [ 17 ]. The PAD management training in this study was mainly aimed at doctors with little experience in PAD management. This course was chosen voluntarily by the intensivists. Before the course started, the outline and content was announced, and the difficulty of the course was explained. Therefore, when students chose courses, they were informed of whether they were suitable according to the contents of the course. Otherwise, we choose an SPOC to carry out online training. The SPOC was smaller and developed for a targeted audience and was, therefore, more suited to the educational needs of our participants. Notably, PAD management has not been promoted in China for a long time, and the training level in different regions varies greatly. Therefore, the working years and age of the trainees were not related to PAD management experience.

All the instructors in this study were willing to teach using the SPOC&CBL mode, and two even preferred to teach with the SPOC&CBL mode only. The flexibility of time and place were undoubtedly outstanding advantages of the SPOC&CBL mode compared to the offline mode. To minimize the shortcomings of less interaction between instructors and students and strengthen the role of instructors in the online SPOC&CBL mode, instructors provided the theoretical knowledge training live, and they could interact with participants at any time during this part. In CBL group discussions, the instructors also participated in and guided the participants' discussions online. As a result, our instructors believed that in the SPOC&CBL mode, students' learning initiative and participation were also good, and students' participation in group discussions was better. Of course, in this mode, instructors had more work content, and two instructors thought that the SPOC&CBL mode consumed more energy and time than the offline mode. It has been reported that teachers believe that they spend considerable time and energy preparing SPOCs [ 18 ]. Teachers using the SPOC&CBL curriculum need professional knowledge, substantial clinical experience, and excellent leadership capability. They need to update the teaching concepts and learn new teaching theories and put them into use. Additionally, they must develop and design an education portal and courses using more information technology. In the future, the relevant staff of the CASER group will further optimize the preparation of training, teaching, and after-class summary processes to help instructors provide online trainings more easily.

The effectiveness of online and offline teaching in medical education remains uncertain. Evaluations have failed to lead to consistent conclusions [ 19 , 20 , 21 ]. In a systematic review and meta-analysis, whether online learning, when compared to offline learning, could improve the learning outcomes of undergraduate medical students was evaluated. Overall, online learning was at least as effective as offline learning [ 21 ]. The results of our study also showed that the effect of the online mode was no worse than that of the offline mode. Since the purpose of the training and the main content were the same in both the offline and SPOC&CBL groups, we tested all the participants using the same test to evaluate the learning effect. The results showed that there was no difference in the scores of the two groups. Therefore, participants’ benefits from the course were not affected by the learning mode. In the Netherlands, a study was conducted to evaluate an SPOC according to interns’ first impressions and satisfaction measures regarding the SPOC [ 22 ]. The evaluation showed that the SPOC was a useful and accessible addition to the clinical learning environment, providing an alternative opportunity for the interns to improve their knowledge and skills. However, it appeared that the interns were not satisfied with the collaboration and relatedness aspects of the SPOC, particularly the web-based interaction and peer feedback. The results of our study also showed that participants' perceptions and acceptance of the SPOC&CBL teaching mode were also relatively good. More than 90% of the participants believed that they benefited from the course. They interacted well with other peers in the course and obtained a rich learning experience. The reason for these differences may be that teachers and students communicated and provided feedback in the online course, strengthening the interactions between teachers and students. Other studies also confirmed that students prefer teacher feedback over peer feedback [ 23 ]. Moreover, our results showed that all participants felt that the flexibility of class time and location was conducive to participating in the training. Our participants came from hospitals all over the country, and the online mode obviously saved them travel and accommodation costs.

An online blended teaching mode based on an SPOC and CBL is a good educational method for PAD management training when students cannot access an offline course. By optimizing the role of CBL in the online mode and strengthening the discussion and analysis of actual cases, the students’ ability to solve practical clinical problems was enhanced. Our innovative exploration provides a new perspective for curriculum reform in clinical medicine. It also offers optimal propagation of information in a cost-effective way and meets students’ expectations for training.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.

Abbreviations

Chinese Analgesia and Sedation Education and Research

Pain, agitation-sedation, and delirium

Small private online course

Case-based learning

Chinese Association of Critical Care Physicians

Intensive care unit

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This study was supported by funds from the National Natural Science Foundation of China (No. 81900076). The funding source had no role in the design, conduct, or reporting of the study.

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Li, S., Su, L., Lou, R. et al. Blended teaching mode based on small private online course and case-based learning in analgesia and sedation education in China: a comparison with an offline mode. BMC Med Educ 24 , 28 (2024). https://doi.org/10.1186/s12909-023-04839-4

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Methodology or method? A critical review of qualitative case study reports

Despite on-going debate about credibility, and reported limitations in comparison to other approaches, case study is an increasingly popular approach among qualitative researchers. We critically analysed the methodological descriptions of published case studies. Three high-impact qualitative methods journals were searched to locate case studies published in the past 5 years; 34 were selected for analysis. Articles were categorized as health and health services ( n= 12), social sciences and anthropology ( n= 7), or methods ( n= 15) case studies. The articles were reviewed using an adapted version of established criteria to determine whether adequate methodological justification was present, and if study aims, methods, and reported findings were consistent with a qualitative case study approach. Findings were grouped into five themes outlining key methodological issues: case study methodology or method, case of something particular and case selection, contextually bound case study, researcher and case interactions and triangulation, and study design inconsistent with methodology reported. Improved reporting of case studies by qualitative researchers will advance the methodology for the benefit of researchers and practitioners.

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Experienced qualitative researchers have identified case study research as a stand-alone qualitative approach (Denzin & Lincoln, 2011b ). Case study research has a level of flexibility that is not readily offered by other qualitative approaches such as grounded theory or phenomenology. Case studies are designed to suit the case and research question and published case studies demonstrate wide diversity in study design. There are two popular case study approaches in qualitative research. The first, proposed by Stake ( 1995 ) and Merriam ( 2009 ), is situated in a social constructivist paradigm, whereas the second, by Yin ( 2012 ), Flyvbjerg ( 2011 ), and Eisenhardt ( 1989 ), approaches case study from a post-positivist viewpoint. Scholarship from both schools of inquiry has contributed to the popularity of case study and development of theoretical frameworks and principles that characterize the methodology.

The diversity of case studies reported in the published literature, and on-going debates about credibility and the use of case study in qualitative research practice, suggests that differences in perspectives on case study methodology may prevent researchers from developing a mutual understanding of practice and rigour. In addition, discussion about case study limitations has led some authors to query whether case study is indeed a methodology (Luck, Jackson, & Usher, 2006 ; Meyer, 2001 ; Thomas, 2010 ; Tight, 2010 ). Methodological discussion of qualitative case study research is timely, and a review is required to analyse and understand how this methodology is applied in the qualitative research literature. The aims of this study were to review methodological descriptions of published qualitative case studies, to review how the case study methodological approach was applied, and to identify issues that need to be addressed by researchers, editors, and reviewers. An outline of the current definitions of case study and an overview of the issues proposed in the qualitative methodological literature are provided to set the scene for the review.

Definitions of qualitative case study research

Case study research is an investigation and analysis of a single or collective case, intended to capture the complexity of the object of study (Stake, 1995 ). Qualitative case study research, as described by Stake ( 1995 ), draws together “naturalistic, holistic, ethnographic, phenomenological, and biographic research methods” in a bricoleur design, or in his words, “a palette of methods” (Stake, 1995 , pp. xi–xii). Case study methodology maintains deep connections to core values and intentions and is “particularistic, descriptive and heuristic” (Merriam, 2009 , p. 46).

As a study design, case study is defined by interest in individual cases rather than the methods of inquiry used. The selection of methods is informed by researcher and case intuition and makes use of naturally occurring sources of knowledge, such as people or observations of interactions that occur in the physical space (Stake, 1998 ). Thomas ( 2011 ) suggested that “analytical eclecticism” is a defining factor (p. 512). Multiple data collection and analysis methods are adopted to further develop and understand the case, shaped by context and emergent data (Stake, 1995 ). This qualitative approach “explores a real-life, contemporary bounded system (a case ) or multiple bounded systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information … and reports a case description and case themes ” (Creswell, 2013b , p. 97). Case study research has been defined by the unit of analysis, the process of study, and the outcome or end product, all essentially the case (Merriam, 2009 ).

The case is an object to be studied for an identified reason that is peculiar or particular. Classification of the case and case selection procedures informs development of the study design and clarifies the research question. Stake ( 1995 ) proposed three types of cases and study design frameworks. These include the intrinsic case, the instrumental case, and the collective instrumental case. The intrinsic case is used to understand the particulars of a single case, rather than what it represents. An instrumental case study provides insight on an issue or is used to refine theory. The case is selected to advance understanding of the object of interest. A collective refers to an instrumental case which is studied as multiple, nested cases, observed in unison, parallel, or sequential order. More than one case can be simultaneously studied; however, each case study is a concentrated, single inquiry, studied holistically in its own entirety (Stake, 1995 , 1998 ).

Researchers who use case study are urged to seek out what is common and what is particular about the case. This involves careful and in-depth consideration of the nature of the case, historical background, physical setting, and other institutional and political contextual factors (Stake, 1998 ). An interpretive or social constructivist approach to qualitative case study research supports a transactional method of inquiry, where the researcher has a personal interaction with the case. The case is developed in a relationship between the researcher and informants, and presented to engage the reader, inviting them to join in this interaction and in case discovery (Stake, 1995 ). A postpositivist approach to case study involves developing a clear case study protocol with careful consideration of validity and potential bias, which might involve an exploratory or pilot phase, and ensures that all elements of the case are measured and adequately described (Yin, 2009 , 2012 ).

Current methodological issues in qualitative case study research

The future of qualitative research will be influenced and constructed by the way research is conducted, and by what is reviewed and published in academic journals (Morse, 2011 ). If case study research is to further develop as a principal qualitative methodological approach, and make a valued contribution to the field of qualitative inquiry, issues related to methodological credibility must be considered. Researchers are required to demonstrate rigour through adequate descriptions of methodological foundations. Case studies published without sufficient detail for the reader to understand the study design, and without rationale for key methodological decisions, may lead to research being interpreted as lacking in quality or credibility (Hallberg, 2013 ; Morse, 2011 ).

There is a level of artistic license that is embraced by qualitative researchers and distinguishes practice, which nurtures creativity, innovation, and reflexivity (Denzin & Lincoln, 2011b ; Morse, 2009 ). Qualitative research is “inherently multimethod” (Denzin & Lincoln, 2011a , p. 5); however, with this creative freedom, it is important for researchers to provide adequate description for methodological justification (Meyer, 2001 ). This includes paradigm and theoretical perspectives that have influenced study design. Without adequate description, study design might not be understood by the reader, and can appear to be dishonest or inaccurate. Reviewers and readers might be confused by the inconsistent or inappropriate terms used to describe case study research approach and methods, and be distracted from important study findings (Sandelowski, 2000 ). This issue extends beyond case study research, and others have noted inconsistencies in reporting of methodology and method by qualitative researchers. Sandelowski ( 2000 , 2010 ) argued for accurate identification of qualitative description as a research approach. She recommended that the selected methodology should be harmonious with the study design, and be reflected in methods and analysis techniques. Similarly, Webb and Kevern ( 2000 ) uncovered inconsistencies in qualitative nursing research with focus group methods, recommending that methodological procedures must cite seminal authors and be applied with respect to the selected theoretical framework. Incorrect labelling using case study might stem from the flexibility in case study design and non-directional character relative to other approaches (Rosenberg & Yates, 2007 ). Methodological integrity is required in design of qualitative studies, including case study, to ensure study rigour and to enhance credibility of the field (Morse, 2011 ).

Case study has been unnecessarily devalued by comparisons with statistical methods (Eisenhardt, 1989 ; Flyvbjerg, 2006 , 2011 ; Jensen & Rodgers, 2001 ; Piekkari, Welch, & Paavilainen, 2009 ; Tight, 2010 ; Yin, 1999 ). It is reputed to be the “the weak sibling” in comparison to other, more rigorous, approaches (Yin, 2009 , p. xiii). Case study is not an inherently comparative approach to research. The objective is not statistical research, and the aim is not to produce outcomes that are generalizable to all populations (Thomas, 2011 ). Comparisons between case study and statistical research do little to advance this qualitative approach, and fail to recognize its inherent value, which can be better understood from the interpretive or social constructionist viewpoint of other authors (Merriam, 2009 ; Stake, 1995 ). Building on discussions relating to “fuzzy” (Bassey, 2001 ), or naturalistic generalizations (Stake, 1978 ), or transference of concepts and theories (Ayres, Kavanaugh, & Knafl, 2003 ; Morse et al., 2011 ) would have more relevance.

Case study research has been used as a catch-all design to justify or add weight to fundamental qualitative descriptive studies that do not fit with other traditional frameworks (Merriam, 2009 ). A case study has been a “convenient label for our research—when we ‘can't think of anything ‘better”—in an attempt to give it [qualitative methodology] some added respectability” (Tight, 2010 , p. 337). Qualitative case study research is a pliable approach (Merriam, 2009 ; Meyer, 2001 ; Stake, 1995 ), and has been likened to a “curious methodological limbo” (Gerring, 2004 , p. 341) or “paradigmatic bridge” (Luck et al., 2006 , p. 104), that is on the borderline between postpositivist and constructionist interpretations. This has resulted in inconsistency in application, which indicates that flexibility comes with limitations (Meyer, 2001 ), and the open nature of case study research might be off-putting to novice researchers (Thomas, 2011 ). The development of a well-(in)formed theoretical framework to guide a case study should improve consistency, rigour, and trust in studies published in qualitative research journals (Meyer, 2001 ).

Assessment of rigour

The purpose of this study was to analyse the methodological descriptions of case studies published in qualitative methods journals. To do this we needed to develop a suitable framework, which used existing, established criteria for appraising qualitative case study research rigour (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ). A number of qualitative authors have developed concepts and criteria that are used to determine whether a study is rigorous (Denzin & Lincoln, 2011b ; Lincoln, 1995 ; Sandelowski & Barroso, 2002 ). The criteria proposed by Stake ( 1995 ) provide a framework for readers and reviewers to make judgements regarding case study quality, and identify key characteristics essential for good methodological rigour. Although each of the factors listed in Stake's criteria could enhance the quality of a qualitative research report, in Table I we present an adapted criteria used in this study, which integrates more recent work by Merriam ( 2009 ) and Creswell ( 2013b ). Stake's ( 1995 ) original criteria were separated into two categories. The first list of general criteria is “relevant for all qualitative research.” The second list, “high relevance to qualitative case study research,” was the criteria that we decided had higher relevance to case study research. This second list was the main criteria used to assess the methodological descriptions of the case studies reviewed. The complete table has been preserved so that the reader can determine how the original criteria were adapted.

Framework for assessing quality in qualitative case study research.

Adapted from Stake ( 1995 , p. 131).

Study design

The critical review method described by Grant and Booth ( 2009 ) was used, which is appropriate for the assessment of research quality, and is used for literature analysis to inform research and practice. This type of review goes beyond the mapping and description of scoping or rapid reviews, to include “analysis and conceptual innovation” (Grant & Booth, 2009 , p. 93). A critical review is used to develop existing, or produce new, hypotheses or models. This is different to systematic reviews that answer clinical questions. It is used to evaluate existing research and competing ideas, to provide a “launch pad” for conceptual development and “subsequent testing” (Grant & Booth, 2009 , p. 93).

Qualitative methods journals were located by a search of the 2011 ISI Journal Citation Reports in Social Science, via the database Web of Knowledge (see m.webofknowledge.com). No “qualitative research methods” category existed in the citation reports; therefore, a search of all categories was performed using the term “qualitative.” In Table II , we present the qualitative methods journals located, ranked by impact factor. The highest ranked journals were selected for searching. We acknowledge that the impact factor ranking system might not be the best measure of journal quality (Cheek, Garnham, & Quan, 2006 ); however, this was the most appropriate and accessible method available.

International Journal of Qualitative Studies on Health and Well-being.

Search strategy

In March 2013, searches of the journals, Qualitative Health Research , Qualitative Research , and Qualitative Inquiry were completed to retrieve studies with “case study” in the abstract field. The search was limited to the past 5 years (1 January 2008 to 1 March 2013). The objective was to locate published qualitative case studies suitable for assessment using the adapted criterion. Viewpoints, commentaries, and other article types were excluded from review. Title and abstracts of the 45 retrieved articles were read by the first author, who identified 34 empirical case studies for review. All authors reviewed the 34 studies to confirm selection and categorization. In Table III , we present the 34 case studies grouped by journal, and categorized by research topic, including health sciences, social sciences and anthropology, and methods research. There was a discrepancy in categorization of one article on pedagogy and a new teaching method published in Qualitative Inquiry (Jorrín-Abellán, Rubia-Avi, Anguita-Martínez, Gómez-Sánchez, & Martínez-Mones, 2008 ). Consensus was to allocate to the methods category.

Outcomes of search of qualitative methods journals.

In Table III , the number of studies located, and final numbers selected for review have been reported. Qualitative Health Research published the most empirical case studies ( n= 16). In the health category, there were 12 case studies of health conditions, health services, and health policy issues, all published in Qualitative Health Research . Seven case studies were categorized as social sciences and anthropology research, which combined case study with biography and ethnography methodologies. All three journals published case studies on methods research to illustrate a data collection or analysis technique, methodological procedure, or related issue.

The methodological descriptions of 34 case studies were critically reviewed using the adapted criteria. All articles reviewed contained a description of study methods; however, the length, amount of detail, and position of the description in the article varied. Few studies provided an accurate description and rationale for using a qualitative case study approach. In the 34 case studies reviewed, three described a theoretical framework informed by Stake ( 1995 ), two by Yin ( 2009 ), and three provided a mixed framework informed by various authors, which might have included both Yin and Stake. Few studies described their case study design, or included a rationale that explained why they excluded or added further procedures, and whether this was to enhance the study design, or to better suit the research question. In 26 of the studies no reference was provided to principal case study authors. From reviewing the description of methods, few authors provided a description or justification of case study methodology that demonstrated how their study was informed by the methodological literature that exists on this approach.

The methodological descriptions of each study were reviewed using the adapted criteria, and the following issues were identified: case study methodology or method; case of something particular and case selection; contextually bound case study; researcher and case interactions and triangulation; and, study design inconsistent with methodology. An outline of how the issues were developed from the critical review is provided, followed by a discussion of how these relate to the current methodological literature.

Case study methodology or method

A third of the case studies reviewed appeared to use a case report method, not case study methodology as described by principal authors (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). Case studies were identified as a case report because of missing methodological detail and by review of the study aims and purpose. These reports presented data for small samples of no more than three people, places or phenomenon. Four studies, or “case reports” were single cases selected retrospectively from larger studies (Bronken, Kirkevold, Martinsen, & Kvigne, 2012 ; Coltart & Henwood, 2012 ; Hooghe, Neimeyer, & Rober, 2012 ; Roscigno et al., 2012 ). Case reports were not a case of something, instead were a case demonstration or an example presented in a report. These reports presented outcomes, and reported on how the case could be generalized. Descriptions focussed on the phenomena, rather than the case itself, and did not appear to study the case in its entirety.

Case reports had minimal in-text references to case study methodology, and were informed by other qualitative traditions or secondary sources (Adamson & Holloway, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nagar-Ron & Motzafi-Haller, 2011 ). This does not suggest that case study methodology cannot be multimethod, however, methodology should be consistent in design, be clearly described (Meyer, 2001 ; Stake, 1995 ), and maintain focus on the case (Creswell, 2013b ).

To demonstrate how case reports were identified, three examples are provided. The first, Yeh ( 2013 ) described their study as, “the examination of the emergence of vegetarianism in Victorian England serves as a case study to reveal the relationships between boundaries and entities” (p. 306). The findings were a historical case report, which resulted from an ethnographic study of vegetarianism. Cunsolo Willox, Harper, Edge, ‘My Word’: Storytelling and Digital Media Lab, and Rigolet Inuit Community Government (2013) used “a case study that illustrates the usage of digital storytelling within an Inuit community” (p. 130). This case study reported how digital storytelling can be used with indigenous communities as a participatory method to illuminate the benefits of this method for other studies. This “case study was conducted in the Inuit community” but did not include the Inuit community in case analysis (Cunsolo Willox et al., 2013 , p. 130). Bronken et al. ( 2012 ) provided a single case report to demonstrate issues observed in a larger clinical study of aphasia and stroke, without adequate case description or analysis.

Case study of something particular and case selection

Case selection is a precursor to case analysis, which needs to be presented as a convincing argument (Merriam, 2009 ). Descriptions of the case were often not adequate to ascertain why the case was selected, or whether it was a particular exemplar or outlier (Thomas, 2011 ). In a number of case studies in the health and social science categories, it was not explicit whether the case was of something particular, or peculiar to their discipline or field (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson, Botelho, Welch, Joseph, & Tennstedt, 2012 ; Mawn et al., 2010 ; Snyder-Young, 2011 ). There were exceptions in the methods category ( Table III ), where cases were selected by researchers to report on a new or innovative method. The cases emerged through heuristic study, and were reported to be particular, relative to the existing methods literature (Ajodhia-Andrews & Berman, 2009 ; Buckley & Waring, 2013 ; Cunsolo Willox et al., 2013 ; De Haene, Grietens, & Verschueren, 2010 ; Gratton & O'Donnell, 2011 ; Sumsion, 2013 ; Wimpenny & Savin-Baden, 2012 ).

Case selection processes were sometimes insufficient to understand why the case was selected from the global population of cases, or what study of this case would contribute to knowledge as compared with other possible cases (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson et al., 2012 ; Mawn et al., 2010 ). In two studies, local cases were selected (Barone, 2010 ; Fourie & Theron, 2012 ) because the researcher was familiar with and had access to the case. Possible limitations of a convenience sample were not acknowledged. Purposeful sampling was used to recruit participants within the case of one study, but not of the case itself (Gallagher et al., 2013 ). Random sampling was completed for case selection in two studies (Colón-Emeric et al., 2010 ; Jackson et al., 2012 ), which has limited meaning in interpretive qualitative research.

To demonstrate how researchers provided a good justification for the selection of case study approaches, four examples are provided. The first, cases of residential care homes, were selected because of reported occurrences of mistreatment, which included residents being locked in rooms at night (Rytterström, Unosson, & Arman, 2013 ). Roscigno et al. ( 2012 ) selected cases of parents who were admitted for early hospitalization in neonatal intensive care with a threatened preterm delivery before 26 weeks. Hooghe et al. ( 2012 ) used random sampling to select 20 couples that had experienced the death of a child; however, the case study was of one couple and a particular metaphor described only by them. The final example, Coltart and Henwood ( 2012 ), provided a detailed account of how they selected two cases from a sample of 46 fathers based on personal characteristics and beliefs. They described how the analysis of the two cases would contribute to their larger study on first time fathers and parenting.

Contextually bound case study

The limits or boundaries of the case are a defining factor of case study methodology (Merriam, 2009 ; Ragin & Becker, 1992 ; Stake, 1995 ; Yin, 2009 ). Adequate contextual description is required to understand the setting or context in which the case is revealed. In the health category, case studies were used to illustrate a clinical phenomenon or issue such as compliance and health behaviour (Colón-Emeric et al., 2010 ; D'Enbeau, Buzzanell, & Duckworth, 2010 ; Gallagher et al., 2013 ; Hooghe et al., 2012 ; Jackson et al., 2012 ; Roscigno et al., 2012 ). In these case studies, contextual boundaries, such as physical and institutional descriptions, were not sufficient to understand the case as a holistic system, for example, the general practitioner (GP) clinic in Gallagher et al. ( 2013 ), or the nursing home in Colón-Emeric et al. ( 2010 ). Similarly, in the social science and methods categories, attention was paid to some components of the case context, but not others, missing important information required to understand the case as a holistic system (Alexander, Moreira, & Kumar, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nairn & Panelli, 2009 ; Wimpenny & Savin-Baden, 2012 ).

In two studies, vicarious experience or vignettes (Nairn & Panelli, 2009 ) and images (Jorrín-Abellán et al., 2008 ) were effective to support description of context, and might have been a useful addition for other case studies. Missing contextual boundaries suggests that the case might not be adequately defined. Additional information, such as the physical, institutional, political, and community context, would improve understanding of the case (Stake, 1998 ). In Boxes 1 and 2 , we present brief synopses of two studies that were reviewed, which demonstrated a well bounded case. In Box 1 , Ledderer ( 2011 ) used a qualitative case study design informed by Stake's tradition. In Box 2 , Gillard, Witt, and Watts ( 2011 ) were informed by Yin's tradition. By providing a brief outline of the case studies in Boxes 1 and 2 , we demonstrate how effective case boundaries can be constructed and reported, which may be of particular interest to prospective case study researchers.

Article synopsis of case study research using Stake's tradition

Ledderer ( 2011 ) used a qualitative case study research design, informed by modern ethnography. The study is bounded to 10 general practice clinics in Denmark, who had received federal funding to implement preventative care services based on a Motivational Interviewing intervention. The researcher question focussed on “why is it so difficult to create change in medical practice?” (Ledderer, 2011 , p. 27). The study context was adequately described, providing detail on the general practitioner (GP) clinics and relevant political and economic influences. Methodological decisions are described in first person narrative, providing insight on researcher perspectives and interaction with the case. Forty-four interviews were conducted, which focussed on how GPs conducted consultations, and the form, nature and content, rather than asking their opinion or experience (Ledderer, 2011 , p. 30). The duration and intensity of researcher immersion in the case enhanced depth of description and trustworthiness of study findings. Analysis was consistent with Stake's tradition, and the researcher provided examples of inquiry techniques used to challenge assumptions about emerging themes. Several other seminal qualitative works were cited. The themes and typology constructed are rich in narrative data and storytelling by clinic staff, demonstrating individual clinic experiences as well as shared meanings and understandings about changing from a biomedical to psychological approach to preventative health intervention. Conclusions make note of social and cultural meanings and lessons learned, which might not have been uncovered using a different methodology.

Article synopsis of case study research using Yin's tradition

Gillard et al. ( 2011 ) study of camps for adolescents living with HIV/AIDs provided a good example of Yin's interpretive case study approach. The context of the case is bounded by the three summer camps of which the researchers had prior professional involvement. A case study protocol was developed that used multiple methods to gather information at three data collection points coinciding with three youth camps (Teen Forum, Discover Camp, and Camp Strong). Gillard and colleagues followed Yin's ( 2009 ) principles, using a consistent data protocol that enhanced cross-case analysis. Data described the young people, the camp physical environment, camp schedule, objectives and outcomes, and the staff of three youth camps. The findings provided a detailed description of the context, with less detail of individual participants, including insight into researcher's interpretations and methodological decisions throughout the data collection and analysis process. Findings provided the reader with a sense of “being there,” and are discovered through constant comparison of the case with the research issues; the case is the unit of analysis. There is evidence of researcher immersion in the case, and Gillard reports spending significant time in the field in a naturalistic and integrated youth mentor role.

This case study is not intended to have a significant impact on broader health policy, although does have implications for health professionals working with adolescents. Study conclusions will inform future camps for young people with chronic disease, and practitioners are able to compare similarities between this case and their own practice (for knowledge translation). No limitations of this article were reported. Limitations related to publication of this case study were that it was 20 pages long and used three tables to provide sufficient description of the camp and program components, and relationships with the research issue.

Researcher and case interactions and triangulation

Researcher and case interactions and transactions are a defining feature of case study methodology (Stake, 1995 ). Narrative stories, vignettes, and thick description are used to provoke vicarious experience and a sense of being there with the researcher in their interaction with the case. Few of the case studies reviewed provided details of the researcher's relationship with the case, researcher–case interactions, and how these influenced the development of the case study (Buzzanell & D'Enbeau, 2009 ; D'Enbeau et al., 2010 ; Gallagher et al., 2013 ; Gillard et al., 2011 ; Ledderer, 2011 ; Nagar-Ron & Motzafi-Haller, 2011 ). The role and position of the researcher needed to be self-examined and understood by readers, to understand how this influenced interactions with participants, and to determine what triangulation is needed (Merriam, 2009 ; Stake, 1995 ).

Gillard et al. ( 2011 ) provided a good example of triangulation, comparing data sources in a table (p. 1513). Triangulation of sources was used to reveal as much depth as possible in the study by Nagar-Ron and Motzafi-Haller ( 2011 ), while also enhancing confirmation validity. There were several case studies that would have benefited from improved range and use of data sources, and descriptions of researcher–case interactions (Ajodhia-Andrews & Berman, 2009 ; Bronken et al., 2012 ; Fincham, Scourfield, & Langer, 2008 ; Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Snyder-Young, 2011 ; Yeh, 2013 ).

Study design inconsistent with methodology

Good, rigorous case studies require a strong methodological justification (Meyer, 2001 ) and a logical and coherent argument that defines paradigm, methodological position, and selection of study methods (Denzin & Lincoln, 2011b ). Methodological justification was insufficient in several of the studies reviewed (Barone, 2010 ; Bronken et al., 2012 ; Hooghe et al., 2012 ; Mawn et al., 2010 ; Roscigno et al., 2012 ; Yeh, 2013 ). This was judged by the absence, or inadequate or inconsistent reference to case study methodology in-text.

In six studies, the methodological justification provided did not relate to case study. There were common issues identified. Secondary sources were used as primary methodological references indicating that study design might not have been theoretically sound (Colón-Emeric et al., 2010 ; Coltart & Henwood, 2012 ; Roscigno et al., 2012 ; Snyder-Young, 2011 ). Authors and sources cited in methodological descriptions were inconsistent with the actual study design and practices used (Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Jorrín-Abellán et al., 2008 ; Mawn et al., 2010 ; Rytterström et al., 2013 ; Wimpenny & Savin-Baden, 2012 ). This occurred when researchers cited Stake or Yin, or both (Mawn et al., 2010 ; Rytterström et al., 2013 ), although did not follow their paradigmatic or methodological approach. In 26 studies there were no citations for a case study methodological approach.

The findings of this study have highlighted a number of issues for researchers. A considerable number of case studies reviewed were missing key elements that define qualitative case study methodology and the tradition cited. A significant number of studies did not provide a clear methodological description or justification relevant to case study. Case studies in health and social sciences did not provide sufficient information for the reader to understand case selection, and why this case was chosen above others. The context of the cases were not described in adequate detail to understand all relevant elements of the case context, which indicated that cases may have not been contextually bounded. There were inconsistencies between reported methodology, study design, and paradigmatic approach in case studies reviewed, which made it difficult to understand the study methodology and theoretical foundations. These issues have implications for methodological integrity and honesty when reporting study design, which are values of the qualitative research tradition and are ethical requirements (Wager & Kleinert, 2010a ). Poorly described methodological descriptions may lead the reader to misinterpret or discredit study findings, which limits the impact of the study, and, as a collective, hinders advancements in the broader qualitative research field.

The issues highlighted in our review build on current debates in the case study literature, and queries about the value of this methodology. Case study research can be situated within different paradigms or designed with an array of methods. In order to maintain the creativity and flexibility that is valued in this methodology, clearer descriptions of paradigm and theoretical position and methods should be provided so that study findings are not undervalued or discredited. Case study research is an interdisciplinary practice, which means that clear methodological descriptions might be more important for this approach than other methodologies that are predominantly driven by fewer disciplines (Creswell, 2013b ).

Authors frequently omit elements of methodologies and include others to strengthen study design, and we do not propose a rigid or purist ideology in this paper. On the contrary, we encourage new ideas about using case study, together with adequate reporting, which will advance the value and practice of case study. The implications of unclear methodological descriptions in the studies reviewed were that study design appeared to be inconsistent with reported methodology, and key elements required for making judgements of rigour were missing. It was not clear whether the deviations from methodological tradition were made by researchers to strengthen the study design, or because of misinterpretations. Morse ( 2011 ) recommended that innovations and deviations from practice are best made by experienced researchers, and that a novice might be unaware of the issues involved with making these changes. To perpetuate the tradition of case study research, applications in the published literature should have consistencies with traditional methodological constructions, and deviations should be described with a rationale that is inherent in study conduct and findings. Providing methodological descriptions that demonstrate a strong theoretical foundation and coherent study design will add credibility to the study, while ensuring the intrinsic meaning of case study is maintained.

The value of this review is that it contributes to discussion of whether case study is a methodology or method. We propose possible reasons why researchers might make this misinterpretation. Researchers may interchange the terms methods and methodology, and conduct research without adequate attention to epistemology and historical tradition (Carter & Little, 2007 ; Sandelowski, 2010 ). If the rich meaning that naming a qualitative methodology brings to the study is not recognized, a case study might appear to be inconsistent with the traditional approaches described by principal authors (Creswell, 2013a ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). If case studies are not methodologically and theoretically situated, then they might appear to be a case report.

Case reports are promoted by university and medical journals as a method of reporting on medical or scientific cases; guidelines for case reports are publicly available on websites ( http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/case_report.html ). The various case report guidelines provide a general criteria for case reports, which describes that this form of report does not meet the criteria of research, is used for retrospective analysis of up to three clinical cases, and is primarily illustrative and for educational purposes. Case reports can be published in academic journals, but do not require approval from a human research ethics committee. Traditionally, case reports describe a single case, to explain how and what occurred in a selected setting, for example, to illustrate a new phenomenon that has emerged from a larger study. A case report is not necessarily particular or the study of a case in its entirety, and the larger study would usually be guided by a different research methodology.

This description of a case report is similar to what was provided in some studies reviewed. This form of report lacks methodological grounding and qualities of research rigour. The case report has publication value in demonstrating an example and for dissemination of knowledge (Flanagan, 1999 ). However, case reports have different meaning and purpose to case study, which needs to be distinguished. Findings of our review suggest that the medical understanding of a case report has been confused with qualitative case study approaches.

In this review, a number of case studies did not have methodological descriptions that included key characteristics of case study listed in the adapted criteria, and several issues have been discussed. There have been calls for improvements in publication quality of qualitative research (Morse, 2011 ), and for improvements in peer review of submitted manuscripts (Carter & Little, 2007 ; Jasper, Vaismoradi, Bondas, & Turunen, 2013 ). The challenging nature of editor and reviewers responsibilities are acknowledged in the literature (Hames, 2013 ; Wager & Kleinert, 2010b ); however, review of case study methodology should be prioritized because of disputes on methodological value.

Authors using case study approaches are recommended to describe their theoretical framework and methods clearly, and to seek and follow specialist methodological advice when needed (Wager & Kleinert, 2010a ). Adequate page space for case study description would contribute to better publications (Gillard et al., 2011 ). Capitalizing on the ability to publish complementary resources should be considered.

Limitations of the review

There is a level of subjectivity involved in this type of review and this should be considered when interpreting study findings. Qualitative methods journals were selected because the aims and scope of these journals are to publish studies that contribute to methodological discussion and development of qualitative research. Generalist health and social science journals were excluded that might have contained good quality case studies. Journals in business or education were also excluded, although a review of case studies in international business journals has been published elsewhere (Piekkari et al., 2009 ).

The criteria used to assess the quality of the case studies were a set of qualitative indicators. A numerical or ranking system might have resulted in different results. Stake's ( 1995 ) criteria have been referenced elsewhere, and was deemed the best available (Creswell, 2013b ; Crowe et al., 2011 ). Not all qualitative studies are reported in a consistent way and some authors choose to report findings in a narrative form in comparison to a typical biomedical report style (Sandelowski & Barroso, 2002 ), if misinterpretations were made this may have affected the review.

Case study research is an increasingly popular approach among qualitative researchers, which provides methodological flexibility through the incorporation of different paradigmatic positions, study designs, and methods. However, whereas flexibility can be an advantage, a myriad of different interpretations has resulted in critics questioning the use of case study as a methodology. Using an adaptation of established criteria, we aimed to identify and assess the methodological descriptions of case studies in high impact, qualitative methods journals. Few articles were identified that applied qualitative case study approaches as described by experts in case study design. There were inconsistencies in methodology and study design, which indicated that researchers were confused whether case study was a methodology or a method. Commonly, there appeared to be confusion between case studies and case reports. Without clear understanding and application of the principles and key elements of case study methodology, there is a risk that the flexibility of the approach will result in haphazard reporting, and will limit its global application as a valuable, theoretically supported methodology that can be rigorously applied across disciplines and fields.

Conflict of interest and funding

The authors have not received any funding or benefits from industry or elsewhere to conduct this study.

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Scientists hail new antibiotic that can kill drug-resistant bacteria

Zosurabalpin has defeated strains of pneumonia and sepsis in mice, raising hopes for human trials

Scientists have discovered an entirely new class of antibiotic that appears to kill one of three bacteria considered to pose the greatest threat to human health because of their extensive drug-resistance.

Zosurabalpin defeated highly drug-resistant strains of Carbapenem-resistant Acinetobacter baumannii (Crab) in mouse models of pneumonia and sepsis, and was being tested in human trials.

Crab is classified as a priority 1 critical pathogen by the World Health Organization, alongside two other drug-resistant forms of bacteria – Pseudomonas aeruginosa and Enterobacteriaceae .

“Crab is a significant cause of infection in hospitals, particularly in people who are on ventilators,” said Dr Andrew Edwards , a senior lecturer in molecular microbiology at Imperial College London, who was not involved in the research. “While it is not an aggressive pathogen it is resistant to multiple different antibiotics, making it very difficult to treat.

“Unfortunately, development of new treatments against this bacterium has been extremely challenging because it is very adept at keeping antibiotics from getting past its outer cell layer. Therefore, this work is really exciting, and provides confidence that the approaches being used to find new antibiotics can bear fruit.”

Antibiotic-resistant infections pose an urgent threat to human health – particularly those caused by a large group of bacteria known as Gram-negative bacteria, which are protected by an outer shell containing a substance called lipopolysaccharide (LPS).

“LPS allows bacteria to live in harsh environments, and it also allows them to evade attack by our immune system,” said Dr Michael Lobritz, the global head of infectious diseases at Roche Pharma Research and Early Development in Basel Switzerland, which developed the new drug.

No new antibiotic for Gram-negative bacteria have been approved in more than 50 years.

Roche had previously identified Zosurabalpin as capable of blocking the growth of A baumannii but it was not clear how it worked, or if it would be effective in animals with Crab-related infections.

Through a series of experiments published in Nature , Prof Daniel Kahne at Harvard University in Cambridge, US, and colleagues showed that the drug prevented LPS from being transported to the outer membrane of the bacterium, killing it. They also found that Zosurabalpin considerably reduced levels of bacteria in mice with Crab-induced pneumonia and prevented the death of those with Crab-related sepsis.

Lobritz said: “This is the first time we’ve found anything that operates in this way, so it is unique in its chemical makeup and mechanism of action.”

While he stressed that this molecule alone would not solve the public health threat of antimicrobial resistant infections, the discovery could lay the foundations for future efforts to drug the same transport system in other bacteria.

Edwards said a different type of antibiotic that was being developed, known as murepavadin, similarly targeted LPS transport – though through a different mechanism.

“It has been shown to be active against a bacterium called Pseudomonas aeruginosa , suggesting that it may be possible to expand this work to other multi-antibiotic resistant bacteria such as Klebsiella and E coli ,” he said.

However, he cautioned that the progression of new drugs from animal studies into humans could be extremely difficult.

Meanwhile, the UK’s science, innovation and technology committee has called for steps to develop the potential of bacteria-killing viruses – called bacteriophages – that could provide an alternative to antibiotics for resistant infections.

In a report published on Wednesday, the committee said development of phage therapies had hit an impasse because in order to enter clinical trials they needed to be manufactured to certain standards, yet investment in manufacturing plants hinged on successful clinical trials.

It recommended that the government should consider establishing a small facility at the mothballed Rosalind Franklin laboratory in the West Midlands, which was originally set up to process Covid tests during the pandemic.

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MIS-C Cohort

Statistical analysis, mis-c case definitions, kd and mis-c, updated case definition of mis-c and implications for clinical care.

FUNDING: Funding was provided by the Samara Jan Turkel Center for Autoimmune Disease, Boston Children’s Hospital.

CONFLICT OF INTEREST DISCLOSURES: The authors have no conflicts of interest to disclose.

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Megan Day-Lewis , Laura Berbert , Annette Baker , Audrey Dionne , Jane W. Newburger , Mary Beth F. Son; Updated Case Definition of MIS-C and Implications for Clinical Care. Pediatrics 2024; e2023063259. 10.1542/peds.2023-063259

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A broad, surveillance case definition was implemented when multisystem inflammatory syndrome in children (MIS-C) emerged in 2020. In 2023, a revised MIS-C case definition was constructed to improve specificity and reduce misclassification with other pediatric inflammatory conditions. This study aims to describe the impact of the updated definition on the classification of patients with MIS-C and Kawasaki Disease (KD).

Patients hospitalized from March 2020 to November 2022 with clinician-diagnosed KD and MIS-C at a single center were studied retrospectively. Specificity and positive predictive value were assessed; McNemar test was used to compare specificity.

Among 119 patients with MIS-C per the 2020 definition, 20 (17%) did not fulfill the 2023 definition. Six of these 20 (30%) had shock or cardiac involvement. Of 59 KD patients, 10 (17%) met the 2020 MIS-C definition. Five patients (8%) met the 2023 MIS-C definition. Specificity for the 2020 and 2023 MIS-C definitions among KD patients were 83.1% and 91.5% respectively (McNemar, P = .0736). Positive predictive value was higher for the 2023 MIS-C case definition compared with the 2020 MIS-C case definition (95.2% vs 92.2%).

Approximately 1 in 5 patients diagnosed with MIS-C using the 2020 case definition did not meet the 2023 definition, including patients with cardiovascular dysfunction. Overlap persisted between patients meeting KD and 2023 MIS-C case definitions, with a false positive rate of 8%. Implications for treatment should be considered, particularly in settings where presumed MIS-C may be treated with corticosteroid monotherapy.

A broad definition for multisystem inflammatory syndrome in children (MIS-C) allowed for national surveillance; however, overlap with other inflammatory conditions posed a challenge. A new case definition was constructed in 2023 to reduce misclassification and the impact is unknown.

The 2023 definition showed improvement in the ability to accurately identify MIS-C cases and discriminate between MIS-C and Kawasaki disease, however this was not statistically significant. Importantly, patients with MIS-C and cardiac involvement were not captured and overlap with Kawasaki disease persisted.

Multisystem inflammatory syndrome in children (MIS-C) is a severe hyperinflammatory condition characterized by fever and multiorgan involvement including cardiac dysfunction as well as shock occurring 2 to 8 weeks after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 1 When this novel syndrome emerged in early 2020, the Centers for Disease Control and Prevention (CDC) constructed a case definition to facilitate US national surveillance 1 requiring the presence of fever, systemic inflammation using a number of biomarkers, and involvement of at least 2 of 7 organ systems. Similar definitions were devised for use in the United Kingdom and Europe. 2 , – 4 The CDC’s intentionally broad definition allowed for inclusion of the full spectrum of a novel illness. However, the overlap with other infectious and inflammatory conditions posed a challenge for clinicians across care settings. 5 , – 8 Conditions that have overlapping features with MIS-C include Kawasaki Disease (KD), culture negative sepsis, and macrophage activation syndrome. However, KD is the most analogous with hallmarks of fever, systemic inflammation, mucocutaneous changes, and cardiovascular findings. 1 , 5 Under the 2020 MIS-C definition, patients who met criteria for both KD and MIS-C were considered to have MIS-C. 1  

In light of the growing wealth of knowledge related to MIS-C 9 and the need to reduce complexity and misclassification, the Council of State and Territorial Epidemiologist (CSTE) implemented a revised MIS-C case definition. 10 The 2023 definition differs from the original in that it includes a threshold for inflammation (C-reactive protein [CRP] ≥3 mg/dL), reduced the number of organ systems included (neurologic, respiratory, and renal systems were eliminated), and revised definitions of involvement for cardiac and hematologic systems. Importantly, KD is designated as an alternative diagnosis under the 2023 MIS-C definition.

It is not clear if use of the updated case definition will better distinguish MIS-C from other febrile conditions compared with the original definition. It is particularly important to examine the possibility of misclassification in regard to KD given the lack of viable differentiating factors and implications for treatment. There is precedent in the literature 11 , – 14 for treatment of MIS-C with corticosteroid monotherapy, which would be contraindicated in KD, as the standard of care for KD is treatment with intravenous immunoglobulin (IVIG). 15  

We applied the 2023 MIS-C case definition to a single-center cohort of MIS-C patients diagnosed using the 2020 case definition and aimed to describe the impact of the updated case definition on this cohort. We also aimed to examine the risk of misclassification of patients with clinician-diagnosed KD by applying the 2020 and 2023 MIS-C definitions ( Table 1 ). 1 , 10 , 15  

Multisystem Inflammatory Syndrome in Children 2020 and 2023 and Kawasaki Disease Case Definitions

RT-PCR, reverse transcription PCR.

Some individuals may fulfill full or partial criteria for Kawasaki disease but should be reported if they meet the case definition for MIS-C.

A diagnosis of Kawasaki Disease should be considered an alternative diagnosis.

Clinician documentation of shock.

Our retrospective study included hospitalized patients diagnosed with MIS-C or KD from March 2020 to November 2022. This study was approved by the Boston Children’s Hospital Institutional Review Board and waiver of consent was granted.

Demographic, clinical, laboratory, and echocardiographic data were extracted from the medical record. In regard to serology testing for SARS CoV-2 infection, SARS-CoV-2 antinucleocapsid antibody testing is used at our institution.

KD patients were identified from our institutional clinical database of patients treated for KD. Cases of KD were reviewed by 3 members of the study team (M.D.L., L.B., M.B.S.) and determined to meet complete or incomplete KD criteria ( Table 1 ). 15 Patients who were treated for KD but did not meet either incomplete or complete criteria, or who were not admitted during the acute phase of illness, were excluded.

Data for the MIS-C patients were identified from an internal institutional database used for tracking and reporting cases to the Massachusetts Department of Public Health. Cases were adjudicated by a total of 3 clinicians in rheumatology and cardiology using the CDC 2020 case definition for MIS-C; cases were reported if ≥2 adjudicators agreed that MIS-C criteria was met. For this report, we excluded cases initially reported as MIS-C that were later found to have alternative diagnoses.

We then applied the updated 2023 case definition to the MIS-C and KD cohorts, and cases were adjudicated by 3 members of the study team (M.D.L., L.B., M.B.S.). The CSTE defines a confirmed case of MIS-C as one where clinical and laboratory criteria are met, and a probable case as one where clinical and epidemiologic criteria are met. 10 For this study, patients were determined to fulfill the 2023 MIS-C case definition if they were a confirmed case. We did not include probable cases as the presence or absence of an epidemiologic link was not documented consistently. Cardiac involvement was defined as left ventricular ejection fraction <55% or left anterior descending or right coronary artery z-score ≥2.5. Clinician documentation was used to determine the presence of shock in accordance with the 2023 case definition. 10 Severe features were defined as clinician-documented shock or cardiac involvement.

Descriptive statistics were summarized as frequency (percent) for categorical variables and median (interquartile range) for continuous variables. McNemar test was used to compare specificity between the 2020 and 2023 MIS-C definitions among patients with KD with 95% confidence intervals. Positive predictive values and 95% confidence intervals are reported for the 2020 and 2023 MIS-C definitions.

We identified 119 patients with MIS-C adjudicated using the 2020 MIS-C case definition. All patients had positive SARS-CoV-2 polymerase chain reaction (PCR) or antinucleocapsid antibody testing, or exposure to a known coronavirus disease 2019 (COVID-19) infection. Of the 112 patients with antibody testing, 109 (97%) were positive. Of the 109 patients in whom SARS-CoV-2 PCR or point-of-care testing was performed, 27 (25%) were positive. Four patients had negative testing, or it was not performed but had documented exposure to an individual with known COVID-19 within the appropriate timeframe.

The KD database search yielded 59 patients with clinician-diagnosed KD who met inclusion criteria. Forty-three patients (73%) met complete criteria, and 16 (27%) patients met incomplete criteria for KD. Demographics, clinical features and outcomes of KD and MIS-C patients can be found in Supplemental Table 2 .

Twenty (17%) of the MIS-C patients adjudicated using the 2020 MIS-C case definition did not fulfill the 2023 MIS-C case definition ( Fig 1 ). Eleven no longer had involvement of 2 organ systems, and 7 had a CRP <3 mg/dL. Two patients had both CRP <3 mg/dL and less than 2 organ systems involved. Six (30%) patients who did not meet the 2023 definition had shock ( n = 4) and/or cardiac involvement ( n = 3); 2 had elevated troponin and 3 had left ventricular (L.V.) dysfunction (ejection fraction 37% to 49%). None had coronary artery abnormalities. Despite these severe features, the 2023 case definition was not met because of CRP <3 mg/dL ( n = 5) and having less than 2 organ systems involved ( n = 1).

Patient classification and characteristics. MIS-C, multisystem inflammatory syndrome in children; KD, Kawasaki disease. a Severe features were defined as clinician-documented shock or cardiac involvement (left ventricular ejection fraction <55% or left anterior descending or right coronary artery z-score ≥2.5).

Patient classification and characteristics. MIS-C, multisystem inflammatory syndrome in children; KD, Kawasaki disease. a Severe features were defined as clinician-documented shock or cardiac involvement (left ventricular ejection fraction <55% or left anterior descending or right coronary artery z -score ≥2.5).

Ten (17%) patients were diagnosed with KD despite meeting the 2020 MIS-C case definition, all of whom had positive SARS CoV-2 antibodies but inconsistent ( n = 5) or unknown ( n = 5) SARS-CoV-2 exposure timeline. One had left ventricle dysfunction (ejection fraction 49%), and 3 had coronary artery dilatation ( z -scores 2.5–3.2) ( Fig 1 ). None had clinician-documented shock or were diagnosed with Kawasaki disease shock syndrome. 16 Five patients with KD (8%) met the 2023 MIS-C definition, including the 3 patients previously described with coronary changes.

We compared the specificity and positive predictive value (PPV) of the 2020 and 2023 MIS-C definitions to understand the impact of the updated case definition and the frequency of false positives among KD patients. The specificity of the 2020 MIS-C case definition was 83.1% (71.5%–90.5%), compared with 91.5% (81.6%–96.3%) for the 2023 definition (McNemar P = .0736). The 2020 MIS-C case definition had a PPV of 92.2% (86.3%–95.7%), and the 2023 MIS-C case definition has a PPV of 95.2% (89.2%–97.9%).

In our center’s MIS-C cohort, 17% of MIS-C patients adjudicated using the 2020 case definition did not meet the 2023 definition, including 6 patients with shock and/or cardiac dysfunction. Among patients with KD, the specificity of the 2023 MIS-C definition was numerically higher compared with the 2020 definition, but this difference was not statistically significant.

The updated 2023 case definition for MIS-C was designed to reduce complexity and misclassification. 10 However, we note that a number of patients who were excluded had shock or cardiac dysfunction that warranted treatment. These findings emphasize, as the CSTE and CDC did, 10 that the 2023 case definition should be used as a means of surveillance rather than to aid in diagnosis, as it may not capture all patients who might benefit from treatment of MIS-C.

Differentiating between MIS-C and KD has presented a significant challenge for clinicians given overlapping features and a lack of diagnostic testing for either condition. We demonstrated that the updated 2023 criteria trended toward better discrimination between KD and MIS-C, although overlap persisted. In our cohort, all patients with KD who had positive antibody testing met criteria for MIS-C. As such, the ability to identify a clear timeline of infection is imperative to confer a diagnosis of MIS-C. However, this is increasingly challenging in the setting of widespread seroprevalence to SARS-CoV-2 and evolving behaviors around testing within communities. The risk of misclassification is important to consider from a surveillance point of view as clinicians transition from the 2020 MIS-C case definition, which included patients who met criteria for KD, to the 2023 case definition, which designates KD as an alternative diagnosis.

In addition to repercussions for accurate surveillance, possible misclassification between KD and MIS-C has implications for management. Treatment of both KD and MIS-C includes IVIG 15 , 17 ; however, use of corticosteroids differs. In KD, corticosteroids are typically reserved for cases with refractory fever or high-risk features such as coronary artery changes on baseline echocardiogram. 15 , 18 In MIS-C, initial therapy with IVIG plus steroids has been shown to result in improved short-term cardiovascular outcomes compared with IVIG alone. 19 , 20 Notably, other publications have suggested that steroid monotherapy may be appropriate for some MIS-C patients, particularly in resource-limited settings where IVIG is less accessible. 11 , – 13 However, steroid monotherapy would be contraindicated in KD. 15 In our cohort, 3 of the 5 patients with KD who met the 2023 MIS-C case definition had coronary changes, for which treatment with IVIG is essential.

Our study is limited by its retrospective, single-center design. The sample size and degree of acuity in our cohort was consistent with studies published from other tertiary care referral centers. 5 , 6 However, it may not reflect the experience at smaller or community hospitals. Poor access to testing early in the pandemic likely limited clinicians’ ability to diagnose or rule-out MIS-C. In the absence of a gold standard diagnostic tool for MIS-C and KD, we relied on clinician conferred diagnoses. Lastly, this study examined the impact of the new MIS-C case definition on KD, which is only 1 of a number of other infectious and inflammatory conditions that share significant clinical overlap with MIS-C. 7 , 8  

In comparing the 2020 and 2023 MIS-C case definitions and the risk of misclassification of KD in our cohort, we identified likely improvements in accuracy of MIS-C cases identified for surveillance and in the ability to differentiate between KD and MIS-C. Nonetheless, MIS-C cases with severe features such as shock or cardiac involvement were excluded in our cohort by the updated MIS-C 2023 case definition. As such, clinicians are encouraged to consider MIS-C in patients with a MIS-C phenotype and such features. Additionally, although the 2023 case definition seems better able to discern MIS-C from KD, there continues to be overlap. Implications for treatment should be carefully considered, particularly in settings where presumed MIS-C may be treated with corticosteroid monotherapy.

Ms Day-Lewis and Dr Son conceptualized and designed the study, drafted the initial manuscript, and critically reviewed and revised the manuscript; Ms Berbert analyzed the data, verified the analytical methods, and drafted the initial manuscript; Drs Newburger, Dionne, and Ms Baker conceptualized and designed the study, and critically reviewed and revised the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Centers for Disease Control and Prevention

C-reactive protein

Council of State and Territorial Epidemiologist

intravenous immunoglobulin

Kawasaki disease

multisystem inflammatory syndrome in children

polymerase chain reaction

positive predictive value

Competing Interests

Supplementary data.

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  • Open access
  • Published: 05 January 2024

Identifying factors in the provision of intravenous stroke thrombolysis in Malaysia: a multiple case study from the healthcare providers’ perspective

  • Wen Yea Hwong 1 , 2 ,
  • Sock Wen Ng 1 ,
  • Seng Fah Tong 3 ,
  • Norazida Ab Rahman 1 ,
  • Wan Chung Law 4 ,
  • Sing Keat Wong 5 ,
  • Santhi Datuk Puvanarajah 5 ,
  • Aisyah Mohd Norzi 1 ,
  • Fiona Suling Lian 6 &
  • Sheamini Sivasampu 1  

BMC Health Services Research volume  24 , Article number:  34 ( 2024 ) Cite this article

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Metrics details

Translation into clinical practice for use of intravenous thrombolysis (IVT) for the management of ischemic stroke remains a challenge especially across low- and middle-income countries, with regional inconsistencies in its rate. This study aimed at identifying factors that influenced the provision of IVT and the variation in its rates in Malaysia.

A multiple case study underpinning the Tailored Implementation for Chronic Diseases framework was carried out in three public hospitals with differing rates of IVT using a multiple method design. Twenty-five in-depth interviews and 12 focus groups discussions were conducted among 89 healthcare providers, along with a survey on hospital resources and a medical records review to identify reasons for not receiving IVT. Qualitative data were analysed using reflective thematic method, before triangulated with quantitative findings.

Of five factors identified, three factors that distinctively influenced the variation of IVT across the hospitals were: 1) leadership through quality stroke champions, 2) team cohesiveness which entailed team dynamics and its degree of alignment and, 3) facilitative work process which included workflow simplification and familiarity with IVT. Two other factors that were consistently identified as barriers in these hospitals included patient factors which largely encompassed delayed presentation, and resource constraints. About 50.0 – 67.6% of ischemic stroke patients missed the opportunity to receive IVT due to delayed presentation.

Conclusions

In addition to the global effort to explore sustainable measures to improve patients’ emergency response for stroke, attempts to improve the provision of IVT for stroke care should also consider the inclusion of interventions targeting on health systems perspectives such as promoting quality leadership, team cohesiveness and workflow optimisation.

Peer Review reports

The introduction of intravenous thrombolysis (IVT) using recombinant tissue plasminogen activator (r-TPA) has created a paradigm shift in the management of ischemic stroke. A decrease in the odds of disability at 3–6 months was proven following IVT [ 1 ]. Similarly, its benefits persisted in reducing the risk of mortality at long term [ 2 ].

Translation of this evidence-based treatment into clinical practice however, remains a challenge. The rate of IVT varied where high-income countries were shown to have a higher uptake at 20.6% in the Netherlands, 15.0% in Sweden and 11.9% in the United Kingdom [ 3 ] as compared to an average of 3% across low and middle-income countries (LMICs) [ 4 ]. Unexpectedly within a country, large regional differences was also reported; local IVT rate varied between 6 and 35% in the state of Hesse in Germany [ 5 ].

Overall, reasons for the low rates have been systematically studied and they ranged widely from patients’ delayed presentation to the hospital to in-hospital factors including healthcare providers’ familiarity and competence in IVT, limited infrastructure and human resources, complex guidelines, and poor organisational support [ 6 , 7 ]. As majority of these studies were conducted in high-income settings, it is imperative to understand the reasons for poorer rates of IVT in LMICs. This is especially when 89% of deaths and disabilities from stroke occur in this region [ 8 ]. These reasons are expected to differ given a vast contrast from the provision of healthcare systems, drug subsidies and reimbursements to socioeconomic statuses of the residents.

Malaysia is one of the LMICs with a two-tiered healthcare system, consisting of a heavily subsidised public facilities and a mainly out-of-pocket private healthcare. The use of r-TPA for IVT in stroke has been approved by the local regulatory since 2012, with recommendations being made available in the local clinical practice guidelines [ 9 ]. With existing universal health coverage in Ministry of Health (MOH) hospitals, treatment provided to Malaysian residents is at minimal charges. Nevertheless, it was recognised that implementation of this service nationwide was not easy. The average IVT rate among ischemic stroke patients in MOH hospitals was low at 1.6% in 2018 (Hiew FL: Stroke Thrombolysis Survey in Ministry of Health Malaysia in 2018, unpublished data) but interestingly, the rates differed widely across different hospitals. Understanding similarities and differences in the challenges faced by respective hospitals and how these challenges were managed is crucial to plan for effective and targeted strategies.

Therefore, this study aimed at identifying factors that influenced the provision of IVT and the variation in its rates across public MOH hospitals in Malaysia, from the perspective of healthcare providers. The identified factors would be examined within the hospitals and cross-compared against the basis of an implementation science framework to identify their influence in the adoption of IVT into clinical practice.

Research team

The main research team members comprised of SFT, a male professor in family medicine with vast experience in qualitative research and four female researchers: WYH, SWN, NAR, and AMN. Under the guidance of SFT, they were trained in qualitative research and were responsible for the conduct of both the qualitative and quantitative data collection methods. WYH and NAR also have higher qualifications in epidemiology with experiences in stroke-related research.

None of the researchers had personal relationships with the participants. Several participants have worked with the researchers for other non-related studies. The researchers are not directly involved in the care of stroke patients and therefore, have impartial views on the discussed topic. Participants were recruited after they consensually agreed that the research was conducted with the purpose to seek ways to improve the provision of IVT in Malaysia.

Other members of the team are neurologists with experience in stroke care (SDP, WCL, SKW) and SS, a public health specialist and health systems researcher. They were involved in study design and providing clinical input in analysis and interpretation of data.

Study design

We used a multiple case study design to allow an in-depth exploration on a phenomenon in its natural setting. As a continuity to our published article depicting the success of IVT from a single hospital [ 10 ], a multiple case design approach has allowed a more comprehensive exploration of the research question by considering the similarities and differences across case studies following detailed understanding of each case.

This study is underpinned by an implementation science framework called the Tailored Implementation for Chronic Disease (TICD), which guides understanding on the determinants of implementation change in clinical practice and is consolidated from 12 reviews of implementation determinants [ 11 ]. Apart from the relevance of its application as a screening tool to identify determinants of implementation change, this framework has also been used in a number of similar studies which focused on the provision of acute stroke care [ 6 , 12 ]. The determinants of practice are categorised in seven domains which include factors related to individual health professionals, professional interactions, guidelines, incentives and resources, patients, capacity for organizational change, and social, political and legal [ 13 ]. The TICD was applied as a guide to develop the interview guides and to conduct the initial coding for data analysis.

Case definition

Hospitals were purposively sampled based on the rate of IVT ranked from highest to lowest among the cases, which refers to all MOH hospitals with neurologists at study initiation ( n  = 13) in 2019. Considering that policies to disburse allocation of financial and human resources should be similar across MOH hospitals, three hospitals with differing rates of IVT (highest provision, average, and least to no provision) were selected. The hospital with the highest rate of IVT was referred to as “Hospital Z,” one with an average rate was named “Hospital Y” whereas the hospital of which IVT was not offered was called “Hospital X”. Overall, the selection of these three hospitals with different IVT rates was deemed to be able to represent a spectrum of challenges and experiences which would have led to the variations in the rates.

Participant selection

Our inclusion criteria were healthcare providers who were directly involved in IVT and senior administrators who were authorized to make decisions on the provision of IVT in respective hospitals. The provision of IVT involves healthcare providers from different professions including mainly: 1) neurologists; 2) physicians or medical officers from emergency department (ED); 3) physicians or medical officers from medical department; 4) radiologists or radiographers; 5) nurses from ED; 6) medical assistants (MA) from ED; 7) nurses from neurology department; 8) pharmacists; and 9) head of medical department and/or hospital director. Medical assistants are typically tasked to care for patients with limited supervision and in Malaysia, patient triaging is one of their main tasks [ 14 ].

An average of 9–17 in-depth interviews (IDIs) or 4–8 focus group discussions (FGDs) are needed to reach saturation [ 15 ]. To ensure saturation and at the same time, allowing sufficient variations of working experiences based on their respective roles, we included at least one healthcare provider from each profession for the interviews and at least two for the focus group discussions. We also verified that those included had at least 6-months experience in the study site to allow their sharing of experience to reflect fairly on the true situation on the ground.

Participants were recruited through contacts with relevant department heads in each hospital. From their recommendations, potential participants were purposively selected. Snowballing of more participants were carried out following suggestions from the participants. Written informed consent were obtained from each participant prior to the IDIs or FGDs. We verbally asked for a reconfirmation of the consent at the start of the interviews or FGDs. In total, 95 participants were invited and three declined for undisclosed reasons. Another three could not attend the interview because of hospital admission ( n  = 1) and emergency calls ( n  = 2).

Data collection

In our study, multiple sources for data were used as a strategy for triangulation:

In-depth interviews (IDIs) and focus group discussions (FGDs)

The main data collection strategies were IDIs and FGDs which were conducted in a semi-structured manner. A total of 25 IDIs and 12 FGDs were conducted (Table 1 ). In-depth interviews were conducted for the professionals where their personal experiences and perceptions towards IVT were comprehensively explored. Focus group discussions were conducted for the supporting providers which included the nurses, MAs, radiographers, and pharmacists, to spur discussions via peer interactions on the experiences and challenges in supporting the professionals for the conduct of IVT among participants with common experiences. Perspectives from FGDs were expected to provide a greater understanding to the programme implementation contextually. Furthermore, moderators in FGD were also more likely to be perceived as less authoritative than IDI interviewers and therefore, would lessen the fear amongst the supporting providers to speak especially on potentially less favourable experiences. English was the main language used, except for the FGDs where both English and Malay languages were used for easier understanding. The number of participants in the FGDs ranged from 2 to 15 in a group. Each IDI and FGD lasted about 45 to 60 min with no repeats.

Interview guides for both IDIs and FGDs were developed using the basis of the determinants from the TICD framework. Selection of relevant domains and determinants to the provision of IVT were made before applying them to develop the guides (Additional files 1 and 2 ). The guides were then adapted for different profession to suit their scope of work as well as opinions from qualitative experts. The guides were tested among a sample of healthcare providers who were not from our study sites and were adapted and finalised following their feedback.

This study was initiated just before the Covid-19 pandemic struck in early 2020 and thus, data collection was impacted by national lockdowns and subsequent restrictions of national standard operating procedures. Apart from a delay in data collection, strategies to collect data were also improvised. In-depth interviews and FGDs were conducted physically in confidential settings within one hospital prior to the first Covid-19 lockdown. Data collection for the other two hospitals had to be shifted to a subscribed video conferencing platform.

Both IDIs and FGDs were recorded using both audio and video recordings with field notes taken to catch non-verbal cues and important responses. All records were transcribed verbatim according to the language used in the interviews and FGDs and checked randomly for accuracy against the audio recording. We did not return the transcripts to participants for comments.

Surveys and medical records review

To augment rigor of findings from the qualitative data, a survey and a medical records review were carried out. The survey focused on quantifying available hospital resources by relevant departments in respective hospitals. Information collected included total number of beds, total number of ischemic stroke patients, stroke services, access to diagnostic imaging and details on the provision of IVT. The medical records review was conducted to explore the reasons for not receiving IVT among ischemic stroke patients, specifically to examine the contribution of patient-related factors. From each hospital, a systematic sampling of every fifth patient from the list of ischemic stroke patients admitted from June to December 2019 was conducted. Medical or stroke registry records were then reviewed to identify reasons why patients did not receive IVT. In total, 105 patient records were included in Hospital Z, 94 from Hospital Y and 106 from Hospital X.

Data analysis

NVivo 12 software was used for compilation and management of the transcripts [ 16 ]. WYH and SWN conducted the initial line-by-line coding independently by deductively applying the 57 determinants from the TICD framework as a guide to identify potential factors affecting a programme implementation. Nevertheless, the coding was neither restricted to the available determinants nor its specific labelling or categorisation from the published framework. The codes were subsequently compared, coded, and classified into relevant domains by inductively deriving them from the context of stroke care in a low- and middle-income setting to ensure an in-depth analysis of the texts rather than solely labelling them with the available TICD determinants. Specifically, determinants which influenced the variations observed across the participating hospitals were also accounted for during the coding and categorisation. The relationship between these domains were also derived in the similar manner. Besides, codes were grouped by the participants’ profession for a clearer understanding of the information provided in its context. The coding exercise was done separately for each hospital, although newly derived codes were shared for similar findings derived across the hospitals.

Similarly, findings from the surveys and medical record reviews were analysed separately for each hospital and presented in descriptive statistics.

The main analysis involved triangulating the qualitative and quantitative data within each participating hospital before considering their similarities and differences via a cross-case comparison. Results from the quantitative data were used to support and converge the evidence on the extent of the contribution of certain domains; medical records review to strengthen findings on mainly patient-related factors whereas the survey to verify findings in terms of availability of resources. Findings were subsequently corroborated with the variation of the IVT rates before iteratively adapted with the purpose to develop the theory on factors influencing the provision of IVT. This process involved several in-depth discussions among the main research team members on explanation of the qualitative findings, whether the quantitative results were consistent with the main findings as well as the choice of quotations to be presented for each case and across cases. Quotations in Malay language was translated into English for reporting purposes. Finally, we verified the credibility of our findings by conducting rounds of feedback with content experts and peers who were not directly involved in data analysis.

Characteristics of stroke care services

Table 2 shows a summary of the characteristics of stroke care services for the cases studied. On average, rates of IVT in Hospital Z increased, with a range between 4.8% in 2014 and 20.8% in 2018. A dedicated stroke team is available, although the neurologists are remotely consulted after office hours. Patients who present with acute neurological deficit in ED will be triaged using a fast-tracked standardised IVT workflow before being sent for CT imaging in a different building. Eligible patients will be sent to the acute stroke unit for thrombolysis.

As opposed to Hospital Z, Hospital Y has a separate Department of Neurology with a neurology ward. The rate of IVT were rather constant at 1.5 – 2.8% before it rose to 4.9% in 2019. Instead of a dedicated stroke team, the neurologists on call would attend to stroke activation calls. Intravenous thrombolysis will be provided either at the CT suite or ED due to the lack of an acute stroke unit at the point of interview.

Intravenous thrombolysis was not offered in Hospital X and therefore, there is no protocol for stroke activations or prioritisation for CT scans for suspected ischemic stroke patients.

Determinants of the provision of IVT

This cross-case analysis identified 5 overarching domains adapted from the TICD framework, which attributed to the provision of IVT in this country. In our single case study, cohesiveness among team members was particularly striking within that hospital, resulting in leadership being embedded as one of the contributing factors to team cohesiveness [ 10 ]. Nevertheless in this cross case comparison, the pivotal role of leadership emerged as one of the key factors to be independently considered. Figure  1 explains the relationship between the domains.

figure 1

Relationship between contributing factors and its respective overarching domain to the provision of intravenous thrombolysis. Grey boxes refer to factors within the specified domain

Quality leadership in stroke champions

Participants in Hospital Z shared that having a leader that is passionate and committed in championing stroke care was the key facilitator in delivering acute stroke care services: “I think the person doing it is very important, Dr A. I can see his dedication. I think we can all share his enthusiasm (Z-11; IDI) ” . Furthermore, the neurologists were praised for being hands-on and were willing to be consulted directly which allowed other healthcare providers to develop confidence in handling stroke cases. Motivation to continue providing IVT has also been attributed to how the neurologists often credited the ground staff for achievements earned from providing IVT: “Dr A does share with us some awards that they achieved. (This brings) some positive reinforcements for the radiographers. They are the ones who do 24 h shift to scan the patients (Z-11; IDI).”

In Hospital Y and X, a lack of passionate stroke champions was consistently brought up: “Our key challenge over the years has been that we have had many neurologists trained in stroke but they have all left for greener pastures (Y-05; IDI) ” and “No matter how hard we push for thrombolysis, but let’s say the (primary) team don’t agree with this, we can’t do anything (X-02; IDI). ”

Personal beliefs and values

Enthusiasm and motivation among the leaders in Hospital Z were evident: “I always believe I wanted to do for others what I wanted them to do for me. I think that is the main drive (Z-01; IDI) ” and “With the introduction of treatments, you can help patient(s) to live (an) independent life. That is a good motivation for me personally because you know that your work makes a difference (Z-07; IDI) .”

In Hospital Y and X however, there were contradicting intentions to provide IVT: “There are two groups of doctors. One will find every single reason to thrombolyse the patients. Another will find every single reason not to thrombolyse patients (Y-10; IDI). ” Importantly, the narrow therapeutic window exerted pressure on the leaders from Hospital Y: “The oldest school are more conservative. Neurology even though it is a tough field, there was an opportunity for you to go back home in the night. Stroke changes it the way it changes for cardiologist (Y-05; IDI) ”.

In Hospital X, there was an inclination to manage stroke patients using an interesting but rather contrasting approach: “We found that by using this (functional medicine) approach, a lot of patients usually recover faster (X-01; IDI) .” Use of thrombolysis was therefore, seen as not the only strategy to provide optimal stroke care: “Irrespective of what method we use, as long as patient gets better, it is a good approach because the ultimate aim (is for the patients) to improve (X-01; IDI) .”

Institutional support

Support from higher authorities and other departments was recognised as an important factor in service establishment and delivery. Participants from Hospital Z shared positive experiences on this where the higher authorities were appreciative of their effort to provide IVT and had innovatively maximised the existing human resources and facilities to support the service, despite having limitations: “There are times that resource is an issue. Then, we (would) look at how to juggle the resources to ensure the best outcome (Z-13; IDI) ”. Contrastingly, there were mixed reactions from those in Hospital Y and X. Some refused to comment but there were also good reflections received: “I think in all levels, from the Director to my head of department (HOD), the neuro HOD, everybody is working together with the same aim. Basically, we all try to increase the number of patients that we thrombolyse (Y-02; IDI) ”.

Team cohesiveness

Interprofessional team dynamics

Effective engagement among team members

Providing opportunities for communication through interdisciplinary meetings and building rapport were observed to lead to effective team dynamics in Hospital Z. “I spent a lot of time going down to the radiology department, talking to the radiologist and making myself known to them (Z-07; IDI) ” and “Communication with each other, interdisciplinary meetings, and discussions. All that to settle problems (Z-12; IDI) .”

Effective engagement was also made possible with having approachable leaders: “Everyone has been approachable. That certainly helped in getting and pulling everyone to work together as a team (Z-07; IDI) .” Besides, having effective engagement has also led to the expansion of IVT to nearby district hospitals without neurosurgeons. The neurosurgeons in Hospital Z were willing to take in patients from these hospitals should complications from IVT arose.

In Hospital Y, several participants concurred to the importance of effective engagement to resolve issues that may potentially prevent the provision of IVT within a department. One doctor illustrated (Y-02, IDI): “We have an open dialogue. Sometimes if they encounter a problem in my department, they just text me straight and I address it. It does not get delayed or dragged on.” Gaps within dynamics of the team however, mainly stemmed from poor inter-department communication. Similarly, difficulties to initiate IVT in Hospital X was also attributed to the lack of communication across departments (X-02; IDI): “It is mainly due to the lack of communication between departments. If one party cannot agree with another party’s opinion, then nothing can be done.”

Joint ownership of responsibility

Trust was a fundamental aspect in nurturing joint ownership of responsibilities in Hospital Z. To cope with the lack of human resources, the neurologists trusted, empowered, and privileged other healthcare providers to independently handle certain tasks within the IVT process: “We do not have trainees. So, a lot of our bout (are) being covered by (medical) physicians (and) medical officers (Z-07; IDI) .” Likewise, the radiologists trusted the neurologists to interpret CT images for stroke patients: “We are okay with them (neurologists) interpreting the scan. For them, (they need) to have immediate (interpretation), because (they) need to act on the scan finding(s) (Z-11; IDI) .”

Besides trust, being interdependent was demonstrated through sharing of the task to send patients to CT suite. One MA explained (Z-06–01; FGD): “Upon stroke activation, sometimes the stroke team or the ED housemen will push the patients for CT scan. They do not rely on MAs, nurses, or porters.” Furthermore, a positive attitude towards the workload from IVT was observed: “We only claim off hours. We do not claim (money) (Z-02–02; FGD) .”

Encouragingly, this working culture was also observed in Hospital Y and X, especially among the ED physicians: “We have been giving thrombolysis for MI patients, just that (this requires) more close monitoring and clear-cut indications. If (if) you can establish (the service) at least half-way, we can try to facilitate (X-02; IDI) .”

Despite such positivity, mixed opinions about IVT remained across departments in all three hospitals. Several participants expressed hesitancies: “Most of us are not there yet. To say that we would take over the decision to thrombolyse, not all of us are used to it (Z-04; IDI) .” Some were concerned about the extra workload the service would entail (X-05; IDI): “I can foresee if the stroke services (start), there’s a (need) for an on-call radiologist. They will need to work harder.” Others were not comfortable with having healthcare providers from other professions to share their roles. One doctor noted (Y-14; IDI): “I think eventually thrombolysis is going to be like giving streptokinase (to MI patients). But you must understand the heart and the brain are two different things. If a general physician wants to do it, they still must consult a neurologist.”

Qualities of effective feedback

Despite not having regular feedback on patient outcomes or work-related performances, Hospital Z participants agreed that there were avenues to provide and receive feedback if the need arises. Negative feedbacks were surprisingly accepted as constructive encouragements to motivate the ground staff to do better: “They (the neurologists) get upset when it (stroke) is missed but not overly upset. Appropriately upset. So, we try not to miss. The culture is such that we want to do it well (Z-09; IDI) ” and “Because we know every (scolding) is for the sake of the patients. (In) the end it is just to make the patients better. It is nothing personal (Z-11; IDI) .” Importantly, the participants shared how information from feedbacks would be transferred to them although the initial discussion involved only the higher authorities. Contrastingly, although regular audits on data for stroke patients were available in Hospital Y, a concern of not receiving feedback was raised: “(For) multi-disciplinary (meetings), the bosses are the ones attending. But information (from the meetings) does not reach the ground staff although it is the ground staff who are attending to these stroke cases (Y-13; IDI) .”

Degree of team alignment on benefits and risks of IVT

Despite having different professions, majority of the ground staff and professionals in Hospital Z shared aligned values on the benefits of IVT on patients’ outcome: “We have seen quite a lot of patients that come in very bad then (could) go home walking. Their quality of life is very much improved (Z-14; IDI) .” Echoed by a nurse (Z-02–03; FGD): “There are some patients with power zero who can improve to three. That makes us satisfied.” Parallel to that was their perspective on the risk of bleeding after IVT: “We are talking about less than 3% (of symptomatic haemorrhagic transformation that potentially might require intervention). I think the benefit outweighs the risk (Z-01; IDI) .”

The scenario appeared different in Hospital Y and X where conflicting arguments on the benefits and risks from IVT arose. While many believed that it would lead to beneficial outcomes, a few remained less comfortable with the rapid expansion of leniency in the recommendations provided. Stressing the importance of careful patient selection, one doctor mentioned (Y-14; IDI): “Some of these patients theoretically may have done well even if you do not thrombolyse. I have enough patients that I do not thrombolyse. But they still do okay. And there are some patients who were thrombolysed, we wished in retrospect we had not thrombolysed.” This sentiment was shared in Hospital X: “Certain groups that they thrombolysed, the scan is within normal limits. How sure are we that this is not TIA because by definition, TIA spontaneously recovers within 24 h (X-01; IDI) ?”.

Facilitative work process

As IVT was not offered, this factor was not analysed in Hospital X because IVT workflow naturally did not exist and participants’ opinions on knowledge, skills and degree of urgency would be hypothetical rather than based on previous experiences.

Availability of simplified workflow

One of the main issues for identification of stroke patients were due to their atypical symptoms or concurrent presenting complaints. Consequently, some of these patients would be mistriaged and this caused either a delay or inability to provide IVT. In response to this, Hospital Z established a lenient and simplified workflow to activate thrombolysis: “We changed the (triaging) protocol to acute neurology deficit. We are very lenient for them (ED) to activate and call us (Z-01; IDI) .” Despite having more false alarms initially, the percentage of patients who received IVT after a stroke activation increased from 53.9% in 2016 to 79.7% in 2018, indicating an improvement in terms of identification of stroke patient at triage with time [ 10 ].

The usual workflow for referrals from district hospitals without CT machine to send patients to Hospital Z was also simplified: “For district hospital without scan, we encourage them that if they think it’s a stroke, call us and bypass (their own hospital) to come (straight) (Z-01; IDI) .” Echoed by a doctor from Hospital Y: “If it is an ambulance call, the team goes to the site and assess the patient. If they establish an acute stroke, they will inform the control centre who would inform the ED team to standby with pre-filled forms and activate stroke calls (Y-02; IDI) .”

In both hospitals, efforts to facilitate the IVT workflow were observed. These include having standardised documents such as acute stroke protocols, stamps for urgent CT requests, and templates for ED clerking and reporting CT imaging. Use of technology has also been applied to aid sending and interpreting CT images.

Figure  2 shows 3.8% of patients who missed the opportunity to receive IVT in Hospital Z. Medical records review revealed potential in-hospital workflow issues where delays in referral for CT imaging and assessment by stroke team occurred, with one being an inpatient stroke. The percentage was higher in Hospital Y at 5.3%, with similar in-hospital workflow-related concerns.

figure 2

Reasons for non-thrombolysis among ischemic stroke patients in respective participating hospital. TIA: Transient ischemic attack; NIHSS: National Institutes of Health Stroke Scale; potential missed opportunity includes those with delayed referral to CT imaging and delayed assessment by stroke team. Unknown reasons in Hospital X refers to potentially eligible patients by timing but may have other reasons to not receive thrombolysis

Familiarity and knowledge with IVT

Being familiar with respective roles and having hands-on experiences through non-structured training such as tagging a senior doctor have also led to competent and knowledgeable staff. One doctor explained (Z-04; IDI): “Over time, we get comfortable with it that it becomes a reflex. You say that this is stroke, people would know what to do.” A radiographer agreed (Z-08–03; FGD) : “It was my seniors who taught me. They also explained the importance of IVT.”

A different situation was observed in Hospital Y. The ground staff admitted that difficulties to identify stroke patients occurred with a lack of knowledge and experience. Emphasized by a medical assistant (Y-03–05; FGD): “Sometimes the triager overlooks and would triage stroke patients as having hypoglycemia, ignoring the need to assess BEFAST. The patients will be sent to yellow zone.”

Degree of understanding the rationale for urgency

It was commonly agreed in Hospital Z that patients for IVT must be treated urgently: “If they activate thrombolysis, we drop everything and attend. We do not hesitate to attend (Z-09; IDI)” and “No matter how busy we are, we will try to expedite the process to send patients (for) CT and activate the stroke team (Z-10; IDI) .”

Contrastingly, participants from Hospital Y shared how different their priorities were despite similarities in the urgency for time-dependent therapies between cases of acute stroke and myocardial infarction: “If a patient (has) myocardial infarction, all the staff will have adrenaline rush to attend the patient. For acute stroke however, we still do not have the adrenaline rush ( Y-06; IDI ).” The lack of urgency was similarly noted in the radiology department (Y-13; IDI): “ They (the radiographers) thought they should finish up the regular appointments first before slotting in stroke patients. Even some doctors were not aware. They thought it is okay to wait.”

Patient factors

One factor which was consistently identified as a barrier to provide IVT across all three hospitals was patient-related factors; the largest attributable factor being delayed presentation.

Delayed presentation

Hospital Z recorded 67.6% of ischemic stroke patients who did not receive IVT arrived at the hospital outside the narrow therapeutic window time, followed by 64.9% in Hospital Y and 50.0% in Hospital X (Fig.  2 ). Among the suggested reasons for delayed presentation include low public awareness of stroke symptoms recognition and the availability of a time-dependent therapy, logistics, and patients’ preferences on where to get treatment.

As distance from district hospitals without CT machines to Hospital Z is far, one pharmacist explained (Z-03–01; FGD): “Our patients in (this region) (has) transport(ation) issues and tend to present very late.” Concurred by another (Y 08–03; FGD): “A lot of people do not even know (that) if they presented early, they can be given thrombolytic therapy.” In addition, the culture of seeking treatment from traditional healers remained prominent in the country: “They (patients) were in denial that they had a stroke. They asked for AOR (discharge at own risk) and go for massages and traditional treatment ( X-04–01; FGD ).”

Consent for therapy

Although few patients would refuse IVT, the participants explained how delays may occur during consent taking due to language barriers or when indecisive patients requested for discussions with family members. Doctors from Hospital Z and Y shared their experiences on the importance of simple explanations to patients and their family members: “If you tell the family members that we give (thrombolysis) there is a chance you will improve and, if we do not, most likely you will remain like this, most of the time, they are quite receptive even though you tell them there is a risk of bleeding (Z-14; IDI).”

Patient comorbidities

Figure  2 shows that patient comorbidities attributed to the reasons for excluding eligible patients from IVT. In Hospital Z, 2.9% of the patients who did not receive IVT had uncontrolled blood pressure levels or seizure upon onset of stroke. Aside from blood pressure control, patients’ medical history of recent stroke or risk of bleeding constituted 9.6% of the reasons for non-thrombolysis in Hospital Y. Besides that, delays could also be caused by patients’ poor condition upon arrival, potentially excluding them from the opportunity to be thrombolysed.

Unclear stroke-related history

Unclear patient history and language barrier could complicate the process of identifying eligible ischemic stroke patients for IVT and subsequently delay referrals. One MA said (Z-06–04; FGD): “Sometimes the family members could not give an exact time and do not know when symptoms have started.” This was agreed by a doctor (Y-07; IDI): “Language would be an issue especially for older patients. A lot of times we cannot really get the exact time of onset and their pre-morbid.” Likewise, this finding was evident from the medical records where patients with unknown onset constituted 24.5% of ischemic stroke patients in Hospital X, 10.5% in Hospital Z, and 1.1% in Hospital Y (Fig.  2 ).

Availability of resources

Resource-intensive therapy

Stroke IVT is acknowledged to be resource intensive. One doctor explained (Z-01; IDI): “Thrombolysis is labour intensive and we must respond very quickly. It is every 15 min monitoring. It is costly. We need CT scan. We used to have to call radiologist(s) to get the permission, then we get patient consent for CT and then push their way to CT scan room which is always not next to ED. And then have to interpret CT. There is always a reservation among neurologists in Malaysia, because it is labour intensive.”

Limited imaging facilities

Participants from all hospitals concurred on the lack of CT machines to accommodate imaging requests in their respective hospital: “Because (there) is only one CT scan, you are competing against poly-trauma cases. So, it sometimes could be a delay before they call you (Y-05; IDI) .” A lack of CT imaging facilities in ED was also brought up as a concern because patients who require CT imaging would have to be transferred to CT suite, attributing to valuable time lost: “Patients who needs CT scan must be sent all the way up to the first floor. The lift is not a dedicated lift for patients (Y-05; IDI) .” In Hospital Z, challenges were also mentioned with the limited availability of MRI slots for extension of window therapy for wake-up stroke: “There is only one MRI machine and the queue is extremely long for MRI (even) for normal standard appointments (Z-07; IDI) .”

Limited beds and space

Issues regarding limited beds and space was expressed by most participants. Neither conducting IVT nor accommodating an imaging machine in ED of Hospital Z was possible due to restricted space. Nevertheless, the neurologists have taken the initiative to establish an acute stroke unit comprising of a cubicle in their medical ward and purchased a weighing bed which is reserved for patients undergoing IVT. Despite not having an acute stroke unit in Hospital Y, stroke care pathway has been structured to allow patients to receive their bolus dose of IVT in the CT suite to shorten door-to-needle time. At the point of interviews, participants from Hospital Y and X attributed their challenges to create an acute stroke unit to having limited beds in their intensive care units.

Lack of human resources

Shortage of manpower, heavy workload and high turnover of staff were among the quoted barriers related to human resources which affected the provision of optimal care for IVT. As mentioned by one doctor (Z-09; IDI ): “Not enough manpower, very busy. You need to run a ward, you need to do rounds, you need to do discharge, you need to attend clinic and then suddenly (when) thrombolysis calls, you have to go and attend.” Echoed by others: “Workload issue. Sometimes when we are attending to patients, one needs to go for CT imaging, one comes in with stroke and the other has to have CPR. Which one do we attend to first? (Y-03–01; FGD) ”

Despite these challenges, higher authorities and the neurologists from Hospital Z took the effort to optimise available manpower and established a dedicated stroke team consisting of medical physicians, medical officers, and nurses, apart from the neurologists themselves to handle IVT. In Hospital Y, the absence of a stroke team has made stroke activations difficult at the point of the interview: “It is quite (a) pity that they have the oncall person (neurologist or trainee) to see everyone. While they are halfway seeing one patient, suddenly there is an acute stroke and they must run there (Y-07; IDI) .”

Financial support for drug availability

Limited budget to support drug availability for IVT were acknowledged. Furthermore, r-TPA has yet to be recognised as an emergency drug in the MOH, making it even more difficult to be readily available within ED. Hospital Z showed an example of how support from higher authorities and other departments have been crucial in maintaining the availability of drug (Z-01; IDI): “every time we said we needed it, they (higher authorities) have never said “No”. Our usage exceeded many times off budget.”

Limited availability of data

The availability of outcome-related IVT data remains limited despite many participants concurring that it is a useful evidence-based measure to prove the benefits of providing the service. The importance of having data to monitor the outcomes from IVT was mentioned: “We update our hospital to tell them our outcomes. (From the data), we think we save the hospital from readmission, disability and then we shorten the hospital stay (Z-01; IDI) ” and “I think data (basically) functions as a proof for people to see that this (IVT) works (Y-02; IDI) ” .

This comparative case study identified five factors that influenced the provision of IVT in the management of ischemic stroke across three public hospitals in Malaysia. Of those factors, our study highlights three factors which varied across these hospitals: leadership from the perspective of having quality stroke champions, team cohesiveness which entailed team dynamics and its degree of alignment, and facilitative work process which included workflow simplification and familiarity and experience on IVT. Two other factors which were consistently identified as barriers in these hospitals were patient factors which largely encompassed delayed presentation, and resource constraints. Supporting these results were review of the medical records which showed that more than half of our ischemic stroke patients missed the opportunity to receive IVT due to delayed presentation (50 – 67.6%).

Consistent with our findings, the pivotal role of leadership in strengthening the quality of healthcare has been proven, both in stroke care [ 12 , 17 ] and in many health related-implementations [ 18 ]. Having good leadership in healthcare settings was associated with better team effectiveness in chronic illnesses and known to improve a multitude of health outcomes including guideline adherence and patient safety [ 18 , 19 ]. Moreover, different types of leadership were observed to exert different influences on the provision of IVT. In our study, enthusiastic and motivated stroke champions have been observed to drive the service forward at a faster rate compared to leaders who tend to be more cautious about potential complications that may result from IVT. Similarly in Sweden, having authoritative leaders was regarded as an important element for successful implementation of IVT rather than those who prefer to get consensus for every matter [ 17 ].

Cohesiveness among team members was another factor that attributed to the variation in IVT rates. To augment team dynamics, engagements among team members via effective communication is crucial to promote interprofessional teamwork in managing integrated care pathways such as stroke care [ 12 , 17 ]. Besides that, the option of responsibility sharing via training of non-neurologists to deliver IVT has been an attractive initiative especially in resource-poor countries where the proportion of neurologists to stroke patients is low [ 20 ]. Nevertheless, apart from heavier workload, different levels of receptiveness were present partly from the concern of possible complications or poorer patient outcomes among the non-neurologists despite reassuring evidences [ 21 , 22 ].

The extent of how aligned team members were in respect to their perspectives on the risk and benefits of IVT have also contributed to team cohesiveness. Discordant beliefs and values is a common view shared in previous studies, where this is often attributable to the lack of knowledge and experience in handling IVT [ 17 ]. Consequently, physicians were reported to feel uncertain with outcomes from thrombolysis or to disapprove of the treatment option [ 7 , 17 ].

Parallel to our findings on optimisation of workflow through simplification of work processes and providing aids, Huang et al. reported significant improvements of 1.4 to 2.3 times the odds of IVT uptake and reduction in time delays by having transportation and stroke protocols in place, establishing in-hospital organisational programmes as well as incorporating the use of technology [ 23 ]. Apart from that, having adequate familiarity and knowledge as well as a sense of urgency to handle IVT among healthcare providers were other essential elements to facilitate the work process. While familiarity and knowledge are commonly quoted to influence the implementation of IVT [ 12 , 17 , 24 ], less was known about the latter. In some studies where an inverse relationship between the onset-to-door and door-to-needle time was found, postulations of possible lack of urgency in patients who arrived earlier because their symptoms were milder or less critical compared to those who reached later were discussed [ 25 ]. Besides being associated to guideline awareness, cultivating the sense of urgency for IVT could depend on priority setting, both from the perspective of the individuals and the organisation.

Although the percentage of patients who arrived beyond 4.5 h of the therapeutic window time ranged widely from 31% in Greece [ 26 ] to 68% in Romania [ 27 ] and 75% in India [ 28 ], delayed presentation remained as the commonly cited patient-related barrier to the uptake of IVT worldwide, and consistently in our study. Multiple reasons were attributed to the delay, including lack of recognition of stroke symptoms, lack of awareness of the availability of IVT as a treatment option, and logistics challenges [ 29 ].

Similar to our findings, resource constraint is a commonly identified barrier to the implementation of IVT in other countries [ 6 , 30 ]. Several challenges were reported, including limited physical space to establish stroke units, bed shortage, lack of imaging facilities, financial constraint and inadequate manpower. Although this issue spans worldwide, the extent of these challenges appeared to be greater in low- and middle-income countries [ 31 ]. Interestingly, our study shared how stroke care is optimised by innovative efforts to maximise the utilisation of existing resources, in coping with resource constraints. With support from their higher authorities, leaders from Hospital Z empowered and privileged other relevant healthcare providers to establish a dedicated stroke team and sectioned off a 6-cubicle area in their medical ward to form an acute stroke unit. One other exemplary case is in Thailand where a stroke fast track programme was established by similarly leveraging on non-neurologists to conduct IVT, creating a network referral system between stroke hospitals and hospitals that cannot provide IVT, and establishing telestroke consultation. This resulted in a 220% increase in terms of patient accessibility to the therapy between 2008 to 2013 [ 32 ].

The strength of our study lies in the methods. The choice of using a case study allowed an in-depth understanding of a multi-faceted complex issue in a real-life setting, which in the context of this study would be the factors influencing the provision of IVT in the management of ischemic stroke. Evidence from multiple case studies allows comparisons or replications to be made across cases and thus, is often regarded to be more robust [ 33 ]. The use of case study also allowed collection of data from multiple sources and triangulation of these information to strengthen the validity and reliability of our findings. To minimise interpretation bias, we conducted independent and cross coding processes by multiple coders before deriving the finalised themes. Regular meetings were held to discuss on coding similarities and differences. Additionally, the application of the TICD framework to guide the process of identifying the determinants of change in clinical practice further reinforced the credibility of our findings. Given that recruitment of the interview participants was conducted purposively, possibilities of selection bias may not be excluded but the bias is deemed minimal because findings comprised of a fair share of negative and positive experiences. Also, the percentages shown in Fig.  2 were based on information available from either medical or stroke registry records and thus, maybe affected by documentation bias.

Implications to clinical practice, policy, and research

Findings are aimed to provide an insightful understanding in planning for targeted interventions to improve the provision of IVT in areas with similar settings. Previous recommendations which were adapted from the positive lessons learnt from our single case study were focused on strategies at respective organisation. This include adopting an interdisciplinary approach via behavioural interventions, optimising work processes for stroke service to identify areas that do not add value to patient outcomes, and providing opportunities for training and capacity building via innovative education [ 10 ].

Having understood the influencing factors and their relationship from a cross case comparison approach, potential strategies from the higher levels of the health systems should be deliberated. Great considerations should be placed into choosing the right leaders to manage stroke care. There are advantages and disadvantages of different leadership type and having a good mix of personalities would ensure optimal success in implementations [ 34 ]. One local intervention that runs parallel to this was a recently implemented initiative of electing state stroke champions in every state of Malaysia. This initiative is hoped to make stroke a priority nationwide and to decentralise the governance of stroke care services at state levels for decisions on stroke action plans to be tailored to the needs of the respective state [ 35 ]. To ensure its success, the choice of these stroke champions should ideally account for their leadership styles and capabilities, apart from their past commitments in stroke care.

From a community’s viewpoint, interventions targeted to improve patients’ delayed presentation should be given due consideration. Although the extent of its influence on the variation of IVT rate is potentially minimal from the consistent findings across three hospitals, the magnitude of its impact on overall IVT uptake calls for immediate actions to be put into place. Effects from public education or mass media campaigns to improve the emergency response for stroke however, remained varied thus far [ 36 , 37 ]. In addition, specific groups may be more receptive to different interventions compared to the others; making it difficult and complex to develop an intervention that is suitable for the general population. One strategy however, that has been seen to deliver effective and sustainable impacts on recognition of stroke symptoms and their response was stroke education to school-going children [ 38 , 39 , 40 ]. Stroke education targeting children is anticipated to be effective and sustainable because inclusion of the programme into school curriculum would ensure that the information reach all ongoing school children in a simple manner. Nurturing their knowledge on stroke symptoms and response from young is likely to build strong awareness on stroke in the future [ 39 ]. In Malaysia, although the FAST Heroes education campaign to enhance community’s stroke preparedness through children’s education has recently been launched [ 41 ], more effort should be placed to ensure its continuous uptake and sustainability.

Eminently, implementation of these interventions should be planned synchronously with research to systematically evaluate their effectiveness and feasibility. Tying these interventions to an evidence-based component would allow monitoring of its sustainability and prevent wasteful healthcare spending.

In addition to the global effort to explore sustainable measures to improve patients’ emergency response for stroke, attempts to improve the provision of IVT for stroke care should also consider the inclusion of interventions targeting on health systems perspectives such as promoting quality leadership, team cohesiveness and workflow optimisation.

Availability of data and materials

The dataset generated and analysed during the current study are not publicly available due to ethical and legal restrictions but are available from the corresponding author on reasonable request.

Abbreviations

  • Intravenous thrombolysis

Recombinant tissue plasminogen activator

Tailored Implementation for Chronic Disease

Ministry of Health

In-depth interview

Focus group discussion

Emergency department

Head of Department

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Acknowledgements

The authors would like to thank the Director General of Health Malaysia for his permission to publish this article.

This study is funded by the Ministry of Health Malaysia research grant under the project “Access to Hyperacute Stroke Care in Malaysia” (NMRR 19–3145-51552). Ministry of Health Malaysia had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Shah Alam, Selangor, Malaysia

Wen Yea Hwong, Sock Wen Ng, Norazida Ab Rahman, Aisyah Mohd Norzi & Sheamini Sivasampu

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

Wen Yea Hwong

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Seng Fah Tong

Neurology Unit, Department of Medicine, Sarawak General Hospital, Ministry of Health Malaysia, Kuching, Sarawak, Malaysia

Wan Chung Law

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WYH, NAR, AMN, SFT, and SS conceptualised and planned the research idea. WYH, SWN, SFT, NAR, AMN, and FSL carried out the data collection. WYH, SWN, SFT, and NAR analysed the data. WCL, SKW, SDP, and SS contributed to data acquisition and interpretation of the results. WYH took the lead in writing the original draft. All authors provided critical feedback and contributed to the final manuscript.

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The study was conducted in accordance with relevant guidelines and regulations. The study was approved by the Medical Research Ethics Committee, Ministry of Health Malaysia (NMRR ID: 19–3145-51552). Written and verbal informed consents were obtained from participants for the interviews and focus group discussions.

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Supplementary Information

Additional file 1. .

Mapping of questions for interview guide to relevant Tailored Implementation for Chronic Disease (TICD) domains.

Additional file 2. 

Interview guide for neurologist/emergency physicians/medical officer.

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Hwong, W.Y., Ng, S.W., Tong, S.F. et al. Identifying factors in the provision of intravenous stroke thrombolysis in Malaysia: a multiple case study from the healthcare providers’ perspective. BMC Health Serv Res 24 , 34 (2024). https://doi.org/10.1186/s12913-023-10397-8

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  • Epidemiology of Robin sequence: geographical variation in the UK/Ireland
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  • Giles Atton 1 ,
  • http://orcid.org/0000-0003-3217-4833 Diana Baralle 1 , 2
  • 1 Wessex Clinical Genetics Service , University Hospital Southampton NHS Foundation Trust , Southampton , UK
  • 2 Faculty of Medicine , University of Southampton , Southampton , UK
  • Correspondence to Professor Diana Baralle, University of Southampton, Southampton, SO16 3HH, UK; D.Baralle{at}soton.ac.uk

https://doi.org/10.1136/archdischild-2023-326079

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  • Epidemiology
  • Paediatrics

Introduction

Pierre Robin sequence (PRS) is a rare congenital malformation sequence characterised by micrognathia, glossoptosis and upper airway obstruction, often in association with a wide U-shaped cleft palate. 1 The aetiology of non-syndromic PRS (nsPRS) remains uncertain; however, non-isolated PRS can present as part of a wider syndromic diagnosis 1 (syndromic PRS (sPRS)). PRS is reported to have a prevalence of ~1/8000 to 1/14000 live births. 1 2 A recent study by Wright et al ( ADC ), which used dual-source case ascertainment and active surveillance methods, estimated a PRS prevalence of 1:5246 live births. 1 This is significantly higher than previous estimates, which may have been miscalculated. 1 Importantly, this study also identified a striking geographical variation in prevalence estimates, which were lowest in England and Wales (1/5789), higher in Ireland (1/4635) and highest in Scotland (1/2692). 1 These findings are broadly corroborated by an earlier study by Wright et al (2018), which identified a PRS incidence of 1/2685 in an East of Scotland patient cohort. 2 This is significantly higher than previously reported estimates in the UK and globally.

Why do PRS prevalence estimates vary?

How could the factors underpinning the geographical variation be elucidated.

A consensus definition for PRS 4 will improve the epidemiological surveillance of PRS cases by enabling a more standardised diagnostic process and study inclusion criteria. This will refine the identification and interpretation of case data, avoid the omission of affected cases and improve the accuracy of PRS prevalence estimates. There is a need for robust epidemiological studies to investigate the geographical variations in PRS prevalence in the UK/Ireland. Comparative studies will enable the identification of risk factors for PRS within and between the populations of the UK/Ireland. 1 They will also allow for any differences between ethnic and sociocultural groups to be identified. Determining the geospatial patterns of PRS incidence and prevalence will enable the identification of risk factors for PRS between populations. Spatial epidemiological studies could enable a focused analysis of geographical variations in PRS prevalence, including the potential contributions of environmental, lifestyle and genetic risk factors. Prospective studies could allow for the identification of risk factors and their relation to PRS prevalence over time. Ultimately, the identification of risk factors for PRS will enable a more thorough understanding of the risk profiles between populations, while also aiding our understanding of the cause of the condition and the provision of treatments and healthcare services.

The important role of genomic testing

PRS is a heterogeneous condition. The cause of sPRS is described according to its causative gene and mutation. 5 However, PRS can present in ‘PRS-plus’ forms and rare syndromes with an undefined genetic basis. 5 Elucidating the genetic factors underpinning sPRS will provide vital insights into understanding the cause of the condition and informing the management of affected patients. The advent of next-generation sequencing technologies (whole genome sequencing, whole exome sequencing and targeted gene panel analysis), which are becoming increasingly commonplace in mainstream clinical care, may help to accelerate our understanding of the genetic factors underpinning this condition. While syndromic (eg, stickler syndrome 5 ) and single-gene associations have been identified (eg, SOX9 5 ), a complex multifactorial aetiology has been hypothesised in nsPRS 1 2 and the contribution of genetic, environmental and lifestyle factors is difficult to establish and poorly understood. Association studies along with functional characterisation and experimental validation could be used to identify and clarify the genotype–phenotype correlations. Furthermore, there is a paucity of large-scale cohort and case–control studies and future studies could focus on the delineation of population-level genetic factors along with familial analyses. The identification of population genetic risk factors may provide vital insights into the geographical variation in PRS prevalence.

Conclusions

The prevalence of PRS is a vital metric to quantify the burden of the disease in a population at a given time. It is essential in planning the provision of healthcare services for PRS patients. PRS is associated with a significant morbidity and mortality: determining the prevalence of the condition is therefore of great importance in improving the recognition and management of PRS patients in the UK/Ireland. There is a need for more robust epidemiological studies, including comparative, spatial epidemiological and prospective studies to elucidate the epidemiology of the condition and thus provide insights into its cause and geographical variation. Genomic testing will be essential in helping to distinguish between sPRS and nsPRS, informing genotype–phenotype correlations and in the identification of population genetic factors that may underpin its striking geographical variation. Ultimately, this information is crucial to inform the management and delivery of healthcare services for patients with PRS in the UK/Ireland.

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Patient consent for publication.

Not applicable.

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  • Wright MF ,
  • Knowles RL ,
  • Cortina-Borja M , et al
  • Mehendale F ,
  • Urquhart DS
  • Santoro M ,
  • Barišić I , et al
  • Breugem CC ,
  • Poets CF , et al
  • Motch Perrine SM ,
  • Holmes G , et al

Contributors GA and DB conceived, wrote and edited the editorial.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

Linked Articles

  • Original research Epidemiology of Robin sequence in the UK and Ireland: an active surveillance study Marie FA Wright Rachel L Knowles Mario Cortina-Borja Sheila Javadpour Felicity V Mehendale Donald S Urquhart Archives of Disease in Childhood 2023; 108 748-753 Published Online First: 27 Jun 2023. doi: 10.1136/archdischild-2023-325556

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