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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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Case study research for better evaluations of complex interventions: rationale and challenges

• Sara Paparini   ORCID: orcid.org/0000-0002-1909-2481 1 ,
• Judith Green 2 ,
• Chrysanthi Papoutsi 1 ,
• Jamie Murdoch 3 ,
• Mark Petticrew 4 ,
• Trish Greenhalgh 1 ,
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The need for better methods for evaluation in health research has been widely recognised. The ‘complexity turn’ has drawn attention to the limitations of relying on causal inference from randomised controlled trials alone for understanding whether, and under which conditions, interventions in complex systems improve health services or the public health, and what mechanisms might link interventions and outcomes. We argue that case study research—currently denigrated as poor evidence—is an under-utilised resource for not only providing evidence about context and transferability, but also for helping strengthen causal inferences when pathways between intervention and effects are likely to be non-linear.

Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. Empirical case studies typically enable dynamic understanding of complex challenges and provide evidence about causal mechanisms and the necessary and sufficient conditions (contexts) for intervention implementation and effects. This is essential evidence not just for researchers concerned about internal and external validity, but also research users in policy and practice who need to know what the likely effects of complex programmes or interventions will be in their settings. The health sciences have much to learn from scholarship on case study methodology in the social sciences. However, there are multiple challenges in fully exploiting the potential learning from case study research. First are misconceptions that case study research can only provide exploratory or descriptive evidence. Second, there is little consensus about what a case study is, and considerable diversity in how empirical case studies are conducted and reported. Finally, as case study researchers typically (and appropriately) focus on thick description (that captures contextual detail), it can be challenging to identify the key messages related to intervention evaluation from case study reports.

Whilst the diversity of published case studies in health services and public health research is rich and productive, we recommend further clarity and specific methodological guidance for those reporting case study research for evaluation audiences.

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The need for methodological development to address the most urgent challenges in health research has been well-documented. Many of the most pressing questions for public health research, where the focus is on system-level determinants [ 1 , 2 ], and for health services research, where provisions typically vary across sites and are provided through interlocking networks of services [ 3 ], require methodological approaches that can attend to complexity. The need for methodological advance has arisen, in part, as a result of the diminishing returns from randomised controlled trials (RCTs) where they have been used to answer questions about the effects of interventions in complex systems [ 4 , 5 , 6 ]. In conditions of complexity, there is limited value in maintaining the current orientation to experimental trial designs in the health sciences as providing ‘gold standard’ evidence of effect.

There are increasing calls for methodological pluralism [ 7 , 8 ], with the recognition that complex intervention and context are not easily or usefully separated (as is often the situation when using trial design), and that system interruptions may have effects that are not reducible to linear causal pathways between intervention and outcome. These calls are reflected in a shifting and contested discourse of trial design, seen with the emergence of realist [ 9 ], adaptive and hybrid (types 1, 2 and 3) [ 10 , 11 ] trials that blend studies of effectiveness with a close consideration of the contexts of implementation. Similarly, process evaluation has now become a core component of complex healthcare intervention trials, reflected in MRC guidance on how to explore implementation, causal mechanisms and context [ 12 ].

Evidence about the context of an intervention is crucial for questions of external validity. As Woolcock [ 4 ] notes, even if RCT designs are accepted as robust for maximising internal validity, questions of transferability (how well the intervention works in different contexts) and generalisability (how well the intervention can be scaled up) remain unanswered [ 5 , 13 ]. For research evidence to have impact on policy and systems organisation, and thus to improve population and patient health, there is an urgent need for better methods for strengthening external validity, including a better understanding of the relationship between intervention and context [ 14 ].

Policymakers, healthcare commissioners and other research users require credible evidence of relevance to their settings and populations [ 15 ], to perform what Rosengarten and Savransky [ 16 ] call ‘careful abstraction’ to the locales that matter for them. They also require robust evidence for understanding complex causal pathways. Case study research, currently under-utilised in public health and health services evaluation, can offer considerable potential for strengthening faith in both external and internal validity. For example, in an empirical case study of how the policy of free bus travel had specific health effects in London, UK, a quasi-experimental evaluation (led by JG) identified how important aspects of context (a good public transport system) and intervention (that it was universal) were necessary conditions for the observed effects, thus providing useful, actionable evidence for decision-makers in other contexts [ 17 ].

The overall approach of case study research is based on the in-depth exploration of complex phenomena in their natural, or ‘real-life’, settings. Empirical case studies typically enable dynamic understanding of complex challenges rather than restricting the focus on narrow problem delineations and simple fixes. Case study research is a diverse and somewhat contested field, with multiple definitions and perspectives grounded in different ways of viewing the world, and involving different combinations of methods. In this paper, we raise awareness of such plurality and highlight the contribution that case study research can make to the evaluation of complex system-level interventions. We review some of the challenges in exploiting the current evidence base from empirical case studies and conclude by recommending that further guidance and minimum reporting criteria for evaluation using case studies, appropriate for audiences in the health sciences, can enhance the take-up of evidence from case study research.

Case study research offers evidence about context, causal inference in complex systems and implementation

Well-conducted and described empirical case studies provide evidence on context, complexity and mechanisms for understanding how, where and why interventions have their observed effects. Recognition of the importance of context for understanding the relationships between interventions and outcomes is hardly new. In 1943, Canguilhem berated an over-reliance on experimental designs for determining universal physiological laws: ‘As if one could determine a phenomenon’s essence apart from its conditions! As if conditions were a mask or frame which changed neither the face nor the picture!’ ([ 18 ] p126). More recently, a concern with context has been expressed in health systems and public health research as part of what has been called the ‘complexity turn’ [ 1 ]: a recognition that many of the most enduring challenges for developing an evidence base require a consideration of system-level effects [ 1 ] and the conceptualisation of interventions as interruptions in systems [ 19 ].

The case study approach is widely recognised as offering an invaluable resource for understanding the dynamic and evolving influence of context on complex, system-level interventions [ 20 , 21 , 22 , 23 ]. Empirically, case studies can directly inform assessments of where, when, how and for whom interventions might be successfully implemented, by helping to specify the necessary and sufficient conditions under which interventions might have effects and to consolidate learning on how interdependencies, emergence and unpredictability can be managed to achieve and sustain desired effects. Case study research has the potential to address four objectives for improving research and reporting of context recently set out by guidance on taking account of context in population health research [ 24 ], that is to (1) improve the appropriateness of intervention development for specific contexts, (2) improve understanding of ‘how’ interventions work, (3) better understand how and why impacts vary across contexts and (4) ensure reports of intervention studies are most useful for decision-makers and researchers.

However, evaluations of complex healthcare interventions have arguably not exploited the full potential of case study research and can learn much from other disciplines. For evaluative research, exploratory case studies have had a traditional role of providing data on ‘process’, or initial ‘hypothesis-generating’ scoping, but might also have an increasing salience for explanatory aims. Across the social and political sciences, different kinds of case studies are undertaken to meet diverse aims (description, exploration or explanation) and across different scales (from small N qualitative studies that aim to elucidate processes, or provide thick description, to more systematic techniques designed for medium-to-large N cases).

Case studies with explanatory aims vary in terms of their positioning within mixed-methods projects, with designs including (but not restricted to) (1) single N of 1 studies of interventions in specific contexts, where the overall design is a case study that may incorporate one or more (randomised or not) comparisons over time and between variables within the case; (2) a series of cases conducted or synthesised to provide explanation from variations between cases; and (3) case studies of particular settings within RCT or quasi-experimental designs to explore variation in effects or implementation.

Detailed qualitative research (typically done as ‘case studies’ within process evaluations) provides evidence for the plausibility of mechanisms [ 25 ], offering theoretical generalisations for how interventions may function under different conditions. Although RCT designs reduce many threats to internal validity, the mechanisms of effect remain opaque, particularly when the causal pathways between ‘intervention’ and ‘effect’ are long and potentially non-linear: case study research has a more fundamental role here, in providing detailed observational evidence for causal claims [ 26 ] as well as producing a rich, nuanced picture of tensions and multiple perspectives [ 8 ].

Longitudinal or cross-case analysis may be best suited for evidence generation in system-level evaluative research. Turner [ 27 ], for instance, reflecting on the complex processes in major system change, has argued for the need for methods that integrate learning across cases, to develop theoretical knowledge that would enable inferences beyond the single case, and to develop generalisable theory about organisational and structural change in health systems. Qualitative Comparative Analysis (QCA) [ 28 ] is one such formal method for deriving causal claims, using set theory mathematics to integrate data from empirical case studies to answer questions about the configurations of causal pathways linking conditions to outcomes [ 29 , 30 ].

Nonetheless, the single N case study, too, provides opportunities for theoretical development [ 31 ], and theoretical generalisation or analytical refinement [ 32 ]. How ‘the case’ and ‘context’ are conceptualised is crucial here. Findings from the single case may seem to be confined to its intrinsic particularities in a specific and distinct context [ 33 ]. However, if such context is viewed as exemplifying wider social and political forces, the single case can be ‘telling’, rather than ‘typical’, and offer insight into a wider issue [ 34 ]. Internal comparisons within the case can offer rich possibilities for logical inferences about causation [ 17 ]. Further, case studies of any size can be used for theory testing through refutation [ 22 ]. The potential lies, then, in utilising the strengths and plurality of case study to support theory-driven research within different methodological paradigms.

Evaluation research in health has much to learn from a range of social sciences where case study methodology has been used to develop various kinds of causal inference. For instance, Gerring [ 35 ] expands on the within-case variations utilised to make causal claims. For Gerring [ 35 ], case studies come into their own with regard to invariant or strong causal claims (such as X is a necessary and/or sufficient condition for Y) rather than for probabilistic causal claims. For the latter (where experimental methods might have an advantage in estimating effect sizes), case studies offer evidence on mechanisms: from observations of X affecting Y, from process tracing or from pattern matching. Case studies also support the study of emergent causation, that is, the multiple interacting properties that account for particular and unexpected outcomes in complex systems, such as in healthcare [ 8 ].

Finally, efficacy (or beliefs about efficacy) is not the only contributor to intervention uptake, with a range of organisational and policy contingencies affecting whether an intervention is likely to be rolled out in practice. Case study research is, therefore, invaluable for learning about contextual contingencies and identifying the conditions necessary for interventions to become normalised (i.e. implemented routinely) in practice [ 36 ].

The challenges in exploiting evidence from case study research

At present, there are significant challenges in exploiting the benefits of case study research in evaluative health research, which relate to status, definition and reporting. Case study research has been marginalised at the bottom of an evidence hierarchy, seen to offer little by way of explanatory power, if nonetheless useful for adding descriptive data on process or providing useful illustrations for policymakers [ 37 ]. This is an opportune moment to revisit this low status. As health researchers are increasingly charged with evaluating ‘natural experiments’—the use of face masks in the response to the COVID-19 pandemic being a recent example [ 38 ]—rather than interventions that take place in settings that can be controlled, research approaches using methods to strengthen causal inference that does not require randomisation become more relevant.

A second challenge for improving the use of case study evidence in evaluative health research is that, as we have seen, what is meant by ‘case study’ varies widely, not only across but also within disciplines. There is indeed little consensus amongst methodologists as to how to define ‘a case study’. Definitions focus, variously, on small sample size or lack of control over the intervention (e.g. [ 39 ] p194), on in-depth study and context [ 40 , 41 ], on the logic of inference used [ 35 ] or on distinct research strategies which incorporate a number of methods to address questions of ‘how’ and ‘why’ [ 42 ]. Moreover, definitions developed for specific disciplines do not capture the range of ways in which case study research is carried out across disciplines. Multiple definitions of case study reflect the richness and diversity of the approach. However, evidence suggests that a lack of consensus across methodologists results in some of the limitations of published reports of empirical case studies [ 43 , 44 ]. Hyett and colleagues [ 43 ], for instance, reviewing reports in qualitative journals, found little match between methodological definitions of case study research and how authors used the term.

This raises the third challenge we identify that case study reports are typically not written in ways that are accessible or useful for the evaluation research community and policymakers. Case studies may not appear in journals widely read by those in the health sciences, either because space constraints preclude the reporting of rich, thick descriptions, or because of the reported lack of willingness of some biomedical journals to publish research that uses qualitative methods [ 45 ], signalling the persistence of the aforementioned evidence hierarchy. Where they do, however, the term ‘case study’ is used to indicate, interchangeably, a qualitative study, an N of 1 sample, or a multi-method, in-depth analysis of one example from a population of phenomena. Definitions of what constitutes the ‘case’ are frequently lacking and appear to be used as a synonym for the settings in which the research is conducted. Despite offering insights for evaluation, the primary aims may not have been evaluative, so the implications may not be explicitly drawn out. Indeed, some case study reports might properly be aiming for thick description without necessarily seeking to inform about context or causality.

Acknowledging plurality and developing guidance

We recognise that definitional and methodological plurality is not only inevitable, but also a necessary and creative reflection of the very different epistemological and disciplinary origins of health researchers, and the aims they have in doing and reporting case study research. Indeed, to provide some clarity, Thomas [ 46 ] has suggested a typology of subject/purpose/approach/process for classifying aims (e.g. evaluative or exploratory), sample rationale and selection and methods for data generation of case studies. We also recognise that the diversity of methods used in case study research, and the necessary focus on narrative reporting, does not lend itself to straightforward development of formal quality or reporting criteria.

Existing checklists for reporting case study research from the social sciences—for example Lincoln and Guba’s [ 47 ] and Stake’s [ 33 ]—are primarily orientated to the quality of narrative produced, and the extent to which they encapsulate thick description, rather than the more pragmatic issues of implications for intervention effects. Those designed for clinical settings, such as the CARE (CAse REports) guidelines, provide specific reporting guidelines for medical case reports about single, or small groups of patients [ 48 ], not for case study research.

The Design of Case Study Research in Health Care (DESCARTE) model [ 44 ] suggests a series of questions to be asked of a case study researcher (including clarity about the philosophy underpinning their research), study design (with a focus on case definition) and analysis (to improve process). The model resembles toolkits for enhancing the quality and robustness of qualitative and mixed-methods research reporting, and it is usefully open-ended and non-prescriptive. However, even if it does include some reflections on context, the model does not fully address aspects of context, logic and causal inference that are perhaps most relevant for evaluative research in health.

Hence, for evaluative research where the aim is to report empirical findings in ways that are intended to be pragmatically useful for health policy and practice, this may be an opportune time to consider how to best navigate plurality around what is (minimally) important to report when publishing empirical case studies, especially with regards to the complex relationships between context and interventions, information that case study research is well placed to provide.

The conventional scientific quest for certainty, predictability and linear causality (maximised in RCT designs) has to be augmented by the study of uncertainty, unpredictability and emergent causality [ 8 ] in complex systems. This will require methodological pluralism, and openness to broadening the evidence base to better understand both causality in and the transferability of system change intervention [ 14 , 20 , 23 , 25 ]. Case study research evidence is essential, yet is currently under exploited in the health sciences. If evaluative health research is to move beyond the current impasse on methods for understanding interventions as interruptions in complex systems, we need to consider in more detail how researchers can conduct and report empirical case studies which do aim to elucidate the contextual factors which interact with interventions to produce particular effects. To this end, supported by the UK’s Medical Research Council, we are embracing the challenge to develop guidance for case study researchers studying complex interventions. Following a meta-narrative review of the literature, we are planning a Delphi study to inform guidance that will, at minimum, cover the value of case study research for evaluating the interrelationship between context and complex system-level interventions; for situating and defining ‘the case’, and generalising from case studies; as well as provide specific guidance on conducting, analysing and reporting case study research. Our hope is that such guidance can support researchers evaluating interventions in complex systems to better exploit the diversity and richness of case study research.

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Abbreviations

Qualitative comparative analysis

Quasi-experimental design

Randomised controlled trial

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This work was funded by the Medical Research Council - MRC Award MR/S014632/1 HCS: Case study, Context and Complex interventions (TRIPLE C). SP was additionally funded by the University of Oxford's Higher Education Innovation Fund (HEIF).

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Paparini, S., Green, J., Papoutsi, C. et al. Case study research for better evaluations of complex interventions: rationale and challenges. BMC Med 18 , 301 (2020). https://doi.org/10.1186/s12916-020-01777-6

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

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What is it?

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

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

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

Benefits and limitations of case studies

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

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

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

Examples of case studies

Example 1: nurses’ paediatric pain management practices.

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

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

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

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

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

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

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

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

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

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

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

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

• Gustafsson J
• Calanzaro M
• Sandelowski M

Competing interests None declared.

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

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

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

Descriptive studies

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

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

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

Observational studies

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

Cross-sectional study:

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

Cohort study:

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

Case-Control Study:

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

Experimental Studies

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

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

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

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

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

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

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

References (pdf)

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

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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No Comments on An introduction to different types of study design

you are amazing one!! if I get you I’m working with you! I’m student from Ethiopian higher education. health sciences student

Very informative and easy understandable

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

Wow very erll explained and easy to understand

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

well understood,thank you so much

Well understood…thanks

Simply explained. Thank You.

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

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

it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

Thanks for this information

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

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

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

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

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

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

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

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

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

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

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Types of Study Design

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Introduction

Study designs are frameworks used in medical research to gather data and explore a specific research question .

Choosing an appropriate study design is one of many essential considerations before conducting research to minimise bias and yield valid results .

This guide provides a summary of study designs commonly used in medical research, their characteristics, advantages and disadvantages.

Case-report and case-series

A case report is a detailed description of a patient’s medical history, diagnosis, treatment, and outcome. A case report typically documents unusual or rare cases or reports  new or unexpected clinical findings .

A case series is a similar study that involves a group of patients sharing a similar disease or condition. A case series involves a comprehensive review of medical records for each patient to identify common features or disease patterns. Case series help better understand a disease’s presentation, diagnosis, and treatment.

While a case report focuses on a single patient, a case series involves a group of patients to provide a broader perspective on a specific disease. Both case reports and case series are important tools for understanding rare or unusual diseases .

Advantages of case series and case reports include:

• Able to describe rare or poorly understood conditions or diseases
• Helpful in generating hypotheses and identifying patterns or trends in patient populations
• Can be conducted relatively quickly and at a lower cost compared to other research designs

Disadvantages

Disadvantages of case series and case reports include:

• Prone to selection bias , meaning that the patients included in the series may not be representative of the general population
• Lack a control group, which makes it difficult to conclude  the effectiveness of different treatments or interventions
• They are descriptive and cannot establish causality or control for confounding factors

Cross-sectional study

A cross-sectional study aims to measure the prevalence or frequency of a disease in a population at a specific point in time. In other words, it provides a “ snapshot ” of the population at a single moment in time.

Cross-sectional studies are unique from other study designs in that they collect data on the exposure and the outcome of interest from a sample of individuals in the population. This type of data is used to investigate the distribution of health-related conditions and behaviours in different populations, which is especially useful for guiding the development of public health interventions .

Example of a cross-sectional study

A cross-sectional study might investigate the prevalence of hypertension (the outcome) in a sample of adults in a particular region. The researchers would measure blood pressure levels in each participant and gather information on other factors that could influence blood pressure, such as age, sex, weight, and lifestyle habits (exposure).

Advantages of cross-sectional studies include:

• Relatively quick and inexpensive to conduct compared to other study designs, such as cohort or case-control studies
• They can provide a snapshot of the prevalence and distribution of a particular health condition in a population
• They can help to identify patterns and associations between exposure and outcome variables, which can be used to generate hypotheses for further research

Disadvantages of cross-sectional studies include:

• They cannot establish causality , as they do not follow participants over time and cannot determine the temporal sequence between exposure and outcome
• Prone to selection bias , as the sample may not represent the entire population being studied
• They cannot account for confounding variables , which may affect the relationship between the exposure and outcome of interest

Case-control study

A case-control study compares people who have developed a disease of interest ( cases ) with people who have not developed the disease ( controls ) to identify potential risk factors associated with the disease.

Once cases and controls have been identified, researchers then collect information about related risk factors , such as age, sex, lifestyle factors, or environmental exposures, from individuals. By comparing the prevalence of risk factors between the cases and the controls, researchers can determine the association between the risk factors and the disease.

Example of a case-control study

A case-control study design might involve comparing a group of individuals with lung cancer (cases) to a group of individuals without lung cancer (controls) to assess the association between smoking (risk factor) and the development of lung cancer.

Advantages of case-control studies include:

• Useful for studying rare diseases , as they allow researchers to selectively recruit cases with the disease of interest
• Useful for investigating potential risk factors for a disease, as the researchers can collect data on many different factors from both cases and controls
• Can be helpful in situations where it is not ethical or practical to manipulate exposure levels or randomise study participants

Disadvantages of case-control studies include:

• Prone to selection bias , as the controls may not be representative of the general population or may have different underlying risk factors than the cases
• Cannot establish causality , as they can only identify associations between factors and disease
• May be limited by the availability of suitable controls , as finding appropriate controls who have similar characteristics to the cases can be challenging

Cohort study

A cohort study follows a group of individuals (a cohort) over time to investigate the relationship between an exposure or risk factor and a particular outcome or health condition. Cohort studies can be further classified into prospective or retrospective cohort studies.

Prospective cohort study

A prospective cohort study is a study in which the researchers select a group of individuals who do not have a particular disease or outcome of interest at the start of the study.

They then follow this cohort over time to track the number of patients who develop the outcome . Before the start of the study, information on exposure(s) of interest may also be collected.

Example of a prospective cohort study

A prospective cohort study might follow a group of individuals who have never smoked and measure their exposure to tobacco smoke over time to investigate the relationship between smoking and lung cancer .

Retrospective cohort study

In contrast, a retrospective cohort study is a study in which the researchers select a group of individuals who have already been exposed to something (e.g. smoking) and look back in time (for example, through patient charts) to see if they developed the outcome (e.g. lung cancer ).

The key difference in retrospective cohort studies is that data on exposure and outcome are collected after the outcome has occurred.

Example of a retrospective cohort study

A retrospective cohort study might look at the medical records of smokers and see if they developed a particular adverse event such as lung cancer.

Advantages of cohort studies include:

• Generally considered to be the most appropriate study design for investigating the temporal relationship between exposure and outcome
• Can provide estimates of incidence and relative risk , which are useful for quantifying the strength of the association between exposure and outcome
• Can be used to investigate multiple outcomes or endpoints associated with a particular exposure, which can help to identify unexpected effects or outcomes

Disadvantages of cohort studies include:

• Can be expensive and time-consuming to conduct, particularly for long-term follow-up
• May suffer from selection bias , as the sample may not be representative of the entire population being studied
• May suffer from attrition bias , as participants may drop out or be lost to follow-up over time

Meta-analysis

A meta-analysis is a type of study that involves extracting outcome data from all relevant studies in the literature and combining the results of multiple studies to produce an overall estimate of the effect size of an intervention or exposure.

Meta-analysis is often conducted alongside a systematic review and can be considered a study of studies . By doing this, researchers provide a more comprehensive and reliable estimate of the overall effect size and their confidence interval (a measure of precision).

Meta-analyses can be conducted for a wide range of research questions , including evaluating the effectiveness of medical interventions, identifying risk factors for disease, or assessing the accuracy of diagnostic tests. They are particularly useful when the results of individual studies are inconsistent or when the sample sizes of individual studies are small, as a meta-analysis can provide a more precise estimate of the true effect size.

When conducting a meta-analysis, researchers must carefully assess the risk of bias in each study to enhance the validity of the meta-analysis. Many aspects of research studies are prone to bias , such as the methodology and the reporting of results. Where studies exhibit a high risk of bias, authors may opt to exclude the study from the analysis or perform a subgroup or sensitivity analysis.

Advantages of a meta-analysis include:

• Combine the results of multiple studies, resulting in a larger sample size and increased statistical power, to provide a more comprehensive and precise estimate of the effect size of an intervention or outcome
• Can help to identify sources of heterogeneity or variability in the results of individual studies by exploring the influence of different study characteristics or subgroups
• Can help to resolve conflicting results or controversies in the literature by providing a more robust estimate of the effect size

Disadvantages of a meta-analysis include:

• Susceptible to publication bias , where studies with statistically significant or positive results are more likely to be published than studies with nonsignificant or negative results. This bias can lead to an overestimation of the treatment effect in a meta-analysis
• May not be appropriate if the studies included are too heterogeneous , as this can make it difficult to draw meaningful conclusions from the pooled results
• Depend on the quality and completeness of the data available from the individual studies and may be limited by the lack of data on certain outcomes or subgroups

Ecological study

An ecological study assesses the relationship between outcome and exposure at a population level or among groups of people rather than studying individuals directly.

The main goal of an ecological study is to observe and analyse patterns or trends at the population level and to identify potential associations or correlations between environmental factors or exposures and health outcomes.

Ecological studies focus on collecting data on population health outcomes , such as disease or mortality rates, and environmental factors or exposures, such as air pollution, temperature, or socioeconomic status.

Example of an ecological study

An ecological study might be used when comparing smoking rates and lung cancer incidence across different countries.

Advantages of an ecological study include:

• Provide insights into how social, economic, and environmental factors may impact health outcomes in real-world settings , which can inform public health policies and interventions
• Cost-effective and efficient, often using existing data or readily available data, such as data from national or regional databases

Disadvantages of an ecological study include:

• Ecological fallacy occurs when conclusions about individual-level associations are drawn from population-level differences
• Ecological studies rely on population-level (i.e. aggregate) rather than individual-level data; they cannot establish causal relationships between exposures and outcomes, as the studies do not account for differences or confounders at the individual level

Randomised controlled trial

A randomised controlled trial (RCT) is an important study design commonly used in medical research to determine the effectiveness of a treatment or intervention . It is considered the gold standard in research design because it allows researchers to draw cause-and-effect conclusions about the effects of an intervention.

In an RCT, participants are randomly assigned to two or more groups. One group receives the intervention being tested, such as a new drug or a specific medical procedure. In contrast, the other group is a control group and receives either no intervention or a placebo .

Randomisation ensures that each participant has an equal chance of being assigned to either group, thereby minimising selection bias . To reduce bias, an RCT often uses a technique called blinding , in which study participants, researchers, or analysts are kept unaware of participant assignment during the study. The participants are then followed over time, and outcome measures are collected and compared to determine if there is any statistical difference between the intervention and control groups.

Example of a randomised controlled trial

An RCT might be employed to evaluate the effectiveness of a new smoking cessation program in helping individuals quit smoking compared to the existing standard of care.

Advantages of an RCT include:

• Considered the most reliable study design for establishing causal relationships between interventions and outcomes and determining the effectiveness of interventions
• Randomisation of participants to intervention and control groups ensures that the groups are similar at the outset, reducing the risk of selection bias and enhancing internal validity
• Using a control group allows researchers to compare with the group that received the intervention while controlling for confounding factors

Disadvantages of an RCT include:

• Can raise ethical concerns ; for example, it may be considered unethical to withhold an intervention from a control group, especially if the intervention is known to be effective
• Can be expensive and time-consuming to conduct, requiring resources for participant recruitment, randomisation, data collection, and analysis
• Often have strict inclusion and exclusion criteria , which may limit the generalisability of the findings to broader populations
• May not always be feasible or practical for certain research questions, especially in rare diseases or when studying long-term outcomes

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• Yuliya L, Qazi MA (eds.). Toronto Notes 2022. Toronto: Toronto Notes for Medical Students Inc; 2022.
• Le T, Bhushan V, Qui C, Chalise A, Kaparaliotis P, Coleman C, Kallianos K. First Aid for the USMLE Step 1 2023. New York: McGraw-Hill Education; 2023.
• Rothman KJ, Greenland S, Lash T. Modern Epidemiology. 3 rd ed. Philadelphia: Lippincott Williams & Wilkins; 2008.

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Study Design 101: Welcome to Study Design 101

• Case Report
• Case Control Study
• Cohort Study
• Randomized Controlled Trial
• Practice Guideline
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• Helpful Formulas
• Finding Specific Study Types

Welcome to Study Design 101

This tutorial is designed to give you:

• An understanding of different types of clinical medical studies and how they relate to each other
• An overview of important formulas relevant to these study types
• The ability to locate articles using each of the different study types
• A glossary of terms related to clinical medical studies

The study designs can be thought of as a pyramid. Case control studies are the first articles published on new topics so they make up the base of the pyramid. As we progress up the pyramid, the studies become more evidence-based and less numerous. Meta-Analyses are at the top of the pyramid because they can only be written after much other research has been done on a topic. There are many fewer of them but they offer very strong evidence.

This tutorial is designed to be read in the order going up the pyramid from the base, but you can jump around according to your needs and interests. There are questions to test yourself about each study type, some helpful formulas related to the study types, a video demonstrating how to find each type of study , and a glossary of relevant terms.

As always, please contact the Reference desk if you have questions or concerns. We are not experts in statistics or clinical research, but we know how to help you get the answers you need!

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• Design thinking as an approach for innovation in healthcare: systematic review and research avenues
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• http://orcid.org/0000-0002-2759-8036 Mariana Oliveira ,
• http://orcid.org/0000-0001-8361-0637 Eduardo Zancul ,
• http://orcid.org/0000-0003-4937-0339 André Leme Fleury
• School of Engineering, Industrial Engineering Department , Universidade de São Paulo (USP) , Sao Paulo , Brazil
• Correspondence to Dr Eduardo Zancul, School of Engineering, Industrial Engineering Department, Universidade de São Paulo (USP), Sao Paulo, Brazil; ezancul{at}usp.br

Design thinking has been increasingly adopted as an approach to support innovation in healthcare. Recent publications report design thinking application to various innovation projects, across medical specialties, including paediatrics, psychiatry, radiology, gastroenterology, oncology, orthopaedics and surgery, as well as to innovation in hospital operations and healthcare management. Current literature in the area typically focuses on single case descriptions. With the recent increase in the number of cases, there is an opportunity to assess multiple cases to identify patterns and avenues for further research. This study provides a systematic review of published design thinking projects in healthcare. The aim of the study is to provide an overview of how design thinking has been applied in the healthcare sector. Data collection was based on Institute of Scientific Information (ISI) Web of Science, PubMed and Scopus databases. The systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 32 original pieces of research was selected for analysis, being classified and assessed. The paper presents current status of research and practice from various perspectives, including the design thinking progression phase—inspiration, ideation, implementation—and the prevalence of design thinking tools. Avenues for further research include the need to increase focus on the inspiration phase, the opportunity for platforms for leveraging the integration of individuals in innovation projects, and the opportunity to enhance the role of lead users in healthcare innovation.

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https://doi.org/10.1136/bmjinnov-2020-000428

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Contributors ALF and MO planned the study. MO conducted the data gathering and literature review analysis. ALF and EZ guided the research method and revised the manuscript.

Funding This study was financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) – Finance Code 001 and by the Ocean R&D Programme.

Competing interests None declared.

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Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Bridging human-centered design and technological innovation, the Stanford Hospital sets a new standard for patient care. Along with executive architect Rafael Viñoly Architects, healthcare architect Perkins Eastman envisioned a biophilic and hospitality-infused building that facilitates connection, effective treatment, and healing. With a modular, resilient design that allows for flexibility and future expansion, the building can be adapted to accommodate the evolving needs of the Stanford community and is capable of withstanding a 500-year seismic event.

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“This building represents a whole new approach to health care, not just in design but in the patient experience.” – Amir Dan Rubin, President and CEO of Stanford Health Care

Conceived of through a collaborative process with Stanford Health Care and the design team, the hospital’s inventive plan mimics a patient’s journey. Four levels, centered on the themes of connect, treat, heal, and care stack vertically and emphasizes overall wellness. An inviting sunlit atrium welcomes patients and caregivers, seamlessly connecting them to advanced treatment areas on the second floor. The third floor’s 40,000 square foot garden, designed with drought-resistant plants and sustainable systems, is the beating heart of the hospital. Integrating nature with nurture, its landscaped terraces are a lush regenerative oasis that promote rest and recovery. Upper level care pavilions comprised of 368 private rooms and ICUs, as well as staff and communal spaces, offer state-of-the-art accommodations for healing and visitation. Stimulating emotional well-being, more than 400 works of art grace the public areas throughout the hospital.

The team set out to reimagine what a hospital room could be with an understanding of how design can directly impact the healing process. In stark contrast to traditional hospitals, each private room features a 14-foot-wide window where patients can gaze out on tranquil views of the Stanford campus and foothills of the Santa Cruz mountains from the comfort of a bed that is set away from the bustling hallways. Large television screens connect patients and family members with health records, service requests, and entertainment options. Loved ones are also encouraged to spend time with patients in recovery, enjoying the privacy and comfort of flexible sleeper sofas and storage space for their belongings. Nurses and doctors have access to a vestibule with a sink, counter, and curtain where they can perform their duties effectively while minimizing disruptions.

Designed to accommodate future interdisciplinary innovations through complex health care technology, Stanford Hospital fosters advancements in medical science at the nexus of Silicon Valley and Stanford University academics. It also embodies advancements in building science and resilience, featuring a highly specialized seismic base isolation system. Built to survive an 8.0 earthquake, the facility can function for the first 96 hours after a significant seismic event, going above and beyond California code requirements. A community-centered institution, Stanford Hospital also has a 900-vehicle garage designed to transform into a triage center during a natural disaster or contagious disease outbreak.

“We used to design for the convenience of physicians and nurses. Today, with the industry’s awareness of the critical link between a patient’s well-being and medical results, Stanford wanted to prioritize the patient-centric experience.” – Erich Burkhart, FAIA, Principal-in-Charge

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Sustainable innovative design of elderly-friendly smart medical products: an integrated model.

1. Introduction

• Based on the fuzzy Kano model, Kansei engineering, and TRIZ, this study proposes a sustainable innovation design framework currently lacking in the field of smart healthcare products for the elderly. This framework addresses the deficiency in Kansei engineering’s application to product design, which often neglects the innovativeness of design solutions, and it complements the TRIZ field by accounting for users’ emotional needs. This provides methodological guidance for the sustainable innovative design of other product types;
• By innovatively using the systematic classification function of the fuzzy Kano model, this study addresses the irrationality in the screening process of core words of emotional needs in the traditional semantic differential method, thereby enhancing the significance level of core words of emotional needs in improving user satisfaction.
• To achieve sustainable innovation in the design of elderly-friendly smart medical products, enabling continuous iteration and optimization to meet the complex and changing emotional needs of the elderly;
• To provide a theoretical basis and practical guidance for the government and related industries in formulating policies on CMEC, promoting the innovation of elder-friendly smart medical products, and improving the quality of elderly care services.

2. Literature Review

2.1. sustainable innovative design of elderly-friendly smart medical products, 2.2. kansei engineering, 2.3. fuzzy kano model, 2.5. sustainable innovation design framework for elderly-friendly smart medical products, 3. research framework, 3.1. analysis of emotional needs of the elderly, 3.1.1. elderly-friendly smart medical product attribute category analysis, 3.1.2. construction of vocabulary of emotional needs, 3.2. extraction of core emotional needs of the elderly, 3.2.1. construction of key vocabulary of emotional needs, 3.2.2. construction of core vocabulary of emotional needs, 3.3. generation of sustainable innovative design solutions for elderly-friendly smart medical products, 4. empirical case studies, 4.1. analysis of emotional needs of the elderly regarding smart blood pressure monitors, 4.1.1. smart blood pressure monitor product attribute category analysis, 4.1.2. construction of vocabulary of emotional needs for smart blood pressure monitor products, 4.2. extraction of core emotional needs of the elderly regarding smart blood pressure monitors, 4.2.1. construction of key vocabulary of emotional needs for smart blood pressure monitor products, 4.2.2. construction of library of core emotional needs for smart blood pressure monitor products, 4.3. generation and realization of sustainable innovative design solutions for smart blood pressure monitor products, 4.3.1. generation stage of sustainable innovation design for smart blood pressure monitor products, 4.3.2. realization stage of sustainable innovation design solution for smart blood pressure monitor products, 5. discussion, 5.1. research advantages, 5.2. policy implications, 5.2.1. implications for enterprise-level research.

• Deepen the understanding of user needs and product positioning: before proposing innovative design solutions for the smart blood pressure monitor, this study had already identified that elderly users prefer three key product attributes: “portability”, “appearance design”, and “functionality”. This conclusion was drawn after extensively collecting and analyzing smart blood pressure monitor pictures and descriptions from major e-commerce platforms and academic literature. This comprehensive understanding of user needs and product positioning ensured a smooth connection between demands and the design. Hence, enterprises must deeply understand the specific needs and preferences of elderly users through meticulous market research. This includes understanding their basic needs, expected needs, and attractive needs in the use of medical products. Enterprises should position their products according to these needs to ensure that the design direction matches the actual needs of the users;
• Promote the integration of Kansei engineering and technological innovation: the core idea of the integrated framework combining the fuzzy Kano model, Kansei engineering, and TRIZ is to ensure that the product innovation process is guided by users’ emotional needs. For example, in designing a smart blood pressure monitor, we first identified three core emotional needs: “no assembly required”, “small”, and “concise data display”. These needs were then mapped to propose four innovative design solutions (S1, S2, S3, and S4) for the smart blood pressure monitor, ensuring that the designs meet the emotional needs of the elderly while also maintaining innovation. Thus, when designing elderly-friendly smart medical products, enterprises should integrate the concept of Kansei engineering into the innovation process and should consider the emotional value and innovative design of the products. This implies that the product should not only fulfill the medical needs with regard to functionality but also bring comfort and pleasure to the elderly users in terms of sensory experience;
• Establishment of a management mechanism for continuous innovation and improvement: the integrated framework of the fuzzy Kano model, Kansei engineering, and TRIZ proposed in this study is merely a method to facilitate sustainable innovation in the design of elderly-friendly smart medical products. However, to truly achieve sustainable innovation in product design, fostering innovative thinking within the design team is the key driving force. Therefore, enterprises should establish a management mechanism for continuous innovation and improvement and encourage team members to use TRIZ and other innovation methods to resolve problems in the design and production process. Enterprises need to cultivate the problem awareness and problem-solving skills of the employees and improve the team’s ability to think creatively and solve problems systematically. Meanwhile, the enterprise should establish a mechanism to quickly respond to market changes, collect user feedback in a timely manner, and use it to rapidly improve products for achieving continuous product iteration and optimization.

5.2.2. Implications for Government-Level Research

• Facilitate collaborative innovation among industry, universities, and research institutes: the practical foundation of the sustainable innovation design framework for elderly-friendly smart medical products is not yet particularly solid, and the innovative design solutions for the smart blood pressure monitor remain at the conceptual stage, requiring further practical validation. In fact, advancing the elderly-friendly smart medical products industry requires close collaboration among various departments and entities. In this process, the government should play the role of a bridge to promote cooperation among enterprises, universities, research institutes, and other relevant parties to jointly promote the sustainable and innovative design of elderly-friendly smart medical products. The government can strengthen exchanges and cooperation among various parties by establishing innovation platforms, funding joint R&D projects, and organizing industry exchange meetings. In addition, the government can promote education and training programs for cultivating talent with expertise in elderly-friendly design and smart medical technology to support the long-term development of this industry;
• Encourage the demonstration and promotion of the application of smart medical products in the field of CMEC: in the process of collecting and analyzing the emotional needs of smart blood pressure monitor users, this study found that many elderly users experience anxiety about using smart devices. To address this issue, the government can encourage the demonstration and promotion of the application of elderly-friendly smart medical products in the field of CMEC through the establishment of demonstration zones and demonstration projects. This approach would provide companies with a practical platform to gather user feedback and optimize product performance, thereby significantly reducing the resistance elderly users may feel toward using these products. The government can also raise public awareness of elderly-friendly smart medical products through media publicity and public education to promote social recognition and acceptance of these products;
• Encourage cross-sectoral collaboration to integrate medical and elderly resources: elderly-friendly smart medical products are just one aspect of the broader CMEC services. To accelerate the development of CMEC, the government should play a role in cross-sectoral coordination and integrate resources in the fields of medical care, elderly care, science, and technology. By establishing a cross-sectoral collaboration platform to promote information sharing, resource integration, and collaborative innovation, the government can help enterprises better understand the needs of the elderly while providing them with the necessary support, such as market access, qualifications, and professional guidance.

5.3. Research Limitations and Future Prospects

6. conclusions.

• In the design of elderly-friendly smart medical products, the emotional needs of users provide the direction for product innovation, and the innovation of product design solutions is a strong guarantee for meeting these needs. The mutual connection between them is key to achieving sustainable innovation in the design of elderly-friendly smart medical products;
• The integration of Kansei engineering and TRIZ enables the mapping of users’ emotional needs to innovative design solutions for elderly-friendly smart medical products. The fuzzy Kano model effectively addresses the inherent limitations of the semantic differential method, enhancing overall user satisfaction;
• The innovative design of the smart blood pressure monitor based on the sustainable innovation design framework can solve the development problems of upstream suppliers and the sales problems of downstream retailers. More importantly, the designed device was popular among the elderly, confirming that the integrated framework can be used to guide product design and the design scheme development process for smart blood pressure monitors and further verifying the feasibility of the integrated framework for promoting sustainable innovative design of elderly-friendly smart medical products;
• The sustainable innovative design of elderly-friendly smart medical products in this study considers the emotional needs of the elderly, which not only can help the elderly maintain an independent life and enhance their self-management ability through iterative optimization of elderly-friendly smart medical product design and the provision of personalized services, significantly reducing the pressure on community health service centers and alleviating the current situation of the uneven distribution of medical resources, but also promotes the collection and analysis of relevant medical and elderly health data, providing valuable information resources for policymakers and promoting the development of intelligent CMEC.

Author Contributions

Institutional review board statement, informed consent statement, data availability statement, conflicts of interest.

Appendix C. Smart Blood Pressure Monitor Product Satisfaction Questionnaire

Click here to enlarge figure

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Share and Cite

Shie, A.-J.; Xu, E.-M.; Ye, Z.-Z.; Meng, Q.-F.; Wu, Y.J. Sustainable Innovative Design of Elderly-Friendly Smart Medical Products: An Integrated Model. Sustainability 2024 , 16 , 7580. https://doi.org/10.3390/su16177580

Shie A-J, Xu E-M, Ye Z-Z, Meng Q-F, Wu YJ. Sustainable Innovative Design of Elderly-Friendly Smart Medical Products: An Integrated Model. Sustainability . 2024; 16(17):7580. https://doi.org/10.3390/su16177580

Shie, An-Jin, En-Min Xu, Zhen-Zhen Ye, Qing-Feng Meng, and Yenchun Jim Wu. 2024. "Sustainable Innovative Design of Elderly-Friendly Smart Medical Products: An Integrated Model" Sustainability 16, no. 17: 7580. https://doi.org/10.3390/su16177580

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• Published: 28 August 2024

The design, implementation, and evaluation of a blended (in-person and virtual) Clinical Competency Examination for final-year nursing students

• Rita Mojtahedzadeh 1 ,
• Tahereh Toulabi 2 , 3 &
• Aeen Mohammadi 1  

BMC Medical Education volume  24 , Article number:  936 ( 2024 ) Cite this article

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Introduction

Studies have reported different results of evaluation methods of clinical competency tests. Therefore, this study aimed to design, implement, and evaluate a blended (in-person and virtual) Competency Examination for final-year Nursing Students.

This interventional study was conducted in two semesters of 2020–2021 using an educational action research method in the nursing and midwifery faculty. Thirteen faculty members and 84 final-year nursing students were included in the study using a census method. Eight programs and related activities were designed and conducted during the examination process. Students completed the Spielberger Anxiety Inventory before the examination, and both faculty members and students completed the Acceptance and Satisfaction questionnaire.

The results of the analysis of focused group discussions and reflections indicated that the virtual CCE was not capable of adequately assessing clinical skills. Therefore, it was decided that the CCE for final-year nursing students would be conducted using a blended method. The activities required for performing the examination were designed and implemented based on action plans. Anxiety and satisfaction were also evaluated as outcomes of the study. There was no statistically significant difference in overt, covert, and overall anxiety scores between the in-person and virtual sections of the examination ( p  > 0.05). The mean (SD) acceptance and satisfaction scores for students in virtual, in-person, and blended sections were 25.49 (4.73), 27.60 (4.70), and 25.57 (4.97), respectively, out of 30 points, in which there was a significant increase in the in-person section compared to the other sections. ( p  = 0.008). The mean acceptance and satisfaction scores for faculty members were 30.31 (4.47) in the virtual, 29.86 (3.94) in the in-person, and 30.00 (4.16) out of 33 in the blended, and there was no significant difference between the three sections ( p  = 0.864).

Evaluating nursing students’ clinical competency using a blended method was implemented and solved the problem of students’ graduation. Therefore, it is suggested that the blended method be used instead of traditional in-person or entirely virtual exams in epidemics or based on conditions, facilities, and human resources. Also, the use of patient simulation, virtual reality, and the development of necessary virtual and in-person training infrastructure for students is recommended for future research. Furthermore, considering that the acceptance of traditional in-person exams among students is higher, it is necessary to develop virtual teaching strategies.

Peer Review reports

The primary mission of the nursing profession is to educate competent, capable, and qualified nurses with the necessary knowledge and skills to provide quality nursing care to preserve and improve the community’s health [ 1 ]. Clinical education is one of the most essential and fundamental components of nursing education, in which students gain clinical experience by interacting with actual patients and addressing real problems. Therefore, assessing clinical skills is very challenging. The main goal of educational evaluation is to improve, ensure, and enhance the quality of the academic program. In this regard, evaluating learners’ performance is one of the critical and sensitive aspects of the teaching and learning process. It is considered one of the fundamental elements of the educational program [ 2 ]. The study area is educational evaluation.

Various methods are used to evaluate nursing students. The Objective Structured Clinical Examination (OSCE) is a valid and reliable method for assessing clinical competence [ 1 , 2 ]. In the last twenty years, the use of OSCE has increased significantly in evaluating medical and paramedical students to overcome the limitations of traditional practical evaluation systems [ 3 , 4 ]. The advantages of this method include providing rapid feedback, uniformity for all examinees, and providing conditions close to reality. However, the time-consuming nature and the need for a lot of personnel and equipment are some disadvantages of OSCE [ 5 , 6 ]. Additionally, some studies have shown that this method is anxiety-provoking for some students and, due to time constraints, being observed by the evaluator and other factors can cause dissatisfaction among students [ 7 , 8 ].

However, some studies have also reported that this method is not only not associated with high levels of stress among students [ 9 ] but also has higher satisfaction than traditional evaluation methods [ 4 ]. In addition, during the COVID-19 pandemic, problems such as overcrowding and student quarantine during the exam have arisen. Therefore, reducing time and costs, eliminating or reducing the tiring quarantine time, optimizing the exam, utilizing all facilities for simulating the clinical environment, using innovative methods for conducting the exam, reducing stress, increasing satisfaction, and ultimately preventing the transmission of COVID-19 are significant problems that need to be further investigated.

Studies show that using virtual space as an alternative solution is strongly felt [ 10 , 11 , 12 ]. In the fall of 2009, following the outbreak of H1N1, educational classes in the United States were held virtually [ 13 ]. Also, in 2005, during Hurricane Katrina, 27 universities in the Gulf of Texas used emergency virtual education and evaluation [ 14 ].

One of the challenges faced by healthcare providers in Iran, like most countries in the world, especially during the COVID-19 outbreak, was the shortage of nursing staff [ 15 , 16 ]. Also, in evaluating and conducting CCE for final-year students and subsequent job seekers in the Clinical Skills Center, problems such as student overcrowding and the need for quarantine during the implementation of OSCE existed. This problem has been reported not only for us but also in other countries [ 17 ]. The intelligent use of technology can solve many of these problems. Therefore, almost all educational institutions have quickly started changing their policies’ paradigms to introduce online teaching and evaluation methods [ 18 , 19 ].

During the COVID-19 pandemic, for the first time, this exam was held virtually in our school. However, feedback from professors and students and the experiences of researchers have shown that the virtual exam can only partially evaluate clinical and practical skills in some stations, such as basic skills, resuscitation, and pediatrics [ 20 ].

Additionally, using OSCE in skills assessment facilitates the evaluation of psychological-motor knowledge and attitudes and helps identify strengths and weaknesses [ 21 ]. Clinical competency is a combination of theoretical knowledge and clinical skills. Therefore, using an effective blended method focusing on the quality and safety of healthcare that measures students’ clinical skills and theoretical expertise more accurately in both in-person and virtual environments is essential. The participation of students, professors, managers, education and training staff, and the Clinical Skills Center was necessary to achieve this important and inevitable goal. Therefore, the Clinical Competency Examination (CCE) for nursing students in our nursing and midwifery school was held in the form of an educational action research process to design, implement, and evaluate a blended method. Implementing this process during the COVID-19 pandemic, when it was impossible to hold an utterly in-person exam, helped improve the quality of the exam and address its limitations and weaknesses while providing the necessary evaluation for students.

The innovation of this research lies in evaluating the clinical competency of final-year nursing students using a blended method that focuses on clinical and practical aspects. In the searches conducted, only a few studies have been done on virtual exams and simulations, and a similar study using a blended method was not found.

The research investigates the scientific and clinical abilities of nursing students through the clinical competency exam. This exam, traditionally administered in person, is a crucial milestone for final-year nursing students, marking their readiness for graduation. However, the unforeseen circumstances of the COVID-19 pandemic and the resulting restrictions rendered in-person exams impractical in 2020. This necessitated a swift and significant transition to an online format, a decision that has profound implications for the future of nursing education. While the adoption of online assessment was a necessary step to ensure student graduation and address the nursing workforce shortage during the pandemic, it was not without its challenges. The accurate assessment of clinical skills, such as dressing and CPR, proved to be a significant hurdle. This underscored the urgent need for a change in the exam format, prompting a deeper exploration of innovative solutions.

To address these problems, the research was conducted collaboratively with stakeholders, considering the context and necessity for change in exam administration. Employing an Action Research (AR) approach, a blend of online and in-person exam modalities was adopted. Necessary changes were implemented through a cyclic process involving problem identification, program design, implementation, reflection, and continuous evaluation.

The research began by posing the following questions:

What are the problems of conducting the CCE for final-year nursing students during COVID-19?

How can these problems be addressed?

What are the solutions and suggestions from the involved stakeholders?

How can the CCE be designed, implemented, and evaluated?

What is the impact of exam type on student anxiety and satisfaction?

These questions guided the research in exploring the complexities of administering the CCE amidst the COVID-19 pandemic and in devising practical solutions to ensure the validity and reliability of the assessment while meeting stakeholders’ needs.

Materials and methods

Research setting, expert panel members, job analysis, and role delineation.

This action research was conducted at the Nursing and Midwifery School of Lorestan University of Medical Sciences, with a history of approximately 40 years. The school accommodates 500 undergraduate and graduate nursing students across six specialized fields, with 84 students enrolled in their final year of undergraduate studies. Additionally, the school employs 26 full-time faculty members in nursing education departments.

An expert panel was assembled, consisting of faculty members specializing in various areas, including medical-surgical nursing, psychiatric nursing, community health nursing, pediatric nursing, and intensive care nursing. The panel also included educational department managers and the examination department supervisor. Through focused group discussions, the panel identified and examined issues regarding the exam format, and members proposed various solutions. Subsequently, after analyzing the proposed solutions and drawing upon the panel members’ experiences, specific roles for each member were delineated.

Sampling and participant selection

Given the nature of the research, purposive sampling was employed, ensuring that all individuals involved in the design, implementation, and evaluation of the exam participated in this study.

The participants in this study included final-year nursing students, faculty members, clinical skills center experts, the dean of the school, the educational deputy, group managers, and the exam department head. However, in the outcome evaluation phase, 13 faculty members participated in-person and virtually (26 times), and 84 final-year nursing students enrolled in the study using a census method in two semesters of 2020–2021 completed the questionnaires, including 37 females and 47 males. In addition, three male and ten female faculty members participated in this study; of this number, 2 were instructors, and 11 were assistant professors.

Data collection tools

In order to enhance the validity and credibility of the study and thoroughly examine the results, this study utilized a triangulation method consisting of demographic information, focus group discussions, the Spielberger Anxiety Scale questionnaire, and an Acceptance and Satisfaction Questionnaire.

Demographic information

A questionnaire was used to gather demographic information from both students and faculty members. For students, this included age, gender, and place of residence, while for faculty members, it included age, gender, field of study, and employment status.

Focus group discussion

Multiple focused group discussions were conducted with the participation of professors, administrators, experts, and students. These discussions were held through various platforms such as WhatsApp Skype, and in-person meetings while adhering to health protocols. The researcher guided the talks toward the research objectives and raised fundamental questions, such as describing the strengths and weaknesses of the previous exam, determining how to conduct the CCE considering the COVID-19 situation, deciding on virtual and in-person stations, specifying the evaluation checklists for stations, and explaining the weighting and scoring of each station.

Spielberger anxiety scale questionnaire

This study used the Spielberger Anxiety Questionnaire to measure students’ overt and covert anxiety levels. This questionnaire is an internationally standardized tool known as the STAI questionnaire that measures both overt (state) and covert (trait) anxiety [ 22 ]. The state anxiety scale (Form Y-1 of STAI) comprises twenty statements that assess the individual’s feelings at the moment of responding. The trait anxiety scale (Form Y-2 of STAI) also includes twenty statements that measure individuals’ general and typical feelings. The scores of each of the two scales ranged from 20 to 80 in the current study. The reliability coefficient of the test for the apparent and hidden anxiety scales, based on Cronbach’s alpha, was confirmed to be 0.9084 and 0.9025, respectively [ 23 , 24 ]. Furthermore, in the present study, Cronbach’s alpha value for the total anxiety questionnaire, overt anxiety, and covert anxiety scales were 0.935, 0.921, and 0.760, respectively.

Acceptance and satisfaction questionnaire

The Acceptability and Satisfaction Questionnaire for Clinical Competency Test was developed by Farajpour et al. (2012). The student questionnaire consists of ten questions, and the professor questionnaire consists of eleven questions, using a four-point Likert scale. Experts have confirmed the validity of these questionnaires, and their Cronbach’s alpha coefficients have been determined to be 0.85 and 0.87 for the professor and student questionnaires, respectively [ 6 ]. In the current study, ten medical education experts also confirmed the validity of the questionnaires. Regarding internal reliability, Cronbach’s alpha coefficients for the student satisfaction questionnaire for both virtual and in-person sections were 0.76 and 0.87, respectively. The professor satisfaction questionnaires were 0.84 and 0.87, respectively. An online platform was used to collect data for the virtual exam.

Data analysis and rigor of study

Qualitative data analysis was conducted using the method proposed by Graneheim and Lundman. Additionally, the criteria established by Lincoln and Guba (1985) were employed to confirm the rigor and validity of the data, including credibility, transferability, dependability, and confirmability [ 26 ].

In this research, data synthesis was performed by combining the collected data with various tools and methods. The findings of this study were reviewed and confirmed by participants, supervisors, mentors, and experts in qualitative research, reflecting their opinions on the alignment of findings with their experiences and perspectives on clinical competence examinations. Therefore, the member check method was used to validate credibility.

Moreover, efforts were made in this study to provide a comprehensive description of the research steps, create a suitable context for implementation, assess the views of others, and ensure the transferability of the results.

Furthermore, researchers’ interest in identifying and describing problems, reflecting, designing, implementing, and evaluating clinical competence examinations, along with the engagement of stakeholders in these examinations, was ensured by the researchers’ long-term engagement of over 25 years with the environment and stakeholders, seeking their opinions and considering their ideas and views. These factors contributed to ensuring confirmability.

In this research, by reflecting the results to the participants and making revisions by the researchers, problem clarification and solution presentation, design, implementation, and evaluation of operational programs with stakeholder participation and continuous presence were attempted to prevent biases, assumptions, and research hypotheses, and to confirm dependability.

Data analysis was performed using SPSS version 21, and descriptive statistical tests (absolute and relative frequency, mean, and standard deviation) and inferential tests (paired t-test, independent t-test, and analysis of variance) were used. The significance level was set at 0.05. Parametric tests were used based on the normality of the data according to the Kolmogorov-Smirnov statistical test.

Given that conducting the CCE for final-year nursing students required the active participation of managers, faculty members, staff, and students, and to answer the research question “How can the CCE for final-year nursing students be conducted?” and achieve the research objective of “designing, implementing, and evaluating the clinical competency exam,” the action research method was employed.

The present study was conducted based on the Dickens & Watkins model. There are four primary stages (Fig.  1 ) in the cyclical action research process: reflect, plan, act, observe, and then reflect to continue through the cycle [ 27 ].

The cyclical process of action research [ 27 ]

Stage 1: Reflection

Identification of the problem.

According to the educational regulations, final semester nursing students must complete the clinical competency exam. However, due to the COVID-19 pandemic and the critical situation in most provinces, inter-city travel restrictions, and insufficient dormitory space, conducting the CCE in-person was not feasible.

This exam was conducted virtually at our institution. However, based on the reflections from experts, researchers have found that virtual exams can only partially assess clinical and practical skills in certain stations, such as basic skills, resuscitation, and pediatrics. Furthermore, utilizing Objective Structured Clinical Examination (OSCE) in skills assessment facilitates the evaluation of psychomotor skills, knowledge, and attitudes, aiding in identifying strengths and weaknesses.

P3, “Due to the COVID-19 pandemic and the critical situation in most provinces, inter-city travel restrictions, and insufficient dormitory space, conducting the CCE in-person is not feasible.”

Stage 2: Planning

Based on the reflections gathered from the participants, the exam was designed using a blended approach (combining in-person and virtual components) as per the schedule outlined in Fig.  2 . All planned activities for the blended CCE for final-year nursing students were executed over two semesters.

P5, “Taking the exam virtually might seem easier for us and the students, but in my opinion, it’s not realistic. For instance, performing wound dressing or airway management is very practical, and it’s not possible to assess students with a virtual scenario. We need to see them in person.”

P6"I believe it’s better to conduct those activities that are highly practical in person, but for those involving communication skills like report writing, professional ethics, etc., we can opt for virtual assessment.”

Design and implementation of the blended CCE

Stage 3: Act

Cce implementation steps.

The CCE was conducted based on the flowchart in Fig.  3 and the following steps:

Steps for conducting the CCE for final-year nursing students using a blended method

Step 1: Designing the framework for conducting the blended Clinical Competency Examination

The panelists were guided to design the blended exam in focused group sessions and virtual panels based on the ADDIE (Analysis, Design, Development, Implementation, Evaluation) model [ 28 ]. Initially, needs assessment and opinion polling were conducted, followed by the operational planning of the exam, including the design of the blueprint table (Table  1 ), determination of station types (in-person or virtual), designing question stems in the form of scenarios, creating checklists and station procedure guides by expert panel groups based on participant analysis, and the development of exam implementation guidelines with participant input [ 27 ]. The design, execution, and evaluation were as follows:

In-person and virtual meetings with professors were held to determine the exam schedule, deadlines for submitting checklists, decision-making regarding the virtual or in-person nature of stations based on the type of skill (practical, communication), and presenting problems and solutions. Based on the decisions, primary skill stations, as well as cardiac and pediatric resuscitation stations, were held in person. In contrast, virtual stations for health, nursing ethics, nursing reports, nursing diagnosis, physical examinations, and psychiatric nursing were held.

News about the exam was communicated to students through the college website and text messages. Then, an online orientation session was held on Skype with students regarding the need assessment of pre-exam educational workshops, virtual and in-person exam standards, how to use exam software, how to conduct virtual exams, explaining the necessary infrastructure for participating in the exam by students, completing anxiety and satisfaction questionnaires, rules and regulations, how to deal with rejected individuals, and exam testing and Q&A. Additionally, a pre-exam in-person orientation session was held.

To inform students about the entire educational process, the resources and educational content recommended by the professors, including PDF files, photos and videos, instructions, and links, were shared through a virtual group on the social media messenger, and scientific information was also, questions were asked and answered through this platform.

Correspondence and necessary coordination were made with the university clinical skills center to conduct in-person workshops and exams.

Following the Test-centered approach, the Angoff Modified method [ 29 , 30 ] was used to determine the scoring criteria for each station by panelists tasked with assigning scores.

Additionally, in establishing standards for this blended CCE for fourth-year nursing students, for whom graduation was a prerequisite, the panelists, as experienced clinical educators familiar with the performance and future roles of these students and the assessment method of the blended exam, were involved [ 29 , 30 ](Table 1 ).

Step 2: Preparing the necessary infrastructure for conducting the exam

Software infrastructure.

The pre- and post-virtual exam questions, scenarios, and questionnaires were uploaded using online software.

The exam was conducted on a trial basis in multiple sessions with the participation of several faculty members, and any issues were addressed. Students were authenticated to enter the exam environment via email and personal information verification. The questions for each station were designed and entered into the software by the respective station instructors and the examination coordinator, who facilitated the exam. The questions were formatted as clinical scenarios, images, descriptive questions, and multiple-choice questions, emphasizing the clinical and practical aspects. This software had various features for administering different types of exams and various question formats, including multiple-choice, descriptive, scenario-based, image-based, video-based, matching, Excel output, and graphical and descriptive statistical analyses. It also had automatic questionnaire completion, notification emails, score addition to questionnaires, prevention of multiple answer submissions, and the ability to upload files up to 4 gigabytes. Student authentication was based on national identification numbers and student IDs, serving as user IDs and passwords. Students could enter the exam environment using their email and multi-level personal information verification. If the information did not match, individuals could not access the exam environment.

Checklists and questionnaires

A student list was prepared, and checklists for the in-person exam and anxiety and satisfaction questionnaires were reproduced.

Empowerment workshops for professors and education staff

Educational needs of faculty members and academic staff include conducting clinical competency exams using the OSCE method; simulating and evaluating OSCE exams; designing standardized questions, checklists, and scenarios; innovative approaches in clinical evaluations; designing physical spaces and setting up stations; and assessing ethics and professional commitment in clinical competency exams.

Student empowerment programs

According to the students’ needs assessment results, in-person workshops on cardiopulmonary resuscitation and airway management and online workshops were held on health, pediatrics, cardiopulmonary resuscitation, ethics, nursing diagnosis, and report writing through Skype messenger. In addition, vaccination notes, psychiatric nursing, and educational files on clinical examinations and basic skills were recorded by instructors and made available to students via virtual groups.

Step 3: CCE implementation

The CCE was held in two parts, in-person and virtual.

In-person exam

The OSCE method was used for this section of the exam. The basic skills station exam included dressing and injections, and the CPR and pediatrics stations were conducted in person. The students were divided into two groups of 21 each semester, and the exam was held in two shifts. While adhering to quarantine protocols, the students performed the procedures for seven minutes at each station, and instructors evaluated them using a checklist. An additional minute was allotted for transitioning to the next station.

Virtual exam

The professional ethics, nursing diagnosis, nursing report, health, psychiatric nursing, and physical examination stations were conducted virtually after the in-person exam. This exam was made available to students via a primary and a secondary link in a virtual space at the scheduled time. Students were first verified, and after the specified time elapsed, the ability to respond to inactive questions and submitted answers was sent. During the exam, full support was provided by the examination center.

The examination coordinator conducted the entire virtual exam process. The exam results were announced 48 h after the exam. A passing grade was considered to be a score higher than 60% in all stations. Students who failed in various stations were given the opportunity for remediation based on faculty feedback, either through additional study or participation in educational workshops. Subsequent exams were held one week apart from the initial exam. It was stipulated that students who failed in more than half of the stations would be evaluated in the following semester. If they failed in more than three sessions at a station, a decision would be made by the faculty’s educational council. However, no students met these situations.

Step 4: Evaluation

The evaluation of the exam was conducted by examiners using a checklist, and the results were announced as pass or fail.

Stage 4: Observation / evaluation

In this study, both process and outcome evaluations were conducted:

Process evaluation

All programs and activities implemented during the test design and administration process were evaluated in the process evaluation. This evaluation was based on operational program control and reflections received from participants through group discussion sessions and virtual groups.

Sample reflections received from faculty members, managers, experts, and students through group discussions and social messaging platforms after the changes:

P7: “The implementation of the blended virtual exam, in the conditions of the COVID-19 crisis where the possibility of holding in-person exams was not fully available, in my opinion, was able to improve the quality of exam administration and address the limitations and weaknesses of the exam entirely virtually.”

P5: “In my opinion, this blended method was able to better evaluate students in terms of clinical readiness for entering clinical practice.”

Outcomes evaluation

The study outcomes were student anxiety, student acceptance and satisfaction, and faculty acceptance and satisfaction. Before the start of the in-person and virtual exams, the Spielberger Anxiety Questionnaire was provided to students. Additionally, immediately after the exam, students and instructors completed the acceptance and satisfaction questionnaire for the relevant section. After the exam, students and instructors completed the acceptance and satisfaction questionnaire again for the entire exam process, including feasibility, satisfaction with its implementation, and educational impact.

Design framework and implementation for the blended Clinical Competency Examination

The exam was planned using a blended method (part in-person, part virtual) according to the Fig.  2 schedule, and all planned programs for the blended CCE for final-year nursing students were implemented in two semesters.

Evaluation results

In this study, 84 final-year nursing students participated, including 37 females (44.05%) and 47 males (55.95%). Among them, 28 (33.3%) were dormitory residents, and 56 (66.7%) were non-dormitory residents.

In this study, both process and outcome evaluations were conducted.

All programs and activities implemented during the test design and administration process were evaluated in the process evaluation (Table  2 ). This evaluation was based on operational program control and reflections received from participants through group discussion sessions and virtual groups on social media.

Anxiety and satisfaction were examined and evaluated as study outcomes, and the results are presented below.

The paired t-test results in Table  3 showed no statistically significant difference in overt anxiety ( p  = 0.56), covert anxiety ( p  = 0.13), and total anxiety scores ( p  = 0.167) between the in-person and virtual sections before the blended Clinical Competency Examination.

However, the mean (SD) of overt anxiety in persons in males and females was 49.27 (11.16) and 43.63 (13.60), respectively, and this difference was statistically significant ( p  = 0.03). Also, the mean (SD) of overt virtual anxiety in males and females was 45.70 (11.88) and 51.00 (9.51), respectively, and this difference was statistically significant ( p  = 0.03). However, there was no significant difference between males and females regarding covert anxiety in the person ( p  = 0.94) and virtual ( p  = 0.60) sections. In addition, the highest percentage of overt anxiety was apparent in the virtual section among women (15.40%) and the in-person section among men (21.28%) and was prevalent at a moderate to high level.

According to Table  4 , One-way analysis of variance showed a significant difference between the virtual, in-person, and blended sections in terms of acceptance and satisfaction scores.

The results of the One-way analysis of variance showed that the mean (SD) acceptance and satisfaction scores of nursing students of the CCE in virtual, in-person, and blended sections were 25.49 (4.73), 27.60 (4.70), and 25.57 (4.97) out of 30, respectively. There was a significant difference between the three sections ( p  = 0.008).

In addition, 3 (7.23%) male and 10 (76.3%) female faculty members participated in this study; of this number, 2 (15.38%) were instructors, and 11 (84.62%) were assistant professors. Moreover, they were between 29 and 50 years old, with a mean (SD) of 41.37 (6.27). Furthermore, they had 4 to 20 years of work experience with a mean and standard deviation of 13.22(4.43).

The results of the analysis of variance showed that the mean (SD) acceptance and satisfaction scores of faculty members of the CCE in virtual, in-person, and blended sections were 30.31 (4.47), 29.86 (3.94), and 30.00 (4.16) out of 33, respectively. There was no significant difference between the three sections ( p  = 0.864).

This action research study showed that the blended CCE for nursing students is feasible and, depending on the conditions and objectives, evaluation stations can be designed and implemented virtually or in person.

The blended exam, combining in-person and virtual elements, managed to address some of the weaknesses of entirely virtual exams conducted in previous terms due to the COVID-19 pandemic. Given the pandemic conditions, the possibility of performing all in-person stations was not feasible due to the risk of students and evaluators contracting the virus, as well as the need for prolonged quarantine. Additionally, to meet the staffing needs of hospitals, nursing students needed to graduate. By implementing the blended exam idea and conducting in-person evaluations at clinical stations, the assessment of nursing students’ clinical competence was brought closer to reality compared to the entirely virtual method.

Furthermore, the need for human resources, station setup costs, and time spent was less than the entirely in-person method. Therefore, in pandemics or conditions where sufficient financial resources and human resources are not available, the blended approach can be utilized.

Additionally, the evaluation results showed that students’ total and overt anxiety in both virtual and in-person sections of the blended CCE did not differ significantly. However, the overt anxiety of female students in the virtual section and male students in the in-person section was considerably higher. Nevertheless, students’ covert anxiety related to personal characteristics did not differ in virtual and in-person exam sections. However, students’ acceptance and satisfaction in the in-person section were higher than in the virtual and blended sections, with a significant difference. The acceptance and satisfaction of faculty members from the CCE in in-person, virtual, and blended sections were the same and relatively high.

A blended CCE nursing competency exam was not found in the literature review. However, recent studies, especially during the COVID-19 pandemic, have designed and implemented this exam using virtual OSCE. Previously, the CCE was held in-person or through traditional OSCE methods.

During the COVID-19 pandemic, nursing schools worldwide faced difficulties administering clinical competency exams for students. The virtual simulation was used to evaluate clinical competency and develop nursing students’ clinical skills in the United States, including standard videos, home videos, and clinical scenarios. Additionally, an online virtual simulation program was designed to assess the clinical competency of senior nursing students in Hong Kong as a potential alternative to traditional clinical training [ 31 ].

A traditional in-person OSCE was also redesigned and developed through a virtual conferencing platform for nursing students at the University of Texas Medical Branch in Galveston. Survey findings showed that most professors and students considered virtual OSCE a highly effective tool for evaluating communication skills, obtaining a medical history, making differential diagnoses, and managing patients. However, professors noted that evaluating examination techniques in a virtual environment is challenging [ 32 ].

However, Biranvand reported that less than half of the nursing students believed the in-person OSCE was stressful [ 33 ]. At the same time, the results of another study showed that 96.2% of nursing students perceived the exam as anxiety-provoking [ 1 ]. Students believe that the stress of this exam is primarily related to exam time, complexity, and the execution of techniques, as well as confusion about exam methods [ 7 ]. In contrast to previous research results, in a study conducted in Egypt, 75% of students reported that the OSCE method has less stress than other examination methods [ 9 ]. However, there has yet to be a consensus across studies on the causes and extent of anxiety-provoking in the OSCE exam. In a study, the researchers found that in addition to the factors mentioned above, the evaluator’s presence could also be a cause of stress [ 34 ]. Another survey study showed that students perceived the OSCE method as more stressful than the traditional method, mainly due to the large number of stations, exam items, and time constraints [ 7 ]. Another study in Egypt, which designed two stages of the OSCE exam for 75 nursing students, found that 65.6% of students reported that the second stage exam was stressful due to the problem-solving station. In contrast, only 38.9% of participants considered the first-stage exam stressful [ 35 ]. Given that various studies have reported anxiety as one of the disadvantages of the OSCE exam, in this study, one of the outcomes evaluated was the anxiety of final-year nursing students. There was no significant difference in total anxiety and overt anxiety between students in the in-person and virtual sections of the blended Clinical Competency Examination. The overt anxiety was higher in male students in the in-person part and female students in the virtual section, which may be due to their personality traits, but further research is needed to confirm this. Moreover, since students’ total and overt anxiety in the in-person and virtual sections of the exam are the same in resource and workforce shortages or pandemics, the blended CCE is suggested as a suitable alternative to the traditional OSCE test. However, for generalization of the results, it is recommended that future studies consider three intervention groups, where all OSCE stations are conducted virtually in the first group, in-person in the second group, and a blend of in-person and virtual in the third group. Furthermore, the results of the study by Rafati et al. showed that the use of the OSCE clinical competency exam using the OSCE method is acceptable, valid, and reliable for assessing nursing skills, as 50% of the students were delighted, and 34.6% were relatively satisfied with the OSCE clinical competency exam. Additionally, 57.7% of the students believed the exam revealed learning weaknesses [ 1 ]. Another survey study showed that despite higher anxiety about the OSCE exam, students thought that this exam provides equal opportunities for everyone, is less complicated than the traditional method, and encourages the active participation of students [ 7 ]. In another study on maternal and infant care, 95% of the students believed the traditional exam only evaluates memory or practical skills. In contrast, the OSCE exam assesses knowledge, understanding, cognitive and analytical skills, communication, and emotional skills. They believed that explicit evaluation goals, appropriate implementation guidelines, appropriate scheduling, wearing uniforms, equipping the workroom, evaluating many skills, and providing fast feedback are among the advantages of this exam [ 36 ]. Moreover, in a survey study, most students were satisfied with the clinical environment offered by the OSCE CCE using the OSCE method, which is close to reality and involves a hypothetical patient in necessary situations that increase work safety. On the other hand, factors such as the scheduling of stations and time constraints have led to dissatisfaction among students [ 37 ].

Furthermore, another study showed that virtual simulations effectively improve students’ skills in tracheostomy suctioning, triage concepts, evaluation, life-saving interventions, clinical reasoning skills, clinical judgment skills, intravenous catheterization skills, role-based nursing care, individual readiness, critical thinking, reducing anxiety levels, and increasing confidence in the laboratory, clinical nursing education, interactive communication, and health evaluation skills. In addition to knowledge and skills, new findings indicate that virtual simulations can increase confidence, change attitudes and behaviors, and be an innovative, flexible, and hopeful approach for new nurses and nursing students [ 38 ].

Various studies have evaluated the satisfaction of students and faculty members with the OSCE Clinical Competency Examination. In this study, one of the evaluated outcomes was the acceptability and satisfaction of students and faculty members with implementing the CCE in blended, virtual, and in-person sections, which was relatively high and consistent with other studies. One crucial factor that influenced the satisfaction of this study was the provision of virtual justification sessions for students and coordination sessions with faculty members. Social messaging groups were formed through virtual and in-person communication, instructions were explained, expectations and tasks were clarified, and questions were answered. Students and faculty members could access the required information with minimal presence in medical education centers and time and cost constraints. Moreover, with the blended evaluation, the researcher’s communication with participants was more accessible. The written guidelines and uploaded educational content of the workshops enabled students to save the desired topics and review them later if needed. Students had easy access to scientific and up-to-date information, and the application of social messengers and Skype allowed for sending photos and videos, conducting workshops, and questions and answering questions. However, the clinical workshops and examinations were held in-person to ensure accuracy. The virtual part of the examination was conducted through online software, and questions focused on each station’s clinical and practical aspects. Students answered various questions, including multiple-choice, descriptive, scenario, picture, and puzzle questions, within a specified time. The blended examination evaluated clinical competency and did not delay these individuals’ entry into the job market. Moreover, during the severe human resource shortage faced by the healthcare system, the examination allowed several nurses to enter the country’s healthcare system. The blended examination can substitute in-person examination in pandemic and non-pandemic situations, saving facilities, equipment, and human resources. The results of this study can also serve as a model to guide other nursing departments that require appropriate planning and arrangements for Conducting Clinical Competency Examinations in blended formats. This examination can also be developed to evaluate students’ clinical performance.

One of the practical limitations of the study was the possibility that participants might need to complete the questionnaires accurately or be concerned about losing marks. Therefore, in a virtual session before the in-person exam, the objectives and importance of the study were explained. Participants were assured that it would not affect their evaluation and that they should not worry about losing marks. Additionally, active participation from all nursing students, faculty members, and staff was necessary for implementing this plan, achieved through prior coordination, virtual meetings, virtual group formation, and continuous reflection of results, creating the motivation for continued collaboration and participation.

Among other limitations of this study included the use of the Spielberger Anxiety Questionnaire to measure students’ anxiety. It is suggested that future studies use a dedicated anxiety questionnaire designed explicitly for pre-exam anxiety measurement. Another limitation of the current research was its implementation in nursing and midwifery faculty. Therefore, it is recommended that similar studies be conducted in nursing and midwifery faculties of other universities, as well as in related fields, and over multiple consecutive semesters. Additionally, for more precise effectiveness assessment, intervention studies in three separate virtual, in-person, and hybrid groups using electronic checklists are proposed. Furthermore, it is recommended that students be evaluated in terms of other dimensions and variables such as awareness, clinical skill acquisition, self-confidence, and self-efficacy.

Conducting in-person Clinical Competency Examination (CCE) during critical situations, such as the COVID-19 pandemic, is challenging. Instead of virtual exams, blended evaluation is a feasible approach to overcome the shortages of virtual ones and closely mimic in-person scenarios. Using a blended method in pandemics or resource shortages, it is possible to design, implement, and evaluate stations that evaluate basic and advanced clinical skills in in-person section, as well as stations that focus on communication, reporting, nursing diagnosis, professional ethics, mental health, and community health based on scenarios in a virtual section, and replace traditional OSCE exams. Furthermore, the use of patient simulators, virtual reality, virtual practice, and the development of virtual and in-person training infrastructure to improve the quality of clinical education and evaluation and obtain the necessary clinical competencies for students is recommended. Also, since few studies have been conducted using the blended method, it is suggested that future research be conducted in three intervention groups, over longer semesters, based on clinical evaluation models and influential on other outcomes such as awareness and clinical skill acquisition self-efficacy, confidence, obtained grades, and estimation of material and human resources costs. This approach reduced the need for physical space for in-person exams, ensuring participant quarantine and health safety with higher quality. Additionally, a more accurate assessment of nursing students’ practical abilities was achieved compared to a solely virtual exam.

Data availability

The datasets generated and analyzed during the current study are available on request from the corresponding author.

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Acknowledgements

We want to thank the Research and Technology deputy of Smart University of Medical Sciences, Tehran, Iran, the faculty members, staff, and officials of the School of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran, and all individuals who participated in this study.

All steps of the study, including study design and data collection, analysis, interpretation, and manuscript drafting, were supported by the Deputy of Research of Smart University of Medical Sciences.

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RM. Participating in study design, accrual of study participants, review of the manuscript, and critical revisions for important intellectual content. TT : The investigator; participated in study design, data collection, accrual of study participants, and writing and reviewing the manuscript. AM: Participating in study design, data analysis, accrual of study participants, and reviewing the manuscript. All authors read and approved the final version of the manuscript.

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This action research was conducted following the participatory method. All methods were performed according to the relevant guidelines and regulations in the Declaration of Helsinki (ethics approval and consent to participate). The study’s aims and procedures were explained to all participants, and necessary assurance was given to them for the anonymity and confidentiality of their information. The results were continuously provided as feedback to the participants. Informed consent (explaining the goals and methods of the study) was obtained from participants. The Smart University of Medical Sciences Ethics Committee approved the study protocol (IR.VUMS.REC.1400.011).

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Mojtahedzadeh, R., Toulabi, T. & Mohammadi, A. The design, implementation, and evaluation of a blended (in-person and virtual) Clinical Competency Examination for final-year nursing students. BMC Med Educ 24 , 936 (2024). https://doi.org/10.1186/s12909-024-05935-9

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Real-world effectiveness of influenza vaccine against medical-attended influenza infection during 2023/24 season in Ili Kazakh Autonomous Prefecture, China: A test-negative, case-control study

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• 1 School of Public Health, Xinjiang Medical University, Urumqi, China.
• 2 Ili Kazakh Autonomous Prefecture Center for Disease Control and Prevention, Ili Kazakh Autonomous Prefecture, China.
• 3 CUHK SZRI, Shenzhen, China.
• 4 JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.
• 5 School of Public Health, Zhejiang University, Hangzhou, China.
• 6 School of Public Health, Tianjin Medical University, Tianjin, China.
• 7 Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin Medical University, Tianjin, China.
• 8 MoE Key Laboratory of Prevention and Control of Major Diseases in the Population, Tianjin Medical University, Tianjin, China.
• 9 The Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
• 10 Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, China.
• 11 School of Public Health, Capital Medical University, Beijing, China.
• 12 Key Laboratory of Special Environment and Health Research in Xinjiang, Xinjiang Medical University, Urumqi, China.
• PMID: 39208849
• PMCID: PMC11364069
• DOI: 10.1080/21645515.2024.2394255

In the post-COVID-19 pandemic era, influenza virus infections continuously lead to a global disease burden. Evaluating vaccine effectiveness against influenza infection is crucial to inform vaccine design and vaccination strategy. In this study, we recruited 1120 patients with influenza-like illness (ILI) who attended fever clinics of 4 sentinel hospitals in the Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China, from January 1 to April 7, 2024. Using a test-negative design, we estimated influenza vaccine effectiveness (VE) of 54.7% (95% CrI: 23.7, 73.1) against medical-attended influenza infection, with 62.3% (95% CrI: 29.3, 79.8) against influenza A, and 51.2% (95% CrI: 28.7, 83.0) against influenza B. Despite the moderate VE estimated in this study, influenza vaccination remains the most important approach to prevent influenza at the community level.

Keywords: Influenza virus; influenza-like illness; test-negative study; vaccine effectiveness.

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• National immunization advisory committee (NIAC) technical working group (TWG), influenza vaccination TWG. Zhonghua Liu Xing Bing Xue Za Zhi. 2023;44(10):1507–6. - PubMed
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• Tenforde MW, Patel MM, Lewis NM, Adams K, Gaglani M, Steingrub JS, Shapiro NI, Duggal A, Prekker ME, Peltan ID, et al. Vaccine effectiveness against influenza A(H3N2)-associated hospitalized illness: United States, 2022. Clin Infect Dis. 2023;76(6):1030–7. - PMC - PubMed
• Feng L, Zhang T, Wang Q, Xie Y, Peng Z, Zheng J, Qin Y, Zhang M, Lai S, Wang D, et al. Impact of COVID-19 outbreaks and interventions on influenza in China and the United States. Nat Commun. 2021. [accessed 2021 May 31];12(1):3249. doi:10.1038/s41467-021-23440-1. - DOI - PMC - PubMed
• Zeng X, Xie Y, Yang X, Peng Z, Tang J, Yang L, Lin S, Han J, Zhang Y, Wang D, et al. SARS-CoV-2 surveillance through china influenza surveillance information system—China, December 1, 2022 to February 12, 2023. China CDC Wkly. 2023;5(7):152–8. doi:10.46234/ccdcw2023.027. - DOI - PMC - PubMed
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Guideline on writing a case report

Basim saleh alsaywid.

1 Department of Surgery, King Abdulaziz Medical City, Ministry of National Guard, Jeddah, Saudi Arabia

2 Department of Research Unit, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia

Nada Mansour Abdulhaq

3 Department of Pediatric, Rabigh Branch, King Abdulaziz University, Jeddah, Saudi Arabia

4 Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia

Research is an important competency that should be mastered by medical professionals. It provides an opportunity for physicians to develop numerous skills including communication, collaboration, time management, and teamwork. Case report, as a research design, describes important scientific observations that are encountered in a clinical setting to expand our knowledge base. Preparing a case report is far easier than conducting any other elaborative research design. Case report, with its main components, should be focused and delivers a clear message. In this article, the key components of a case report were described with the aim of providing guidance to novice authors to improve the quality of their reporting.

INTRODUCTION

“The best teaching of medicine is that taught by the patient himself” is a famous statement by William Osler which describes the opportunities we have as physicians to learn from our encounters with patients.[ 1 ] This learning experience, based on the observation of clinical cases, can be transferred to others, locally, nationally, and internationally, through communication and reporting. A case report is the first effort for many doctors, and other health professionals to convey a message to the entire medical profession by the means of specialized journal and remain essential to the art of medicine.[ 2 ] The purpose of the case report is to expand our knowledge on clinical manifestation, diagnostic approach, or therapeutic alternative of a disease, ultimately, to improve the quality of care provided to our patients. A case report that is worth reading should, therefore, contain both practical and educational messages.[ 3 , 4 ]

The clinical case report has been an integral part of medical literature throughout history. The oldest example of a preserved clinical case in medical literature is a text from an ancient Egyptian papyrus dating from the 16 th to the 17 th dynasty, 1600 BC, addressing the management of dislocated jawbone.[ 5 ] From Hippocratic case histories, “Epidemics” 400 BC, through Galenic case reports, in the second century AD, case reports were usually used to tell other doctors or colleagues about interesting cases they have encountered. Muslim scholars have reported case histories as well, particularly, Abu Bakr Mohamed Ibn Zakariya Al-Razi (865–929 AD), where he left a large collection of case reports in his 25-volume medical encyclopedia “Kitab Al-Hawi.”[ 5 ]

Those case histories were not a publication but rather a documentation or a message between the medical professionals, and it is usually kept in their records. Case reports have now been developed and accepted as a scholarly publication to disseminate knowledge to a wide medical audience.

GENERAL PRINCIPLES OF CASES REPORT

The case report is a research design where an unexpected or novel occurrence is described in a detailed report of findings, clinical course, and prognosis of an individual patient, which might be, but not mandatory, accompanied by a review of the literature of other reported cases. Although case reports are considered the lowest in the hierarchy of evidence-based practice in the medical literature [ Figure 1 ], it provides essential information for unfamiliar events and shared individual experiences, for better understanding and optimizing patient care. This approach might generate an idea or hypothesis, but it will not be confirmed unless we conduct further confirmatory quantitative experimental or observational study designs such as clinical trials or cohort studies. Despite that, case report provides the medical community with information which cannot be picked up by any other designs. Just to name a few, in 1819, James Parkinson published a case report entitled “An essay on the shaking palsy”[ 6 ] and lead to the discovery of Parkinson's disease. And in 1981, a case report was published in the literature as “Preliminary communication on extensively disseminated Kaposi sarcoma in a young homosexual man”[ 7 ] few years later, HIV from this case report was discovered. Furthermore, in 2012, Ali Zaki reported an article in New England Journal of Medicine titled “Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia” which ultimately, lead to the discovery of Middle East Respiratory Syndrome Coronavirus.[ 8 ] All those previous examples show how important is case report in the advancement of medical practice. The case report might be in the tail of the hierarchy of evidence-based medicine but if properly selected and appropriately reported it might stand a better chance of publication in high impact journals than even a clinical trial.

Hierarchy of evidence base medicine

Some scientist classifies case reports as a qualitative study design, others might consider it a quantitative approach or even a mixed method design.[ 9 ] This polarization of the case report is unfair. However, if we have to categorize it; when we consider all research approaches in medicine, it can be classified into exploratory or confirmatory; then, case reports definitely will be considered an exploratory research approach. Case report can be classified as a single case report, two case reports or case series, which aggregate more than two cases in a report. Case reports are usually retrospective by nature, however, it can be prospectively designed, for example, applying a new diagnostic or management approach or guideline of a particular health condition to discover new cases.[ 10 ]

Cases deemed appropriate for a publication are listed in Table 1 .[ 3 ] Despite these restrictive criteria, any case report could have a reasonable chance of publication even if it was not novel, as long as it was authentic, lead to an incremental advance in medicine or carries an educational value.

Criteria for published case report

STAGES IN PREPARING A CASE REPORT

The source of case reports is clinical setting, every single patient is a potential case report therefore, always keep an eye on unusual cases in your practice either in the ward or in the clinic. Once a potential case is identified, and the patient is in hospital, follow him through hospitalization until discharge. Give the case an appropriate time frame in the course of the disease to observe the development over time. Wait for 6 months during multiple visits, before you start writing a case report to allow adequate time to complete the clinical course.

Once you have a potential case, how would you know if this is an appropriate for reporting or not? Especially if you are a novice physician, once you encounter a possible case and you are suspecting if this patient fulfills one of those criteria which are described in Table 1 . The first step is a high index of suspicion; keep your eyes open for every case, once you suspect a case then ask your colleagues either directly or in a group related to the same discipline, locally, to confirm that this could be a case report. The next step would be asking an expert from the national or international medical community about this case scenario, get their opinion and feedback, including the appropriateness of reporting this case. Once the feedback is positive, perform extensive literature search, through PubMed, Embase, Google Scholar, and databases for case reports to ensure that you retrieve all available information on this topic. Do not forget to look at popular case reports which are not indexed in PubMed and read through previously published case reports that will enhance your understanding of the subject and gives you a general scaffold to prepare your own report.

Once the decision was made to report this case, obtain an informed consent from the patient; otherwise, it will not be accepted for publication. Moreover, take a permission from consultant in-charge of the case before writing your report.

Once you have reviewed the literature and improved your knowledge on the topic, use the patient's note to record the key points in history, examination findings, relevant data results and interpretation, treatment (including operational findings), and outcomes. Delete all patients’ personal information, identifiers or contact detailed from the prepared report, including the radiological or histopathological images before you copy them into your article. Save the prepared report on a password protected hospital computer.

The last step would be checking the journal which is most appropriate for your case report. Those journals provide you with the required criteria and appropriate format to prepare your report, to enhance their acceptability for publication. Many journals are interested in published case reports, but not all. In 2007, the first case report journal was created “Journal of Medical Case Reports” since then, the interest raised and many other journals dedicated for case reports were created including a specific database for all case reports are aggregated and continuously updated from several publishers.[ 3 ]

FORMAT FOR WRITING A CASE REPORTS

The word count for case report may vary from one journal to another, but generally should not exceed 1500 words, therefore, your final version of the report should be clear, concise, and focused, including only relevant information with enough details.[ 3 ] If a shorter version is required by the journal, then you can always edit or trim off the discussion section of your article. The general format adopted for most case reports is detailed in the following subsection and summarized as a checklist in Table 2 .

Checklist for writing a case report

This is the most commonly read part of your article; therefore, it should be relevant, concise, informative, descriptive, and appealing enough to attract readers to your report. It is placed in the first page of the manuscript, but some journal might request you to specify a separate file from the manuscript, labeled as a “title page” file. In preparing the title, avoid unnecessary words, wordplay, double meaning, cute wording, and never uses abbreviations in the title. It is always advisable to add “case report” in your title. Beneath the title, list all authors and their affiliations on the same page including their E-mails account. Most of the case reports are not prepared by a single author, but it should not exceed more than six authors; otherwise, the journal might not accept your case report for publication. Finally, under the subsection of corresponding author, assign one author to communicate with the journal and include all details of communication, such as institutional address, E-mail, and phone numbers.

Who should be the corresponding author? Any person who will submit the article to the journal to get the feedback from the editor of the journal and should be one of the article's authors.

It is the most important part of your article as it will be freely accessible for others to read when retrieved from any medical databases during the relevant search. However, it is the last part written in your article. It should include a brief summary that gives a general idea of the content of the case report. It should not include any references or abbreviations and should not exceed 350 words, preferably <250 words. Check your journal instructions for a detailed guideline on word counts. The abstract is usually arranged into three subsections: background, case presentation, and conclusion. The background should clarify the importance of reporting such a unique case. Afterward, a brief description of the clinical scenario of the patient listing only the important details. Finally, the conclusion should be brief with lesson learned and impact on the interested group.

This is quite important for indexing your article, and it should be from three to ten words, and you should be very careful in your selection, as it would help in retrieving your paper during the search.

Introduction

In this section, the definition and brief description of the pathology, including common presentations and disease progression is discussed, explaining the background of the selected topic. Followed by a brief description of what is about to be reported and the importance of reporting such case. The content should be clear, focused, concise, and attract the reader's attention and interest.

Case presentation

Provide a clear picture of the patient's condition and presentation, and it is best presented in chronological order with sufficient detail and explanation. Describe the relevant demographic information of the patient censoring any details that could lead to the patient being identified. Start with the current medical condition and primary complaint with detailed history including relevant family history, occupational and social history, medication, and allergy. Findings of physical examination should be briefly reported with all relevant investigation, laboratory results and images, and its analysis. Describe the differential diagnosis and the rational of the management approach, including follow-up results and final diagnosis. Avoid any extensive interpretation or defense for the approach you took. This section can be broken up into small subsections if needed, and it should be supplemented with necessary images and tables to facilitate reader's understanding of the case.

Probably, this is an optional section, but it is preferable if reported, as it would explain more of your rational and approach with added additional relevant information about the uniqueness of this case. Compare your findings with what is known in the literature and why you think this case is different. Only discuss what is relevant to your case and do not provide any unproven and unsupported speculation. Acknowledge and explain any ambiguity or unexpected features occurred even if it is contradicting your concept. Explain how this case would contribute to the literature and suggest justifiable recommendations.

The section should include a concise and brief statement, explaining the importance and relevance of your case and it should relate to the purpose of the paper.

Patient's perspective

This new section is an optional, but it adds a new dimension to your paper, as it gives the chance to patients with their own perspective to write and describe their experiences throughout the disease process. Make sure that any patient's identifiers are removed, and his identity is managed appropriately with confidentiality, removing all irrelevant information to the case report.

Before submission, make sure that the patient gave his informed consent for publication, and statement indicating that should be clearly narrated in the report. You do not need to send the consent form on submission, but it should be available if requested. In case of the child, the parent or legal guardian should be consented instead, and if the child is a teenager then both patient and his parent should be consented. Many journals will not proceed with the peer review process unless a statement like “written informed consent was obtained from the patient for publication” is clearly stated. This statement could be in a separate section, as indicated here, or within the content of the report. If the patient is incapacitated or deceased, obtain the consent from the next-of-kin, and this should be stated clearly in the report. If the patient is deceased and next-of-kin is unreachable, you should exhaust all reasonable attempts to obtain the consent. If you fail, then you should state that in your report. If the patient is still alive but unreachable and you did not obtain the consent, do not bother publishing the case.[ 3 ]

Competing of interest

In this mandatory part, all authors should disclose any financial competing interest. If none, then, a statement like “the authors declare that they have no competing interests” should be clearly stated.

Author contribution

In this section, you need to credit all individuals who made a substantial contribution to the production of this study. Criteria of qualification to be an author should be strictly followed and explicitly stated for each author, separately. The first criterion is being a part of the conceptual development, data acquisition or analysis, then involvement in drafting part of the manuscript, and finally approving the final version of the manuscript. If those criteria are not fulfilled, then those individuals should be acknowledged in the next section. Be cautious from excessive authorship as this might lead to rejecting your article.

You need to mention around 15 references if possible, and few of them should be within the past 5 years, but do not exceed more than 25 references.

Cover letter

This is an optional supplementary document, addressed to the editor-in-chief, in a formal letter. Explain why this report is important and why it should be published in this journal.

JOURNAL EVALUATION FOR A CASE REPORT

Writing a case report varies from one physician to another, depending on the expertise of the author who prepared the report. This variation is influenced by many factors ranging from the author's knowledge base to his writing skills. The Peer review process will detect this variation to assure the quality of reporting through critical appraisal. It will assess the report, provide a valuable, supposedly constructive, feedback and helps the editor in a decision regarding the publication. This assessment should be as objective as possible to reach an unbiased decision. Therefore, several schemes were formulated to evaluate the quality of the case report. One of which is the Piersons 5-component scheme which relays on five major components, each component is scored from 0 to two, with a possible total score of 10 and lowest score of zero. The five major components are uniqueness, documentation, interpretation, objectivity, and educational value.[ 11 ] If the calculated score is more than 8, then this report is worth publishing. A score from 6 to 8, indicate possible publication with caution about validity. Any score <6, indicate the insufficient quality of the case report. Further details about this evaluation scheme are explained in Table 3 .

Matrix of case report evaluation

The calculated total score: Score of 9-10: Excellent report and most likely will add new information to the medical literature, Score of 6-8: Can be published but reader should be caution of validity and clinical value, Score of 5 or Less: Report is considered inadequate and inappropriate for publication

Case report remains an important source of information and common method in knowledge dissemination among physicians due to its simplicity in design. It will continue providing new research ideas through hypotheses generation. Finally, as I commenced my article with William Osler, I will end by quoting his other famous statement…. “Always note and record the unusual…. Publish it, place it on permanent record as a short, concise note. Such communication is always of value.”

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Acknowledgment

You need to mention and acknowledge the source of the research fund if any. Moreover, acknowledging all people who helped you, supervised you, or assisted you in finalizing this report, if they are not fulfilling the criteria to be an author.

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Polygenic Risk Scores and Twin Concordance for Schizophrenia and Bipolar Disorder

• 1 Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China
• 2 Med-X Center for Informatics, Sichuan University, Chengdu, China
• 3 Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
• 4 Department of Clinical Sciences, Psychiatry, Umeå University, Umeå, Sweden
• 5 College of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada
• 6 Department of Psychology, Yale University, New Haven, Connecticut
• 7 Departments of Genetics and Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill

Question   Is genetic risk for bipolar disorder and schizophrenia (psychosis) associated with twin concordance for these disorders?

Findings   In this case-control study including 146 pairs of twins from the Schizophrenia and Bipolar Twin Study in Sweden and 21 356 pairs of twins from the Swedish Twin Registry, polygenic risk scores for psychosis (ie, schizophrenia or bipolar disorder) were associated with case status and twin concordance, although concordance did not depend on zygosity.

Meaning   Using the natural experiment of twins, results suggest that genetic liability carries predictive power for psychosis, even in a small sample.

Importance   Schizophrenia and bipolar disorder are highly heritable psychiatric disorders with strong genetic and phenotypic overlap. Twin and molecular methods can be leveraged to predict the shared genetic liability to these disorders.

Objective   To investigate whether twin concordance for psychosis depends on the level of polygenic risk score (PRS) for psychosis and zygosity and compare PRS from cases and controls from several large samples and estimate the twin heritability of psychosis.

Design, Setting, and Participants   In this case-control study, psychosis PRS were generated from a genome-wide association study (GWAS) combining schizophrenia and bipolar disorder into a single psychosis phenotype and compared between cases and controls from the Schizophrenia and Bipolar Twin Study in Sweden (STAR) project. Further tests were conducted to ascertain if twin concordance for psychosis depended on the mean PRS for psychosis. Structural equation modeling was used to estimate heritability. This study constituted an analysis of existing clinical and population datasets with genotype and/or twin data. Included were twins from the STAR cohort and from the Swedish Twin Registry. Data were collected during the 2006 to 2013 period and analyzed from March 2023 to June 2024.

Exposures   PRS for psychosis based on the most recent GWAS of combined schizophrenia/bipolar disorder.

Main Outcomes and Measures   Psychosis case status was assessed by clinical interviews and/or Swedish National Register data.

Results   The final cohort comprised 87 pairs of twins with 1 or both affected and 59 unaffected pairs from the STAR project (for a total of 292 twins) as well as 443 pairs with 1 or both affected and 20 913 unaffected pairs from the Swedish Twin Registry. Among the 292 twins (mean [SD] birth year, 1960 [10.8] years; 158 female [54.1%]; 134 male [45.9%]), 134 were monozygotic twins, and 158 were dyzygotic twins. PRS for psychosis was higher in cases than in controls and associated with twin concordance for psychosis (1-SD increase in PRS, odds ratio [OR], 2.12; 95% CI, 1.23-3.87 on case status in monozygotic twins and OR, 2.74; 95% CI, 1.56-5.30 in dizygotic twins). The association between PRS for psychosis and concordance was not modified by zygosity. The twin heritability was estimated at 0.73 (95% CI, 0.30-1.00), which overlapped with the estimate in the full Swedish Twin Registry (0.69; 95% CI, 0.43-0.85).

Conclusions and Relevance   In this case-control study, using the natural experiment of twins, results suggest that twins with greater inherited liability for psychosis were more likely to have an affected co-twin. Results from twin and molecular designs largely aligned. Even as illness vulnerability is not solely genetic, PRS carried predictive power for psychosis even in a modest sample size.

Read More About

Song J , Pasman JA , Johansson V, et al. Polygenic Risk Scores and Twin Concordance for Schizophrenia and Bipolar Disorder. JAMA Psychiatry. Published online August 28, 2024. doi:10.1001/jamapsychiatry.2024.2406

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