The case study approach

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  • 1 Division of Primary Care, The University of Nottingham, Nottingham, UK. [email protected]
  • PMID: 21707982
  • PMCID: PMC3141799
  • DOI: 10.1186/1471-2288-11-100

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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  • Data Interpretation, Statistical
  • Research Design*
  • Research Report
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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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N2 - 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.

AB - 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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AU - Sheikh, Aziz

N2 - 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.

AB - 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.

U2 - 10.1186/1471-2288-11-100

DO - 10.1186/1471-2288-11-100

M3 - Article

C2 - 21707982

SN - 1471-2288

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

The case study approach

S. Crowe , K. Cresswell , A. Robertson + 3 more authors

Jun 27, 2011

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Key Takeaway : The case study approach offers in-depth exploration of complex issues in real-life settings, with advantages and disadvantages, and a checklist to help assess the quality of health-related case study reports.

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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  • Published: 10 November 2020

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 ,
  • Benjamin Hanckel 5 &
  • Sara Shaw 1  

BMC Medicine volume  18 , Article number:  301 ( 2020 ) Cite this article

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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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crowe et al the case study approach 2011

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This chapter reviews the strengths and limitations of case study as a research method in social sciences. It provides an account of an evidence base to justify why a case study is best suitable for some research questions and why not for some other research questions. Case study designing around the research context, defining the structure and modality, conducting the study, collecting the data through triangulation mode, analysing the data, and interpreting the data and theory building at the end give a holistic view of it. In addition, the chapter also focuses on the types of case study and when and where to use case study as a research method in social science research.

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Channaveer, R.M., Baikady, R. (2022). Case Study. In: Islam, M.R., Khan, N.A., Baikady, R. (eds) Principles of Social Research Methodology. Springer, Singapore. https://doi.org/10.1007/978-981-19-5441-2_21

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  • Published: 22 June 2023

Assessing safe and personalised maternity and neonatal care through a pandemic: a case study of outcomes and experiences in two trusts in England using the ASPIRE COVID-19 framework

  • Sarah Neal 1 ,
  • Lucy Stone 2 ,
  • Gill Moncrieff 3 ,
  • Zoë Matthews 1 ,
  • Carol Kingdon 3 ,
  • Anastasia Topalidou 3 ,
  • Marie-Clare Balaam 3 ,
  • Sarah Cordey 3 ,
  • Nicola Crossland 4 ,
  • Claire Feeley 5 ,
  • Deborah Powney 6 ,
  • Arni Sarian 7 ,
  • Alan Fenton 8 ,
  • Alexander E P Heazell 9 ,
  • Ank de Jonge 10 ,
  • Alexandra Severns 11 ,
  • Gill Thomson 4 &
  • Soo Downe 3  

BMC Health Services Research volume  23 , Article number:  675 ( 2023 ) Cite this article

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The COVID-19 pandemic has resulted in profound and far-reaching impacts on maternal and newborn care and outcomes. As part of the ASPIRE COVID-19 project, we describe processes and outcome measures relating to safe and personalised maternity care in England which we map against a pre-developed ASPIRE framework to establish the potential impact of the COVID-19 pandemic for two UK trusts.

We undertook a mixed-methods system-wide case study using quantitative routinely collected data and qualitative data from two Trusts and their service users from 2019 to 2021 (start and completion dates varied by available data). We mapped findings to our prior ASPIRE conceptual framework that explains pathways for the impact of COVID-19 on safe and personalised care.

The ASPIRE framework enabled us to develop a comprehensive, systems-level understanding of the impact of the pandemic on service delivery, user experience and staff wellbeing, and place it within the context of pre-existing challenges.

Maternity services experienced some impacts on core service coverage, though not on Trust level clinical health outcomes (with the possible exception of readmissions in one Trust). Both users and staff found some pandemic-driven changes challenging such as remote or reduced antenatal and community postnatal contacts, and restrictions on companionship. Other key changes included an increased need for mental health support, changes in the availability and uptake of home birth services and changes in induction procedures. Many emergency adaptations persisted at the end of data collection. Differences between the trusts indicate complex change pathways. Staff reported some removal of bureaucracy, which allowed greater flexibility.

During the first wave of COVID-19 staffing numbers increased, resolving some pre-pandemic shortages: however, by October 2021 they declined markedly. Trying to maintain the quality and availability of services had marked negative consequences for personnel. Timely routine clinical and staffing data were not always available and personalised care and user and staff experiences were poorly captured.

Conclusions

The COVID-19 crisis magnified pre-pandemic problems and in particular, poor staffing levels. Maintaining services took a significant toll on staff wellbeing. There is some evidence that these pressures are continuing. There was marked variation in Trust responses. Lack of accessible and timely data at Trust and national levels hampered rapid insights. The ASPIRE COVID-19 framework could be useful for modelling the impact of future crises on routine care.

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Introduction

The impact of COVID-19 on maternal health care has been both profound and complex. As well as the direct impact of infections on maternal and newborn outcomes [ 1 ] evidence is still emerging about the changes in access to care resulting in indirect impacts [ 2 ], and the various social and economic consequences [ 3 ]. Throughout much of the world, including the UK, the pandemic led to changes in access and quality of care because of specific policy decisions, pressure on services, and alteration in user behaviour due to concerns about infection risk.

There is increasing evidence on how COVID-19 has affected the delivery of reproductive care globally. Many services deemed “non-essential” were postponed or curtailed to reduce transmission and the strain on struggling health systems e.g. access to contraception and abortion were disrupted, particularly in low and middle-income countries [ 4 ]. A UK survey found that the majority of responding maternity organisations reduced the number of antenatal care (ANC) and postnatal (PN) contacts, using remote alternatives to face-to-face appointments [ 5 ]. Widespread restrictions were placed on companionship during ANC appointments, birth and the PN period [ 6 ].These changes resulted in poor care and distress for women [ 7 ]. Kotlar et al. [ 4 ] raised concerns that the pandemic resulted in changes to maternity services without evidence of benefit, and that some of these changes negatively impacted the health and rights of women, including reduced emotional support during pregnancy and labour, and reduced post-partum hospital stays.

However, there was marked heterogeneity in how these changes were introduced, as well as in the impacts both between and within countries. To date, there have been no studies of impacts at a system-wide level. The ASPIRE COVID-19 project, initiated in July 2020, was designed to examine what makes maternity and neonatal care safe and personalised in a pandemic, and beyond. The focus on “safe and personalised” reflects UK Government policy which is articulated in the “Better Births” National Maternity Review Report’s call for maternity care to focus on personalised care that priorises safety, continuity and the empowerment of women [ 8 ]. paper aims to develop a coherent and comprehensive understanding at the English National Health Service (NHS) provider level regarding the processes and outcomes of changes in safe and personalised maternity care before and during the COVID-19 pandemic. We present two case studies from separate health trusts (an NHS trust is an organisational unit within the National Health Services of England and Wales, generally serving either a geographical area or a specialised function and set up to provide goods and services for the purposes of the health service) and compare changes to resources, service delivery and outcomes that occurred before and during the pandemic to date. We applied a conceptual framework to the case studies designed to understand how COVID-19 (or indeed any other potential health system shock both within the UK and globally) impacts safe and personalised maternity care.

Methodology

Use of a case study methodology.

Crowe et al. (2011) state that a case study methodology is “a research approach used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context,” which fits within the aim of our research. The method offers the opportunity to explore a phenomenon, policy, or situation from a range of perspectives. These characteristics make them popular for health systems research, which requires the analysis of multiple factors from the viewpoints of different stakeholders which can be placed over time within a changing context [ 9 , 10 ], which again fits with our objectives. A case study has five key stages: defining the case, identifying the case, collecting and analysing the data, interpreting data and reporting the findings [ 9 ].

We used a mixed-methods organisational case study approach drawing on qualitative and quantitative data to triangulate our findings and provide greater depth and scope; total reliance on qualitative material would mean there was no possibility to include objective measures of change in service delivery and outcomes, whereas quantitative data alone would lead to areas being missed where no indicators were available, and an inability to explore the drivers and pathways of change and impacts on stakeholders. Our approach is essentially descriptive, with the purpose to describe a phenomenon in its real-world context. Adequate integration is key to an effective mixed-methods case study, and we adopted a convergent design where the qualitative and quantitative data were extracted and analysed during a similar timeframe (although the qualitative data had been collected earlier in 2021). Based on Stake’s definitions of case study purpose we suggest that our studies are defined as instrumental in that we use them to gain a broader appreciation of the impact of COVID-19 on the delivery of maternity care by trusts in England, but there is also a collective element as we compare data from both trusts to provide wider insights [ 9 ].

Applying a conceptual framework for data analysis

The case study analysis was structured around the ASPIRE trust-level conceptual framework (see Fig.  1 ) which was one of the wider outputs from the ASPIRE COVID-19 project. This framework was developed as an iterative process. Initial work drew on the growing literature on the impact of COVID-19 on health services, and led a temporal framework outlining the maternal health processes and outcomes that could be influenced by the pandemic. This was augmented by earlier work within the ASPIRE COVID-19 project that included thematic analysis of interviews across the seven trusts, interviews with national policy makers, survey analysis and analysis of policy documents, which enabled a more detailed framework which established pathways of potential impact [ 6 , 11 , 12 , 13 ].

figure 1

Conceptual framework for analysing the impact of COVID-19 (and other crises) on safe and personalised care

The framework suggests a starting point of the pre-pandemic baseline, and then a flow from inputs through to processes and health and wellbeing outcomes for both staff and service users. Directional arrows suggest paths of influence, and the possible influence of policy changes on demand, processes and outcomes are included. It is designed to be adapted to other future crises, or for analysis and development of routine maternity and neonatal care. Use of a framework provides a clear structure for comparing the two trusts. Each component of the framework was expanded and illustrated with trust-level data from the two case studies.

As part of the wider ASPIRE COVID-19 there was an attempt to define the components of safe and personalised care. Our initial starting point drew from how NHS England defined personal and safe care in March 2020 [ 14 ] as:

Implementing best practice care, such as that set out in the Saving Babies’ Lives Care Bundle

Rolling out Continuity of Carer

Working as a multi-disciplinary team across maternity and neonatal services

Reviewing and learning from incidents

Taking part in the Maternity and Neonatal Safety Improvement Programme

Ensuring women are supported to make decisions about their care and that these are recorded in a Personalised Care and Support Plan

Making Maternity Digital Care Records available to all women

Working towards 75% of Black and Asian women receiving Continuity of Carer by 2024, along with women living in the most deprived areas.

A further literature review using the National Maternity Review Report [ 8 ] as a starting point fed into a round table discussion with members of the ASPIRE COVID-19 stakeholder group, who represent leaders and policy makers in maternal health care from a range of backgrounds. These discussions fed into the development of the framework, as well as the process for choosing variables.

Case study trust selection: defining and identifying the cases

The two NHS organizations are part of seven NHS maternity providers within England included in the wider ASPIRE COVID-19 project. These seven trusts were identified through a sampling plan that ensured diversity, depth and breadth of the target population. The sampling plan drew on macro-level factors known to impact maternal health (e.g. deprivation, ethnicity), meso-level factors according to health service organisation (Care Quality Commission – CQC-rating, facilities), and micro level factors such as parity.

Trust A is located in the north of England. It manages around 4,500 births each year across three sites. It services a mixed socio-economic population, with some areas among the top 25 most deprived in the country, while others are much more socially advantaged. Less than 1% of the population are from ethnic minorities. In 2018 Trust A had a CQC rating of “requires improvement.” Trust B is in the Midlands and manages around 2,500 -3,000 births a year, so smaller than Trust A. It is an area of low deprivation with around 7% of the population from ethnic minorities. Conversely this trust had a 2018 CQC rating of “outstanding,” providing a strong contrast. Neither trusts had level three neonatal intensive care provision. Both organisations were chosen for the case study because they were able to provide at least some timely and high-quality clinical and service-related quantitative data (there were difficulties accessing quantitative data for several the other trusts). These two trusts represent geographic, and to some extent socio-economic diversity, but we acknowledge these are not representative of UK maternity providers as a whole.

Collecting and analysing the data

The case studies draw on both quantitative and qualitative data from a range of sources. trusts were requested to provide data on key quantitative indicators from routinely collected data. As there is no agreed list of variables to measure safe and personalised care, a list was identified through an initial analysis of key documents, in particular the National Maternity Review report which introduced these concepts into NHS policy [ 8 , 15 ] and was also informed by the stakeholder discussions described earlier. They were then reviewed with the research staff taking part in ASPIRE COVID-19 at trust level to establish which indicators were accessible and available (see Appendix 1 ). The data were requested from the beginning of 2018 to allow an understanding of pre-pandemic trends, but was not always available for the full period.

Other quantitative data were taken from:

The Family and Friends test [ 16 ]: a short, anonymous survey designed to help service providers gather user’s views on the service.

Safe Staffing data [ 17 ]: Trusts are required to publish information about the number of registered and non-registered nursing staff and midwives working on each ward, as well as the percentage of shifts meeting ‘safe staffing’ guidelines.

UK Government data on COVID-19 incidence [ 18 ]: These were taken from the official UK government website for data and insights on coronavirus

NHS data on COVID-19 hospital admissions [ 19 ]. This was based on data compiled monthly.

For the qualitative component, 30 in-depth interview transcripts (half from each trust) from service users and staff were randomly sampled from 96 in-depth interviews undertaken in the included trusts as part of the wider ASPIRE COVID-19 study between March 2021 and October 2021. These semi-structured interviews explored the views and experiences of service users and staff across all levels of the maternity and neonatal services in relation to the organisational response during the pandemic. Interviews were sampled for pragmatic reasons related to time and resources, with one in three transcripts chosen from the ungrouped data repository for each trust until the required number were reached. Sampling was not based specifically on achieving data saturation as we were not undertaking an inductive analysis, but looking for processes and experiences that could explain components in the ASPIRE model or direct the quantitative analysis, or that might contextualise the quantitative findings. However, 30 interviews were chosen as while the issue is deeply contested, this is frequently suggested as sufficient for supplying sufficient depth [ 20 ].

Full details of the methodology for the qualitative data collection can be found in Appendix 2 . Of these transcripts, 17 were from service users and 13 were from staff, with a total of eight staff being at managerial level. Transcripts were analysed to gain insight into experiences and perspectives relating to the changes and impacts of the pandemic, for both staff and service users. Additionally, we gathered documentary evidence from Board Reports and trust communications outlining changes in policies and practice.

Quantitative variables and findings from the qualitative interviews and documents were mapped against the conceptual framework. Quantitative data were analysed over time using appropriate graphic methods (line and bar graphs), and notable trends were recorded. Qualitative and documentary data sources were used to triangulate trends and identify information gaps, as well as identify discord and concurrence.

Interpreting and reporting the findings

Findings were shared within the team (including those involved in collecting the qualitative data), and with wider members of the stakeholder group and research staff within the two trusts to discuss possible interpretations. Each case study was written up separately in report format to enable the first draft of the manuscript to compare findings from the two trusts.

Our findings are structured under sub-headings that relate to components of the framework in Fig.  1 .

Inputs: demand and need for maternity services in case study trusts

A crisis can directly change the level of need by changing the number of service users, intensity or type of services required. In the case of COVID-19, this may be either through the need to care for COVID-positive women within the maternity health care system or through the need for protective measures to prevent the spread of infection.

Direct changes in need: COVID-19 incidence and admissions

An examination of monthly bookings and births, as well as the booking profiles by parity and decile, found there was no evidence of any change in demand for services occurring in either trust. We were unable to acquire information on the number of women testing positive for COVID-19 within the maternity health system, but analysis of regional incidence data and trust admission data enabled us to map the waves of the pandemic for both trusts (see Fig.  2 ). At the beginning of the pandemic, cases and admissions were fairly low in the locality of both case studies (although cases are subject to under-reporting because of a lack of testing services). After the first wave, there were then two spikes in cases, between August 2020 and February 2021 with a concurrent increase in COVID-19 admissions that peaked in January – February 2021. Following a dip in cases in March and April 2021, cases then increased again and remained high up to the end of September 2021, but in this wave hospital admissions did not rise so markedly. These data give some indication of when stresses are likely to be greatest on the health system, both in terms of cases, which will affect both the need for measures to reduce transmission and possible staff sickness and admissions that will increase demand on the hospital infrastructure.

figure 2

COVID-19 regional infection rates (7-day rolling rate per 100,000) and hospital admission numbers

Indirect need: mental health concerns

A crisis can also produce indirect changes to the need for services. For instance, during the COVID-19 pandemic, there was a documented increase in intimate partner violence [ 21 ] and a risk of increased mental health concerns [ 22 ]. Both trusts acknowledged these increased risks in communications and guidelines provided to staff, but there were no data to track the incidence of domestic violence. Data were, however, available for both trusts related to mental health concerns at booking, and referral at any time during pregnancy to mental health services (see Figs.  3 and 4 ). Trust A shows a marked and consistent increase in reported mental health concerns (from a very low baseline) to a height of around 50% at the end of 2020. Referrals to mental health services at any time during the pandemic also increased from mid-2019. Trust B however, demonstrated no change in reported mental health concerns, and a decline in referrals.

figure 3

Percentage of bookings with mental health concerns, 2-month rolling average for Trusts A and B

figure 4

Number of women referred for mental health concerns after booking 2-month rolling average

As it is unlikely there will be such marked differences between regions in mental health and wellbeing, it is likely that to some extent patterns reflect the way midwives identify women with mental health concerns and the availability of specialist referral facilities. The increased identification and referral in Trust A could be due to strong perinatal mental health services in Trust A, which appears to have prioritised this area. Maternal anxiety was described in the qualitative data for both trusts. Trust B did acknowledge the issue since they introduced a system through which inpatients could indicate if they wished to talk about anxieties or concerns.

Inputs: resources

The COVID-19 pandemic saw rises in staff sickness and self-isolation and redeployment in both trusts. Data from the safe staffing datasets (which provides information on actual staff hours worked versus those estimated as required) for both trusts showed that before the pandemic in Trust A there was already a staff shortfall for registered midwives, while for trust B this was much less marked. Both trusts saw an increase in staffing for registered midwives in the early phase of the pandemic (see Fig.  5 ), which may reflect the national drive to increase the NHS workforce at that point. In Trust A, the increased staffing levels continued until around the end of 2020 (although the increase was inconsistent), but then reverted to pre-pandemic levels before summer 2021, subsequently falling further.

figure 5

Data for registered midwives (combined for day and night staff and across sites) fill rate: actual staff as % of planned staff for Trusts A and B

In Trust B there was a shorter period of increased staffing (March-June 2020) before returning to pre-pandemic levels, and then figures showed a marked decrease from June 2021 onwards. Data for non-registered staff (e.g., support workers) was more inconsistent, particularly for Trust B (possibly due to small numbers not shown), but Trust A again showed a marked decrease in staffing from around June 2021. No data were available on trends in other health professionals.

Although the quantitative data suggest a more concerning situation in Trust A, the qualitative data from both trusts highlighted the negative impact of staff shortages. Several responses from Trust A acknowledged that staffing was a long-term problem pre-pandemic and not specific to the COVID-19 situation:

I think, to be quite honest, the pandemic’s come at a time when we were probably at a national shortage of midwives. We had stress before. Eighteen months ago, we were short of staff. So, you know, so even probably before the pandemic hit, I think we were short of staff. So, it just cemented it even more, really, I think the unit was run on goodwill, and I think to a degree, it still is. Health care provider, Trust A.

While Trust B’s staffing figures may not have looked too concerning until mid-2021, the qualitative evidence suggests that staffing levels were maintained at some individual cost to health care providers who felt morally obliged to work more hours than they wanted, with detrimental effects on their mental wellbeing:

“I can remember walking into work literally in tears thinking, what am I doing going in here? You know, I'm retired. I shouldn't be coming in. You know, I'm bank [temporary staff]. I shouldn't really be working here. But I also knew from a, from the point of view of staffing, having been the coordinator, how you reliant on your bank, everybody to turn up (…). So, I felt a moral obligation to come in and I do enjoy going to work but of recent I do feel very anxious because again, because of the staffing …” Health care provider, Trust B.

When asked what is needed to ensure safe and personalised maternity care in the future, most respondents said that the answer lies in safe staffing. Interview data indicate that women also noted the low staffing levels, particularly on the postnatal ward.

Access to resources

Beyond staffing levels, concern with excessive bureaucracy was reported as a way to free up time to care for front-line care providers and to create conditions for system agility e.g. making resources available without spending excessive time negotiating opaque organisational systems or being denied requested resources altogether. A reduction in bureaucracy early on in the pandemic was one of the few positive factors raised across several sites in the wider ASPIRE study, which meant they could rapidly access resources that had previously been tied up in ‘red tape’. Streamlined processes meant they could access equipment needed, quickly and easily:

“We bought, we used every resource we had. So, and actually, what was quite liberating at the beginning was everything was, you can have the resources there, you can have this, you can have it, whatever you need to preserve life, you can have (…). And actually we have the permission to do that, how we always want to run the service, you know, and that was quite liberating. And, you know, you weren’t questioned because it was like, if that's what you need.” Manager, Trust B.

Processes and outputs for safe and personalised care

In terms of the framework, changes in demand/need and resourcesare likely to directly impact on the processes and outputs for safe and personalised care. However, changes in policy and guidelines either at national or provider level may also, in turn, bring about more structured changes in delivery of care such as new advice on criteria for interventions or restrictions on birthing options. Changes in processes and output are hypothesised to affect access, acceptability, quality and delivery of care across antenatal, intrapartum and PN care. Our case studies produce a wealth of information on a range of components of care in line with the framework. Here, we focus on summarising key findings that illustrate the pathways to change.

Processes of ANC

In the case of ANC, both Trusts implemented policies to carry out some contacts remotely. Neither seemed to set a particular target for the proportion that should be remote, although Trust B produced advice about which visits could be remote and Trust A published public-facing guidance saying appointments would be remote where possible. Available data suggest that the percentage of appointments delivered remotely was low in both trusts: the highest proportion of remote contacts in any month was 12% in Trust A and around 10% for Trust B.

Possibly more importantly than the way services were accessed, the percentage of women who received fewer than six ANC contacts (the minimum recommended by the Royal College of Midwives) increased in both trusts, with a revised and reduced schedule of ANC introduced in Trust B (although still with a recommended minimum of over six visits).

As the pandemic progressed, in Trust A the patterns show an increase in the percentage of women experiencing less than six ANC contacts in the months after the start of the first wave (see Fig.  6 ). This percentage then decreased, whereas in Trust B (which had a much higher percentage of women receiving less than six ANC contacts than Trust A) there is a steady increase in the percentage of women receiving less than 6 ANC contacts before the start of the pandemic, followed by a sharp increase in the percentage of women receiving a lower number of ANC contacts from September 2021. This suggests that the number of ANC contacts may have been reducing in Trust B before the pandemic. Changes in Trust B may be less related to changes made in service delivery as initial responses to the pandemic, but the ongoing crisis may have exacerbated a situation already in existence. There was no clear pattern of change for gestational age at first booking for either trust.

figure 6

Percentage of women having less than 6 ANC contacts as % of all births, 2-month rolling average

It should be highlighted that here the routinely collected quantitative data contrasts with the experiences and perspectives of service users and staff. The interview data suggest that many women experienced remote appointments, particularly at the beginning of the pandemic, and that some staff were significantly concerned about the impact of this on both the psychological and physical health of service users. Interviews with both staff and service users in the trusts indicated a feeling that this potentially reduced the quality of service and raised levels of anxiety, and, along with fewer ANC contacts, raised concerns about problems not being adequately detected.

All of it is over telephone conversation and it isn’t unheard of, even at 16-weeks they still haven’t seen their midwives and they’re coming through at twenty-four, twenty-eight weeks, having not seen an actual midwife, only had a virtual contact. When you speak to the patient for them, for some of them who've had babies before they go, oh, it’s very different, but for those new mums, first-time mums find it’s difficult. They are quite anxious, the not knowing and because obviously it's all new, it makes it very difficult for them. Health care provider, Trust B. I had less face-to-face appointments with midwives. It was telephone appointments or just a couple of face-to-face. I wasn't able to go and look around the hospital to see the labour ward or anything like that, all I could do was look on the website. But I would say it was more like, I couldn't really go and hear the baby's heartbeat. I think it was that, it was that lack of face-to-face contact with the midwife team that I found the saddest. Service user, Trust B.

Home births

Choice of place of birth is integral to persoinalised care. In terms of home birth, the policy responses of the two trusts played out differently. In both trusts overall numbers of home births were low, but in Trust A the initial response was to suspend home births for several months. However, they were reinstated after pressure from service users:

I think if I remember correctly, we stopped the home birth. We stopped the home birth. And then there was a serious objection came from the patients. And then our senior management was questioning that decision because from a PPE [personal protective equipment], you know, thinking from a patient point of view, what they said is that home is safer than your hospital, so we want to deliver at home. So, if I remember correctly, I think we went back and said, it is OK, we will do it. But the initial reaction was to stop it. Manager, Trust A.

Trust B, however, actively promoted home births as safer in terms of infection control. As a result, the trust provided extra training and support to enable the increased and more seamless provision of their home birth service.

And we were saying, right, let’s suspend the home birth service …. suddenly our head of service said, hang on a minute, we need to turn this on its head. We need to, where's the safest place for people to be at home, so we need to keep them at home … … And so, then we decided actually let’s shift the priority. So, let’s… let’s … because what we actually did was expand our home birth service at that point. Manager, Trust A.

Quantitative trends are based on small numbers (monthly numbers per trust ranges from zero to nine across the period of study), but the data do demonstrate a cessation of home births for several months in Trust A followed by a modest increase, in contrast to a sharp increase from the outset of the pandemic in Trust B followed by a gradual decline (see Fig.  7 ). These differences occurred under the same national guidance, which recommended continuing all options for place of birth unless specific criteria of low staff or lack of availability of ambulance services were met [ 23 ].

figure 7

Actual number of home births in Trusts A and B, 2-month rolling average (actual numbers were used as were such a small proportion of overall births)

Induction of labour

Another example of diversity between the two trusts was the process of induction of labour, which clearly impacts both safety and personalization of care. Early in the pandemic the Royal College of Obstetricians and Gynaecologists issued guidance to avoid induction of labour “for indications that are not strictly necessary” [ 24 ]. Trust A showed a marked fall in inductions that may have been in response to this guidance, whereas Trust B shows a slight increase (see Fig.  8 ), which is supported by qualitative evidence from one interview suggesting some inclination to move births forward to protect vulnerable pregnant women from the increased risk they face from COVID-19.

Obviously, the third trimester was the point at which they were vulnerable. I wouldn’t say I was inducing earlier, but I would say and I don’t think I'm alone in this, but I think a lot of us had a mind-set that let's get them delivered and then they're no longer pregnant and their risk profile reduces, you know, because obviously the outcome, pregnant women on ICU were the worst. So, that was something I was very aware of, I wanted those women delivered. Health care provider, Trust B.

figure 8

Percentage of births started using induction (including attempted induction), 2 month rolling average

Postnatal care

Quantitative data for both trusts showed a reduction in the length of time women spent in hospital after the birth, with a decrease in stays over 48 h (see Fig.  9 ). This does not seem to be the result of a specific policy, but a combination of staff concerns over the risk of COVID-19 transmission and women discharging early, largely due to restrictions to partners being present. Staff raised this as a potential safety issue, and limited postnatal care clearly affected levels of personalization.

The staff obviously were very anxious about visitors on the ward. And, you know, in a bay of six once you have got another six partners and six babies your air exchange has completely gone down, and it was very difficult. We were often stuck between a rock and a hard place, you know, and the women didn’t want to stay in very long. So, we were worried about the impact of that you know, would the success of feeding be OK? You know, we kept thinking we were getting more wound infections, but we haven’t actually, you know, seen that evidence. it felt like we were getting a lot of people coming back in postnatally with problems but, you know, on audit, it doesn’t look like, you know, that was a correlation, although it felt like it. Manager, Trust B.

figure 9

Percentage of women who had a length of PN stay more than 48 h, 2 months rolling average

Women reported challenging experiences on the PN ward including reduced or restricted partner visits, a lack of support by staff and general confusion about what was going on in the ward.

If I could change anything, it would be once you’d have the baby. And I totally understand that with COVID, visitors can’t stay too long. But forget the visitors. I just think the care, I would make it so that I felt more looked after, more reassured, helped more with feeding. And just have that whole, it’s such a … nothing can prepare you for it. I thought “Oh, I know what to expect”. You just don’t and that there with this newborn life and you’re on your own, pandemic or not, you want people that are the professionals. And not make you feel like you’re an inconvenience and they haven’t got time for you, which is, I don’t think it’s any fault of their own. I think maybe they’re understaffed. But it wasn’t a positive experience afterwards, and it could have been so easily better. Service user, Trust B.

The number of PN contacts reduced in both trusts from a mean average of around six before the pandemic in Trust A to an average of 5.4 during the pandemic, whereas the median number of visits in Trust B fell from between six and seven pre-pandemic to five during the pandemic (although again there was evidence of reducing numbers pre-pandemic: see Fig.  10 ). In Trust A they rose somewhat after an initial sharp drop at the start of the pandemic but fell again in early 2021. It is worth mentioning that there was some uncertainty in what was meant by a “PN contact”: these numbers are greater than might be normally expected from community post-discharge contacts and suggest that contacts on the ward before discharge were also included which means these data should be interpreted with caution. However, as the mode of data collection is unlikely to have changed at this time it is not unrealistic to think that these trends represent a change, even if it is not possible to separate hospital and home- based contact. Increased reliance on phone contacts caused concern for both staff and service users.

So, they normally get a day three visit for feeding, to keep breastfeeding, and that was done over the phone. And the discharge visit is usually done over the phone now, which I think probably has impacted on our breastfeeding rates and readmission rates and infection rates. Service provider, Trust A.

figure 10

Number of PN contacts, mean for Trust A, median for Trust B, 2-month rolling average

Readmission to hospital

Fears about safety were raised by staff along with concerns about readmission: while an audit did not suggest any increase in readmission in Trust B, an analysis of the incident reports for Trust A showed a potential increase. Neonatal readmissions increased from approximately five reported incidents per quarter just before the start of the pandemic to 13 incidents in quarter two of 2020, remaining at an average of nine throughout 2020 (see Appendix 3 ). This coincides with the first wave of the pandemic, as well as a fall in PN care during the pandemic, reaching a maximum of eight reported incidents, up from an average of three just before the pandemic. However, as there were also obvious sharp increases in readmissions in 2018 (particularly for babies), this situation cannot be attributed with any certainty to the pandemic per se.

Companionship and neonatal visiting

Companionship is a key area of personalised care. For many women and healthcare professionals, one of the most impactful changes to maternity services were the restrictions on partners and other visitors throughout the maternity care journey. This was as a result of national and local policies [ 25 ], but these tended to be interpreted somewhat variably, particularly during birth. No quantitative data were available on this, but qualitative data graphically illustrated how women had to attend antenatal (AN) appointments, including scans, alone, which reportedly left their partners anxious and distanced from the experience.

Things like the scans and as well having a partner just missing from, he wasn’t part of the birth, apart from showing up at the end, for a couple of hours. You know, he wasn’t part of it, of the whole thing. But yeah, I think it had a huge effect. So things like my 12-week scan, that’s one thing that sticks heavily in my mind. I previously had miscarriages, so I’ve had two miscarriages in the past. My last time I’ve had a 12-week scan, I found out I was going to miscarry. So when I went to the scan and he wasn't allowed in and I just sat in tears with these complete strangers who were lovely and did their best. But they … they knew that they weren't what was actually needed in support terms. My partner was sat in the car park waiting for me. Service user, Trust A.

For consultant appointments in particular, women felt that they would have benefited from having their partners' input in decision-making, and to help them take in and process information. Although women reported concerns about not having their partners with them for labour, they did have companionship during the birth itself (although it wasn’t clear at what stage of labour this became possible).

Views on the impact of PN restrictions on visitors showed a division between users and staff. Some service users felt vulnerable and isolated without their partner there to support them emotionally and physically with their new baby. However, some staff members felt that reduced visiting on the PN ward had been beneficial to women, in terms of breastfeeding and bonding, and for staff, because they had fewer additional matters to attend to.

One participant described the difficulties her family experienced when their baby had to be admitted to the Special Care Baby Unit (SCBU) immediately following birth, whereby partner restrictions compounded the trauma of being separated from her baby, not knowing what condition she was in.

They said, well, you’ve got to go home now, and I was like, hang on a second, I’m like, you know, I can’t move, so I couldn’t go be with her. She was all alone, just born, in SCBU, awful. You know, oxygen, everything all over the place and all tubes and everything. And then [name] had to leave immediately and he had to go home and we were just, I couldn’t move. She was in SCBU like who knows what, we didn’t know yet what had happened to her. So we didn’t know she had [condition]. We didn’t know if she was going to recover, if she would die, like who knows, like we didn’t know. Service user, Trust B.

Changes in outcomes through the pandemic

In the framework, outcomes have been divided into maternal, fetal and neonatal mortality, morbidity and wellbeing, service user experience and staff wellbeing and safety. These can be influenced either through changes in the delivery of safe and personalised care, or more directly as a result of changes in demand and need: for instance, COVID-19 infection in pregnant women may lead to a high risk of poor outcomes even when quality of care is maintained.

At trust level, it is not realistic to examine trends in mortality for women and neonates as cases are rare, and these are not likely to be responsive quantitative indicators of changes in service quality unless conditions deteriorate to a catastrophic degree. There was no evidence of changes in gestational age at birth (although the data shows marked variability between months, making it difficult to ascertain trends). There was a possible slight reduction in babies with birth weights below 10% the last quarter of 2020, but this was quite unconvincing and could be a data anomaly. However, it is interesting to note that this trend has been found in national-level data in several countries including the UK [ 26 , 27 ]. It is notable that, as mentioned earlier, there were increases in readmission rates, as well as increases in the previously undiagnosed incidence of small for gestational age (SGA) in Trust A, which could potentially reflect shortcomings in PN support and ANC which may warrant further investigation (see Appendix 4 ).

User experience

There is little quantitative evidence on either user or staff experience. The Family and Friends test was suspended for most of 2020, and when reinstated uptake was low. Qualitative evidence suggests service user experiences were mixed. Positive experiences included instances where health professionals had time for women and where there was constant provision of information. The difference that the individual midwife, doctor or health visitor can make was notable, and there is clearly appreciation for staff who went “the extra mile” in the face of acknowledged constraints. Several service users, however, suggested that their care was more cursory and less personalised than with previous births.

So, you know, there was a lot of communication. I didn’t feel that that was missing or that because of COVID, that they didn’t have enough time to talk these things through with me. I felt, I do, I say this all the time, the care that I got what I would have expected, even if COVID wasn’t on. So, with all those extra steps in place, worked really well. Service user, Trust A.
I definitely wasn’t seen as often as I was with [name], that’s for sure. Yeah, it was very short and brief on the on the times you know, that we did. Yeah, I did see them basically, I remember when I had [name] there was a lot more in-depth like questions and going through things and measurements and all that kind of stuff, whereas this was like, are you OK? Yes. OK, let’s hear where baby is, brilliant, your urine’s fine, crack on off you go. So it was, yeah, it was much more kind of like in and out. Service user, Trust B.

Staff wellbeing and safety

Data are not routinely collected about staff wellbeing and safety. Information from Board reports, while not reported separately for maternal health staff, reported high proportions of staff sickness caused by depression, anxiety, and other mental health issues for both trusts as a whole. In April 2020 in Trust A it was the second most common cause of sickness, but by November 2020 it was the most common cause. It was again reported as the most common cause in May and November 2021.

In direct response to national concerns on the impact of the epidemic on health care workers, Trust A instituted several support mechanisms fairly early in the pandemic including individual wellbeing conversations, telephone helplines, opportunities for face-to-face counselling, an online portal with peer-to-peer and personal resilience support and bereavement counselling. However, the qualitative data suggest that staff in both trusts were struggling at the time of the qualitative interviews due to low staffing and the changing nature of their job. What is clear from the qualitative data is that staff continued to strive to provide safe and personalised care when they had the resources to do so, and some went above and beyond even without sufficient resources. However, this is not sustainable and does not provide individualised, person-centred care for the majority of women and their families.

I think, you know, from my point of view, I think our maternity services need to look on maternity. Bosses need to look at the providing of the staffing ratios per patient because I think you know the term, what is it now, making gold out of sows ear, you know comes to mind because you can’t give such a high standard of care with minimal staff, and I think, I can see it now more than before the staff are absolutely exhausted because working with all these PPE is tiring … And I think, you know, especially with young junior midwives that are not getting the support they need, they will burn out or leave the profession. And that’s what bothers me. Health care provider, Trust B. We need bums on seats because we never get to sit, particularly long, to be able to provide them and spend the extra time, happy face to face appointments, go to women’s houses, see who they are, be available to them rather than this need to get as many in, as many out as we can, because that’s all the time we’ve been given and, have those facilities to be able to them to get the scans when they need them and to be able to see their own midwife and things like that. I’m probably being idealistic, but that’s certainly not the job I wanted when I applied those years ago to be a midwife, I could be there and have a relationship with the women and the families and just make them feel that they were well looked after and that I care. Healthcare provider, Trust A.

This study demonstrates complex and wide-ranging, systems-level changes in demand and processes. It demonstrates limited changes in clinical outcomes, but marked changes related to user experience and staff wellbeing outcomes. It adds to the existing literature by looking more broadly at multiple factors across the maternal health system and documenting the breadth and implications of changes, as well as possible drivers and pathways through which change happened.

Continuation of services, but adaptation and change

Despite major challenges, mainstream maternity and neonatal services continued to be provided, although some adaptations caused challenges. Lack of strong evidence of poor physical outcomes to mother or baby could reflect that most indicators are unlikely to be responsive to relatively short-term changes as they measure rare events. However, it is also worth noting that the fact that staff consistently “went the extra mile” in extremely difficult circumstances [ 11 ] may have ensured that women continued to receive safe care.

Maintaining maternal health was often at considerable cost to staff, who were overstretched even before the pandemic. Qualitative interviews showed examples of women feeling that they had received excellent care, with staff going above and beyond what could be expected of them, and there was evidence that staff reported a strong sense of commitment and purpose. Clearly, however, there were areas where user experience was adversely affected, and services were adapted in ways that both users and staff found challenging. The key three areas for this were the move to remote AN contacts, reduced PN support (particularly in the home) and restrictions on companionship and neonatal visiting.

In contrast to the routine data, the incident reports from Trust A suggest a marked increase in undiagnosed SGA at this time. It is possible that introducing an intervention (such as remote ANC) aimed at promoting safety for service users and staff by reducing the risk of infection can carry other unforeseen risks that should be studied in more detail, and this should be a key area for further research. Similarly, adverse effects on PN care were seen, with concerns raised about the impact on breastfeeding and support more generally. This could be partly responsible for the increased PN admissions for both mothers and babies noted in Trust A’s incident reports (although we cannot provide evidence to support this), and again this could be a useful area for further research. The impact of the pandemic on PN care has been an under-researched area in the UK and requires more analysis. [ 28 , 29 ].

The importance of maintaining personalised care in maternity services, including during the pandemic, has been emphasised [ 29 ]. However, much of the negative feedback relates to a lack of personalisation, including in the user and staff interviews around companionship. There are concerns that restrictions on companionship during ultrasound scans, and in early labour are persisting in some trusts, even though the acute phase of the pandemic appears to be over. Such restrictive policies should be reviewed both now and in anticipation of future crises to ascertain the unintended consequences, and how best to create a balance between reducing infection (or other adverse events, depending on the crisis) and supporting women’s choices [ 30 ].

The changes to the way services were delivered were driven by national and trust policy, as well as individual or collective behaviour by health care staff (including management) and service user behaviour change and preference. This complexity may partly explain the difference in responses between the two trusts regarding some aspects of care provision, which is possible due to the level of autonomy given to trusts and practitioners in the UK. This is particularly notable for home births and inductions. One trust responded to national guidelines, while the other did not. These differences are reflected in a national study that found the majority of Trusts in the UK made no major changes to induction practices during the COVID-19 pandemic [ 31 ]. National evidence also confirms the temporary cessation of home births in many areas [ 5 ].

In many instances, changes made during the initial response to the crisis had not returned to the pre-pandemic situation by the end of our data series (late summer 2021). While trusts may still be facing specific challenges, it is imperative that adaptations such as restricting companionship or telehealth do not become the norm for future practice, just on the basis that they may make the delivery of services easier and/or more efficient for the organisation [ 32 ]. Any such changes require rigorous evaluation of negative implications, and a will for rapid de-implementation of processes that are no longer fit for purpose [ 13 ].

Magnification of existing challenges as well as the creation of new ones

One of the particular areas where challenges were identified was staffing. However, it is notable that staffing shortages had existed pre-epidemic, and at the start of the first wave of COVID-19 the situation actually improved, as staff came back from retirement, and the final year student workforce was mobilised. There continued to be no evidence of staffing shortages in the two trusts concerned during the second wave of COVID-19 in Autumn 2020, suggesting that short-term sickness was not impacting significantly on personnel. A marked decline started in May 2021, coinciding with an increase in COVID cases. This decline did not reverse when COVID cases reduced, suggesting that the resilience shown during the first year of the pandemic was wearing out. Both quantitative and qualitative data suggest a more sustained and deep-rooted declinethat is partly driven by the challenges staff have faced throughout the epidemic. Specifically the qualitative evidence points to increasing retirements and disillusionment as a continuation of an ongoing pattern entrenched before the pandemic. This concept of magnification has been a key finding of the ASPIRE COVID-19 project more broadly. It must also be acknowledged that midwifery shortfalls were occurring in the context of other staffing restrictions: the Royal College of Obstetricians and Gynaecologists highlight the widespread redeployment of both junior and senior Obstetricians and Gynaecologists as well as significant levels of absence due to sickness or vulnerability [ 33 ].

There were also known and deep-rooted problems with PN care pre-pandemic, that became magnified (and continued to deteriorate) during the pandemic period. Our data suggest that the number of PN visits was declining before the pandemic and this trend continued during the pandemic period. The lack of focus on personalised care found in the case study has also been widely critiqued pre-pandemic. The Friends and Family Test has been the main tool for gathering user feedback within the NHS but has been criticised as being generally inadequate [ 34 ]. However, even this poor system was suspended during most of 2020 due to the pandemic, and uptake has not reached anything like pre-pandemic levels now it has been reinstated.

Critique of the case study methodology for evaluating changes during crisis

The case study methodology enabled us to gather detailed information across time on the dynamic changes which can be compared across trusts. A strength of this study is the integration of quantitative and qualitative data, which allows different perspectives to be triangulated. Quantitative data were limited in some respects, particularly around indicators for personalisation (e.g., companionship). In many cases, the quantitative and qualitative findings complemented each other (e.g., reduction in PN support) but in a few areas, there was some discrepancy: the most notable was remote ANC contact, where quantitative data showed a very small proportion of contacts were not face-to-face meetings, while a number of qualitative comments indicated that face to face contact was perceived by service users to be very limited. This could reflect either a limitation in the quantitative data, or of the qualitative data, that may have highlighted particularly negative experiences or users who had an unusually high number of remote contacts. However, it must be recognised that the data from qualitative interviews may not be representative of users and care providers as a whole as it is based on those who volunteered to take part in the study, who may be a biased sample.

Generally, there were problems with identifying trends in routine data due to missing values, low numbers and general variability for some indicators. These problems were also identified in the other five trusts involved in ASPIRE COVID-19. In some cases, data were not available for a sufficient period before the pandemic to ascertain whether any changes were likely to be attributed to natural variation over time or COVID-related. In particular, there were far fewer data around personalisation than clinical outcomes and safety. Data on continuity of care and the implementation of personalised care packages are routinely collected and reported to the National Maternity Services Dataset but, inconsistency of reporting made this difficult to use.

User and staff experiences are not well represented in the quantitative data, and this is an issue found more widely in UK trusts. Their perspective is critical in understanding the impact of changes either directly or indirectly resulting from the pandemic. In particular, the consistent and regular collection of staff experience is vital in understanding potential deterioration in service delivery, as well as a decline in working conditions. With the current national maternity staff shortages, mechanisms must be set up to consistently collect feedback and act on staff experience, as well as gather their suggestions for service improvement.

Overall, the ASPIRE framework worked well as a method of structuring findings and allowing comparison. We suggest it could be a useful tool in understanding the impacts of shocks and crises on maternal health services more widely than the COVID-19 pandemic and could help structure studies of the impact of adverse events on service delivery, as well as improving routine care throughout the process.

The case study approach identified widespread direct effects how maternity care was delivered as a result of the pandemic. Deterioration of both AN and PN care, a lack of personalised care and restriction on birth companionship emerged in particular. The quantitative data suggest that problems were present pre-pandemic, leading to a magnification of effect once the crisis took hold. Changes to service uptake and delivery were influenced by national and trust guidelines, as well as staff and user behaviours. There were marked differences in the way the two trusts responded to some situations. Some adaptations introduced early in the pandemic were continued beyond the acute stage of the crisis, with a possibility that they may become the new norm. There were also some unexpected benefits such as easier and expedited procedures for procuring resources, that freed up staff time that was usually engaged in bureaucratic processes.

The impact on user experience could only really be identified from qualitative data as data tracking user experience were unavailable, or unreliable. Additionally, the effects on staff have been considerable. Even after the peak of the pandemic, staff continue to struggle and experience personal sacrifice, mainly due to low staffing and the changing demands of their jobs.

Results were obtained across the entire maternity and neonatal care provision spectrum in two trusts, based on a framework of possible pandemic effects. They suggest that services continued throughout the pandemic, albeit with adaptation and change, yet challenges that pre-dated the pandemic were magnified. This is clear evidence of the need for strong health system components to be in place before new crises and pandemics arise—especially related to staffing, staff and patient wellbeing, and data collection, review and response. Safe and personalised care can still be delivered, even in a crisis, but the stresses on the health infrastructure, especially on staff, should not be underestimated. The ASPIRE COVID-19 framework proved to be a valuable tool in structuring the extensive data gathered and mapping changes in different areas of service provision and may be useful in identifying and tracking changes in the delivery of safe and personalised care in future emergencies or crises, as well as in less critical situations.

Availability of data and materials

All relevant quantitative and qualitative data will be openly available from the UK Data Service’s online data repository ReShare. Digital object identifiers for each dataset will be provided on paper acceptance.

Abbreviations

Antenatal care

Care quality commission

National health service

Personal protective equipment

Small for gestational age

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Acknowledgements

The authors would like to particularly thank the Research Midwives in both trusts for their support in accessing and compiling routine data and documents. Furthermore, the authors acknowledge the invaluable input and advice of members of the ASPIRE COVID-19 collaborative group, and of the service users and staff who kindly gave their time to contribute to the study.

ASPIRE-COVID-19 Collaborative Group:

Co-investigators : Soo Downe; University of Central Lancashire (CI), George Ellison; University of Central Lancashire, Alan Fenton; Newcastle upon Tyne Hospitals NHS Foundation Trust, Alexander Heazell; University of Manchester, Ank de Jonge; Amsterdam University Medical Center, Carol Kingdon; University of Central Lancashire, Zoe Matthews; University of Southampton, Sarah Neal, University of Southampton; Alexandra Severns; NHS England and NHS Improvement North West, Gill Thomson; University of Central Lancashire, Anastasia Topalidou, University of Central Lancashire, Alison Wright; Royal Free Teaching Hospital, London.

Research staff: Naseerah Akooji; University of Central Lancashire, Marie-Clare Balaam; University of Central Lancashire, Jo Cull; University of Central Lancashire, Lauri van den Berg; Amsterdam University Medical Center, Nicola Crossland; University of Central Lancashire, Claire Feeley; University of Central Lancashire, Beata Franso; Amsterdam University Medical Center, Steph Heys; University of Central Lancashire, Gill Moncrieff; University of Central Lancashire, Rebecca Nowland; University of Central Lancashire, Arni Sarian; University of Central Lancashire, Lucy Stone; Swansea University.

Steering committee: Maria Booker; Birthrights, Jane Sandall; Kings College London, Jim Thornton (chair); the University of Nottingham, Tisian Lynskey-Wilkie; University of Central Lancashire, Vanessa Wilson; Lancashire and South Cumbria Local Maternity System.

Stakeholder group : Rebecca Abe and Tinuke Awe; FivexMore, Toyin Adeyinka; MVP BAME group, Ruth Bender-Atik; the Miscarriage Association, Lia Brigante; RCM, Rebecca Brione; Independent, Franka Cadée; International Confederation of Midwives, Elizabeth Duff; Expert, postnatal care, Tim Draycott; Royal College of Obstetricians and Gynaecologists, Duncan Fisher; fathers included/family included/the family initiative, Annie Francis; Independent Midwifery Advisor, Arie Franx; Erasmus MC, Lucy Frith; University of Liverpool, Louise Griew; National Maternity Voices, Clea Harmer; Sands, Caroline Homer; Burnet Institute, Australia, Marian Knight; National Perinatal Epidemiology Unit, Amali Lokugamage; Whittington Health NHS Trust/University College London, Amanda Mansfield; London Ambulance Service Trust, Neil Marlow; University College London, Trixie Mcaree; NHS England, David Monteith; Grace in Action, Keith Reed; Twins Trust, Yana Richens; UCL and City University, Lucia Rocca-Ihenacho; Midwifery Unit Network, Mary Ross-Davie; Royal College of Midwives Scotland, Seana Talbot; BirthWise NI, Myles Taylor; British Maternal and Fetal Medicine Society, Maureen Treadwell; Birth Trauma Association.

This research is funded by the Economic and Social Research Council, as part of UK Research and Innovation’s rapid response to COVID-19 [grant number ES/V004581/1]. Full details of the main study are available via Research Registry (researchregistry5911) and via UKRI Gateway ( https://gtr.ukri.org/projects?ref=ES%2FV004581%2F1 ).

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Sarah Neal & Zoë Matthews

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Gill Moncrieff, Carol Kingdon, Anastasia Topalidou, Marie-Clare Balaam, Sarah Cordey & Soo Downe

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Deborah Powney

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Arni Sarian

Newcastle Neonatal Service, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK

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Alexander E P Heazell

Department of Midwifery Science, AVAG/Amsterdam Public Health, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam, Netherlands

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Lancashire And South Cumbria Cardiac Network, Preston, UK

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Contributions

All authors were involved in developing the concept or planning the wider study from which the data is taken. SN wrote the first draft. LS carried out the quantitative analysis. GM extracted the qualitative data from the qualitative interviews. All authors commented on drafts and agreed the final draft. SD designed and oversaw the ASPIRE COVID-19 project, with AT, CK, MCB, NC, AdJ, GT, AS, AH, AF and ZM. AT was the project manager, and CK led the ASPIRE COVID-19 work package, from which the trust level data were taken. DP, GM, SC and CF arranged and undertook interviews, coordinated data collection with trusts, and managed the data.

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Correspondence to Sarah Neal .

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Ethics approval and consent to participate.

The study received Health Research Authority and Research Ethics Committee approval on 23rd October 2020 (IRAS285693). The application was fast-tracked for approval and assessed as under the scope of the COPI Notice. Individual trusts made their own priority assessment in accordance with the RESTART Framework or RECOVERY Framework. All interview participants provided informed consent, audio recorded using MS Teams and on an electronic consent form. We have endeavoured to protect participants’ anonymity and participating sites by removing identifying information from the data.

All methods were carried out in accordance with relevant guidelines and regulations along with ethical approval statement and informed consent to participation.

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Supplementary Information

Additional file 1:.

Appendix 1. Quantitative variables requested for the case study (not all were available in both Trusts).  Appendix 2. Methodological details for qualitative interviews. Appendix 3.  Number of reported readmissions of baby and mother based on incident reports (IR1s), quarterly totals for Trust A.  Appendix 4. Number of reported incidences of undiagnosed SGA, Trust A IR1s (three monthly average). 

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Neal, S., Stone, L., Moncrieff, G. et al. Assessing safe and personalised maternity and neonatal care through a pandemic: a case study of outcomes and experiences in two trusts in England using the ASPIRE COVID-19 framework. BMC Health Serv Res 23 , 675 (2023). https://doi.org/10.1186/s12913-023-09669-0

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The case study approach.

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  • Sheikh A | 0000-0001-7022-3056
  • Avery A | 0000-0001-7591-4438

BMC Medical Research Methodology , 27 Jun 2011 , 11: 100 https://doi.org/10.1186/1471-2288-11-100   PMID: 21707982  PMCID: PMC3141799

Abstract 

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The case study approach

Sarah crowe.

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

Kathrin Cresswell

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

Ann Robertson

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

Anthony Avery

Aziz sheikh.

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.

  • 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 ​ Tables1, 1 , ​ ,2, 2 , ​ ,3 3 and ​ and4) 4 ) and those of others to illustrate our discussion[ 3 - 7 ].

Example of a case study investigating the reasons for differences in recruitment rates of minority ethnic people in asthma research[ 3 ]

Example of a case study investigating the process of planning and implementing a service in Primary Care Organisations[ 4 ]

Example of a case study investigating the introduction of the electronic health records[ 5 ]

Example of a case study investigating the formal and informal ways students learn about patient safety[ 6 ]

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 ​ (Table5), 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.

Definitions of a case study

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 ​ (Table1), 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 ​ Tables2, 2 , ​ ,3 3 and ​ and4) 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 ​ (Table2) 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 ​ Tables2 2 and ​ and3, 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 ​ (Table4 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 ​ (Table6). 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 ].

Example of epistemological approaches that may be used in case study research

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 ​ Table7 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 ].

Example of a checklist for rating a case study proposal[ 8 ]

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table ​ (Table3), 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 ​ (Table1) 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 ​ Table3) 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 ​ (Table2 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 ​ (Table1 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 ​ (Table3 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 ​ (Table4 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 ​ Table3, 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 ​ (Table4), 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 ​ Table8 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 ​ (Table9 9 )[ 8 ].

Potential pitfalls and mitigating actions when undertaking case study research

Stake's checklist for assessing the quality of a case study report[ 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.

  • Competing interests

The authors declare that they have no competing interests.

  • Authors' contributions

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

  • Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2288/11/100/prepub

  • 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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Outcome Measurement Program Case Studies

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This case study (See Appendix C for study protocol) is one of a series aimed at understanding the components and procedures of HCBS outcome measurement tools to describe factors that strengthen or impede high fidelity implementation of a measurement program. Information learned from these case studies will be used to answer the following research questions: 

  • What methodological components need to be in place to ensure measure administration fidelity in the implementation of HCBS outcome measures?
  • What are the strengths and challenges of various outcome measurement (OM) programs, and how do these impact measure administration fidelities?
  • What are the similarities and differences in implementing various OM programs?
  • What factors, characteristics, or components of OM programs strengthen or deter effective outcome measurement of community living and participation programs (HCBS)?

Multiple Case Study Approach

A multiple case study approach was selected to enable the research team to use a holistic and integrated approach (Crowe et al., 2011; Yin, 1994) to understand how the HCBS OM tools are implemented in real-life contexts. The goal of these case studies was to assess if they are implemented as their designers intended, a concept described as “implementation fidelity” (Dusenbury et al., 2003, Carroll et al., 2007, Damschroder et al., 2009).  A series of case studies also allows researchers to compare and contrast implementation patterns across multiple types of HCBS OM tools (Crowe et al. 2011).  Past research demonstrates that the degree of implementation fidelity in the application of a program model is viewed as a potential moderating factor in how well a program achieves its desired goals or outcomes (Dusenbury, Brannigan, Falco, and Hansen, 2003; Schneider, 1998).   For this reason, researchers in recent decades have focused significant attention on implementation issues. The methods and theories on the relationship of implementation to program success have evolved considerably. 

The Consolidated Framework for Implementation Research (CFIR) was used for these case studies (Damschroder et al., 2009). The CFIR was derived through an analysis of implementation science research efforts that offer iterative steps toward standard terms and theories (Damschroder et al., 2009).  The CFIR provides a limited group of constructs supported by well-researched evidence tied to constructs of implementation effectiveness.  CFIR is intended to be used as a menu from which researchers can select constructs that are relevant to their proposed analysis, and the CFIR developers encourage users to adapt the framework as needed (Damschroder et al., 2009).

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  1. The case study approach

    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 ...

  2. The case study approach

    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 ...

  3. The case study approach

    (2011) Crowe et al. BMC Medical Research Methodology. 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 healt...

  4. (PDF) The Case Study Approach

    CS is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context (Crowe et al., 2011). It is extensively used in a wide ...

  5. The case study approach

    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 ...

  6. [PDF] The case study approach

    The case study approach. Based on the experiences of conducting several health-related case studies, a 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.

  7. PDF The case study approach

    case study is typically undertaken to learn about a unique phenomenon. The researcher should define the * Correspondence: [email protected] 1Division of Primary Care, The University of Nottingham, Nottingham, UK Full list of author information is available at the end of the article Crowe et al. BMC Medical Research Methodology 2011 ...

  8. The case study approach

    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 ...

  9. The case study approach

    Abstract. Abstract 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 ...

  10. The case study approach

    Key takeaway: 'The case study approach offers in-depth exploration of complex issues in real-life settings, with advantages and disadvantages, and a checklist to help assess the quality of health-related case study reports.'

  11. Case study research for better evaluations of complex interventions

    Case study research, as an overall approach, is based on in-depth explorations of complex phenomena in their natural, or real-life, settings. ... an exploration of the potential of case study research strategies. Palliat Med. 2011;25(8):774-81. Article Google Scholar ... Papoutsi, C. et al. Case study research for better evaluations of ...

  12. Methodology or method? A critical review of qualitative case study

    A postpositivist approach to case study involves developing a clear case study protocol with careful consideration of validity and ... (Creswell, 2013b; Crowe et al., 2011). Not all qualitative studies are reported in a consistent way and some authors choose to report findings in a narrative form in comparison to a typical biomedical ...

  13. Finding a path in a methodological jungle: a qualitative research of

    In contrast to experimental designs, which seek to test a specific hypothesis through manipulating the environment, the case study approach lends itself well to capturing information on more explanatory questions "how", "what", and "why" (Crowe et al., 2011). Case study research is an increasingly popular approach among qualitative ...

  14. PDF Case Study Research Defined

    The case study approach is particularly useful to employ when ... natural real-life context (Crowe et al., 2011). Case studies provide researchers with an opportunity for greater depth of ...

  15. Case Study

    Case study as an approach explore multifaceted issues like poverty, unemployment, illiteracy and other social, economic, personal, physical, and environmental problems (Crowe et al., 2011). Generally, case study is a detailed description of a person, group, organization, community or any kind of situation, and report of a real-life situation.

  16. Assessing safe and personalised maternity and neonatal care through a

    Crowe et al. (2011) state that a case study methodology is "a research approach used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context," which fits within the aim of our research. ... The case study approach identified widespread direct effects how maternity care was delivered as a result of ...

  17. Navigating data governance approvals to use routine health and social

    A case study approach was applied to the approvals process, to gain 'an in-depth, multifaceted understanding of a complex issue in its real-life context' (Crowe et al., 2011: 1). Such a case study is considered instrumental (aiding broader understanding of an issue) (Crowe et al., 2011) in that elements of this approvals process will be ...

  18. Experiences of Educational Researchers in the Use of the Case Study

    Theory (SCT; Crowe et al., 2011), the Interpretative approach (Stake, 1995) and from the Constructivist approach (Merriam, 1998). Due to the nature of this study, it focused on the experi-ences of educational researchers in usingacase studyapproach during the Covid-10 pandemic for knowledge creation.

  19. The Qualitative Case Study Research Strategy as Applied on a Rural

    However, the most commonly quoted definition in the methodology literature (e.g., Piekkari et al., 2009; Crowe et al., 2011; Schwandt & Gates, 2018; Lavarda & Bellucci, 2022) is the one by the other foundational writer, Yin (2018, p. 45), which says "a case study is an empirical inquiry that investigates a contemporary phenomenon in-depth and ...

  20. The case study approach.

    The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. ... In another example of an intrinsic case study, Hellstrom et al. ... Cresswell K, Takian A, Petrakaki D, Crowe S, Cornford T. et al.Prospective evaluation of the implementation and adoption of NHS Connecting for Health's ...

  21. Outcome Measurement Program Case Studies

    A multiple case study approach was selected to enable the research team to use a holistic and integrated approach (Crowe et al., 2011; Yin, 1994) to understand how the HCBS OM tools are implemented in real-life contexts. The goal of these case studies was to assess if they are implemented as their designers intended, a concept described as ...

  22. Case study research for better evaluations of complex interventions

    The case study approach is widely recognised as offering an invaluable resource for understanding the dynamic and evolving ... 2011; 101 (9) :1627-1634. doi ... Riley DS, Barber MS, Kienle GS, Aronson JK, Schoen-Angerer T, Tugwell P, et al. CARE guidelines for case reports: explanation and elaboration document. J Clin Epidemiol. 2017; 89:218 ...