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The Multiple Case Study Design

The Multiple Case Study Design

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Most organizations today operate in volatile economic and social environments and qualitative research plays an essential role in investigating leadership and management problems. This unique volume offers novice and experienced researchers a brief, student-centric research methods text specifically devoted to the multiple case study design.

The multiple case study design is a valuable qualitative research tool in studying the links between the personal, social, behavioral, psychological, organizational, cultural, and environmental factors that guide organizational and leadership development. Case study research is essential for the in-depth study of participants' perspectives on the phenomenon within its natural context. Rigorously designed management and leadership case studies in the extant literature have a central focus on individual managers' and leaders' stories and their perceptions of the broader forces operating within and outside their organizations.

This is a comprehensive methodology book exploring the multiple case study design with step-by-step and easily accessible guidelines on the topic, making it especially valuable to researchers, academics, and students in the areas of business, management, and leadership.

TABLE OF CONTENTS

Chapter 1 | 6  pages, a refresher on the philosophical foundations of academic research, chapter 2 | 6  pages, research methodologies, chapter 3 | 3  pages, the role of theory in qualitative research, chapter 4 | 6  pages, how does the novice researcher design a multiple case study, chapter 5 | 5  pages, the advantage of the multiple case study design for management researchers, chapter 6 | 6  pages, applying data collection methods in multiple case study research, chapter 7 | 9  pages, the data analysis process for multiple case study research, chapter 8 | 3  pages, extending theory with multiple case study design, chapter 9 | 7  pages, incorporating multiple case design and methodologies into teaching and professional practice, chapter 10 | 9  pages, writing and publishing multiple case study research, chapter 11 | 2  pages, concluding thoughts.

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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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Sarah Crowe & Anthony Avery

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

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

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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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Lifestyle Medicine Implementation in 8 Health Systems: Protocol for a Multiple Case Study Investigation

Meghan l ames.

1 Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States

Micaela C Karlsen

2 American College of Lifestyle Medicine, Chesterfield, MO, United States

Samantha M Sundermeir

Neve durrwachter, tyler a hemmingson, melissa m reznar.

3 School of Health Sciences, Oakland University, Rochester, MI, United States

Kara Livingston Staffier

Bruce weeks, joel gittelsohn, associated data.

In-depth interview guide.

Case study narrative outline.

The data presented in this study cannot be shared due to privacy concerns and the inability to adequately secure the identity of the participants.

Lifestyle medicine (LM) is the use of therapeutic lifestyle changes (including a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection) to prevent and treat chronic illness. Despite growing evidence, LM is still not widely implemented in health care settings. Potential challenges to LM implementation include lack of clinician training, staffing concerns, and misalignment of LM services with fee-for-service reimbursement, but the full range of factors facilitating or obstructing its implementation and long-term success are not yet understood. To learn important lessons for success and failure, it is crucial to understand the experiences of different LM programs.

This study aims to describe in depth the protocol used to identify barriers and facilitators impacting the implementation of LM in health systems.

The study team comprises team members at the American College of Lifestyle Medicine (ACLM), including staff and researchers with expertise in public health, LM, and qualitative research. We recruited health systems that were members of the ACLM Health Systems Council. From among 15 self-nominating health systems, we selected 7 to represent a diversity of geographic location, type, size, expertise, funding, patients, and LM services. Partway through the study, we recruited 1 additional contrasting health system to serve as a negative case. For each case, we conducted in-depth interviews, document reviews, site visits (limited due to the COVID-19 pandemic), and study team debriefs. Interviews lasted 45-90 minutes and followed a semistructured interview guide, loosely based on the Consolidated Framework for Implementation Research (CFIR) model. We are constructing detailed case narrative reports for each health system that are subsequently used in cross-case analyses to develop a contextually rich and detailed understanding of various predetermined and emergent topics. Cross-case analyses will draw on a variety of methodologies, including in-depth case familiarization, inductive or deductive coding, and thematic analysis, to identify cross-cutting themes.

The study team has completed data collection for all 8 participating health systems, including 68 interviews and 1 site visit. We are currently drafting descriptive case narratives, which will be disseminated to participating health systems for member checking and shared broadly as applied vignettes. We are also conducting cross-case analyses to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation, and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout.

Conclusions

This protocol paper offers real-world insights into research methods and practices to identify barriers and facilitators to the implementation of LM in health systems. Findings can advise LM implementation across various health system contexts. Methodological limitations and lessons learned can guide the execution of other studies with similar methodologies.

International Registered Report Identifier (IRRID)

DERR1-10.2196/51562

Introduction

Cardiovascular disease, diabetes, and other chronic illnesses (including mood disorders) continue to be the leading causes of morbidity and mortality in the United States [ 1 , 2 ]. An estimated US $4.1 trillion is spent annually on health care for individuals with chronic physical and mental health conditions [ 2 ]. Poor health behaviors, such as a less healthy diet, physical inactivity, and substance use, exacerbate these conditions and cost the United States an estimated US $1.3 trillion per year [ 3 ]. An estimated 75%-90% of chronic illnesses could be prevented by lifestyle modification [ 4 ].

Lifestyle medicine (LM) is a “medical specialty that uses therapeutic lifestyle interventions as a primary modality” to prevent, treat, and reverse chronic conditions [ 5 ]. This “evidence-based, whole-person, prescriptive lifestyle change” is built around 6 pillars: a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection [ 5 ]. These innovative and comprehensive approaches, especially those related to diet, have been shown to promote healthy weight, decrease the risk of type 2 diabetes, reduce cardiovascular risk factors, and improve quality of life [ 6 - 15 ]. Experts estimate US $116 billion could be saved annually through modest changes in health behavior and care delivery that result in improved treatment rates, increased physical activity, reduced smoking, and reduced obesity [ 16 ].

Interest in LM is growing, as evidenced by the rising membership of the American College of Lifestyle Medicine (ACLM), which increased by approximately 300% between 2018 and 2021 [ 17 ]. In 2017, the American Medical Association House of Delegates emphasized the importance of LM treatment by passing a resolution supporting providers to prescribe healthy lifestyle behaviors [ 18 ]. Despite these advances, adoption in clinical practice is slow [ 12 , 13 , 19 - 21 ], and additional research is needed to better understand the barriers and facilitators to implement this approach in health care settings [ 20 ].

The Consolidated Framework for Implementation Research (CFIR) is commonly referenced in the implementation science field to characterize factors that can influence the successful implementation of health services [ 22 ]. It includes 5 domains: intervention, inner setting, outer setting, individuals involved, and the implementation process. About 13% of the estimated 625 health systems across the United States are members of the ACLM Health Systems Council and are at varying stages of LM implementation [ 23 , 24 ]. Commonly, the inner setting of LM takes place within primary care and the general internal medicine environment, as well as medical specialties such as diabetes and oncology. Implementation processes and strategies can often extend across disciplines, such as the case with the modification of electronic medical records to prompt behavioral screening and referrals. Systematic implementation of LM faces various challenges, including inadequate leadership support and clinician training in the inner setting and patient preferences and reimbursement complexities in the outer setting [ 19 , 20 , 22 , 25 ]. A 2019 survey of ACLM members assessed respondents’ current practice of LM, including reimbursement, quality measures, and patient outcomes [ 26 ]. In reviewing findings (published elsewhere), ACLM leadership and consultants determined that greater critical richness and additional details could be achieved through a qualitative examination of a subset of US health care systems with LM programs.

ACLM’s mission calls for additional high-quality research, education, and advocacy to continue building evidence that LM should be more comprehensively implemented by US health care systems [ 27 ]. However, the current literature lacks documentation of the most effective implementation strategies to support LM practice. To address this gap, we are conducting a multi–health system case study to understand the factors that led to the development, growth, and maintenance of successful LM programs within health systems. Specific aims of Lifestyle Medicine Integration in Health Systems: A Case Study Project include: (1) examining in-depth 8 LM programs and constructing a detailed case narrative report for each system; (2) identifying factors influencing the initiation and growth of LM practices; and (3) describing common facilitators and barriers across health systems to the continued implementation of LM.

This paper outlines the study protocol, including case selection, data analysis, and dissemination of research findings. It will aid in interpreting study findings and advise the research execution of other studies that incorporate similar methodologies across various settings.

In response to a gap in the rich understanding of barriers and facilitators to implementing LM in health systems, the research team selected a qualitative research approach investigating multiple health systems as individual case studies. This multiple case study approach incorporates insights from multiple instances of the phenomenon of interest [ 28 , 29 ].

This paper describes the 8 steps used to conduct this research, as outlined in Table 1 . At the time of this writing, steps 1-5 have been completed and steps 6-8 are in progress.

Protocol steps for the Lifestyle Medicine Integration in Health Systems study.

StepActivityStatus
1Formation of the study teamComplete
2Selection of methodsComplete
3Recruitment and training of the study teamComplete
4Case study nomination and selectionComplete
5Iterative data collectionComplete
6Iterative preparation of case study narrativesIn progress
7Preparation of cross-case reportsIn progress
8Dissemination of findingsIn progress

a As of February 1, 2024.

Step 1: Formation of Study Team (Completed)

The study team comprises team members at ACLM staff and researchers with expertise in public health, LM (including behavior change), and qualitative research. As the national medical professional organization representing physicians and other health professionals practicing LM, ACLM is uniquely positioned to form and coordinate this study team. In addition to representing individual practitioners, ACLM also coordinates a network of health systems, the Health Systems Council (HSC). This group comprises integrated health systems around the United States committed to growing their LM service offerings and sharing their experiences and learnings with other council members [ 24 ]. In July 2021, the study team initiated regular (weekly or biweekly) meetings to discuss research aims and methods. The study team has continued to meet throughout the duration of the project.

Step 2: Selection of Methods (Completed)

Through discussion at regular meetings and review of qualitative literature, the study team identified the methods that would be used for this project. We selected a qualitative case study approach, embracing constructivist epistemology (the belief that there is no one truth and that findings are created by the interaction between the patients or informants and the observer or data collector) [ 30 ]. Case studies are a qualitative methodology that facilitates the exploration of a specific topic through the development of complex narratives, promoting rich insights from multiple sources within single and multiple cases [ 28 , 31 , 32 ]. Although findings are heavily influenced by contextual factors, the cross-case reports (described later) provide insights that can be transferred to other settings. This need for transferability suggests a multiple case (rather than single-case) design would be appropriate for the identified research questions [ 32 ].

We selected case studies to allow for contextual diversity and triangulation, or the gathering of evidence from multiple data sources, to yield convergent findings [ 28 , 33 ]. To facilitate triangulation, the study methodologies included data collection from multiple stakeholders and source types (in-depth interviews, document review, survey responses, and direct observation). Further, document review allows for the gathering of evidence by interviewers ahead of interviews and reduces the burden on informants [ 32 ]. We selected in-depth interviews instead of focus groups to allow for triangulation from different perspectives (both individual experiences and professional roles) and reduce social desirability bias and fear of disclosure among informants [ 34 ]. Finally, direct observation (in the form of in-person site visits) yields insights that interviewees may have accidentally omitted due to their own familiarity with their particular context.

Step 3: Recruitment and Training of Study Team (Completed)

The study team is coled by the principal investigator (MCK) and a senior investigator with expertise in qualitative research and case study methods (JG). Additional expert advisors representing ACLM (TAH and KLS) and academic institutions (MLA, SMS, ND, and MMR) offer critical insights and guidance to protocol development and implementation. All data collection was completed by researchers who are external to ACLM, apart from 2 students who were previously involved as members of ACLM. ACLM staff advise on study design or implementation, participate in team meetings, and are part of the iterative review process, but do not conduct data collection.

There were 8 data collectors, who primarily comprised graduate-level students trained in the fields of public health and medicine. Data collectors were hired as research assistants and recruited through study team networks. All data collectors completed data collection training designed and delivered by the academic consultant. The training included general principles of qualitative research, qualitative interviewing techniques, and a review of the study protocol.

Step 4: Case Study Nomination and Selection (Completed)

Multiple case studies are recommended to contain 4-10 cases to achieve sufficient variability while providing a manageable amount of transferrable insights [ 28 ]. Stake [ 28 ] identifies 3 criteria that should be present when selecting cases: (1) the case must be relevant to the quintain (or phenomenon of interest, which is LM implementation); (2) the cases must provide contextual diversity; and (3) the cases must allow researchers to observe and explore complexities and contexts.

We followed a purposive sampling approach that leveraged the preexisting ACLM HSC network, which is uniquely positioned to access health systems with LM programs. From March 21-April 1, 2022, recruitment emails were disseminated through ACLM HSC email communications. During the recruitment period, 15 health systems were self-nominated by an employee representative from each interested health system. The self-nomination form captured data on the health system's geographic location, patient demographics, payer types, LM practitioners, programs available, and the estimated reach of the LM program.

Table 2 includes selected self-reported data for the participating health systems and describes geographic location by census-based US regions to preserve health system anonymity [ 35 ]. Data reported through the nomination form were not corroborated and should be interpreted conservatively. One health system (site code H) did not complete the nomination form and was recruited through a different mechanism, described below.

Summary of self-reported characteristics of participating health systems.

Site codeRegionLevel of focus Reach
ASouthSubspecialtySmall
BWestSpecialtyLarge
CMidwestSubspecialtyMedium
DWestSpecialtyMedium
ESouthSpecialtyMedium
FMidwestSubspecialtySmall
GWestSpecialtyLarge
HSouth

a “Specialty” indicates lifestyle medicine is a stand-alone area of treatment programming; “subspecialty” indicates lifestyle medicine is an adjunct approach embedded in other treatment specialties.

b Reported estimated number of patients receiving care at the time of nomination, where “large” is >5000, “medium” is 1000-5000, and “small” is <1000.

c Not available.

Study team members reviewed all self-nomination forms and came to a consensus through discussion about which cases to include to achieve contextual diversity, including variability in program size, age, geographic location, payer model, and population served. We selected 4 instrumental cases that were generally representative of the “typical” nominees seen but varied in the aforementioned characteristics [ 28 ]. We also selected 2 intrinsic cases that offered a unique context due to their stage (either very early or relatively mature in development), size, and extent of LM practice integration [ 28 ]. Selected cases were invited to confirm participation through a health system representative authority.

Partway through case recruitment and data collection, the study team determined that a contrasting case was needed to demonstrate the experiences of a health system that had initiated and then aborted an LM program. The study team agreed that this perspective would yield unique insights about implementation barriers to LM. This iterative approach is an accepted multiple case study procedure, through which redesign can emerge partway through case selection [ 32 ]. Original recruitment strategies did not satisfy this need, and the study team used an additional recruitment strategy that built upon individual communications rather than wide-reaching HSC communications channels. One case (site code H) was recruited using this approach and varied slightly in the data collection methods described below.

Step 5: Iterative Data Collection (Completed)

Each participating health system was assigned a single data collector as a site lead, whose responsibilities included coordinating data collection and drafting the case narrative. The site lead managed a team of 1-2 other data collectors, who conducted individual interviews with different members of the health system’s LM team. Overall, 4 types of data were collected: in-depth interviews, site visits, existing documents, and study team notes.

In-Depth Interviews

The study team conducted at least 6-8 in-depth interviews with individuals identified in each participating health system. Health system liaisons were asked to identify employees who were integral to the implementation of the LM programming. They were provided a list of potential types of roles sought for interviews and asked to prioritize individuals who served as health system leaders or administrators (including billing professionals) and physicians. Other health care professionals delivering LM were also requested and included nurse practitioners, registered dietitians, behavioral health specialists, health coaches, exercise physiologists, physical therapists, kinesiologists, and mental health professionals. Only in the instance of the contrasting case were former employees also invited to participate in interviews.

Interviews lasted 45-90 minutes and were conducted through video call (typically), telephone (rarely), or in-person (rarely). When using video call, interviewees had the option of participating with their camera on (typically) or off (rarely). Interviews were open-ended and exploratory and followed a semistructured interview guide designed to achieve the study aims and allow for adaptability based on the interviewee or health system context. The interview guide was iteratively designed by study team members and loosely structured on the CFIR model [ 22 ]. Minor updates to the interview guide were made as emergent topics were identified.

In alignment with the CFIR, interviewees were asked about the inner (structural characteristics, culture, and available resources) and outer (patient population, billing, or payer practices) settings of their health system in addition to individual factors (their specific role and the roles of others) [ 22 ]. They were also asked to describe their understanding of the intervention (LM), how it differs from other types of medicine within their setting, and how it was adapted for their specific setting. The interview also included questions about barriers, facilitators, and processes related to program launch and growth. Interviewers were trained to probe topics particularly relevant to the interviewee or health system context. If warranted, the interviewer requested a follow-up interview with an interviewee. These follow-up interviews were intended to answer specific questions, provide missing details, or explore a topic not previously discussed. The most recent version of the interview guide at the time of publication is available in Multimedia Appendix 1 .

The 2 study team members assigned to each participating health system were responsible for participating in each associated interview, either as a primary interviewer or as an interview reviewer, which involves reviewing the transcript. Interviews were recorded using the video meeting software (Zoom; Zoom Video Communications [ 36 ]) or a recording device (or sometimes both for redundancy) and stored in a secure location on the cloud. Recordings were transcribed using the Microsoft One Drive (Microsoft Corporation) transcription and then manually reviewed and edited for accuracy by study team members. Additionally, interviewers documented emerging themes or other contextual factors following each interview.

Document Review

Interviews were supplemented by the review of available health system documentation. The study team collected and reviewed publicly available annual reports, websites, program promotional materials, strategic plans, and relevant community health needs assessments. Interviewees were asked about additional materials they thought were relevant to the interview themes, and such materials (which may include organizational charts, internal planning documents, and patient education materials) were also reviewed. The study team maintained a database of all reviewed documents to aid in identifying additional documents for review. Interviewers referenced documents if and as needed when reflecting on and taking notes about past interviews, preparing for upcoming interviews, and sharing updates during study team discussions. For example, if an interviewee mentions an LM program that is referenced by multiple names, the interviewer can reference the health system website and patient recruitment materials to confirm the official name of the program. Additionally, documents are referenced during the preparation of the case study narratives and cross-case analysis to corroborate findings, fill in missing details, and provide illustrative examples. For example, if a health system reported promoting referrals by sending email communications to physicians, the language from the communication may be included in the case study narrative as an example of that recruitment strategy.

Site Visits

An in-person site visit occurred for 1 site and included unstructured observations of the settings and conversations with health system employees, which mirrored themes included in the in-depth interview guide. Photos from the site visit (including patient waiting areas, exam rooms, dining and exercise facilities, offices, and other available areas) are referenced in the qualitative data analysis. Otherwise, site visits were not conducted. This decision was made due to the restrictions of the COVID-19 pandemic.

Weekly Study Team Discussions and Iterative Review (Currently in Progress)

Following the principle of emergent design [ 37 ], the study team meets 2-4 times per month to debrief from interviews and discuss emerging themes. During team meetings, data collectors report on themes from recent interviews, and the study team discusses how findings enhance the understanding of health system LM implementation and identifies areas to probe further in future interviews. This is also when the study team discusses similarities and differences among health systems and determines the need for potential changes to the study protocol, case selection, interview guide, case narrative outline, and cross-case analysis. Additionally, study team members report on current events and publications that are relevant to research aims. Meeting recordings and minutes are available for study team members to reference during data analysis.

Step 6: Preparation of Case Study Narratives (Currently in Progress)

In collective case study analysis, it is prudent to conduct individual analysis initially (described below) and follow with cross-case analysis (described in step 7) [ 38 ]. Through an iterative and collaborative process, the study team developed a case report format that is followed for the preparation of each case narrative to facilitate intercase comparison. This requires that case narratives open with a presentation of objective data, including name, location, size, payer model, etc. The following sections align with the overall study aims and include potential barriers and facilitators to initiation and sustainment. After completing 2 of the case study narratives, the study team decided to add 2 additional sections focused on clinician training and provider burnout to capture emergent themes. All case reports will follow the same report template (the original 2 case study narratives were revised to align with the updated structure) but vary in length and subtopics covered specific to each health system. The case narrative template is included in Multimedia Appendix 2 .

The site’s lead data collector is primarily responsible for writing the case study narrative. Other study team members review and comment on case narrative drafts until a consensus is reached. As appropriate and necessary, study team members may conduct additional follow-up interviews or share versions of the case narratives with interviewees (with individual identifiers removed) to facilitate member checking. Additionally, 1 team member is responsible for reviewing all reports for consistency in form, content, and style.

Step 7: Cross-Case Analysis (Currently in Progress)

Following the completion of case study narratives, the study team completes cross-case analyses focused on topics of interest. Specific analysis topics are not yet final but will likely include billing, care delivery models, clinician training, leadership support, buy-in, intervention content, workplace culture, and burnout. Each cross-case analysis will yield a manuscript to be submitted for peer-reviewed publication. Because the cross-case analyses are not yet complete, the following methods offer a high-level overview of the procedures planned for each analysis report.

Some cross-case analyses will follow the multiple case study methodology reported by Stake [ 28 ], which includes the following steps: (1) plan the cross-case analysis and identify themes relevant to research questions; (2) become familiar with individual cases; (3) assess case utility for each cross-case theme; and (4) sort and merge findings relevant to themes. In the Stake [ 28 ] approach, a series of interactive worksheets are completed to identify emergent themes, guide analysts through their review of case narratives, and plan and execute a cross-case report. This case study analysis methodology was selected as it preserves contextual information to a large degree. Other cross-case analyses may leverage a coding approach, which uses search queries to identify relevant segments of transcripts or documents and then applies an inductive coding schema to the resulting data.

Step 8: Dissemination of Findings (Currently in Progress)

The study team plans to disseminate a series of manuscripts. This paper offers an overview of the methods conducted and planned for data collection, analysis, and reporting. We also plan to disseminate shortened, deidentified versions of the case study narratives to serve as vignettes for consideration by other practitioners. Additional papers will provide insights for each of the cross-case analyses by comparing and contrasting specific findings for each case study site and highlighting common practices seen in instrumental cases and unusual situations seen in intrinsic cases [ 28 ]. These can advise on the implementation and integration of LM programs into health systems that can be applied in other settings to initiate or scale current LM offerings.

Additionally, we plan to share deidentified case narratives with the respective participating health systems. This serves the dual purpose of (1) facilitating member checking and (2) offering the benefit of an external perspective to participating health systems.

Ethical Considerations

The University of New England’s institutional review board (IRB) reviewed the study protocol and determined it was exempt from IRB review and oversight (project number 1221-21). Before the interview, all participating individuals completed a written informed consent, which included an overview of the study purpose, a request for participation, a description of privacy protection efforts, and a review of potential risks and benefits. Participants were not compensated for their time.

At the time of this writing (February 1, 2024), the study team has completed all the interviews at 8 health systems. The team interviewed 63 individuals, 5 of whom participated in a follow-up interview, resulting in 68 total interviews. Every site included an interview with at least 1 administrator and physician. Across all sites, interviews were conducted with 25 health system leaders or administrators; 16 physicians; 7 registered dietitians; 6 behavioral health specialists or health coaches; 4 nurse practitioners; 2 exercise physiologists, physical therapists, or kinesiologists; 2 mental health professionals; and 1 individual with an unclassified role.

The study team has completed initial drafts of all 8 case study narratives and is abridging and deidentifying them for member checking and broader dissemination. Cross-case analysis is underway to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout. Additional analyses may investigate how billing strategies, care delivery models, leadership support or buy-in, and intervention content can impact LM implementation in health systems.

This research is the first multiple case study examining facilitators and barriers to LM implementation in health system settings. It will address a gap in the literature by providing insight into the barriers and facilitators to adopting LM practice in health systems. Below is a discussion of limitations, strengths, and opportunities for further research.

Limitations

ACLM serves as the primary funder for this work, potentially introducing a pro-LM bias. To reduce the influence of this bias, the study team was intentionally designed to be diverse and include experts who are external to ACLM and thus not biased in the same way that ACLM affiliates are. Additionally, all methodological and analysis decisions are made during study team meetings, which include multiple perspectives, including 1 senior advisor, in addition to ACLM.

In some cases, the study team was challenged to identify interviewees who comprehensively represented the breadth of LM activities in a single health system. This is partly due to the size and complexity of participating health systems. Individual interviewees were identified by 1 or 2 liaisons at each health system and sometimes did not include groups or types of individuals who would have offered valuable insights. For example, 1 site provided names of individuals who were involved in implementing one specific LM program but were not familiar with the LM residency program that was offered by a different unit of the health system. This resulted in in-depth data about the specific LM program but fewer insights into the LM residency offerings. Additionally, some health systems were unable to allow nonexempt employees to participate in in-depth interviews because the study was not compensating interviewees for their participation. This resulted in an overrepresentation of leadership and an underrepresentation of front-line workers and intervention delivery personnel. To address these challenges, the study team circled back to health system liaisons to request interviews with additional individuals whose perspectives were not initially included, although the requests were not always met. Data collection methods did not directly include patients or community members, resulting in a gap in these perspectives. Interviewees were asked to speak about the experiences of these individuals, but future research should also investigate these perspectives, specifically.

Finally, site visits and in-person interviews were limited due to restrictions associated with the COVID-19 pandemic. We were only able to conduct 1 site visit, which was conducted in person. To adapt, we revised our methods to prioritize internet-based interviews. Through this process, we learned that internet-based interviews facilitated easier scheduling and access to individuals and often yielded high-quality interviews that were thought to be comparable to in-person interviews. Considering the added logistical benefits, the study team determined the internet-based interview approach to be preferable to in-person site visits. No interviews were conducted in person.

This multiple case study methodology and our iterative team-based approach are strengths of this research. By preserving the context of each case, researchers can gain a rich understanding of the many factors impacting the phenomenon of interest [ 28 , 31 ]. Although the selection of ACLM HSC members allows for insights into the experiences of early adopters, the findings may not be translatable to relatively more nascent programs. Throughout the early stages of case selection, our team reviewed health system components to ensure variability in program maturation. We intentionally selected health systems with more recently established LM programs and also sought out and recruited a contrasting case that had initiated and then greatly reduced LM programming. However, the study would have been further strengthened by the inclusion of additional negative cases. The heterogeneity of participating health systems will contribute to the transportability of the study findings. Future research should investigate if and how barriers and facilitators are different among health systems that are not currently aligned with LM.

A strength of this study is that the cases and analyses take place at the health system level, allowing a more comprehensive perspective that incorporates all CFIR domains [ 22 ]. Health systems are complex systems of hospitals, clinics, and individuals connected through joint ownership or management [ 38 ]. Within these systems are varying cultures (“individuals involved” domain), policies, and processes (“inner setting” domain), which can impact practices (“process domain”). Examination at the health system organization level offers insights into the macrolevel factors (“inner” and “outer setting” domains) that impact LM implementation. Gaining permission to work with such large and complex organizations can be challenging, however, and in some instances, investigation was delayed and even prohibited due to the inability or unwillingness of health system leadership to provide permission for participation. Some health system leaders expressed confidentiality concerns, noting that patient perspectives of the organization and their practices were a critical consideration.

This protocol paper offers real-world examples of research methodologies used to gather data on a series of health systems. Additionally, the study findings will yield practical insights into strategies to effectively implement LM in health systems. Health system leaders and administrators can draw on these findings to establish and grow their own LM programs and integrate LM practices into existing services. Expanded access to LM treatment may result in improved morbidity and mortality outcomes related to chronic diseases [ 1 , 6 , 12 ].

Acknowledgments

The authors would like to thank the participating health systems and staff for their support of this project, as well as American College of Lifestyle Medicine employees, including Kaitlyn Pauly, who advised on this work.

Abbreviations

ACLMAmerican College of Lifestyle Medicine
CFIRConsolidated Framework For Implementation Research
HSCHealth Systems Council
IRBinstitutional review board
LMlifestyle medicine

Multimedia Appendix 1

Multimedia appendix 2, data availability.

Authors' Contributions: MCK and JG are co–principal investigators. MLA, JG, MCK, and SMS contributed to the methodology. MLA was involved in writing and preparing the original draft of the manuscript. MLA, ND, JG, TAH, MCK, MMR, KLS, SMS, and BW contributed to the writing, reviewing, and editing of the manuscript. MCK and SMS were responsible for project administration. MCK was responsible for funding acquisition. All authors have read and agreed to the published version of the manuscript.

Conflicts of Interest: MCK, TAH, and KLS are employed by the American College of Lifestyle Medicine. The other coauthors receive consulting payments from the American College of Lifestyle Medicine.

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How to Write a Multiple Case Study Effectively

Table of Contents

Have you ever been assigned to write a multiple case study but don’t know where to begin? Are you intimidated by the complexity and challenge it brings? Don’t worry! This article will help you learn how to write a multiple case study effectively that will make an impactful impression. So, let’s begin by defining a multiple case study.

What Is a Multiple Case Study?

A multiple case study is a research method examining several different entities. It helps researchers gain an understanding of the entities’ individual characteristics and disclose any shared patterns or insights. This type of investigation often uses both qualitative and quantitative data. These are usually collected from interviews, surveys, field observations, archival records, and other sources. This is done to analyze the relationships between each entity and its environment. The results can provide valuable insights for policymakers and decision-makers.

Why Is a Multiple Case Study Important?

A multiple case study is invaluable in providing a comprehensive view of a particular issue or phenomenon. Analyzing a range of cases allows for comparisons and contrasts to be drawn. And this can help identify broader trends, implications, and causes that might otherwise remain undetected. This method is particularly useful in developing theories and testing hypotheses. This is because the range of data collected provides more robust evidence than what could be achieved from one single case alone.

A person writing on a notebook with a laptop next to them

How to Write a Multiple Case Study

Below are the key steps on how to write a multiple case study :

1. Brainstorm Potential Case Studies

Before beginning your multiple case study, you should brainstorm potential cases suitable for the research project. Consider both theoretical and practical implications when deciding which cases are most appropriate. Think about how these cases can best illustrate the issue or question at hand. Make sure to consider all relevant information before making any decisions.

2. Conduct Background Research on Each Case

After selecting the individual cases for your multiple case study, the next step is to do background research for each case. Conducting extensive background research on each case will help you better understand the context of the study. This research will allow you to form an educated opinion and provide insight into the problems and challenges that each case may present.

3. Establish a Research Methodology

A successful multiple-case study requires a sound research methodology. This includes deciding on the methods of data collection and analysis and setting objectives. It also involves developing criteria for evaluating the results and determining what kind of data needs to be collected from each case. All of this must be done carefully, considering the purpose of the study and its outcomes.

4. Collect Data

Once a research method has been established, it is time to collect data from each case included in the study. Depending on the nature of the research project, this could involve interviewing participants, gathering statistics, or observing behaviors in certain settings. It is crucial to ensure that all data collected is accurate and reliable.

5. Analyze & Interpret Data

After the data has been collected, it must be analyzed to draw meaningful conclusions from it. This process involves examining patterns and trends within the data, identifying relationships between variables, and looking for commonalities among different cases. These findings must then be interpreted in light of the initial questions posed by the study.

6. Write the Report

After completing the analysis and interpretation of the data, it is finally time to write up the results of the multiple case study. This should include a summary of the key findings and an explanation of why these findings are significant. In addition, the limitations of the study should be acknowledged, along with recommendations for future research in this area.

Writing a multiple case study requires careful planning and execution. But the process becomes easier when you know the proper steps to conduct and create a multiple case study. It requires you to focus on the design of the study, including the sample chosen and the research methodology established. Conducting background research on each case and collecting data are also crucial steps in the process. To guide you through the process, this article outlines the key steps to help you easily write a well-structured multiple-case study .

How to Write a Multiple Case Study Effectively

Abir Ghenaiet

Abir is a data analyst and researcher. Among her interests are artificial intelligence, machine learning, and natural language processing. As a humanitarian and educator, she actively supports women in tech and promotes diversity.

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Using the matrixed multiple case study methodology to understand site differences in the outcomes of a Hybrid Type 1 trial of a peer-led healthy lifestyle intervention for people with serious mental illness

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Daniela Tuda, Lauren Bochicchio, Ana Stefancic, Mark Hawes, Jun-Hong Chen, Byron J Powell, Leopoldo J Cabassa, Using the matrixed multiple case study methodology to understand site differences in the outcomes of a Hybrid Type 1 trial of a peer-led healthy lifestyle intervention for people with serious mental illness, Translational Behavioral Medicine , Volume 13, Issue 12, December 2023, Pages 919–927, https://doi.org/10.1093/tbm/ibad060

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Site differences in implementation trial outcomes are common but often not examined. In a Hybrid Type 1 trial examining the effectiveness-implementation of a peer-led group life-style balance (PGLB) intervention for people with serious mental illness (SMI) in three supportive housing agencies, we found that PGLB recipients’ physical health outcomes differed by study sites. The matrixed multiple case study methodology was used to explore how implementation outcomes and changes in context of usual care (UC) services contributed to these site differences. Two implementation outcomes (i.e. PGLB fidelity ratings and intervention recipients’ acceptability of PGLB and UC) and changes in healthcare services integration at the study sites were examined. ANOVAs were used to examine site differences in fidelity ratings and client satisfaction. Directed content analysis was used to analyze leadership interviews to identify changes in the context of UC services. Site 3 showed a trend approaching significance ( P  = .05) towards higher fidelity ratings. High levels of satisfaction with PGLB were reported at all sites. Significant differences in PGLB recipients’ satisfaction with UC were found, with Site 3 reporting the lowest levels of satisfaction. Agency leaders reported an increase in prioritizing client’s health throughout the trial with sites differing in how these priorities were put into action. Differences in PGLB recipients’ satisfaction with UC, and changes in healthcare service integration seemed to have contributed to the site differences in our trial. The matrixed multiple case study methodology is a useful approach to identify implementation outcomes contributing to the heterogeneity of multisite implementation trial results.

A healthy lifestyle intervention delivered by people with lived experience of serious mental illness (SMI) led to improved health outcomes among participants living with SMI in three supportive housing agencies, but these outcomes differed by study sites. This study aimed to identify which factors influenced these site differences in study outcomes by examining if the intervention was delivered as intended, intervention recipients’ satisfaction with the intervention and the pre-existing health care services delivered at each study site, and what changes occurred in health care services offered at each of the supportive housing agencies throughout the study. The intervention was found to have high levels of satisfaction across all three agencies but the agency which had the best outcomes also had the highest levels of intervention delivery adherence and the lowest levels of intervention recipients’ satisfaction with existing health care services. Additionally, during the study period, the same agency described minimal changes in their existing health care services while the other two agencies were found to have made more significant changes integrating health care services to their day-to-day operations. As a result, findings from this study emphasize the importance of understanding the context in which interventions are delivered in routine practice settings to ensure their overall success.

Practice: The matrixed multiple case study design can be used to identify implementation outcomes that may contribute to sites differences in the clinical outcomes of multisite implementation trials.

Policy: Clarifying what worked, for whom, and under which conditions is needed to successfully implement healthy lifestyle interventions that aim to eliminate health inequities in people with serious mental illness (SMI).

Research: Future research is needed to examine additional implementation outcomes that can lead to intervention success in multisite trials.

Site differences in the outcomes of multisite implementation trials are common but often not rigorously examined [ 1 , 2 ]. Clinical, organizational, and community complexities inherent in conducting implementation trials in routine practice settings can contribute to the heterogeneity of trials’ clinical outcomes [ 3 ]. For example, sites participating in implementation trials may implement the intervention slightly differently due to local conditions, resources, and infrastructure. Clients, providers, and organizational leaders from different study sites may vary in their acceptance of the intervention thus influencing its implementation and clinical outcomes. Moreover, changes in the context of practice (e.g. the introduction of new services, changes in local, state, or federal health policies, new emerging needs in the community being served) that occur as a trial is being conducted can impact multiple factors, including the delivery of usual care (UC) services (often the comparison condition in implementation trials), implementation of the interventions being tested, and trial outcomes. Efforts to systematically examine how these site differences impact implementation trial outcomes is critical for advancing the translation of research into practice as they can help clarify how and why an intervention worked in certain settings and not others.

A recently developed methodology by Kim and colleagues [ 4 ] called the matrixed multiple case study design combines qualitative and quantitative data generated from an implementation trial to identify implementation outcomes and processes contributing to site differences in trial outcomes. This mixed methods approach provides a systematic structure to examine, organize, and compare heterogeneous findings across study sites to identify the factors and local conditions influencing the outcomes of an implementation trial. This methodology uses a systematic step-by-step process, including specifying a research goal (e.g. to understand site differences), defining relevant independent and dependent variables (e.g. implementation factors [acceptability, fidelity], client outcomes), organizing quantitative and qualitative data on these variables in a table (or matrix), and using these tables to examine within and cross-site trends to answer two central questions: (i) how are sites similar or different in their implementation outcomes?; and (ii) how do changes in agency context influence implementation success, in what ways, and under what circumstances? [ 4 ]. The strength of this methodology is that it makes maximum use of available qualitative and quantitative data collected from an implementation trial. This enables us to gain valuable insights into implementation outcomes and the conditions that were present across settings in which an intervention was successful or failed to achieve the primary clinical outcomes.

In this study, we applied the matrixed multiple case study design to explore how implementation outcomes may have contributed to site differences we observed in intervention recipients’ health outcomes (e.g. weight loss, reduction in the risk for cardiovascular disease) in a Hybrid Type 1 trial. The trial tested the effectiveness and examined the implementation of a 12-month Peer-led Group Healthy Lifestyle Balance (PGLB) intervention in predominantly racial/ethnic minoritized individuals with serious mental illness (SMI; e.g. schizophrenia, bipolar disorder) who were overweight/obese (Body Mass Index; BMI ≥25) and living in supportive housing [ 5 ]. Adults with SMI die at an earlier age than people in the general population largely due to higher rates of obesity, type-2 diabetes, and cardiovascular disease [ 6 ]. Healthy lifestyle interventions that promote and help increase healthy dietary habits and physical activity can improve the health of people with SMI [ 7 , 8 ].

In our trial, 314 participants (81% were from racial/ethnic minoritized groups) from 3 supportive housing agencies located in two northeastern U.S. cities were recruited between June 2015 to January 2019 and randomly assigned to PGLB or UC. Assessments were conducted at baseline, and at 6-, 12-, and 18-months post-randomization. Eighty percent ( n = 252) of our original sample was retained at the 18-month follow-up. The trial’s primary outcome was clinically significant weight loss (i.e. weight loss of ≥5% from baseline at 12- and 18-months). After controlling for site and baseline weight, there were no statistically significant differences between PGLB and UC on the trial’s main outcome [ 9 ]. However, study outcomes differed by study site. Sites 1 and 2 reported null findings between PGLB and UC at all time-points on our main outcome. Site 3 showed a different pattern. At this site, PGLB was significantly better than UC, with twice as many PGLB recipients achieving clinically significant weight loss at 18-months (PGLB = 42% vs UC = 23%, Adjusted Odds Ratio = 2.57, 95% CI [1.02, 6.49] [ 9 ]).

These findings suggest that PGLB benefits were not uniform across study sites, thus a methodology like the matrixed multiple case study design is suitable to help clarify why and how PGLB worked in certain settings and not others. Based on data collected in this Hybrid Type 1 effectiveness-implementation trial, fidelity and acceptability, two implementation outcomes known to influence intervention outcomes were examined to determine whether they could help explain site differences in clinical outcomes [ 3 , 10 ]. Fidelity is the degree to which an intervention is delivered as prescribed [ 10 ]. Variations in fidelity across study sites can contribute to differential intervention effects. Acceptability is defined as “the perceptions among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory,” and it can also contribute to site differences in trial outcomes [ 11 ]. For instance, variations across sites in PGLB recipients’ satisfaction with the intervention, a commonly used proxy measure for capturing a dimension of acceptability, can result in differential treatment engagement and retention which can contribute to differences in study outcomes [ 12 ]. Additionally, changes in the context of practice within study sites that occur as an implementation trial is being conducted can also contribute to the site differences in study outcomes. For example, study sites may introduce new services or reconfigure their UC during an implementation trial due to the changing needs of their clients, shifting priorities of their organizations, or changes in healthcare policies. These dynamic changes in the practice context are important to examine as they can transform the local conditions in which the intervention is being implemented. In this paper, we illustrate how we applied the matrixed multiple case study design using existing trial data to identify whether implementation outcomes and changes in the context of UC regarding the integration of health care services in each of our three study sites could have contributed to the site differences we observed in PGLB recipients’ health outcomes. Specifically, we explored how site differences in fidelity to PGLB as delivered by peer specialists, intervention recipients’ acceptability to PGLB and UC, and changes in the context of practices described by agency leadership (i.e. program managers and agency directors) might have contributed to the differential impact of PGLB. This is the logical next step in our work as it can help elucidate why PGLB worked in certain settings and not others. Findings will inform future implementation efforts by clarifying what resources, actions, and practice conditions are needed to successfully implement interventions like PGLB to help eliminate health inequities in people with SMI.

This study uses the matrixed multiple case study design to conduct a secondary analysis of data from a Hybrid Type 1 trial testing the effectiveness and examining the implementation of PGLB for people with SMI and a BMI ≥25 living in three supportive housing agencies, two of which used a “treatment first” approach and one used a “housing first” approach. Supportive housing is an important service sector for people with SMI because it combines community-based housing with a range of physical, mental health, and social services [ 13 ]. “Treatment first” supportive housing requires individuals to first undergo mental health treatment or meet specific criteria before receiving housing [ 13 ]. In contrast, a “housing first” approach prioritizes access to stable housing, regardless of treatment readiness, and offers services to address individual needs and promote housing stability [ 14 ]. The trial’s protocol and main outcomes have been published elsewhere and are also available in clinicaltrials.gov (NCT02175641). All study procedures were approved by the institutional review boards of Columbia University and Washington University in St. Louis and Philadelphia Departments of Public Health.

Matrixed multiple case study design

This mixed methods approach uses a multiphase process to systematically identify and examine within and cross-site factors that could help explain site differences in implementation and trial outcomes. In phase 1, we convened meetings with our research team (i.e. the principal investigator, project director, and research assistants) and an implementation science expert to specify our research goal (i.e. to understand site differences) and select the relevant implementation outcomes to address our research goal. Informed by the available data generated from our trial and from the recommendation of our implementation science expert, the team selected the following implementation outcomes to examine: three quantitative data sources: PGLB’s peer specialist fidelity ratings, a measure of PGLB recipients’ satisfaction with PGLB, and a measure of PGLB recipients’ satisfaction with UC. We also utilized one qualitative data source that included two sets of semi-structured qualitative interviews with agency leaders (4 per study site). One set of interviews was conducted prior to the implementation of PGLB. The other set was conducted after the trial ended. The qualitative data generated from these two sets of interviews enable us to examine changes in the integration of healthcare services that occurred during the trial at each study site (see sections below for a more detailed description of each of these data sources).

In phase 2, we analyzed each of these data sources by study site. During this phase, we conducted several meetings with our research team and implementation science expert to discuss our analytical process, present preliminary findings for each of the data sources by study site and make refinements to our analytical plan. In phase 3, we then developed a table in which each row represented a study site and columns represented the implementation outcomes (e.g. PGLB fidelity, satisfaction with PGLB, and satisfaction with UC), changes in the integration of health care services throughout the trial, and PGLB recipients’ health outcomes comparing PGLB vs. UC to identify within and cross-site trends linked to site differences in PGLB recipients’ health outcomes.

PGLB fidelity rating

PGLB fidelity was measured by rating the degree to which PGLB intervention content (e.g. explained how to use a pedometer, explained how to count calories) and processes (e.g. assigned the appropriate session homework) were present in session audio recordings of peer specialists who delivered the intervention. Trained PGLB clinical supervisors, who were all master-level clinicians (e.g. social workers), independently rated these session recordings using a PGLB fidelity rating checklist for each of the 22 intervention sessions. While all PGLB sessions were to be audio recorded, a pre-defined sampling scheme was used to determine the number of sessions to be reviewed. The fidelity scheme required that all sessions were reviewed if it was the peer specialist’s first cohort for which they delivered PGLB. For the subsequent cohort, all core and transition sessions (sessions 1 through 16) were reviewed with a random sampling employed for two of the remaining six sessions to be reviewed. For peer specialists’ third cohort and beyond, the first seven sessions were always reviewed followed by a random sample of two sessions in each module 8–12 (subset of core), 13–16 (transition), 17–22 (maintenance). These checklists asked raters to identify whether specific PGLB content and processes were present or absent in the session. In total, 300 of 389 PGLB sessions selected for review were collected and rated: 75% for site 1, 71% for site 2, and 83% for site 3. Missing sessions were generally due to recorder issues (e.g. technical problems), participant not wanting session recorded, or sessions taking place in an environment not conducive to recording (e.g. loud restaurant). For the present analyses, we used the overall PGLB fidelity score which captures the average percentage of PGLB criteria marked as present in the sessions reviewed for each study site.

Satisfaction with PGLB and usual care

Two modified versions of the Client Satisfaction Questionnaire (CSQ) were used to capture PGLB recipients’ satisfaction with PGLB and UC at 12-month post-randomization [ 15 ]. This period was selected because this marked the end of the PGLB intervention. The CSQ is a brief eight question instrument that measures participant satisfaction with services received on a four-point scale (e.g. quite dissatisfied to very satisfied). In this trial, the CSQ was modified to assess PGLB recipients’ satisfaction with the intervention (e.g. How would you rate the quality of the services you received from the healthy lifestyle program?) and the UC services provided at their agency (e.g. In a general sense, how satisfied are you with the services you have received from [agency] to help you with your physical health conditions?). An overall satisfaction score was calculated by summing the participants’ ratings on each of the eight items, producing a score ranging from 8 to 32, with higher values representing higher satisfaction. CSQ’s scoring guidelines call for dropping cases that answer less than four items. This resulted in one case being dropped from the analysis. For this analysis, PGLB recipients’ CSQ scores for PGLB and UC were examined by study site.

Agency leaders interviews

Two sets of semi-structured qualitative interviews were conducted in person or via telephone by three of the authors, A2, A3, and A7, with 12 agency leaders (4 per study site) prior to and following the implementation of PGLB at each study site. During phase 2, we conducted follow-up interviews with ten out of the twelve leadership staff (83%) from phase 1. Additionally, two program managers from sites 1 and 3 were interviewed during phase 2, reflecting changes in agency leadership personnel. We started by interviewing agency directors as key informants and then asked them each to nominate up to three program managers overseeing health programs at their respective sites. All program managers who were nominated subsequently participated in these interviews. The first set of interviews was conducted in year one before we initiated the trial and explored how each agency provided health services to their clients and their views of PGLB. Interview questions asked during phase 1 included: What type of programs or services are currently offered at [study site] to address clients’ physical health needs? What new health care programs, intervention, or services have been introduced at [study site] in recent years (during the past 5 years)? The findings from these questions enabled us to characterize the agency’s healthcare environment and culture before PGLB’s implementation [ 16 ]. The second set of interviews occurred in year four following completion of the PGLB intervention and for this analysis we focused on questions capturing if and how the context of health services changed over the course of the study. Examples of questions asked during phase 2 interviews included: Since we began this project in 2015, have there been any changes to the types of programs or services offered at [study site] to address clients’ physical health needs besides the healthy lifestyle program? How has participation in this project impacted how [study site] views or addresses the physical health of your clients? All interviews last approximately 60 minutes, were audio recorded and then transcribed verbatim.

Data analysis

ANOVAs, and the non-parametric alternative (i.e. Kruskal–Wallis), were used to examine site differences in peer specialists’ PGLB fidelity ratings and PGLB recipients’ satisfaction with PGLB and UC. In our study, we also employed a combined approach that integrated both directed content analysis and interpretive/emergent analysis methods [ 17 , 18 ]. Directed content analysis was utilized in our initial examination of the qualitative data which provided a structured framework for our analysis to help identify and categorize the changes that each study site reported in their integration of healthcare services throughout the trial. We then incorporated interpretive/emergent analysis to explore the data longitudinally beyond the identified categories that might not have been captured by the initial categories. Through interpretive/emergent analysis, we allowed new themes and patterns to emerge from the data itself, enabling a more comprehensive understanding of the multifaceted phenomena under investigation.

To begin this process, an initial codebook was developed after two research team members reviewed each of the study transcripts independently. The preliminary codebook was then applied to four transcripts by two research team members. After finalizing the codebook, transcripts were coded line by line using ATLAS.ti. We then used an interpretive/emergent analysis, an approach suitable for uncovering underlying causes of intricate, interconnected, or diverse social processes that can be derived from existing qualitative data when exploring multifaceted phenomena such as systemic change over time [ 17 ]. Specifically, we sought to identify recurring patterns in a set of interviews and better understand how these common themes represented changes over time across the three sites. All ATLAS.ti reports were derived from the codes relevant to healthcare integration of physical health services including those that described the UC health services delivered at the study sites and the agency’s context regarding their approach toward delivering health services and addressing the health needs of their clients. Each of the relevant reports from phase 1 was then reviewed by three researchers to identify the agency’s context for delivering healthcare services and their level of health care integration from the leadership perspective. We applied the same method to phase 2 reports as well and focused on capturing changes from phase 1 to phase 2 in the delivery and integration of health care services at each study site. To facilitate our analysis of changes from phase 1 to phase 2, we created narrative case summaries of each site and then developed a matrix by site to illustrate changes between the two phases in the delivery and integration of health care services. A matrix was then presented with preliminary findings to gain feedback from the broader study team. Changes in healthcare integration was defined by any actions taken that resulted in further integration of physical health services (e.g. primary care services, visiting physical health nurse, access to healthy lifestyle workshops, smoking cessation groups) into routine operations offered by each supportive housing agency. According to the research team’s feedback, the two researchers then re-reviewed transcripts and revised the narrative case studies for each site. Using these narrative case studies, we then categorized the amount of change in health care services integration at each study site using three categories: status quo, some, or high. This was defined by how leadership described how the prioritization for the integration of physical health services resulted in concrete actions between phases 1 and 2. The level of integration of UC services for physical health was defined by whether agency leaders reported if the organization’s approach to physical health remained unchanged ( status quo ); began to make active steps (e.g. implementation of some wellness groups) towards expanding how they addressed physical health within the agency but were not yet fully integrated ( some ); or successfully implemented activities (e.g. primary care clinic) that increased access and availability of UC services integrated into the fabric of organization ( high ).

Further, to assure researchers’ positionality and biases were addressed, reflexivity was integrated into the qualitative analysis. Through critical self-reflection, the researchers examined their personal backgrounds, experiences, and perspectives that could have impacted data interpretation. Additionally, regular peer debriefing sessions were conducted with the entire research team to encourage an open dialogue and challenge any preconceived notions or assumptions.

Integration of quantitative and qualitative data

To integrate our quantitative and qualitative results, we developed a table in which each row represented a study site, and each column represented the implementation outcomes and changes in context examined in our study (see Table 1 ). This table enabled us to visually present side-by-side our quantitative and qualitative results. As a team, we then visually inspected the table looking for patterns across study sites that could help elucidate explanations for site differences in the trial outcomes. The use of joint displays to triangulate and help interpret the mix of quantitative and qualitative data is a commonly used approach in mixed methods research for integrating different types of data sources and analyses [ 19 ]. Several strategies were used to enhance rigor and trustworthiness of our analyses including maintaining an audit trail, using multiple coders, and conducting peer debriefing meetings to reach consensus in the interpretation of our findings [ 20 ].

Summary of implementation factors and client outcomes by study site

SitesImplementation factorsClient outcomes PGLB vs. UC
Overall PGLB fidelity rating (%)Satisfaction with PGLB (CSQ Score)Satisfaction with Usual Care (CSQ Score)Changes in the integration of healthcare services throughout the trial
Mean (SD)Mean (SD)
19227.4 (3.9)28.4 (3.7)High integrationNull findings
29128.1 (3.9)24.5 (7.2)Some integrationNull findings
39527.5 (3.3)24.4 (6.3)*Status QuoPGLB significantly outperformed UC on clinically significant weight loss and cardiovascular disease risk reductions
SitesImplementation factorsClient outcomes PGLB vs. UC
Overall PGLB fidelity rating (%)Satisfaction with PGLB (CSQ Score)Satisfaction with Usual Care (CSQ Score)Changes in the integration of healthcare services throughout the trial
Mean (SD)Mean (SD)
19227.4 (3.9)28.4 (3.7)High integrationNull findings
29128.1 (3.9)24.5 (7.2)Some integrationNull findings
39527.5 (3.3)24.4 (6.3)*Status QuoPGLB significantly outperformed UC on clinically significant weight loss and cardiovascular disease risk reductions

* Post-hoc analysis using the Sidak test for multiple comparisons indicated statistically significant differences in the mean value of UC satisfaction scores between Site 1 and Site 2 (P < .01) and between Site 1 and Site 3 (P <.001).

Site characteristics

Site 1 is a housing first supportive housing agency that provides integrated health services in partnership with a Federally Qualified Health Center (FQHC), including access to primary medical care, nurse care management, and peer-led outreach to over 500 adults with co-occurring disorders (i.e. SMI and substance use disorder). Site 2 is a treatment first housing provider serving over 900 individuals and operates an FQHC that provides access to primary care, wellness services (e.g. diabetes management groups), and integrated care coordination. Site 3 also follows a treatment first housing model offering a range of services, including partnership with an FQHC, coordination with primary care, and substance use treatment to over 1300 individuals.

Fidelity ratings for PGLB sessions delivered by the peer specialists were high across all study sites, 92% at site 1, 91% at site 2, and 95% at site 3 (see Table 1 ). A trend approaching significance found the highest fidelity ratings at Site 3 [ F (2,19) =3.42, P  = .05].

Acceptability of PGLB

High levels of PGLB recipients’ satisfaction with the intervention were consistently reported across study sites (see Table 1 ). However, results indicated statistically significant differences ( P  < .001) in PGLB recipients’ satisfaction with UC delivered at their respective housing agency, with Site 3 reporting the lowest levels of satisfaction with UC and Site 1 reporting the highest level of acceptability with UC. In our post-hoc analysis using the Sidak test for multiple comparisons, we found significant differences in the mean value of UC satisfaction scores between Site 1 and Site 2 ( P  < .01) and between Site 1 and Site 3 ( P < .001). However, no statistically significant differences were observed between Site 2 and Site 3 ( P = .998).

Changes in the health integration context

Among the 14 agency leaders interviewed, the majority identified as non-Hispanic white (93%) and female (79%). Most were social workers (43%), with an average tenure of 3.7 years within their respective agencies and over 15 years of experience working with individuals with SMI. Agency leaders across all study sites consistently reported an increase in their prioritization of clients’ physical health throughout the trial. However, sites differed in how integrated services were at the start of the intervention and to what degree (i.e. status quo, some or high) a heightened prioritization changed UC services by the end of the trial. The following section presents agency leaders’ views on healthcare integration before and after the implementation of PGLB at each agency site.

Site 1 reported the highest changes in health integration as they secured a Substance Abuse and Mental Health Services Administration (SAMHSA) grant during our trial to help them integrate healthcare services into their day-to-day operations, thus transforming UC to be more responsive to the health care needs of their clients. Prior to the implementation of PGLB, Site 1 recognized the importance of further integrating physical health into the UC services. As one program manager described,

We work hard to integrate everything. It’s hard to put a percentage on it because, there’s mental health involved in doing diabetes teaching and there’s diabetes involved in addressing someone’s thought process. We’re working hard to undo what the city has done by separating the insurance for physical and mental health. It has detached the head from the body and we’re trying hard to reintegrate that in the way we deliver our services. (Program Manager [PM])

Over the course of the study period, leadership approached the agency with various ways to increase integration of physical health and later secured funding through SAMSHA to address these issues, resulting in an increase in resources and capacity for UC services focusing on health. The program director of this site described how PGLB “unintentionally raised awareness” regarding the importance of addressing physical health in conjunction with mental health allowing for it to become “institutionalized slowly.” Additionally, this director acknowledged that PGLB’s implementation,

…[PGLB] came at a really good time as we were looking at what integrated care means and how we could do integration better. [PGLB] was a good addition to the primary care that we were already doing and having that in place and using that grant as leverage in conversation with other funders helped us to pick up some other grants. (Director [D])

Site 2 reported some changes in integration as they were starting to expand staff roles and health promotion programming, but these were not fully integrated into their housing program by the end of our trial. At phase 1, leadership described the various ways in which physical health was currently being addressed often relying on connecting individuals to outside relevant resources,

What we do is we connect people to other resources. A lot of our folks have intensive case managers with other organizations. Their role is to help connect to resources on healthcare. It’s helping people go to those services… (D)

In phase 2 interviews, one program manager reflected on having implemented a more passive adoption of health services and healthy living in the past but noted recent attempts in raising awareness regarding the food quality at residential sites. The program manager noted concerns regarding the actual impact, “I can tell you they’re more aware; but I don’t know how much change it is.” (PM)

Agency leadership described how there were attempts to break down the silos between residential and primary care but still emphasized some challenges. Leadership explained that although PGLB allowed for a better way to communicate about health issues within the agency, they still struggled to integrate health completely.

We’ve been siloed for a long time. The healthcare piece has been super tiny within Site 2 for a long time, and it only began to expand in the last couple years. . . PGLB was one of those concrete long-term and we got together and communicate around the issue. That’s been good from an internal organizational structural communication piece. (PM)

Despite some challenges, stakeholders described desired changes within the agency around health prioritization such as plans to embed a full-time nurse in new residential sites along with an expansion of a series of health promotion groups (e.g. diabetes support group, smoking cessation, overeaters group). One program manager expressed hope in their ability to further integrate physical health with the addition of the nurse role,

More around physical health; connecting people. Resource connection. Helping people deal with acute issues because they haven’t been to primary (care) in a long time, or they don’t want to go. Helping people who have been discharged from the hospital recently. . . [Staff] Saying, ‘so and so came home with all these bands on their arm. We don’t know what’s going on. They just showed up last night; can you help us figure out how they’re doing.’ She’ll [Nurse] deal with acute stuff. (PM)

Site 3 Overall, agency leadership described Site 3’s desires to further increase the integration of healthcare services, yet minimal changes (i.e. status quo) were observed to have occurred by the end of the trial. During phase 1 interviews, Site 3 leaders shared ways in which physical health was being addressed but was described as “very basic”:

I’ll be frank. Yes, we refer. We request a [physical] annually. We do the best that we can in terms of diets and wellness. We do monitor medication at the transitional level. But it’s very basic. We are looking to initiate Wellness Recovery Action Plans (WRAP) to see what that would look like. That helps the counselors better understand what the client wants and needs. But we’re not there yet. (PM)

A leader at Site 3 noted that because of the lack of existing health integration efforts, PGLB came at a time in which the agency was ready for change. One program manager described,

…last three years our culture has changed. Our thought process has changed. We’ve had more restructuring and hiring and new ideas. It was perfect timing because it was around the time when we started thinking about aging in place. We started thinking ‘oh my god maybe a traveling RN to help us understand anything medical would be good.’ It fit right in. (PM)

By phase 2, Site 3 leadership acknowledged a shift in how health was discussed within the agency after PGLB was implemented. One program manager noted,

It’s started to shift the conversation in terms of the importance. Site 3 is a bit behind in every way in terms of new models and where the State is moving. We’re making very quick changes that will increase that. A lot of that goes to the Healthy Lifestyle… that’s been a big part of it. Thinking about how to do groups, and how do we integrate the peers. (PM)

Despite having some initial conversations regarding further integrating health, Site 3 leadership admitted to being “a little behind” and felt there still weren’t any concrete changes in terms of the types of services offered to clients by phase 2:

I don’t think there have been any significant changes. Since [Leadership role] has gotten here, there is a closer working relationship with (Partner Physical Health Clinic). She has instituted a weekly huddle with the staff. But in terms of the actual services provided, no, I don’t think there have been any changes. (D)

Integration of quantitative and qualitative findings

Across all study sites, PGLB was delivered by peer specialists with high levels of fidelity and PGLB recipients reported high levels of satisfaction with the intervention indicating that supportive housing agencies with the appropriate supports can successfully deliver this peer-led healthy lifestyle intervention. The success of the PGLB intervention seems to be related to high levels of fidelity and a clear relative advantage over UC services, particularly in settings with no changes in healthcare integration for UC services (e.g. Site 3) where PGLB may represent a new type of health intervention not currently offered in these service settings.

Heterogeneity in the effectiveness of an intervention across multiple sites reflects the interplay of its implementation with the local context in which it is delivered [ 21 ]. This study applied a matrixed multiple case study design to identify implementation outcomes and changes in agency context associated with the success of a peer-led healthy lifestyle intervention across three supportive housing agencies serving people with SMI. Introducing a new intervention into an organization is a complex social process shaped by the fit of the intervention with the local context of the organization [ 22 ]. The site differences in intervention outcomes found in our study highlight the importance of discerning unique facets of this complex interaction to help identify the local conditions that can impact the implementation and clinical outcomes of an intervention. Slight differences in PGLB recipients’ satisfaction with UC, and changes in the delivery and integration of usual healthcare services delivered at each site as described by agency leaders during our study seemed to have contributed to the site differences in health outcomes observed in our trial.

Fidelity is a central implementation outcome that captures the degree to which an intervention is delivered as prescribed [ 10 ]. Failure to meet intervention fidelity during implementation may explain why interventions fail to yield effectiveness [ 23 , 24 ]. We know of no study to date that has reported fidelity findings related to the delivery of healthy lifestyle interventions for people with SMI, particularly those delivered by peer specialists within the context of an effectiveness trial [ 25 ]. Our findings address this important gap and indicate that with the appropriate training and supervision peer specialists can deliver a manualized 12-month health lifestyle intervention with high fidelity in community settings like supportive housing agencies.

Acceptability is also an important implementation outcome as low levels of acceptability by recipients of an intervention have been linked to low attendance, treatment disengagement, and poor intervention outcomes [ 12 ]. Our peer-led health intervention was well received by study participants in all study sites as evidenced by the high scores of PGLB recipients’ satisfaction with the intervention. Moreover, our findings indicate that a potential interaction between PGLB recipients’ low levels of acceptability with UC services delivered at study sites, high levels of fidelity to PGLB delivered by peer specialists, and minimal changes in the integration of health care services at study sites reported by agency leaders during our trial could help explain the site differences in study outcomes we observed in our trial. Site 3 was the only study site in which PGLB significantly outperformed UC in helping participants achieve clinically significant weight loss, and clinically significant reductions in cardiovascular disease risk [ 9 ]. This site also reported the highest levels of PGLB fidelity, the lowest levels of PGLB recipients’ satisfaction with UC health services compared to the other study sites, and few changes described by agency leaders in the integration of health care services throughout our study. This finding could suggest that PGLB may have had a potential significant relative advantage over UC, producing better outcomes for participants who received PGLB at Site 3 compared to those who only received UC services at this site. Relative advantage is a key concept from the diffusion of innovation theory that captures the degree to which stakeholders, in our case intervention recipients, perceive the practice innovation being implemented in an organization as being better that the status quo [ 26 , 27 ]. The success of the PGLB intervention was observed when high levels of fidelity were achieved in settings with minimal changes in healthcare integration, where PGLB may represent a novel type of health intervention not currently offered. Future work is needed to examine whether the success of PGLB is linked to a potential relative advantage over UC services, particularly in these types of settings.

Furthermore, a key finding that emerged from our qualitative analysis revealed contextual influences that impacted the level of integration of physical health services within each agency over time. A heightened prioritization of addressing physical health was noted by leadership across all sites with varying degrees of successful integration into UC, with Site 3 having minimal changes when compared to Site 1 and 2 following the implementation of PGLB. Therefore, identifying organizations in need of more integrated physical health services while ensuring high fidelity and maintaining participant satisfaction with the intervention are important considerations in the implementation of peer-led healthy lifestyle interventions among this population. Altogether, these findings highlight the importance of shifting questions regarding effectiveness from whether PGLB did or did not work, to a more nuanced understanding of the conditions that could have contributed to PGLB’s success in some sites versus others.

Limitations

There are several limitations to this study. First, our qualitative data assessing the changes in health care integration depended on a small sample of leadership roles (e.g. directors and program managers) from the participating sites. Further, we were unable to retain all those who participated in phase 1 interviews during the phase 2 interviews, given leadership staff turnover. However, we utilized these interviews to longitudinally compare how agency leaders discussed UC services before and after the implementation of PGLB to determine the extent of changes in healthcare integration per study site. Second, our quantitative data did not examine provider’s acceptability of PGLB or UC. However, we did have a broad understanding of UC by including the entire sample of participants who were randomized to the intervention. Third, only a small set of indicators across study sites were examined to understand the varying effects across the three sites. Fourth, we conducted our study in three supportive housing agencies that would be considered early adopters which may not be representative of other supportive housing agency contexts that do not typically provide health-related services. Finally, we examined implementation outcomes and changes in agency context for a peer-led healthy lifestyle intervention in a specific service setting and population. Future work should consider a larger clustered randomized study at the site level and include additional implementation outcomes (e.g. cost, adoption) to ensure the identification of a more comprehensive combination of implementation outcomes that can contribute to differing study outcomes in multisite trials.

To help organizations bridge the gap between research and practice it is important to move beyond the question of whether a new intervention works. The matrixed multiple case study methodology is a useful approach to identify implementation outcomes contributing to the heterogeneity of multisite implementation trial results. This mixed method approach provides a systematic process for clarifying what worked, for whom, and under which conditions, which is critical since it can help future implementation efforts know what resources, actions, and health integration conditions are needed to successfully implement an intervention like PGLB.

The authors report no conflict of interest.

This study was funded by grants from the National Institute of Mental Health (R01MH104574 and T32MH019960) and the Center for Dissemination and Implementation at Washington University in St Louis (CDI2020-01-PG).

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by the Washington University in St. Louis Institutional Review Board.

Informed consent was obtained from all individual participants included in the study.

Not applicable since no animals were in involved this study.

Study registration: This study was pre-registered at Clinicaltrials.gov: NCT0217564 https://clinicaltrials.gov .

The analysis plan was not formally pre-registered.

De-identified data from this study are not available in a public archive. De-identified data from this study may be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.

Analytic code used to conduct the analyses presented in this study us not available in a public archive. They may be available by emailing the corresponding author.

Materials used to conduct the study are not publicly available.

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Lifestyle Medicine Implementation in 8 Health Systems: Protocol for a Multiple Case Study Investigation

Affiliations.

  • 1 Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.
  • 2 American College of Lifestyle Medicine, Chesterfield, MO, United States.
  • 3 School of Health Sciences, Oakland University, Rochester, MI, United States.
  • PMID: 38320320
  • PMCID: PMC10973966
  • DOI: 10.2196/51562

Background: Lifestyle medicine (LM) is the use of therapeutic lifestyle changes (including a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection) to prevent and treat chronic illness. Despite growing evidence, LM is still not widely implemented in health care settings. Potential challenges to LM implementation include lack of clinician training, staffing concerns, and misalignment of LM services with fee-for-service reimbursement, but the full range of factors facilitating or obstructing its implementation and long-term success are not yet understood. To learn important lessons for success and failure, it is crucial to understand the experiences of different LM programs.

Objective: This study aims to describe in depth the protocol used to identify barriers and facilitators impacting the implementation of LM in health systems.

Methods: The study team comprises team members at the American College of Lifestyle Medicine (ACLM), including staff and researchers with expertise in public health, LM, and qualitative research. We recruited health systems that were members of the ACLM Health Systems Council. From among 15 self-nominating health systems, we selected 7 to represent a diversity of geographic location, type, size, expertise, funding, patients, and LM services. Partway through the study, we recruited 1 additional contrasting health system to serve as a negative case. For each case, we conducted in-depth interviews, document reviews, site visits (limited due to the COVID-19 pandemic), and study team debriefs. Interviews lasted 45-90 minutes and followed a semistructured interview guide, loosely based on the Consolidated Framework for Implementation Research (CFIR) model. We are constructing detailed case narrative reports for each health system that are subsequently used in cross-case analyses to develop a contextually rich and detailed understanding of various predetermined and emergent topics. Cross-case analyses will draw on a variety of methodologies, including in-depth case familiarization, inductive or deductive coding, and thematic analysis, to identify cross-cutting themes.

Results: The study team has completed data collection for all 8 participating health systems, including 68 interviews and 1 site visit. We are currently drafting descriptive case narratives, which will be disseminated to participating health systems for member checking and shared broadly as applied vignettes. We are also conducting cross-case analyses to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation, and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout.

Conclusions: This protocol paper offers real-world insights into research methods and practices to identify barriers and facilitators to the implementation of LM in health systems. Findings can advise LM implementation across various health system contexts. Methodological limitations and lessons learned can guide the execution of other studies with similar methodologies.

International registered report identifier (irrid): DERR1-10.2196/51562.

Keywords: healthy lifestyle; implementation science; lifestyle medicine; multiple case study; noncommunicable diseases; prevention; qualitative methods.

©Meghan L Ames, Micaela C Karlsen, Samantha M Sundermeir, Neve Durrwachter, Tyler A Hemmingson, Melissa M Reznar, Kara Livingston Staffier, Bruce Weeks, Joel Gittelsohn. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.03.2024.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: MCK, TAH, and KLS are employed by the American College of Lifestyle Medicine. The other coauthors receive consulting payments from the American College of Lifestyle Medicine.

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[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR312.32]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
SUBCHAPTER D - DRUGS FOR HUMAN USE
Sec. 312.32 IND safety reporting.
The following definitions of terms apply to this section:

means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

or An adverse event or suspected adverse reaction is considered "life-threatening" if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death.

or An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, "reasonable possibility" means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug.

or An adverse event or suspected adverse reaction is considered "unexpected" if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the investigator brochure referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the investigator brochure listed only cerebral vascular accidents. "Unexpected," as used in this definition, also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.

The sponsor must promptly review all information relevant to the safety of the drug obtained or otherwise received by the sponsor from foreign or domestic sources, including information derived from any clinical or epidemiological investigations, animal or in vitro studies, reports in the scientific literature, and unpublished scientific papers, as well as reports from foreign regulatory authorities and reports of foreign commercial marketing experience for drugs that are not marketed in the United States.

The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any investigator's IND) in an IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than 15 calendar days after the sponsor determines that the information qualifies for reporting under paragraph (c)(1)(i), (c)(1)(ii), (c)(1)(iii), or (c)(1)(iv) of this section. In each IND safety report, the sponsor must identify all IND safety reports previously submitted to FDA concerning a similar suspected adverse reaction, and must analyze the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information.

The sponsor must report any suspected adverse reaction that is both serious and unexpected. The sponsor must report an adverse event as a suspected adverse reaction only if there is evidence to suggest a causal relationship between the drug and the adverse event, such as:

The sponsor must report any findings from epidemiological studies, pooled analysis of multiple studies, or clinical studies (other than those reported under paragraph (c)(1)(i) of this section), whether or not conducted under an IND, and whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug. Ordinarily, such a finding would result in a safety-related change in the protocol, informed consent, investigator brochure (excluding routine updates of these documents), or other aspects of the overall conduct of the clinical investigation.

The sponsor must report any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity, or reports of significant organ toxicity at or near the expected human exposure. Ordinarily, any such findings would result in a safety-related change in the protocol, informed consent, investigator brochure (excluding routine updates of these documents), or other aspects of the overall conduct of the clinical investigation.

The sponsor must report any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The sponsor must submit each IND safety report in a narrative format or on FDA Form 3500A or in an electronic format that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files). The sponsor may submit foreign suspected adverse reactions on a Council for International Organizations of Medical Sciences (CIOMS) I Form instead of a FDA Form 3500A. Reports of overall findings or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical studies must be submitted in a narrative format. Each notification to FDA must bear prominent identification of its contents, i.e., "IND Safety Report," and must be transmitted to the review division in the Center for Drug Evaluation and Research or in the Center for Biologics Evaluation and Research that has responsibility for review of the IND. Upon request from FDA, the sponsor must submit to FDA any additional data or information that the agency deems necessary, as soon as possible, but in no case later than 15 calendar days after receiving the request.

The sponsor must also notify FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than 7 calendar days after the sponsor's initial receipt of the information.

FDA may require a sponsor to submit IND safety reports in a format or at a frequency different than that required under this paragraph. The sponsor may also propose and adopt a different reporting format or frequency if the change is agreed to in advance by the director of the FDA review division that has responsibility for review of the IND.

A sponsor of a clinical study of a drug marketed or approved in the United States that is conducted under an IND is required to submit IND safety reports for suspected adverse reactions that are observed in the clinical study, at domestic or foreign study sites. The sponsor must also submit safety information from the clinical study as prescribed by the postmarketing safety reporting requirements (e.g., §§ 310.305, 314.80, and 600.80 of this chapter).

Study endpoints (e.g., mortality or major morbidity) must be reported to FDA by the sponsor as described in the protocol and ordinarily would not be reported under paragraph (c) of this section. However, if a serious and unexpected adverse event occurs for which there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis), the event must be reported under § 312.32(c)(1)(i) as a serious and unexpected suspected adverse reaction even if it is a component of the study endpoint (e.g., all-cause mortality).

(1) The sponsor must promptly investigate all safety information it receives.

A safety report or other information submitted by a sponsor under this part (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the sponsor or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse event. A sponsor need not admit, and may deny, that the report or information submitted by the sponsor constitutes an admission that the drug caused or contributed to an adverse event.

[75 FR 59961, Sept. 29, 2010]

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Rapper Sean “Diddy” Combs’ accusers may soon testify before a federal grand jury and have already been interviewed by investigators, sources told CNN , days after he was hit with his seventh civil sexual assault lawsuit in less than a year—all of which he has denied.

Combs has denied wrongdoing across all of the lawsuits and not been criminally charged. (Photo by ... [+] Paras Griffin/Getty Images)

May 29 Federal investigators may bring Combs’ accusers to testify before a grand jury soon and most plaintiffs who have filed lawsuits against the rapper have already been interviewed by investigators, sources told CNN —a move that could indicate prosecutors are looking to charge somebody, though no charges have been filed yet.

May 24 Plaintiff April Lampros accuses Combs in a lawsuit filed in New York on Thursday of sexual assault over four “terrifying sexual encounters” between 1995 and 2001, including three incidents of rape and one instance of Combs forcing her to take ecstasy.

May 22 Former model Crystal McKinney files a lawsuit in Manhattan federal court accusing the rapper of drugging and sexually assaulting her at his New York recording studio in 2003.

May 19 Cassie Ventura, Combs’ ex-girlfriend, speaks out after CNN obtained a 2016 video of Combs attacking her in a hotel hallway, stating on Instagram Thursday morning that domestic violence “broke” her and she will “always be recovering” from her past—Combs later apologized for the video.

February 26 In February, producer Rodney “Lil Rod” Jones sues the rapper in New York in February and alleges he was “subjected to unwanted advances by associates of Diddy at his direction” and was forced to engage in relations with sex workers he hired. In a set of widely covered allegations, Jones says in the lawsuit that Combs regularly hosted “sex-trafficking parties” with underage women and illegal drugs, and implies record label executives who looked the other way financially benefited from access to celebrities and dignitaries like the British royal Prince Harry, who is not accused of any wrongdoing or of attending parties himself (Combs’ attorney tells the Los Angeles Times the suit includes “reckless name-dropping about events that are pure fiction”).

December 6 Combs is hit with another sexual assault suit in December, accusing the rapper of drugging and participating in a gang rape of the unnamed woman in 2003, when the accuser was 17 years old.

November 23 A woman named Joie Dickerson-Neal alleges in a lawsuit Combs drugged her, sexually assaulted her and secretly recorded the assault while she was a college student in 1991.

November 23 An anonymous plaintiff accuses Combs and singer-songwriter Aaron Hall of raping her and a friend in 1990 or 1991 after meeting at an MCA Records event in New York—a suit that, like the Dickerson-Neal complaint, was filed shortly before the expiration of a New York law temporarily allowing lawsuits for older assault allegations that would ordinarily be past the statute of limitations.

November 17 Ventura’s $30 million suit is settled the day after it was filed for an undisclosed amount, with Ventura telling CNN she chose to “resolve this matter amicably,” while Combs’ attorney says the settlement was “in no way an admission of wrongdoing” and didn’t change his denial of the allegations.

November 16 Cassie Ventura files the suit against Combs, alleging he raped her in 2018 and subjected her to a years-long abusive relationship that included physical abuse and his assertion of “complete control” over her personal and professional life.

Get Forbes Breaking News Text Alerts: We’re launching text message alerts so you'll always know the biggest stories shaping the day’s headlines. Text “Alerts” to (201) 335-0739 or sign up here : joinsubtext.com/forbes.

What We Don’t Know

Why Combs’ homes in Los Angeles and Miami were raided by federal Homeland Security Investigations agents in March. The agency did not elaborate on the investigation that prompted the searches, though NBC News and the Associated Press reported the searches stem from a sex trafficking probe. Combs has not been charged or accused by federal prosecutors of a crime, and it’s unclear whether charges against anybody are forthcoming.

Combs, 54, has denied all of the allegations against him, with his attorneys characterizing some of the lawsuits and their accusations to Forbes as money grabs , “ baseless ” or “ sickening .” Combs has not been criminally charged.

What To Watch For

An upcoming docuseries. Producer Curtis “50 Cent” Jackson said Tuesday that Netflix had won a “bidding war” for a docuseries about the string of recent abuse, rape and sex trafficking allegations against Combs. Jackson confirmed in a tweet Tuesday that the streamer bought the G-Unit Film & Television series about Combs he first started teasing in December, adding that, “if more victims keep coming out, I’m gonna need more episodes.” Proceeds from the film go to victims of sexual assault, Jackson said in November.

On Sunday, Combs posted to Instagram to apologize for his “disgusting” behavior in the surveillance video that showed him grabbing, dragging and kicking Cassie in 2016. The video seemed to back up much of the claims Ventura made in her November lawsuit, which an attorney for Combs called “offensive and outrageous” at the time. Los Angeles District Attorney’s Office called the video “extremely disturbing” and “difficult to watch” but said no charges would be filed because the apparent assault took place beyond the statue of limitation in California. In his apology video, Combs said the events occurred in "one of the darkest times” of his life and said he was “truly sorry” for his behavior. Meredith Firetog, one of Ventura's lawyers, later slammed the apology as disingenuous in a statement and said it was “more about himself than the many people he has hurt.” In Ventura’s November lawsuit, she accused Combs of paying the hotel in which the surveillance video was captured $50,000 for the footage.

Surprising Fact

Combs’ former personal chef, Cindy Rueda, accused Combs in a since-settled 2017 sexual harassment lawsuit of having her prepare and serve food to the rapper and his guests while they were engaged in sexual activity or right after they had done so.

Key Background

The allegations contained in lawsuits against Combs date as far back as the 1990s, when he founded his own record label, Bad Boy Records, which Rolling Stone has called “one of the most influential hip-hop labels of all time.” The label has signed major artists like The Notorious B.I.G., Janelle Monáe and Cassie, and has put out several of Combs' own albums, including "Press Play" and "Last Train To Paris.” Combs sold a 50% stake in Bad Boy to Warner Music Group in a reported $30 million deal in 2005. Combs has built a fortune through Bad Boy Records, several liquor brands, a fashion label and other ventures. He sold his share in the DeLeón tequila brand for $200 million earlier this year. He was ranked No. 14 on Forbes' list of the highest-paid entertainers in 2022, making an estimated $90 million that year. One of the rapper’s raided homes is located in Holmby Hills, an affluent neighborhood where Combs purchased a home for $40 million ten years ago.

Further Reading

Feds Search Sean ‘Diddy’ Combs’ L.A. And Miami Homes (Forbes)

Sean Combs Accused Of Sexually Assaulting 17-Year-Old In Latest Lawsuit (Forbes)

Rapper Sean ‘Diddy’ Combs Accused Of Rape And Sexual Assault In Two New Separate Lawsuits (Forbes)

Rapper Sean ‘Diddy’ Combs Accused Of Rape And Sex Trafficking By Singer And Former Partner (Forbes)

Antonio Pequeño IV

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Keeping Track of the Trump Criminal Cases

By The New York Times Updated May 30

Donald J. Trump is facing multiple legal challenges related to his business and political activities, with the cases expected to play out over the coming months in the midst of the 2024 election season. Here is a guide to the major criminal cases involving the former president.

Latest development May 30

Former President Donald J. Trump was found guilty of falsifying business records, related to the reimbursement of hush money paid to the porn star Stormy Daniels to cover up a sex scandal around the 2016 presidential election. He is the first president to be convicted of a crime.

Where Does Each Case Stand?

Mr. Trump is at the center of at least four separate criminal cases, at both the state and federal levels, into matters related to his business and political careers.

Federal Jan. 6 Case ›

Related to Mr. Trump’s efforts to retain power after the 2020 election and the Jan. 6, 2021, attack on the Capitol. Expand summary +

Election Case in Georgia ›

Related to efforts to reverse Mr. Trump’s 2020 election loss in Georgia. Expand summary +

Classified Documents Case ›

Related to Mr. Trump’s handling of sensitive government documents he took with him when he left office. Expand summary +

Manhattan Hush-Money Case ›

Related to payments to cover up a sex scandal during the 2016 presidential campaign. Expand summary +

What Are the Charges Against Trump?

Mr. Trump faces dozens of counts across the four cases in which he has been charged.

Federal Jan. 6 Case

Election case in georgia, classified documents case, manhattan hush-money case, who are the prosecutors in each case.

Jack Smith was appointed by Attorney General Merrick B. Garland in November to investigate two federal cases against Mr. Trump: his attempt to overturn the 2020 election and his retention of classified materials. Two cases against Mr. Trump at the state level are led by district attorneys in New York and Fulton County, Ga.

Jan. 6 Case, Classified Documents Case

Special counsel

Fani T. Willis

Fulton County district attorney

Alvin L. Bragg

Manhattan district attorney

What Comes Next?

Mr. Trump has been indicted in four inquiries, with the cases unfolding as he runs for president again. In the first case to reach a verdict, related to hush money paid to cover up a sex scandal around the 2016 presidential election, Mr. Trump was found guilty on all 34 counts. He is expected to appeal.

Jan. 6 Case

Investigation began, charges filed.

Alleged crime took place in 2017. Investigation began in 2018.

Trial began

Due to a technical error, an earlier version of a graphic with this story showed an incorrect date for the start of the hush-money investigation. It was 2018, not 2019.

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First human case of H5N2 bird flu died from multiple factors: WHO

bird flu

A man infected with H5N2 bird flu, the first confirmed human infection with the strain, died from multiple factors, the WHO said on Friday, adding that investigations were ongoing.

The World Health Organization on Wednesday announced that the first laboratory-confirmed human case of infection with H5N2 avian influenza virus had been reported from Mexico.

Mexico's health ministry said the 59-year-old man had "a history of chronic kidney disease, type 2 diabetes (and) long-standing systemic arterial hypertension".

He had been bedridden for three weeks before the onset of acute symptoms, developing fever, shortness of breath, diarrhea, nausea and general malaise on April 17.

The man was taken to hospital in Mexico City a week later and died that day.

"The death is a multi-factorial death, not a death attributable to H5N2," WHO spokesman Christian Lindmeier told journalists in Geneva on Friday.

His body was tested for flu and other viruses, and H5N2 was detected, Lindmeier said.

Seventeen hospital contacts were identified but all tested negative for influenza.

In the man's place of residence, 12 contacts in the weeks beforehand were identified. All likewise tested negative.

"The infection of H5N2 is being investigated to see whether he was infected by somebody visiting or by any contact with any animals before," Lindmeier said.

The WHO on Wednesday said that the source of exposure to the virus was unknown, though H5N2 viruses have been reported in poultry in Mexico.

The United Nations' health agency assesses the current risk to the general population posed by the virus as low.

Two-year-old catches H5N1

Later on Friday, the WHO said a two-and-a-half-year-old girl tested positive for H5N1, a different strain of bird flu, and needed hospital intensive care treatment in Australia after returning from India.

"This is the first confirmed human infection caused by avian influenza A(H5N1) virus detected and reported by Australia," a statement said.

"The exposure likely occurred in India" where the girl had traveled, and where this group of "viruses has been detected in birds in the past," the WHO added.

The girl had traveled to Kolkata from February 12 to 29, returned to Australia on March 1 and was admitted to a hospital in the southeastern Victoria state the following day.

The girl is reported to be well, the WHO said, while no relatives in either Australia or India have developed symptoms.

H5N1 spread

H5N1 first emerged in 1996 but since 2020, the number of outbreaks in birds has surged exponentially, alongside an increase in the number of infected mammals.

The strain has led to the deaths of tens of millions of poultry, with wild birds and land and marine mammals also infected.

The WHO said that from 2003 to May 22 this year, 891 cases of human H5N1 infections, including 463 deaths, were reported from 24 countries.

The human cases recorded in Europe and the United States since the virus surged have largely been mild.

H5N1 has been spreading for weeks among dairy cow herds in the United States, with a small number of cases reported among humans.

But none of them are human-to-human infections, with the disease jumping instead from cattle to people, authorities have said.

Low food risk

Markus Lipp, senior food safety officer at the UN's Food and Agriculture Organization, said the risk of contracting avian influenza though eating poultry was "negligibly low".

"In all the hundred years of avian influenza... there has not been any demonstrated food-borne transmission," he told the media briefing via video-link from the FAO's headquarters in Rome.

"Humans do not have avian influenza receptors in their gastro-intestinal tract, contrary to certain animal species, as far as we know. So there is a very slim likelihood, just from that perspective."

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An Investigation of Couples’ Help-Seeking: A Multiple Case Study

  • Original Paper
  • Published: 05 September 2017
  • Volume 40 , pages 110–117, ( 2018 )

Cite this article

multiple case study investigation

  • Kenneth J. Parnell   ORCID: orcid.org/0000-0001-8846-9476 1 ,
  • Michael J. Scheel 2 ,
  • Chelsi Klentz Davis 2 &
  • Whitney W. Black 3  

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11 Citations

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Research of the effectiveness of couples counseling has demonstrated clear benefits (e.g.; Lebow et al. ( Journal of Marital and Family Therapy, 38 (1):145–168, 2012)). However, relatively few couples initiate counseling and seek help. This exploratory study employed a qualitative multiple case study approach to heterosexual couples ( N  = 7) that were currently in the process of seeking conjoint therapy to identify intra and interpersonal factors that influence relational help-seeking. Participants reported that female partners were the first to perceive a problem and suggest seeking professional help. In turn, male partners reported feeling a sense of failure and fear of judgment when considering couples counseling. Patterns of blame, withdrawal, and aggression contributed to increased distress, which eventually led these couples to counseling, some with mixed-agendas for services.

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Kenneth J. Parnell

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Parnell, K.J., Scheel, M.J., Davis, C.K. et al. An Investigation of Couples’ Help-Seeking: A Multiple Case Study. Contemp Fam Ther 40 , 110–117 (2018). https://doi.org/10.1007/s10591-017-9427-9

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Published : 05 September 2017

Issue Date : March 2018

DOI : https://doi.org/10.1007/s10591-017-9427-9

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Case Investigation and Patient Interview

At a glance.

• Promptly investigate 1 each confirmed case of malaria. Investigations should establish the presumed route of infection to determine case classification.

There are multiple ways to submit malaria case investigation reports to CDC. However, the preference is to submit them using the CDC malaria electronic case report form (eCRF) or via HL7 using the malaria message mapping guide (MMG) standards.

  • CDC supports HL7 reporting for malaria via two MMGs: GenV2 and the malaria specific MMG. Reach out to the CDC malaria surveillance epidemiologist to discuss onboarding for the malaria MMG. Reporting via GenV2 alone does not cover all aspects of the case investigation and therefore full case reports should still be sent to CDC in another format.
  • To complete a malaria electronic case report form (eCRF), follow the instructions provided on pages 4-5 of the CDC eCRF. If the CDC eCRF is not used then follow jurisdiction-specific recommendations to complete the investigation using a customized investigation form and online reporting system.
  • Page 3 of the eCRF form collects additional data for multiple hospitalizations, lab tests, travel histories, and other data.
  • Note that Chemoprophylaxis (section 5 a – c of the malaria case report form) refers to medication taken before, during, and after travel to prevent malaria illness. Treatments given to cure the acute illness should be documented in section 5 h of the malaria case report form.
  • Submit individual eCRFs (or .csv reports derived from the pdf files) to the CDC domestic malaria surveillance epidemiologist or to the mailbox [email protected] via secure email. Note that some secure email systems require individual credentials, which aren’t accessible from the group inbox. Do not include personally identifiable information (PII) in the body or subject of the email.
  • The infecting species should be determined, and potentially relapsing cases should be carefully investigated to assess if the person had traveled since their previous illness.
  • CDC classifies cases according to where the person acquired the infection. If the initial infection was acquired internationally, then the relapse case is classified as imported. If the initial infection was acquired through a local exposure, for example by locally acquired mosquito transmission, then those relapse cases will also be classified as introduced.
  • There are rare case reports for persons who have a late recrudescence, occurring many months or years after an earlier illness. A late recrudescence is difficult to prove. These rare cases must be thoroughly investigated to rule out other exposures and are often classified as cryptic.

Case investigation

Provide as much information as possible for the case investigation. CDC uses data to classify risk groups, describe disease severity, and determine if treatment follows CDC’s guidelines.

  • More information on malaria diagnosis and treatment can be found in the Malaria Clinical Guidelines Quick Reference (Appendix C).
  • If country-specific travel details are missing, then indicate the Region traveled. Partial dates (year and month, or year alone) can be provided. Because travel information is used to classify case acquisition, it is not recommended to indicate ‘unknown’ for a person who traveled in multiple countries.
  • Please follow the CSTE guidelines for completing the “Country of Usual Residence” data element. If the person is establishing residence in the U.S., then “Country of Usual Residence” should be “United States.” However, if the malaria exposure occurred when they were previously residents of another country then the “Subject’s country of residence prior to most recent travel” should be their former country of residence.

During the patient interview, counsel all patients diagnosed with malaria to avoid mosquito bites during their convalescence.

CDC provides malaria consultations to clinical providers through the CDC Malaria Hotline. If we receive an inquiry from the Malaria Hotline regarding a patient who has delayed parasite clearance or who has recurrent parasitemia within 4 weeks of initial treatment, then we usually request whole blood specimens (pre and/or post-treatment) be sent to CDC for molecular surveillance. In that situation CDC will reach out to the state health department epidemiologists to coordinate specimen shipping from the hospital to the PHL and then to CDC.

For patients who are lost to follow-up, rely on medical records or healthcare provider information to complete the malaria case report. The most important task is to try to determine how malaria was acquired. If it is known that the patient traveled internationally but if all details are not known, then indicate “Yes, traveled outside the U.S.”, and leave the specific country and travel dates blank. This will result in classifying the case as “Imported” with travel details “Unknown.” If no information is available, then indicate that the case importation status is “Unknown.”

If you have any questions or concerns about a case, including the timing of travel and illness onset, reach out to the CDC malaria surveillance epidemiologist or the CDC Malaria Hotline (after hours).

If the initial case investigation does not yield a recent travel history (in the past two years) or prior malaria illness (within 2 – 3 years), then an enhanced investigation is warranted to assess their classification as possibly cryptic or locally acquired. If you think an enhanced investigation is necessary, please reach out to your state health department (if applicable) and the CDC Malaria Branch immediately ( [email protected] or 770-488-7788).

Enhanced investigation

For cases under enhanced investigation, a more detailed patient interview should review the risk factors for acquiring malaria, including detailed travel history, sick contacts (e.g., household members), occupation, outdoor activities:

  • Identify specific dates the patient was in a malaria-endemic country and the areas visited.
  • If the person previously lived in a malaria-endemic country, when did they immigrate to the U.S. or to another non-endemic country?
  • If yes, specific dates and if (and what) treatment received?
  • If diagnosed with a relapsing species ( P. vivax or P. ovale ), did they receive antirelapse therapy (primaquine for 14 days, or a single dose of tafenoquine)?
  • Ask about blood exposures such as blood transfusions, organ transplants, needlestick injuries, unsafe needle sharing, or home tattoos.
  • Prior to illness, were there any visitors, household members, co-workers who were sick with malaria or another febrile illness?
  • Has the patient been in an area where Babesia parasites are transmitted? Has the patient had a recent tick bite?
  • Has the patient recently slept outdoors? Are they currently or have they recently experienced unstable housing or homelessness?

Obtain additional details from the medical record including past medical history (especially immunocompromising conditions, asplenia, and pregnancy status), recent hospitalizations and medical procedures.

Please contact CDC (CDC malaria surveillance epidemiologist or the CDC Hotline [email protected] ) for malaria diagnosed in a newborn without travel (congenital malaria). Congenital cases occurring in non-endemic settings have been reported weeks or up to two months after birth.

__________________________________________________________________________________

1 Jurisdiction-specific recommendations should be followed. Typically, the malaria case investigations are initiated between 24 hours and one week from the notification. If there is concern that the case may be locally acquired or doesn't have a travel history to a country with ongoing malaria transmission in approximately the previous two years, or if the patient is severely ill, then urgency is recommended to ensure timely public health responses and appropriate treatment.

Malaria is a serious disease caused by a parasite that infects the Anopheles mosquito. You get malaria when bitten by an infective mosquito.

For Everyone

Health care providers, public health.

Here are the states where 2020 Trump electors have been charged

Republicans around the country have been charged with forgery and other crimes for filing paperwork claiming to be presidential electors in states that Donald Trump lost

multiple case study investigation

Republicans in five states are facing charges after submitting documents to Congress falsely claiming that Donald Trump won the 2020 presidential election in their states. Investigations are ongoing and more charges could be filed.

Every four years, presidential electors in every state meet on the same day in December to submit electoral ballots to federal authorities so Congress can finalize the results. On that day in 2020, Republicans in seven states signed ballots for Trump even though Joe Biden had won in their states. In five of the states, they claimed to be legitimate electors even though they were not. In the other two, they signed paperwork saying their states’ electoral votes for Trump should be counted only if Biden’s victory was overturned.

State and local prosecutors have investigated and issued charges. The Justice Department is also investigating the issue. Here’s a look at where the cases stand in each state.

Arizona: Charges filed

An Arizona grand jury in April indicted 11 state Republicans , as well as seven attorneys, aides and advisers affiliated with Trump’s 2020 presidential campaign on felony charges over their alleged efforts to subvert Biden’s 2020 win in the state.

The group is charged on counts pertaining to conspiracy, fraudulent schemes and forgery. The charges were announced by Arizona Attorney General Kris Mayes (D), capping the end of a year-long investigation into how the elector strategy played out in Arizona. A number of those who were charged immediately denied the accusations or insisted they were politically motivated and vowed to fight them in court. George Terwilliger, a lawyer representing former Trump White House chief of staff Mark Meadows, called the indictment “a blatantly political and politicized accusation” that “will be contested and defeated.”

Those indicted include Meadows, attorneys Rudy Giuliani, Jenna Ellis, John Eastman and Christina Bobb, top campaign adviser Boris Epshteyn and former campaign aide Mike Roman.

Also charged are the Republicans who signed paperwork on Dec. 14, 2020, that falsely purported Trump was the rightful winner, including former state party chair Kelli Ward, state Sens. Jake Hoffman and Anthony Kern, and Tyler Bowyer, a GOP national committeeman and chief operating officer of Turning Point Action.

Trump was not charged, but he is described in the indictment as an unindicted co-conspirator.

Georgia: Charges filed

Three of the 16 Republicans who claimed to be electors in Georgia were charged in August 2023 as part of a sweeping indictment alleging Trump and others conspired to steal the 2020 election. The three would-be electors were charged with racketeering, impersonating a public official, forgery and other crimes. Prosecutors gave many of the others who claimed to be Georgia electors immunity deals as they conducted their broad investigation into Trump.

A grand jury charged several people who assisted the would-be electors with crimes related to their activities, including Trump, Giuliani, Ellis and Roman. Most have pleaded not guilty, but two of them — Ellis and attorney Kenneth Chesebro — reached plea deals with prosecutors in October. Ellis pleaded guilty to a felony count of aiding and abetting false statements and writings, and Chesebro pleaded guilty to a felony count of conspiring to file false documents. The others have pleaded not guilty.

In April, a state prosecutor said he was separately investigating Georgia Lt. Gov. Burt Jones (R), who was among those who claimed to be an elector.

Michigan: Charges filed

State Attorney General Dana Nessel (D) in July 2023 brought the first charges in the country against those purporting to be electors. She charged each of the 16 Republicans with eight felonies, including forgery and conspiracy to commit forgery. Prosecutors in October dropped the charges against one of them, James Renner, in exchange for his testimony. The others have pleaded not guilty.

Nevada: Charges filed

A grand jury in December 2023 charged the six Republicans in Nevada who claimed to be electors with two felonies each, for forging documents and attempting to file false documents. They face up to nine years in prison and up to $15,000 in fines. They have pleaded not guilty.

Among those who were charged are Michael J. McDonald, the chairman of the state Republican Party, and Jim DeGraffenreid, a Republican national committeeman. Those two received limited immunity in the separate federal investigation into election interference that special counsel Jack Smith is conducting.

Wisconsin: Charges filed

State Attorney General Josh Kaul (D) in June charged Chesebro, Roman and Trump attorney James Troupis with one felony count of forgery each.

Separately, Chesebro, Troupis and the 10 Wisconsin Republicans who posed as electors recently settled a lawsuit brought by two of the state’s legitimate electors. As part of the deals, they publicly released records about their efforts and withdrew their false filings from the National Archives. In addition, those who acted as electors agreed not to do so again this year or any time Trump is on the ballot. Troupis paid an unspecified amount of money to those who brought the suit.

New Mexico: No charges filed

State Attorney General Raúl Torrez (D) in January announced that the five Republicans who met as electors in New Mexico were not subject to prosecution under state law. The Republicans in New Mexico included wording in their paperwork saying their electoral votes should be counted only if they were found to be legitimate electors.

Pennsylvania: No charges filed

State investigators determined in early 2022 that Republicans in Pennsylvania probably did not violate the law because they included a caveat in their paperwork saying their electoral votes were to be counted only if a court found they were legitimate electors. The review of the matter was overseen by Democrat Josh Shapiro, who was attorney general at the time and is now governor.

Maegan Vazquez contributed to this report.

multiple case study investigation

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  30. Republicans in multiple states charged for posing as electors

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