case study design method or comprehensive strategy

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Case study: design? Method? Or comprehensive strategy?

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1 Faculty of Health & Applied Social Sciences, School of Nursing & Healthcare Studies, Liverpool John Moores University, Liverpool, UK.
PMID: 15065485
DOI: 10.7748/nr2004.04.11.3.70.c6206

As the case study approach gains popularity in nursing research, questions arise with regard to what it exactly is, and where it appears to fit paradigmatically. Is it a method, a design, are such distinctions important? Colin Jones and Christina Lyons review some of the key issues, with specific emphasis on the use of case study within an interpretevist philosophy.

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Content area

* case study

* paradigms

* flexibility

* multiple sources of evidence

Introduction

Approaches such as case study, and particularly those which utilise qualitative orientations, have been the subject of much debate regarding evidenced based health care. Green (1998) identifies that, despite qualitative approaches sometimes being viewed as unscientific and anecdotal, professions such as medicine and nursing involve more than the application of rigid, formal scientific rules. Equally as important are issues based on personal experience, observation, reflection and the need to translate scientific results into the treatment and care of patients. Green points out that qualitative approaches can help to bridge the gap between formal scientific evidence and clinical practice and more importantly, stresses there should be an acknowledgement that different research questions require different kinds of research.

Some nurses can feel constrained by the 'traditional rigidity' of some research approaches, making the case study (Yin 1993) a welcome alternative. Frequently in nursing studies, an approach with sufficient flexibility at the outset is required, to take into consideration events which may unfold during data collection. Research involving person-centred phenomena often follows an unpredictable path, presenting the researcher with many challenges; it is possible that the case study approach as a 'comprehensive research strategy' could help address some of these problems. However, it is not clear if a case study is a design or a method.

Case study: method or design?

There appears to be confusion between case study being seen as a design or method; many texts use the terms interchangeably, compounding the ambiguity. Even those authors considered to be the 'gurus' of the speciality, use the terms interchangeably (Yin 1993, 1994).

DeVaus (2001) makes a good attempt to clarify the distinction between design and method thus:

'The function of research design is to ensure that the evidence obtained enables us to answer the initial question as unambiguously as possible'

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DOI: 10.7748/NR2004.04.11.3.70.C6206
Corpus ID: 33914953

Case study: design? Method? Or comprehensive strategy?

Colin. Jones , C. Lyons
Published in Nurse Researcher 2004
Medicine, Philosophy

74 Citations

Case study: a bridge across the paradigms., qualitative case study methodology in nursing research: an integrative review., clinical placement and case study methodology: a complex affair., using case study research as a rigorous form of inquiry., modern matrons in an acute setting: a qualitative case study, an examination of case studies in management research: a paradigmatic bridge, a review of the literature on case study research, "will someone walk with me": a case study exploration of graduate nurses perceptions of the preceptored experience.

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Case study: design method or comprehensive strategy, colin jones senior lecturer critical care, faculty of health & applied social sciences, school of nursing & healthcare studies, liverpool john moores university, liverpool, uk, christina lyons principal lecturer in mental health, faculty of health & applied social sciences, school of nursing & healthcare studies, liverpool john moores university, liverpool, uk.

Nurse Researcher . 11, 3, 70-76. doi: 10.7748/nr2004.04.11.3.70.c6206

case study - paradigms - flexibility - multiple sources of evidence

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01 April 2004 / Vol 11 issue 3

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Case Study Research

First Online: 29 September 2022

Cite this chapter

Robert E. White ORCID: orcid.org/0000-0002-8045-164X 3 &
Karyn Cooper 4

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As a footnote to the previous chapter, there is such a beast known as the ethnographic case study. Ethnographic case study has found its way into this chapter rather than into the previous one because of grammatical considerations. Simply put, the “case study” part of the phrase is the noun (with “case” as an adjective defining what kind of study it is), while the “ethnographic” part of the phrase is an adjective defining the type of case study that is being conducted. As such, the case study becomes the methodology, while the ethnography part refers to a method, mode or approach relating to the development of the study.

The experiential account that we get from a case study or qualitative research of a similar vein is just so necessary. How things happen over time and the degree to which they are subject to personality and how they are only gradually perceived as tolerable or intolerable by the communities and the groups that are involved is so important. Robert Stake, University of Illinois, Urbana-Champaign

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A Case in Case Study Methodology

Christine Benedichte Meyer

Norwegian School of Economics and Business Administration

Meyer, C. B. (2001). A Case in Case Study Methodology. Field Methods 13 (4), 329-352.

The purpose of this article is to provide a comprehensive view of the case study process from the researcher’s perspective, emphasizing methodological considerations. As opposed to other qualitative or quantitative research strategies, such as grounded theory or surveys, there are virtually no specific requirements guiding case research. This is both the strength and the weakness of this approach. It is a strength because it allows tailoring the design and data collection procedures to the research questions. On the other hand, this approach has resulted in many poor case studies, leaving it open to criticism, especially from the quantitative field of research. This article argues that there is a particular need in case studies to be explicit about the methodological choices one makes. This implies discussing the wide range of decisions concerned with design requirements, data collection procedures, data analysis, and validity and reliability. The approach here is to illustrate these decisions through a particular case study of two mergers in the financial industry in Norway.

In the past few years, a number of books have been published that give useful guidance in conducting qualitative studies (Gummesson 1988; Cassell & Symon 1994; Miles & Huberman 1994; Creswell 1998; Flick 1998; Rossman & Rallis 1998; Bryman & Burgess 1999; Marshall & Rossman 1999; Denzin & Lincoln 2000). One approach often mentioned is the case study (Yin 1989). Case studies are widely used in organizational studies in the social science disciplines of sociology, industrial relations, and anthropology (Hartley 1994). Such a study consists of detailed investigation of one or more organizations, or groups within organizations, with a view to providing an analysis of the context and processes involved in the phenomenon under study.

As opposed to other qualitative or quantitative research strategies, such as grounded theory (Glaser and Strauss 1967) or surveys (Nachmias & Nachmias 1981), there are virtually no specific requirements guiding case research. Yin (1989) and Eisenhardt (1989) give useful insights into the case study as a research strategy, but leave most of the design decisions on the table. This is both the strength and the weakness of this approach. It is a strength because it allows tailoring the design and data collection procedures to the research questions. On the other hand, this approach has resulted in many poor case studies, leaving it open to criticism, especially from the quantitative field of research (Cook and Campbell 1979). The fact that the case study is a rather loose design implies that there are a number of choices that need to be addressed in a principled way.

Although case studies have become a common research strategy, the scope of methodology sections in articles published in journals is far too limited to give the readers a detailed and comprehensive view of the decisions taken in the particular studies, and, given the format of methodology sections, will remain so. The few books (Yin 1989, 1993; Hamel, Dufour, & Fortin 1993; Stake 1995) and book chapters on case studies (Hartley 1994; Silverman 2000) are, on the other hand, mainly normative and span a broad range of different kinds of case studies. One exception is Pettigrew (1990, 1992), who places the case study in the context of a research tradition (the Warwick process research).

Given the contextual nature of the case study and its strength in addressing contemporary phenomena in real-life contexts, I believe that there is a need for articles that provide a comprehensive overview of the case study process from the researcher’s perspective, emphasizing methodological considerations. This implies addressing the whole range of choices concerning specific design requirements, data collection procedures, data analysis, and validity and reliability.

WHY A CASE STUDY?

Case studies are tailor-made for exploring new processes or behaviors or ones that are little understood (Hartley 1994). Hence, the approach is particularly useful for responding to how and why questions about a contemporary set of events (Leonard-Barton 1990). Moreover, researchers have argued that certain kinds of information can be difficult or even impossible to tackle by means other than qualitative approaches such as the case study (Sykes 1990). Gummesson (1988:76) argues that an important advantage of case study research is the opportunity for a holistic view of the process: “The detailed observations entailed in the case study method enable us to study many different aspects, examine them in relation to each other, view the process within its total environment and also use the researchers’ capacity for ‘verstehen.’ ”

The contextual nature of the case study is illustrated in Yin’s (1993:59) definition of a case study as an empirical inquiry that “investigates a contemporary phenomenon within its real-life context and addresses a situation in which the boundaries between phenomenon and context are not clearly evident.”

The key difference between the case study and other qualitative designs such as grounded theory and ethnography (Glaser & Strauss 1967; Strauss & Corbin 1990; Gioia & Chittipeddi 1991) is that the case study is open to the use of theory or conceptual categories that guide the research and analysis of data. In contrast, grounded theory or ethnography presupposes that theoretical perspectives are grounded in and emerge from firsthand data. Hartley (1994) argues that without a theoretical framework, the researcher is in severe danger of providing description without meaning. Gummesson (1988) says that a lack of preunderstanding will cause the researcher to spend considerable time gathering basic information. This preunderstanding may arise from general knowledge such as theories, models, and concepts or from specific knowledge of institutional conditions and social patterns. According to Gummesson, the key is not to require researchers to have split but dual personalities: “Those who are able to balance on a razor’s edge using their pre-understanding without being its slave” (p. 58).

DESCRIPTION OF THE ILLUSTRATIVE STUDY

The study that will be used for illustrative purposes is a comparative and longitudinal case study of organizational integration in mergers and acquisitions taking place in Norway. The study had two purposes: (1) to identify contextual factors and features of integration that facilitated or impeded organizational integration, and (2) to study how the three dimensions of organizational integration (integration of tasks, unification of power, and integration of cultures and identities) interrelated and evolved over time. Examples of contextual factors were relative power, degree of friendliness, and economic climate. Integration features included factors such as participation, communication, and allocation of positions and functions.

Mergers and acquisitions are inherently complex. Researchers in the field have suggested that managers continuously underestimate the task of integrating the merging organizations in the postintegration process (Haspeslaph & Jemison 1991). The process of organizational integration can lead to sharp interorganizational conflict as the different top management styles, organizational and work unit cultures, systems, and other aspects of organizational life come into contact (Blake & Mounton 1985; Schweiger & Walsh 1990; Cartwright & Cooper 1993). Furthermore, cultural change in mergers and acquisitions is compounded by additional uncertainties, ambiguities, and stress inherent in the combination process (Buono & Bowditch 1989).

I focused on two combinations: one merger and one acquisition. The first case was a merger between two major Norwegian banks, Bergen Bank and DnC (to be named DnB), that started in the late 1980s. The second case was a study of a major acquisition in the insurance industry (i.e., Gjensidige’s acquisition of Forenede), that started in the early 1990s. Both combinations aimed to realize operational synergies though merging the two organizations into one entity. This implied disruption of organizational boundaries and threat to the existing power distribution and organizational cultures.

The study of integration processes in mergers and acquisitions illustrates the need to find a design that opens for exploration of sensitive issues such as power struggles between the two merging organizations. Furthermore, the inherent complexity in the integration process, involving integration of tasks, unification of power, and cultural integration stressed the need for in-depth study of the phenomenon over time. To understand the cultural integration process, the design also had to be linked to the past history of the two organizations.

DESIGN DECISIONS

In the introduction, I stressed that a case is a rather loose design that requires that a number of design choices be made. In this section, I go through the most important choices I faced in the study of organizational integration in mergers and acquisitions. These include: (1) selection of cases; (2) sampling time; (3) choosing business areas, divisions, and sites; and (4) selection of and choices regarding data collection procedures, interviews, documents, and observation.

Selection of Cases

There are several choices involved in selecting cases. First, there is the question of how many cases to include. Second, one must sample cases and decide on a unit of analysis. I will explore these issues subsequently.

Single or Multiple Cases

Case studies can involve single or multiple cases. The problem of single cases is limitations in generalizability and several information-processing biases (Eisenhardt 1989).

One way to respond to these biases is by applying a multi-case approach (Leonard-Barton 1990). Multiple cases augment external validity and help guard against observer biases. Moreover, multi-case sampling adds confidence to findings. By looking at a range of similar and contrasting cases, we can understand a single-case finding, grounding it by specifying how and where and, if possible, why it behaves as it does. (Miles & Huberman 1994)

Given these limitations of the single case study, it is desirable to include more than one case study in the study. However, the desire for depth and a pluralist perspective and tracking the cases over time implies that the number of cases must be fairly few. I chose two cases, which clearly does not support generalizability any more than does one case, but allows for comparison and contrast between the cases as well as a deeper and richer look at each case.

Originally, I planned to include a third case in the study. Due to changes in management during the initial integration process, my access to the case was limited and I left this case entirely. However, a positive side effect was that it allowed a deeper investigation of the two original cases and in hindsight turned out to be a good decision.

Sampling Cases

The logic of sampling cases is fundamentally different from statistical sampling. The logic in case studies involves theoretical sampling, in which the goal is to choose cases that are likely to replicate or extend the emergent theory or to fill theoretical categories and provide examples for polar types (Eisenhardt 1989). Hence, whereas quantitative sampling concerns itself with representativeness, qualitative sampling seeks information richness and selects the cases purposefully rather than randomly (Crabtree and Miller 1992).

The choice of cases was guided by George (1979) and Pettigrew’s (1990) recommendations. The aim was to find cases that matched the three dimensions in the dependent variable and provided variation in the contextual factors, thus representing polar cases.

To match the choice of outcome variable, organizational integration, I chose cases in which the purpose was to fully consolidate the merging parties’ operations. A full consolidation would imply considerable disruption in the organizational boundaries and would be expected to affect the task-related, political, and cultural features of the organizations. As for the contextual factors, the two cases varied in contextual factors such as relative power, friendliness, and economic climate. The DnB merger was a friendly combination between two equal partners in an unfriendly economic climate. Gjensidige’s acquisition of Forenede was, in contrast, an unfriendly and unbalanced acquisition in a friendly economic climate.

Unit of Analysis

Another way to respond to researchers’ and respondents’ biases is to have more than one unit of analysis in each case (Yin 1993). This implies that, in addition to developing contrasts between the cases, researchers can focus on contrasts within the cases (Hartley 1994). In case studies, there is a choice of a holistic or embedded design (Yin 1989). A holistic design examines the global nature of the phenomenon, whereas an embedded design also pays attention to subunit(s).

I used an embedded design to analyze the cases (i.e., within each case, I also gave attention to subunits and subprocesses). In both cases, I compared the combination processes in the various divisions and local networks. Moreover, I compared three distinct change processes in DnB: before the merger, during the initial combination, and two years after the merger. The overall and most important unit of analysis in the two cases was, however, the integration process.

Sampling Time

According to Pettigrew (1990), time sets a reference for what changes can be seen and how those changes are explained. When conducting a case study, there are several important issues to decide when sampling time. The first regards how many times data should be collected, while the second concerns when to enter the organizations. There is also a need to decide whether to collect data on a continuous basis or in distinct periods.

Number of data collections. I studied the process by collecting real time and retrospective data at two points in time, with one-and-a-half- and two-year intervals in the two cases. Collecting data twice had some interesting implications for the interpretations of the data. During the first data collection in the DnB study, for example, I collected retrospective data about the premerger and initial combination phase and real-time data about the second step in the combination process.

Although I gained a picture of how the employees experienced the second stage of the combination process, it was too early to assess the effects of this process at that stage. I entered the organization two years later and found interesting effects that I had not anticipated the first time. Moreover, it was interesting to observe how people’s attitudes toward the merger processes changed over time to be more positive and less emotional.

When to enter the organizations. It would be desirable to have had the opportunity to collect data in the precombination processes. However, researchers are rarely given access in this period due to secrecy. The emphasis in this study was to focus on the postcombination process. As such, the precombination events were classified as contextual factors. This implied that it was most important to collect real-time data after the parties had been given government approval to merge or acquire. What would have been desirable was to gain access earlier in the postcombination process. This was not possible because access had to be negotiated. Due to the change of CEO in the middle of the merger process and the need for renegotiating access, this took longer than expected.

Regarding the second case, I was restricted by the time frame of the study. In essence, I had to choose between entering the combination process as soon as governmental approval was given, or entering the organization at a later stage. In light of the previous studies in the field that have failed to go beyond the initial two years, and given the need to collect data about the cultural integration process, I chose the latter strategy. And I decided to enter the organizations at two distinct periods of time rather than on a continuous basis.

There were several reasons for this approach, some methodological and some practical. First, data collection on a continuous basis would have required use of extensive observation that I didn’t have access to, and getting access to two data collections in DnB was difficult in itself. Second, I had a stay abroad between the first and second data collection in Gjensidige. Collecting data on a continuous basis would probably have allowed for better mapping of the ongoing integration process, but the contrasts between the two different stages in the integration process that I wanted to elaborate would probably be more difficult to detect. In Table 1 I have listed the periods of time in which I collected data in the two combinations.

Sampling Business Areas, Divisions, and Sites

Even when the cases for a study have been chosen, it is often necessary to make further choices within each case to make the cases researchable. The most important criteria that set the boundaries for the study are importance or criticality, relevance, and representativeness. At the time of the data collection, my criteria for making these decisions were not as conscious as they may appear here. Rather, being restricted by time and my own capacity as a researcher, I had to limit the sites and act instinctively. In both cases, I decided to concentrate on the core businesses (criticality criterion) and left out the business units that were only mildly affected by the integration process (relevance criterion). In the choice of regional offices, I used the representativeness criterion as the number of offices widely exceeded the number of sites possible to study. In making these choices, I relied on key informants in the organizations.

SELECTION OF DATA COLLECTION PROCEDURES

The choice of data collection procedures should be guided by the research question and the choice of design. The case study approach typically combines data collection methods such as archives, interviews, questionnaires, and observations (Yin 1989). This triangulated methodology provides stronger substantiation of constructs and hypotheses. However, the choice of data collection methods is also subject to constraints in time, financial resources, and access.

I chose a combination of interviews, archives, and observation, with main emphasis on the first two. Conducting a survey was inappropriate due to the lack of established concepts and indicators. The reason for limited observation, on the other hand, was due to problems in obtaining access early in the study and time and resource constraints. In addition to choosing among several different data collection methods, there are a number of choices to be made for each individual method.

When relying on interviews as the primary data collection method, the issue of building trust between the researcher and the interviewees becomes very important. I addressed this issue by several means. First, I established a procedure of how to approach the interviewees. In most cases, I called them first, then sent out a letter explaining the key features of the project and outlining the broad issues to be addressed in the interview. In this letter, the support from the institution’s top management was also communicated. In most cases, the top management’s support of the project was an important prerequisite for the respondent’s input. Some interviewees did, however, fear that their input would be open to the top management without disguising the information source. Hence, it became important to communicate how I intended to use and store the information.

To establish trust, I also actively used my preunderstanding of the context in the first case and the phenomenon in the second case. As I built up an understanding of the cases, I used this information to gain confidence. The active use of my preunderstanding did, however, pose important challenges in not revealing too much of the research hypotheses and in balancing between asking open-ended questions and appearing knowledgeable.

There are two choices involved in conducting interviews. The first concerns the sampling of interviewees. The second is that you must decide on issues such as the structure of the interviews, use of tape recorder, and involvement of other researchers.

Sampling Interviewees

Following the desire for detailed knowledge of each case and for grasping different participant’s views the aim was, in line with Pettigrew (1990), to apply a pluralist view by describing and analyzing competing versions of reality as seen by actors in the combination processes.

I used four criteria for sampling informants. First, I drew informants from populations representing multiple perspectives. The first data collection in DnB was primarily focused on the top management level. Moreover, most middle managers in the first data collection were employed at the head offices, either in Bergen or Oslo. In the second data collection, I compensated for this skew by including eight local middle managers in the sample. The difference between the number of employees interviewed in DnB and Gjensidige was primarily due to the fact that Gjensidige has three unions, whereas DnB only has one. The distribution of interviewees is outlined in Table 2 .

The second criterion was to use multiple informants. According to Glick et al. (1990), an important advantage of using multiple informants is that the validity of information provided by one informant can be checked against that provided by other informants. Moreover, the validity of the data used by the researcher can be enhanced by resolving the discrepancies among different informants’ reports. Hence, I selected multiple respondents from each perspective.

Third, I focused on key informants who were expected to be knowledgeable about the combination process. These people included top management members, managers, and employees involved in the integration project. To validate the information from these informants, I also used a fourth criterion by selecting managers and employees who had been affected by the process but who were not involved in the project groups.

Structured versus unstructured. In line with the explorative nature of the study, the goal of the interviews was to see the research topic from the perspective of the interviewee, and to understand why he or she came to have this particular perspective. To meet this goal, King (1994:15) recommends that one have “a low degree of structure imposed on the interviewer, a preponderance of open questions, a focus on specific situations and action sequences in the world of the interviewee rather than abstractions and general opinions.” In line with these recommendations, the collection of primary data in this study consists of unstructured interviews.

Using tape recorders and involving other researchers. The majority of the interviews were tape-recorded, and I could thus concentrate fully on asking questions and responding to the interviewees’ answers. In the few interviews that were not tape-recorded, most of which were conducted in the first phase of the DnB-study, two researchers were present. This was useful as we were both able to discuss the interviews later and had feedback on the role of an interviewer.

In hindsight, however, I wish that these interviews had been tape-recorded to maintain the level of accuracy and richness of data. Hence, in the next phases of data collection, I tape-recorded all interviews, with two exceptions (people who strongly opposed the use of this device). All interviews that were tape-recorded were transcribed by me in full, which gave me closeness and a good grasp of the data.

When organizations merge or make acquisitions, there are often a vast number of documents to choose from to build up an understanding of what has happened and to use in the analyses. Furthermore, when firms make acquisitions or merge, they often hire external consultants, each of whom produces more documents. Due to time constraints, it is seldom possible to collect and analyze all these documents, and thus the researcher has to make a selection.

The choice of documentation was guided by my previous experience with merger and acquisition processes and the research question. Hence, obtaining information on the postintegration process was more important than gaining access to the due-diligence analysis. As I learned about the process, I obtained more documents on specific issues. I did not, however, gain access to all the documents I asked for, and, in some cases, documents had been lost or shredded.

The documents were helpful in a number of ways. First, and most important, they were used as inputs to the interview guide and saved me time, because I did not have to ask for facts in the interviews. They were also useful for tracing the history of the organizations and statements made by key people in the organizations. Third, the documents were helpful in counteracting the biases of the interviews. A list of the documents used in writing the cases is shown in Table 3 .

Observation

The major strength of direct observation is that it is unobtrusive and does not require direct interaction with participants (Adler and Adler 1994). Observation produces rigor when it is combined with other methods. When the researcher has access to group processes, direct observation can illuminate the discrepancies between what people said in the interviews and casual conversations and what they actually do (Pettigrew 1990).

As with interviews, there are a number of choices involved in conducting observations. Although I did some observations in the study, I used interviews as the key data collection source. Discussion in this article about observations will thus be somewhat limited. Nevertheless, I faced a number of choices in conducting observations, including type of observation, when to enter, how much observation to conduct, and which groups to observe.

The are four ways in which an observer may gather data: (1) the complete participant who operates covertly, concealing any intention to observe the setting; (2) the participant-as-observer, who forms relationships and participates in activities, but makes no secret of his or her intentions to observe events; (3) the observer-as-participant, who maintains only superficial contact with the people being studied; and (4) the complete observer, who merely stands back and eavesdrops on the proceedings (Waddington 1994).

In this study, I used the second and third ways of observing. The use of the participant-as-observer mode, on which much ethnographic research is based, was rather limited in the study. There were two reasons for this. First, I had limited time available for collecting data, and in my view interviews made more effective use of this limited time than extensive participant observation. Second, people were rather reluctant to let me observe these political and sensitive processes until they knew me better and felt I could be trusted. Indeed, I was dependent on starting the data collection before having built sufficient trust to observe key groups in the integration process. Nevertheless, Gjensidige allowed me to study two employee seminars to acquaint me with the organization. Here I admitted my role as an observer but participated fully in the activities. To achieve variation, I chose two seminars representing polar groups of employees.

As observer-as-participant, I attended a top management meeting at the end of the first data collection in Gjensidige and observed the respondents during interviews and in more informal meetings, such as lunches. All these observations gave me an opportunity to validate the data from the interviews. Observing the top management group was by far the most interesting and rewarding in terms of input.

Both DnB and Gjensidige started to open up for more extensive observation when I was about to finish the data collection. By then, I had built up the trust needed to undertake this approach. Unfortunately, this came a little late for me to take advantage of it.

DATA ANALYSIS

Published studies generally describe research sites and data-collection methods, but give little space to discuss the analysis (Eisenhardt 1989). Thus, one cannot follow how a researcher arrives at the final conclusions from a large volume of field notes (Miles and Huberman 1994).

In this study, I went through the stages by which the data were reduced and analyzed. This involved establishing the chronology, coding, writing up the data according to phases and themes, introducing organizational integration into the analysis, comparing the cases, and applying the theory. I will discuss these phases accordingly.

The first step in the analysis was to establish the chronology of the cases. To do this, I used internal and external documents. I wrote the chronologies up and included appendices in the final report.

The next step was to code the data into phases and themes reflecting the contextual factors and features of integration. For the interviews, this implied marking the text with a specific phase and a theme, and grouping the paragraphs on the same theme and phase together. I followed the same procedure in organizing the documents.

I then wrote up the cases using phases and themes to structure them. Before starting to write up the cases, I scanned the information on each theme, built up the facts and filled in with perceptions and reactions that were illustrative and representative of the data.

The documents were primarily useful in establishing the facts, but they also provided me with some perceptions and reactions that were validated in the interviews. The documents used included internal letters and newsletters as well as articles from the press. The interviews were less factual, as intended, and gave me input to assess perceptions and reactions. The limited observation was useful to validate the data from the interviews. The result of this step was two descriptive cases.

To make each case more analytical, I introduced the three dimensions of organizational integration—integration of tasks, unification of power, and cultural integration—into the analysis. This helped to focus the case and to develop a framework that could be used to compare the cases. The cases were thus structured according to phases, organizational integration, and themes reflecting the factors and features in the study.

I took all these steps to become more familiar with each case as an individual entity. According to Eisenhardt (1989:540), this is a process that “allows the unique patterns of each case to emerge before the investigators push to generalise patterns across cases. In addition it gives investigators a rich familiarity with each case which, in turn, accelerates cross-case comparison.”

The comparison between the cases constituted the next step in the analysis. Here, I used the categories from the case chapters, filled in the features and factors, and compared and contrasted the findings. The idea behind cross-case searching tactics is to force investigators to go beyond initial impressions, especially through the use of structural and diverse lenses on the data. These tactics improve the likelihood of accurate and reliable theory, that is, theory with a close fit to the data (Eisenhardt 1989).

As a result, I had a number of overall themes, concepts, and relationships that had emerged from the within-case analysis and cross-case comparisons. The next step was to compare these emergent findings with theory from the organizational field of mergers and acquisitions, as well as other relevant perspectives.

This method of generalization is known as analytical generalization. In this approach, a previously developed theory is used as a template with which to compare the empirical results of the case study (Yin 1989). This comparison of emergent concepts, theory, or hypotheses with the extant literature involves asking what it is similar to, what it contradicts, and why. The key to this process is to consider a broad range of theory (Eisenhardt 1989). On the whole, linking emergent theory to existent literature enhances the internal validity, generalizability, and theoretical level of theory-building from case research.

According to Eisenhardt (1989), examining literature that conflicts with the emergent literature is important for two reasons. First, the chance of neglecting conflicting findings is reduced. Second, “conflicting results forces researchers into a more creative, frame-breaking mode of thinking than they might otherwise be able to achieve” (p. 544). Similarly, Eisenhardt (1989) claims that literature discussing similar findings is important because it ties together underlying similarities in phenomena not normally associated with each other. The result is often a theory with a stronger internal validity, wider generalizability, and a higher conceptual level.

The analytical generalization in the study included exploring and developing the concepts and examining the relationships between the constructs. In carrying out this analytical generalization, I acted on Eisenhardt’s (1989) recommendation to use a broad range of theory. First, I compared and contrasted the findings with the organizational stream on mergers and acquisition literature. Then I discussed other relevant literatures, including strategic change, power and politics, social justice, and social identity theory to explore how these perspectives could contribute to the understanding of the findings. Finally, I discussed the findings that could not be explained either by the merger and acquisition literature or the four theoretical perspectives.

In every scientific study, questions are raised about whether the study is valid and reliable. The issues of validity and reliability in case studies are just as important as for more deductive designs, but the application is fundamentally different.

VALIDITY AND RELIABILITY

The problems of validity in qualitative studies are related to the fact that most qualitative researchers work alone in the field, they focus on the findings rather than describe how the results were reached, and they are limited in processing information (Miles and Huberman 1994).

Researchers writing about qualitative methods have questioned whether the same criteria can be used for qualitative and quantitative studies (Kirk & Miller 1986; Sykes 1990; Maxwell 1992). The problem with the validity criteria suggested in qualitative research is that there is little consistency across the articles as each author suggests a new set of criteria.

One approach in examining validity and reliability is to apply the criteria used in quantitative research. Hence, the criteria to be examined here are objectivity/intersubjectivity, construct validity, internal validity, external validity, and reliability.

Objectivity/Intersubjectivity

The basic issue of objectivity can be framed as one of relative neutrality and reasonable freedom from unacknowledged research biases (Miles & Huberman 1994). In a real-time longitudinal study, the researcher is in danger of losing objectivity and of becoming too involved with the organization, the people, and the process. Hence, Leonard-Barton (1990) claims that one may be perceived as, and may even become, an advocate rather than an observer.

According to King (1994), however, qualitative research, in seeking to describe and make sense of the world, does not require researchers to strive for objectivity and distance themselves from research participants. Indeed, to do so would make good qualitative research impossible, as the interviewer’s sensitivity to subjective aspects of his or her relationship with the interviewee is an essential part of the research process (King 1994:31).

This does not imply, however, that the issue of possible research bias can be ignored. It is just as important as in a structured quantitative interview that the findings are not simply the product of the researcher’s prejudices and prior experience. One way to guard against this bias is for the researcher to explicitly recognize his or her presuppositions and to make a conscious effort to set these aside in the analysis (Gummesson 1988). Furthermore, rival conclusions should be considered (Miles & Huberman 1994).

My experience from the first phase of the DnB study was that it was difficult to focus the questions and the analysis of the data when the research questions were too vague and broad. As such, developing a framework before collecting the data for the study was useful in guiding the collection and analysis of data. Nevertheless, it was important to be open-minded and receptive to new and surprising data. In the DnB study, for example, the positive effect of the reorganization process on the integration of cultures came as a complete surprise to me and thus needed further elaboration.

I also consciously searched for negative evidence and problems by interviewing outliers (Miles & Huberman 1994) and asking problem-oriented questions. In Gjensidige, the first interviews with the top management revealed a much more positive perception of the cultural integration process than I had expected. To explore whether this was a result of overreliance on elite informants, I continued posing problem-oriented questions to outliers and people at lower levels in the organization. Moreover, I told them about the DnB study to be explicit about my presuppositions.

Another important issue when assessing objectivity is whether other researchers can trace the interpretations made in the case studies, or what is called intersubjectivity. To deal with this issue, Miles & Huberman (1994) suggest that: (1) the study’s general methods and procedures should be described in detail, (2) one should be able to follow the process of analysis, (3) conclusions should be explicitly linked with exhibits of displayed data, and (4) the data from the study should be made available for reanalysis by others.

In response to these requirements, I described the study’s data collection procedures and processing in detail. Then, the primary data were displayed in the written report in the form of quotations and extracts from documents to support and illustrate the interpretations of the data. Because the study was written up in English, I included the Norwegian text in a separate appendix. Finally, all the primary data from the study were accessible for a small group of distinguished researchers.

Construct Validity

Construct validity refers to whether there is substantial evidence that the theoretical paradigm correctly corresponds to observation (Kirk & Miller 1986). In this form of validity, the issue is the legitimacy of the application of a given concept or theory to established facts.

The strength of qualitative research lies in the flexible and responsive interaction between the interviewer and the respondents (Sykes 1990). Thus, meaning can be probed, topics covered easily from a number of angles, and questions made clear for respondents. This is an advantage for exploring the concepts (construct or theoretical validity) and the relationships between them (internal validity). Similarly, Hakim (1987) says the great strength of qualitative research is the validity of data obtained because individuals are interviewed in sufficient detail for the results to be taken as true, correct, and believable reports of their views and experiences.

Construct validity can be strengthened by applying a longitudinal multicase approach, triangulation, and use of feedback loops. The advantage of applying a longitudinal approach is that one gets the opportunity to test sensitivity of construct measures to the passage of time. Leonard-Barton (1990), for example, found that one of her main constructs, communicability, varied across time and relative to different groups of users. Thus, the longitudinal study aided in defining the construct more precisely. By using more than one case study, one can validate stability of construct across situations (Leonard-Barton 1990). Since my study only consists of two case studies, the opportunity to test stability of constructs across cases is somewhat limited. However, the use of more than one unit of analysis helps to overcome this limitation.

Construct validity is strengthened by the use of multiple sources of evidence to build construct measures, which define the construct and distinguish it from other constructs. These multiple sources of evidence can include multiple viewpoints within and across the data sources. My study responds to these requirements in its sampling of interviewees and uses of multiple data sources.

Use of feedback loops implies returning to interviewees with interpretations and developing theory and actively seeking contradictions in data (Crabtree & Miller 1992; King 1994). In DnB, the written report had to be approved by the bank’s top management after the first data collection. Apart from one minor correction, the bank had no objections to the established facts. In their comments on my analysis, some of the top managers expressed the view that the political process had been overemphasized, and that the CEO’s role in initiating a strategic process was undervalued. Hence, an important objective in the second data collection was to explore these comments further. Moreover, the report was not as positive as the management had hoped for, and negotiations had to be conducted to publish the report. The result of these negotiations was that publication of the report was postponed one-and-a-half years.

The experiences from the first data collection in the DnB had some consequences. I was more cautious and brought up the problems of confidentiality and the need to publish at the outset of the Gjensidige study. Also, I had to struggle to get access to the DnB case for the second data collection and some of the information I asked for was not released. At Gjensidige, I sent a preliminary draft of the case chapter to the corporation’s top management for comments, in addition to having second interviews with a small number of people. Beside testing out the factual description, these sessions gave me the opportunity to test out the theoretical categories established as a result of the within-case analysis.

Internal Validity

Internal validity concerns the validity of the postulated relationships among the concepts. The main problem of internal validity as a criterion in qualitative research is that it is often not open to scrutiny. According to Sykes (1990), the researcher can always provide a plausible account and, with careful editing, may ensure its coherence. Recognition of this problem has led to calls for better documentation of the processes of data collection, the data itself, and the interpretative contribution of the researcher. The discussion of how I met these requirements was outlined in the section on objectivity/subjectivity above.

However, there are some advantages in using qualitative methods, too. First, the flexible and responsive methods of data collection allow cross-checking and amplification of information from individual units as it is generated. Respondents’ opinions and understandings can be thoroughly explored. The internal validity results from strategies that eliminate ambiguity and contradiction, filling in detail and establishing strong connections in data.

Second, the longitudinal study enables one to track cause and effect. Moreover, it can make one aware of intervening variables (Leonard-Barton 1990). Eisenhardt (1989:542) states, “Just as hypothesis testing research an apparent relationship may simply be a spurious correlation or may reflect the impact of some third variable on each of the other two. Therefore, it is important to discover the underlying reasons for why the relationship exists.”

Generalizability

According to Mitchell (1983), case studies are not based on statistical inference. Quite the contrary, the inferring process turns exclusively on the theoretically necessary links among the features in the case study. The validity of the extrapolation depends not on the typicality or representativeness of the case but on the cogency of the theoretical reasoning. Hartley (1994:225) claims, “The detailed knowledge of the organization and especially the knowledge about the processes underlying the behaviour and its context can help to specify the conditions under which behaviour can be expected to occur. In other words, the generalisation is about theoretical propositions not about populations.”

Generalizability is normally based on the assumption that this theory may be useful in making sense of similar persons or situations (Maxwell 1992). One way to increase the generalizability is to apply a multicase approach (Leonard-Barton 1990). The advantage of this approach is that one can replicate the findings from one case study to another. This replication logic is similar to that used on multiple experiments (Yin 1993).

Given the choice of two case studies, the generalizability criterion is not supported in this study. Through the discussion of my choices, I have tried to show that I had to strike a balance between the need for depth and mapping changes over time and the number of cases. In doing so, I deliberately chose to provide a deeper and richer look at each case, allowing the reader to make judgments about the applicability rather than making a case for generalizability.

Reliability

Reliability focuses on whether the process of the study is consistent and reasonably stable over time and across researchers and methods (Miles & Huberman 1994). In the context of qualitative research, reliability is concerned with two questions (Sykes 1990): Could the same study carried out by two researchers produce the same findings? and Could a study be repeated using the same researcher and respondents to yield the same findings?

The problem of reliability in qualitative research is that differences between replicated studies using different researchers are to be expected. However, while it may not be surprising that different researchers generate different findings and reach different conclusions, controlling for reliability may still be relevant. Kirk and Miller’s (1986:311) definition takes into account the particular relationship between the researcher’s orientation, the generation of data, and its interpretation:

For reliability to be calculated, it is incumbent on the scientific investigator to document his or her procedure. This must be accomplished at such a level of abstraction that the loci of decisions internal to the project are made apparent. The curious public deserves to know how the qualitative researcher prepares him or herself for the endeavour, and how the data is collected and analysed.

The study addresses these requirements by discussing my point of departure regarding experience and framework, the sampling and data collection procedures, and data analysis.

Case studies often lack academic rigor and are, as such, regarded as inferior to more rigorous methods where there are more specific guidelines for collecting and analyzing data. These criticisms stress that there is a need to be very explicit about the choices one makes and the need to justify them.

One reason why case studies are criticized may be that researchers disagree about the definition and the purpose of carrying out case studies. Case studies have been regarded as a design (Cook and Campbell 1979), as a qualitative methodology (Cassell and Symon 1994), as a particular data collection procedure (Andersen 1997), and as a research strategy (Yin 1989). Furthermore, the purpose for carrying out case studies is unclear. Some regard case studies as supplements to more rigorous qualitative studies to be carried out in the early stage of the research process; others claim that it can be used for multiple purposes and as a research strategy in its own right (Gummesson 1988; Yin 1989). Given this unclear status, researchers need to be very clear about their interpretation of the case study and the purpose of carrying out the study.

This article has taken Yin’s (1989) definition of the case study as a research strategy as a starting point and argued that the choice of the case study should be guided by the research question(s). In the illustrative study, I used a case study strategy because of a need to explore sensitive, ill-defined concepts in depth, over time, taking into account the context and history of the mergers and the existing knowledge about the phenomenon. However, the choice of a case study strategy extended rather than limited the number of decisions to be made. In Schramm’s (1971, cited in Yin 1989:22–23) words, “The essence of a case study, the central tendency among all types of case study, is that it tries to illuminate a decision or set of decisions, why they were taken, how they were implemented, and with what result.”

Hence, the purpose of this article has been to illustrate the wide range of decisions that need to be made in the context of a particular case study and to discuss the methodological considerations linked to these decisions. I argue that there is a particular need in case studies to be explicit about the methodological choices one makes and that these choices can be best illustrated through a case study of the case study strategy.

As in all case studies, however, there are limitations to the generalizability of using one particular case study for illustrative purposes. As such, the strength of linking the methodological considerations to a specific context and phenomenon also becomes a weakness. However, I would argue that the questions raised in this article are applicable to many case studies, but that the answers are very likely to vary. The design choices are shown in Table 4 . Hence, researchers choosing a longitudinal, comparative case study need to address the same set of questions with regard to design, data collection procedures, and analysis, but they are likely to come up with other conclusions, given their different research questions.

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Christine Benedichte Meyer is an associate professor in the Department of Strategy and Management in the Norwegian School of Economics and Business Administration, Bergen-Sandviken, Norway. Her research interests are mergers and acquisitions, strategic change, and qualitative research. Recent publications include: “Allocation Processes in Mergers and Acquisitions: An Organisational Justice Perspective” (British Journal of Management 2001) and “Motives for Acquisitions in the Norwegian Financial Industry” (CEMS Business Review 1997).

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White, R.E., Cooper, K. (2022). Case Study Research. In: Qualitative Research in the Post-Modern Era. Springer, Cham. https://doi.org/10.1007/978-3-030-85124-8_7

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

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

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

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

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

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

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

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

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

Case study examples
Research question	Case study
What are the ecological effects of wolf reintroduction?	Case study of wolf reintroduction in Yellowstone National Park
How do populist politicians use narratives about history to gain support?	Case studies of Hungarian prime minister Viktor Orbán and US president Donald Trump
How can teachers implement active learning strategies in mixed-level classrooms?	Case study of a local school that promotes active learning
What are the main advantages and disadvantages of wind farms for rural communities?	Case studies of three rural wind farm development projects in different parts of the country
How are viral marketing strategies changing the relationship between companies and consumers?	Case study of the iPhone X marketing campaign
How do experiences of work in the gig economy differ by gender, race and age?	Case studies of Deliveroo and Uber drivers in London

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Research bias

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

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

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

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

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

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

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

Multiple-Case Study

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

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

Exploratory Case Study

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

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

Descriptive Case Study

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

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

Instrumental Case Study

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

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

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

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

Observations

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

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

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

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

How to conduct Case Study Research

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

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

Examples of Case Study

Here are some examples of case study research:

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

Application of Case Study

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

Business and Management

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

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

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

Social Sciences

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

Law and Ethics

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

Purpose of Case Study

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

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

Case studies can also serve other purposes, including:

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

Advantages of Case Study Research

There are several advantages of case study research, including:

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

Limitations of Case Study Research

There are several limitations of case study research, including:

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

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The Ultimate Guide to Qualitative Research - Part 1: The Basics

Introduction and overview
What is qualitative research?
What is qualitative data?
Examples of qualitative data
Qualitative vs. quantitative research
Mixed methods
Qualitative research preparation
Theoretical perspective
Theoretical framework
Literature reviews

Research question

Conceptual framework
Conceptual vs. theoretical framework

Data collection

Qualitative research methods
Focus groups
Observational research

What is a case study?

Applications for case study research, what is a good case study, process of case study design, benefits and limitations of case studies.

Ethnographical research
Ethical considerations
Confidentiality and privacy
Power dynamics
Reflexivity

Case studies

Case studies are essential to qualitative research , offering a lens through which researchers can investigate complex phenomena within their real-life contexts. This chapter explores the concept, purpose, applications, examples, and types of case studies and provides guidance on how to conduct case study research effectively.

Whereas quantitative methods look at phenomena at scale, case study research looks at a concept or phenomenon in considerable detail. While analyzing a single case can help understand one perspective regarding the object of research inquiry, analyzing multiple cases can help obtain a more holistic sense of the topic or issue. Let's provide a basic definition of a case study, then explore its characteristics and role in the qualitative research process.

Definition of a case study

A case study in qualitative research is a strategy of inquiry that involves an in-depth investigation of a phenomenon within its real-world context. It provides researchers with the opportunity to acquire an in-depth understanding of intricate details that might not be as apparent or accessible through other methods of research. The specific case or cases being studied can be a single person, group, or organization – demarcating what constitutes a relevant case worth studying depends on the researcher and their research question .

Among qualitative research methods , a case study relies on multiple sources of evidence, such as documents, artifacts, interviews , or observations , to present a complete and nuanced understanding of the phenomenon under investigation. The objective is to illuminate the readers' understanding of the phenomenon beyond its abstract statistical or theoretical explanations.

Characteristics of case studies

Case studies typically possess a number of distinct characteristics that set them apart from other research methods. These characteristics include a focus on holistic description and explanation, flexibility in the design and data collection methods, reliance on multiple sources of evidence, and emphasis on the context in which the phenomenon occurs.

Furthermore, case studies can often involve a longitudinal examination of the case, meaning they study the case over a period of time. These characteristics allow case studies to yield comprehensive, in-depth, and richly contextualized insights about the phenomenon of interest.

The role of case studies in research

Case studies hold a unique position in the broader landscape of research methods aimed at theory development. They are instrumental when the primary research interest is to gain an intensive, detailed understanding of a phenomenon in its real-life context.

In addition, case studies can serve different purposes within research - they can be used for exploratory, descriptive, or explanatory purposes, depending on the research question and objectives. This flexibility and depth make case studies a valuable tool in the toolkit of qualitative researchers.

Remember, a well-conducted case study can offer a rich, insightful contribution to both academic and practical knowledge through theory development or theory verification, thus enhancing our understanding of complex phenomena in their real-world contexts.

What is the purpose of a case study?

Case study research aims for a more comprehensive understanding of phenomena, requiring various research methods to gather information for qualitative analysis . Ultimately, a case study can allow the researcher to gain insight into a particular object of inquiry and develop a theoretical framework relevant to the research inquiry.

Why use case studies in qualitative research?

Using case studies as a research strategy depends mainly on the nature of the research question and the researcher's access to the data.

Conducting case study research provides a level of detail and contextual richness that other research methods might not offer. They are beneficial when there's a need to understand complex social phenomena within their natural contexts.

The explanatory, exploratory, and descriptive roles of case studies

Case studies can take on various roles depending on the research objectives. They can be exploratory when the research aims to discover new phenomena or define new research questions; they are descriptive when the objective is to depict a phenomenon within its context in a detailed manner; and they can be explanatory if the goal is to understand specific relationships within the studied context. Thus, the versatility of case studies allows researchers to approach their topic from different angles, offering multiple ways to uncover and interpret the data .

The impact of case studies on knowledge development

Case studies play a significant role in knowledge development across various disciplines. Analysis of cases provides an avenue for researchers to explore phenomena within their context based on the collected data.

This can result in the production of rich, practical insights that can be instrumental in both theory-building and practice. Case studies allow researchers to delve into the intricacies and complexities of real-life situations, uncovering insights that might otherwise remain hidden.

Types of case studies

In qualitative research , a case study is not a one-size-fits-all approach. Depending on the nature of the research question and the specific objectives of the study, researchers might choose to use different types of case studies. These types differ in their focus, methodology, and the level of detail they provide about the phenomenon under investigation.

Understanding these types is crucial for selecting the most appropriate approach for your research project and effectively achieving your research goals. Let's briefly look at the main types of case studies.

Exploratory case studies

Exploratory case studies are typically conducted to develop a theory or framework around an understudied phenomenon. They can also serve as a precursor to a larger-scale research project. Exploratory case studies are useful when a researcher wants to identify the key issues or questions which can spur more extensive study or be used to develop propositions for further research. These case studies are characterized by flexibility, allowing researchers to explore various aspects of a phenomenon as they emerge, which can also form the foundation for subsequent studies.

Descriptive case studies

Descriptive case studies aim to provide a complete and accurate representation of a phenomenon or event within its context. These case studies are often based on an established theoretical framework, which guides how data is collected and analyzed. The researcher is concerned with describing the phenomenon in detail, as it occurs naturally, without trying to influence or manipulate it.

Explanatory case studies

Explanatory case studies are focused on explanation - they seek to clarify how or why certain phenomena occur. Often used in complex, real-life situations, they can be particularly valuable in clarifying causal relationships among concepts and understanding the interplay between different factors within a specific context.

Intrinsic, instrumental, and collective case studies

These three categories of case studies focus on the nature and purpose of the study. An intrinsic case study is conducted when a researcher has an inherent interest in the case itself. Instrumental case studies are employed when the case is used to provide insight into a particular issue or phenomenon. A collective case study, on the other hand, involves studying multiple cases simultaneously to investigate some general phenomena.

Each type of case study serves a different purpose and has its own strengths and challenges. The selection of the type should be guided by the research question and objectives, as well as the context and constraints of the research.

The flexibility, depth, and contextual richness offered by case studies make this approach an excellent research method for various fields of study. They enable researchers to investigate real-world phenomena within their specific contexts, capturing nuances that other research methods might miss. Across numerous fields, case studies provide valuable insights into complex issues.

Critical information systems research

Case studies provide a detailed understanding of the role and impact of information systems in different contexts. They offer a platform to explore how information systems are designed, implemented, and used and how they interact with various social, economic, and political factors. Case studies in this field often focus on examining the intricate relationship between technology, organizational processes, and user behavior, helping to uncover insights that can inform better system design and implementation.

Health research

Health research is another field where case studies are highly valuable. They offer a way to explore patient experiences, healthcare delivery processes, and the impact of various interventions in a real-world context.

Case studies can provide a deep understanding of a patient's journey, giving insights into the intricacies of disease progression, treatment effects, and the psychosocial aspects of health and illness.

Asthma research studies

Specifically within medical research, studies on asthma often employ case studies to explore the individual and environmental factors that influence asthma development, management, and outcomes. A case study can provide rich, detailed data about individual patients' experiences, from the triggers and symptoms they experience to the effectiveness of various management strategies. This can be crucial for developing patient-centered asthma care approaches.

Other fields

Apart from the fields mentioned, case studies are also extensively used in business and management research, education research, and political sciences, among many others. They provide an opportunity to delve into the intricacies of real-world situations, allowing for a comprehensive understanding of various phenomena.

Case studies, with their depth and contextual focus, offer unique insights across these varied fields. They allow researchers to illuminate the complexities of real-life situations, contributing to both theory and practice.

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Understanding the key elements of case study design is crucial for conducting rigorous and impactful case study research. A well-structured design guides the researcher through the process, ensuring that the study is methodologically sound and its findings are reliable and valid. The main elements of case study design include the research question , propositions, units of analysis, and the logic linking the data to the propositions.

The research question is the foundation of any research study. A good research question guides the direction of the study and informs the selection of the case, the methods of collecting data, and the analysis techniques. A well-formulated research question in case study research is typically clear, focused, and complex enough to merit further detailed examination of the relevant case(s).

Propositions

Propositions, though not necessary in every case study, provide a direction by stating what we might expect to find in the data collected. They guide how data is collected and analyzed by helping researchers focus on specific aspects of the case. They are particularly important in explanatory case studies, which seek to understand the relationships among concepts within the studied phenomenon.

Units of analysis

The unit of analysis refers to the case, or the main entity or entities that are being analyzed in the study. In case study research, the unit of analysis can be an individual, a group, an organization, a decision, an event, or even a time period. It's crucial to clearly define the unit of analysis, as it shapes the qualitative data analysis process by allowing the researcher to analyze a particular case and synthesize analysis across multiple case studies to draw conclusions.

Argumentation

This refers to the inferential model that allows researchers to draw conclusions from the data. The researcher needs to ensure that there is a clear link between the data, the propositions (if any), and the conclusions drawn. This argumentation is what enables the researcher to make valid and credible inferences about the phenomenon under study.

Understanding and carefully considering these elements in the design phase of a case study can significantly enhance the quality of the research. It can help ensure that the study is methodologically sound and its findings contribute meaningful insights about the case.

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Conducting a case study involves several steps, from defining the research question and selecting the case to collecting and analyzing data . This section outlines these key stages, providing a practical guide on how to conduct case study research.

Defining the research question

The first step in case study research is defining a clear, focused research question. This question should guide the entire research process, from case selection to analysis. It's crucial to ensure that the research question is suitable for a case study approach. Typically, such questions are exploratory or descriptive in nature and focus on understanding a phenomenon within its real-life context.

Selecting and defining the case

The selection of the case should be based on the research question and the objectives of the study. It involves choosing a unique example or a set of examples that provide rich, in-depth data about the phenomenon under investigation. After selecting the case, it's crucial to define it clearly, setting the boundaries of the case, including the time period and the specific context.

Previous research can help guide the case study design. When considering a case study, an example of a case could be taken from previous case study research and used to define cases in a new research inquiry. Considering recently published examples can help understand how to select and define cases effectively.

Developing a detailed case study protocol

A case study protocol outlines the procedures and general rules to be followed during the case study. This includes the data collection methods to be used, the sources of data, and the procedures for analysis. Having a detailed case study protocol ensures consistency and reliability in the study.

The protocol should also consider how to work with the people involved in the research context to grant the research team access to collecting data. As mentioned in previous sections of this guide, establishing rapport is an essential component of qualitative research as it shapes the overall potential for collecting and analyzing data.

Collecting data

Gathering data in case study research often involves multiple sources of evidence, including documents, archival records, interviews, observations, and physical artifacts. This allows for a comprehensive understanding of the case. The process for gathering data should be systematic and carefully documented to ensure the reliability and validity of the study.

Analyzing and interpreting data

The next step is analyzing the data. This involves organizing the data , categorizing it into themes or patterns , and interpreting these patterns to answer the research question. The analysis might also involve comparing the findings with prior research or theoretical propositions.

Writing the case study report

The final step is writing the case study report . This should provide a detailed description of the case, the data, the analysis process, and the findings. The report should be clear, organized, and carefully written to ensure that the reader can understand the case and the conclusions drawn from it.

Each of these steps is crucial in ensuring that the case study research is rigorous, reliable, and provides valuable insights about the case.

The type, depth, and quality of data in your study can significantly influence the validity and utility of the study. In case study research, data is usually collected from multiple sources to provide a comprehensive and nuanced understanding of the case. This section will outline the various methods of collecting data used in case study research and discuss considerations for ensuring the quality of the data.

Interviews are a common method of gathering data in case study research. They can provide rich, in-depth data about the perspectives, experiences, and interpretations of the individuals involved in the case. Interviews can be structured , semi-structured , or unstructured , depending on the research question and the degree of flexibility needed.

Observations

Observations involve the researcher observing the case in its natural setting, providing first-hand information about the case and its context. Observations can provide data that might not be revealed in interviews or documents, such as non-verbal cues or contextual information.

Documents and artifacts

Documents and archival records provide a valuable source of data in case study research. They can include reports, letters, memos, meeting minutes, email correspondence, and various public and private documents related to the case.

These records can provide historical context, corroborate evidence from other sources, and offer insights into the case that might not be apparent from interviews or observations.

Physical artifacts refer to any physical evidence related to the case, such as tools, products, or physical environments. These artifacts can provide tangible insights into the case, complementing the data gathered from other sources.

Ensuring the quality of data collection

Determining the quality of data in case study research requires careful planning and execution. It's crucial to ensure that the data is reliable, accurate, and relevant to the research question. This involves selecting appropriate methods of collecting data, properly training interviewers or observers, and systematically recording and storing the data. It also includes considering ethical issues related to collecting and handling data, such as obtaining informed consent and ensuring the privacy and confidentiality of the participants.

Data analysis

Analyzing case study research involves making sense of the rich, detailed data to answer the research question. This process can be challenging due to the volume and complexity of case study data. However, a systematic and rigorous approach to analysis can ensure that the findings are credible and meaningful. This section outlines the main steps and considerations in analyzing data in case study research.

Organizing the data

The first step in the analysis is organizing the data. This involves sorting the data into manageable sections, often according to the data source or the theme. This step can also involve transcribing interviews, digitizing physical artifacts, or organizing observational data.

Categorizing and coding the data

Once the data is organized, the next step is to categorize or code the data. This involves identifying common themes, patterns, or concepts in the data and assigning codes to relevant data segments. Coding can be done manually or with the help of software tools, and in either case, qualitative analysis software can greatly facilitate the entire coding process. Coding helps to reduce the data to a set of themes or categories that can be more easily analyzed.

Identifying patterns and themes

After coding the data, the researcher looks for patterns or themes in the coded data. This involves comparing and contrasting the codes and looking for relationships or patterns among them. The identified patterns and themes should help answer the research question.

Interpreting the data

Once patterns and themes have been identified, the next step is to interpret these findings. This involves explaining what the patterns or themes mean in the context of the research question and the case. This interpretation should be grounded in the data, but it can also involve drawing on theoretical concepts or prior research.

Verification of the data

The last step in the analysis is verification. This involves checking the accuracy and consistency of the analysis process and confirming that the findings are supported by the data. This can involve re-checking the original data, checking the consistency of codes, or seeking feedback from research participants or peers.

Like any research method , case study research has its strengths and limitations. Researchers must be aware of these, as they can influence the design, conduct, and interpretation of the study.

Understanding the strengths and limitations of case study research can also guide researchers in deciding whether this approach is suitable for their research question . This section outlines some of the key strengths and limitations of case study research.

Benefits include the following:

Rich, detailed data: One of the main strengths of case study research is that it can generate rich, detailed data about the case. This can provide a deep understanding of the case and its context, which can be valuable in exploring complex phenomena.
Flexibility: Case study research is flexible in terms of design , data collection , and analysis . A sufficient degree of flexibility allows the researcher to adapt the study according to the case and the emerging findings.
Real-world context: Case study research involves studying the case in its real-world context, which can provide valuable insights into the interplay between the case and its context.
Multiple sources of evidence: Case study research often involves collecting data from multiple sources , which can enhance the robustness and validity of the findings.

On the other hand, researchers should consider the following limitations:

Generalizability: A common criticism of case study research is that its findings might not be generalizable to other cases due to the specificity and uniqueness of each case.
Time and resource intensive: Case study research can be time and resource intensive due to the depth of the investigation and the amount of collected data.
Complexity of analysis: The rich, detailed data generated in case study research can make analyzing the data challenging.
Subjectivity: Given the nature of case study research, there may be a higher degree of subjectivity in interpreting the data , so researchers need to reflect on this and transparently convey to audiences how the research was conducted.

Being aware of these strengths and limitations can help researchers design and conduct case study research effectively and interpret and report the findings appropriately.

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Designing and Conducting Case Studies

This guide examines case studies, a form of qualitative descriptive research that is used to look at individuals, a small group of participants, or a group as a whole. Researchers collect data about participants using participant and direct observations, interviews, protocols, tests, examinations of records, and collections of writing samples. Starting with a definition of the case study, the guide moves to a brief history of this research method. Using several well documented case studies, the guide then looks at applications and methods including data collection and analysis. A discussion of ways to handle validity, reliability, and generalizability follows, with special attention to case studies as they are applied to composition studies. Finally, this guide examines the strengths and weaknesses of case studies.

Definition and Overview

Case study refers to the collection and presentation of detailed information about a particular participant or small group, frequently including the accounts of subjects themselves. A form of qualitative descriptive research, the case study looks intensely at an individual or small participant pool, drawing conclusions only about that participant or group and only in that specific context. Researchers do not focus on the discovery of a universal, generalizable truth, nor do they typically look for cause-effect relationships; instead, emphasis is placed on exploration and description.

Case studies typically examine the interplay of all variables in order to provide as complete an understanding of an event or situation as possible. This type of comprehensive understanding is arrived at through a process known as thick description, which involves an in-depth description of the entity being evaluated, the circumstances under which it is used, the characteristics of the people involved in it, and the nature of the community in which it is located. Thick description also involves interpreting the meaning of demographic and descriptive data such as cultural norms and mores, community values, ingrained attitudes, and motives.

Unlike quantitative methods of research, like the survey, which focus on the questions of who, what, where, how much, and how many, and archival analysis, which often situates the participant in some form of historical context, case studies are the preferred strategy when how or why questions are asked. Likewise, they are the preferred method when the researcher has little control over the events, and when there is a contemporary focus within a real life context. In addition, unlike more specifically directed experiments, case studies require a problem that seeks a holistic understanding of the event or situation in question using inductive logic--reasoning from specific to more general terms.

In scholarly circles, case studies are frequently discussed within the context of qualitative research and naturalistic inquiry. Case studies are often referred to interchangeably with ethnography, field study, and participant observation. The underlying philosophical assumptions in the case are similar to these types of qualitative research because each takes place in a natural setting (such as a classroom, neighborhood, or private home), and strives for a more holistic interpretation of the event or situation under study.

Unlike more statistically-based studies which search for quantifiable data, the goal of a case study is to offer new variables and questions for further research. F.H. Giddings, a sociologist in the early part of the century, compares statistical methods to the case study on the basis that the former are concerned with the distribution of a particular trait, or a small number of traits, in a population, whereas the case study is concerned with the whole variety of traits to be found in a particular instance" (Hammersley 95).

Case studies are not a new form of research; naturalistic inquiry was the primary research tool until the development of the scientific method. The fields of sociology and anthropology are credited with the primary shaping of the concept as we know it today. However, case study research has drawn from a number of other areas as well: the clinical methods of doctors; the casework technique being developed by social workers; the methods of historians and anthropologists, plus the qualitative descriptions provided by quantitative researchers like LePlay; and, in the case of Robert Park, the techniques of newspaper reporters and novelists.

Park was an ex-newspaper reporter and editor who became very influential in developing sociological case studies at the University of Chicago in the 1920s. As a newspaper professional he coined the term "scientific" or "depth" reporting: the description of local events in a way that pointed to major social trends. Park viewed the sociologist as "merely a more accurate, responsible, and scientific reporter." Park stressed the variety and value of human experience. He believed that sociology sought to arrive at natural, but fluid, laws and generalizations in regard to human nature and society. These laws weren't static laws of the kind sought by many positivists and natural law theorists, but rather, they were laws of becoming--with a constant possibility of change. Park encouraged students to get out of the library, to quit looking at papers and books, and to view the constant experiment of human experience. He writes, "Go and sit in the lounges of the luxury hotels and on the doorsteps of the flophouses; sit on the Gold Coast settees and on the slum shakedowns; sit in the Orchestra Hall and in the Star and Garter Burlesque. In short, gentlemen [sic], go get the seats of your pants dirty in real research."

But over the years, case studies have drawn their share of criticism. In fact, the method had its detractors from the start. In the 1920s, the debate between pro-qualitative and pro-quantitative became quite heated. Case studies, when compared to statistics, were considered by many to be unscientific. From the 1930's on, the rise of positivism had a growing influence on quantitative methods in sociology. People wanted static, generalizable laws in science. The sociological positivists were looking for stable laws of social phenomena. They criticized case study research because it failed to provide evidence of inter subjective agreement. Also, they condemned it because of the few number of cases studied and that the under-standardized character of their descriptions made generalization impossible. By the 1950s, quantitative methods, in the form of survey research, had become the dominant sociological approach and case study had become a minority practice.

Educational Applications

The 1950's marked the dawning of a new era in case study research, namely that of the utilization of the case study as a teaching method. "Instituted at Harvard Business School in the 1950s as a primary method of teaching, cases have since been used in classrooms and lecture halls alike, either as part of a course of study or as the main focus of the course to which other teaching material is added" (Armisted 1984). The basic purpose of instituting the case method as a teaching strategy was "to transfer much of the responsibility for learning from the teacher on to the student, whose role, as a result, shifts away from passive absorption toward active construction" (Boehrer 1990). Through careful examination and discussion of various cases, "students learn to identify actual problems, to recognize key players and their agendas, and to become aware of those aspects of the situation that contribute to the problem" (Merseth 1991). In addition, students are encouraged to "generate their own analysis of the problems under consideration, to develop their own solutions, and to practically apply their own knowledge of theory to these problems" (Boyce 1993). Along the way, students also develop "the power to analyze and to master a tangled circumstance by identifying and delineating important factors; the ability to utilize ideas, to test them against facts, and to throw them into fresh combinations" (Merseth 1991).

In addition to the practical application and testing of scholarly knowledge, case discussions can also help students prepare for real-world problems, situations and crises by providing an approximation of various professional environments (i.e. classroom, board room, courtroom, or hospital). Thus, through the examination of specific cases, students are given the opportunity to work out their own professional issues through the trials, tribulations, experiences, and research findings of others. An obvious advantage to this mode of instruction is that it allows students the exposure to settings and contexts that they might not otherwise experience. For example, a student interested in studying the effects of poverty on minority secondary student's grade point averages and S.A.T. scores could access and analyze information from schools as geographically diverse as Los Angeles, New York City, Miami, and New Mexico without ever having to leave the classroom.

The case study method also incorporates the idea that students can learn from one another "by engaging with each other and with each other's ideas, by asserting something and then having it questioned, challenged and thrown back at them so that they can reflect on what they hear, and then refine what they say" (Boehrer 1990). In summary, students can direct their own learning by formulating questions and taking responsibility for the study.

Types and Design Concerns

Researchers use multiple methods and approaches to conduct case studies.

Types of Case Studies

Under the more generalized category of case study exist several subdivisions, each of which is custom selected for use depending upon the goals and/or objectives of the investigator. These types of case study include the following:

Illustrative Case Studies These are primarily descriptive studies. They typically utilize one or two instances of an event to show what a situation is like. Illustrative case studies serve primarily to make the unfamiliar familiar and to give readers a common language about the topic in question.

Exploratory (or pilot) Case Studies These are condensed case studies performed before implementing a large scale investigation. Their basic function is to help identify questions and select types of measurement prior to the main investigation. The primary pitfall of this type of study is that initial findings may seem convincing enough to be released prematurely as conclusions.

Cumulative Case Studies These serve to aggregate information from several sites collected at different times. The idea behind these studies is the collection of past studies will allow for greater generalization without additional cost or time being expended on new, possibly repetitive studies.

Critical Instance Case Studies These examine one or more sites for either the purpose of examining a situation of unique interest with little to no interest in generalizability, or to call into question or challenge a highly generalized or universal assertion. This method is useful for answering cause and effect questions.

Identifying a Theoretical Perspective

Much of the case study's design is inherently determined for researchers, depending on the field from which they are working. In composition studies, researchers are typically working from a qualitative, descriptive standpoint. In contrast, physicists will approach their research from a more quantitative perspective. Still, in designing the study, researchers need to make explicit the questions to be explored and the theoretical perspective from which they will approach the case. The three most commonly adopted theories are listed below:

Individual Theories These focus primarily on the individual development, cognitive behavior, personality, learning and disability, and interpersonal interactions of a particular subject.

Organizational Theories These focus on bureaucracies, institutions, organizational structure and functions, or excellence in organizational performance.

Social Theories These focus on urban development, group behavior, cultural institutions, or marketplace functions.

Two examples of case studies are used consistently throughout this chapter. The first, a study produced by Berkenkotter, Huckin, and Ackerman (1988), looks at a first year graduate student's initiation into an academic writing program. The study uses participant-observer and linguistic data collecting techniques to assess the student's knowledge of appropriate discourse conventions. Using the pseudonym Nate to refer to the subject, the study sought to illuminate the particular experience rather than to generalize about the experience of fledgling academic writers collectively.

For example, in Berkenkotter, Huckin, and Ackerman's (1988) study we are told that the researchers are interested in disciplinary communities. In the first paragraph, they ask what constitutes membership in a disciplinary community and how achieving membership might affect a writer's understanding and production of texts. In the third paragraph they state that researchers must negotiate their claims "within the context of his sub specialty's accepted knowledge and methodology." In the next paragraph they ask, "How is literacy acquired? What is the process through which novices gain community membership? And what factors either aid or hinder students learning the requisite linguistic behaviors?" This introductory section ends with a paragraph in which the study's authors claim that during the course of the study, the subject, Nate, successfully makes the transition from "skilled novice" to become an initiated member of the academic discourse community and that his texts exhibit linguistic changes which indicate this transition. In the next section the authors make explicit the sociolinguistic theoretical and methodological assumptions on which the study is based (1988). Thus the reader has a good understanding of the authors' theoretical background and purpose in conducting the study even before it is explicitly stated on the fourth page of the study. "Our purpose was to examine the effects of the educational context on one graduate student's production of texts as he wrote in different courses and for different faculty members over the academic year 1984-85." The goal of the study then, was to explore the idea that writers must be initiated into a writing community, and that this initiation will change the way one writes.

The second example is Janet Emig's (1971) study of the composing process of a group of twelfth graders. In this study, Emig seeks to answer the question of what happens to the self as a result educational stimuli in terms of academic writing. The case study used methods such as protocol analysis, tape-recorded interviews, and discourse analysis.

In the case of Janet Emig's (1971) study of the composing process of eight twelfth graders, four specific hypotheses were made:

Twelfth grade writers engage in two modes of composing: reflexive and extensive.
These differences can be ascertained and characterized through having the writers compose aloud their composition process.
A set of implied stylistic principles governs the writing process.
For twelfth grade writers, extensive writing occurs chiefly as a school-sponsored activity, or reflexive, as a self-sponsored activity.

In this study, the chief distinction is between the two dominant modes of composing among older, secondary school students. The distinctions are:

The reflexive mode, which focuses on the writer's thoughts and feelings.
The extensive mode, which focuses on conveying a message.

Emig also outlines the specific questions which guided the research in the opening pages of her Review of Literature , preceding the report.

Designing a Case Study

After considering the different sub categories of case study and identifying a theoretical perspective, researchers can begin to design their study. Research design is the string of logic that ultimately links the data to be collected and the conclusions to be drawn to the initial questions of the study. Typically, research designs deal with at least four problems:

What questions to study
What data are relevant
What data to collect
How to analyze that data

In other words, a research design is basically a blueprint for getting from the beginning to the end of a study. The beginning is an initial set of questions to be answered, and the end is some set of conclusions about those questions.

Because case studies are conducted on topics as diverse as Anglo-Saxon Literature (Thrane 1986) and AIDS prevention (Van Vugt 1994), it is virtually impossible to outline any strict or universal method or design for conducting the case study. However, Robert K. Yin (1993) does offer five basic components of a research design:

A study's questions.
A study's propositions (if any).
A study's units of analysis.
The logic that links the data to the propositions.
The criteria for interpreting the findings.

In addition to these five basic components, Yin also stresses the importance of clearly articulating one's theoretical perspective, determining the goals of the study, selecting one's subject(s), selecting the appropriate method(s) of collecting data, and providing some considerations to the composition of the final report.

Conducting Case Studies

To obtain as complete a picture of the participant as possible, case study researchers can employ a variety of approaches and methods. These approaches, methods, and related issues are discussed in depth in this section.

Method: Single or Multi-modal?

To obtain as complete a picture of the participant as possible, case study researchers can employ a variety of methods. Some common methods include interviews , protocol analyses, field studies, and participant-observations. Emig (1971) chose to use several methods of data collection. Her sources included conversations with the students, protocol analysis, discrete observations of actual composition, writing samples from each student, and school records (Lauer and Asher 1988).

Berkenkotter, Huckin, and Ackerman (1988) collected data by observing classrooms, conducting faculty and student interviews, collecting self reports from the subject, and by looking at the subject's written work.

A study that was criticized for using a single method model was done by Flower and Hayes (1984). In this study that explores the ways in which writers use different forms of knowing to create space, the authors used only protocol analysis to gather data. The study came under heavy fire because of their decision to use only one method.

Participant Selection

Case studies can use one participant, or a small group of participants. However, it is important that the participant pool remain relatively small. The participants can represent a diverse cross section of society, but this isn't necessary.

For example, the Berkenkotter, Huckin, and Ackerman (1988) study looked at just one participant, Nate. By contrast, in Janet Emig's (1971) study of the composition process of twelfth graders, eight participants were selected representing a diverse cross section of the community, with volunteers from an all-white upper-middle-class suburban school, an all-black inner-city school, a racially mixed lower-middle-class school, an economically and racially mixed school, and a university school.

Often, a brief "case history" is done on the participants of the study in order to provide researchers with a clearer understanding of their participants, as well as some insight as to how their own personal histories might affect the outcome of the study. For instance, in Emig's study, the investigator had access to the school records of five of the participants, and to standardized test scores for the remaining three. Also made available to the researcher was the information that three of the eight students were selected as NCTE Achievement Award winners. These personal histories can be useful in later stages of the study when data are being analyzed and conclusions drawn.

Data Collection

There are six types of data collected in case studies:

Archival records.
Interviews.
Direct observation.
Participant observation.

In the field of composition research, these six sources might be:

A writer's drafts.
School records of student writers.
Transcripts of interviews with a writer.
Transcripts of conversations between writers (and protocols).
Videotapes and notes from direct field observations.
Hard copies of a writer's work on computer.

Depending on whether researchers have chosen to use a single or multi-modal approach for the case study, they may choose to collect data from one or any combination of these sources.

Protocols, that is, transcriptions of participants talking aloud about what they are doing as they do it, have been particularly common in composition case studies. For example, in Emig's (1971) study, the students were asked, in four different sessions, to give oral autobiographies of their writing experiences and to compose aloud three themes in the presence of a tape recorder and the investigator.

In some studies, only one method of data collection is conducted. For example, the Flower and Hayes (1981) report on the cognitive process theory of writing depends on protocol analysis alone. However, using multiple sources of evidence to increase the reliability and validity of the data can be advantageous.

Case studies are likely to be much more convincing and accurate if they are based on several different sources of information, following a corroborating mode. This conclusion is echoed among many composition researchers. For example, in her study of predrafting processes of high and low-apprehensive writers, Cynthia Selfe (1985) argues that because "methods of indirect observation provide only an incomplete reflection of the complex set of processes involved in composing, a combination of several such methods should be used to gather data in any one study." Thus, in this study, Selfe collected her data from protocols, observations of students role playing their writing processes, audio taped interviews with the students, and videotaped observations of the students in the process of composing.

It can be said then, that cross checking data from multiple sources can help provide a multidimensional profile of composing activities in a particular setting. Sharan Merriam (1985) suggests "checking, verifying, testing, probing, and confirming collected data as you go, arguing that this process will follow in a funnel-like design resulting in less data gathering in later phases of the study along with a congruent increase in analysis checking, verifying, and confirming."

It is important to note that in case studies, as in any qualitative descriptive research, while researchers begin their studies with one or several questions driving the inquiry (which influence the key factors the researcher will be looking for during data collection), a researcher may find new key factors emerging during data collection. These might be unexpected patterns or linguistic features which become evident only during the course of the research. While not bearing directly on the researcher's guiding questions, these variables may become the basis for new questions asked at the end of the report, thus linking to the possibility of further research.

Data Analysis

As the information is collected, researchers strive to make sense of their data. Generally, researchers interpret their data in one of two ways: holistically or through coding. Holistic analysis does not attempt to break the evidence into parts, but rather to draw conclusions based on the text as a whole. Flower and Hayes (1981), for example, make inferences from entire sections of their students' protocols, rather than searching through the transcripts to look for isolatable characteristics.

However, composition researchers commonly interpret their data by coding, that is by systematically searching data to identify and/or categorize specific observable actions or characteristics. These observable actions then become the key variables in the study. Sharan Merriam (1988) suggests seven analytic frameworks for the organization and presentation of data:

The role of participants.
The network analysis of formal and informal exchanges among groups.
Historical.
Thematical.
Ritual and symbolism.
Critical incidents that challenge or reinforce fundamental beliefs, practices, and values.

There are two purposes of these frameworks: to look for patterns among the data and to look for patterns that give meaning to the case study.

As stated above, while most researchers begin their case studies expecting to look for particular observable characteristics, it is not unusual for key variables to emerge during data collection. Typical variables coded in case studies of writers include pauses writers make in the production of a text, the use of specific linguistic units (such as nouns or verbs), and writing processes (planning, drafting, revising, and editing). In the Berkenkotter, Huckin, and Ackerman (1988) study, for example, researchers coded the participant's texts for use of connectives, discourse demonstratives, average sentence length, off-register words, use of the first person pronoun, and the ratio of definite articles to indefinite articles.

Since coding is inherently subjective, more than one coder is usually employed. In the Berkenkotter, Huckin, and Ackerman (1988) study, for example, three rhetoricians were employed to code the participant's texts for off-register phrases. The researchers established the agreement among the coders before concluding that the participant used fewer off-register words as the graduate program progressed.

Composing the Case Study Report

In the many forms it can take, "a case study is generically a story; it presents the concrete narrative detail of actual, or at least realistic events, it has a plot, exposition, characters, and sometimes even dialogue" (Boehrer 1990). Generally, case study reports are extensively descriptive, with "the most problematic issue often referred to as being the determination of the right combination of description and analysis" (1990). Typically, authors address each step of the research process, and attempt to give the reader as much context as possible for the decisions made in the research design and for the conclusions drawn.

This contextualization usually includes a detailed explanation of the researchers' theoretical positions, of how those theories drove the inquiry or led to the guiding research questions, of the participants' backgrounds, of the processes of data collection, of the training and limitations of the coders, along with a strong attempt to make connections between the data and the conclusions evident.

Although the Berkenkotter, Huckin, and Ackerman (1988) study does not, case study reports often include the reactions of the participants to the study or to the researchers' conclusions. Because case studies tend to be exploratory, most end with implications for further study. Here researchers may identify significant variables that emerged during the research and suggest studies related to these, or the authors may suggest further general questions that their case study generated.

For example, Emig's (1971) study concludes with a section dedicated solely to the topic of implications for further research, in which she suggests several means by which this particular study could have been improved, as well as questions and ideas raised by this study which other researchers might like to address, such as: is there a correlation between a certain personality and a certain composing process profile (e.g. is there a positive correlation between ego strength and persistence in revising)?

Also included in Emig's study is a section dedicated to implications for teaching, which outlines the pedagogical ramifications of the study's findings for teachers currently involved in high school writing programs.

Sharan Merriam (1985) also offers several suggestions for alternative presentations of data:

Prepare specialized condensations for appropriate groups.
Replace narrative sections with a series of answers to open-ended questions.
Present "skimmer's" summaries at beginning of each section.
Incorporate headlines that encapsulate information from text.
Prepare analytic summaries with supporting data appendixes.
Present data in colorful and/or unique graphic representations.

Issues of Validity and Reliability

Once key variables have been identified, they can be analyzed. Reliability becomes a key concern at this stage, and many case study researchers go to great lengths to ensure that their interpretations of the data will be both reliable and valid. Because issues of validity and reliability are an important part of any study in the social sciences, it is important to identify some ways of dealing with results.

Multi-modal case study researchers often balance the results of their coding with data from interviews or writer's reflections upon their own work. Consequently, the researchers' conclusions become highly contextualized. For example, in a case study which looked at the time spent in different stages of the writing process, Berkenkotter concluded that her participant, Donald Murray, spent more time planning his essays than in other writing stages. The report of this case study is followed by Murray's reply, wherein he agrees with some of Berkenkotter's conclusions and disagrees with others.

As is the case with other research methodologies, issues of external validity, construct validity, and reliability need to be carefully considered.

Commentary on Case Studies

Researchers often debate the relative merits of particular methods, among them case study. In this section, we comment on two key issues. To read the commentaries, choose any of the items below:

Strengths and Weaknesses of Case Studies

Most case study advocates point out that case studies produce much more detailed information than what is available through a statistical analysis. Advocates will also hold that while statistical methods might be able to deal with situations where behavior is homogeneous and routine, case studies are needed to deal with creativity, innovation, and context. Detractors argue that case studies are difficult to generalize because of inherent subjectivity and because they are based on qualitative subjective data, generalizable only to a particular context.

Flexibility

The case study approach is a comparatively flexible method of scientific research. Because its project designs seem to emphasize exploration rather than prescription or prediction, researchers are comparatively freer to discover and address issues as they arise in their experiments. In addition, the looser format of case studies allows researchers to begin with broad questions and narrow their focus as their experiment progresses rather than attempt to predict every possible outcome before the experiment is conducted.

Emphasis on Context

By seeking to understand as much as possible about a single subject or small group of subjects, case studies specialize in "deep data," or "thick description"--information based on particular contexts that can give research results a more human face. This emphasis can help bridge the gap between abstract research and concrete practice by allowing researchers to compare their firsthand observations with the quantitative results obtained through other methods of research.

Inherent Subjectivity

"The case study has long been stereotyped as the weak sibling among social science methods," and is often criticized as being too subjective and even pseudo-scientific. Likewise, "investigators who do case studies are often regarded as having deviated from their academic disciplines, and their investigations as having insufficient precision (that is, quantification), objectivity and rigor" (Yin 1989). Opponents cite opportunities for subjectivity in the implementation, presentation, and evaluation of case study research. The approach relies on personal interpretation of data and inferences. Results may not be generalizable, are difficult to test for validity, and rarely offer a problem-solving prescription. Simply put, relying on one or a few subjects as a basis for cognitive extrapolations runs the risk of inferring too much from what might be circumstance.

High Investment

Case studies can involve learning more about the subjects being tested than most researchers would care to know--their educational background, emotional background, perceptions of themselves and their surroundings, their likes, dislikes, and so on. Because of its emphasis on "deep data," the case study is out of reach for many large-scale research projects which look at a subject pool in the tens of thousands. A budget request of $10,000 to examine 200 subjects sounds more efficient than a similar request to examine four subjects.

Ethical Considerations

Researchers conducting case studies should consider certain ethical issues. For example, many educational case studies are often financed by people who have, either directly or indirectly, power over both those being studied and those conducting the investigation (1985). This conflict of interests can hinder the credibility of the study.

The personal integrity, sensitivity, and possible prejudices and/or biases of the investigators need to be taken into consideration as well. Personal biases can creep into how the research is conducted, alternative research methods used, and the preparation of surveys and questionnaires.

A common complaint in case study research is that investigators change direction during the course of the study unaware that their original research design was inadequate for the revised investigation. Thus, the researchers leave unknown gaps and biases in the study. To avoid this, researchers should report preliminary findings so that the likelihood of bias will be reduced.

Concerns about Reliability, Validity, and Generalizability

Merriam (1985) offers several suggestions for how case study researchers might actively combat the popular attacks on the validity, reliability, and generalizability of case studies:

Prolong the Processes of Data Gathering on Site: This will help to insure the accuracy of the findings by providing the researcher with more concrete information upon which to formulate interpretations.
Employ the Process of "Triangulation": Use a variety of data sources as opposed to relying solely upon one avenue of observation. One example of such a data check would be what McClintock, Brannon, and Maynard (1985) refer to as a "case cluster method," that is, when a single unit within a larger case is randomly sampled, and that data treated quantitatively." For instance, in Emig's (1971) study, the case cluster method was employed, singling out the productivity of a single student named Lynn. This cluster profile included an advanced case history of the subject, specific examination and analysis of individual compositions and protocols, and extensive interview sessions. The seven remaining students were then compared with the case of Lynn, to ascertain if there are any shared, or unique dimensions to the composing process engaged in by these eight students.
Conduct Member Checks: Initiate and maintain an active corroboration on the interpretation of data between the researcher and those who provided the data. In other words, talk to your subjects.
Collect Referential Materials: Complement the file of materials from the actual site with additional document support. For example, Emig (1971) supports her initial propositions with historical accounts by writers such as T.S. Eliot, James Joyce, and D.H. Lawrence. Emig also cites examples of theoretical research done with regards to the creative process, as well as examples of empirical research dealing with the writing of adolescents. Specific attention is then given to the four stages description of the composing process delineated by Helmoltz, Wallas, and Cowley, as it serves as the focal point in this study.
Engage in Peer Consultation: Prior to composing the final draft of the report, researchers should consult with colleagues in order to establish validity through pooled judgment.

Although little can be done to combat challenges concerning the generalizability of case studies, "most writers suggest that qualitative research should be judged as credible and confirmable as opposed to valid and reliable" (Merriam 1985). Likewise, it has been argued that "rather than transplanting statistical, quantitative notions of generalizability and thus finding qualitative research inadequate, it makes more sense to develop an understanding of generalization that is congruent with the basic characteristics of qualitative inquiry" (1985). After all, criticizing the case study method for being ungeneralizable is comparable to criticizing a washing machine for not being able to tell the correct time. In other words, it is unjust to criticize a method for not being able to do something which it was never originally designed to do in the first place.

Annotated Bibliography

Armisted, C. (1984). How Useful are Case Studies. Training and Development Journal, 38 (2), 75-77.

This article looks at eight types of case studies, offers pros and cons of using case studies in the classroom, and gives suggestions for successfully writing and using case studies.

Bardovi-Harlig, K. (1997). Beyond Methods: Components of Second Language Teacher Education . New York: McGraw-Hill.

A compilation of various research essays which address issues of language teacher education. Essays included are: "Non-native reading research and theory" by Lee, "The case for Psycholinguistics" by VanPatten, and "Assessment and Second Language Teaching" by Gradman and Reed.

Bartlett, L. (1989). A Question of Good Judgment; Interpretation Theory and Qualitative Enquiry Address. 70th Annual Meeting of the American Educational Research Association. San Francisco.

Bartlett selected "quasi-historical" methodology, which focuses on the "truth" found in case records, as one that will provide "good judgments" in educational inquiry. He argues that although the method is not comprehensive, it can try to connect theory with practice.

Baydere, S. et. al. (1993). Multimedia conferencing as a tool for collaborative writing: a case study in Computer Supported Collaborative Writing. New York: Springer-Verlag.

The case study by Baydere et. al. is just one of the many essays in this book found in the series "Computer Supported Cooperative Work." Denley, Witefield and May explore similar issues in their essay, "A case study in task analysis for the design of a collaborative document production system."

Berkenkotter, C., Huckin, T., N., & Ackerman J. (1988). Conventions, Conversations, and the Writer: Case Study of a Student in a Rhetoric Ph.D. Program. Research in the Teaching of English, 22, 9-44.

The authors focused on how the writing of their subject, Nate or Ackerman, changed as he became more acquainted or familiar with his field's discourse community.

Berninger, V., W., and Gans, B., M. (1986). Language Profiles in Nonspeaking Individuals of Normal Intelligence with Severe Cerebral Palsy. Augmentative and Alternative Communication, 2, 45-50.

Argues that generalizations about language abilities in patients with severe cerebral palsy (CP) should be avoided. Standardized tests of different levels of processing oral language, of processing written language, and of producing written language were administered to 3 male participants (aged 9, 16, and 40 yrs).

Bockman, J., R., and Couture, B. (1984). The Case Method in Technical Communication: Theory and Models. Texas: Association of Teachers of Technical Writing.

Examines the study and teaching of technical writing, communication of technical information, and the case method in terms of those applications.

Boehrer, J. (1990). Teaching With Cases: Learning to Question. New Directions for Teaching and Learning, 42 41-57.

This article discusses the origins of the case method, looks at the question of what is a case, gives ideas about learning in case teaching, the purposes it can serve in the classroom, the ground rules for the case discussion, including the role of the question, and new directions for case teaching.

Bowman, W. R. (1993). Evaluating JTPA Programs for Economically Disadvantaged Adults: A Case Study of Utah and General Findings . Washington: National Commission for Employment Policy.

"To encourage state-level evaluations of JTPA, the Commission and the State of Utah co-sponsored this report on the effectiveness of JTPA Title II programs for adults in Utah. The technique used is non-experimental and the comparison group was selected from registrants with Utah's Employment Security. In a step-by-step approach, the report documents how non-experimental techniques can be applied and several specific technical issues can be addressed."

Boyce, A. (1993) The Case Study Approach for Pedagogists. Annual Meeting of the American Alliance for Health, Physical Education, Recreation and Dance. (Address). Washington DC.

This paper addresses how case studies 1) bridge the gap between teaching theory and application, 2) enable students to analyze problems and develop solutions for situations that will be encountered in the real world of teaching, and 3) helps students to evaluate the feasibility of alternatives and to understand the ramifications of a particular course of action.

Carson, J. (1993) The Case Study: Ideal Home of WAC Quantitative and Qualitative Data. Annual Meeting of the Conference on College Composition and Communication. (Address). San Diego.

"Increasingly, one of the most pressing questions for WAC advocates is how to keep [WAC] programs going in the face of numerous difficulties. Case histories offer the best chance for fashioning rhetorical arguments to keep WAC programs going because they offer the opportunity to provide a coherent narrative that contextualizes all documents and data, including what is generally considered scientific data. A case study of the WAC program, . . . at Robert Morris College in Pittsburgh demonstrates the advantages of this research method. Such studies are ideal homes for both naturalistic and positivistic data as well as both quantitative and qualitative information."

---. (1991). A Cognitive Process Theory of Writing. College Composition and Communication. 32. 365-87.

No abstract available.

Cromer, R. (1994) A Case Study of Dissociations Between Language and Cognition. Constraints on Language Acquisition: Studies of Atypical Children . Hillsdale: Lawrence Erlbaum Associates, 141-153.

Crossley, M. (1983) Case Study in Comparative and International Education: An Approach to Bridging the Theory-Practice Gap. Proceedings of the 11th Annual Conference of the Australian Comparative and International Education Society. Hamilton, NZ.

Case study research, as presented here, helps bridge the theory-practice gap in comparative and international research studies of education because it focuses on the practical, day-to-day context rather than on the national arena. The paper asserts that the case study method can be valuable at all levels of research, formation, and verification of theories in education.

Daillak, R., H., and Alkin, M., C. (1982). Qualitative Studies in Context: Reflections on the CSE Studies of Evaluation Use . California: EDRS

The report shows how the Center of the Study of Evaluation (CSE) applied qualitative techniques to a study of evaluation information use in local, Los Angeles schools. It critiques the effectiveness and the limitations of using case study, evaluation, field study, and user interview survey methodologies.

Davey, L. (1991). The Application of Case Study Evaluations. ERIC/TM Digest.

This article examines six types of case studies, the type of evaluation questions that can be answered, the functions served, some design features, and some pitfalls of the method.

Deutch, C. E. (1996). A course in research ethics for graduate students. College Teaching, 44, 2, 56-60.

This article describes a one-credit discussion course in research ethics for graduate students in biology. Case studies are focused on within the four parts of the course: 1) major issues, 2 )practical issues in scholarly work, 3) ownership of research results, and 4) training and personal decisions.

DeVoss, G. (1981). Ethics in Fieldwork Research. RIE 27p. (ERIC)

This article examines four of the ethical problems that can happen when conducting case study research: acquiring permission to do research, knowing when to stop digging, the pitfalls of doing collaborative research, and preserving the integrity of the participants.

Driscoll, A. (1985). Case Study of a Research Intervention: the University of Utah’s Collaborative Approach . San Francisco: Far West Library for Educational Research Development.

Paper presented at the annual meeting of the American Association of Colleges of Teacher Education, Denver, CO, March 1985. Offers information of in-service training, specifically case studies application.

Ellram, L. M. (1996). The Use of the Case Study Method in Logistics Research. Journal of Business Logistics, 17, 2, 93.

This article discusses the increased use of case study in business research, and the lack of understanding of when and how to use case study methodology in business.

Emig, J. (1971) The Composing Processes of Twelfth Graders . Urbana: NTCE.

This case study uses observation, tape recordings, writing samples, and school records to show that writing in reflexive and extensive situations caused different lengths of discourse and different clusterings of the components of the writing process.

Feagin, J. R. (1991). A Case For the Case Study . Chapel Hill: The University of North Carolina Press.

This book discusses the nature, characteristics, and basic methodological issues of the case study as a research method.

Feldman, H., Holland, A., & Keefe, K. (1989) Language Abilities after Left Hemisphere Brain Injury: A Case Study of Twins. Topics in Early Childhood Special Education, 9, 32-47.

"Describes the language abilities of 2 twin pairs in which 1 twin (the experimental) suffered brain injury to the left cerebral hemisphere around the time of birth and1 twin (the control) did not. One pair of twins was initially assessed at age 23 mo. and the other at about 30 mo.; they were subsequently evaluated in their homes 3 times at about 6-mo intervals."

Fidel, R. (1984). The Case Study Method: A Case Study. Library and Information Science Research, 6.

The article describes the use of case study methodology to systematically develop a model of online searching behavior in which study design is flexible, subject manner determines data gathering and analyses, and procedures adapt to the study's progressive change.

Flower, L., & Hayes, J. R. (1984). Images, Plans and Prose: The Representation of Meaning in Writing. Written Communication, 1, 120-160.

Explores the ways in which writers actually use different forms of knowing to create prose.

Frey, L. R. (1992). Interpreting Communication Research: A Case Study Approach Englewood Cliffs, N.J.: Prentice Hall.

The book discusses research methodologies in the Communication field. It focuses on how case studies bridge the gap between communication research, theory, and practice.

Gilbert, V. K. (1981). The Case Study as a Research Methodology: Difficulties and Advantages of Integrating the Positivistic, Phenomenological and Grounded Theory Approaches . The Annual Meeting of the Canadian Association for the Study of Educational Administration. (Address) Halifax, NS, Can.

This study on an innovative secondary school in England shows how a "low-profile" participant-observer case study was crucial to the initial observation, the testing of hypotheses, the interpretive approach, and the grounded theory.

Gilgun, J. F. (1994). A Case for Case Studies in Social Work Research. Social Work, 39, 4, 371-381.

This article defines case study research, presents guidelines for evaluation of case studies, and shows the relevance of case studies to social work research. It also looks at issues such as evaluation and interpretations of case studies.

Glennan, S. L., Sharp-Bittner, M. A. & Tullos, D. C. (1991). Augmentative and Alternative Communication Training with a Nonspeaking Adult: Lessons from MH. Augmentative and Alternative Communication, 7, 240-7.

"A response-guided case study documented changes in a nonspeaking 36-yr-old man's ability to communicate using 3 trained augmentative communication modes. . . . Data were collected in videotaped interaction sessions between the nonspeaking adult and a series of adult speaking."

Graves, D. (1981). An Examination of the Writing Processes of Seven Year Old Children. Research in the Teaching of English, 15, 113-134.

Hamel, J. (1993). Case Study Methods . Newbury Park: Sage. .

"In a most economical fashion, Hamel provides a practical guide for producing theoretically sharp and empirically sound sociological case studies. A central idea put forth by Hamel is that case studies must "locate the global in the local" thus making the careful selection of the research site the most critical decision in the analytic process."

Karthigesu, R. (1986, July). Television as a Tool for Nation-Building in the Third World: A Post-Colonial Pattern, Using Malaysia as a Case-Study. International Television Studies Conference. (Address). London, 10-12.

"The extent to which Television Malaysia, as a national mass media organization, has been able to play a role in nation building in the post-colonial period is . . . studied in two parts: how the choice of a model of nation building determines the character of the organization; and how the character of the organization influences the output of the organization."

Kenny, R. (1984). Making the Case for the Case Study. Journal of Curriculum Studies, 16, (1), 37-51.

The article looks at how and why the case study is justified as a viable and valuable approach to educational research and program evaluation.

Knirk, F. (1991). Case Materials: Research and Practice. Performance Improvement Quarterly, 4 (1 ), 73-81.

The article addresses the effectiveness of case studies, subject areas where case studies are commonly used, recent examples of their use, and case study design considerations.

Klos, D. (1976). Students as Case Writers. Teaching of Psychology, 3.2, 63-66.

This article reviews a course in which students gather data for an original case study of another person. The task requires the students to design the study, collect the data, write the narrative, and interpret the findings.

Leftwich, A. (1981). The Politics of Case Study: Problems of Innovation in University Education. Higher Education Review, 13.2, 38-64.

The article discusses the use of case studies as a teaching method. Emphasis is on the instructional materials, interdisciplinarity, and the complex relationships within the university that help or hinder the method.

Mabrito, M. (1991, Oct.). Electronic Mail as a Vehicle for Peer Response: Conversations of High and Low Apprehensive Writers. Written Communication, 509-32.

McCarthy, S., J. (1955). The Influence of Classroom Discourse on Student Texts: The Case of Ella . East Lansing: Institute for Research on Teaching.

A look at how students of color become marginalized within traditional classroom discourse. The essay follows the struggles of one black student: Ella.

Matsuhashi, A., ed. (1987). Writing in Real Time: Modeling Production Processes Norwood, NJ: Ablex Publishing Corporation.

Investigates how writers plan to produce discourse for different purposes to report, to generalize, and to persuade, as well as how writers plan for sentence level units of language. To learn about planning, an observational measure of pause time was used" (ERIC).

Merriam, S. B. (1985). The Case Study in Educational Research: A Review of Selected Literature. Journal of Educational Thought, 19.3, 204-17.

The article examines the characteristics of, philosophical assumptions underlying the case study, the mechanics of conducting a case study, and the concerns about the reliability, validity, and generalizability of the method.

---. (1988). Case Study Research in Education: A Qualitative Approach San Francisco: Jossey Bass.

Merry, S. E., & Milner, N. eds. (1993). The Possibility of Popular Justice: A Case Study of Community Mediation in the United States . Ann Arbor: U of Michigan.

". . . this volume presents a case study of one experiment in popular justice, the San Francisco Community Boards. This program has made an explicit claim to create an alternative justice, or new justice, in the midst of a society ordered by state law. The contributors to this volume explore the history and experience of the program and compare it to other versions of popular justice in the United States, Europe, and the Third World."

Merseth, K. K. (1991). The Case for Cases in Teacher Education. RIE. 42p. (ERIC).

This monograph argues that the case method of instruction offers unique potential for revitalizing the field of teacher education.

Michaels, S. (1987). Text and Context: A New Approach to the Study of Classroom Writing. Discourse Processes, 10, 321-346.

"This paper argues for and illustrates an approach to the study of writing that integrates ethnographic analysis of classroom interaction with linguistic analysis of written texts and teacher/student conversational exchanges. The approach is illustrated through a case study of writing in a single sixth grade classroom during a single writing assignment."

Milburn, G. (1995). Deciphering a Code or Unraveling a Riddle: A Case Study in the Application of a Humanistic Metaphor to the Reporting of Social Studies Teaching. Theory and Research in Education, 13.

This citation serves as an example of how case studies document learning procedures in a senior-level economics course.

Milley, J. E. (1979). An Investigation of Case Study as an Approach to Program Evaluation. 19th Annual Forum of the Association for Institutional Research. (Address). San Diego.

The case study method merged a narrative report focusing on the evaluator as participant-observer with document review, interview, content analysis, attitude questionnaire survey, and sociogram analysis. Milley argues that case study program evaluation has great potential for widespread use.

Minnis, J. R. (1985, Sept.). Ethnography, Case Study, Grounded Theory, and Distance Education Research. Distance Education, 6.2.

This article describes and defines the strengths and weaknesses of ethnography, case study, and grounded theory.

Nunan, D. (1992). Collaborative language learning and teaching . New York: Cambridge University Press.

Included in this series of essays is Peter Sturman’s "Team Teaching: a case study from Japan" and David Nunan’s own "Toward a collaborative approach to curriculum development: a case study."

Nystrand, M., ed. (1982). What Writers Know: The Language, Process, and Structure of Written Discourse . New York: Academic Press.

Owenby, P. H. (1992). Making Case Studies Come Alive. Training, 29, (1), 43-46. (ERIC)

This article provides tips for writing more effective case studies.

---. (1981). Pausing and Planning: The Tempo of Writer Discourse Production. Research in the Teaching of English, 15 (2),113-34.

Perl, S. (1979). The Composing Processes of Unskilled College Writers. Research in the Teaching of English, 13, 317-336.

"Summarizes a study of five unskilled college writers, focusing especially on one of the five, and discusses the findings in light of current pedagogical practice and research design."

Pilcher J. and A. Coffey. eds. (1996). Gender and Qualitative Research . Brookfield: Aldershot, Hants, England.

This book provides a series of essays which look at gender identity research, qualitative research and applications of case study to questions of gendered pedagogy.

Pirie, B. S. (1993). The Case of Morty: A Four Year Study. Gifted Education International, 9 (2), 105-109.

This case study describes a boy from kindergarten through third grade with above average intelligence but difficulty in learning to read, write, and spell.

Popkewitz, T. (1993). Changing Patterns of Power: Social Regulation and Teacher Education Reform. Albany: SUNY Press.

Popkewitz edits this series of essays that address case studies on educational change and the training of teachers. The essays vary in terms of discipline and scope. Also, several authors include case studies of educational practices in countries other than the United States.

---. (1984). The Predrafting Processes of Four High- and Four Low Apprehensive Writers. Research in the Teaching of English, 18, (1), 45-64.

Rasmussen, P. (1985, March) A Case Study on the Evaluation of Research at the Technical University of Denmark. International Journal of Institutional Management in Higher Education, 9 (1).

This is an example of a case study methodology used to evaluate the chemistry and chemical engineering departments at the University of Denmark.

Roth, K. J. (1986). Curriculum Materials, Teacher Talk, and Student Learning: Case Studies in Fifth-Grade Science Teaching . East Lansing: Institute for Research on Teaching.

Roth offers case studies on elementary teachers, elementary school teaching, science studies and teaching, and verbal learning.

Selfe, C. L. (1985). An Apprehensive Writer Composes. When a Writer Can't Write: Studies in Writer's Block and Other Composing-Process Problems . (pp. 83-95). Ed. Mike Rose. NMY: Guilford.

Smith-Lewis, M., R. and Ford, A. (1987). A User's Perspective on Augmentative Communication. Augmentative and Alternative Communication, 3, 12-7.

"During a series of in-depth interviews, a 25-yr-old woman with cerebral palsy who utilized augmentative communication reflected on the effectiveness of the devices designed for her during her school career."

St. Pierre, R., G. (1980, April). Follow Through: A Case Study in Metaevaluation Research . 64th Annual Meeting of the American Educational Research Association. (Address).

The three approaches to metaevaluation are evaluation of primary evaluations, integrative meta-analysis with combined primary evaluation results, and re-analysis of the raw data from a primary evaluation.

Stahler, T., M. (1996, Feb.) Early Field Experiences: A Model That Worked. ERIC.

"This case study of a field and theory class examines a model designed to provide meaningful field experiences for preservice teachers while remaining consistent with the instructor's beliefs about the role of teacher education in preparing teachers for the classroom."

Stake, R. E. (1995). The Art of Case Study Research. Thousand Oaks: Sage Publications.

This book examines case study research in education and case study methodology.

Stiegelbauer, S. (1984) Community, Context, and Co-curriculum: Situational Factors Influencing School Improvements in a Study of High Schools. Presented at the annual meeting of the American Educational Research Association, New Orleans, LA.

Discussion of several case studies: one looking at high school environments, another examining educational innovations.

Stolovitch, H. (1990). Case Study Method. Performance And Instruction, 29, (9), 35-37.

This article describes the case study method as a form of simulation and presents guidelines for their use in professional training situations.

Thaller, E. (1994). Bibliography for the Case Method: Using Case Studies in Teacher Education. RIE. 37 p.

This bibliography presents approximately 450 citations on the use of case studies in teacher education from 1921-1993.

Thrane, T. (1986). On Delimiting the Senses of Near-Synonyms in Historical Semantics: A Case Study of Adjectives of 'Moral Sufficiency' in the Old English Andreas. Linguistics Across Historical and Geographical Boundaries: In Honor of Jacek Fisiak on the Occasion of his Fiftieth Birthday . Berlin: Mouton de Gruyter.

United Nations. (1975). Food and Agriculture Organization. Report on the FAO/UNFPA Seminar on Methodology, Research and Country: Case Studies on Population, Employment and Productivity . Rome: United Nations.

This example case study shows how the methodology can be used in a demographic and psychographic evaluation. At the same time, it discusses the formation and instigation of the case study methodology itself.

Van Vugt, J. P., ed. (1994). Aids Prevention and Services: Community Based Research . Westport: Bergin and Garvey.

"This volume has been five years in the making. In the process, some of the policy applications called for have met with limited success, such as free needle exchange programs in a limited number of American cities, providing condoms to prison inmates, and advertisements that depict same-sex couples. Rather than dating our chapters that deal with such subjects, such policy applications are verifications of the type of research demonstrated here. Furthermore, they indicate the critical need to continue community based research in the various communities threatened by acquired immuno-deficiency syndrome (AIDS) . . . "

Welch, W., ed. (1981, May). Case Study Methodology in Educational Evaluation. Proceedings of the Minnesota Evaluation Conference. Minnesota. (Address).

The four papers in these proceedings provide a comprehensive picture of the rationale, methodology, strengths, and limitations of case studies.

Williams, G. (1987). The Case Method: An Approach to Teaching and Learning in Educational Administration. RIE, 31p.

This paper examines the viability of the case method as a teaching and learning strategy in instructional systems geared toward the training of personnel of the administration of various aspects of educational systems.

Yin, R. K. (1993). Advancing Rigorous Methodologies: A Review of 'Towards Rigor in Reviews of Multivocal Literatures.' Review of Educational Research, 61, (3).

"R. T. Ogawa and B. Malen's article does not meet its own recommended standards for rigorous testing and presentation of its own conclusions. Use of the exploratory case study to analyze multivocal literatures is not supported, and the claim of grounded theory to analyze multivocal literatures may be stronger."

---. (1989). Case Study Research: Design and Methods. London: Sage Publications Inc.

This book discusses in great detail, the entire design process of the case study, including entire chapters on collecting evidence, analyzing evidence, composing the case study report, and designing single and multiple case studies.

Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial

Elvira E. Jimenez ORCID: orcid.org/0009-0009-7189-6370 1 , 2 , 4 ,
Ann-Marie Rosland 3 , 4 na1 ,
Susan E. Stockdale 1 , 2 na1 ,
Ashok Reddy 5 , 6 na1 ,
Michelle S. Wong 1 na1 ,
Natasha Torrence 3 , 4 na1 ,
Alexis Huynh 1 na1 &
Evelyn T. Chang 1 , 7 na1

Implementation Science Communications volume 5 , Article number: 75 ( 2024 ) Cite this article

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Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans’ Health Administration (VHA) patients at high risk for hospitalization or death (“high-risk Veterans”) are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population’s complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown.

The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients’ cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.

We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.

We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.

Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.

Trial registration

ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643

Protocol version

This protocol is Version 1.0 which was created on 6/3/2020.

Contributions to the literature

The first study to compare the effectiveness of Evidence-Based Quality Improvement (EBQI) conducted individually with one site or conducted with a group of sites.

Implementation of evidence-based practices to improve care for high-risk patients in primary care.

Patients who are at the highest risk for hospitalization (“high-risk patients”) are a heterogenous subset of patients who have significant multimorbidity and pose the most significant medical challenges within any healthcare organization [ 1 ]. These patients are at high risk for poor health outcomes and account for the majority of the Veterans Health Administration (VHA) healthcare costs [ 2 ], similar to other healthcare systems [ 3 , 4 ]. Previous Medicare demonstrations, such as advanced primary care home models called Comprehensive Primary Care Plus (CPC +), have shown that caring for high-risk patients can be challenging despite financial alignment that promotes coordination of care delivery [ 5 ]. Primary care teams bear most of the responsibility in caring for complex patients; in VHA over 93% of high-risk Veterans are managed by general primary care teams, despite the availability of specialized primary care teams for patients with advanced health conditions [ 6 ]. Yet, complex, high-risk patients often do not receive the most effective evidence-based care within general primary care teams [ 7 ].

Many of the evidence-based practices (EBPs) have been ineffective in the management of high-risk patients due to the lack of EBPs that properly address multimorbidity— most EBPs focus on a single problem [ 8 , 9 ]. However, there are a few EBPs that have shown to be effective for high-risk patients in geriatrics and other specialized settings, such as comprehensive assessments, individualized care plans, and care coordination among the multidisciplinary team members [ 10 , 11 , 12 ]. Evidence also supports patient-centered approaches to support self-management for high-risk patients with competing medical and self-care demands, including shared decision making and health coaching [ 12 , 13 , 14 ]. However, primary care teams have not implemented these EBPs widely [ 15 , 16 ]. Despite the availability of these effective practices, the most effective implementation strategies to increase uptake of EBPs for high-risk patients in primary care are unknown. EBQI has been used successfully to implement complex EBPs in VA primary care, such as the patient-centered medical home model [ 17 ] and primary care-mental health integration [ 18 , 19 ]. EBQI is, in fact, a bundle of implementation strategies that emphasizes a systematic approach to developing a researcher-clinical partnership that engages national, regional, and local-level senior organizational leaders and local QI teams in adapting and implementing EBPs in the context of prior evidence and local practice conditions [ 17 ]. Core elements of EBQI include engaging multi-level multidisciplinary stakeholders in evidence-based agenda setting (developing a “QI Roadmap”), training clinical champions in QI methods to meet agenda goals, and practice facilitation [ 17 , 18 , 20 , 21 ]. The theoretical basis underlying EBQI elements includes theories of organizational change [ 22 , 23 , 24 , 25 ], clinical quality improvement, [ 26 , 27 , 28 ] complex adaptive systems [ 25 ], and diffusion of innovation [ 29 ]; each element can be mapped to documented implementation strategies [ 30 ]. However, beyond these core elements, EBQI initiatives have widely varied in the extent and types of interactions with implementation facilitators, specifically in practice facilitation and training. Some initiatives have combined EBQI core components with individual ongoing consultation [ 17 , 20 ], which can require significant researcher and quality coordinator time and resources. Other VHA EBQI initiatives have used across-site learning collaboratives (i.e., depression collaborative care [ 18 , 19 ] and opioid use disorder [ 31 ]), which may require fewer resources and impact a greater number of health professionals. While both variations have been effective, individual site-level consultation has never been empirically compared with learning collaboratives; implementers lack guidance on which of these strategies are effective in what setting.

This study uses a mixed-methods type 3 hybrid implementation-effectiveness evaluation using a Concurrent Stepped Wedge design, evaluation of two separate interventions in different clusters, [ 32 ] to compare the two variants of EBQI aimed at increasing reach of the proposed EBPs (CACP or MAA). The Practical, Robust Implementation and Sustainability Model (PRISM) framework (Fig. 1 ) [ 33 , 34 ] will guide the planning, implementation, and evaluation of the RIVET Program. The PRISM framework specifies contextual factors which align well with the components of our implementation strategies, and which will guide our evaluation of factors that influence Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes [ 34 ]. The Consolidated Framework for Implementation Research (CFRI) framework will identify implementation determinants, i.e., barriers and facilitators to implementation.

RIVET implementation timeline for each site

Evidence‑based practices (EBPs)

We selected two EBPs that guide primary care teams to identify modifiable needs among high-risk patients through standardized assessments and utilize the expertise of the multidisciplinary staff in the primary care team: Comprehensive Assessment and Care Plan (CACP) and Medication Adherence Assessment (MAA).

EBP Comprehensive Assessment and Care Plan (CACP) for high-risk patients

The CACP is an assessment that helps the primary care team to develop an individualized treatment plan based on identified needs for high-risk patients of any age [ 35 ]. It was adapted from the Comprehensive Geriatric Assessment (CGA), which has been shown in multiple randomized control trials (RCTs) to lead to improved outcomes for older adults with complex care needs [ 36 , 37 ]. According to meta-analyses, the CGA has consistently led to improved outcomes for frail, older adults, such as decreased mortality (OR 0.86, 95% CI 0.75–0.98), decreased readmissions (OR 0.88, 95% CI 0.79–0.98), and decreased length of stay (1.63–40.7 days in intervention group vs 1.8–42.8 days in usual care) compared to those who did not receive the CGA [ 38 , 39 , 40 ].

While the CGA assesses several domains that are important for complex patients, some domains may not be broadly applicable to high-risk Veterans of all ages (i.e., nutrition, vision, hearing, continence). According to our analyses, half of high-risk Veterans are younger than 65 years old and have greater psychiatric comorbidities than older high-risk Veterans [ 6 ]. We added domains to specifically assess for modifiable risk factors that are common among high-risk Veterans (e.g., transportation assistance, health literacy, behavioral health symptoms, and coordination with non-VHA healthcare systems) [ 41 , 42 , 43 ]. The CACP screening questions are taken from standard sources, including the National Academy of Medicine Recommendations for High-Need Patients [ 44 ] and the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE) [ 45 ].

The CACP prompts the primary care team member to explore identified risk factors further or to refer to another team member for an in-depth assessment if needed. After the assessment, the CACP is then used to guide the development and implementation of an individualized treatment plan that addresses the patient’s health-related needs in the context of the patient’s preferences [ 10 ]. The treatment plan can be coordinated and monitored through team huddles (consisting of the primary care provider, nurses, clerk) or monthly interdisciplinary team meetings.

EBP Medication Adherence Assessment (MAA)

High-risk Veterans often experience complicated medication regimens, potential side effects, and other known barriers to medication adherence [ 46 ]. Medication nonadherence represents a common problem among multimorbid patients [ 47 ], and is one of the largest contributors to preventable emergency department visits and hospitalizations among high-risk Veterans. Many approaches to improving medication adherence are limited by a focus on particular diseases rather than the entire medication regimen and by a focus on the healthcare providers’ point of view, rather than on patients’ goals and agency around medication taking [ 48 ].

A standardized Medication Adherence Assessment (MAA) guides primary care teams to assess for barriers and challenges to medication adherence through open-ended questions and enables primary care teams to understand high-risk patients’ goals and preferences and better impact medication-taking behaviors across the patients’ medication conditions [ 12 , 13 ]. The MAA prompts the clinician to employ specific strategies around adherence and potentially use motivational interviewing or health coaching if the patient is ambivalent about taking a medication. Health coaching has emerged as an effective, patient-centered, collaborative approach to understand patient goals and preferences and enhance patients’ adherence to modifiable health behaviors [ 49 ]. Health coaching is a type of cognitive-based behavior change technique that employs motivational interviewing and goal-setting to guide the patient to change health behaviors, such as diet, exercise, and medication adherence [ 49 ]. Meta-analyses have shown that cognitive-based behavior change techniques (e.g., health coaching) to improve medication management are associated with an effect size of 0.34 (95% CI 0.23–0.46) on improved medication adherence [ 50 ].

EBQI Implementation strategies

The high-Risk VETeran (RIVET) Program will compare two variants of Evidence-Based Quality Improvement (EBQI)—practice facilitation through Individual Consultation (IC) or through Learning Collaboratives (LC) to determine which of the two is the most effective and less costly implementation strategy and explore which is better suited for which contexts.

Individual Consultation (IC)

Individual consultation, often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy in and of itself. In RIVET, external facilitators from the study team will provide training to QI participants, who are front-line primary care staff, from an individual medical facility. The RIVET IC will provide regular individualized EBQI training and coaching to implement the EBP. Consultation allows experts to tailor complex skills and training to needs of the organization and to the QI participants, using active learning and providing practice opportunities [ 51 ]. It also provides QI participants with problem-solving skills and accountability [ 51 ]. Literature has demonstrated increased uptake and adherence to EBPs and increase sustainability with IC [ 51 , 52 ].

Learning Collaboratives (LC)

Learning collaboratives are also widely used in healthcare settings and are an effective implementation strategy [ 30 ]. The RIVET learning collaboratives consists of external facilitators from the study team providing quality improvement training to QI participants from multiple sites in a group, and encourages interaction and collaboration among QI participants (e.g., providing feedback to each other). The effectiveness of learning collaboratives vary, but generally, they have demonstrated improvement in health professionals’ knowledge, problem-solving skills and attitude, and teamwork [ 53 ]. The mechanisms by which learning collaboratives may be effective include factors within an organization and factors between multiple organizations. In terms of factors within an organization, participation in learning collaboratives may increase staff confidence in using data to make decisions and to problem solve, increase accountability by making standards explicit, promote peer reflection, and facilitate teamwork, shared responsibility, and joint problem solving [ 53 ]. Mechanistic factors between organizations include normative pressure from peers, friendly competition, a platform for capacity building, and collaboration with other sites [ 53 ].

Site selection and eligibility

We will implement the EBPs at 16 primary care sites, targeting those with high ambulatory care-sensitive hospitalization rates. Each site will be implementing a single EBP. Implementation strategies are randomized by site. Site implementation consists of four overlapping cohorts of four sites (three randomized to LC and one to IC); all will undergo 18-months of RIVET facilitation (see Figure#1). Time periods without active implementation will serve as the usual care periods for EBQI strategies. Usual care sites will receive Office of Primary Care educational campaigns and dissemination of tools for high-risk patients among primary care teams. VHA regional leaders or VHA facility leaders will select the EBP for primary care sites to implement.

VHA primary care uses a multi-disciplinary patient-centered team-based approach (Patient-Aligned Care Teams; PACTs) where teams of health care professionals provide longitudinal care to a panel of patients [ 35 ]. Team members include a primary care provider, nurses, clerk, integrated mental health provider, social worker, and a pharmacist. Teams have access to multiple dashboards and reports for care management, including the Care Assessment Need (CAN) score [ 54 ], which describes the patient’s risk for future VA hospitalization or death by percentile.

EBQI activities

We first engaged regional and local multidisciplinary stakeholders to discuss implementation of each EBP, such as the target patient population and the clinical staff who might perform the assessment, developing a “QI Roadmap.” QI training and practice facilitation spans 18 months of video calls with site clinical champions, selected by their facility leadership. Meetings are led by a trained RIVET external facilitator and include structured QI didactics, designing Plan-Do-Study-Act cycles, coaching, review of data, and developing structured action plans (Fig. 1 ). The RIVET implementation team provides quarterly data reports and regularly discuss next steps with the champions.

The same structured QI didactics are utilized for both LC and IC groups (Fig. 1 ). The IC sites participate in individual meetings with the clinical champions every month, on average. Learning collaboratives consist of three EBQI-LC sites that participate in monthly meetings. All sites randomly assigned to EBQI-LC participate in the same learning collaborative regardless of EBP (CACP vs MAA), as both EBPs involve the same goal, the same target population, in the same clinical setting, similar to prior initiatives [ 17 , 31 , 55 ].

Data sources

Data sources include VHA Central Data Warehouse (CDW) administrative data, surveys to high-risk patients, surveys to Primary Care staff, key stakeholder interviews, implementation facilitation logs, time activity surveys, and site administrative documents.

EHR Administrative data

VHA CDW contains data on patient characteristics, outpatient encounters, provider types for each encounter, acute and inpatient care utilization, medication fill history, and Healthcare Effectiveness Data and Information Set (HEDIS) quality metric status. Health factor administrative data is generated by templates constructed for each EBP within the EHR. Managerial Cost Accounting (MCA) data will be utilized for the cost analyses.

High-risk patient surveys

Patient surveys will collect data on patient experiences among high-risk primary care patients at participating sites. Patient surveys will be mailed at the beginning and end of the 18-month active implementation phase to 500 randomly selected high-risk patients empaneled to primary care teams at each site, sampled cross-sectionally at each time period with replacement. Patient eligibility is based on the following criteria: a Care Assessment Need (CAN) score ≥ 90th percentile within the month prior to the sampling date; a visit with primary care within the last six months of the sampling date; and empanelment to the clinical champion team’s panel. When possible, patient experience and satisfaction questions were sourced from the Patient-Centered Medical Home (PCMH) version of the VHA Survey of Healthcare Experiences of Patients (SHEP), based on the Consumer Assessment of Healthcare Providers and Systems (CAHPS). Additional survey items measure direct impacts of specific EBPs (such as medication adherence), and items that may impact patient engagement in and benefit from EBPs, such as trust in their primary care provider (PCP). See Table 1 for details on included measures.

Clinical staff surveys

Clinical staff surveys will be administered site-wide, to assess factors that may influence update of RIVET EBPs at the clinic, 1) other tools, resources and practices used when managing high-risk patients, and 2) exposure to RIVET EBPs (post-implementation only), and 3) confidence with practices promoted by RIVET EBPs and with overall high-risk patient care. Most items were derived from previous VA primary care staff surveys, including those conducted for the purposes of evaluating staff experiences and approaches to high-risk patient care [ 65 ]. Electronic surveys will be sent to all primary care providers, nurses, and medical assistants on eligible teams at participating sites at the beginning and end of the 18-month active implementation phase. Eligible teams include general and women’s health primary care teams, as well as any ‘specialty’ primary care teams (e.g., geriatric primary care) that the site’s champion considers eligible for EBP spread. Clinician eligibility criteria includes being a member of at least one PACT teamlet at the RIVET site; being either a physician, physician assistant, nurse practitioner, registered nurse, licensed practical or vocational nurse, a medical assistant, or a health technician; providing direct patient care at the site; and working at the primary care site for at least three months.

Key stakeholder interviews

Guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and Consolidated Framework for Implementation Research (CFIR) frameworks, we will conduct pre- and post- semi-structured qualitative telephone interviews with key middle managers (Primary Care Medical Director, Primary Care Nursing lead, Social Work lead, Integrated Mental Health lead, Pharmacy lead) and frontline clinicians who participate in EBQI and implementation activities. The interviews will assess readiness (inner context) and its subconstructs of leadership and engagement, available resources, and access to knowledge and information; implementation climate (inner context) and its subconstructs of relative priority and values; implementation process and its subconstructs of engaging key stakeholders and executing the implementation plan; characteristics of Individuals and its subconstruct of knowledge and beliefs about the intervention; and intervention characteristics and its subconstructs of relative advantage and complexity.

Implementation facilitation logs

We will use templated implementation facilitation logs to collect information about participants’ attendance at EBQI activities (including facilitation sessions and other meetings), participants’ role in RIVET, plan-do-study-act cycles, ‘real time’ adaptations to the EBPs, and barriers to implementation. The Implementation facilitators and coordinator will complete the implementation facilitation logs for both EBQI-IC and EBQI-LC sites after each meeting and any contact with implementation sites and leadership.

Time activity surveys

We will administer weekly time surveys to the RIVET implementation team which will capture RIVET staff time spent in various implementation activities. To assess time spent on RIVET implementation activities by site participants outside of facilitation sessions and other meetings with the RIVET implementation team, we will conduct brief monthly polls via Teams during facilitation sessions.

Periodic reflections

Using a semi-structured interview guide, a 30-min recorded monthly meeting will be conducted with the facilitation staff to elicit information and their overall impression of implementation progress and process. The meeting will document any implementation challenges and successes, adaptations, stakeholder engagement and relevant contextual issues. We will assess contextual factors, such as organizational readiness (leadership engagement, resources, access to knowledge and information) and anticipated barriers/facilitators at each site.

LC and IC site administrative documents

The site administrative documents include the QI roadmap for each EBP, site action plans developed by clinical champions, meeting minutes, written reports and presentations to leadership, and attendance records.

The Practical, Robust Implementation and Sustainability Model (PRISM) framework) [ 33 , 34 ] will guide the planning, implementation, and evaluation of the RIVET Program. The PRISM framework specifies contextual factors which align well with the components of our implementation strategies, and which will guide our evaluation of factors that influence Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) outcomes [ 34 ]. We will use mixed methods to evaluate RE-AIM outcomes, EBP fidelity, implementation strategy fidelity, adaptations, costs, benefits, and value.

Reach is defined in this study as the proportion of high-risk patients on each study team’s panel that received one of the EBPs during the 18-month implementation period. See Table 2 for details on included reach measures. We define “high-risk patients” using a VHA-specific risk score called the Care Assessment Need score, previously developed and validated by VA through machine-learning to predict a patient’s risk for a VHA hospitalization or mortality [ 54 ]. We define ‘receipt’ as having the EBP assessment at least partially documented in the electronic health record (EHR). We will also examine the patient characteristics (sociodemographic, Elixhauser comorbidity score [ 66 ]) of eligible patients who did vs. did not receive the EBP.

Effectiveness

EBP effectiveness measures will include type of referrals or actions generated by each EBP, and whether they were completed, as measured by EHR template use, administrative consult data, and encounters. We will also use administrative EHR data to measure number of patient encounters with primary care team members (social work, pharmacist, nurse, integrated mental health), as an indicator of engagement of primary care teams for high-risk patient care. Impacts of RIVET on patient experience will be evaluated with a patient survey that includes measures (described above) of satisfaction and access to resources and support for caring for high-risk patients. We will also assess clinical performance metrics that are expected to be directly impacted by each EBP. For both EBPs, we will measure acute care utilization, such as emergency department (ED) visits, total acute and ambulatory care-sensitive (ACS)-related hospitalizations. For MAA, we will also measure adherence to medications for common chronic conditions, such as hypertension and diabetes. See Table 2 for details on included effectiveness measures.

We will assess adoption by measuring number and proportion of staff trained on each EBP, and how many and which types of staff delivered each EBP (representativeness), using administrative training records and administrative clinical data for each EBP.

Implementation fidelity

We will assess implementation strategy fidelity using the EBQI fidelity assessment tool [ 55 ]. The fidelity assessment tool draws from data collected from key stakeholder interviews, implementation facilitation logs, administrative documents, and weekly time diaries (described below). We will apply criteria to rate sites as high, medium, or low fidelity on the EBQI elements. Using the implementation facilitation logs, we will assess participation in the EBQI activities by frontline providers, staff, and leadership.

Maintenance

We assess maintenance by the extent to which EBPs are implemented after practice facilitation ends (e.g., about 18 months). We also plan to study if the EBPs are spread to other primary care teams within the site and to other sites within the healthcare system.

Outcomes and data analyses

To analyze our primary outcome, receipt of each EBP among top 10th percentile high-risk patients during the 18-month implementation period (Reach), we will model uptake of both practices in our Concurrent Stepped Wedge Design as a multilevel hierarchical model with a repeated cross-sectional data structure in which sites are followed over time. In this design, the data structure includes patients at level 1 (where Reach, the main outcome of interest, in measured), nested within time at level 2, and nested within sites at level 3. The main predictors will be site implementation strategy assignment (EBQI-IC vs. EBQI-LC vs Usual Care) over time (measure as the number of quarter). We will first describe differences in trends using unadjusted analyses, then add covariates for patient characteristics (i.e., age, sex, Elixhauser comorbidity score [ 66 ]) and site-level covariates (i.e., number of unique patients served in primary care, rural vs urban). Secondary analyses of Reach will include models by key patient subgroups, including those hospitalized in the 90 days prior to the quarter examined, and models with an interaction term for assigned implementation strategy by EBQI fidelity level (as defined above), to examine how implementation strategy fidelity may have impacted Reach.

To analyze our secondary outcomes of care processes, patient experiences, provider experiences, and performance measures (Effectiveness), we will first model unadjusted trends in outcomes over time for each EBP, by site implementation strategy assignment. We will then model outcomes using two or three-level (depending on whether the metric is measured at the patient or site level) hierarchical models based on the concurrent Stepped Wedge Design using repeated cross-sectional data, adjusted for the same covariates included in the models for our primary outcome. In models of medication adherence, we will add covariates for medication regimen complexity, as indicated by total number of classes of medication prescribed for the condition of interest, and patient co-pay status. If we find differences in outcomes, we will perform mediation analyses that consider how Reach and EBP fidelity may have mediated outcomes [ 67 ].

To assess differences in adoption between EBQI-IC and EBQI-LC sites, we will use bivariate analyses to compare the number and proportion of staff trained on each EBP, and how many and which types of staff delivered each EBP. To assess differences in implementation strategy fidelity among sites, we will compare the number of sites with high, medium, and low fidelity on each element of EBQI, as well as overall fidelity to EBQI. Similarly, we will compare number of sites with overall high, medium, or low EBP fidelity among EBQI-IC vs EBQI-LC sites.

We will qualitatively assess the impact of contextual factors on implementation, using a matrix analysis approach [ 68 ] to explore a priori themes based on the interview guides, but also allow for emergent themes. Specifically, we will code and analyze interview data for core elements of the EBQI implementation strategy and for contextual features, intervention characteristics, and implementation infrastructure guided by the PRISM framework [ 33 ]. Two trained qualitative analysts will construct and validate the codebook [ 69 ]. Using this codebook, one analyst will code all interviews, and a second qualitative analyst will review all coding. After generating a report for all codes, they will use a matrix analysis approach [ 68 ] to populate a participant-by-theme matrix and create site level summaries for each theme to facilitate comparisons between EBQI-IC and EBQI-LC sites. To ensure rigor, summaries will also be reviewed, compared with the original data, and discussed by at least two analysts to reach consensus for any discrepancies. Finally, we will link this qualitative matrix with site-level implementation strategy and EBP fidelity measures to compare how specific contextual features, intervention characteristics, and implementation infrastructure impacted fidelity.

Return-On-Investment (ROI) Analyses

We will conduct a budget impact analysis to inform the sustainability of each EBP. Following the VHA recommendation to evaluate cost of projects [ 70 ], we will identify the relevant costs associated with implementation of the EBP, the EBP itself, and the consequences of the EBP (e.g., healthcare utilization). Using a micro-costing approach [ 71 ], we will collect costs for EBQI-IC and EBQI-LC sites, measuring: 1) implementation costs as one-time costs to develop the intervention; and 2) intervention and downstream costs as costs that would be incurred by facilities adopting the EBPs (e.g., site participants; RIVET implementation team members’ time spent in training, meetings and preparing for meetings; staff time performing the intervention). To capture RIVET implementation team staff time spent in various implementation activities, data will be collected through the implementation facilitation log, administrative documents, and weekly time surveys. For both EBPs, clinical staff will document the estimated time spent to complete EBP through an EHR template. Finally, we will identify the costs of healthcare utilization which may be impacted by the implementation of these EBPs from the VA administrative data, such as change in outpatient utilization (e.g., primary care, social work, mental health, pharmacy) and inpatient utilization. This will be done by estimating the excess cost for patients exposed to the EBP compared to a control group of unexposed patients using multivariable regression models to control for measured confounders. We will use generalized linear models for continuous data and two-part models for semi-continuous data with distributional families chosen to best fit the data. If preliminary data reveals that medication adherence changed with MAA implementation, we will also include changes in pharmacy costs.

We will measure whether EBPs were maintained during each sites’ sustainment period (time period following the 18-month active implementation period), how EBPs spread within the original sites and to new sites, and what factors are associated with maintenance and spread. We will also assess adaptations made to the EBPs in response to changing VHA context.

For sustainment and spread, we will continue to assess receipt of each EBP among top 10% CAN score patients (Reach) longitudinally during the sustainment period by measuring 6 and 12 months after the active implementation phase. We will incorporate Adoption measures to assess spread within the implementation site and in new sites by measuring how many additional staff were trained on each EBP, proportion of staff trained on each EBP, and which types of healthcare staff delivered each EBP (representativeness). We will compare EBQI-IC and EBQI-LC sites to determine which implementation strategy is most effective for sustaining the EBPs. Using the matrix analysis approach described above, we will analyze qualitative interview data to explore the role of contextual factors on sustainment, and the “fit” between context, intervention, and implementation strategy on sustainability.

The RIVET project aims to implement two evidence-based assessments to improve the management of the high-risk patient population within VHA primary care using two EBQI strategies. This work will add to a much needed body of literature evaluating the effectiveness of different approaches to EBQI to implement EBPs within primary care [ 1 ]. It is the first study to compare the effectiveness of EBQI conducted with individual sites (EBQI-IC) vs conducted with groups of sites as a learning collaborative (EBQI-LC) and to compare which implementation strategy is most effective under various contexts accounting for unique barriers, facilitators, and adaptations. Additionally, RIVET will provide evidence on which of the two strategies is the most cost-efficient strategy. Comparing EBQI-LC and EBQI-IC will allow our VHA primary care leaders to tailor the implementation strategy to the primary care context in preparation for widespread implementation. While our project focuses on EBPs for high-risk patients, we anticipate that this comparison of EBQI strategies can inform those implementing EBPs with other primary care patient populations.

The EBPs aim to systematically identify modifiable risk factors within primary care for patients with complex needs—enabling primary care to provide comprehensive and holistic care. Furthermore, by selecting the most effective, less burdensome, and less costly implementation strategy ensures greater buy-in from clinical leadership interested in offering advanced primary care and frontline staff who are often overwhelmed with clinical demands and chronic staffing shortages.

We anticipate several potential challenges to optimal implementation. The major challenge for the RIVET project is that, as with any project embedded in pragmatic healthcare system operations, it is vulnerable to national and local VHA contextual factors. Specifically, success of the project can be compromised by VHA staffing changes within the sites and study teams. In addition, since primary care teams are tasked with a wide variety of care, new health system initiatives and external circumstances (e.g., pandemic-induced changes in care delivery) can unexpectedly compete with high-risk patient care priorities. In addition, the active implementation period requires 18-month engagement from clinical champions to learn EBQI practices and to properly use the EBP in their routine care of high-risk patients. Finally, RIVET EBQI IC and LC sessions will be held virtually. Although most provider training has moved to virtual modalities post-Covid, the best methods to keep staff engaged may vary over time and setting. The RIVET project will not only implement EBP tools that will help better manage high-risk Veterans at 16 VA sites but will provide the tools and evidence on the best implementation strategies for primary care staff at VHA working to improve high-risk patient care and primary care delivery.

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

Ambulatory care-sensitive

Comprehensive Assessment and Care Planning

Consumer Assessment of Healthcare Providers and Systems

Care Assessment Need

Consolidated Framework for Implementation Research

Comprehensive Geriatric Assessment

Comprehensive Primary Care Plus

Central Data Warehouse

Evidence-based practice

Evidence-Based Quality Improvement

Emergency department

Electronic health record

Healthcare Effectiveness Data and Information Set

Individual coaching

Learning collaborative

Medication Adherence Assessment

Managerial Cost Accounting

Office of Primary Care

Patient-Aligned Care Team

Patient-Centered Medical Home

Primary care provider

Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences

Practical, Robust Implementation and Sustainability Model

Quality Enhancement Research Initiative

Randomized control trial

Reach, Effectiveness, Adoption, Implementation, and Maintenance

High-RIsk VETerans

Return-On-Investment

Survey of Healthcare Experiences of Patients

Veterans’ Health Administration

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Acknowledgements

We would like to acknowledge Kelsey Cummings, MS and Emily Wong, MPH for their contribution to the implementation of the project; Bridget Kranke, MSSA, LSW for assisting with editing; and the VA Office of Primary Care (OPC), Geriatrics and Extended Care (GEC), Patient-Centered Care and Cultural Transformation (OPCC&CT), Primary Care Improvement and Innovation and the primary care leads from Veterans Integrated Services Networks (VISNs) 9, 10, 12 for their advice and support.

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, or the US government, or other affiliated institutions.

This project is funded by the VA Quality Enhancement Research Initiative (QUERI) program, project #: QUE-20–018.

Author information

Ann-Marie Rosland, Susan Stockdale, Ashok Reddy, Michelle Wong, Natasha Torrence, Alexis Huynh and Evelyn Chang contributed equally to this work.

Authors and Affiliations

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA

Elvira E. Jimenez, Susan E. Stockdale, Michelle S. Wong, Alexis Huynh & Evelyn T. Chang

Department of Neurology, David Geffen School of Medicine, University of California Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA

Elvira E. Jimenez & Susan E. Stockdale

Center for Health Equity Research and Promotion (CHERP), VA Pittsburgh Healthcare System, 1 University Dr, Pittsburgh, PA, 15240, USA

Ann-Marie Rosland & Natasha Torrence

Caring for Complex Chronic Conditions Research Center & Division of General Internal Medicine, School of Medicine, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA, 15213, USA

Elvira E. Jimenez, Ann-Marie Rosland & Natasha Torrence

Department of Medicine, Division of General Internal Medicine, Harborview Medical Center, University of Washington, 325 Ninth Ave, Box 359780, Seattle, WA, 98104, USA

Ashok Reddy

Center for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA, 98108, USA

Division of General Internal Medicine, Department of Medicine, David Geffen School of Medicine, UCLA, 740 Charles E Young Dr S, Los Angeles, CA, 90095, USA

Evelyn T. Chang

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Contributions to the creation and design of the funded project includes AMR, SS, and EC. Development of the project design at implementation stage includes EJ, AMR, SS, AR, MW, NT, AH, and EC. All listed authors contributed to writing/editing the manuscript. All authors read and approved the final manuscript.

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Correspondence to Elvira E. Jimenez .

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The RIVET project was determined to qualify as non-research conducted under the authority of VHA Office of Primary Care, as it was designed and implemented with the intent to improve internal patient care at VHA and not conduct systematic research to advance scientific knowledge base. In accordance with VHA policies and guidelines, this program is considered as non-research by IRB (Subcommittee on Human Studies) of the VHA Greater Los Angeles Healthcare System Research Service (691/151) which is authorized to determined projects as non-research activities for which additional IRB oversight is not required, as defined per VHA Handbook 1058.05 in the section “Officials Authorized to Provide Documentation of VHA Program Office Non-Research Operations Activities” and later updated in Sect. 5a of the VHA Program Guide 1200.21.

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Jimenez, E.E., Rosland, AM., Stockdale, S.E. et al. Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial. Implement Sci Commun 5 , 75 (2024). https://doi.org/10.1186/s43058-024-00613-9

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DOI : https://doi.org/10.1186/s43058-024-00613-9

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Optimization strategies for the envelope of student dormitories in hot summer and cold winter regions: multi-criteria assessment method, 1. introduction, 2. materials and methods, 2.1. research flowchart, 2.2. case study, 2.2.1. building overview, 2.2.2. simulation, 2.3. multi-goal optimization model, 2.3.1. life cycle energy assessment, 2.3.2. life cycle carbon emission assessment, 2.3.3. life cycle cost assessment, 2.3.4. optimal multi-objectives, 2.4. detailed calculation of optimizing the envelope, 2.4.1. exterior window, 2.4.2. selection of insulation materials, 2.4.3. determination of insulation material thickness, 3. results and discussion, 3.1. establishment of a single parameter retrofit construction plan, 3.1.1. exterior wall, 3.1.2. exterior window, 3.1.3. exterior roof, 3.2. establishment of a combined retrofit construction plan, 4. conclusions, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest, nomenclature.

Abbreviations		Greek letters
CE	Carbon Emission		Roof thickness (mm)
CEF	Carbon Emission Factor		Exterior wall density (kg/m )
LCA	Life Cycle Assessment		Roof mass energy (MJ/kg)
LCE	Life Cycle Energy Assessment		Roof density (kg/m )
LCCE	Life Cycle Carbon Emission Assessment		Exterior wall thickness(mm)
LCC	Life Cycle Cost Assessment		Exterior wall mass energy (MJ/kg)
ESR	Energy Saving Rate		Carbon emission coefficient of electricity (tCO /MWh)
CESR	Carbon Emission Saving Rate		Thermal conductivity coefficient (W/(m·K))
CSR	Cost Saving Rate		Heat transfer coefficient (m ·K/W)
WWR	Window-to-Wall Ratio		Correction coefficient
HVAC	Heating, Ventilation and Air-Conditioning	Subscripts
RMB	Ren Min Bi (Chinese Currency)	s	Summer
USD	United States Dollar	w	Winter
Symbols		ep	Lighting equipment
F(x)	Objective function	m	Production stage of building material
E	Energy consumption (GJ)	op	The operational phase
C	Cost (USD)	i	The i material
CE	Carbon emissions (kg)	opt	Objective function value of the optimal solution
A	Surface area (m2)	bc	Initial function value of the building
PWF	Present value factor		Total energy consumption of exterior wall
g	Inflation rate (%)		Total energy consumption of roof
I	Loan interest rate (%)		I material of exterior wall
	Hourly temperature difference between indoor and outdoor (K)		K material of roof
R	Heat transfer resistance (K/W)	n	year
		N	year

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Click here to enlarge figure

Parameter	Value	Unit
Stories	6	/
Building total height	21	m
Window opening area	583.92	m
Gross roof area	702.24	m
Gross wall area	2210.40	m
Gross total area	4213.44	m
Gross area of typical floor	702.24	m
Floor height	3	m
Gross window-to-wall ratio	26.42	%

Envelope Structure	Thickness and Material of Each Layer (From Outside to Inside)	Thermal Conductivity K [W/(m·K)]
Roof	50 mm C20 concrete + 6 mm waterproof coil + 10 mm cement mortar + 120 mm reinforced concrete roof panel + 10 mm cement mortar	3.376
Window	Aluminum alloy ordinary hollow window	4.2
Wall	2 mm paint + 5 mm cement mortar + 200 mm concrete block	0.965

	Open Date	Opening Time
Spring Semester (Summer)	1 July–15 August	12:00 a.m.–14:00 p.m./18:30 p.m.–8:00 a.m.
Summer Semester (Winter)	1 December–15 January	12:00 a.m.–14:00 p.m./18:30 p.m.–8:00 a.m.

Time and Room Ratio
Time	1	2	3	4	5	6	7	8	9	10	11	12
Room ratio	100%	100%	100%	100%	100%	100%	100%	50%	20%	20%	20%	50%
Time	13	14	15	16	17	18	19	20	21	22	23	24
Room ratio	100%	100%	20%	20%	50%	50%	70%	70%	70%	90%	100%	100%

Summer			Winter
Cooling Capacity (W)	Cooling Power (W)	Cooling Energy Consumption Ratio	Heating Capacity (W)	Heating Power (W)	Heating Energy Consumption Ratio
3500	1080	3.28	3850	1120	3.44

	Type	Thickness (mm)	Costs (USD/m )
Ordinary	Aluminium alloy plate glass window	3 + 6A + 3	66.14
Retrofitted	Broken heat aluminum alloy hollow glass window	3 + 12A + 3	110.23
	Low-E insulating glass window of aluminum alloy	5 + 12A + 3	80.83
	PVC plastic steel Low-E hollow glass window	5 + 12A + 3	124.92
	PVC plastic steel hollow glass window	3 + 12A + 3	80.83

Structure	Type	Carbon Emission Factor (kg CO e/m )
Window	Aluminum–wood composite window	147
	Broken hot aluminum alloy window	254
	PVC plastic steel window	121
Glass	Ordinary insulating glass	15.6
	Insulating glass	23.45
	Low-E glass	24.12

Type	Thermal Conductivity ([W/(m·K)])	Energy Consumption (MJ/kg)	Density (kg/m )	Carbon Emission Factor (kg CO e/t)
EPS	0.041	102.9	18~22	5020
PU	0.024	87.3	40	5220
RW	0.04	37.8	140	1980
XPS	0.03	85.4	30	6120

Climatic Region	Thermal Conductivity/[W/(m·K)]
Climatic Region	Exterior Wall	Roof	Exterior Window
Hot summer and cold winter zone	0.15~0.40	0.15~0.35	≤2.0

Ri([(m ·K)/W])	Re ([(m ·K)/W])
/	Summer	Winter
0.11	0.05	0.04

	Exterior Wall			Exterior Roof
Type	Initial Thickness (mm)	Thickness Interval (mm)	Thickness Replacement (mm)	Initial Thickness (mm)	Thickness Interval (mm)	Thickness Replacement (mm)
XPS	50	50–160	20	80	80–190	10
EPS	60	60–220	20	110	110–260	10
PU	40	40–130	20	70	70–150	10
RW	50	30–200	20	/	/	/

Type	Relation	R	Limit Thickness (mm)	Specification Range (mm)	Optimum Thickness (mm)
XPS	y = 0.0012x − 0.3117x + 557.91	96.79%	130	[40,165]	130
EPS	y = 0.0007x − 0.23x + 556.94	95.57%	164	[55,226]	164
PU	y = 0.002x − 0.4057x + 557.7	95.64%	101	[32,132]	101
RW	y = 0.0006x − 0.2284x + 556.8	95.06%	190	[54,220]	190

	XPS (mm)		EPS (mm)		PU (mm)
Life Cycle Energy Assessment	177.73	85.60	116.01	263.99	199.42	59.91
Life Cycle Carbon Emissions Assessment	64.87	178.88	96.94	237.99	42	540.21
Life Cycle Cost Assessment	24	254	68.66	309.20	21.10	211.44
Optimal thickness	179		238		62

	Configuration of Envelope Structure	Life Cycle Energy Assessment (GJ)	Life Cycle Carbon Emissions Assessment (×10 kg CO e)	Life Cycle Costs Assessment (×10 USD)
Ordinary	/	560.08	165.24	104.57
Retrofit-1	Wall (164 mm EPS) + window (DRLow-E) + roof (62 mm PU)	381.99	259.73	120.86
Retrofit-2	Wall (55 mm EPS) + window (DRLow-E) + roof (62 mm PU)	391.84	238.16	121.98

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Xie, F.; Wu, Y.; Wang, X.; Zhou, X. Optimization Strategies for the Envelope of Student Dormitories in Hot Summer and Cold Winter Regions: Multi-Criteria Assessment Method. Sustainability 2024 , 16 , 6172. https://doi.org/10.3390/su16146172

Xie F, Wu Y, Wang X, Zhou X. Optimization Strategies for the Envelope of Student Dormitories in Hot Summer and Cold Winter Regions: Multi-Criteria Assessment Method. Sustainability . 2024; 16(14):6172. https://doi.org/10.3390/su16146172

Xie, Fangyuan, Yi Wu, Xinqi Wang, and Xiling Zhou. 2024. "Optimization Strategies for the Envelope of Student Dormitories in Hot Summer and Cold Winter Regions: Multi-Criteria Assessment Method" Sustainability 16, no. 14: 6172. https://doi.org/10.3390/su16146172

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Published: 17 July 2024

Causal association between skin cancer and immune cells: mendelian randomization (MR) study

Wei Yin 1 na1 ,
Ruilei Li 1 na1 ,
Zhaoqi Zhang 1 na1 ,
Ying Wang 1 ,
Xinghua Tang 1 ,
Lin Zhu 1 ,
Hong Yao 1 &

BMC Cancer volume 24 , Article number: 849 ( 2024 ) Cite this article

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Numerous meta-analyses and clinical studies have shown that subtypes of immune cells are associated with the development of skin cancer, but it is not clear whether this association is causal or biased. Mendelian randomization (MR) analysis reduces the effect of confounding factors and improves the accuracy of the results when compared to traditional studies. Thus, in order to examine the causal relationship between various immune cell and skin cancer, this study employs two-sample MR.

This study assesses the causal association between 731 immune cell characteristics and skin cancer using a two-sample Mendel randomization (MR) methodology. Multiple MR methods were used to bias and to derive reliable estimates of causality between instrumental variables and outcomes. Comprehensive sensitivity analyses were used to validate the stability, heterogeneity and horizontal multiplicity of the results.

We discovered that potential causal relationships between different types of immune cells and skin cancer disease. Specifically, one type of immune cell as potentially causal to malignant melanoma of skin (MM), eight different types of immune cells as potentially causal to basal cell carcinoma (BCC), four different types of immune cells as potentially causal to actinic keratosis (AK), and no different types of immune cells were found to have a potential causal association with squamous cell carcinoma(SCC), with stability in all of the results.

This study demonstrates the close connection between immune cells and skin cancer disease by genetic means, which enriches the current knowledge about the role of immune cells in skin cancer and also contributes to the design of therapeutic strategies from an immunological perspective.

Peer Review reports

Introduction

Skin cancer is a widespread type of cancer worldwide, primarily caused by mutations, abnormal differentiation, and irregular nuclear division of epidermal keratinocytes. According to the origin of tumor cells, it can be divided into three categories: melanoma (MM), basal cell carcinoma (BCC), and squamous cell carcinoma (SCC) [ 1 ]. Actinic keratosis (AK) is a precancerous lesion characterized by aberrant proliferation of keratinocytes, often considered a precursor to SCC [ 2 ]. BCC and SCC account for the majority of skin cancer cases, approximately 95% [ 1 ], while MM represents only 2% of skin cancer cases. However, MM has a high risk of early metastasis and a mortality rate as high as 80% [ 3 ]. According to World Health Organization statistics, in 2020, there were nearly 1.2 million new cases of BCC and SCC globally and 330,000 new cases of MM [ 4 ]. The exact causes of skin cancer remain unclear and may be associated with factors such as exposure to ultraviolet radiation, chronic irritation, immunity, and genetics. Currently, in addition to surgical excision, common treatments for skin cancer include targeted therapy and immunotherapy. However, tumor resistance often leads to treatment failure in a significant number of patients [ 5 , 6 ]. Hence, there is an urgent need to explore novel treatment strategies and develop innovative therapeutic drugs.

Multiple relevant studies have indicated that the immune system plays a pivotal role in the occurrence, growth, and metastasis of malignancies [ 7 ]. The skin, as an integral component of the innate immune system, serves as a protective barrier against external threats. When this barrier is breached, innate immune cells and adaptive immune cells are promptly activated. They mount a swift and effective response, both non-antigen-specific and antigen-specific, aimed at eliminating the invading pathogens [ 8 ]. Furthermore, the immune system plays a crucial role in detecting and destroying tumor cells. The process of skin immune surveillance is primarily mediated by antigen-presenting cells (APCs). These APCs have the ability to enter the skin-draining lymph nodes, where they present antigens to T cells, ultimately initiating immune responses [ 9 , 10 ]. Bacci et al. [ 11 ]. discovered that UV radiation diminishes the number of APCs that migrate to the skin-draining lymph nodes, thereby impairing APC function. APCs present antigens to cytotoxic T cells (CD8+) through HLA I. Subsequently, co-stimulatory molecules such as CD28 on T cells and B7.1 on APCs activate cytotoxic T cell responses [ 11 , 12 ]. Furthermore, macrophages play a significant role in the occurrence and development of tumors. Low levels of interferon-γ and high levels of IL-4 promote macrophage differentiation into M2, facilitating tumor progression. Meanwhile, CD4 + T cells downregulate interferon-γ and IL-2, increase the production of IL-4 and IL-5, further promoting tumor development [ 13 ]. Besides protecting the body from pathogen invasion, the immune system also prevents tumor development and eliminates malignant cells. Exploring the function and mechanisms of the immune system in skin cancer can provide new insights for treatment methods, improving the treatment and prognosis of malignant skin tumor patients. However, up to date, research results on the relationship between immune cells and skin cancer have been inconsistent, possibly due to limited sample sizes, study design flaws, and confounding factors beyond the scope of existing research.

Mendelian randomization (MR) is a statistical approach rooted in genetic variation, utilized to ascertain causal connections between exposures or risk factors and clinically relevant outcomes [ 14 ]. MR employs genetic variants intimately linked to the exposure level within the population as instrumental variables (IVs), simulating the conditions of random allocation in experiments. This method enables the identification of causal relationships untainted by confounding factors and guards against reverse causation [ 15 ]. This type of analysis relies on three core assumptions: (1) genetic variation is directly associated with the exposure; (2) genetic variation is not associated with confounding factors between the exposure and the outcome; (3) genetic variation does not affect the outcome through mechanisms other than the exposure [ 16 ] (Fig. 1 ).

The three key assumptions of MR

Therefore, this study utilized the MR method to analyze the causal relationship between different types of immune cell phenotypes and skin cancer in the European population. Two-sample MR analyses were conducted to examine potential causal relationships between different types of immune cells and the risk of skin cancers such as MM, SCC, AK, and BCC. This study aims to provide new strategies for the prevention and treatment of skin cancer diseases. The workflow is shown in Fig. 2 .

Workflow of our research

Materials and methods

Research design.

Using a two-sample Mendelian randomization (MR) approach, we conducted an analysis to assess the causal relationships between 731 immune cell subtypes and skin cancer. MR analysis typically utilizes genetic variation as instrumental variables to assess the causal impact of exposures on outcomes. As this study was based on publicly available data, no additional ethical approval or consent was required.

Data sources for exposure and outcome

Gwas data sources for skin cancer.

In this study, skin cancer diseases include MM, BCC, SCC, and AK. The data retrived from the GWAS website ( https://gwas.mrcieu.ac.uk/ ). For MM, the genetic data are from Neale et al., who conducted a GWAS on 361,194 Europeans (Ncase = 2,534, Ncontrol = 358,660), identifying a total of 10,855,955 SNPs. The genetic data for BCC are from Adolphe et al. [ 17 ], who performed a GWAS on 392,971 Europeans (Ncase = 17,416, Ncontrol = 375,455), confirming 71 GWAS loci and 46 functional candidate BCC susceptibility genes. Among these genes, 26 with decreased expression and 20 with increased expression were associated with an increased risk of BCC, totaling 7,244,167 SNPs. The genetic data for SCC are from the Neale Lab, which conducted a GWAS on 337,159 Europeans (Ncase = 404, Ncontrol = 336,755), identifying a total of 10,894,596 SNPs. In the genetic data for AK, researchers performed a GWAS on 218,090 Europeans (Ncase = 4,817, Ncontrol = 213,273), identifying a total of 16,380,463 SNPs.

GWAS data sources for immune cells

In this research, we obtained publicly available GWAS data for immune cells from the GWAS catalog and conducted an extensive analysis of genetic variations in a population of 3,757 individuals from Sardinia, evaluating 731 immune cell types to identify genetic variations associated with immune cell characteristics. Through a large-scale analysis of genetic variations at 70 loci, including 53 newly discovered, and 459 cellular traits in these Sardinian individuals, we identified 122 significantly independent association signals. This identification provides insights into several molecules and mechanisms involved in cellular regulation. Flow cytometry analysis encompassed 118 absolute cell (AC) counts, 389 median fluorescence intensities (MFI) reflecting surface antigen levels, 32 morphological parameters (MP), and 192 relative cell (RC) counts. Specifically, MFI, AC, and RC features included B cells, CDCs, mature stage T cells, monocytes, myeloid cells, TBNK (T cells, B cells, natural killer cells), and Treg cells. Meanwhile, MP features included CDC and TBNK cells [ 18 , 19 ].

Instrument selection

To identify SNPs associated with the exposure factor and ensure the reliability and accuracy of conclusions regarding the relationship between immune cells and skin cancer risk, the following steps were taken to select the most optimal SNPs. Initially, acknowledging that only a limited number of SNPs in the immune cell group met the genome-wide significance threshold ( p < 5 × 10 − 8 ). Additionally, to ensure the independence of the selected instrumental variables (IVs) and minimize bias resulting from residual linkage disequilibrium of genetic variations, we employed the two-sample MR R package with a distance set at 10,000 kb and a linkage disequilibrium threshold of r 2 < 0.001. On top of that, to mitigate the potential bias resulting from weak instrumental variables, the F-statistic was utilized to assess the statistical strength of the correlation between each SNP and the exposure. IVs with an F-statistic exceeding 10 were considered strong instruments, while those with an F-statistic less than 10 indicated a weak correlation between SNPs and the exposure. During the analysis, SNPs with palindromic structures were automatically excluded. The F-statistic calculation employed the formula F = R 2 /(1-R 2 )∙(N-K-1)/K , where N signifies the sample size of the GWAS, K represents the number of single nucleotide polymorphisms (SNPs), R 2 reflects the proportion of variance explained by SNPs in the exposure database, $\:{R}^{2}=2\times\:\left(1-MAF\right)\times\:MAF\times\:\raisebox{1ex}{$\beta\:$}\!\left/\:\!\raisebox{-1ex}{$SD$}\right.$ . MAF is the minor allele frequency (equivalent to the frequency of the effect allele), and β is the effect value of the allele [ 20 ].

Statistical analysis

All statistical analyses were implemented by the package Two-Sample MR (version 0.5.6) and Radial MR (version 1.0) in R (version 4.2.1).

In this study, we applied five MR methods to validate the causal associations between genetic variations in immune cells and MM, BCC, SCC, and AK. The methods comprised inverse variance weighted analysis (IVW), weighted median (WM), simple median (SM), weighted median estimator (WME), and MR-Egger regression. In the analysis, the IVW method, based on genotype summary data, served as the primary approach [ 21 ]. The IVW method combined Wald estimates for each single nucleotide polymorphism through a meta-analysis, resulting in an overall estimate. The weighted regression slope of the effect of the result on the effect of the exposure, with the intercept constrained to zero, represented the overall estimate. This approach provided a comprehensive evaluation of the causal relationship between genetic variations in immune cells and MM, BCC, SCC, and AK.

In secondary sensitivity analysis, we employed Cochran’s Q method to assess the heterogeneity of the selected IVs [ 22 ]. A significant result ( p < 0.05) would indicate significant heterogeneity in the analysis outcomes. To reduce the influence of horizontal pleiotropy, we utilized the MR-Egger regression test [ 23 ]. If a significant intercept term is observed ( p < 0.05), it suggests the presence of horizontal pleiotropy. Additionally, we applied the Bonferroni method for correction, considering only results with p -values < Bonferroni value in the final analysis. The Bonferroni correction formula is 0.05 / (number of exposures included in the study * number of outcomes included in the study) [ 24 ].

Finally, in order to explore whether skin cancer diseases have any causal relationship with established important immune cells, we conducted a reverse MR analysis using SNPs related to skin cancer diseases as IVs (skin cancer diseases as exposure and established immune cells as outcomes).

After the selection of instrumental variables (IVs), potential causal relationships were identified between one type of immune cell and MM, eight different types of immune cells and BCC, four different types of immune cells and actinic keratosis AK, no different types of immune cells were found to have a potential causal association with SCC. All IVs had F-statistics greater than 10, indicating the absence of weak instrument bias. Following Bonferroni correction, all p -values were below the Bonferroni threshold.

Causal relationship between immune cells and MM

Our study revealed a potential causal relationship between one type of immune cell and melanoma (MM). Specifically, an increase in the abundance of CD25 on IgD + CD24- B cells was negatively correlated with the risk of MM (OR = 0.998, 95% CI = 0.996-1.000, p = 4.04E-05). In the reverse MR analysis of immune cells and MM, all MR results were greater than 0.05, indicating that MM had no impact on the included immune cells. The final results demonstrate a potential causal relationship between one type of immune cell and MM (Fig. 3 ).

The forest plot shows the causal relationship between immune cell traits and MM

Causal relationship between immune cells and BCC

In our study, we revealed that eight types of immune cells were potentially causally associated with BCC. Among them, an increase in the abundance of CD25 on IgD- CD38dim B cells and HLA DR on CD33- HLA DR + was negatively correlated with the risk of BCC, while the remaining immune cells showed a positive correlation. The IVW analysis results are as follows: CD25 on IgD- CD38dim B cell (OR = 0.895, 95% CI = 0.842–0.951, p = 3.37E-04), CD33 on CD33 + HLA DR+ (OR = 1.037, 95% CI = 1.019–1.055, p = 4.53E-05), CD33 on Monocytic Myeloid-Derived Suppressor Cells (OR = 1.039, 95% CI = 1.020–1.059, p = 4.54E-05), CD33 on CD33 + HLA DR + CD14- (OR = 1.036, 95% CI = 1.019–1.055, p = 4.63E-05), CD33 on CD33 + HLA DR + CD14dim (OR = 1.037, 95% CI = 1.019–1.055, p = 4.64E-05), HLA DR on CD33- HLA DR+ (OR = 0.942, 95% CI = 0.915–0.970, p = 5.01E-05), Basophil %CD33dim HLA DR- CD66b- (OR = 1.091, 95% CI = 1.045–1.140, p = 7.49E-05), Granulocytic Myeloid-Derived Suppressor Cells Absolute Count (OR = 1.158, 95% CI = 1.076–1.255, p = 9.48E-05). Finally, in the reverse MR analysis of all immune cells and BCC, all MR results were greater than 0.05, indicating that BCC had no effect on the included immune cells. The ultimate results demonstrate potential causal relationships between eight phenotypes of immune cells and BCC (Fig. 4 ).

The forest plot shows the causal relationship between immune cell traits and BCC

Causal relationship between immune cells and AK

Our analysis identified potential causal relationships between four types of immune cells and AK. An increase in the abundance of HLA DR on monocytes, HLA DR on dendritic cells, CD28 on CD28 + CD45RA + CD8 + T cells, and HLA DR + + monocyte %leukocyte was negatively correlated with the risk of AK, indicating that an increase in the abundance of these immune cells leads to a decrease in AK risk. The IVW analysis results for all immune cells are as follows: HLA DR on monocyte (OR = 0.864, 95% CI = 0.808–0.924, p = 1.98E-04), HLA DR on dendritic cell (OR = 0.909, 95% CI = 0.867–0.952, p = 5.40E-04), CD28 on CD28 + CD45RA + CD8 + T cell (OR = 0.804, 95% CI = 0.722–0.896, p = 7.70E-04), HLA DR + + monocyte %leukocyte (OR = 0.735, 95% CI = 0.630–0.857, p = 8.58E-04). We performed reverse MR analysis of all immune cell phenotypes with AK, all MR results were greater than 0.05, indicating that AK had no impact on the included immune cells. The final results demonstrate potential causal relationships between the four immune cell phenotypes and AK (Fig. 5 ).

The forest plot shows the causal relationship between immune cell traits and AK

Causal relationship between immune cells and SCC

In order to strictly control the deviation, the FDR was adjusted in this study, and only immune cells with PFDR less than 0.05 were considered to have a defined causal relationship with the outcome. Therefore, no immune cells were found to have a potential causal association with SCC in this study. Secondly, it may be related to the formation of an immunosuppressive microenvironment in which immune cell function is impaired. The latest research results have proved that although SCC is a highly immunogenic skin cancer, the abnormal epigenetic characteristics of tumor cells during its development not only affect the malignant phenotype of tumor cells, but also alter the function of immune cells and remodel the tumor microenvironment, which can diminish the efficacy of immune cells and the infiltration of immune cell [ 25 ]. In addition, tumor-derived function of tumor protein P63 (TP63), a master transcription factor in SCC, in promoting immune evasion and influencing the efficacy of immunotherapy in squamous carcinoma, revealing that IFNγ/α signaling is the pathway that is most significantly inhibited by TP63, which is usually specifically overexpressed in SCC, and that in human SCC patients, TP63 expression was negatively correlated with CD8 + T cell infiltration and activation [ 26 ]. However, since AK serves as a precursor lesion to SCC, further analysis of the potential causal relationships between immune cell subtypes and AK could provide new insights for the prevention and early treatment of SCC.

In the sensitivity analysis, we conducted heterogeneity and pleiotropy analyses for the immune cells included in the study and their corresponding skin cancer diseases. The results showed p -values greater than 0.05, indicating the absence of heterogeneity and pleiotropy in the SNPs (Tables 1 and 2 ). Additionally, leave-one-out analysis was performed, further confirming the stability of the causal relationships mentioned above. Scatter plots and funnel plots also indicated the stability of the results. The leave-one-out plot, scatter plots and funnel plots are available in the Supplementary Materials .

The MR analysis elucidated potential causal relationships between exposure factors and outcomes. In this study, we used MR analysis to genetically explore the causal relationship between 731 immune cell phenotypes and skin cancer disease. This represents the first MR analysis investigating the causal relationships between various immune cell phenotypes and skin cancer diseases. Among the four immune traits (MFI, RC, AC, and MP), our analyses revealed that one type of immune cell was potentially causally associated with MM, eight types of immune cells were potentially causally associated with BCC, and four types of immune cells were potentially causally associated with AK.

In MM, the immune cell subtype associated with CD25 is closely linked to the disease. CD25 is the alpha chain of the heterotrimeric IL-2 receptor. In various hematologic malignancies, CD25 is highly expressed, but its expression levels are generally lower in most solid tumors [ 27 ]. CD25 is highly expressed on both resting and activated regulatory T (Tregs) cells but is not expressed on naïve T cells, memory T cells, or follicular helper T cells. Therefore, CD25 is currently the most commonly used marker for Tregs cells [ 28 ]. In 1995, Sakaguchi et al. [ 29 ]. first discovered that Tregs have immunosuppressive and immune-regulatory functions and reported that the Tregs phenotype is CD4 + and CD25+. CD25 is primarily involved in the differentiation and proliferation of regulatory CD4 + T cells. In CD4 + CD25 + Tregs cells, CD25 serves as a crucial component of the IL-2 receptor, inducing structural changes in IL-2, thereby promoting the formation of the IL2Rα/β/γ and IL-2 tetramer, activating JAK/STAT5, PI3K/Akt/mTOR, and mitogen-activated protein kinase (MAPK) signaling pathways, enabling Treg cells to exert immune-regulatory functions [ 30 , 31 , 32 ]. Experiments by Shang et al. demonstrated that Treg cell numbers significantly increase in different types of tumor microenvironments (TME), and the degree of Treg cell infiltration is associated with poor tumor prognosis [ 33 ]. Depletion of Tregs not only eliminates Treg-mediated immunosuppressive activity but also stimulates anti-tumor immunity. Rasku et al. demonstrated through a phase II trial in patients with unresectable stage IV melanoma that transient Treg clearance can reduce melanoma metastasis and promote the proliferation of tumor-specific effector T cells [ 34 ]. While CD25 is primarily expressed on activated T cells, it is also expressed in some B cell subgroups. On B cells, CD25 acts as an activation marker, indicating that B cells have been stimulated and have entered an activated state. Activated B cells can produce specific antibodies or IL-2. In the TME, they participate in M1 cell polarization and recruit effector T cells, playing an anti-cancer role [ 35 ]. The MR analysis in this study showed a negative correlation between CD25-labelled B cells and the risk of MM. However, research on the anti-cancer mechanisms of CD25-marked B cells is currently lacking. Therefore, the conclusions of this study provide a theoretical foundation for subsequent research.

HLA DR, which stands for Human Leukocyte Antigen - DR is a major histocompatibility complex (MHC) class II antigen expressed on the surface of B lymphocytes, monocytes, and macrophages, playing a role in presenting antigens to CD4 + T cells. The majority of T cells do not express HLA DR, and it is only in the late stages of T cell activation during the immune response that a proportion of activated T cells can express HLA DR. HLA DR is an important antigen on the surface of monocytes, and it is critical for the recognition of foreign antigens in the activation of specific T cells for the immune response. Kohchiyama et al. [ 36 ]. suggested that in BCC, the expression of the HLA DR antigen on tumor cells not only participates in various immune activities but may also be involved in cellular immune responses, acting as a defense mechanism against tumor cell proliferation. In this study, we also found that HLA DR-associated immune cells were negatively correlated with the risk of BCC, suggesting that HLA DR may play an anti-tumour role in BCC. HLA DR is considered essential for initiating autoimmune reactions, and low HLA DR expression may reduce CD4 T cell-mediated anti-tumor immunity [ 37 ]. Gadeyne [ 38 ] et al. found by a multi-omics approach that the microenvironment of HLA DR-positive melanoma regions was enriched with characteristic antigen-presenting cells, including dendritic cells and macrophages, and that cytotoxic T-cell depletion phenotypes were more prevalent in these regions. Meanwhile, these areas also exhibit enhanced signals related to interferon-gamma (IFNγ), leukocyte adhesion, and monocyte proliferation. The expression of cytokines associated with germinal center cells, such as CXCL12, CXCL13, and CCL19, is also increased in these regions. This suggests that HLA-DR-positive regions in melanoma attract anti-tumour immune cell infiltration by creating an atrophic microenvironment similar to the germinal centre. The findings indicate a complex interplay between HLA DR expression, immune cell composition, and the microenvironment in the context of Basal Cell Carcinoma, shedding light on the potential immunological mechanisms involved in this type of skin cancer. But as of yet, research on the role of HLA-DR-associated cells in BCC disease is limited, and the relationship between HLA DR and the immune system remains to be explored.

AK is a common precancerous skin lesion characterized by chronic reactive proliferation of keratinocytes, and some lesions may progress to SCC. Changes in immune defense mechanisms are believed to play a crucial role in the process of AK transforming into SCC. Hu et al. [ 39 ]. found a group of fibroblasts specifically expressing tryptophan 2,3-dioxygenase (TDO2) in the distant part of cancer nests, while CD4 + T cells and CD8 + T cells were enriched around these fibroblasts, demonstrating that TDO2 has a chemotactic capacity for T cells, inducing the transformation of CD4 + T cells into Treg cells, leading to functional impairment of CD8 + T cells. Treatment with a TDO2 inhibitor restored the anti-tumor function of T cells and prevented the malignant progression of AK to SCC. In MR analysis, we found that HLA DR and CD28-associated immune cells were negatively correlated with the risk of AK, so we suggest that altered immune defence mechanisms play an important role in the transformation of AK into SCC. Comparing with AK and early-stage SCC, there was a significant increase in the number of CD8 + T cells in advanced SCC. Activated HLA DR and IL-2R CD4 + T cells were able to directly kill tumor cells by mediating MHC II, inhibiting tumor cell growth [ 40 ]. In primary SCC, CD8 + T cells exhibited high expression of CTLA4 and TIGIT, while in recurrent SCC, CD8 + T cells showed high expression of HAVCR2 and CXCL13, down-regulating TNF and IL-17 signaling pathways and up-regulating oxidative phosphorylation functions. This indicated that T cell exhaustion in primary and recurrent SCC is caused by different immune inhibitory factors, and T cells in recurrent SCC are in a high metabolic state [ 41 ]. Similarly, reducing macrophage-mediated T cell rejection can enhance the surveillance of CD8 + T cells against tumors [ 42 ]. CD28 is a co-stimulatory molecule expressed on the surface of T lymphocytes, playing a crucial role in T cell activation. It binds to B7 molecules on antigen-presenting cells (APCs), mediating T cell co-stimulation and promoting T cell survival, proliferation, and cytokine production [ 43 ]. In addition, high levels of CD28 signaling can enhance the glycolytic pathway, further promoting the differentiation of exhausted precursor T cells (Tpex) into exhausted terminal T cells (Tex) [ 44 ]. Currently, immune checkpoint inhibitors (ICIs) have revolutionized tumour therapy, such as monacizumab targeting NKG2A inhibition to enhance NK cell and CD8 + T cell activity and further promote anti-tumor immunity [ 45 ], but ICIs still present a number of challenges. One of the biggest challenges is that only a small number of patients are able to benefit from current immunotherapies, and many patients develop resistance to treatment or fail to produce the expected response. Recently investigators identified Immunoscore-IC, a powerful biomarker that predicts the effectiveness of (ICIs) in tumor patients. Immunoscore-IC quantifies the density of CD4 + T and CD8 + cells and the distance between their cells in the tumor microenvironment, distinguishes between patients with tumors that respond and those that do not respond to treatment with ICIs, and is considered a promising predictive marker of response to antimmunotherapy [ 46 , 47 ]. Mlecnik B [ 48 ] et al. found that Immunoscore accurately stratified high-risk and low-risk patients and acted as a predictor of response to chemotherapy.

After the first development of tumor immunotherapies, the understanding of tumor resistance and immunosuppression has gradually deepened, and the demand for personalized and precise medicine has gradually increased, and immunotherapy has become a major breakthrough in the field of cancer treatment [ 49 ]. However, despite the impressive achievements of immunotherapies such as immune checkpoint inhibitors and CAR-T cell therapy, only a small number of patients are still able to benefit from current immunotherapies [ 50 ], and many patients become resistant to treatment or fail to produce the expected response, which can be partly explained by differences in immune subtypes. Therefore, by comprehensively analyzing the immune subtypes of tumors, gaining a deeper understanding of the interactions between tumors and the immune system, and exploring the molecular mechanisms of the immune response, we can more accurately predict the response of patients to specific immune therapies, and thus guide a more personalized therapeutic strategy.

Second, immune subtyping provides a theoretical basis for precision immunotherapy. With the advent of the era of precision medicine, the concept of immune subtyping provides a new personalized dimension for cancer treatment. By gaining a deeper understanding of the complexity of the tumor immune microenvironment and how it affects the therapeutic effects, immune subtyping is expected to become an important indicator for assessing patients’ suitability for specific immunotherapy regimens. This study reveals the causal relationship between different types of immune cell subtypes and four types of skin cancers through an in-depth analysis of genetic data from different types of skin cancers. These subtypes span different cancer types, revealing commonalities and differences in tumor immune responses. This finding not only provides a new perspective for understanding tumor immune escape mechanisms, but also provides a theoretical basis for precision immunotherapy.

In addition, immune subtypes serve as potential indicators for personalized medicine. The analysis of immune subtypes can also reveal potential therapeutic targets and provide clues for the development of new immunotherapeutic strategies. For example, certain immune subtypes may indicate that a tumor is particularly sensitive to specific immunomodulatory molecules [ 51 ], and these molecules can then become new therapeutic targets. Similarly, by analyzing the immune subtypes of patients whose response is predicted to be poor, the possibility of using other treatments in combination to improve the therapeutic outcome can be explored. Therefore, this study delves into the relationship between tumor immune subtypes and different types of skin cancer, providing an important biological basis for personalized medicine.

Finally, this study reveals the causal relationship between specific immune subtypes and different types of skin cancer, providing clues for the discovery of new therapeutic targets and drugs. The application of this statistical approach based on genetic variation not only enhances our understanding of the tumor immune microenvironment, but also offers the possibility of developing new immunotherapeutic strategies.

This study has several strengths and limitations. Firstly, the research employed a large sample size for immune traits and skin cancer, enhancing statistical efficiency in the two-sample Mendelian randomization (MR) analysis. Secondly, the conclusions drawn in this study are based on genetic instrumental variables, utilizing five MR analysis methods for causal inference, providing results with a degree of stability and less susceptibility to horizontal pleiotropy and heterogeneity. However, the study has certain limitations. First, due to a lack of individual-level information, further stratified analysis within the general population was not feasible. Second, immune cell data and skin cancer data were derived from different studies, introducing some differences in sample size, quality control methods, and racial composition, which might lead to some errors. Third, the majority of participants in the GWAS data used in this study were of European ancestry, potentially impacting the generalizability of the findings to other ethnic groups.

In summary, we demonstrated a causal relationship between immune cells and skin cancer by comprehensive bidirectional MR analysis. In addition, our study significantly reduced the effects of unavoidable confounders, reverse causality, and other factors. This may provide new insights for researchers to explore the immunology of skin cancer pathogenesis and help to explore early intervention and therapeutic approaches. However, there are some limitations of this study and more experimental studies are still needed to further explore the potential mechanisms between the identified immune cells and skin cancer risk.

Data availability

The data used in the present study are all publicly available at https://gwas.mrcieu.ac.uk/. The original contributions presented in the study are included in the article/Supplementary Material.

Abbreviations

Malignant melanoma

Basal cell carcinoma

Squamous cell carcinoma

Actinic keratosis

Mendelian randomization

Instrumental variable

Antigen-presenting cells

Tumor microenvironment

Regulatory T cells

Genome-wide association studies

Median fluorescence intensities

Relative cell

Absolute cell

Morphological parameters

Single nucleotide polymorphism

False discovery rate

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This work was supported by Yunnan Province Expert Workstation of Professor Guo jun (Project No.202105AF150038 ), 2022the Joint Special Funds for the Department of Science and Technology of Yunnan Province‑Kunming Medical University(NO.202201AY070001-155)and Scientific Research Fund Project of Education Department of Yunnan Province (No.2023Y0661).

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Wei Yin, Ruilei Li and Zhaoqi Zhang contributed equally to this work and share first authorship.

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Cancer Biotherapy Center, Key Laboratory of Melanoma Research, The Third Affiliated Hospital of Kunming Medical University (Tumor Hospital of Yunnan Province), Kunming, Yunnan Province, 650000, China

Wei Yin, Ruilei Li, Zhaoqi Zhang, Ying Wang, Xinghua Tang, Lin Zhu, Hong Yao & Ke Li

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All authors contributed to the article, WY wrote the manuscript with support from YW, XT, and LZ. RL and ZZ: performed data analysis and data interpretation. HY and KL: Supervision and revising the manuscript.

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Yin, W., Li, R., Zhang, Z. et al. Causal association between skin cancer and immune cells: mendelian randomization (MR) study. BMC Cancer 24 , 849 (2024). https://doi.org/10.1186/s12885-024-12603-0

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