qualitative research organisation studies

Qualitative Research in Organization Studies

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• Dariusz Jemielniak 4 &
• Malgorzata Ciesielska 5  

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This chapter provides an introduction to the qualitative methods and their use in the organization studies. It also provides an overview of the book and particular chapters within it.

Dariusz Jemielniak’s work on the publication was possible thanks to a research grant from the Polish National Science Center (no. UMO-2012/05/E/HS4/01498).

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Jemielniak, D., Ciesielska, M. (2018). Qualitative Research in Organization Studies. In: Ciesielska, M., Jemielniak, D. (eds) Qualitative Methodologies in Organization Studies. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-65217-7_1

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Article contents

Qualitative designs and methodologies for business, management, and organizational research.

• Robert P. Gephart Robert P. Gephart Alberta School of Business, University of Alberta
•  and  Rohny Saylors Rohny Saylors Carson College of Business, Washington State University
• https://doi.org/10.1093/acrefore/9780190224851.013.230
• Published online: 28 September 2020

Qualitative research designs provide future-oriented plans for undertaking research. Designs should describe how to effectively address and answer a specific research question using qualitative data and qualitative analysis techniques. Designs connect research objectives to observations, data, methods, interpretations, and research outcomes. Qualitative research designs focus initially on collecting data to provide a naturalistic view of social phenomena and understand the meaning the social world holds from the point of view of social actors in real settings. The outcomes of qualitative research designs are situated narratives of peoples’ activities in real settings, reasoned explanations of behavior, discoveries of new phenomena, and creating and testing of theories.

A three-level framework can be used to describe the layers of qualitative research design and conceptualize its multifaceted nature. Note, however, that qualitative research is a flexible and not fixed process, unlike conventional positivist research designs that are unchanged after data collection commences. Flexibility provides qualitative research with the capacity to alter foci during the research process and make new and emerging discoveries.

The first or methods layer of the research design process uses social science methods to rigorously describe organizational phenomena and provide evidence that is useful for explaining phenomena and developing theory. Description is done using empirical research methods for data collection including case studies, interviews, participant observation, ethnography, and collection of texts, records, and documents.

The second or methodological layer of research design offers three formal logical strategies to analyze data and address research questions: (a) induction to answer descriptive “what” questions; (b) deduction and hypothesis testing to address theory oriented “why” questions; and (c) abduction to understand questions about what, how, and why phenomena occur.

The third or social science paradigm layer of research design is formed by broad social science traditions and approaches that reflect distinct theoretical epistemologies—theories of knowledge—and diverse empirical research practices. These perspectives include positivism, interpretive induction, and interpretive abduction (interpretive science). There are also scholarly research perspectives that reflect on and challenge or seek to change management thinking and practice, rather than producing rigorous empirical research or evidence based findings. These perspectives include critical research, postmodern research, and organization development.

Three additional issues are important to future qualitative research designs. First, there is renewed interest in the value of covert research undertaken without the informed consent of participants. Second, there is an ongoing discussion of the best style to use for reporting qualitative research. Third, there are new ways to integrate qualitative and quantitative data. These are needed to better address the interplay of qualitative and quantitative phenomena that are both found in everyday discourse, a phenomenon that has been overlooked.

• qualitative methods
• research design
• methods and methodologies
• interpretive induction
• interpretive science
• critical theory
• postmodernism
• organization development

Introduction

Qualitative research uses linguistic symbols and stories to describe and understand actual behavior in real settings (Denzin & Lincoln, 1994 ). Understanding requires describing “specific instances of social phenomena” (Van Maanen, 1998 , p. xi) to determine what this behavior means to lay participants and to scientific researchers. This process produces “narratives-non-fiction division that link events to events in storied or dramatic fashion” to uncover broad social science principles at work in specific cases (p. xii).

A research design and/or proposal is often created at the outset of research to act as a guide. But qualitative research is not a rule-governed process and “no one knows” the rules to write memorable and publishable qualitative research (Van Maanen, 1998 , p. xxv). Thus qualitative research “is anything but standardized, or, more tellingly, impersonal” (p. xi). Design is emergent and is often created as it is being done.

Qualitative research is also complex. This complexity is addressed by providing a framework with three distinct layers of knowledge creation resources that are assembled during qualitative research: the methods layer, the logic layer, and the paradigmatic layer. Research methods are addressed first because “there is no necessary connection between research strategies and methods of data collection and analysis” (Blaikie, 2010 , p. 227). Research methods (e.g., interviews) must be adapted for use with the specific logical strategies and paradigmatic assumptions in mind.

The first, or methods, layer uses qualitative methods to “collect data.” That is, to observe phenomena and record written descriptions of observations, often through field notes. Established methods for description include participant and non-participant observation, ethnography, focus groups, individual interviews, and collection of documentary data. The article explains how established methods have been adapted and used to answer a range of qualitative research questions.

The second, or logic, layer involves selecting a research strategy—a “logic, or set of procedures, for answering research questions” (Blaikie, 2010 , p. 18). Research strategies link research objectives, data collection methods, and logics of analysis. The three logical strategies used in qualitative organizational research are inductive logic, deductive logic and abductive logic (Blaikie, 2010 , p. 79). 1 Each logical strategy makes distinct assumptions about the nature of knowledge (epistemology), the nature of being (ontology), and how logical strategies and assumptions are used in data collection and analysis. The task is to describe important methods suitable for each logical strategy, factors to consider when selecting methods (Blaikie, 2010 ), and illustrates how data collection and analysis methods are adapted to ensure for consistency with specific logics and paradigms.

The third, or paradigms, layer of research design addresses broad frameworks and scholarly traditions for understanding research findings. Commitment to a paradigm or research tradition entails commitments to theories, research strategies, and methods. Three paradigms that do empirical research and seek scientific knowledge are addressed first: positivism, interpretive induction, and interpretive abduction. Then, three scholarly and humanist approaches that critique conventional research and practice to encourage organizational change are discussed: critical theory and research, postmodern perspectives, and organization development (OD). Paradigms or traditions provide broad scholarly contexts that make specific studies comprehensible and meaningful. Lack of grounding in an intellectual tradition limits the ability of research to contribute: contributions always relate to advancing the state of knowledge in specific unfolding research traditions that also set norms for assessing research quality. The six research designs are explained to show how consistency in design levels can be achieved for each of the different paradigms. Further, qualitative research designs must balance the need for a clear plan to achieve goals with the need for adaptability and flexibility to incorporate insights and overcome obstacles that emerge during research.

Our general goal has been to provide a practical guide to inspire and assist readers to better understand, design, implement, and publish qualitative research. We conclude by addressing future challenges and trends in qualitative research.

The Substance of Research Design

A research design is a written text that can be prepared prior to the start of a research project (Blaikie, 2010 , p. 4) and shared or used as “a private working document.” Figure 1 depicts the elements of a qualitative research design and research process. Interest in a topic or problem leads researchers to pose questions and select relevant research methods to fulfill research purposes. Implementation of the methods requires use of logical strategies in conjunction with paradigms of research to specify concepts, theories, and models. The outcomes, depending on decisions made during research, are scientific knowledge, scholarly (non-scientific) knowledge, or applied knowledge useful for practice.

Figure 1. Elements of qualitative research design.

Research designs describe a problem or research question and explain how to use specific qualitative methods to collect and analyze qualitative data that answer a research question. The purposes of design are to describe and justify the decisions made during the research process and to explain how the research outcomes can be produced. Designs are thus future-oriented plans that specify research activities, connect activities to research goals and objectives, and explain how to interpret the research outcomes using paradigms and theories.

In contrast, a research proposal is “a public document that is used to obtain necessary approvals for a research proposal to proceed” (Blaikie, 2010 , p. 4). Research designs are often prepared prior to creating a research proposal, and research proposals often require the inclusion of research designs. Proposals also require greater formality when they are the basis for a legal contract between a researcher and a funding agency. Thus, designs and proposals are mutually relevant and have considerable overlap but are addressed to different audiences. Table 1 provides the specific features of designs and proposals. This discussion focuses on designs.

Table 1. Decisions Necessitated by Research Designs and Proposals

Source: Based on Blaikie ( 2010 ), pp. 12–34.

The “real starting point” for a research design (or proposal) is “the formulation of the research question” (Blaikie, 2010 , p. 17). There are three types of research questions: “what” questions seek descriptions; “why” questions seek answers and understanding; and “how” questions address conditions where certain events occur, underlying mechanisms, and conditions necessary for change interventions (p. 17). It is useful to start with research questions rather than goals, and to explain what the research is intended to achieve (p. 17) in a technical way.

The process of finding a topic and formulating a useful research question requires several considerations (Silverman, 2014 , pp. 31–33, 34–40). Researchers must avoid settings where data collection will be difficult (pp. 31–32); specify an appropriate scope for the topic—neither too wide or too narrow—that can be addressed (pp. 35–36); fit research questions into a relevant theory (p. 39); find the appropriate level of theory to address (p. 42); select appropriate designs and research methods (pp. 42–44); ensure the volume of data can be handled (p. 48); and do an effective literature review (p. 48).

A literature review is an important way to link the proposed research to current knowledge in the field, and to explain what was previously known or what theory suggests to be the case (Blaikie, 2010 , p. 17). Research questions can used to bound and frame the literature review while the literature review often inspires research questions. The review may also provide bases for creating new hypotheses and for answering some of the initial research questions (Blaikie, 2010 , p. 18).

Layers of Research Design

There are three layers of research design. The first layer focuses on research methods for collecting data. The second layer focuses on the logical frameworks used for analyzing data. The third layer focuses on the paradigm used to create a coherent worldview from research methods and logical frameworks.

Layer One: Design as Research Methods

Qualitative research addresses the meanings people have for phenomena. It collects narratives of organizational activity, uses analytical induction to create coherent representations of the truths and meanings in organizational contexts, and then creates explanations of this conduct and its prevalence (Van Maanan, 1998 , pp. xi–xii). Thus qualitative research involves “doing research with words” (Gephart, 2013 , title) in order to describe the linguistic symbols and stories that members use in specific settings.

There are four general methods for collecting qualitative data and creating qualitative descriptions (see Table 2 ). The in-depth case study approach provides a history of an event or phenomenon over time using multiple data sources. Observational strategies use the researcher to observe and describe behavior in actual settings. Interview strategies use a format where a researcher asks questions of an informant. And documentary research collects texts, documents, official records, photographs, and videos as data—formally written or visually recorded evidence that can be replayed and reviewed (Creswell, 2014 , p. 190). These methods are adapted to fit the needs of specific projects.

Table 2. Qualitative Data Collection Methods

The in-depth case study method.

The in-depth case study is a key strategy for qualitative research (Piekkari & Welch, 2012 ). It was the most common qualitative method used during the formative years of the field, from 1956 to 1965 , when 48% of qualitative papers published in the Administrative Science Quarterly used the case study method (Van Maanen, 1998 , p. xix). The case design uses one or more data collection strategies to describe in detail how a single event or phenomenon, selected by a researcher, has changed over time. This provides an understanding of the processes that underlie changes to the phenomenon. In-depth case study methods use observations, documents, records, and interviews that describe the events in the case unfolded and their implications. Case studies contextualize phenomena by studying them in actual situations. They provide rich insights into multiple dimensions of a single phenomenon (Campbell, 1975 ); offer empirical insights into what, how, and why questions related to phenomena; and assist in the creation of robust theory by providing diverse data collected over time (Gephart & Richardson, 2008 , p. 36).

Maniha and Perrow ( 1965 ) provide an example of a case study concerned with organizational goal displacement, an important issue in early organizational theorizing that proposed organizations emerge from rational goals. Organizational rationality was becoming questioned at the time that the authors studied a Youth Commission with nine members in a city of 70,000 persons (Maniha & Perrow, 1965 ). The organization’s activities were reconstructed from interviews with principals and stakeholders of the organization, minutes from Youth Commission meetings, documents, letters, and newspaper accounts (Maniha & Perrow, 1965 ).

The account that emerged from the data analysis is a history of how a “reluctant organization” with “no goals to guide it” was used by other aggressive organizations for their own ends. It ultimately created its own mission (Maniha & Perrow, 1965 ). Thus, an organization that initially lacked rational goals developed a mission through the irrational process of goal slippage or displacement. This finding challenged prevailing thinking at the time.

Observational Strategies

Observational strategies involve a researcher present in a situation who observes and records, the activities and conversations that occur in the setting, usually in written field notes. The three observational strategies in Table 2 —participant observation, ethnography, and systematic self-observation—differ in terms of the role of the researcher and in the data collection approach.

Participant observation . This is one of the earliest qualitative methods (McCall & Simmons, 1969 ). One gains access to a setting and an informant holding an appropriate social role, for example, client, customer, volunteer, or researcher. One then observes and records what occurs in the setting using field notes. Many features or topics in a setting can become a focus for participant observers. And observations can be conducted using continuum of different roles from the complete participant, observer as participant, and participant observer, to the complete observer who observes without participation (Creswell, 2014 , Table 9.2, p. 191).

Ethnography . An ethnography is “a written representation of culture” (Van Maanen, 1988 ) produced after extended participation in a culture. Ethnography is a form of participant observation that focuses on the cultural aspects of the group or organization under study (Van Maanen, 1988 , 2010 ). It involves prolonged and close contact with group members in a role where the observer becomes an apprentice to an informant to learn about a culture (Agar, 1980 ; McCurdy, Spradley, & Shandy, 2005 ; Spradley, 1979 ).

Ethnography produces fine-grained descriptions of a micro-culture, based on in-depth cultural participation (McCurdy et al., 2005 ; Spradley, 1979 , 2016 ). Ethnographic observations seek to capture cultural members’ worldviews (see Perlow, 1997 ; Van Maanen, 1988 ; Watson, 1994 ). Ethnographic techniques for interviewing informants have been refined into an integrated developmental research strategy—“the ethno-semantic method”—for undertaking qualitative research (Spradley, 1979 , 2016 ; Van Maanen, 1981 ). The ethnosemantic method uses a structured approach to uncover and confirm key cultural features, themes, and cultural reasoning processes (McCurdy et al., 2005 , Table 3 ; Spradley, 1979 ).

Systematic Self-Observation . Systematic self-observation (SSO) involves “training informants to observe and record a selected feature of their own everyday experience” (Rodrigues & Ryave, 2002 , p. 2; Rodriguez, Ryave, & Tracewell, 1998 ). Once aware that they are experiencing the target phenomenon, informants “immediately write a field report on their observation” (Rodrigues & Ryave, 2002 , p. 2) describing what was said and done, and providing background information on the context, thoughts, emotions, and relationships of people involved. SSO generates high-quality field notes that provide accurate descriptions of informants’ experiences (pp. 4–5). SSO allows informants to directly provide descriptions of their personal experiences including difficult to capture emotions.

Interview Strategies

Interviews are conversations between researchers and research participants—termed “subjects” in positivist research and informants in “interpretive research.” Interviews can be conducted as individual face-to-face interactions (Creswell, 2014 , p. 190) or by telephone, email, or through computer-based media. Two broad types of interview strategies are (a) the individual interview and (b) the group interview or focus group (Morgan, 1997 ). Interviews elicit informants’ insights into their culture and background information, and obtain answers and opinions. Interviews typically address topics and issues that occur outside the interview setting and at previous times. Interview data are thus reconstructions or undocumented descriptions of action in past settings (Creswell, 2014 , p. 191) that provide descriptions that are less accurate and valid descriptions than direct, real-time observations of settings.

Structured and unstructured interviews. Structured interviews pose a standardized set of fixed, closed-ended questions (Easterby-Smith, Thorpe, & Jackson, 2012 ) to respondents whose responses are recorded as factual information. Responses may be forced choice or open ended. However, most qualitative research uses unstructured or partially structured interviews that pose open-ended questions in a flexible order that can be adapted. Unstructured interviews allow for detailed responses and clarification of statements (Easterby-Smith et al., 2012 ; McLeod, 2014 )and the content and format can be tailored to the needs and assumptions of specific research projects (Gephart & Richardson, 2008 , p. 40).

The informant interview (Spradley, 1979 ) poses questions to informants to elicit and clarify background information about their culture, and to validate ethnographic observations. In interviews, informants teach the researcher their culture (Spradley, 1979 , pp. 24–39). The informant interview is part of a developmental research sequence (McCurdy et al., 2005 ; Spradley, 1979 ) that begins with broad “grand tour” questions that ask an informant to describe an important domain in their culture. The questions later narrow to focus on details of cultural domains and members’ folk concepts. This process uncovers semantic relationships among concepts of members and deeper cultural themes (McCurdy et al., 2005 ; Spradley, 1979 ).

The long interview (McCracken, 1988 ) involves a lengthy, quasi-structured interview sessions with informants to acquire rapid and efficient access to cultural themes and issues in a group. Long interviews differ ethnographic interviews by using a “more efficient and less obtrusive format” (p. 7). This creates a “sharply focused, rapid and highly intense interview process” that avoids indeterminate and redundant questions and pre-empts the need for observation or involvement in a culture. There are four stages in the long interview: (a) review literature to uncover analytical categories and design the interview; (b) review cultural categories to prepare the interview guide; (c) construct the questionnaire; and (d) analyze data to discover analytical categories (p. 30, fig. 1 ).

The active interview is a dynamic process where the researcher and informant co-construct and negotiate interview responses (Holstein & Gubrium, 1995 ). The goal is to uncover the subjective meanings that informants hold for phenomenon, and to understand how meaning is produced through communication. The active approach is common in interpretive, critical, and postmodern research that assumes a negotiated order. For example, Richardson and McKenna ( 2000 ) explored how ex-patriate British faculty members themselves interpreted and explained their expatriate experience. The researchers viewed the interview setting as one where the researchers and informants negotiated meanings between themselves, rather than a setting where prepared questions and answers were shared.

Documentary, Photographic, and Video Records as Data

Documents, records, artifacts, photographs, and video recordings are physically enduring forms of data that are separable from their producers and provide mute evidence with no inherent meaning until they are read, written about, and discussed (Hodder, 1994 , p. 393). Records (e.g., marriage certificate) attest to a formal transaction, are associated with formal governmental institutions, and may have legally restricted access. In contrast, documents are texts prepared for personal reasons with fewer legal restrictions but greater need for contextual interpretation. Several approaches to documentary and textual data analysis have been developed (see Table 3 ). Documents that researchers have found useful to collect include public documents and minutes of meetings; detailed transcripts of public hearings; corporate and government press releases; annual reports and financial documents; private documents such as diaries of informants; and news media reports.

Photographs and videos are useful for capturing “accurate” visual images of physical phenomena (Ray & Smith, 2012 ) that can be repeatedly reexamined and used as evidence to substantiate research claims (LeBaron, Jarzabkowski, Pratt, & Fetzer, 2018 ). Photos taken from different positions in space may also reveal different features of phenomena. Videos show movement and reveal activities as processes unfolding over time and space. Both photos and videos integrate and display the spatiotemporal contexts of action.

Layer Two: Design as Logical Frameworks

The second research design layer links data collection and analysis methods (Tables 2 and 3 ) to three logics of enquiry that answer specific questions: inductive, deductive, and abductive logical strategies (see Table 4 ). Each logical strategy focuses on producing different types of knowledge using distinctive research principles, processes, and types of research questions they can address.

Table 3. Data Analysis and Integrated Data Collection and Analysis Strategies

Table 4. logical strategies for answering qualitative research questions with evidence.

Based in part on Blaikie ( 1993 ), ch. 5 & 6; Blaikie ( 2010 ), p. 84, table 4.1

The Inductive Strategy

Induction is the scientific method for many scholars (Blaikie, 1993 , p. 134), and an essential logic for qualitative management research (Pratt, 2009 , p. 856). Inductive strategies ask “what” questions to explore a domain to discover unknown features of a phenomenon (Blaikie, 2010 , p. 83). There are four stages to the inductive strategy: (a) observe and record all facts without selection or anticipating their importance; (b) analyze, compare, and classify facts without employing hypotheses; (c) develop generalizations inductively based on the analyses; and (d) subject generalizations to further testing (Blaikie, 1993 , p. 137).

Inductive research assumes a real world outside human thought that can be directly sensed and described (Blaikie, 2010 ). Principles of inductive research reflect a realist and objectivist ontology. The selection, definition, and measurement of characteristics to be studied are developed from an objective, scientific point of view. Facts about organizational features need to be obtained using unbiased measurement. Further, the elimination method is used to find “the characteristics present in all the positive cases, which are absent in all the negative cases, and which vary in appropriate degrees” (Blaikie, 1993 , p. 135). This requires data collection methods that provide unbiased evidence of the objective facts without pre-supposing their importance.

Induction can establish limited generalizations about phenomena based solely on the observations collected. Generalizations need to be based on the entire sample of data, not on selected observations from large data sets, to establish their validity. The scope of generalization is limited to the sample of data itself. Induction creates evidence to increase our confidence in a conclusion, but the conclusions do not logically follow from premises (Blaikie, 1993 , p. 164). Indeed, inferences from induction cannot be extended beyond the original set of observations and no logical or formal process exists to establish the universality of inferences.

Key data collection methods for inductive designs include observational strategies that allow the researcher to view behavior without making a priori hypotheses, to describe behavior that occurs “naturally” in settings, and to record non-impressionistic descriptions of behavior. Interviews can also elicit descriptions of settings and behavior for inductive qualitative research. Data analysis methods need to describe actual interactions in real settings including discourse among members. These methods include ethnosemantic analysis to uncover key terms and validate actual meanings used by members; analyses of conversational practices that show how meaning is negotiated through sequential turn taking in discourse; and grounded theory-based concept coding and theory development that use the constant comparative method.

Facts or descriptions of events can be compared to one another and generalizations can be made about the world using induction (Blaikie, 2010 ). Outcomes from inductive analysis include descriptions of features in a limited domain of social action that are inferred to exist in other similar settings. Propositions and broader insights can be developed inductively from these descriptions.

The Deductive Strategy

Deductive logic (Blaikie, 1993 , 2010 ) addresses “why” questions to explain associations between concepts that represent phenomena of interest. Researchers can use induction, abduction, or any means, to develop then test the hypotheses to see if they are valid. Hypotheses that are not rejected are temporarily corroborated. The outcomes from deduction are tested hypotheses. Researchers can thus be very creative in hypothesis construction but they cannot discover new phenomena with deduction that is based only on phenomena known in advance (Blaikie, 2010 ). And there is also no purely logical or mechanical process to establish “the validity of [inductively constructed] universal statements from a set of singular statements” from which deductive hypotheses were formed (Hempel, 1966 , p. 15 cited in Blaikie, 1993 , p. 140).

The deductive strategy uses a realist and objectivist ontology and imitates natural science methods. Useful data collection methods include observation, interviewing, and collection of documents that contain facts. Deduction addresses the assumedly objective features of settings and interactions. Appropriate data analysis methods include content coding to identify different types, features, and frequencies of observed phenomena; grounded theory coding and analytical induction to create categories in data, determine how categories are interrelated, and induce theory from observations; and pattern recognition to compare current data to prior models and samples. Content analysis and non-parametric statistics can be used to quantify qualitative data and make it more amenable to analysis, although quantitative analysis of qualitative data is not, strictly speaking, qualitative research (Gephart, 2004 ).

The Abductive Strategy

Abduction is “the process used to produce social scientific accounts of social life by drawing on the concepts and meanings used by social actors, and the activities in which they engage” (Blaikie, 1993 , p. 176). Abductive reasoning assumes that the socially meaningful world is the world experienced by members. The first abductive task is to discover the insider view that is basic to the actions of social actors (p. 176) by uncovering the subjective meanings held by social actors. Subjective meaning (Schutz, 1973a , 1973b ) refers to the meaning that actions hold for the actors themselves and that they can express verbally. Subjective meaning is not inexpressible ideas locked in one’s mind. Abduction starts with lay descriptions of social life, then moves to technical, scientific descriptions of social life (Blaikie, 1993 , p. 177) (see Table 4 ). Abduction answers “what” questions with induction, why questions with deduction, and “how” questions with hypothesized processes that explain how, and under what conditions, phenomena occur. Abduction involves making a logical leap that infers an explanatory process to explain an outcome in an oscillating logic. Deductive, inductive, and inferential processes move recursively from actors’ accounts to social science accounts and back again in abduction (Gephart, 2018 ). This process enables all theory and second-order scientific concepts to be grounded in actors’ first-order meanings.

The abductive strategy contains four layers: (a) everyday concepts and meanings of actors, used for (b) social interaction, from which (c) actors provide accounts, from which (d) social scientific descriptions are made, or theories are generated and applied, to interpret phenomena (Blaikie, 1993 , p. 177). The multifaceted research process, described in Table 4 , requires locating and comprehending members’ important everyday concepts and theories before observing or creating disruptions that force members to explain the unstated knowledge behind their action. The researcher then integrates members’ first-order concepts into a general, second-order scientific theory that makes first-order understandings recoverable.

Abduction emerged from Weber’s interpretive sociology ( 1978 ) and Peirce’s ( 1936 ) philosophy. But Alfred Schutz ( 1973a , 1973b ) is the contemporary scholar who did the most to extend our understanding of abduction, although he never used the term “abduction” (Blaikie, 1993 , 2010 ; Gephart, 2018 ). Schutz conceived abduction as an approach to verifiable interpretive knowledge that is scientific and rigorous (Blaikie, 1993 ; Gephart, 2018 ). Abduction is appropriate for research that seeks to go beyond description to explanation and prediction (Blaikie, 1993 , p. 163) and discovery (Gephart, 2018 ). It employs an interpretive ontology (Schutz, 1973a , 1973b ) and social constructionist epistemology (Berger & Luckmann, 1966 ), using qualitative methods to discover “why people do what they do” (Blaikie, 1993 ).

Dynamic data collection methods are needed for abductive research to capture descriptions of interactions in actual settings and their meanings to members. Observational and interview approaches that elicit members’ concepts and theories are particularly relevant to abductive understanding (see Table 2 ). Data analysis methods must analyze situated, first-order (common sense) discourse as it unfolds in real settings and then systematically develop second-order concepts or theories from data. Relevant approaches to produce and validate findings include ethnography, ethnomethodology, and grounded theorizing (see Table 3 ). The combination of what, why, and how questions used in abduction produces a broader understanding of phenomena than do what and why deductive and inductive questions.

Layer Three: Paradigms of Research

Scholarly paradigms integrate methods, logics, and intellectual worldviews into coherent theoretical perspectives and form the most abstract level of research design. Six paradigms are widely used in management research (Burrell & Morgan, 1979 ; Cunliffe, 2011 ; Gephart, 2004 , 2013 ; Gephart & Richardson, 2008 ; Hassard, 1993 ). The first three perspectives—positivism, interpretive induction, and interpretive abduction—build on logics of design and seek to produce rigorous empirical research that constitutes evidence (see Table 5 ). Three additional perspectives pursue philosophical, critical, and practical knowledge: critical theory, postmodernism, and organization development (see Table 6 ). Tables 5 and 6 describe important features of each research design to show similarities and differences in the processes through which theoretical meaning is bestowed on research results in management and organization studies.

Table 5. Paradigms, Logical Strategies, and Methodologies for Empirical Research

Sources: Based on and adapted and extended from Blaikie ( 1993 , pp. 137, 145, & 152); Blaikie ( 2010 , Table 4.1, p. 84); Gephart ( 2013 , Table 9.1, p. 291) and Gephart ( 2018 , Table 3.1, pp. 38–39).

Table 6. Alternative Paradigms, Logical Strategies, and Methodologies

Based in part on Gephart ( 2004 , 2013 , 2018 ).

The Positivist Approach

The qualitative positivist approach makes assumptions equivalent to those of quantitative research (Gephart, 2004 , 2018 ). It assumes the world is objectively describable and comprehensible using inductive and deductive logics. And rigor is important and achieved by reliability, validity, and generalizability of findings (Kirk & Miller, 1986 ; Malterud, 2001 ). Qualitative positivism mimics natural science logics and methods using data recorded as words and talk rather than numerals.

Positivist research (Bitektine, 2008 ; Su, 2018 ) starts with a hypothesis. This can, but need not, be based in data or inductive theory. The research process, aimed at publication in peer-reviewed journals, requires researchers to (a) identify variables to measure, (b) develop operational definitions of the variables, (c) measure (describe) the variables and their inter-relationships, (d) pose hypotheses to test relationships among variables, then (e) compare observations to hypotheses for testing (Blaikie, 2010 ). When data are consistent with theory, theory passes the test. Otherwise the theory fails. This theory is also assessed for its logical correctness and value for knowledge. The positivist approach can assess deductive and inductive generalizations and provide evidence concerning why something occurs—if proposed hypotheses are not rejected.

Positivists view qualitative research as highly subject to biases that must be prevented to ensure rigor, and 23 methodological steps are recommended to enhance rigor and prevent bias (Gibbert & Ruigrok, 2010 , p. 720). Replicability is another concern because methodology descriptions in qualitative publications “insufficiently describe” how methods are used (Lee, Mitchell, & Sablynski, 1999 , p. 182) and thereby prevent replication. To ensure replicability, a qualitative “article’s description of the method must be sufficiently detailed to allow a reader . . . to replicate that reported study either in a hypothetical or actual manner.”

Qualitative research allows positivists to observe naturally unfolding behavior in real settings and allow “the real world” of work to inform research and theory (Locke & Golden-Biddle, 2004 ). Encounters with the actual world provide insights into meaning construction by members that cannot be captured with outsider (etic) approaches. For example, past quantitative research provided inconsistent findings on the importance of pre- and post-recruitment screening interviews for job choices of recruits. A deeper investigation was thus designed to examine how recruitment impacts job selection (Rynes, Bretz, & Gerhart, 1991 ). To do so, students undergoing recruitment were asked to “tell us in their own words” how their recruiting and decision processes unfolded (Rynes et al., 1991 , p. 399). Using qualitative evidence, the researchers found that, in contrast to quantitative findings, “people do make choices based on how they are treated” (p. 509), and the choices impact recruitment outcomes. Rich descriptions of actual behavior can disconfirm quantitative findings and produce new findings that move the field forward.

An important limitation of positivism is its common emphasis on outsiders’ or scientific observers’ objective conceptions of the world. This limits the attention positivist research gives to members’ knowledge and allows positivist research to impose outsiders’ meanings on members’ everyday behavior, leading to a lack of understanding of what the behavior means to members. Another limitation is that no formal, logical, or proven techniques exist to assess the strength of “relationships” among qualitative variables, although such assessments can be formally done using well-formed quantitative data and techniques. Thus, qualitative positivists often provide ambiguous or inexplicit quantitative depictions of variable relations (e.g., “strong relationship”). Alternatively, the analysts quantify qualitative data by assigning numeric codes to categories (Greckhamer, Misngyi, Elms, & Lacey, 2008 ), using non-parametric statistics, or quantitative content analysis (Sonpar & Golden-Biddle, 2008 ) to create numerals that depict associations among variables.

An illustrative example of positivist research . Cole ( 1985 ) studied why and how organizations change their working structures from bureaucratic forms to small, self-supervised work teams that allow for worker participation in shop floor activities. Cole found that existing research on workplace change focused on the micropolitical level of organizations. He hypothesized that knowledge could be advanced differently, by examining the macropolitical change in industries or nations. Next, a testable conclusion was deduced: a macro analysis of the politics of change can better predict the success of work team implementation, measured as the spread of small group work structures, than an examination of the micropolitics of small groups ( 1985 ). Three settings were selected for the research: Japan, Sweden, and the United States. Japanese data were collected from company visits and interviews with employment officials and union leaders. Swedish documentary data on semiautonomous work groups were used and supplemented by interviews at Volvo and Saab, and prior field research in Sweden. U.S. data were collected through direct observations and a survey of early quality circle adopters.

Extensive change was observed in Sweden and Japan but changes to small work groups were limited in the United States (Cole, 1985 ). This conclusion was verified using records of the experiences of the three nations in work reform, compared across four dimensions: timing and scope of changes, managerial incentives to innovate, characteristics of mobilization, and political dimensions of change. Data revealed the United States had piecemeal experimentation and resistance to reform through the 1970s; diffusion emerged in Japan in the early 1960s and became extensive; and Swedish workplace reform started in the 1960s and was widely and rapidly diffused.

Cole then answered the questions of “why” and “how” the change occurred in some countries but not others. Regarding why Japanese and Swedish managers were motivated to introduce workplace change due to perceived managerial problems and the changing national labor market. Differences in the political processes also influenced change. Management, labor, and government interest in workplace change was evident in Japan and Sweden but not in the United States where widespread resistance occurred. As to how, the change occurred through macropolitical processes (Cole, 1985 , p. 120), specifically, the commitment of the national business leadership to the change and whether or not the change was contested or uncontested by labor impacted the adoption of change. Organizational change usually occurs through broad macropolitical processes, hence “the importance of macro-political variables in explaining these outcomes” (p. 122).

Interpretive Induction

Two streams of qualitative research claim the label of “interpretive research” in management and organization studies. The first stream, interpretive induction, emphasizes induction as its primary logical strategy (e.g., Locke, 2001 , 2002 ; Pratt, 2009 ). It assumes a “real world” that is inherently objective but interpreted through subjective lenses, hence different people can perceive or report different things. This research is interpretive because it addresses the meanings and interpretations people give to organizational phenomena, and how this meaning is provided and used. Interpretive induction contributes to scientific knowledge by providing empirical descriptions, generalizations, and low-level theories about specific contexts based on thick descriptions of members’ settings and interactions (first-order understandings) as data.

The interpretive induction paradigm addresses “what” questions that describe and explain the existence and features of phenomena. It seeks to uncover the subjective, personal knowledge that subjects have of the objective world and does so by creating descriptive accounts of the activities of organizational members. Interpretive induction creates inductive theories based on limited samples that provide low-scope, abstract theory. Limitations (Table 5 ) include the fact that inductive generalizations are limited to the sample used for induction and need to be subjected to additional tests and comparisons for substantiation. Second, research reports often fail to provide details to allow replication of the research. Third, formal methods for assessing the accuracy and validity of results and findings are limited. Fourth, while many features of scientific research are evident in interpretive induction research, the research moves closer to humanistic knowledge than to science when the basic assumptions of inductive analysis are relaxed—a common occurrence.

An illustrative example of interpretive induction research . Adler and Adler ( 1988 , 1998 ) undertook a five-year participant-observation study of a college basketball program (Adler, 1998 , p. 32). They sought to “examine the development of intense loyalty in one organization.” Intense loyalty evokes “devotional commitment of . . . (organizational) members through a subordination that sometime borders on subservience” (p. 32). The goal was to “describe and analyze the structural factors that emerged as most related” to intense loyalty (p. 32).

The researchers divided their roles. Peter Adler was the active observer and “expert” who undertook direct observations while providing counsel to players (p. 33). Patricia Adler took the peripheral role of “wife” and debriefed the observer. Two research questions were posed: (a) “what” kinds of organizational characteristics foster intense loyalty? (b) “how” do organizations with intense loyalty differ structurally from those that lack intense loyalty?

The first design stage (Table 5 ) recorded unbiased observations in extensive field notes. Detailed “life history” accounts were obtained from 38 team members interviewed (Adler & Adler, 1998 , p. 33). Then analytical induction and the constant comparative method (Glaser & Strauss, 1967 ) were used to classify and compare observations (p. 33). Once patterns emerged, informants were questioned about variations in patterns (p. 34) to develop “total patterns” (p. 34) reflecting the collective belief system of the group. This process required a “careful and rigorous means of data collection and analysis” that was “designed to maximize both the reliability and validity of our findings” (p. 34). The study found five conceptual elements were essential to the development of intense loyalty: domination, identification, commitment, integration, and goal alignment (p. 35).

The “what” question was answered by inducing a generalization (stage 3): paternalistic organizations with charismatic leadership seek people who “fit” the organization’s style and these people require extensive socialization to foster intense loyalty. This description contrasts with rational bureaucratic organizations that seek people who fit specific, generally known job descriptions and require limited socialization (p. 46). The “how” question is answered by inductive creation of another generalization: organizations that control the extra-organizational activities of members are more likely to evoke intense loyalty by forcing members to subordinate all other interests to those of the organization (p. 46).

The Interpretive Abduction Approach

The second stream of interpretive research—interpretive abduction—produces scientific knowledge using qualitative methods (Gephart, 2018 ). The approach assumes that commonsense knowledge is foundational to how actors know the world. Abductive theory is scientifically built from, and refers to, everyday life meanings, in contrast to positivist and interpretive induction research that omits concern with the worldview of members. Further, interpretive abduction produces second-order or scientific theory and concepts from members’ first-order commonsense concepts and meanings (Gephart, 2018 , p. 34; Schutz, 1973a , 1973b ).

The research process, detailed in Table 5 (process and stages), focuses on collecting thick descriptive data on organizations, identifying and interpreting first-order lay concepts, and creating abstract second-order technical constructs of science. The second-order concepts describe the first-order principles and terms social actors use to organize their experience. They compose scientific concepts that form a theoretical system to objectively describe, predict, and explain social organization (Gephart, 2018 , p. 35). This requires researchers to understand the subjective view of the social actors they study, and to develop second-order theory based on actors’ subjective meanings. Subjective meaning can be shared with others through language use and communication and is not private knowledge.

A central analytical task for interpretive abduction is creating second-order, ideal-type models of social roles, motives, and interactions that describe the behavioral trajectories of typical actors. Ideal-type models can be objectively compared to one another and are the special devices that social science requires to address differences between social phenomena and natural phenomena (Schutz, 1973a , 1973b ). The models, once built, are refined to preserve actors’ subjective meanings, to be logically consistent, and to present human action from the actor’s point of view. Researchers can then vary and compare the models to observe the different outcomes that emerge. Scientific descriptions can then be produced, and theories can be created. Interpretive abduction (Gephart, 2018 , p. 35) allows one to addresses what, why, and how questions in a holistic manner, to describe relationships among scientific constructs, and to produce “empirically ascertainable” and verifiable relations among concepts (Schutz, 1973b , p. 65) that are logical, hold practical meaning to lay actors, and provide abstract, objective meaning to interpretive scientists (Gephart, 2018 , p. 35). Abduction produces knowledge about socially shared realities by observing interactions, uncovering members’ first-order meanings, and then developing technical second-order or scientific accounts from lay accounts.

Interpretive abduction (Gephart, 2018 ) uses well-developed methods to create, refine, test, and verify second-order models, and it provides well-developed tools to support technical, second-level analyses. Research using the interpretive abduction approach includes a study of how technology change impacts sales automobile practices (Barley, 2015 ) and an investigation study of how abduction was used to develop new prescription drugs (Dunne & Dougherty, 2016 ).

An illustrative example of the interpretive abduction approach . Perlow ( 1997 ) studied time management among software engineers facing a product launch deadline. Past research verified the widespread belief that long working hours for staff are necessary for organizational success. This belief has adversely impacted work life and led to the concept of a “time bind” faced by professionals (Hochschild, 1997 ). One research question that subsequently emerged was, “what underlies ‘the time bind’ experienced by engineers who face constant deadlines and work interruptions?” (Perlow, 1997 , p. xvii). This is an inductive question about the causes and consequences of long working hours not answered in prior research that is hard to address using induction or deduction. Perlow then explored assumption underlying the hypothesis, supported by lay knowledge and management literature, that even if long working hours cause professionals to destroy their life style, long work hours “further the goals of our organizations” and “maximize the corporation’s bottom line” (Perlow, 1997 , p. 2).

The research commenced (Table 5 , step 1) when Perlow gained access to “Ditto,” a leader in implementing flexible work policies (Perlow, 1997 , p. 141) and spent nine months doing participant observation four days a week. Perlow collected descriptive data by walking around to observe and converse with people, attended meetings and social events, interviewed engineers at work and home and spouses at home, asked participants to record activities they undertook on selected working days (Perlow, 1997 , p. 143), and made “thousands of pages of field notes” (p. 146) to uncover trade-offs between work and home life.

Perlow ( 1997 , pp. 146–147) analyzed first-order concepts uncovered through his observations and interviews from 17 stories he wrote for each individual he had studied. The stories described workstyles, family lives, and traits of individuals; provided objective accounts of subjective meanings each held for work and home; offered background information; and highlighted first-order concepts. Similarities and differences in informant accounts were explored with an empirically grounded scheme for coding observations into categories using grounded theory processes (Gioia, Corley, & Hamilton, 2012 ). The process allowed Perlow to find key themes in stories that show work patterns and perceptions of the requirements of work success, and to create ideal-type models of workers (step 3). Five stories were selected for detailed analysis because they reveal important themes Perlow ( 1997 , p. 147). For example, second-order, ideal-type models of different “roles” were constructed in step 3 including the “organizational superstar” (pp. 15–21) and “ideal female employee” (pp. 22–32) based on first-order accounts of members. The second-order ideal-type scientific models were refined to include typical motives. The models were compared to one another (step 4) to describe and understand how the actions of these employee types differed from other employee types and how these variations produced different outcomes for each trajectory of action (steps 4 and 5).

Perlow ( 1997 ) found that constant help-seeking led engineers to interrupt other engineers to get solutions to problems. This observation led to the abductively developed hypothesis that interruptions create a time crisis atmosphere for engineers. Perlow ( 1997 ) then created a testable, second-order ideal-type (scientific) model of “the vicious working cycle” (p. 96), developed from first-order data, that explains the productivity problems that the firm (and other research and development firms)—commonly face. Specifically, time pressure → crisis mentality → individual heroics → constant interruptions of others’ work to get help → negative consequences for individual → negative consequences for the organization.

Perlow ( 1997 ) then tested the abductive hypothesis that the vicious work cycle caused productivity problems (stage 5). To do so, the vicious work cycle was transformed into a virtuous cycle using scheduling quiet times to prevent work interruptions: relaxed work atmosphere → individuals focus on own work completion → few interruptions → positive consequences for individual and organization. To test the hypothesis, an experiment was conducted (research process 2 in Table 5 ) with engineers given scheduled quiet times each morning with no interruptions. The experiment was successful: the project deadline was met. The hypothesis about work interruptions and the false belief that long hours are needed for success were supported (design stage 6). Unfortunately, the change was not sustained and engineers reverted to work interruptions when the experiment ended.

There are three additional qualitative approaches used in management research that pursue objectives other than producing empirical findings and developing or testing theories. These include critical theory and research, postmodernism, and change intervention research (see Table 6 ).

The Critical Theory and Research Approach

The term “critical” has many meanings including (a) critiques oriented to uncovering ideological manifestations in social relations (Gephart, 2013 , p. 284); (b) critiques of underlying assumptions of theories; and (c) critique as self-reflection that reflexively encapsulates the investigator (Morrow, 1994 , p. 9). Critical theory and critical management studies bring these conceptions of critical to bear on organizations and employees.

Critical theory and research extend the theories Karl Marx, and the Frankfurt School in Germany (Gephart & Kulicki, 2008 ; Gephart & Pitter, 1995 ; Habermas, 1973 , 1979 ; Morrow, 1994 ; Offe, 1984 , 1985 ). Critical theory and research assume that social science research differs from natural science research because social facts are human creations and social phenomena cannot be controlled as readily as natural phenomena (Gephart, 2013 , p. 284; Morrow, 1994 , p. 9). As a result, critical theory often uses a historical approach to explore issues that arise from the fundamental contradictions of capitalism. Critical research explores ongoing changes within capitalist societies and organizations, and analyzes the objective structures that constrain human imagination and action (Morrow, 1994 ). It seeks to uncover the contradictions of advanced capitalism that emerge from the fundamental contradiction of capitalism: owners of capital have the right to appropriate the surplus value created by workers. This basic contradiction produces further contradictions that become sources of workplace oppression and resistance that create labor issues. Thus contradictions reveal how power creates consciousness (Poutanen & Kovalainen, 2010 ). Critical reflection is used to de-reify taken-for-granted structures that create power inequities and to motivate resistance and critique and escape from dominant structures (see Table 6 ).

Critical management studies build on critical theory in sociology. It seeks to transform management and provide alternatives to mainstream theory (Adler, Forbes, & Willmott, 2007 ). The focus is “the social injustice and environmental destruction of the broader social and economic systems” served by conventional, capitalist managers (Adler et al., 2007 , p. 118). Critical management research examines “the systemic corrosion of moral responsibility when any concern for people or for the environment . . . requires justification in terms of its contribution to profitable growth” (p. 4). Critical management studies goes beyond scientific skepticism to undertake a radical critique of socially divisive and environmentally destructive patterns and structures (Adler et al., 2007 , p. 119). These studies use critical reflexivity to uncover reified capitalist structures that allow certain groups to dominate others. Critical reflection is used to de-reify and challenge the facts of social life that are seen as immutable and inevitable (Gephart & Richardson, 2008 , p. 34). The combination of dialogical inquiry, critical reflection, and a combination of qualitative and quantitative methods and data are common in this research (Gephart, 2013 , p. 285). Some researchers use deductive logics to build falsifiable theories while other researchers do grounded theory building (Blaikie, 2010 ). Validity of critical research is assessed as the capability the research has to produce critical reflexivity that comprehends dominant ideologies and transforms repressive structures into democratic processes and institutions (Gephart & Richardson, 2008 ).

An illustrative example of critical research . Barker ( 1998 , p. 130) studied “concertive control” in self-managed work teams in a small manufacturing firm. Concertive control refers to how workers collaborate to engage in self-control. Barker sought to understand how control practices in the self-managed team setting, established to allow workers greater control over their work, differed from previous bureaucratic processes. Interviews, observations, and documents were used as data sources. The resultant description of work activities and control shows that rather than allowing workers greater control, the control process enacted by workers themselves became stronger: “The iron cage becomes stronger” and almost invisible “to the workers it incarcerates” (Barker, 1998 , p. 155). This study shows how traditional participant observation methods can be used to uncover and contest reified structures and taken-for-granted truths, and to reveal the hidden managerial interests served.

Postmodern Perspectives

The postmodern perspective (Boje, Gephart, & Thatchenkery, 1996 ) is based in philosophy, the humanities, and literary criticism. Postmodernism, as an era, refers to the historical stage following modernity that evidences a new cultural worldview and style of intellectual production (Boje et al., 1996 ; Jameson, 1991 ; Rosenau, 1992 ). Postmodernism offers a humanistic approach to reconceptualize our experience of the social world in an era where it is impossible to establish any foundational underpinnings for knowledge. The postmodern perspective assumes that realities are contradictory in nature and value-laden (Gephart & Richardson, 2008 ; Rosenau, 1992 , p. 6). It addresses the values and contradictions of contemporary settings, how hidden power operates, and how people are categorized (Gephart, 2013 ). Postmodernism also challenges the idea that scientific research is value free, and asks “whose values are served by research?”

Postmodern essays depart from concerns with systematic, replicable research methods and designs (Calas, 1987 ). They seek instead to explore the values and contradictions of contemporary organizational life (Gephart, 2013 , p. 289). Research reports have the character of essays that seek to reconceptualize how people experience the world (Martin, 1990 ; Rosenau, 1992 ) and to disrupt this experience by producing “reading effects” that unsettle a community (Calas & Smircich, 1991 ).

Postmodernism examines intertextual relations—how texts become embedded in other texts—rather than causal relations. It assumes there are no singular realities or truths, only multiple realities and multiple truths, none of which are superior to other truths (Gephart, 2013 ). Truth is conceived as the outcome of language use in a context where power relations and multiple realities exist.

From a methodological view, postmodern research tends to focus on discourse: texts and talk. Data collection (in so far as it occurs) focuses on records of discourse—texts of spoken and written verbal communication (Fairclough, 1992 ). Use of formal or official records including recordings, texts and transcripts is common. Analytically, scholars tend to use critical discourse analysis (Fairclough, 1992 ), narrative analysis (Czarniawska, 1998 ; Ganzin, Gephart, & Suddaby, 2014 ), rhetorical analysis (Culler, 1982 ; Gephart, 1988 ; McCloskey, 1984 ) and deconstruction (Calais & Smircich, 1991 ; Gephart, 1988 ; Kilduff, 1993 ; Martin, 1990 ) to understand how categories are shaped through language use and come to privilege or subordinate individuals.

Postmodernism challenges models of knowledge production by showing how political discourses produce totalizing categories, showing how categorization is a tool for social control, and attempting to create opportunities for alternative representations of the world. It thus provides a means to uncover and expose discursive features of domination, subordination, and resistance in society (Locke & Golden-Biddle, 2004 ).

An illustrative example of postmodern research . Martin ( 1990 ) deconstructed a conference speech by a company president. The president was so “deeply concerned” about employee well-being and involvement at work that he encouraged a woman manager “to have her Caesarian yesterday” so she could participate in an upcoming product launch. Martin deconstructs the story to reveal the suppression of gender conflict in the dialogue and how this allows gender conflict and subjugation to continue. This research established the existence of important domains of organizational life, such as tacit gender conflict, that have not been adequately addressed and explored the power dynamics therein.

The Organization Development Approach

OD involves a planned and systematic diagnosis and intervention into an organizational system, supported by top management, with the intent of improving the organization’s effectiveness (Beckhard, 1969 ; Palmer, Dunford, & Buchanan, 2017 , p. 282). OD research (termed “clinical research” by Schein, 1987 ) is concerned with changing attitudes and behaviors to instantiate fundamental values in organizations. OD research often follows the general process of action research (Lalonde, 2019 ) that involves working with actors in an organization to help improve the organization. OD research involves a set of stages the OD practitioner (the leader of the intervention) uses: (a) problem identification; (b) consultation between OD practitioner and client; (c) data collection and problem diagnosis; (d) feedback; (e) joint problem diagnosis; (f) joint action planning; (g) change actions; and (h) further data gathering to move recursively to a refined step 1.

An illustrative example of the organization development approach . Numerous OD techniques exist to help organizations change (Palmer et al., 2017 ). The OD approach is illustrated here by the socioeconomic approach to management (SEAM) (Buono & Savall, 2007 ; Savall, 2007 ). SEAM provides a scientific approach to organizational intervention consulting that integrates qualitative information on work practices and employee and customer needs (socio) with quantitative and financial performance measures (economics). The socioeconomic intervention process commences by uncovering dysfunctions that require attention in an organization. SEAM assumes that organizations produce both (a) explicit benefits and costs and (b) hidden benefits and costs. Hidden costs refer to economic implications of organizational dysfunctions (Worley, Zardet, Bonnet, & Savall, 2015 , pp. 28–29). These include problems in working conditions; work organization; communication, co-ordination, and co-operation; time management; integrated training; and strategy implementation (Savall, Zardet, & Bonnet, 2008 , p. 33). Explicit costs are emphasized in management decision-making but hidden costs are ignored. Yet hidden costs from dysfunctions often greatly outstrip explicit costs.

For example, a fishing company sought to protect its market share by reducing the price and quality of products, leading to the purchase of poor-quality fish (Savall et al., 2008 , pp. 31–32). This reduced visible costs by €500,000. However, some customers stopped purchasing because of the lower-quality product, producing a loss of sales of €4,000,000 in revenue or an overall drop in economic performance of €3,500,000. The managers then changed their strategy to focus on health and quality. They implemented the SEAM approach, assessed the negative impact of the hidden costs on value added and revenue received, and purchased higher-quality fish. Visible costs (expenses) increased by €1,000,000 due to the higher cost for a better-quality product, but the improved quality (performance) cut the hidden costs by increasing loyalty and increased sales by €5,000,000 leaving an increased profit of €4,000,000.

SEAM allows organizations to uncover hidden costs in their operations and to convert these costs into value-added human potential through a process termed “qualimetrics.” Qualimetrics assesses the nature of hidden costs and organizational dysfunctions, develops estimates of the frequencies and amounts of hidden costs in specific organizational domains, and develops actions to reduce the hidden costs and thereby release additional value added for the organization (Savall & Zardet, 2011 ). The qualimetric process is participative and involves researchers who use observations, interviews and focus groups of employees to (a) describe, qualitatively, the dysfunctions experienced at work (qualitative data); (b) estimate the frequencies with which dysfunctions occur (quantitative data); and (c) estimate the costs of each dysfunction (financial data). Then, strategic change actions are developed to (a) identify ways to reduce or overcome the dysfunction, (b) estimate how frequently the dysfunction can be remedied, and (c) estimate the overall net costs of removing the hidden costs to enhance value added. The economic balance is then assessed for changes to transform the hidden costs into value added.

OD research creates actionable knowledge from practice (Lalonde, 2019 ). OD intervention consultants use multistep processes to change organizations that are flexible practices not fixed research designs. OD plays an important role in developing evidence-based practices to improve organizational functioning and performance. Worley et al. ( 2015 ) provide a detailed example of the large-scale implementation of the SEAM OD approach in a large, international firm.

Here we discuss implication of qualitative research designs for covert research, reporting qualitative work and novel integrations of qualitative and quantitative work.

Covert Research

University ethics boards require researchers who undertake research with human participants to obtain informed consent from the participants. Consent requires that all participants must be informed of details of the research procedure in which they will be involved and any risks of participation. Researchers must protect subjects’ identities, offer safeguards to limit risks, and insure informant anonymity. This consent must be obtained in the form of a signed agreement from the participant, obtained prior to the commencement of research observations (McCurdy et al., 2005 , pp. 29–32).

Covert research that fails to fully disclose research purposes or practices to participants, or that is otherwise deceptive by design or tacit practice, has long been considered “suspect” in the field (Graham, 1995 ; Roulet, Gill, Stenger, & Gill, 2017 ). This is changing. Research methodologists have shown that the over/covert dimension is a continuum, not a dichotomy, and that unintended covert elements occur in many situations (Roulet et al., 2017 ). Thus all qualitative observation involves some degree of deception due practical constraints on doing observations since it is difficult to do fully overt research, particularly in observational contexts with many people, and to gain advance consent from everyone in the organization one might encounter.

There are compelling benefits to covert research. It can provide insights not possible if subjects are fully informed of the nature or existence of the research. For example, the year-long, covert observational study of an asylum as a “total institution” (Goffman, 1961 ) showed how ineffective the treatment of mental illness was at the time. This opened the field of mental health to social science research (Roulet et al., 2017 , p. 493). Covert research can also provide access to institutions that researchers would otherwise be excluded from, including secretive and secret organizations (p. 492). This could allow researchers to collect data as an insider and to better see and experience the world from members’ perspective. It could also reduce “researcher demand effects” that occur when informants obscure their normal behavior to conform to research expectations. Thus, the inclusion of covert research data collection in research designs and proposals is an emerging trend and realistic possibility. Ethics applications can be developed that allow for aspects of covert research, and observations in many public settings do not require informed consent.

The Appropriate Style for Reporting Qualitative Work

The appropriate style for reporting qualitative research has become an issue of concern. For example, editors of the influential Academy of Management Journal have noted the emergence of an “AMJ style” for qualitative work (Bansal & Corley, 2011 , p. 234). They suggest that all qualitative work should use this style so that qualitative research can “benefit” from: “decades of refinement in the style of quantitative work.” The argument is that most scholars can assess the empirical and theoretical contributions of quantitative work but find it difficult to do so for qualitative research. It is easier for quantitatively trained editors and scholars “to spot the contribution of qualitative work that mimics the style of quantitative research.” Further, “the majority of papers submitted to . . . AMJ tend to subscribe to the paradigm of normal science that aims to find relationships among valid constructs that can be replicated by anyone” (Bansal, Smith, & Vaara, 2018 , p. 1193). These recommendations appear to explicitly encourage the reporting of qualitative results as if they were quantitatively produced and interpreted and highlights the advantage of conformity to the prevailing positivist perspective to gain publication in AMJ.

Yet AMJ editors have also called for researchers to “ensure that the research questions, data, and analysis are internally consistent ” (Bansal et al., 2018 , p. 1193) and to “Be authentic , detailed and clear in argumentation” (emphasis added) (Bansal et al., 2018 , p. 1193). These calls for consistency appear to be inconsistent with suggestions to present all qualitative research using a style that mimics quantitative, positivist research. Adopting the quantitative or positivist style for all qualitative reports may also confuse scholars, limit research quality, and hamper efforts to produce innovative, non-positivist research. This article provides six qualitative research designs to ensure a range of qualitative research publications are internally consistent in methods, logics, paradigmatic commitments, and writing styles. These designs provide alternatives to positivist mimicry in non-positivist scholarly texts.

Integrating Qualitative and Quantitative Research in New Ways

Qualitative research often omits consideration of the naturally occurring uses of numbers and statistics in everyday discourse. And quantitative researchers tend to ignore qualitative evidence such as stories and discourse. Yet knowledge production processes in society “rely on experts and laypeople and, in so doing, make use of both statistics and stories in their attempt to represent and understand social reality” (Ainsworth & Hardy, 2012 , p. 1649). Numbers and statistics are often used in stories to create legitimacy, and stories provide meaning to numbers (Gephart, 1988 ). Hence stories and statistics cannot be separated in processes of knowledge production (Ainsworth & Hardy, 2012 , p. 1697). The lack of attention to the role of quantification in everyday life means a huge domain of organizational discourse—all talk that uses numbers, quantities, and statistics—is largely unexplored in organizational research.

Qualitative research has, however, begun to study how words and numbers are mutually used for organizational storytelling (Ainsworth & Hardy, 2012 ; Gephart, 2016 ). This focus offers the opportunity to develop research designs to explore qualitative features and processes involved in quantitative phenomena such as financial crises (Gephart, 2016 ), to address how stories and numbers need to work together to create legitimate knowledge (Ainsworth & Hardy, 2012 ), and to show how statistics are used rhetorically to convince others of truths in organizational research (Gephart, 1988 ).

Ethnostatistics (Gephart, 1988 ; Gephart & Saylors, 2019 ) provides one example of how to integrate qualitative and quantitative research. Ethnostatistics examines how statistics are constructed and used by professionals. It explores how statistics are constructed in real settings, how violations of technical assumptions impact statistical outcomes, and how statistics are used rhetorically to convince others of the truth of research outcomes. Ethnostatistics has been used to reinterpret data from four celebrated network studies that themselves were reanalyzed (Kilduff & Oh, 2006 ). The ethnostatistical reanalyses revealed how ad hoc practices, including judgment calls and the imputation of new data into old data set for reanalysis, transformed the focus of network research from diffusion models to structural equivalence models.

Another innovative study uses a Bayesian ethnostatistical approach to understand how the pressure to produce sophisticated and increasingly complex theoretical narratives for causal models has impacted the quantitative knowledge generated in top journals (Saylors & Trafimow, 2020 ). The use of complex causal models has increased substantially over time due to a qualitative and untested belief that complex models are true. Yet statistically speaking, as the number of variables in a model increase, the likelihood the model is true rapidly decreases (Saylors & Trafimow, 2020 , p. 3).

The authors test the previously untested (qualitative) belief that complex causal models can be true. They found that “the joint probability of a six variable model is about 3.5%” (Saylors & Trafimow, 2020 , p. 1). They conclude that “much of the knowledge generated in top journals is likely false” hence “not reporting a (prior) belief in a complex model” should be relegated to the set of questionable research practices. This study shows how qualitative research that explores the lay theories and beliefs of statisticians and quantitative researchers can challenge and disrupt conventions in quantitative research, improve quantitative practices, and contribute qualitative foundations to quantitative research. Ethnostatistics thus opens the qualitative foundations of quantitative research to critical qualitative analyses.

The six qualitative research design processes discussed in this article are evident in scholarly research on organizations and management and provide distinct qualitative research designs and approaches to use. Qualitative research can provide research insights from several theoretical perspectives, using well-developed methods to produce scientific and scholarly insights into management and organizations. These approaches and designs can also inform management practice by creating actionable knowledge. The intended contribution of this article is to describe these well-developed methods, articulate key practices, and display core research designs. The hope is both to better equip researchers to do qualitative research, and to inspire them to do so.

Acknowledgments

The authors wish to acknowledge the assistance of Karen Lund at The University of Alberta for carefully preparing Figure 1 . Thanks also to Beverly Zubot for close reading of the manuscript and helpful suggestions.

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1. The fourth logic is retroduction. This refers to the process of building hypothetical models of structures and mechanisms that are assumed to produce empirical phenomena. It is the primary logic used in the critical realist approach to scientific research (Avenier & Thomas, 2015 ; Bhaskar, 1978 ). Retroduction requires the use of inductive or abductive strategies to discover the mechanisms that explain regularities (Blaikie, 2010 , p. 87). There is no evident logic for discovering mechanisms and this requires disciplined scientific thinking aided by creative imagination, intuition, and guesswork (Blaikie, 2010 ). Retroduction is likr deduction in asking “what” questions and differs from abduction because it produces explanations rather than understanding, causes rather than reasons, and hypothetical conceptual mechanisms rather than descriptions of behavioral processes as outcomes. Retroduction is becoming important in the field but has not as yet been extensively used in management and organization studies (for examples of uses, see Avenier & Thomas, 2015 ); hence, we do not address it at length in this article.

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Qualitative Research in Organizations and Management: ten years on

Qualitative Research in Organizations and Management

ISSN : 1746-5648

Article publication date: 7 December 2015

Cassell, C. and Symon, G. (2015), "Qualitative Research in Organizations and Management: ten years on", Qualitative Research in Organizations and Management , Vol. 10 No. 4. https://doi.org/10.1108/QROM-10-2015-1329

Emerald Group Publishing Limited

Article Type: Editorial From: Qualitative Research in Organizations and Management: An International Journal, Volume 10, Issue 4.

Just ten years ago we proudly introduced a new journal Qualitative Research in Organizations and Management: An International Journal ( QROM ) to the world with the statement that "We are delighted to be involved in the production of such a journal, and believe it is a much needed and useful addition to the organization and management field" (Cassell and Symon, 2006, p. 1). We grandly stated that "In providing this outlet for high quality qualitative research, we wish to encourage an increased recognition of the significance and value of qualitative research in the organization and management field and continue its development both methodologically and epistemologically" (Cassell and Symon, 2006, p. 10). We also emphasised the need for such a publication given the invisibility of qualitative research within the field more generally and highlighted our intention to establish a journal that would both showcase excellent qualitative research and provide a forum where qualitative researchers from all over the world could discuss their work and share their experiences.

Ten years later we are equally proud of what the journal has achieved, though also somewhat reflective as we retire from our editorial roles and hand the journal over to the incoming editorial team. In this short paper we reflect upon what we believe the journal has achieved so far, and highlight some of the challenges that lie ahead for qualitative researchers in our field. We also introduce the invited commentaries that follow in this special issue, where those who have been involved in QROM over the years offer their views about the key issues and challenges facing qualitative researchers and comment upon the future of qualitative management and organisational research. It is not our intention here to provide a review of what has been published in the journal over the years, although some of our contributors do provide useful overviews. Rather, we want to take the opportunity before we stand down to celebrate what the journal has achieved so far and consider its prospects for the future.

Reflections on the editorial process

Setting up a new journal is fraught with tensions and challenges and QROM has been no different. The ongoing challenge of securing excellent qualitative articles that meet the journal's aims and objectives has proved a demanding one. The struggle of finding good reviewers who will review qualitative papers using appropriate criteria is one we anticipated, but we have found a welcoming community of academic scholars out there wanting to help. Throughout these editorial challenges during the last ten years we have been supported by a superb team of Associate Editors who have not only assisted us in dealing with papers submitted, but also importantly helped us shape the flavour of the journal. Their input has been invaluable and we thank them sincerely for their contributions. We are also grateful for the important contribution of our Editorial Advisory Board in reviewing papers in an open-minded fashion and for the ongoing, daily support from the team at Emerald Publishing Group.

Editing a journal comes with some responsibility and we have tried to take this seriously. Our aim is that those submitting to QROM receive constructive feedback on their papers regardless of whether they go into the review process or otherwise. As Katrina Pritchard says in her contribution that follows, when submitting to QROM the assumption is that the author will get a fair hearing. Our intention has been to build an international community of qualitative scholars in an academic environment that can sometimes be both unfamiliar and unfriendly. Hence we want to support qualitative researchers rather than undermine their efforts. As Ann Cunliffe and Karen Locke suggest in this issue, QROM is a journal that offers rich opportunities for qualitative researchers to learn their craft, something we hope will continue.

The journal is also international, and has become increasingly international during the last ten years as its reach has expanded. In the last year alone we received submissions from over 20 different countries. A key player in the development of this international qualitative research community has been the biennial QROM conference hosted by Ann Cunliffe and Karen Locke at the University of New Mexico. As well as promoting the journal and bringing the community together, this conference has served to produce some of the most insightful special issues that the journal has published. Carefully edited by Ann and Karen – together with Steve Linstead – these themed issues have highlighted the diversity of qualitative research and the contemporary challenges that are taxing qualitative researchers. We are indebted to them for their support for the journal during the last ten years.

Methodological diversity and novelty

A particular commitment of ours has been that the content of QROM both demonstrates and promotes the diversity of qualitative research. One of the issues that emerges from the contributions that follow is the recognition of the variety of methodological and philosophical approaches that come under the umbrella term of qualitative research. As editors we have sought to both cherish and encourage that diversity. QROM has championed new and emerging approaches in the organisation and management field, as well as critiquing well-rehearsed approaches, for example the special issues on visual methods (Davison et al. , 2012) and case studies (Lee et al. , 2007). The journal has also contributed to discussions of important and neglected topics, for example the special issues on knowing, learning and acting in healthcare (Bosio et al. , 2012) and dirty work (Grandy et al. , 2014). Silvia Gheradi argues that one of the things that has distinguished QROM from other journals is the attention given to the application of qualitative methods to unusual topics, and there are many more to explore as Natasha Slutskaya highlights in her account. Our intention has been to highlight the potential that the wide variety of qualitative methods has to enable the investigation of different contemporary organisational phenomena. In highlighting the diversity of qualitative research we seek to encourage other researchers to use the techniques and become excited by the opportunities they offer. It has also enabled us to raise awareness of new methods as Davison, McLean and Warren suggest in their contribution to this issue.

Moreover our aim has been that QROM become a journal where diversity can be both expressed and celebrated. Paula Hyde uses the term "polyvocal" in her contribution that follows, and we would contend that QROM is a journal where qualitative researchers from a variety of post-positivist perspectives can feel included and showcase their work.

Standardisation in the qualitative landscape

Inevitably we have seen some changes in the qualitative research landscape during the last ten years and one that has been particularly apparent to us – and is also discussed in a number of the commentaries that follow – is the increased pressure on qualitative researchers to standardise their work and conform to a given set of quality criteria. The increased disciplining of qualitative researchers has not gone un-noticed in the more general methodological literature indeed Lather (2013, p. 635) describes how the field has become "centred, disciplined, regulated and normalized". Our concern has been to promote discussion of these trends, plus to seek to support those who resist them through the pages of QROM . These trends are manifested in a number of ways. Phil Johnson in the account that follows discusses the inappropriate lauding of neo-positivist criteriological assumptions of some commentators in articles published elsewhere (e.g. Bluhm et al. , 2011) whilst Joanne Duberley highlights the dangers of a one best way approach to qualitative research methodology. Bill Lee discusses the implications of the methodological regulation that inevitably emerges as a result of artefacts like the UK Association of Business Schools (ABS) Journal Quality Guide and Yiannis Gabriel discusses his concerns about the emergence of the standard qualitative doctoral thesis.

In contributing to the debate about such pressures, our aim for the journal has been to expect and encourage high quality work but to be eclectic about precisely how that is made manifest. We would hope that the publication opportunities presented by QROM can off-set some of the negative impact of the standardisation of qualitative research that is happening elsewhere and concerns both us, our editorial team and our contributors. However, as a journal we are also subject to the same disciplining processes as our authors. Indeed the fact that QROM is a 1 * journal on the ABS list likely deters some UK researchers from submitting to it. Hence this probably does undermine QROM 's potential as a mechanism for legitimating qualitative research. So although we leave our editorial roles excited for the future of qualitative management and organisational research, we are somewhat tired by the ongoing challenges of dealing with journal quality lists, rankings and resultant pressures to enhance citation counts.

As Editors we have also experienced tensions with our own criteriological assumptions. One potentially contentious issue of our editorship is that we have unequivocally sought to privilege both qualitative data and qualitative forms of data analysis. Some of the hardest decisions we have taken are about papers using qualitative forms of data collection where the data has been analysed and presented through some form of descriptive statistics, for example a frequency analysis. We have deliberated many times about such papers and have desk rejected most of them, though in some cases have gone back to the authors and asked if they are prepared to analyse their findings more discursively. This has led to some reflection on our part as clearly we have been excluding papers based on mixed methods – see Giampietro Gobo's contribution that follows. Our view has been that such papers may not benefit from or need the specialist support we have to offer. Throughout, our concern has been to promote the view that qualitative methods can stand on their own as a legitimate research design. The journal is unique in this respect, hence this is an editorial policy we have been keen to maintain. However, we recognise that this reflects our own epistemological assumptions about qualitative research; that our editorial decisions have excluded mixed methods designs; and that an alternative editorial team may have seen such papers in a different light.

Reflexivity

In our first editorial for the journal ten years ago we suggested that "We are particularly welcoming of papers in which authors have engaged in a critical appraisal of their own research practices and recognise their own underlying assumptions and how this has shaped their work" (Cassell and Symon, 2006, p. 6). This statement has been embraced by our contributors and an enduring theme in the journal throughout the last ten years has been the encouragement of a reflexive stance towards qualitative research. This has been achieved in a number of ways through the pages of QROM . First, through the publication of a range of insider accounts where researchers talk about their experiences of conducting qualitative research. It is important that these accounts are not sanitised but rather present the process "warts and all". As Joanne Duberley says, there is an increasing recognition of the messiness of qualitative research and it is important that novice researchers are aware that complexity and ambiguity are the context within which they work. Hence insider accounts such as those in the special issue entitled "Untold stories of the fields and beyond" (edited by Donnelly et al. , 2013) have been important in setting the agenda of the journal. As Grandy, Mavin and Simpson suggest in their contribution to this issue, QROM is a forum where there is space to discuss such things as the awkwardness of the research experience.

Second, the journal has carried a number of explicit discussions of reflexivity and how it can be interpreted (e.g. Haynes, 2011; Hibbert et al. , 2010). Hence QROM has developed as a place where qualitative researchers can expose their reflexive concerns plus engage in debates with others in their community about the meaning and practice of reflexivity. Such discussion is important, because as Yiannis Gabriel cautions us in his account that follows, we should not be taking a mechanistic approach to reflexivity where qualitative researchers use it as some kind of checklist, but rather we need to take a more critical approach, seeking to expose some of the assumptions that underpin our own qualitative research practice.

Towards the future

Ten years on there is more evidence of published qualitative research within our field and the community of qualitative management and organisational researchers is growing (Üsdiken, 2014). Albert Mills in his account that follows suggests that qualitative research has gained more adherents and legitimacy over the past decade whilst Michael Myers suggests that in relation to his own field of information systems research, the acceptance of qualitative research is increasing and qualitative researchers no longer need to apologise for their approach.

Although we clearly welcome this progress, we are comforted and inspired by the knowledge that the contributors to this special issue believe that there is still a need for a journal like QROM . In her contribution, Silvia Gheradi invites readers to look back over the first ten years of QROM , suggesting that we read things differently ten years later. We would encourage you to do the same. There is much in the content of QROM that can be re-discovered and resonates differently on a second reading.

In our first editorial we noted that QROM would come to nothing without the commitment of other qualitative researchers. As we suggested: "The main protagonists in this endeavour, however, are the researchers and practitioners who pursue qualitative research. Our goals depend on you as authors of high-quality research and we, therefore, encourage your support through your submissions" (Cassell and Symon, 2006, p. 10). So our final thank you is to all of those who have supported the journal through their contributions during the last ten years. It has been an honour to read and deliberate on your work. We wish the new editorial team and everyone else involved in the journal all the best for its ongoing development and future success.

Catherine Cassell and Gillian Symon

Bluhm, D.J., Harman, W., Lee, T.W. and Mitchell, T.R. (2011), "Qualitative research in management: a decade of progress", Journal of Management Studies , Vol. 48 No. 8, pp. 1866-1891

Bosio, C., Graffigna, G. and Scaratti, G. (2012), "Knowing, learning and acting in healthcare", Qualitative Research in Organizations and Management: An International Journal , Vol. 7 No. 3, Special issue

Cassell, C.M and Symon, G. (2006), "Taking qualitative methods in organization and management research seriously", Qualitative Research in Organizations and Management: An International Journal , Vol. 1 No. 1, pp. 4-12

Davison, J., McLean, C. and Warren, S. (2012), "Exploring the visual in organizations and management", Vol. 7 No. 1, Special issue

Donnelly, P, Gabriel, Y. and Özkazanç-Pan, B. (2013), "Untold stories of the field and beyond: narrating the chaos", Qualitative Research in Organizations and Management: An International Journal , Vol. 8 No. 1, Special issue

Grandy, G., Mavin, S. and Simpson, R. (2014), "Doing dirty research", Qualitative Research in Organizations and Management: An International Journal , Vol. 9 No. 3, Special issue

Haynes, K. (2011), "Tensions in (re)presenting the self in reflexive autoethnographical research", Qualitative Research in Organizations and Management: An International Journal , Vol. 6 No. 2, pp. 134-149

Hibbert, P., Coupland, C. and MacIntosh, R. (2010), "Reflexivity: recursion and relationality in organizational research processes", Qualitative Research in Organizations and Management , Vol. 5 No. 1, pp. 47-62

Lather, P. (2013), "Methodology-21: what do we do in the afterward?", Qualitative Studies in Education , Vol. 26 No. 6, pp. 634-645

Lee, B., Collier, P.M. and Cullen, J. (2007), "Case studies", Qualitative Research in Organizations and Management , Vol. 2 No. 3, Special issue

Üsdiken, B. (2014), "Centers and peripheries: research styles and publication patterns in 'top' US journals and their European alternatives, 1960-2010", Journal of Management Studies , Vol. 51 No. 5, pp. 764-789

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How to use and assess qualitative research methods

Loraine busetto.

1 Department of Neurology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

Wolfgang Wick

2 Clinical Cooperation Unit Neuro-Oncology, German Cancer Research Center, Heidelberg, Germany

Christoph Gumbinger

Associated data.

Not applicable.

This paper aims to provide an overview of the use and assessment of qualitative research methods in the health sciences. Qualitative research can be defined as the study of the nature of phenomena and is especially appropriate for answering questions of why something is (not) observed, assessing complex multi-component interventions, and focussing on intervention improvement. The most common methods of data collection are document study, (non-) participant observations, semi-structured interviews and focus groups. For data analysis, field-notes and audio-recordings are transcribed into protocols and transcripts, and coded using qualitative data management software. Criteria such as checklists, reflexivity, sampling strategies, piloting, co-coding, member-checking and stakeholder involvement can be used to enhance and assess the quality of the research conducted. Using qualitative in addition to quantitative designs will equip us with better tools to address a greater range of research problems, and to fill in blind spots in current neurological research and practice.

The aim of this paper is to provide an overview of qualitative research methods, including hands-on information on how they can be used, reported and assessed. This article is intended for beginning qualitative researchers in the health sciences as well as experienced quantitative researchers who wish to broaden their understanding of qualitative research.

What is qualitative research?

Qualitative research is defined as “the study of the nature of phenomena”, including “their quality, different manifestations, the context in which they appear or the perspectives from which they can be perceived” , but excluding “their range, frequency and place in an objectively determined chain of cause and effect” [ 1 ]. This formal definition can be complemented with a more pragmatic rule of thumb: qualitative research generally includes data in form of words rather than numbers [ 2 ].

Why conduct qualitative research?

Because some research questions cannot be answered using (only) quantitative methods. For example, one Australian study addressed the issue of why patients from Aboriginal communities often present late or not at all to specialist services offered by tertiary care hospitals. Using qualitative interviews with patients and staff, it found one of the most significant access barriers to be transportation problems, including some towns and communities simply not having a bus service to the hospital [ 3 ]. A quantitative study could have measured the number of patients over time or even looked at possible explanatory factors – but only those previously known or suspected to be of relevance. To discover reasons for observed patterns, especially the invisible or surprising ones, qualitative designs are needed.

While qualitative research is common in other fields, it is still relatively underrepresented in health services research. The latter field is more traditionally rooted in the evidence-based-medicine paradigm, as seen in " research that involves testing the effectiveness of various strategies to achieve changes in clinical practice, preferably applying randomised controlled trial study designs (...) " [ 4 ]. This focus on quantitative research and specifically randomised controlled trials (RCT) is visible in the idea of a hierarchy of research evidence which assumes that some research designs are objectively better than others, and that choosing a "lesser" design is only acceptable when the better ones are not practically or ethically feasible [ 5 , 6 ]. Others, however, argue that an objective hierarchy does not exist, and that, instead, the research design and methods should be chosen to fit the specific research question at hand – "questions before methods" [ 2 , 7 – 9 ]. This means that even when an RCT is possible, some research problems require a different design that is better suited to addressing them. Arguing in JAMA, Berwick uses the example of rapid response teams in hospitals, which he describes as " a complex, multicomponent intervention – essentially a process of social change" susceptible to a range of different context factors including leadership or organisation history. According to him, "[in] such complex terrain, the RCT is an impoverished way to learn. Critics who use it as a truth standard in this context are incorrect" [ 8 ] . Instead of limiting oneself to RCTs, Berwick recommends embracing a wider range of methods , including qualitative ones, which for "these specific applications, (...) are not compromises in learning how to improve; they are superior" [ 8 ].

Research problems that can be approached particularly well using qualitative methods include assessing complex multi-component interventions or systems (of change), addressing questions beyond “what works”, towards “what works for whom when, how and why”, and focussing on intervention improvement rather than accreditation [ 7 , 9 – 12 ]. Using qualitative methods can also help shed light on the “softer” side of medical treatment. For example, while quantitative trials can measure the costs and benefits of neuro-oncological treatment in terms of survival rates or adverse effects, qualitative research can help provide a better understanding of patient or caregiver stress, visibility of illness or out-of-pocket expenses.

How to conduct qualitative research?

Given that qualitative research is characterised by flexibility, openness and responsivity to context, the steps of data collection and analysis are not as separate and consecutive as they tend to be in quantitative research [ 13 , 14 ]. As Fossey puts it : “sampling, data collection, analysis and interpretation are related to each other in a cyclical (iterative) manner, rather than following one after another in a stepwise approach” [ 15 ]. The researcher can make educated decisions with regard to the choice of method, how they are implemented, and to which and how many units they are applied [ 13 ]. As shown in Fig.  1 , this can involve several back-and-forth steps between data collection and analysis where new insights and experiences can lead to adaption and expansion of the original plan. Some insights may also necessitate a revision of the research question and/or the research design as a whole. The process ends when saturation is achieved, i.e. when no relevant new information can be found (see also below: sampling and saturation). For reasons of transparency, it is essential for all decisions as well as the underlying reasoning to be well-documented.

Iterative research process

While it is not always explicitly addressed, qualitative methods reflect a different underlying research paradigm than quantitative research (e.g. constructivism or interpretivism as opposed to positivism). The choice of methods can be based on the respective underlying substantive theory or theoretical framework used by the researcher [ 2 ].

Data collection

The methods of qualitative data collection most commonly used in health research are document study, observations, semi-structured interviews and focus groups [ 1 , 14 , 16 , 17 ].

Document study

Document study (also called document analysis) refers to the review by the researcher of written materials [ 14 ]. These can include personal and non-personal documents such as archives, annual reports, guidelines, policy documents, diaries or letters.

Observations

Observations are particularly useful to gain insights into a certain setting and actual behaviour – as opposed to reported behaviour or opinions [ 13 ]. Qualitative observations can be either participant or non-participant in nature. In participant observations, the observer is part of the observed setting, for example a nurse working in an intensive care unit [ 18 ]. In non-participant observations, the observer is “on the outside looking in”, i.e. present in but not part of the situation, trying not to influence the setting by their presence. Observations can be planned (e.g. for 3 h during the day or night shift) or ad hoc (e.g. as soon as a stroke patient arrives at the emergency room). During the observation, the observer takes notes on everything or certain pre-determined parts of what is happening around them, for example focusing on physician-patient interactions or communication between different professional groups. Written notes can be taken during or after the observations, depending on feasibility (which is usually lower during participant observations) and acceptability (e.g. when the observer is perceived to be judging the observed). Afterwards, these field notes are transcribed into observation protocols. If more than one observer was involved, field notes are taken independently, but notes can be consolidated into one protocol after discussions. Advantages of conducting observations include minimising the distance between the researcher and the researched, the potential discovery of topics that the researcher did not realise were relevant and gaining deeper insights into the real-world dimensions of the research problem at hand [ 18 ].

Semi-structured interviews

Hijmans & Kuyper describe qualitative interviews as “an exchange with an informal character, a conversation with a goal” [ 19 ]. Interviews are used to gain insights into a person’s subjective experiences, opinions and motivations – as opposed to facts or behaviours [ 13 ]. Interviews can be distinguished by the degree to which they are structured (i.e. a questionnaire), open (e.g. free conversation or autobiographical interviews) or semi-structured [ 2 , 13 ]. Semi-structured interviews are characterized by open-ended questions and the use of an interview guide (or topic guide/list) in which the broad areas of interest, sometimes including sub-questions, are defined [ 19 ]. The pre-defined topics in the interview guide can be derived from the literature, previous research or a preliminary method of data collection, e.g. document study or observations. The topic list is usually adapted and improved at the start of the data collection process as the interviewer learns more about the field [ 20 ]. Across interviews the focus on the different (blocks of) questions may differ and some questions may be skipped altogether (e.g. if the interviewee is not able or willing to answer the questions or for concerns about the total length of the interview) [ 20 ]. Qualitative interviews are usually not conducted in written format as it impedes on the interactive component of the method [ 20 ]. In comparison to written surveys, qualitative interviews have the advantage of being interactive and allowing for unexpected topics to emerge and to be taken up by the researcher. This can also help overcome a provider or researcher-centred bias often found in written surveys, which by nature, can only measure what is already known or expected to be of relevance to the researcher. Interviews can be audio- or video-taped; but sometimes it is only feasible or acceptable for the interviewer to take written notes [ 14 , 16 , 20 ].

Focus groups

Focus groups are group interviews to explore participants’ expertise and experiences, including explorations of how and why people behave in certain ways [ 1 ]. Focus groups usually consist of 6–8 people and are led by an experienced moderator following a topic guide or “script” [ 21 ]. They can involve an observer who takes note of the non-verbal aspects of the situation, possibly using an observation guide [ 21 ]. Depending on researchers’ and participants’ preferences, the discussions can be audio- or video-taped and transcribed afterwards [ 21 ]. Focus groups are useful for bringing together homogeneous (to a lesser extent heterogeneous) groups of participants with relevant expertise and experience on a given topic on which they can share detailed information [ 21 ]. Focus groups are a relatively easy, fast and inexpensive method to gain access to information on interactions in a given group, i.e. “the sharing and comparing” among participants [ 21 ]. Disadvantages include less control over the process and a lesser extent to which each individual may participate. Moreover, focus group moderators need experience, as do those tasked with the analysis of the resulting data. Focus groups can be less appropriate for discussing sensitive topics that participants might be reluctant to disclose in a group setting [ 13 ]. Moreover, attention must be paid to the emergence of “groupthink” as well as possible power dynamics within the group, e.g. when patients are awed or intimidated by health professionals.

Choosing the “right” method

As explained above, the school of thought underlying qualitative research assumes no objective hierarchy of evidence and methods. This means that each choice of single or combined methods has to be based on the research question that needs to be answered and a critical assessment with regard to whether or to what extent the chosen method can accomplish this – i.e. the “fit” between question and method [ 14 ]. It is necessary for these decisions to be documented when they are being made, and to be critically discussed when reporting methods and results.

Let us assume that our research aim is to examine the (clinical) processes around acute endovascular treatment (EVT), from the patient’s arrival at the emergency room to recanalization, with the aim to identify possible causes for delay and/or other causes for sub-optimal treatment outcome. As a first step, we could conduct a document study of the relevant standard operating procedures (SOPs) for this phase of care – are they up-to-date and in line with current guidelines? Do they contain any mistakes, irregularities or uncertainties that could cause delays or other problems? Regardless of the answers to these questions, the results have to be interpreted based on what they are: a written outline of what care processes in this hospital should look like. If we want to know what they actually look like in practice, we can conduct observations of the processes described in the SOPs. These results can (and should) be analysed in themselves, but also in comparison to the results of the document analysis, especially as regards relevant discrepancies. Do the SOPs outline specific tests for which no equipment can be observed or tasks to be performed by specialized nurses who are not present during the observation? It might also be possible that the written SOP is outdated, but the actual care provided is in line with current best practice. In order to find out why these discrepancies exist, it can be useful to conduct interviews. Are the physicians simply not aware of the SOPs (because their existence is limited to the hospital’s intranet) or do they actively disagree with them or does the infrastructure make it impossible to provide the care as described? Another rationale for adding interviews is that some situations (or all of their possible variations for different patient groups or the day, night or weekend shift) cannot practically or ethically be observed. In this case, it is possible to ask those involved to report on their actions – being aware that this is not the same as the actual observation. A senior physician’s or hospital manager’s description of certain situations might differ from a nurse’s or junior physician’s one, maybe because they intentionally misrepresent facts or maybe because different aspects of the process are visible or important to them. In some cases, it can also be relevant to consider to whom the interviewee is disclosing this information – someone they trust, someone they are otherwise not connected to, or someone they suspect or are aware of being in a potentially “dangerous” power relationship to them. Lastly, a focus group could be conducted with representatives of the relevant professional groups to explore how and why exactly they provide care around EVT. The discussion might reveal discrepancies (between SOPs and actual care or between different physicians) and motivations to the researchers as well as to the focus group members that they might not have been aware of themselves. For the focus group to deliver relevant information, attention has to be paid to its composition and conduct, for example, to make sure that all participants feel safe to disclose sensitive or potentially problematic information or that the discussion is not dominated by (senior) physicians only. The resulting combination of data collection methods is shown in Fig.  2 .

Possible combination of data collection methods

Attributions for icons: “Book” by Serhii Smirnov, “Interview” by Adrien Coquet, FR, “Magnifying Glass” by anggun, ID, “Business communication” by Vectors Market; all from the Noun Project

The combination of multiple data source as described for this example can be referred to as “triangulation”, in which multiple measurements are carried out from different angles to achieve a more comprehensive understanding of the phenomenon under study [ 22 , 23 ].

Data analysis

To analyse the data collected through observations, interviews and focus groups these need to be transcribed into protocols and transcripts (see Fig.  3 ). Interviews and focus groups can be transcribed verbatim , with or without annotations for behaviour (e.g. laughing, crying, pausing) and with or without phonetic transcription of dialects and filler words, depending on what is expected or known to be relevant for the analysis. In the next step, the protocols and transcripts are coded , that is, marked (or tagged, labelled) with one or more short descriptors of the content of a sentence or paragraph [ 2 , 15 , 23 ]. Jansen describes coding as “connecting the raw data with “theoretical” terms” [ 20 ]. In a more practical sense, coding makes raw data sortable. This makes it possible to extract and examine all segments describing, say, a tele-neurology consultation from multiple data sources (e.g. SOPs, emergency room observations, staff and patient interview). In a process of synthesis and abstraction, the codes are then grouped, summarised and/or categorised [ 15 , 20 ]. The end product of the coding or analysis process is a descriptive theory of the behavioural pattern under investigation [ 20 ]. The coding process is performed using qualitative data management software, the most common ones being InVivo, MaxQDA and Atlas.ti. It should be noted that these are data management tools which support the analysis performed by the researcher(s) [ 14 ].

From data collection to data analysis

Attributions for icons: see Fig. ​ Fig.2, 2 , also “Speech to text” by Trevor Dsouza, “Field Notes” by Mike O’Brien, US, “Voice Record” by ProSymbols, US, “Inspection” by Made, AU, and “Cloud” by Graphic Tigers; all from the Noun Project

How to report qualitative research?

Protocols of qualitative research can be published separately and in advance of the study results. However, the aim is not the same as in RCT protocols, i.e. to pre-define and set in stone the research questions and primary or secondary endpoints. Rather, it is a way to describe the research methods in detail, which might not be possible in the results paper given journals’ word limits. Qualitative research papers are usually longer than their quantitative counterparts to allow for deep understanding and so-called “thick description”. In the methods section, the focus is on transparency of the methods used, including why, how and by whom they were implemented in the specific study setting, so as to enable a discussion of whether and how this may have influenced data collection, analysis and interpretation. The results section usually starts with a paragraph outlining the main findings, followed by more detailed descriptions of, for example, the commonalities, discrepancies or exceptions per category [ 20 ]. Here it is important to support main findings by relevant quotations, which may add information, context, emphasis or real-life examples [ 20 , 23 ]. It is subject to debate in the field whether it is relevant to state the exact number or percentage of respondents supporting a certain statement (e.g. “Five interviewees expressed negative feelings towards XYZ”) [ 21 ].

How to combine qualitative with quantitative research?

Qualitative methods can be combined with other methods in multi- or mixed methods designs, which “[employ] two or more different methods [ …] within the same study or research program rather than confining the research to one single method” [ 24 ]. Reasons for combining methods can be diverse, including triangulation for corroboration of findings, complementarity for illustration and clarification of results, expansion to extend the breadth and range of the study, explanation of (unexpected) results generated with one method with the help of another, or offsetting the weakness of one method with the strength of another [ 1 , 17 , 24 – 26 ]. The resulting designs can be classified according to when, why and how the different quantitative and/or qualitative data strands are combined. The three most common types of mixed method designs are the convergent parallel design , the explanatory sequential design and the exploratory sequential design. The designs with examples are shown in Fig.  4 .

Three common mixed methods designs

In the convergent parallel design, a qualitative study is conducted in parallel to and independently of a quantitative study, and the results of both studies are compared and combined at the stage of interpretation of results. Using the above example of EVT provision, this could entail setting up a quantitative EVT registry to measure process times and patient outcomes in parallel to conducting the qualitative research outlined above, and then comparing results. Amongst other things, this would make it possible to assess whether interview respondents’ subjective impressions of patients receiving good care match modified Rankin Scores at follow-up, or whether observed delays in care provision are exceptions or the rule when compared to door-to-needle times as documented in the registry. In the explanatory sequential design, a quantitative study is carried out first, followed by a qualitative study to help explain the results from the quantitative study. This would be an appropriate design if the registry alone had revealed relevant delays in door-to-needle times and the qualitative study would be used to understand where and why these occurred, and how they could be improved. In the exploratory design, the qualitative study is carried out first and its results help informing and building the quantitative study in the next step [ 26 ]. If the qualitative study around EVT provision had shown a high level of dissatisfaction among the staff members involved, a quantitative questionnaire investigating staff satisfaction could be set up in the next step, informed by the qualitative study on which topics dissatisfaction had been expressed. Amongst other things, the questionnaire design would make it possible to widen the reach of the research to more respondents from different (types of) hospitals, regions, countries or settings, and to conduct sub-group analyses for different professional groups.

How to assess qualitative research?

A variety of assessment criteria and lists have been developed for qualitative research, ranging in their focus and comprehensiveness [ 14 , 17 , 27 ]. However, none of these has been elevated to the “gold standard” in the field. In the following, we therefore focus on a set of commonly used assessment criteria that, from a practical standpoint, a researcher can look for when assessing a qualitative research report or paper.

Assessors should check the authors’ use of and adherence to the relevant reporting checklists (e.g. Standards for Reporting Qualitative Research (SRQR)) to make sure all items that are relevant for this type of research are addressed [ 23 , 28 ]. Discussions of quantitative measures in addition to or instead of these qualitative measures can be a sign of lower quality of the research (paper). Providing and adhering to a checklist for qualitative research contributes to an important quality criterion for qualitative research, namely transparency [ 15 , 17 , 23 ].

Reflexivity

While methodological transparency and complete reporting is relevant for all types of research, some additional criteria must be taken into account for qualitative research. This includes what is called reflexivity, i.e. sensitivity to the relationship between the researcher and the researched, including how contact was established and maintained, or the background and experience of the researcher(s) involved in data collection and analysis. Depending on the research question and population to be researched this can be limited to professional experience, but it may also include gender, age or ethnicity [ 17 , 27 ]. These details are relevant because in qualitative research, as opposed to quantitative research, the researcher as a person cannot be isolated from the research process [ 23 ]. It may influence the conversation when an interviewed patient speaks to an interviewer who is a physician, or when an interviewee is asked to discuss a gynaecological procedure with a male interviewer, and therefore the reader must be made aware of these details [ 19 ].

Sampling and saturation

The aim of qualitative sampling is for all variants of the objects of observation that are deemed relevant for the study to be present in the sample “ to see the issue and its meanings from as many angles as possible” [ 1 , 16 , 19 , 20 , 27 ] , and to ensure “information-richness [ 15 ]. An iterative sampling approach is advised, in which data collection (e.g. five interviews) is followed by data analysis, followed by more data collection to find variants that are lacking in the current sample. This process continues until no new (relevant) information can be found and further sampling becomes redundant – which is called saturation [ 1 , 15 ] . In other words: qualitative data collection finds its end point not a priori , but when the research team determines that saturation has been reached [ 29 , 30 ].

This is also the reason why most qualitative studies use deliberate instead of random sampling strategies. This is generally referred to as “ purposive sampling” , in which researchers pre-define which types of participants or cases they need to include so as to cover all variations that are expected to be of relevance, based on the literature, previous experience or theory (i.e. theoretical sampling) [ 14 , 20 ]. Other types of purposive sampling include (but are not limited to) maximum variation sampling, critical case sampling or extreme or deviant case sampling [ 2 ]. In the above EVT example, a purposive sample could include all relevant professional groups and/or all relevant stakeholders (patients, relatives) and/or all relevant times of observation (day, night and weekend shift).

Assessors of qualitative research should check whether the considerations underlying the sampling strategy were sound and whether or how researchers tried to adapt and improve their strategies in stepwise or cyclical approaches between data collection and analysis to achieve saturation [ 14 ].

Good qualitative research is iterative in nature, i.e. it goes back and forth between data collection and analysis, revising and improving the approach where necessary. One example of this are pilot interviews, where different aspects of the interview (especially the interview guide, but also, for example, the site of the interview or whether the interview can be audio-recorded) are tested with a small number of respondents, evaluated and revised [ 19 ]. In doing so, the interviewer learns which wording or types of questions work best, or which is the best length of an interview with patients who have trouble concentrating for an extended time. Of course, the same reasoning applies to observations or focus groups which can also be piloted.

Ideally, coding should be performed by at least two researchers, especially at the beginning of the coding process when a common approach must be defined, including the establishment of a useful coding list (or tree), and when a common meaning of individual codes must be established [ 23 ]. An initial sub-set or all transcripts can be coded independently by the coders and then compared and consolidated after regular discussions in the research team. This is to make sure that codes are applied consistently to the research data.

Member checking

Member checking, also called respondent validation , refers to the practice of checking back with study respondents to see if the research is in line with their views [ 14 , 27 ]. This can happen after data collection or analysis or when first results are available [ 23 ]. For example, interviewees can be provided with (summaries of) their transcripts and asked whether they believe this to be a complete representation of their views or whether they would like to clarify or elaborate on their responses [ 17 ]. Respondents’ feedback on these issues then becomes part of the data collection and analysis [ 27 ].

Stakeholder involvement

In those niches where qualitative approaches have been able to evolve and grow, a new trend has seen the inclusion of patients and their representatives not only as study participants (i.e. “members”, see above) but as consultants to and active participants in the broader research process [ 31 – 33 ]. The underlying assumption is that patients and other stakeholders hold unique perspectives and experiences that add value beyond their own single story, making the research more relevant and beneficial to researchers, study participants and (future) patients alike [ 34 , 35 ]. Using the example of patients on or nearing dialysis, a recent scoping review found that 80% of clinical research did not address the top 10 research priorities identified by patients and caregivers [ 32 , 36 ]. In this sense, the involvement of the relevant stakeholders, especially patients and relatives, is increasingly being seen as a quality indicator in and of itself.

How not to assess qualitative research

The above overview does not include certain items that are routine in assessments of quantitative research. What follows is a non-exhaustive, non-representative, experience-based list of the quantitative criteria often applied to the assessment of qualitative research, as well as an explanation of the limited usefulness of these endeavours.

Protocol adherence

Given the openness and flexibility of qualitative research, it should not be assessed by how well it adheres to pre-determined and fixed strategies – in other words: its rigidity. Instead, the assessor should look for signs of adaptation and refinement based on lessons learned from earlier steps in the research process.

Sample size

For the reasons explained above, qualitative research does not require specific sample sizes, nor does it require that the sample size be determined a priori [ 1 , 14 , 27 , 37 – 39 ]. Sample size can only be a useful quality indicator when related to the research purpose, the chosen methodology and the composition of the sample, i.e. who was included and why.

Randomisation

While some authors argue that randomisation can be used in qualitative research, this is not commonly the case, as neither its feasibility nor its necessity or usefulness has been convincingly established for qualitative research [ 13 , 27 ]. Relevant disadvantages include the negative impact of a too large sample size as well as the possibility (or probability) of selecting “ quiet, uncooperative or inarticulate individuals ” [ 17 ]. Qualitative studies do not use control groups, either.

Interrater reliability, variability and other “objectivity checks”

The concept of “interrater reliability” is sometimes used in qualitative research to assess to which extent the coding approach overlaps between the two co-coders. However, it is not clear what this measure tells us about the quality of the analysis [ 23 ]. This means that these scores can be included in qualitative research reports, preferably with some additional information on what the score means for the analysis, but it is not a requirement. Relatedly, it is not relevant for the quality or “objectivity” of qualitative research to separate those who recruited the study participants and collected and analysed the data. Experiences even show that it might be better to have the same person or team perform all of these tasks [ 20 ]. First, when researchers introduce themselves during recruitment this can enhance trust when the interview takes place days or weeks later with the same researcher. Second, when the audio-recording is transcribed for analysis, the researcher conducting the interviews will usually remember the interviewee and the specific interview situation during data analysis. This might be helpful in providing additional context information for interpretation of data, e.g. on whether something might have been meant as a joke [ 18 ].

Not being quantitative research

Being qualitative research instead of quantitative research should not be used as an assessment criterion if it is used irrespectively of the research problem at hand. Similarly, qualitative research should not be required to be combined with quantitative research per se – unless mixed methods research is judged as inherently better than single-method research. In this case, the same criterion should be applied for quantitative studies without a qualitative component.

The main take-away points of this paper are summarised in Table ​ Table1. 1 . We aimed to show that, if conducted well, qualitative research can answer specific research questions that cannot to be adequately answered using (only) quantitative designs. Seeing qualitative and quantitative methods as equal will help us become more aware and critical of the “fit” between the research problem and our chosen methods: I can conduct an RCT to determine the reasons for transportation delays of acute stroke patients – but should I? It also provides us with a greater range of tools to tackle a greater range of research problems more appropriately and successfully, filling in the blind spots on one half of the methodological spectrum to better address the whole complexity of neurological research and practice.

Take-away-points

Acknowledgements

Abbreviations, authors’ contributions.

LB drafted the manuscript; WW and CG revised the manuscript; all authors approved the final versions.

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The authors declare no competing interests.

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eAppendix 1. Invitation Email

eAppendix 2. Interview Protocol

eTable. Characteristics of Participating Versus Non-Participating ACOs

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Khullar D , Schpero WL , Casalino LP, et al. Accountable Care Organization Leader Perspectives on the Medicare Shared Savings Program : A Qualitative Study . JAMA Health Forum. 2024;5(3):e240126. doi:10.1001/jamahealthforum.2024.0126

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Accountable Care Organization Leader Perspectives on the Medicare Shared Savings Program : A Qualitative Study

• 1 Division of Health Policy and Economics, Department of Population Health Sciences, Weill Cornell Medical College, New York, New York
• 2 Division of General Internal Medicine, Department of Medicine, Weill Cornell Medical College, New York, New York
• 3 Center for Health Equity, Cornell University, New York, New York

Question   A decade into the Medicare Shared Savings Program, what do leaders of accountable care organizations (ACOs) report as key priorities and challenges?

Findings   In this qualitative study of 49 ACOs, leaders identified a focus on wellness visits, coding practices, and care transitions, and described using quality dashboards, personal relationships, and shared savings distributions to engage clinicians. Competition from Medicare Advantage presented a growing challenge for recruitment and retention of patients and practices, and some leaders of hospital-associated ACOs reported misaligned incentives.

Meaning   Findings of this study suggest that policymakers may wish to consider the shifting strategies and challenges of ACO leaders as they reform the program.

Importance   The Medicare Shared Savings Program (MSSP) includes more than 400 accountable care organizations (ACOs) and is among the largest and longest running value-based payment efforts in the US. However, given recent program reforms and other changes in the health care system, the experiences and perspectives of ACO leaders remain incompletely characterized.

Objective   To understand the priorities, strategies, and challenges of ACO leaders in MSSP.

Design, Setting, and Participants   In this qualitative study, interviews were conducted with leaders of 49 ACOs of differing sizes, leadership structures, and geographies from MSSP between September 29 and December 29, 2022. Participants were asked about their clinical and care management efforts; how they engaged frontline clinicians; the process by which they distributed shared savings and added or removed practices; and other factors that they believed influenced their success or failure in the program.

Main Outcomes and Measures   Leader perspectives on major themes related to ACO initiatives, performance improvement, and the recruitment, engagement, and retention of clinicians.

Results   Of the 49 ACOs interviewed, 34 were hospital-associated ACOs (69%), 35 were medium or large (>10 000 attributed beneficiaries) (71%), and 17 were rural (35%). The ACOs had a mean (SD) tenure of 8.1 (2.1) years in MSSP. Five major themes emerged: (1) ACO leaders reported a focus on annual wellness visits, coding practices, and care transitions; (2) leaders used both relationship-based and metrics-based strategies to promote clinician engagement; (3) ACOs generally distributed half or more of shared savings to participating practices; (4) ACO recruitment and retention efforts were increasingly influenced by market competition; and (5) some hospital-associated ACOs faced misaligned incentives.

Conclusions and Relevance   In this study, the ACO leaders reported varied approaches to promoting clinician alignment with ACO goals, an emphasis on increasing annual wellness visits, and new pressures related to growth of other care models. Policymakers hoping to modify or expand the program may wish to incorporate these perspectives into future reforms.

Accountable care organizations (ACOs)—groups of clinicians and health care organizations that are financially responsible for the quality and costs of attributed patients—were first proposed in 2006 in response to a recognition that traditional Medicare payment did little to promote efficient and coordinated care and that previous incentive programs erroneously emphasized measurement at the individual instead of organizational level. 1 Policymakers incorporated the concept into delivery system reforms of the Affordable Care Act, and hundreds of organizations have since participated in ACO models, the largest of which—the Medicare Shared Savings Program (MSSP)—has been in continuous operation for more than a decade. In 2022, approximately 11 million patients, or roughly 1 in 6 Medicare beneficiaries (and 1 in 3 of those in the fee-for-service program), were attributed to ACOs. 2

Different ACO models and tracks have allowed organizations to assume varying levels of financial risk. In MSSP, an organization’s savings or losses are determined by comparing its annual costs relative to its own historical spending and since 2017 to regional spending benchmarks. Research suggests that MSSP has led to modest improvements in quality and spending for Medicare beneficiaries, 3 - 6 but observers have also raised concerns about adverse patient selection, inadequate risk adjustment, and perverse benchmarking incentives. 7 - 9

Prior survey-based and qualitative research, generally using data collected prior to 2018, has found that ACOs had introduced care plans to manage conditions in patients with medical complexity and engaged external management partners, 10 , 11 and that ACOs were more likely than non-ACO organizations to use home visits and to provide clinician-level feedback to improve performance. 12 , 13 In recent years, however, policymakers have introduced a number of changes to MSSP, and the current priorities, strategies, and challenges of ACO leaders remain incompletely characterized, especially in light of widespread changes in the US health care system, such as intensifying consolidation, growth of the Medicare Advantage program, and the COVID-19 pandemic. In this qualitative study, we aimed to understand how ACO leaders respond to the incentives of MSSP—a program that has matured into one of Medicare’s most prominent value-based payment efforts. Using in-depth semistructured interviews with a broad set of organizations, we examined the initiatives that ACO leaders prioritize to try to succeed in MSSP, their approach to clinician engagement and performance improvement, and the strategies they use to recruit and retain clinicians and practices.

We identified organizations that participated in MSSP using the 2022 Medicare Shared Savings Program ACO participant list. 14 Because recruitment of organizations was conducted partly for a separate study on health care disparities, ACOs were eligible to be interviewed if at least 5% of their attributed beneficiaries were Black or dually eligible for Medicare and Medicaid, as determined by the Centers for Medicare & Medicaid Services (CMS) 2021 ACO Performance Year Financial and Quality Results file. 15 To ensure adequate experience with the ACO program, we required organizations to have participated in MSSP for 4 or more years. These criteria resulted in a list of 229 eligible ACOs of the 483 organizations that participated in MSSP in 2022.

Similar to prior studies, we classified ACOs as “hospital-associated” if they included a hospital; otherwise, they were considered “physician-group” ACOs. 6 We defined an ACO as rural if at least 25% of counties occupied by its practices were located in nonmetropolitan areas, as indicated by rural-urban commuting area codes. 16 According to program rules, MSSP ACOs are required to have at least 5000 attributed beneficiaries, but no official definitions exist to categorize ACOs by size. In this study, we defined ACOs with fewer than 10 000 beneficiaries as small and those with 10 000 or more beneficiaries were considered medium or large.

We invited leaders of all 229 eligible ACOs to participate in the study by email (eAppendix 1 in Supplement 1 ). These individuals were sent 2 follow-up emails and received 2 follow-up phone calls if they did not respond to the initial invitation. If an ACO leader agreed to participate, they received a screening questionnaire to confirm how long the ACO had participated in MSSP, whether it included a hospital, and how many attributed beneficiaries it had in 2022.

In total, 49 ACOs agreed to participate. Between September 29 and December 29, 2022, 1 to 2 faculty members (D.K., W.L.S., L.P.C., or A.M.B.) conducted a 45-minute semistructured audio or video interview with 1 or more ACO leaders. Some leaders preferred to have other members of their team present; in these cases, interviews included 2 to 4 ACO participants. Interviews were conducted with individuals who held senior positions within ACOs, such as executive director or chief medical officer. These individuals did not receive compensation in exchange for being interviewed. Some participants preferred not to be taped. To ensure consistency across the interviews and to encourage interviewees to speak candidly, interviews were not recorded. Instead, an experienced research assistant (R.P. or S.C.) took detailed near-verbatim notes.

Because the study met exemption requirements, the Institutional Review Board at Weill Cornell Medicine waived review and informed consent. The study’s findings are presented in accordance with the Standards for Reporting Qualitative Research ( SRQR ) reporting guideline.

The interview protocol (eAppendix 2 in Supplement 1 ) was developed through pilot interviews with ACO leaders and experts, as well as literature review of Medicare value-based payment programs. In addition to some specific questions about socially vulnerable patients for a separate study, the protocol included open-ended questions about the ACO key clinical and care management initiatives; how leadership decisions and strategies are communicated to clinicians; how shared savings are distributed; the process by which medical groups are added or removed; and other factors that leaders believe affect the likelihood of success or failure in the program.

The research team analyzed detailed notes taken by research assistants during the interviews. Major themes were identified using a framework analysis. 17 Three research team members (D.K., R.P., and S.C.) began by inductively coding 10 interview notes. During this process, the researchers familiarized themselves with the interview notes, assigned labels to phrases or sentences that were striking, relevant, or repeated across multiple interviews, and then grouped related labels into broader categories of codes. This list of codes was then discussed with the entire research group, including a senior researcher with extensive qualitative research experience (L.P.C.), to develop a working analytic framework. The codes were iteratively refined as more interview notes were coded, and any differences of opinion among research team members were resolved through discussion, leading to consensus and a final set of codes. Finally, D.K. used this list to deductively code all interview notes using qualitative analysis software (ATLAS.ti, version 8.4.5; ATLAS.ti Scientific Software Development, GmBH), resulting in a final set of themes.

Of the 49 ACOs interviewed, 34 were hospital-associated (69%), 35 were medium or large (71%), and 17 were rural (35%); ACOs had a mean (SD) tenure of 8.1 (2.1) years in MSSP ( Table 1 ). Participating ACOs had similar characteristics compared with nonparticipants (eTable in Supplement 1 ). Qualitative analysis of the interviews identified 5 major themes; these are presented in Table 2 along with representative quotations.

ACOs engage in numerous clinical and care management activities, but many leaders reported recent efforts focused in 3 key domains: increasing provision of annual wellness visits; ensuring that patients' medical complexity was captured by rigorous coding efforts; and improving transitions of care, with a focus on postacute care. Increasing annual wellness visits was a major focus at many ACOs, with 1 respondent saying, “We’ve come to realize that Medicare wellness visits drive almost everything in terms of quality and cost.” Leaders described these visits as an opportunity to engage patients, to identify their needs, and to provide evidence-based preventive care.

Second, many ACO leaders reported that they had undertaken efforts to enhance coding practices to capture the clinical complexity of their organization’s attributed patients. This focus may have been accelerated by changes to MSSP financial benchmarking, including the introduction of regional benchmarking in 2017, through which an ACO’s per-beneficiary costs are compared with costs for other Medicare beneficiaries in the area. One leader said that coding has become “an arms race across the industry.” Prior research suggests that organizations that care for more socially disadvantaged populations exited MSSP at higher rates after the implementation of regional benchmarking, possibly because they were not able to fully capture the medical and social complexity of patients. 18

A third major initiative centered on care transitions. Many ACO leaders reported investing heavily in care management programs that aim to improve the flow of patients across care settings through medication reconciliation efforts, posthospitalization phone calls, and early posthospitalization primary care visits. Leaders noted a special focus on managing postacute care—an area in which research has shown large practice variation—with many working closely with physicians to ensure that patients are referred to high-quality subacute rehabilitation and skilled nursing facilities. 19

ACO leaders used both relationship-based and metrics-based strategies to promote clinician alignment with ACO goals. Many ACOs implemented dashboards for clinicians to view their performance on quality and cost measures; in some cases, these were unblinded to allow for peer comparisons. However, leaders reported that the extent to which clinicians choose to visit these dashboards—and to modify their behavior in response—remains variable.

In addition, ACO leaders emphasized the importance of personal relationships when it came to engaging clinicians in programmatic efforts. At some organizations, leaders regularly visited practices and met with clinicians to discuss the rationale for new initiatives and to jointly develop care delivery strategies. Although ACOs of all sizes reported relationship-based quality improvement efforts, the approach was most often emphasized by leaders of small ACOs. The leader of one small ACO indicated that the organization does not struggle with clinician engagement because “I personally visit every practice. I’m not some faceless bureaucrat.”

ACO leaders described a range of approaches to distribute savings when their organization met the minimum savings threshold, based on a combination of patient attribution, clinician engagement, and quality performance. Most leaders reported distributing at least 50% of savings to participating practices—often more in markets in which organizations faced greater competition for recruitment and retention. Most ACOs distributed savings to practices, not individuals, recognizing that many clinicians contribute to the care of a given patient. “We don’t want to do it at the physician-level or they’ll start playing ‘not it’ with challenging patients,” one leader said. Many leaders reported that payments were based on the number of attributed patients, although some reported trying to link payments to quality performance and clinician engagement. In general, practices could use savings as they saw fit; ACO leaders offered examples such as investing in new medical equipment, making bonus payments, and arranging staff appreciation events.

ACOs’ recruitment and retention efforts of practices and patients were increasingly influenced by market competition resulting from health system consolidation and large medical groups, as well as the growth of the Medicare Advantage program. Some leaders reported difficulty maintaining interest and participation in MSSP, given the increasing numbers of patients and clinicians engaging in other forms of care. For example, between 2012 and 2022, the proportion of beneficiaries enrolled in Medicare Advantage plans relative to traditional Medicare nearly doubled, from 29% to 50%. 20 At the same time, health system consolidation and private equity acquisition of physician practices have grown substantially, disrupting existing care patterns and networks. 21 - 25

One leader said, “We are desperate to stay alive, so we will take anyone who is willing to be engaged.” Another noted difficulty retaining sufficient numbers of Medicare fee-for-service patients in the ACO, stating “Medicare Advantage has whittled away our numbers tremendously.” In general, leaders noted that practices were more likely to choose to leave the ACO than to be removed; some reported that practices were disaffiliated if they were minimally engaged with the ACO’s efforts or if they demonstrated consistently poor performance.

Several leaders said that a helpful recruiting tactic was contrasting ACO participation with the Merit-based Incentive Payment System (MIPS), which imposes administrative burdens on practices, often with minimal rewards. 26 , 27 One leader reported that, “in exchange for listening to our ACO spiel, we tell the [physicians] we’re giving them a ‘get-out-of-MIPS-free card.’”

Leaders of hospital-associated ACOs held mixed views of whether hospitals help or hinder the ACO’s objectives, but many reported misaligned incentives. One leader said, “Nobody fights you on improving quality, but it’s hard to get alignment on reducing utilization.” Another reported that such alignment was possible, but primarily as a way to change the hospital system’s payer mix: “The hospitals are happy when Medicare patients are kept out of the hospital because they can fill their beds with commercial patients that generate more revenue.”

Other leaders, however, reported the inclusion of a hospital in the ACO could be an advantage. Hospitals often have more resources than medical groups to invest in quality-improvement processes, and integration with hospitals can aid in smoothing care transitions before and after hospitalization. One leader indicated that the ACO’s ability to communicate with inpatient care management teams was helpful, saying “It doesn’t mean that we get everything we want, but it is a lot easier than if we were just community-based [physicians] saying, “Hey, stop sending our patients to that [skilled nursing facility] with really poor quality!”

In interviews with 49 ACOs of varying sizes and structures across the US, we identified 5 major themes about the initiatives, challenges, and engagement strategies of ACOs participating in MSSP in 2022. Many leaders reported a growing focus on activities such as increasing annual wellness visits, enhancing coding practices, and improving transitions in care. Leaders described the use of quality dashboards and interpersonal relationships to engage clinicians in ACO programming, and most organizations distributed at least 50% of their shared savings to participants, usually at the practice level. In recent years, growing Medicare Advantage penetration, as well as private equity– and health system–based consolidation, presented difficulties for some ACOs in recruiting clinicians and retaining patients. Leaders of hospital-associated ACOs reported additional challenges related to conflicting incentives for reducing acute care utilization.

Our results suggest that greater research and policy attention is warranted in several areas. For example, most ACOs distributed shared savings at the practice level, not the individual clinician level, and future research could examine the outcomes of various distribution strategies with regard to clinician engagement and the quality of care at ACOs. In addition, our findings renew questions about whether aggressive coding practices, pursued by some ACOs, are an effort to heighten the risk profile of their attributed beneficiaries to secure favorable benchmarks and extract greater savings, as opposed to improving care quality or patient outcomes. Lawmakers have expressed ongoing concerns about the potential for upcoding in new ACO programs. 28

Researchers should also continue to study the benefits and drawbacks of annual wellness visits for Medicare beneficiaries, which have increased substantially over time. 29 , 30 Although some work suggests that these visits are associated with greater use of preventive services, 31 - 33 they may also increase receipt of low-value care and their long-term implications remain uncertain. 34 - 37 The Medicare Payment Advisory Commission (MedPAC) has raised concerns that wellness visits may allow for favorable selection in ACOs, especially those with retrospective patient attribution; a recent report found that Medicare beneficiaries in ACOs were more likely to receive these visits compared with non-ACO beneficiaries, and that ACOs provided a disproportionate share of the visits in the last quarter of the year, possibly in an effort to assign beneficiaries with low spending relative to claims-based risk scores. 9 To mitigate this concern, MedPAC has recommended that all ACOs be required to adopt prospective beneficiary assignment.

Although MSSP remains a major value-based payment program in the US, Medicare now offers many options for clinicians to engage in value-based payment, and the Medicare Advantage program has grown substantially in the past decade. Some leaders reported that these and other trends have introduced difficulties in maintaining participation and engagement in MSSP. The implications of this shift are unclear: a decade after the implementation of ACOs, evidence of their effectiveness remains mixed relative to both traditional fee-for-service payment and the Medicare Advantage program. 38 , 39 More research is needed to evaluate outcomes for patients attributed to ACOs vs those in other value-based payment programs, and CMS may also want to devote greater attention to facilitating multipayer ACO models. 40 - 42

Early quantitative research found that physician-group ACOs were more likely to produce shared savings than hospital-associated ACOs, possibly because the latter face conflicting incentives when it comes to reducing acute care utilization; our study’s findings are consistent with this work. 6 While there may be advantages for hospital participation (eg, greater capitalization, resources, and communication across care settings), leaders of hospital-associated ACOs described difficulties deploying programs that would reduce inpatient utilization. Some reported focusing instead on producing savings from postacute care and other types of care.

To our knowledge, no large-scale peer-reviewed qualitative study focused on MSSP ACO leadership, operations, and recruitment has been published in at least 5 years. Prior qualitative work on ACOs tended to focus on specific aspects of care, such as care coordination, home-based care, preventive services, and management of serious illnesses. 12 , 43 - 45 A qualitative study on the first 18 months of the ACO program found that, at the time, leaders concentrated on transforming primary care and reducing avoidable emergency department use, and that “few ACOs were focused on any strategies around nursing homes or postacute care, such as improving care transitions between hospitals and postacute care facilities.” 43 Our study suggests that, over the past decade, the latter has evolved into a primary concern for ACO leaders, and this finding is consistent with quantitative work showing that changes in postacute utilization account for a relatively large portion of the savings generated by ACOs. 46 , 47

A strength of this study is that it included a large number of interviews with ACO leaders. Although surveys can include an even larger and possibly more representative sample of ACO leaders, interviews can elicit more nuanced responses from ACO leaders and can discover perspectives not foreseen when creating a survey (or interview) protocol. However, this study also has limitations. First, we could not determine whether the reports of ACO leaders were associated with objective improvements in care; future work should aim to link qualitative and quantitative analyses to understand which aspects of ACO operations, culture, and leadership are connected to better quality or lower costs. Second, it is possible that interviewees selectively presented favorable parts of their work and that a different set of questions, such as those focused on program failures, might have resulted in a different range of responses. This concern may be somewhat mitigated because participants were assured that their responses would be anonymized and aggregated. Third, the interview protocol included a focus on care for socially vulnerable patients for a separate study; however, the interviews also included a broad set of questions regarding global ACO management and care delivery, and participants were provided ample opportunity to discuss these areas. Fourth, although this study included leaders from a broad range of ACOs and is among the largest of its kind, the perspectives of these individuals may not generalize to other organizations, especially newer ACOs and those that care for very few low-income individuals or members of racial and ethnic minority groups.

In this study of 49 ACOs of varying sizes and structures across the US, 5 major themes about the initiatives, challenges, and engagement strategies of ACOs participating in MSSP in 2022 were identified. Accountable care organizations maintain bipartisan consensus and Congress appears committed to continuing the model, which is the only Medicare value-based payment program authorized by statute. As CMS continues to refine the ACO program and introduce new opportunities for clinicians and health care organizations to engage in value-based payment, it may benefit from an understanding of the priorities, strategies, and challenges of ACO leaders, as well as how the incentives embedded in national policy manifest on the front lines of care delivery.

Accepted for Publication: January 21, 2024.

Published: March 15, 2024. doi:10.1001/jamahealthforum.2024.0126

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Khullar D et al. JAMA Health Forum .

Corresponding Author: Amelia M. Bond, PhD, Dept of Population Health Sciences, Weill Cornell Medical College, 402 E 67th St, New York, NY 10065 ( [email protected] ).

Author Contributions: Dr Khullar and Mr Carter had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Khullar, Schpero, Casalino, Carter, Bond.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Khullar.

Critical review of the manuscript for important intellectual content: Khullar, Schpero, Casalino, Pierre, Carter, Civelek, Zhang, Bond.

Statistical analysis: Schpero, Civelek, Zhang.

Obtained funding: Khullar, Casalino, Bond.

Administrative, technical, or material support: Pierre, Carter, Bond.

Supervision: Khullar, Bond.

Conflict of Interest Disclosures: Dr Khullar reported receiving grants from Arnold Ventures and Physicians Foundation during the conduct of the study; grants from the National Institutes of Health and the Agency for Healthcare Research and Quality (AHRQ) outside the submitted work. Dr Schpero reported receiving grants from Arnold Ventures and the Physicians Foundation during the conduct of the study; grants from the AHRQ, Arnold Ventures, the Commonwealth Fund, Flatiron, the Milbank Memorial Fund, the National Institute on Aging, the National Institute on Minority Health and Health Disparities, the Patient-Centered Outcomes Research Institute, the Physicians Foundation, and the Robert Wood Johnson Foundation outside the submitted work. Dr Bond reported receiving grants from Arnold Ventures and The Physicians Foundation Center for the Study of Physician Practice and Leadership during the conduct of the study; grants from AHRQ, grants from Commonwealth Fund, and grants from Defense Health Agency outside the submitted work. No other disclosures were reported.

Funding/Support: This work was supported by Arnold Ventures and The Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2 .

Case Study Research Method in Psychology

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

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

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

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

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

On This Page:

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

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

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

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

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

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

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

 Famous Case Studies

• Anna O – One of the most famous case studies, documenting psychoanalyst Josef Breuer’s treatment of “Anna O” (real name Bertha Pappenheim) for hysteria in the late 1800s using early psychoanalytic theory.
• Little Hans – A child psychoanalysis case study published by Sigmund Freud in 1909 analyzing his five-year-old patient Herbert Graf’s house phobia as related to the Oedipus complex.
• Bruce/Brenda – Gender identity case of the boy (Bruce) whose botched circumcision led psychologist John Money to advise gender reassignment and raise him as a girl (Brenda) in the 1960s.
• Genie Wiley – Linguistics/psychological development case of the victim of extreme isolation abuse who was studied in 1970s California for effects of early language deprivation on acquiring speech later in life.
• Phineas Gage – One of the most famous neuropsychology case studies analyzes personality changes in railroad worker Phineas Gage after an 1848 brain injury involving a tamping iron piercing his skull.

Clinical Case Studies

• Studying the effectiveness of psychotherapy approaches with an individual patient
• Assessing and treating mental illnesses like depression, anxiety disorders, PTSD
• Neuropsychological cases investigating brain injuries or disorders

Child Psychology Case Studies

• Studying psychological development from birth through adolescence
• Cases of learning disabilities, autism spectrum disorders, ADHD
• Effects of trauma, abuse, deprivation on development

Types of Case Studies

• Explanatory case studies : Used to explore causation in order to find underlying principles. Helpful for doing qualitative analysis to explain presumed causal links.
• Exploratory case studies : Used to explore situations where an intervention being evaluated has no clear set of outcomes. It helps define questions and hypotheses for future research.
• Descriptive case studies : Describe an intervention or phenomenon and the real-life context in which it occurred. It is helpful for illustrating certain topics within an evaluation.
• Multiple-case studies : Used to explore differences between cases and replicate findings across cases. Helpful for comparing and contrasting specific cases.
• Intrinsic : Used to gain a better understanding of a particular case. Helpful for capturing the complexity of a single case.
• Collective : Used to explore a general phenomenon using multiple case studies. Helpful for jointly studying a group of cases in order to inquire into the phenomenon.

Where Do You Find Data for a Case Study?

There are several places to find data for a case study. The key is to gather data from multiple sources to get a complete picture of the case and corroborate facts or findings through triangulation of evidence. Most of this information is likely qualitative (i.e., verbal description rather than measurement), but the psychologist might also collect numerical data.

1. Primary sources

• Interviews – Interviewing key people related to the case to get their perspectives and insights. The interview is an extremely effective procedure for obtaining information about an individual, and it may be used to collect comments from the person’s friends, parents, employer, workmates, and others who have a good knowledge of the person, as well as to obtain facts from the person him or herself.
• Observations – Observing behaviors, interactions, processes, etc., related to the case as they unfold in real-time.
• Documents & Records – Reviewing private documents, diaries, public records, correspondence, meeting minutes, etc., relevant to the case.

2. Secondary sources

• News/Media – News coverage of events related to the case study.
• Academic articles – Journal articles, dissertations etc. that discuss the case.
• Government reports – Official data and records related to the case context.
• Books/films – Books, documentaries or films discussing the case.

3. Archival records

Searching historical archives, museum collections and databases to find relevant documents, visual/audio records related to the case history and context.

Public archives like newspapers, organizational records, photographic collections could all include potentially relevant pieces of information to shed light on attitudes, cultural perspectives, common practices and historical contexts related to psychology.

4. Organizational records

Organizational records offer the advantage of often having large datasets collected over time that can reveal or confirm psychological insights.

Of course, privacy and ethical concerns regarding confidential data must be navigated carefully.

However, with proper protocols, organizational records can provide invaluable context and empirical depth to qualitative case studies exploring the intersection of psychology and organizations.

• Organizational/industrial psychology research : Organizational records like employee surveys, turnover/retention data, policies, incident reports etc. may provide insight into topics like job satisfaction, workplace culture and dynamics, leadership issues, employee behaviors etc.
• Clinical psychology : Therapists/hospitals may grant access to anonymized medical records to study aspects like assessments, diagnoses, treatment plans etc. This could shed light on clinical practices.
• School psychology : Studies could utilize anonymized student records like test scores, grades, disciplinary issues, and counseling referrals to study child development, learning barriers, effectiveness of support programs, and more.

How do I Write a Case Study in Psychology?

Follow specified case study guidelines provided by a journal or your psychology tutor. General components of clinical case studies include: background, symptoms, assessments, diagnosis, treatment, and outcomes. Interpreting the information means the researcher decides what to include or leave out. A good case study should always clarify which information is the factual description and which is an inference or the researcher’s opinion.

1. Introduction

• Provide background on the case context and why it is of interest, presenting background information like demographics, relevant history, and presenting problem.
• Compare briefly to similar published cases if applicable. Clearly state the focus/importance of the case.

2. Case Presentation

• Describe the presenting problem in detail, including symptoms, duration,and impact on daily life.
• Include client demographics like age and gender, information about social relationships, and mental health history.
• Describe all physical, emotional, and/or sensory symptoms reported by the client.
• Use patient quotes to describe the initial complaint verbatim. Follow with full-sentence summaries of relevant history details gathered, including key components that led to a working diagnosis.
• Summarize clinical exam results, namely orthopedic/neurological tests, imaging, lab tests, etc. Note actual results rather than subjective conclusions. Provide images if clearly reproducible/anonymized.
• Clearly state the working diagnosis or clinical impression before transitioning to management.

3. Management and Outcome

• Indicate the total duration of care and number of treatments given over what timeframe. Use specific names/descriptions for any therapies/interventions applied.
• Present the results of the intervention,including any quantitative or qualitative data collected.
• For outcomes, utilize visual analog scales for pain, medication usage logs, etc., if possible. Include patient self-reports of improvement/worsening of symptoms. Note the reason for discharge/end of care.

4. Discussion

• Analyze the case, exploring contributing factors, limitations of the study, and connections to existing research.
• Analyze the effectiveness of the intervention,considering factors like participant adherence, limitations of the study, and potential alternative explanations for the results.
• Identify any questions raised in the case analysis and relate insights to established theories and current research if applicable. Avoid definitive claims about physiological explanations.
• Offer clinical implications, and suggest future research directions.

5. Additional Items

• Thank specific assistants for writing support only. No patient acknowledgments.
• References should directly support any key claims or quotes included.
• Use tables/figures/images only if substantially informative. Include permissions and legends/explanatory notes.
• Provides detailed (rich qualitative) information.
• Provides insight for further research.
• Permitting investigation of otherwise impractical (or unethical) situations.

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

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

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

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

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

Limitations

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

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

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

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

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

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

Breuer, J., & Freud, S. (1895).  Studies on hysteria . Standard Edition 2: London.

Curtiss, S. (1981). Genie: The case of a modern wild child .

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

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

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

Harlow J. M. (1848). Passage of an iron rod through the head.  Boston Medical and Surgical Journal, 39 , 389–393.

Harlow, J. M. (1868).  Recovery from the Passage of an Iron Bar through the Head .  Publications of the Massachusetts Medical Society. 2  (3), 327-347.

Money, J., & Ehrhardt, A. A. (1972).  Man & Woman, Boy & Girl : The Differentiation and Dimorphism of Gender Identity from Conception to Maturity. Baltimore, Maryland: Johns Hopkins University Press.

Money, J., & Tucker, P. (1975). Sexual signatures: On being a man or a woman.

Further Information

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

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• Open access
• Published: 29 May 2024

The implementation of person-centred plans in the community-care sector: a qualitative study of organizations in Ontario, Canada

• Samina Idrees 1 ,
• Gillian Young 1 ,
• Brian Dunne 2 ,
• Donnie Antony 2 ,
• Leslie Meredith 1 &
• Maria Mathews 1  

BMC Health Services Research volume  24 , Article number:  680 ( 2024 ) Cite this article

Metrics details

Person-centred planning refers to a model of care in which programs and services are developed in collaboration with persons receiving care (i.e., persons-supported) and tailored to their unique needs and goals. In recent decades, governments around the world have enacted policies requiring community-care agencies to adopt an individualized or person-centred approach to service delivery. Although regional mandates provide a framework for directing care, it is unclear how this guidance is implemented in practice given the diversity and range of organizations within the sector. This study aims to address a gap in the literature by describing how person-centred care plans are implemented in community-care organizations.

We conducted semi-structured interviews with administrators from community-care organizations in Ontario, Canada. We asked participants about their organization’s approach to developing and updating person-centred care plans, including relevant supports and barriers. We analyzed the data thematically using a pragmatic, qualitative, descriptive approach.

We interviewed administrators from 12 community-care organizations. We identified three overarching categories or processes related to organizational characteristics and person-centred planning: (1) organizational context, (2) organizational culture, and (3) the design and delivery of person-centred care plans. The context of care and the types of services offered by the organization were directly informed by the needs and characteristics of the population served. The culture of the organization (e.g., their values, attitudes and beliefs surrounding persons-supported) was a key influence in the development and implementation of person-centred care plans. Participants described the person-centred planning process as being iterative and collaborative, involving initial and continued consultations with persons-supported and their close family and friends, while also citing implementation challenges in cases where persons had difficulty communicating, and in cases where they preferred not to have a formal plan in place.

Conclusions

The person-centred planning process is largely informed by organizational context and culture. There are ongoing challenges in the implementation of person-centred care plans, highlighting a gap between policy and practice and suggesting a need for comprehensive guidance and enhanced adaptability in current regulations. Policymakers, administrators, and service providers can leverage these insights to refine policies, advocating for inclusive, flexible approaches that better align with diverse community needs.

Peer Review reports

The community-care sector facilitates the coordination and administration of in-home and community-based health and social services. Community-care services include supports for independent living, residential services, complex medical care, and community-participation services to support personal and professional goals (e.g., education, employment, and recreation-based supports) [ 1 ]. There is substantial heterogeneity in the clinical and demographic characteristics of the community-care population, including individuals with physical and developmental disabilities, and complex medical needs [ 2 ]. We refer to the individuals served by these organizations as ‘persons-supported’ in line with person-first language conventions [ 3 , 4 ].

In recent decades, governments across the world have enacted policies requiring community-care agencies to adopt an individualized or person-centred approach to service delivery [ 5 , 6 , 7 , 8 ]. Person-centred care encompasses a broad framework designed to direct care delivery, as opposed to a singular standardized process. In the context of community-care, person-centred planning refers to a model of care provision in which programs and services are developed in collaboration with persons-supported and tailored to their unique needs and desired outcomes [ 9 , 10 ].

In Ontario, Canada, community-care services are funded by the Ministry of Health (MOH) and the Ministry of Children, Community and Social Services (MCCSS). Service agreements between these ministries and individual agencies can be complex and contingent on different factors including compliance with a number of regulatory items and policies [ 7 , 11 ]. MOH provides funding for health-based services including in-home physiotherapy, respiratory therapy, and personal support services, among several others. MOH funds Home and Community Care Support Services (HCCSS), a network of organizations responsible for coordinating the delivery of in-home and community-based care in the province. MCCSS funds social service agencies including those providing community participation and residential support for people with intellectual and developmental disabilities (IDDs).

Several tools and resources have been developed to aid organizations in providing person-centred care and organizations may differ in their use of these tools and their specific approach. Although regional mandates provide a framework for directing care delivery, it is unclear how this guidance is implemented in practice given the diversity and range of organizations within the sector. In addition, as noted by a recent scoping review, there is limited literature on the implementation process and impact of person-centred planning on individual outcomes [ 12 ]. Using a pragmatic, qualitative, descriptive approach [ 13 ], we outline how community-care organizations enact a person-centred approach to care and the factors that shape their enactment. By describing existing practices in the context of the community-care sector, we aim to provide insight on how to optimize care delivery to improve outcomes and inform current policy. This study is part of a larger, multi-methods project examining the implementation of person-centred care plans in the community-care sector. This project encompasses qualitative interviews with representatives from different community-care organizations, as well as staff and persons-supported at a partner community-care organization. This paper focuses on analyzing data from interviews with representatives from different community-care organizations.

We conducted semi-structured interviews with administrators from community-care organizations in Southwestern Ontario (roughly the Ontario Health West Region) between October 2022 and January 2023. We included community-care organizations funded by MOH or MCCSS. We excluded organizations that did not provide services in Southwestern Ontario. We identified eligible organizations and participants by searching online databases, including community resource lists, as well as through consultation with members of the research team.

We used maximum variation sampling [ 14 ], to recruit participants from organizations with a wide range of characteristics including location (i.e., urban, rural), organization type (i.e., for-profit, not-for-profit), and types of services provided (e.g., residential, recreation, transportation, etc.) We contacted eligible organizations via email, providing them with study information and inviting them to participate. We recruited until the data reached saturation, defined as the point at which there was sufficient data to enable rigorous analysis [ 14 , 15 ].

In each interview, we asked participants about their organization’s approach to developing and updating individual service agreements or person-centred care plans, and the supports and barriers (e.g., organizational, funding, staffing, etc.) that facilitate or hinder the implementation of these plans (Supplementary Material 1 : Interview Guide). We also collected information on relevant participant and organizational characteristics, including participant gender, position, years of experience, organization location, type (i.e., for-profit, not-for-profit), services offered, years in operation, and client load. The interviews were approximately one hour in length and conducted virtually via Zoom (Zoom Video Communications Inc.) or by telephone. The interviews were audio-recorded and transcribed verbatim. Interviewer field notes were also used in data analysis.

We analyzed the data thematically [ 16 ]. The coding process followed a collaborative and multi-step approach. Initially, three members of the research team independently reviewed and coded a selection of transcripts to identify key ideas and patterns in the data, and form a preliminary coding template. We then met to consolidate individual coding efforts. We compared coding of each transcript, resolving conflicts through discussion and consensus. In coding subsequent transcripts and through a series of meetings, we worked together to finalize the codebook to reflect more analytic codes. We used the finalized template to code all interview transcripts in NVivo (QSR International), a software designed to facilitate qualitative data analysis. We refined the codebook on an as-needed basis by incorporating novel insights gleaned from the coding of additional transcripts, reflecting the iterative nature of the analysis.

We increased the robustness of our methodology by pre-testing interview questions, documenting interview and transcription protocols, using experienced interviewers, and confirming meaning with participants in interviews [ 14 , 15 , 16 ]. We kept detailed records of interviews, field notes, and drafts of the coding template. We made efforts to identify negative cases and provided rich descriptions and illustrative quotes [ 17 ]. We included individuals directly involved in the administration of community-care services on our research team. These individuals provided important context and feedback at each stage of the research process.

This study was approved by the research ethics board at Western University. We obtained informed consent from participants prior to the onset of interviews. We maintained confidentiality through secure storage of interview data (e.g., audio recordings), password-protection of sensitive documents, and the de-identification of transcripts.

Positionality

The authors represent a multidisciplinary team of researchers, clinicians, and community-care leaders. The community-care leaders and clinicians on our team provided key practical expertise to inform the development of interview questions and the analysis of study findings.

We interviewed administrators across 12 community-care organizations in Southwestern Ontario. The sample included representatives from seven organizations that received funding from MCCSS, three organizations that received funding from MOH, and two organizations that received funding from both MCCSS and MOH (Table  1 ). Eleven organizations were not-for-profit, one was a for-profit agency. The organizations provided care in rural ( n =  3), urban ( n =  4), or both rural and urban populations ( n =  5). Seven of the 12 participants were women, nine had been working with their organization for more than 11 years, and all had been working in the community-care sector for more than 12 years (Table  2 ).

We identified three key categories or processes relating to organizational characteristics and their impact on the design and delivery of person-centred care plans: (1) organizational context, (2) organizational culture, and (3) the development and implementation of person-centred care plans.

Organizational context

Organizational context refers to the characteristics of persons-supported, and the nature of services provided. Organizational context accounts for the considerable heterogeneity across organizations in the community-care sector and their approach to person-centred care plans.

Populations served

The majority of organizations included in the study supported individuals with IDDs: “all of the people have been identified as having a developmental disability. That’s part of the eligibility criteria for any funded developmental service in Ontario.” [P10]. Participants described how eligibility was ascertained through the referral process: “ the DSO [Developmental Services Ontario] figures all of that out and then refers them to us .” [P08]. These descriptions highlighted a common access point for publicly-funded adult developmental services in the province. Accordingly, these organizations were primarily funded by MCCSS. Other organizations focused on medically complex individuals including those with acquired brain injuries or those unable to access out-patient services due to physical disabilities: “the typical reason for referral is going to be around a physical impairment… But, with this medically complex population, you’re often seeing comorbidities where there may be some cognitive impairment, early dementia.” [P04]. In these organizations, eligibility and referral were usually coordinated by HCCSS. These insights highlighted the diverse characteristics of community-care populations, emphasizing the need to consider both physical and cognitive health challenges in care provision approaches.

Services offered

The characteristics of persons-supported informed the context of care and the type of services offered by the organization. The different dimensions of services offered within this sector include social and medical care, short and long-term care provision, in-home and community-care, and full and part-time care.

Nature of care: social vs. medical

Many organizations serving individuals with IDDs employed a holistic, psychosocial model of care, designed to support all areas of an individual’s life including supports for independent-living, and community-based education, employment, and recreation services to support personal and professional goals: “we support people in their homes, so residential supports. We also support people in the community, to be a part of the community, participate in the community and also to work in the community.” [P06]. These descriptions reflect a comprehensive approach to care, aiming to address needs within and beyond residential settings to promote active participation within the broader community. In contrast, some organizations followed a biomedical model of care, designed to support specific health needs: “We provide all five therapies… physiotherapy, occupational therapy, speech, social work, and nutrition. In some locations we provide visiting nursing, at some locations shift nursing. We have some clinic-nursing… and we provide personal support and home-making services in a number of locations as well.” [P04]. These organizations adopted a more clinically-focused approach to care. In either instance, the care model and the nature of services offered were largely determined by an organization’s mandate including which gaps they aimed to fill within the community. Many organizations described providing a mixture of social and medical care for individuals with complex needs. However, the implementation of care plans could be impacted by the lack of integration between social and medical care sectors, as some participants spoke to the importance of “[integrating] all of the different healthcare sector services… [including] acute care and public health and home and community care and primary care, and mental health and addictions.” [P04].

Duration of care: short-term vs. long-term

The duration of care also varied based on the needs of persons-supported. Organizations serving individuals with IDDs usually offered support across the lifespan: “We support adults with developmental disabilities and we support them from 18 [years] up until the end of their life.” [P06]. Some organizations provided temporary supports aimed at addressing specific health needs: “For therapies – these are all short-term interventions and typically they’re very specific and focused on certain goals. And so, you may get a referral for physiotherapy that is authorized for three visits or five visits” [P04], or crisis situations (e.g., homelessness): “Our services are then brought in to help provide some level of support, guidance, stabilization resource, and once essentially sustainability and positive outcomes are achieved—then our services are immediately withdrawn.” [P12]. One organization employed a model of care with two service streams, an initial rehabilitation stream that was intended to be short-term and an ongoing service stream for individuals requiring continuing support.

In-home vs. community-based care

Many organizations provided in-home care and community-based supports, where residential supports were designed to help individuals lead independent lives, and community-based supports encouraged participation in community activities to further inclusion and address personal and professional goals. One participant spoke about the range of services offered in the home and community:

“There’s probably two big categories of [services we offer]: community support services—so that includes things like adult day programs, assisted living, meals on wheels, transportation, friendly visiting … and things like blood pressure clinics, exercise programs… and then on the other side we do home care services. In the home care basket, we provide personal support, and we also provide social work support.” [P05].

Likewise, another participant spoke in further detail on the types of services that allow individuals to live independently within their homes, or in community-based residential settings (e.g., long-term care facilities):

“We provide accommodation supports to about 100 people living in our community—which means that we will provide support to them in their own homes. So, anywhere from an hour a week to 24 hours a day. And that service can include things from personal care to home management to money management, cooking, cleaning, and being out and about in communities—so community participation. We also provide supports for about 50 people living in long-term care facilities and that is all community participation support. So, minus the last 2 and a half years because of the pandemic, what that means is that a person living in a long-term care facility with a developmental disability can have our support to get out and about for 2 or 3 hours a week, on average.” [P10].

Full-time vs. part-time support

The person-supported’s needs also determined whether they would receive care within their homes and if they would be supported on a full-time (i.e., 24 h a day, 7 days a week) or part-time basis:

“ It really does range from that intensive 24- hour/7 day a week support, which we actually do provide that level of intense support in the family home, if that’s needed. And then, all the way through to just occasional advocacy support and phone check-in.” [P01].

Organizational Culture

Organizational culture was described as a key influence in the development and implementation of person-centred care plans. The culture of the organization includes their perceptions, attitudes and beliefs surrounding persons-supported; their model of care provision; as well as their willingness to evolve and adapt service provision to optimize care delivery.

Perceptions, attitudes, and beliefs regarding persons-supported

Participants described their organization’s view of persons-supported, with many organizations adopting an inclusionary framework where persons-supported were afforded the same rights and dignities as others in the community. This organizational philosophy was described as being deeply intertwined with an organization’s approach to personalizing programs and services:

“…an organization needs to be able to listen to the people who are receiving the service… and support them, to learn more, figure out, articulate, whatever it is, the service or the supports that they need in order to get and move forward with their life.” [P10].

The focus on the person-supported, their needs, likes, and dislikes, was echoed across organizations, with an emphasis on the impact of “culture and trying to embed for each person who delivers service the importance of understanding the individual.” [P05]. Participants also described their organization’s approach to allowing persons-supported to take risks, make mistakes, and live life on their own terms:

“You have to go and venture out and take some [risks]… We try to exercise that philosophy - people with disabilities should have the same rights and responsibilities as other people in the community. Whether that’s birthing or education, getting a job, having a house they can be proud of, accessing community supports, whether that be [a] library or community centre, or service club, whatever that is.” [P03].

Model of care provision

The model of care provision was heavily influenced by the organization’s values and philosophy. Several organizations employed a flexible model of care where supports were developed around the needs, preferences, and desired outcomes of the person-supported:

“…if we don’t offer [the program they want], we certainly build it. Honestly, most of our programs were either created or built by someone coming to us [and] saying ‘I want to do this with my life,’ or …‘my son would like to do art.’” [P02].

Although there were similarities in models across the different organizations, one participant noted that flexibility can be limited in the congregate care setting as staff must tend to the needs of a group as opposed to an individual:

“Our typical plan of operation outside of the congregate setting is we design services around the needs of the person. We don’t ask them to fit into what we need, we build services for what they need. Within the congregate care setting, we have a specific set of rules and regulations for safety and well-being of the other people that are here.” [P11].

Evolving service orientation

In organizations serving individuals with IDDs, many described shifting from program-based services to more individualized and community-based supports: “The goal was always to get people involved in their community and build in some of those natural supports … [we] are looking to support people in their own communities based on their individual plans.” [P07]. One participant described this model as a person-directed approach as opposed to person-centred, citing the limitations of program-based services in meeting individual needs:

“[Persons-supported] couldn’t [do] what they wanted because they were part of a bigger group. We would listen to the bigger group, but if one person didn’t want to go bowling … we couldn’t support them because everybody had to go bowling.” [P06].

The focus on individualized support could potentially lead to increased inclusion for persons-supported in their communities:

“… people go to Tim Horton’s, and if they go every day at 9 they probably, eventually will meet other people that go at 9 o’clock and maybe strike up a conversation and get to know somebody and join a table … and meet people in the community.” [P02].

By creating routines centred on individual preferences, the person-supported becomes a part of a community with shared interests and values.

Person-centred care plans

Community-care organizations enacted a person-centred approach by creating person-centred care plans for each person-supported. Although all participants said their organization provided person-centred services, there was considerable variation in the specific processes for developing, implementing, and updating care plans.

Developing a person-centred care plan

The development of a care plan includes assessment, consultation, and prioritization. The initial development of the care plan usually involved an assessment of an individual’s needs and goals. Participants described agency-specific assessment processes that often incorporated information from service referrals: “ In addition to the material we get from the DSO [Disability Services Ontario] we facilitate the delivery of an intake package specifically for our services. And that intake package helps to further understand the nature and needs of an individual.” [P12]. Agency-specific assessment processes differed by the nature of services provided and the characteristics of the population. However, most organizations included assessments of “not only physical functioning capabilities, but also cognitive.” [P01]. Assessment also included an appraisal of the suitability of the organization’s services. In instances where persons-supported were seeking residential placements or independent-living support, organizations assessed their ability to carry out the activities of daily living:

“[Our internal assessment] is an overview of all areas of their life. From, ‘do they need assistance with baking, cooking, groceries, cleaning, laundry? Is there going to be day program opportunities included in that residential request for placement? What the medical needs are?’” [P02].

In contrast, the person-supported’s community-based activities were primarily informed by their interests and desired outcomes: “We talk about what kinds of goals they want to work on. What kind of outcomes we’re looking for…” [P06].

The development of the care plan also included a consultation phase, involving conversations with the person-supported, their family members, and potentially external care providers: “We would use the application information, we’d use the supports intensity scale, but we’d also spend time with the person and their connections, their family and friends, in their home to figure out what are the kinds of things that this person needs assistance with.” [P10]. Participants described the person-supported’s view as taking precedence in these meetings: “We definitely include the family or [alternate] decision-maker in that plan, but the person-supported ultimately has the final stamp of approval.” [P08]. Many participants also acknowledged the difficulty of identifying and incorporating the person-supported’s view in cases where opinions clash and the person-supported has difficulty communicating and/or is non-verbal: “Some of the people we support are very good at expressing what they want. Some people are not. Some of our staff are really strong in expressing what they support. …And some of the family members are very strong. So you have to be very careful that the [person-supported] is not being lost in the middle of it.” [P06].

Participants also noted that some persons-supported preferred not to have a care plan:

“Some of the people say ‘I hate [the plans] I don’t want to do them’…. we look at it in a different way then. We’ll use graphic art, we’ll use video, we’ll think outside the box to get them to somehow—because at the end of the day when we’re audited by MCCSS every [person-supported] either has to have [a plan]… or there has to be [an approval of] why it wasn’t completed.” [P02].

Plan development may also include a prioritization process, particularly in cases where resources are limited. A person-supported’s goals could be prioritized using different schemas. One participant noted that “the support coordinator takes the cue from the person-supported - … what they’ve identified as ‘have to have’ and ‘nice to have’. … because the ‘have to haves’ are prioritized.” [P09]. Likewise, the person-supported’s preference could also be identified through “[an] exercise, called ‘what’s important for and what’s important to .’” [P06]. This model, based on a Helen Sanderson approach [ 18 ], was described as being helpful in highlighting what is important to the person-supported, as opposed to what others (i.e., friends, family, staff, etc.) feel is important for them.

Several organizations updated care plans throughout the year, to document progress towards goals, adapt to changing needs and plan for future goals: “We revisit the plan periodically through the year. And if they say the goal is done, we may set another goal.” [P06]. Organizations may also change plans to adapt to the person-supported’s changing health status or personal capacity.

Implementing a person-centred care plan

The implementation of care plans differed based on the nature of services provided by the organization. The delivery of health-based or personal support services often involved matching the length and intensity of care with the individual’s needs and capacity:

“Sometimes that is a long time, sometimes it’s a short time, sometimes it’s an intervention that’s needed for a bit, and then the person is able to function.” [P05].

In contrast, the delivery of community-based services involved matching activities and staff by interests: “[if] a person-supported wants to go out and be involved in the music community, then we pull the staff pool in and match them up according to interest.” [P06].

Broad personal goals were broken down into smaller, specific activities. For example, one participant described their organization’s plan in helping a person-supported achieve his professional goal of securing employment:

“[The person-supported] said ‘Okay, I want a job.’ So for three weeks he was matched up with a facilitator. They came up with an action plan in terms of how to get a job, what kind of job he’s looking for, where he wants to go, where he wants to apply, how to conduct an interview. And after three weeks he got a job.” [P09].

Organizations that provided residential services focused on developing independent-living skills. One participant described their organization’s plan to empowering persons-supported by allowing them to make their own financial decisions:

“If one month they’re looking after their own finances, and they’ve overspent. Well, maybe we help them out with a grocery card or something and say ‘okay, next month how are you going to do this?’ [The person-supported may say], ‘well, maybe I’ll put so much money aside each week rather than doing a big grocery shop the first week and not having enough money left at the end of the month.’” [P03].

The participant noted that “a tremendous amount of learning [happens] when a person is allowed to [take] risks and make their own decisions.” [P03].

Likewise, participants representing organizations that provided residential services described tailoring care to the persons-supported’s sleeping schedule and daily routine:

“We develop a plan and tweak it as we go. With [the person-supported] coming to the home, what worked well was, we found that he wanted to sleep in, so we adjusted the [staff] time. We took a look at his [medication] times in the morning… and [changed] his [medication] times. We found that he wanted to sleep [until] later in the day, so he would get up at 10 o’clock, so then instead of having breakfast, lunch, and supper he would just have a bigger brunch. Just really tailoring the plan around the person-supported, and it’s worked out well.” [P08].

These examples highlight how organizational context and culture influence how organizations operationalize person-centred care plans; the same individual may experience different approaches to care and engage in different activities depending on the organization they receive services from.

In this paper, we described key elements of the person-centred planning process across different community-care organizations in Southwestern Ontario. We also identified that the context and culture of an organization play a central role in informing the process by which services are personalized to an individual’s needs. These findings shed light on the diversity of factors that influence the implementation of person-centred care plans and the degree to which organizations are able to address medical and social needs in an integrated fashion. They also inform future evaluations of person and system-related outcomes of person-centred planning.

There are regulations around individualizing services delivered by community-care organizations, whereby care providers must allow persons-supported to participate in the development and evaluation of their care plans. HCCSS or MOH-funded services are largely focused on in-home rehabilitation or medical care. In contrast, MCCSS-funded organizations often focus on developing independent living skills or promoting community participation, thus highlighting the role of the funding agency in determining organizational context as well as the nature of services and personalization of care plans.

We also identified organizational culture as a key influence in the person-centred planning process. In previous reports, organizational culture, and specifically the way in which staff perceive and view persons-supported and their decision-making capabilities can impact the effective delivery of person-centred care [ 19 ]. Staff support, including their commitment to persons-supported and the person-centred process, has been regarded as one of the most powerful predictors of positive outcomes and goal attainment in the developmental services sector [ 20 , 21 ]. Moreover, in order to be successful, commitment to this process should extend across all levels of the organization, be fully integrated into organizational service delivery, and be reflected in organizational philosophy, values and views of persons-supported [ 22 , 23 , 24 ].

MCCSS mandates that agencies serving individuals with IDDs develop an individual service plan (ISP) for each person-supported, one “that address[es] the person’s goals, preferences and needs.” [ 7 ]. We reference ISPs as person-centred care plans, as is in line with the view of participants in interviews. There are a series of checklists designed to measure compliance with these policies, and the process is iterative, with mandated annual reviews of care plans and active participation by the person-supported [ 25 ]. In our study, the agencies funded by MCCSS adhered to the general framework outlined by these regulations and informed service delivery accordingly. However, participants also described areas for improvement with respect to the implementation of these policies in practice. These policies, while well-intentioned, may imply a one-size-fits-all approach and appear more as an administrative exercise as opposed to a meaningful endeavor designed to optimize care. Participants spoke about individuals who preferred not to have an ISP, and how that in and of itself is a person-centred approach, respecting the person’s wishes. Additionally, we heard about how the goal-setting process may not be realistic as it can be perceived as unnatural to have goals at each point in one’s life. Moreover, participants noted challenges in implementing person-centred care in shared residential settings (e.g., group homes) or in cases where persons-supported had difficulty communicating.

Prior research indicates that individuals living in semi-independent settings fare better across several quality-of-life measures relative to individuals living in group homes, including decreased social dissatisfaction, increased community participation, increased participation in activities of daily living, and increased empowerment [ 26 ]. Furthermore, a recent study by İsvan et al. (2023) found that individuals living in the community (e.g., own home, family home, or foster home) exhibit greater autonomy in making everyday and life decisions, and greater satisfaction with their inclusion in the community [ 27 ]. These findings may be indicative of a reduced focus on person-centred care plan development and implementation in congregate care settings, where limited staff capacity can make it difficult to tend to the needs of everyone in the home. However, poor outcomes may also be explained by potentially more complex health challenges or more severe disability in persons-supported living in congregate care settings. The challenges described in our study are consistent with calls to improve the quality of care provided in residential group home settings [ 28 , 29 ].

In line with our findings, previous literature also describes challenges in implementing person-centred planning for individuals who have difficulty communicating or are non-verbal [ 19 , 30 , 31 , 32 ]. Communication has also been identified as a barrier to patient-centred care for adults with IDDs in healthcare settings [ 33 , 34 ]. Other reports have identified a need for increased training and awareness of diverse communication styles (including careful observation of non-verbal cues) to aid staff in including persons-supported in the development of care plans [ 35 , 36 , 37 ]. Importantly, these methods take substantial time which is often limited, and compounded by staffing shortages that are widespread across the sector [ 38 ]. Similar barriers were identified in interviews with staff and persons-supported at a partner community-care agency within our larger project [ 39 ]; other papers from the project examine strategies used by the organization to overcome these barriers.

Limitations

The findings from this study should be interpreted in the context of the following limitations. There is a risk for social desirability bias, whereby participants may feel pressure to present their care plan process in a more positive light due to societal norms and expectations [ 40 ]. Additionally, the experiences and views of community-care organizations may vary by region and organization type (i.e., for-profit vs. not-for-profit). In this study, we limited participation to agencies providing services in Southwestern Ontario and we were only able to interview one for-profit agency, despite concerted recruitment efforts. Consequently, we may not have fully captured how financial pressures, or different contextual and cultural components of an organization impact their implementation of care plans.

The person-centred planning process in community-care organizations is largely informed by the characteristics of the population served and the nature of services offered (i.e., organizational context). This process usually involves initial and continued consultations with persons-supported to tailor plans to their specific needs and desired outcomes. There are ongoing challenges in the implementation of person-centred planning, including a need for increased adaptability and clarity in current regulations. In some areas, there may be benefit to incorporating nuance in the application of policies (e.g., in cases where a person-supported does not want to have a formal plan in place). In other areas, it may be helpful to have increased guidance on how to optimize care delivery to improve outcomes (e.g., in cases where a person-supported has difficulty communicating, or is residing in a group home). Policymakers, administrators, and service providers can leverage these insights to refine policies, advocating for inclusive, flexible approaches that better align with diverse community needs.

Data availability

The datasets generated and analyzed in the current study are not publicly available to maintain participant confidentiality, however access may be granted by the corresponding author upon reasonable request.

Abbreviations

Acquired Brain Injury

Disability Services Ontario

Home and Community Care Support Services

Intellectual and Developmental Disabilities

Individual Service Plan

Ministry of Children, Community and Social Services

Ministry of Health

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Acknowledgements

The authors thank Ruth Armstrong, from PHSS - Medical & Complex Care in Community, for her valuable feedback and support throughout the research process.

This research was funded by the Canadian Institutes of Health Research. The funding agency had no role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript.

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S.I. conducted the interviews, developed the coding template, coded the data, thematically analyzed the data, and prepared the manuscript. G.Y. helped develop the coding template, and reviewed and approved the final manuscript. B.D. and D.A. helped conceptualize the study, aided in the interpretation and analysis of study findings, and reviewed and approved the final manuscript. L.M. coordinated research activities, aided in the interpretation and analysis of study findings, and reviewed and approved the final manuscript. M.M. conceptualized the study, supervised its implementation, and was a major contributor in reviewing and editing the manuscript. All authors have read and approved the final manuscript.

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Correspondence to Maria Mathews .

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Idrees, S., Young, G., Dunne, B. et al. The implementation of person-centred plans in the community-care sector: a qualitative study of organizations in Ontario, Canada. BMC Health Serv Res 24 , 680 (2024). https://doi.org/10.1186/s12913-024-11089-7

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‘My parkrun friends.’ A qualitative study of social experiences of men at parkrun in Ireland

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Allison Dunne, Helen Quirk, Alice Bullas, Steve Haake, ‘My parkrun friends.’ A qualitative study of social experiences of men at parkrun in Ireland, Health Promotion International , Volume 39, Issue 3, June 2024, daae045, https://doi.org/10.1093/heapro/daae045

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Social support is a well-established determinant of mental wellbeing. Community initiatives, which combine a purposeful activity with social connection, may be appropriate to promote the mental wellbeing of middle-aged men in Ireland—a group at risk of poor mental wellbeing due to social isolation. parkrun offers free, weekly, 5km run or walk events in 22 countries. This study aims to explore the social experience of parkrun participation for middle-aged men in Ireland and considers how social connections made at parkrun relate to mental wellbeing. Online semi-structured interviews were conducted in 2022/23 with 39 men aged 45–64 years, who run, walk or volunteer at parkrun in Ireland, recruited purposively in rural and urban communities. Men with a range of parkrun experience gave interviews lasting a mean of 32 minutes. Interviews were recorded and transcribed verbatim. Reflexive thematic analysis resulted in three themes and ten subthemes. The men described parkrun as offering a welcoming and supportive environment (Theme 1). Men at parkrun could choose the level of social connections, building strong or weak social ties to provide social support and improve mental wellbeing (Theme 2). Social engagement with parkrun evolved following repeated participation (Theme 3). The results suggest that parkrun is a suitable community initiative for middle-aged men at risk of poor mental wellbeing due to social isolation. Social connections were developed after repeated participation in parkrun and these connections improved subjective mental wellbeing. The findings from this study could be used to design new initiatives for mental health promotion.

This study considers how social connections made through community initiatives, such as parkrun, can be used to support mental wellbeing in middle-aged men in Ireland.

Both strong and weak social ties provided social support.

Social connections were developed after repeated participation in parkrun and these connections improved subjective mental wellbeing.

This information can be useful when recommending community initiatives to populations at risk of poor mental wellbeing due to social isolation.

It could also be useful when designing new interventions for mental health promotion.

Mental wellbeing is defined as a state of positive mental health which is vital for quality of life ( World Health Organization, 2022 ). Maintaining a state of good mental wellbeing can be preventative against mental health conditions and suicide ( Keyes et al ., 2010 ; Barry et al ., 2019 ). Social connections, incorporating social support, social capital and social networks, are recognized as determinants of mental health and wellbeing ( Umberson and Karas Montez, 2010 ; Thoits, 2011 ; Holt-Lunstad, 2022 ) and have been identified as a priority area for public health policy ( Holt-Lunstad, 2023 ; World Health Organization, 2023 ).

Ireland’s national mental health promotion plan Stronger Together highlights the importance of community programmes to improve social connection, particularly in the post-COVID-19 pandemic environment where communities are recovering from long periods of lockdowns and hardship which saw people become socially isolated ( Health Service Executive, 2022 ). Social isolation and the subjective feeling of loneliness are risk factors for premature mortality ( Elovainio et al ., 2017 ) and mental health conditions. One population group in Ireland who are known to be at risk of social isolation and poor mental wellbeing are middle-aged men (often defined as aged 45–65 years) who live in deprived neighbourhoods or who belong to marginalized groups ( Health Service Executive, 2016 ; O’Donnell & Richardson, 2020 ). Unemployment, relationship breakdown and living in rural communities can exacerbate this risk ( O’Donnell & Richardson, 2020 ; McGrath et al ., 2022 ; O’Donnell et al ., 2022 ). Men’s physical and mental health is seen as a priority issue in Ireland due to the continued lower life expectancy of men, when compared to women, and the persistent gender gap in mortality by suicide ( Health Service Executive, 2016 ; Department of Health, 2024 ). To address this, the government of Ireland were the first in the world to introduce a men’s health policy ( Health Service Executive, 2016 ).

Previous research has explored ‘what works’ for men’s mental health promotion ( Robertson et al ., 2018 ). Recommendations include using a safe space where men can gather, away from clinical settings ( Robertson et al ., 2018 ) and harnessing interest in sports or physical activity ( Zwolinsky et al ., 2013 ; Sharp et al ., 2021 ). Giving men control over the design and application of interventions was shown to be important ( Robertson et al ., 2018 ). A study on the design of men’s health interventions in Ireland reported that a focus on wellness rather than health (illness) was beneficial for engaging with men ( Lefkowich et al ., 2017 ).

Community-based initiatives, which combine a purposeful activity with social contact, support mental wellbeing by addressing the social determinants of health ( McLeroy et al ., 2003 ; Ballinger et al ., 2008 ; Golding, 2011 ; Baskin et al ., 2021 ) contributing to the building of social support and social capital ( Cohen and Wills, 1985 ; Linnemann et al ., 2017 ; Wiltshire and Stevinson, 2018 ). One community initiative which has the potential to support middle-aged men in Ireland to improve social connections is parkrun. In a similar way to walking football, parkrun includes a physical activity which is open to all genders ( Cholerton et al ., 2020 ; Andersson et al ., 2023 ), and, as with Men’s Sheds, it offers a place to socialize away from pubs and bars ( O’Donnell and Richardson, 2020 ). parkrun (branded with a small ‘p’) is a registered charity which supports free, weekly, timed events in the UK and over 20 other countries worldwide ( parkrun, 2021 ) in which adults and children (4 years and older) run or walk a 5km route in an outdoor setting on Saturday mornings ( parkrun UK, 2021 ). Volunteers from the local community organize the events ( parkrun support, 2021 ). By the start of 2024, parkrun was available at 107 locations in Ireland, with events in both rural and urban settings ( parkrun Ireland, 2024 ). Considering the evidence for what works for men’s health, parkrun combines several of the qualities recommended for a viable health promotion offering for men. These include the natural setting, using running as a hook for engagement, involvement of participants in the organization of the event and a focus on wellbeing rather than illness prevention.

Along with the physical health benefits associated with running and walking at parkrun, such as cardiovascular fitness and body weight control ( Stevinson and Hickson, 2014 , 2019 ), previous research also suggests parkrun participation improves mental wellbeing in the short-term and long-term. The subjective mental wellbeing of parkrun participants was first explored in a cross-sectional study by Stevinson and Hickson (2014) where parkrun attendance was positively associated with high mental wellbeing scores. Research has found that mental wellbeing indicators (self-esteem, stress and mood) improve immediately after parkrun participation ( Rogerson et al ., 2016 ) with benefits for some maintained after 12 months of participation (increased happiness and decreased risk of stress and depression) ( Stevinson and Hickson, 2019 ).

The link between social connections at parkrun and mental wellbeing has not been fully established. Research exploring the social experience of parkrun participants has consistently reported positive effects on social interaction, social capital and connections ( Wiltshire and Stevinson, 2018 ; Sharman et al ., 2019 ) but little research has explored the mechanisms through which parkrun can influence mental wellbeing ( Grunseit et al ., 2020 ). One study did note that men at parkrun describe a change in wellbeing related to community connectedness ( Grunseit et al ., 2017 ), suggesting that parkrun may be a suitable setting for men to form social connections which could in turn improve mental wellbeing. Research in Ireland suggests a possible link between social factors at parkrun and mental wellbeing ( Haake et al ., 2019 ; Dunne et al ., 2023 ). To date, there has been no detailed exploration of these phenomena in an Irish setting, or with a focus on middle-aged men.

The current study aims to explore the relationship between mental wellbeing and social experiences for middle-aged men in Ireland with the principal research question:

What is the social experience of parkrun participation for middle-aged men in Ireland and how is this related to mental wellbeing?

Research team and reflexivity

The interviews were all conducted by lead researcher A.D., a female pharmacist with over 20 years of patient-facing clinical experience in mental health care. With regard to the positionality of the lead researcher, the following reflections were considered. The researcher is in the same age category as the men interviewed, although a different gender. She moved to Ireland as an adult so has experienced Ireland as a newcomer. She has run or walked over 100 parkruns and has volunteered over 70 times, visiting more than 25 parkrun sites. The researcher noted that she should be mindful of her position as a keen and confident parkrunner and that this may influence her interpretation of the data. Reflexive thematic analysis ( Braun and Clarke, 2022 ) was chosen as the researcher could use her experiences as an embedded parkrun participant to engage with the interviewees and understand nuances in the interview data. This method recognizes there will be a subjective nature to the data analysis and is commonly used in health research ( Braun and Clarke, 2021 ; Campbell et al ., 2021 ).

In this study, the term participants is used to describe people who run, walk or volunteer at parkrun. To avoid confusion, the term interviewees will be used to describe the men who took part in the current study. The interviewees were all parkrun participants. The nine interviewees from Knocknacarra parkrun (one of the recruitment sites) had met A.D. briefly at previous parkrun events but did not have a confiding relationship with her prior to study commencement. At the start of each interview, all 39 interviewees were told that A.D. was a researcher who had an interest in mental health and wellbeing. If the topics arose during the interview A.D. described her participation in parkrun events as a runner and volunteer and disclosed her background as a pharmacist.

Semi-structured interviews were used to explore the type and value of social experiences among middle-aged men attending parkrun in Ireland. An interview guide was developed in consultation with parkrun participants, health professionals and the public. Interview questions were designed to be exploratory in nature and the interview script was semi-structured, allowing for the interviewer to explore topics around mental wellbeing and social experiences at parkrun. Putnam’s definition of social capital ( Putnam et al ., 1993 ) and Cohen’s concept of social support ( Cohen and Wills, 1985 ) were used to list possible topics and questions. The interview questions and prompts can be found in Table 1 .

Interview questions and prompts for semi-structured interviews with men aged 45–64 years attending parkrun in Ireland

Ethical approval for this project was granted by Sheffield Hallam University on 16/9/2022 (Ethics Review ID: ER42513594). Purposive participant recruitment took place from 21/09/2022 to 09/02/2023 via parkrun event Facebook pages and in-person visits to parkrun events across Ireland. Recruitment ceased when the lead researcher (A.D.) was satisfied with the geographical spread of participants and the information power of the interview data ( Malterud et al ., 2016 ). Information power indicates the richness and detail of the data, and its suitability to answer the research question and is more appropriate than data saturation for the reflexive thematic analysis method ( Malterud et al ., 2016 ; Braun and Clarke, 2022 ).

Each participant completed a short demographics questionnaire using Qualtrics survey software after giving online informed consent. Demographics included date of birth, Eircode (Irish postcode) and parkrun participation type (runner/walker, runner/walker/volunteer or volunteer only).

Interviews were conducted using Microsoft Teams video conferencing software and took place between 24/09/2022 and 16/02/2023. The interviews were between researcher A.D. and the interviewee only, with no non-participants present. A.D. used Teams from a home office and the interviewees used their own choice of location, either their own home or workplace office. A single interview was conducted with each interviewee, with no repeat interviews. The audio was recorded on an encrypted Dictaphone for all participants. Those who gave consent for video recording also had their Teams video saved. Handwritten notes were made during and immediately after each interview to capture the researcher’s (A.D.) observations. Auto transcription on Teams was used, with transcription manually checked by A.D. before sending it to each participant for final approval. Names, specific locations and any identifiers were redacted from the transcription. At the time of reporting, the interviewees did not provide feedback on the final findings.

Reflexive thematic analysis used the six-step, iterative, process described by Braun and Clarke (2022) . The lead researcher (A.D.) was the sole coder, a recommended feature of this type of analysis ( Braun and Clarke, 2022 ). Two critical friends were consulted during the theme development process ( Costa and Kallick, 1993 ). NVivo 12 (Lumivero) was used as a tool to manage the inductive coding process. The report was written following the Consolidated Criteria for Reporting Qualitative Studies (COREQ) ( Tong et al ., 2007 ). When the findings of reflexive thematic analysis are reported there is an option to report the results and discussion together or separately ( Braun and Clarke, 2022 ). For this study, the latter style was chosen.

By the end of the recruitment period, 41 interviews had been conducted. Two interviews were not used in the final data set as information regarding study eligibility became apparent during the interview, one participant was not living in the Republic of Ireland at the time and one participant did not take part in parkrun as runner/walker/volunteer, although had observed events without participating. The final number of interviews used for the study was 39.

The mean length of interviews was 32 min 12 s (with a range of 9 min 58 s to 53 min 15 s). All 39 interviewees identified as male and had a mean age of 54 years and 3 months (with a range of 45–64 years). A total of 33 interviewees (84.6%) self-identified their parkrun participation type as runners or walkers who volunteer. The remainder self-identified as runners or walkers (who did not volunteer). All but one of the men had done more than ten events, a threshold used to describe an ‘established’ parkrunner in previous studies ( Morris and Scott, 2019 ). The men lived in nine counties across Ireland (Clare, Cork, Dublin, Galway, Kildare, Mayo, Meath, Roscommon and Sligo). Seven men had moved to Ireland from other countries across the UK and Europe: England (two men), Italy, Poland, Scotland and Wales (two men).

Reflexive thematic analysis of the interview transcripts generated three themes, each with several subthemes: these, with example quotes, are shown in Table 2 .

Themes and subthemes from reflexive thematic analysis of interviews with 39 parkrun participants, all male, aged 45–64 years living in Ireland (rwv = runner or walker who volunteers rw = runner or walker only)

In the following narrative, quantifying language such as occasionally, many or most is used to give an approximation of the strength or consistency associated with each theme, using proportions suggested by Terry (2010) . When the term occasionally is used it will refer to themes or subthemes which involved a quarter or less of the interviewees (10 or less). When some is used it describes 11–25 interviewees. When the term many or often is used, it refers to two-thirds or more of the interviewees (26 or more). Each respondent was given a pseudonym. Age in years at the time of the interview is noted. The abbreviations rwv for runner or walker who volunteers and rw for runner or walker only are used.

Theme 1: parkrun offers a supportive environment for health

Theme 1 encompasses the way that many men in the study positively described the operational characteristics of parkrun such as free access, weekly events, worldwide locations and gender mix.

The interviewees occasionally described the location of the parkrun as being a familiar place where they felt comfortable and welcome (Theme 1a). ‘It’s just a nice, nice [sic] area and as kids, we’d have grown up there, so like it was just nice to go back to it again’ (Jimmy, age 56, rwv).

Many of the men described attending parkrun events with members of their family such as partners or children (Theme 1b). Occasionally, this had also been their route into parkrun; they had attended for the first time with a family member, or had been encouraged by them. ‘Three generations of families, we’re actually seeing grandparents, their kids and their grandchildren out running’ (Séamus, age 62, rwv).

Some men described parkrun as being welcoming (Theme 1c), especially the first time attending ‘I’ve done probably eight different locations. Something like that. But anywhere I was… always welcomed with the smile’ (Jakub, age 47, rwv, originally from Eastern Europe). Occasionally, the men specifically stated that inclusiveness at parkrun is one of the things that support their mental wellbeing (Theme 1c). ‘I enjoyed the, you know, the camaraderie, the atmosphere and the inclusiveness of parkrun’ (Eric, age 64, rwv).

The men often noted that parkrun is open to anyone, regardless of their age, physical ability, mental health status or sexuality and that they are all part of the parkrun community (Theme 1d). ‘…sexuality for me would have been probably a challenge for me, like being a gay man and not entering sports or not entering competitions … with parkrun there’s kind of, there’s a sense of community there, and non-judgmental’ (Don, age 47, rwv).

The men often described being able to interact with new people at parkrun. The way parkrun events are organized gives time for social contact before, during and after the run/walk (Theme 1e). ‘The buzz is the connection with all the different people. That’s the key for parkrun. All the different people … all the new friends I’ve met’ (Pat, age 59, rwv). The people the men met at parkrun ranged from those within their existing networks (e.g. colleagues and neighbours) to ones that they didn’t know from any other setting.

Some men described interacting with people outside of the parkrun setting, after originally meeting at parkrun (Theme 1e). Diarmuid describes how he learned about an adult education group at parkrun; ‘I didn’t know anybody there at all. At the end of the parkrun I heard a guy talking about doing Irish language classes… I’m going to go to his class tomorrow evening’ (Diarmuid, age 52, rw).

The men were asked about negative social interactions at parkrun, including cliques. Only one participant said he had experienced cliques at parkrun, but was not negatively impacted (Theme 1e). ‘Sometimes if there’s an in-group, and you’re not in it you’ll just head for the car, which is also fine’ (Karl, age 46, rwv).

These five subthemes were grouped to form Theme 1 as researcher A.D. felt that they were all describing the conditions and atmosphere at parkrun events which allow social contact to take place. These conditions may contribute to an environment which can support mental wellbeing directly or indirectly. These concepts will be described in more detail in the discussion section.

Theme 2: men who attend parkrun can choose the level of sociability

Theme 2 demonstrates that many men in the study described a range of social connections between themselves and other parkrun participants. Whilst parkrun events support socialization, there is no requirement to socialize; it is possible to turn up, run or walk and go home without speaking to anyone. ‘At parkrun you don’t have to be friends with everyone…it can be at your own kind of level’ (Jarleth, age 52, rwv).

For men who did wish to have social contact, they described two different levels of sociability: deep connections (Theme 2a) and casual social bonds (Theme 2b).

Some men talked about deep connections with people they spoke to at parkrun (Theme 2a). These were either with people they had met at parkrun and developed a friendship with over time, or a strengthening of relationships with people they already knew. These deep connections at parkrun were identified by the men as being good for mental wellbeing. After describing a parkrun participant who had been recently diagnosed with cancer, Derek notes ‘Definitely the social side of it and being able to talk about stuff and actively talking about stuff, it’s a positive… in terms of mental wellbeing’ (Derek, age 60, rwv).

One man, who had moved to Ireland from the UK, described parkrun as a route to making new, deep, friendships which help his mental wellbeing (Theme 2a). ‘Some of my best friends now in Ireland are people I didn’t know at all in parkrun a few years ago. So that’s what helps… I think it’s the social aspect that helps you’ (Dylan, age 64, rwv, originally from the UK).

When talking about casual social bonds at parkrun the men would occasionally use the phrase ‘parkrun friends’ (Theme 2b). This is not an official term from the parkrun charity but seems to have developed organically. ‘It’s actually created a kind of a separate friend group or peer group for me…. There are parkrun friends who are only parkrun friends’ (Finbarr, age 49, rwv). parkrun friends (Theme 2b) were described as people that the men meet at parkrun on Saturday mornings. They chat at the start line, while volunteering or at the café afterwards. However, they would not make any effort to meet up with those people outside of the parkrun setting. ‘You may say hello to lots and lots of people and that you may know over a period of time because of parkrun, but… you don’t have to develop any huge relationship’ (Stefan, age 51, rwv).

Many men noted that topics of conversation among parkrun friends are light-hearted and personal issues are not usually discussed (Theme 2b). ‘A lot of the chat is [about] health and fitness’ (Jimmy, age 56, rwv).

Some men stated directly that the social aspects of parkrun participation were good for their mental wellbeing (Theme 2b) ‘It’s meeting people and getting out there…you can see what it does, especially if you’re crew [a volunteer]… so many stories, that gives you good feeling…You do really, really, really feel great after. You know, a real buzz’ (Mike, age 64, rwv).

Theme 3: the parkrun experience can change over time

Although it is possible to attend just one parkrun event and not return, all but one of the men in this study were regular parkrunners who had attended 10 or more events. Theme 3 captures how they described their feelings before their first parkrun event and how their social experiences had changed over months and years of regular attendance.

One man, Ken, described his journey from a new parkrunner to now being an Event Director (the volunteer responsible for parkrun operations at a particular location) (Theme 3a). Talking about his first time attending a parkrun; ‘I was pretty, bit [ sic ] nervous going up because I wouldn’t have ran with a group of people before… So the bit of running I would have done would have been on my own and well away from people’ (Ken, age 55, rwv). Ken continues to describe how he came to take on the role of Event Director at the same parkrun several years later; ‘With the Event Director like, nobody was stepping up to do it. And I said I’ll do it just for the sake of the run not being, you know, cancelled then’ (Ken, age 55, rwv).

The social connections made at parkrun didn’t always happen immediately. Some of the men described gradually getting to know other people at parkrun over months or years (Theme 3a) ‘I met nobody the first time, you know, but you know how it is, you go and you talk to one or two people, you run with people, you complain about the hills … and you get to know people’ (Dylan, age 64, rwv, originally from the UK).

Occasionally the men explained how their perception of parkrun changed as they became regular participants (Theme 3b). ‘I heard of parkrun for a number of years but I always felt it was… too short for my own running…. once I started the parkruns I just absolutely love them’ (Rob, age 57, rwv).

The final subtheme describes the sense of pride that comes with being a member of the parkrun community (Theme 3c). Garrett describes his pride in being on the team that set up a new parkrun in a rural area of Ireland ‘We take great pride and credit and say We were there for the first one ’ (Garrett, age 52, rwv).

The key concept for these three subthemes is change. The social benefits of parkrun described by the men didn’t usually happen on the first visit. Their repeated participation allowed social contacts to develop and feelings like pride to grow.

This study focussed on the social experience of middle-aged men at parkrun, as this is a population who are at risk of social isolation and poor mental wellbeing and could therefore potentially benefit from community initiatives which combine an activity with social interaction. The results suggest that the men perceived parkrun as a suitable place to make or enhance social connections while participating as runners, walkers or volunteers. Regular participation may maximize the social element of the parkrun experience.

The operational characteristics of parkrun appear to be important in encouraging social interaction (Theme 1). These include: time for social interaction before, during and after the parkrun; a welcoming atmosphere; opportunities to volunteer and regular events. These elements combine to create a supportive environment for health, one of the five action areas for health promotion described in the Ottawa Charter ( World Health Organization, 1986 ).

The results of the current study show that the universal nature of parkrun, with access for all genders, is important for building social connections for middle-aged men in Ireland (Theme 1). Many health promotion initiatives aimed at improving the wellbeing of Irish men take place in a single-gender environment, for example, Men’s Sheds and the physical activity programme Men on the Move ( Kelly et al ., 2019 ; McGrath et al ., 2022 ). While there is certainly a place for single-gender activities ( Health Service Executive, 2016 ), the study by Lefkowich noted that single-gender activities are not always desired by Irish men ( Lefkowich et al ., 2017 ). Men from the current study described attending parkrun with friends, partners and family members of all genders, supporting previous parkrun research about the facilitators of participation ( Wiltshire and Stevinson, 2018 ).

The two openly gay men in the study found that parkrun was a welcoming environment. Gay men in Ireland are a group which are vulnerable to poor mental wellbeing ( Ceatha et al ., 2019 ) so an initiative like parkrun gives an opportunity for this population group to build social connections and support their mental wellbeing. Developing activities which are supportive of men, and that are also welcoming to women and members of the lesbian, gay, bisexual, transgender, queer and other sexual orientations and gender identities (LGBTQ+) communities will minimize the chance that groups may feel excluded from attending. The parkrun charity have recently acknowledged this opportunity for inclusivity by adding an option for gender for new registrants ‘prefer not to say’ and (in the majority of parkrun countries) an additional option of ‘another gender identity’: previously there had been only options for ‘male’ or ‘female’ ( parkrun Global, 2023 ). Further research on the inclusivity of all-gender community initiatives compared to men-only groups is recommended.

The men from this study described having a choice of whether to interact socially with other parkrunners or avoid social contact (Theme 2). For those who wish to socialize, the type of social interaction can be split into two types: casual social bonds and deep connections. These types of interactions echo those described by Granovetter as weak or strong ties, taking into consideration the time investment, emotional intensity, intimacy and reciprocity involved ( Granovetter, 1973 ). Weak ties are valuable in forming connections between people from diverse groups and strengthening communities ( Granovetter, 1973 ). The descriptions of weak social ties between the study participants and other parkrunners reinforce Hindley’s proposal that parkrun is a suitable place for casual sociability ( Hindley, 2020 ). The men in the current study explicitly described weak social ties as being beneficial for their mental wellbeing and for their continued engagement with parkrun events. This link between weak ties and mental wellbeing is similar to that described in previous research in the community setting where brief interactions with strangers were shown to positively impact happiness and wellbeing ( Sandstrom and Boothby, 2021 ; Van Lange and Columbus, 2021 ). Social support from both strong and weak ties is well-established as beneficial for mental wellbeing ( Berkman et al ., 2000 ; Golden et al ., 2009 ; Thoits, 2011 ; Moreton et al ., 2023 ) with an even balance of strong and weak ties being ideal ( Collins et al ., 2022 ).

One finding of this study was that it took repeated visits to parkrun events for the men to see the full benefit of social connections (Theme 3). A feature of parkrun is that it takes place in multiple locations, every week, 52 weeks of the year, which facilitates regular attendance. Other initiatives aimed at Irish men, such as Men on the Move, do not continue through the summer, with research by Kelly et al. (2019) noting that a long summer break contributed to men permanently discontinuing the physical activity programme. The continuous nature of parkrun would minimize the risk of this happening. The ‘practice makes perfect’ strategy of repeatedly attempting social contact with strangers to reduce discomfort and build weak ties was recommended by Sandstrom and Boothby (2021) and is an appropriate practice for new parkrun participants wishing to develop social interactions at parkrun events. A health promotion initiative to promote this strategy is an area for future consideration.

The results of the current study suggest that middle-aged men in Ireland could participate in parkrun to increase the number of social connections and develop weak or strong ties with those connections. This has the potential to support their mental wellbeing via the mechanism of social support or social capital. The topic of loneliness was not specifically discussed in this study but the results suggest that this could be an additional benefit from parkrun participation and is an area for further research.

The focus of this study was the experience of middle-aged men in Ireland. It is possible that some or all of the benefits described by the men may be experienced by men of different age groups or women who participate in parkrun and these are areas for further exploration. Grunseit et al. (2017) showed that there appear to be gender differences in the social experiences of parkrun participants so it could be worthwhile repeating this study with a female population to explore this in more detail. Additionally, a further study with men who are over 65 years old could explore the social experiences of this group, a population at risk of social isolation following retirement ( Abramowska-Kmon and Łątkowski, 2021 ).

Community initiatives which provide social support have been identified in Ireland as a national and international health promotion priority, particularly for men at risk of social isolation. Using parkrun as an example of a community initiative allows for the application of the learnings to other community-based events which combine a purposeful activity with time for social interaction for middle-aged men. This type of initiative is often recommended by social prescribing (community referral) schemes ( Fleming et al ., 2020 ; Alison and Simon, 2022 ). The results of this study suggest that activities which are gender-neutral, provide a supportive environment for social interaction and offer a continuous service to maximize the social and mental wellbeing benefits could be included as social prescribing options for men at risk of social isolation. Newcomers to this type of activity should be advised that repeated attendance may be necessary to gradually build social connections.

One consideration is that all but one of the men interviewed were regular parkrunners (who had participated in more than 10 events) so assumptions cannot be made about the application of these results to men who are new to parkrun participation. All men in the study were runners or walkers at events, at least some of the time. An extension of the study could include interviews with men who volunteer at parkrun without running or walking to explore their insights into the social aspects of parkrun.

This research took place in a post-COVID-19 pandemic environment. Research by Quirk et al. (2022) showed that happiness and life satisfaction among the parkrun population in the UK declined during the COVID-19 pandemic, although the effect was felt more strongly by females and younger adults. The current study took place in 2022/23 when parkrun events had been back in operation for at least 12 months following the COVID-19 pause (since September 2021) ( parkrun Ireland, 2021 ). As the long-term impact of the pandemic on men’s health and wellbeing is currently unknown, it is prudent to consider the results in light of the post-pandemic recovery period.

The current study explored the experiences of middle-aged men in Ireland without defining their socioeconomic status. More research into the barriers to participation for this population group is clearly indicated, particularly as men from areas of deprivation may have the most to gain from social connections at parkrun.

The men in the current study perceived that parkrun in Ireland has a diverse community and the demographics of the men in the current study did reflect some diversity in their country of birth. Future studies could extend this further, in particular, to include under-represented groups in this study, and in the wider parkrun community, such as Irish Travellers and people with Asian or African racial backgrounds.

The results of this study suggest that parkrun provides a supportive environment for middle-aged men in Ireland to form strong and weak social ties. These social ties may be beneficial to mental wellbeing through the mechanism of social support. The universal (all-gender) nature of initiatives such as parkrun allows for family involvement, and a diverse group of participants, which may both be important for initial and continued participation. New participants in this type of activity should be advised that repeated attendance may be necessary to gradually build social connections. Given parkrun’s global reach and the increase in loneliness since the COVID-19 pandemic lockdowns, the results may be relevant outside of the Irish setting. The findings from this study can be applied to other community initiatives which combine a purposeful activity with social connection to provide appropriate health promotion opportunities for middle-aged men at risk of poor mental wellbeing.

The authors would like to thank all the men who took part in the interviews. Many thanks also to the parkrun participants, members of the local community, healthcare professionals and the Advanced Wellbeing Research Centre Public Involvement in Research Group for their assistance in designing the recruitment materials and question script. Thank you to Sue Davison and Amy Murray-Evans from Sheffield Hallam University who acted as critical friends during the data analysis stage of this research. Many thanks to Pauline Dunne, University College Dublin, for advice on the reporting of reflexive thematic analysis results. Finally, thank you to the parkrun research board for approving this research project.

A.D., S.H., A.B. and H.Q. designed the study. A.D. completed the data analysis with the assistance of H.Q. A.D. drafted the manuscript. All authors contributed to the writing of and approval of the final manuscript.

Researcher A.D. was funded via a fees-only scholarship from the Centre for Sports Engineering Research, Sheffield Hallam University, UK. Authors have no additional funding to declare. The views, thoughts and opinions expressed in the manuscript belong solely to the author/s, and do not necessarily reflect the position of parkrun, the parkrun Research Board or any funder(s).

A.D., A.B., H.Q., S.H. (author initials) are all parkrun registrants. A.B., H.Q., S.H. were members of the parkrun Research Board ( https://awrcparkrunresearch.wordpress.com/ ) based at the Advanced Wellbeing Research Centre (AWRC) at Sheffield Hallam University (UK) at the time of writing this article. S.H. is the Chair and H.Q. and A.B. are the deputy Vice Chairs of the parkrun Research Board.

For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising from this submission.

The research design and consent procedures for this study were reviewed and approved by Sheffield Hallam University Research Ethics Committee (Reference number: ER42513594). Written and verbal informed consent was received from all participants before the online interviews. Final transcripts were approved by the participants before use in the study.

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• Open access
• Published: 16 May 2024

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

• Jeremy Segrott   ORCID: orcid.org/0000-0001-6215-0870 1 ,
• Sue Channon 2 ,
• Amy Lloyd 4 ,
• Eleni Glarou 2 , 3 ,
• Josie Henley 5 ,
• Jacqueline Hughes 2 ,
• Nina Jacob 2 ,
• Sarah Milosevic 2 ,
• Yvonne Moriarty 2 ,
• Bethan Pell 6 ,
• Mike Robling 2 ,
• Heather Strange 2 ,
• Julia Townson 2 ,
• Qualitative Research Group &
• Lucy Brookes-Howell 2  

Trials volume  25 , Article number:  323 ( 2024 ) Cite this article

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Background/aims

The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University’s Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration.

We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper.

Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies.

Conclusions

Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

Peer Review reports

The value of using qualitative methods within randomised control trials (RCTs) is widely recognised [ 1 , 2 , 3 ]. Qualitative research generates important evidence on factors affecting trial recruitment/retention [ 4 ] and implementation, aiding interpretation of quantitative data [ 5 ]. Though RCTs have traditionally been viewed as sitting within a positivist paradigm, recent methodological innovations have developed new trial designs that draw explicitly on both quantitative and qualitative methods. For instance, in the field of complex public health interventions, realist RCTs seek to understand the mechanisms through which interventions generate hypothesised impacts, and how interactions across different implementation contexts form part of these mechanisms. Proponents of realist RCTs—which integrate experimental and realist paradigms—highlight the importance of using quantitative and qualitative methods to fully realise these aims and to generate an understanding of intervention mechanisms and how context shapes them [ 6 ].

A need for guidance on how to conduct good quality qualitative research is being addressed, particularly in relation to feasibility studies for RCTs [ 7 ] and process evaluations embedded within trials of complex interventions [ 5 ]. There is also guidance on the conduct of qualitative research within trials at different points in the research cycle, including development, conduct and reporting [ 8 , 9 ].

A high proportion of trials are based within or involve clinical trials units (CTUs). In the UK the UKCRC Registered CTU Network describes them as:

… specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological, and other methodological advice and coordination to undertake successful clinical trials. In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials.

Thus, CTUs provide the specialist methodological expertise needed for the conduct of trials, and in the case of trials of investigational medicinal products, their involvement may be mandated to ensure compliance with relevant regulations. As the definition above suggests, CTUs also conduct and support other types of study apart from RCTs, providing a range of methodological and subject-based expertise.

However, despite their central role in the conduct and design of trials, (and other evaluation designs) little has been written about how CTUs have integrated qualitative work within their organisation at a time when such methods are, as stated above, now recognised as an important aspect of RCTs and evaluation studies more generally. This is a significant gap, since integration at the organisational level arguably shapes how qualitative research is integrated within individual studies, and thus it is valuable to understand how CTUs have approached the task. There are different ways of involving qualitative work in trials units, such as partnering with other departments (e.g. social science) or employing qualitative researchers directly. Qualitative research can be imagined and configured in different ways—as a method that generates data to inform future trial and intervention design, as an embedded component within an RCT or other evaluation type, or as a parallel strand of research focusing on lived experiences of illness, for instance. Understanding how trials units have integrated qualitative research is valuable, as it can shed light on which strategies show promise, and in which contexts, and how qualitative research is positioned within the field of trials research, foregrounding the value of qualitative research. However, although much has been written about its use within trials, few accounts exist of how trials units have integrated qualitative research within their systems and structures.

This paper discusses the process of embedding qualitative research within the work of one CTU—Cardiff University’s Centre for Trials Research (CTR). It highlights facilitators of this process and identifies challenges to integration. We use the Normalisation Process Theory (NPT) as a framework to structure our experience and approach. The key gap addressed by this paper is the implementation of strategies to integrate qualitative research (a relatively newly adopted set of practices and processes) within CTU systems and structures. We acknowledge from the outset that there are multiple ways of approaching this task. What follows therefore is not a set of recommendations for a preferred or best way to integrate qualitative research, as this will comprise diverse actions according to specific contexts. Rather, we examine the processes through which integration occurred in our own setting and highlight the potential value of these insights for others engaged in the work of promoting qualitative research within trials units.

Background to the integration of qualitative research within CTR

The CTR was formed in 2015 [ 10 ]. It brought together three existing trials units at Cardiff University: the South East Wales Trials Unit, the Wales Cancer Trials Unit, and the Haematology Clinical Trials Unit. From its inception, the CTR had a stated aim of developing a programme of qualitative research and integrating it within trials and other studies. In the sections below, we map these approaches onto the framework offered by Normalisation Process Theory to understand the processes through which they helped achieve embedding and integration of qualitative research.

CTR’s aims (including those relating to the development of qualitative research) were included within its strategy documents and communicated to others through infrastructure funding applications, annual reports and its website. A Qualitative Research Group (QRG), which had previously existed within the South East Wales Trials Unit, with dedicated funding for methodological specialists and group lead academics, was a key mechanism through which the development of a qualitative portfolio was put into action. Integration of qualitative research within Centre systems and processes occurred through the inclusion of qualitative research in study adoption processes and representation on committees. The CTR’s study portfolio provided a basis to track qualitative methods in new and existing studies, identify opportunities to embed qualitative methods within recently adopted studies (at the funding application stage) and to manage staff resources. Capacity building and training were an important focus of the QRG’s work, including training courses, mentoring, creation of an academic network open to university staff and practitioners working in the field of healthcare, presentations at CTR staff meetings and securing of PhD studentships. Standard operating procedures and methodological guidance on the design and conduct of qualitative research (e.g. templates for developing analysis plans) aimed to create a shared understanding of how to undertake high-quality research, and a means to monitor the implementation of rigorous approaches. As the QRG expanded its expertise it sought to develop innovative approaches, including the use of visual [ 11 ] and ethnographic methods [ 12 ].

Understanding implementation—Normalisation Process Theory (NPT)

Normalisation Process Theory (NPT) provides a model with which to understand the implementation of new sets of practices and their normalisation within organisational settings. The term ‘normalisation’ refers to how new practices become routinised (part of the everyday work of an organisation) through embedding and integration [ 13 , 14 ]. NPT defines implementation as ‘the social organisation of work’ and is concerned with the social processes that take place as new practices are introduced. Embedding involves ‘making practices routine elements of everyday life’ within an organisation. Integration takes the form of ‘sustaining embedded practices in social contexts’, and how these processes lead to the practices becoming (or not becoming) ‘normal and routine’ [ 14 ]. NPT is concerned with the factors which promote or ‘inhibit’ attempts to embed and integrate the operationalisation of new practices [ 13 , 14 , 15 ].

Embedding new practices is therefore achieved through implementation—which takes the form of interactions in specific contexts. Implementation is operationalised through four ‘generative mechanisms’— coherence , cognitive participation , collective action and reflexive monitoring [ 14 ]. Each mechanism is characterised by components comprising immediate and organisational work, with actions of individuals and organisations (or groups of individuals) interdependent. The mechanisms operate partly through forms of investment (i.e. meaning, commitment, effort, and comprehension) [ 14 ].

Coherence refers to how individuals/groups make sense of, and give meaning to, new practices. Sense-making concerns the coherence of a practice—whether it ‘holds together’, and its differentiation from existing activities [ 15 ]. Communal and individual specification involve understanding new practices and their potential benefits for oneself or an organisation. Individuals consider what new practices mean for them in terms of tasks and responsibilities ( internalisation ) [ 14 ].

NPT frames the second mechanism, cognitive participation , as the building of a ‘community of practice’. For a new practice to be initiated, individuals and groups within an organisation must commit to it [ 14 , 15 ]. Cognitive participation occurs through enrolment —how people relate to the new practice; legitimation —the belief that it is right for them to be involved; and activation —defining which actions are necessary to sustain the practice and their involvement [ 14 ]. Making the new practices work may require changes to roles (new responsibilities, altered procedures) and reconfiguring how colleagues work together (changed relationships).

Third, Collective Action refers to ‘the operational work that people do to enact a set of practices’ [ 14 ]. Individuals engage with the new practices ( interactional workability ) reshaping how members of an organisation interact with each other, through creation of new roles and expectations ( relational interaction ) [ 15 ]. Skill set workability concerns how the work of implementing a new set of practices is distributed and the necessary roles and skillsets defined [ 14 ]. Contextual integration draws attention to the incorporation of a practice within social contexts, and the potential for aspects of these contexts, such as systems and procedures, to be modified as a result [ 15 ].

Reflexive monitoring is the final implementation mechanism. Collective and individual appraisal evaluate the value of a set of practices, which depends on the collection of information—formally and informally ( systematisation ). Appraisal may lead to reconfiguration in which procedures of the practice are redefined or reshaped [ 14 , 15 ].

We sought to map the following: (1) the strategies used to embed qualitative research within the Centre, (2) key facilitators, and (3) barriers to their implementation. Through focused group discussions during the monthly meetings of the CTR QRG and in discussion with the CTR senior management team throughout 2019–2020 we identified nine types of documents (22 individual documents in total) produced within the CTR which had relevant information about the integration of qualitative research within its work (Table  1 ). The QRG had an ‘open door’ policy to membership and welcomed all staff/students with an interest in qualitative research. It included researchers who were employed specifically to undertake qualitative research and other staff with a range of study roles, including trial managers, statisticians, and data managers. There was also diversity in terms of career stage, including PhD students, mid-career researchers and members of the Centre’s Executive team. Membership was therefore largely self-selected, and comprised of individuals with a role related to, or an interest in, embedding qualitative research within trials. However, the group brought together diverse methodological perspectives and was not solely comprised of methodological ‘champions’ whose job it was to promote the development of qualitative research within the centre. Thus whilst the group (and by extension, the authors of this paper) had a shared appreciation of the value of qualitative research within a trials centre, they also brought varied methodological perspectives and ways of engaging with it.

All members of the QRG ( n  = 26) were invited to take part in a face-to-face, day-long workshop in February 2019 on ‘How to optimise and operationalise qualitative research in trials: reflections on CTR structure’. The workshop was attended by 12 members of staff and PhD students, including members of the QRG and the CTR’s senior management team. Recruitment to the workshop was therefore inclusive, and to some extent opportunistic, but all members of the QRG were able to contribute to discussions during regular monthly group meetings and the drafting of the current paper.

The aim of the workshop was to bring together information from the documents in Table  1 to generate discussion around the key strategies (and their component activities) that had been adopted to integrate qualitative research into CTR, as well as barriers to, and facilitators of, their implementation. The agenda for the workshop involved four key areas: development and history of the CTR model; mapping the current model within CTR; discussing the structure of other CTUs; and exploring the advantages and disadvantages of the CTR model.

During the workshop, we discussed the use of NPT to conceptualise how qualitative research had been embedded within CTR’s systems and practices. The group produced spider diagrams to map strategies and actions on to the four key domains (or ‘generative mechanisms’ of NPT) summarised above, to aid the understanding of how they had functioned, and the utility of NPT as a framework. This is summarised in Table  2 .

Detailed notes were made during the workshop. A core writing group then used these notes and the documents in Table  1 to develop a draft of the current paper. This was circulated to all members of the CTR QRG ( n  = 26) and stored within a central repository accessible to them to allow involvement and incorporate the views of those who were not able to attend the workshop. This draft was again presented for comments in the monthly CTR QRG meeting in February 2021 attended by n  = 10. The Standards for QUality Improvement Reporting Excellence 2.0 (SQUIRE) guidelines were used to inform the structure and content of the paper (see supplementary material) [ 16 ].

In the following sections, we describe the strategies CTR adopted to integrate qualitative research. These are mapped against NPT’s four generative mechanisms to explore the processes through which the strategies promoted integration, and facilitators of and barriers to their implementation. A summary of the strategies and their functioning in terms of the generative mechanisms is provided in Table  2 .

Coherence—making sense of qualitative research

In CTR, many of the actions taken to build a portfolio of qualitative research were aimed at enabling colleagues, and external actors, to make sense of this set of methodologies. Centre-level strategies and grant applications for infrastructure funding highlighted the value of qualitative research, the added benefits it would bring, and positioned it as a legitimate set of practices alongside existing methods. For example, a 2014 application for renewal of trials unit infrastructure funding stated:

We are currently in the process of undertaking […] restructuring for our qualitative research team and are planning similar for trial management next year. The aim of this restructuring is to establish greater hierarchical management and opportunities for staff development and also provide a structure that can accommodate continuing growth.

Within the CTR, various forms of communication on the development of qualitative research were designed to enable staff and students to make sense of it, and to think through its potential value for them, and ways in which they might engage with it. These included presentations at staff meetings, informal meetings between project teams and the qualitative group lead, and the visibility of qualitative research on the public-facing Centre website and Centre committees and systems. For instance, qualitative methods were included (and framed as a distinct set of practices) within study adoption forms and committee agendas. Information for colleagues described how qualitative methods could be incorporated within funding applications for RCTs and other evaluation studies to generate new insights into questions research teams were already keen to answer, such as influences on intervention implementation fidelity. Where externally based chief investigators approached the Centre to be involved in new grant applications, the existence of the qualitative team and group lead enabled the inclusion of qualitative research to be actively promoted at an early stage, and such opportunities were highlighted in the Centre’s brochure for new collaborators. Monthly qualitative research network meetings—advertised across CTR and to external research collaborators, were also designed to create a shared understanding of qualitative research methods and their utility within trials and other study types (e.g. intervention development, feasibility studies, and observational studies). Training events (discussed in more detail below) also aided sense-making.

Several factors facilitated the promotion of qualitative research as a distinctive and valuable entity. Among these was the influence of the broader methodological landscape within trial design which was promoting the value of qualitative research, such as guidance on the evaluation of complex interventions by the Medical Research Council [ 17 ], and the growing emphasis placed on process evaluations within trials (with qualitative methods important in understanding participant experience and influences on implementation) [ 5 ]. The attention given to lived experience (both through process evaluations and the move to embed public involvement in trials) helped to frame qualitative research within the Centre as something that was appropriate, legitimate, and of value. Recognition by research funders of the value of qualitative research within studies was also helpful in normalising and legitimising its adoption within grant applications.

The inclusion of qualitative methods within influential methodological guidance helped CTR researchers to develop a ‘shared language’ around these methods, and a way that a common understanding of the role of qualitative research could be generated. One barrier to such sense-making work was the varying extent to which staff and teams had existing knowledge or experience of qualitative research. This varied across methodological and subject groups within the Centre and reflected the history of the individual trials units which had merged to form the Centre.

Cognitive participation—legitimising qualitative research

Senior CTR leaders promoted the value and legitimacy of qualitative research. Its inclusion in centre strategies, infrastructure funding applications, and in public-facing materials (e.g. website, investigator brochures), signalled that it was appropriate for individuals to conduct qualitative research within their roles, or to support others in doing so. Legitimisation also took place through informal channels, such as senior leadership support for qualitative research methods in staff meetings and participation in QRG seminars. Continued development of the QRG (with dedicated infrastructure funding) provided a visible identity and equivalence with other methodological groups (e.g. trial managers, statisticians).

Staff were asked to engage with qualitative research in two main ways. First, there was an expansion in the number of staff for whom qualitative research formed part of their formal role and responsibilities. One of the three trials units that merged to form CTR brought with it a qualitative team comprising methodological specialists and a group lead. CTR continued the expansion of this group with the creation of new roles and an enlarged nucleus of researchers for whom qualitative research was the sole focus of their work. In part, this was linked to the successful award of projects that included a large qualitative component, and that were coordinated by CTR (see Table  3 which describes the PUMA study).

Members of the QRG were encouraged to develop their own research ideas and to gain experience as principal investigators, and group seminars were used to explore new ideas and provide peer support. This was communicated through line management, appraisal, and informal peer interaction. Boundaries were not strictly demarcated (i.e. staff located outside the qualitative team were already using qualitative methods), but the new team became a central focus for developing a growing programme of work.

Second, individuals and studies were called upon to engage in new ways with qualitative research, and with the qualitative team. A key goal for the Centre was that groups developing new research ideas should give more consideration in general to the potential value and inclusion of qualitative research within their funding applications. Specifically, they were asked to do this by thinking about qualitative research at an early point in their application’s development (rather than ‘bolting it on’ after other elements had been designed) and to draw upon the expertise and input of the qualitative team. An example was the inclusion of questions on qualitative methods within the Centre’s study adoption form and representation from the qualitative team at the committee which reviewed new adoption requests. Where adoption requests indicated the inclusion of qualitative methods, colleagues were encouraged to liaise with the qualitative team, facilitating the integration of its expertise from an early stage. Qualitative seminars offered an informal and supportive space in which researchers could share initial ideas and refine their methodological approach. The benefits of this included the provision of sufficient time for methodological specialists to be involved in the design of the proposed qualitative component and ensuring adequate costings had been drawn up. At study adoption group meetings, scrutiny of new proposals included consideration of whether new research proposals might be strengthened through the use of qualitative methods where these had not initially been included. Meetings of the QRG—which reviewed the Centre’s portfolio of new studies and gathered intelligence on new ideas—also helped to identify, early on, opportunities to integrate qualitative methods. Communication across teams was useful in identifying new research ideas and embedding qualitative researchers within emerging study development groups.

Actions to promote greater use of qualitative methods in funding applications fed through into a growing number of studies with a qualitative component. This helped to increase the visibility and legitimacy of qualitative methods within the Centre. For example, the PUMA study [ 12 ], which brought together a large multidisciplinary team to develop and evaluate a Paediatric early warning system, drew heavily on qualitative methods, with the qualitative research located within the QRG. The project introduced an extensive network of collaborators and clinical colleagues to qualitative methods and how they could be used during intervention development and the generation of case studies. Further information about the PUMA study is provided in Table  3 .

Increasing the legitimacy of qualitative work across an extensive network of staff, students and collaborators was a complex process. Set within the continuing dominance of quantitative methods with clinical trials, there were variations in the extent to which clinicians and other collaborators embraced the value of qualitative methods. Research funding schemes, which often continued to emphasise the quantitative element of randomised controlled trials, inevitably fed through into the focus of new research proposals. Staff and external collaborators were sometimes uncertain about the added value that qualitative methods would bring to their trials. Across the CTR there were variations in the speed at which qualitative research methods gained legitimacy, partly based on disciplinary traditions and their influences. For instance, population health trials, often located within non-health settings such as schools or community settings, frequently involved collaboration with social scientists who brought with them experience in qualitative methods. Methodological guidance in this field, such as MRC guidance on process evaluations, highlighted the value of qualitative methods and alternatives to the positivist paradigm, such as the value of realist RCTs. In other, more clinical areas, positivist paradigms had greater dominance. Established practices and methodological traditions across different funders also influenced the ease of obtaining funding to include qualitative research within studies. For drugs trials (CTIMPs), the influence of regulatory frameworks on study design, data collection and the allocation of staff resources may have played a role. Over time, teams gained repeated experience of embedding qualitative research (and researchers) within their work and took this learning with them to subsequent studies. For example, the senior clinician quoted within the PUMA case study (Table  3 below) described how they had gained an appreciation of the rigour of qualitative research and an understanding of its language. Through these repeated interactions, embedding of qualitative research within studies started to become the norm rather than the exception.

Collective action—operationalising qualitative research

Collective action concerns the operationalisation of new practices within organisations—the allocation and management of the work, how individuals interact with each other, and the work itself. In CTR the formation of a Qualitative Research Group helped to allocate and organise the work of building a portfolio of studies. Researchers across the Centre were called upon to interact with qualitative research in new ways. Presentations at staff meetings and the inclusion of qualitative research methods in portfolio study adoption forms were examples of this ( interactive workability ). It was operationalised by encouraging study teams to liaise with the qualitative research lead. Development of standard operating procedures, templates for costing qualitative research and methodological guidance (e.g. on analysis plans) also helped encourage researchers to interact with these methods in new ways. For some qualitative researchers who had been trained in the social sciences, working within a trials unit meant that they needed to interact in new and sometimes unfamiliar ways with standard operating procedures, risk assessments, and other trial-based systems. Thus, training needs and capacity-building efforts were multidirectional.

Whereas there had been a tendency for qualitative research to be ‘bolted on’ to proposals for RCTs, the systems described above were designed to embed thinking about the value and design of the qualitative component from the outset. They were also intended to integrate members of the qualitative team with trial teams from an early stage to promote effective integration of qualitative methods within larger trials and build relationships over time.

Standard Operating Procedures (SOPs), formal and informal training, and interaction between the qualitative team and other researchers increased the relational workability of qualitative methods within the Centre—the confidence individuals felt in including these methods within their studies, and their accountability for doing so. For instance, study adoption forms prompted researchers to interact routinely with the qualitative team at an early stage, whilst guidance on costing grants provided clear expectations about the resources needed to deliver a proposed set of qualitative data collection.

Formation of the Qualitative Research Group—comprised of methodological specialists, created new roles and skillsets ( skill set workability ). Research teams were encouraged to draw on these when writing funding applications for projects that included a qualitative component. Capacity-building initiatives were used to increase the number of researchers with the skills needed to undertake qualitative research, and for these individuals to develop their expertise over time. This was achieved through formal training courses, academic seminars, mentoring from experienced colleagues, and informal knowledge exchange. Links with external collaborators and centres engaged in building qualitative research supported these efforts. Within the Centre, the co-location of qualitative researchers with other methodological and trial teams facilitated knowledge exchange and building of collaborative relationships, whilst grouping of the qualitative team within a dedicated office space supported a collective identity and opportunities for informal peer support.

Some aspects of the context in which qualitative research was being developed created challenges to operationalisation. Dependence on project grants to fund qualitative methodologists meant that there was a continuing need to write further grant applications whilst limiting the amount of time available to do so. Similarly, researchers within the team whose role was funded largely by specific research projects could sometimes find it hard to create sufficient time to develop their personal methodological interests. However, the cultivation of a methodologically varied portfolio of work enabled members of the team to build significant expertise in different approaches (e.g. ethnography, discourse analysis) that connected individual studies.

Reflexive monitoring—evaluating the impact of qualitative research

Inclusion of questions/fields relating to qualitative research within the Centre’s study portfolio database was a key way in which information was collected ( systematisation ). It captured numbers of funding applications and funded studies, research design, and income generation. Alongside this database, a qualitative resource planner spreadsheet was used to link individual members of the qualitative team with projects and facilitate resource planning, further reinforcing the core responsibilities and roles of qualitative researchers within CTR. As with all staff in the Centre, members of the qualitative team were placed on ongoing rather than fixed-term contracts, reflecting their core role within CTR. Planning and strategy meetings used the database and resource planner to assess the integration of qualitative research within Centre research, identify opportunities for increasing involvement, and manage staff recruitment and sustainability of researcher posts. Academic meetings and day-to-day interaction fulfilled informal appraisal of the development of the group, and its position within the Centre. Individual appraisal was also important, with members of the qualitative team given opportunities to shape their role, reflect on progress, identify training needs, and further develop their skillset, particularly through line management systems.

These forms of systematisation and appraisal were used to reconfigure the development of qualitative research and its integration within the Centre. For example, group strategies considered how to achieve long-term integration of qualitative research from its initial embedding through further promoting the belief that it formed a core part of the Centre’s business. The visibility and legitimacy of qualitative research were promoted through initiatives such as greater prominence on the Centre’s website. Ongoing review of the qualitative portfolio and discussion at academic meetings enabled the identification of areas where increased capacity would be helpful, both for qualitative staff, and more broadly within the Centre. This prompted the qualitative group to develop an introductory course to qualitative methods open to all Centre staff and PhD students, aimed at increasing understanding and awareness. As the qualitative team built its expertise and experience it also sought to develop new and innovative approaches to conducting qualitative research. This included the use of visual and diary-based methods [ 11 ] and the adoption of ethnography to evaluate system-level clinical interventions [ 12 ]. Restrictions on conventional face-to-face qualitative data collection due to the COVID-19 pandemic prompted rapid adoption of virtual/online methods for interviews, observation, and use of new internet platforms such as Padlet—a form of digital note board.

In this paper, we have described the work undertaken by one CTU to integrate qualitative research within its studies and organisational culture. The parallel efforts of many trials units to achieve these goals arguably come at an opportune time. The traditional designs of RCTs have been challenged and re-imagined by the increasing influence of realist evaluation [ 6 , 18 ] and the widespread acceptance that trials need to understand implementation and intervention theory as well as assess outcomes [ 17 ]. Hence the widespread adoption of embedded mixed methods process evaluations within RCTs. These broad shifts in methodological orthodoxies, the production of high-profile methodological guidance, and the expectations of research funders all create fertile ground for the continued expansion of qualitative methods within trials units. However, whilst much has been written about the importance of developing qualitative research and the possible approaches to integrating qualitative and quantitative methods within studies, much less has been published on how to operationalise this within trials units. Filling this lacuna is important. Our paper highlights how the integration of a new set of practices within an organisation can become embedded as part of its ‘normal’ everyday work whilst also shaping the practices being integrated. In the case of CTR, it could be argued that the integration of qualitative research helped shape how this work was done (e.g. systems to assess progress and innovation).

In our trials unit, the presence of a dedicated research group of methodological specialists was a key action that helped realise the development of a portfolio of qualitative research and was perhaps the most visible evidence of a commitment to do so. However, our experience demonstrates that to fully realise the goal of developing qualitative research, much work focuses on the interaction between this ‘new’ set of methods and the organisation into which it is introduced. Whilst the team of methodological specialists was tasked with, and ‘able’ to do the work, the ‘work’ itself needed to be integrated and embedded within the existing system. Thus, alongside the creation of a team and methodological capacity, promoting the legitimacy of qualitative research was important to communicate to others that it was both a distinctive and different entity, yet similar and equivalent to more established groups and practices (e.g. trial management, statistics, data management). The framing of qualitative research within strategies, the messages given out by senior leaders (formally and informally) and the general visibility of qualitative research within the system all helped to achieve this.

Normalisation Process Theory draws our attention to the concepts of embedding (making a new practice routine, normal within an organisation) and integration —the long-term sustaining of these processes. An important process through which embedding took place in our centre concerned the creation of messages and systems that called upon individuals and research teams to interact with qualitative research. Research teams were encouraged to think about qualitative research and consider its potential value for their studies. Critically, they were asked to do so at specific points, and in particular ways. Early consideration of qualitative methods to maximise and optimise their inclusion within studies was emphasised, with timely input from the qualitative team. Study adoption systems, centre-level processes for managing financial and human resources, creation of a qualitative resource planner, and awareness raising among staff, helped to reinforce this. These processes of embedding and integration were complex and they varied in intensity and speed across different areas of the Centre’s work. In part this depended on existing research traditions, the extent of prior experience of working with qualitative researchers and methods, and the priorities of subject areas and funders. Centre-wide systems, sometimes linked to CTR’s operation as a CTU, also helped to legitimise and embed qualitative research, lending it equivalence with other research activity. For example, like all CTUs, CTR was required to conform with the principles of Good Clinical Practice, necessitating the creation of a quality management system, operationalised through standard operating procedures for all areas of its work. Qualitative research was included, and became embedded, within these systems, with SOPs produced to guide activities such as qualitative analysis.

NPT provides a helpful way of understanding how trials units might integrate qualitative research within their work. It highlights how new practices interact with existing organisational systems and the work needed to promote effective interaction. That is, alongside the creation of a team or programme of qualitative research, much of the work concerns how members of an organisation understand it, engage with it, and create systems to sustain it. Embedding a new set of practices may be just as important as the quality or characteristics of the practices themselves. High-quality qualitative research is of little value if it is not recognised and drawn upon within new studies for instance. NPT also offers a helpful lens with which to understand how integration and embedding occur, and the mechanisms through which they operate. For example, promoting the legitimacy of a new set of practices, or creating systems that embed it, can help sustain these practices by creating an organisational ambition and encouraging (or requiring) individuals to interact with them in certain ways, redefining their roles accordingly. NPT highlights the ways in which integration of new practices involves bi-directional exchanges with the organisation’s existing practices, with each having the potential to re-shape the other as interaction takes place. For instance, in CTR, qualitative researchers needed to integrate and apply their methods within the quality management and other systems of a CTU, such as the formalisation of key processes within standard operating procedures, something less likely to occur outside trials units. Equally, project teams (including those led by externally based chief investigators) increased the integration of qualitative methods within their overall study design, providing opportunities for new insights on intervention theory, implementation and the experiences of practitioners and participants.

We note two aspects of the normalisation processes within CTR that are slightly less well conceptualised by NPT. The first concerns the emphasis within coherence on identifying the distinctiveness of new practices, and how they differ from existing activities. Whilst differentiation was an important aspect of the integration of qualitative research in CTR, such integration could be seen as operating partly through processes of de-differentiation, or at least equivalence. That is, part of the integration of qualitative research was to see it as similar in terms of rigour, coherence, and importance to other forms of research within the Centre. To be viewed as similar, or at least comparable to existing practices, was to be legitimised.

Second, whilst NPT focuses mainly on the interaction between a new set of practices and the organisational context into which it is introduced, our own experience of introducing qualitative research into a trials unit was shaped by broader organisational and methodological contexts. For example, the increasing emphasis placed upon understanding implementation processes and the experiences of research participants in the field of clinical trials (e.g. by funders), created an environment conducive to the development of qualitative research methods within our Centre. Attempts to integrate qualitative research within studies were also cross-organisational, given that many of the studies managed within the CTR drew together multi-institutional teams. This provided important opportunities to integrate qualitative research within a portfolio of studies that extended beyond CTR and build a network of collaborators who increasingly included qualitative methods within their funding proposals. The work of growing and integrating qualitative research within a trials unit is an ongoing one in which ever-shifting macro-level influences can help or hinder, and where the organisations within which we work are never static in terms of barriers and facilitators.

The importance of utilising qualitative methods within RCTs is now widely recognised. Increased emphasis on the evaluation of complex interventions, the influence of realist methods directing greater attention to complexity and the widespread adoption of mixed methods process evaluations are key drivers of this shift. The inclusion of qualitative methods within individual trials is important and previous research has explored approaches to their incorporation and some of the challenges encountered. Our paper highlights that the integration of qualitative methods at the organisational level of the CTU can shape how they are taken up by individual trials. Within CTR, it can be argued that qualitative research achieved high levels of integration, as conceptualised by Normalisation Process Theory. Thus, qualitative research became recognised as a coherent and valuable set of practices, secured legitimisation as an appropriate focus of individual and organisational activity and benefitted from forms of collective action which operationalised these organisational processes. Crucially, the routinisation of qualitative research appeared to be sustained, something which NPT suggests helps define integration (as opposed to initial embedding). However, our analysis suggested that the degree of integration varied by trial area. This variation reflected a complex mix of factors including disciplinary traditions, methodological guidance, existing (un)familiarity with qualitative research, and the influence of regulatory frameworks for certain clinical trials.

NPT provides a valuable framework with which to understand how these processes of embedding and integration occur. Our use of NPT draws attention to the importance of sense-making and legitimisation as important steps in introducing a new set of practices within the work of an organisation. Integration also depends, across each mechanism of NPT, on the building of effective relationships, which allow individuals and teams to work together in new ways. By reflecting on our experiences and the decisions taken within CTR we have made explicit one such process for embedding qualitative research within a trials unit, whilst acknowledging that approaches may differ across trials units. Mindful of this fact, and the focus of the current paper on one trials unit’s experience, we do not propose a set of recommendations for others who are working to achieve similar goals. Rather, we offer three overarching reflections (framed by NPT) which may act as a useful starting point for trials units (and other infrastructures) seeking to promote the adoption of qualitative research.

First, whilst research organisations such as trials units are highly heterogenous, processes of embedding and integration, which we have foregrounded in this paper, are likely to be important across different contexts in sustaining the use of qualitative research. Second, developing a plan for the integration of qualitative research will benefit from mapping out the characteristics of the extant system. For example, it is valuable to know how familiar staff are with qualitative research and any variations across teams within an organisation. Thirdly, NPT frames integration as a process of implementation which operates through key generative mechanisms— coherence , cognitive participation , collective action and reflexive monitoring . These mechanisms can help guide understanding of which actions help achieve embedding and integration. Importantly, they span multiple aspects of how organisations, and the individuals within them, work. The ways in which people make sense of a new set of practices ( coherence ), their commitment towards it ( cognitive participation ), how it is operationalised ( collective action ) and the evaluation of its introduction ( reflexive monitoring ) are all important. Thus, for example, qualitative research, even when well organised and operationalised within an organisation, is unlikely to be sustained if appreciation of its value is limited, or people are not committed to it.

We present our experience of engaging with the processes described above to open dialogue with other trials units on ways to operationalise and optimise qualitative research in trials. Understanding how best to integrate qualitative research within these settings may help to fully realise the significant contribution which it makes the design and conduct of trials.

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Acknowledgements

Members of the Centre for Trials Research (CTR) Qualitative Research Group were collaborating authors: C Drew (Senior Research Fellow—Senior Trial Manager, Brain Health and Mental Wellbeing Division), D Gillespie (Director, Infection, Inflammation and Immunity Trials, Principal Research Fellow), R Hale (now Research Associate, School of Social Sciences, Cardiff University), J Latchem-Hastings (now Lecturer and Postdoctoral Fellow, School of Healthcare Sciences, Cardiff University), R Milton (Research Associate—Trial Manager), B Pell (now PhD student, DECIPHer Centre, Cardiff University), H Prout (Research Associate—Qualitative), V Shepherd (Senior Research Fellow), K Smallman (Research Associate), H Stanton (Research Associate—Senior Data Manager). Thanks are due to Kerry Hood and Aimee Grant for their involvement in developing processes and systems for qualitative research within CTR.

No specific grant was received to support the writing of this paper.

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JS contributed to the design of the work and interpretation of data and was responsible for leading the drafting and revision of the paper. SC contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. AL contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. EG contributed to a critical review of the manuscript and provided additional relevant references. JH provided feedback on initial drafts of the paper and contributed to subsequent revisions. JHu provided feedback on initial drafts of the paper and contributed to subsequent revisions. NG provided feedback on initial drafts of the paper and contributed to subsequent revisions. SM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. YM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. MR was involved in the interpretation of data and critical review and revision of the paper. HS contributed to the conception and design of the work, the acquisition and analysis of data, and the revision of the manuscript. JT provided feedback on initial drafts of the paper and contributed to subsequent revisions. LB-H made a substantial contribution to the design and conception of the work, led the acquisition and analysis of data, and contributed to the drafting and revision of the paper.

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Segrott, J., Channon, S., Lloyd, A. et al. Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts. Trials 25 , 323 (2024). https://doi.org/10.1186/s13063-024-08124-7

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Received : 20 October 2023

Accepted : 17 April 2024

Published : 16 May 2024

DOI : https://doi.org/10.1186/s13063-024-08124-7

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• Qualitative research
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• Randomised controlled trials

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Organizational aspects of tissue engineering clinical translation: insights from a qualitative case study

• Renan Gonçalves Leonel da Silva   ORCID: orcid.org/0000-0001-9679-6389 1 ,
• Larry Au 2 &
• Alessandro Blasimme 1  

Translational Medicine Communications volume  9 , Article number:  17 ( 2024 ) Cite this article

Metrics details

Tissue engineering is a multidisciplinary field that combines principles from cell biology, bioengineering, material sciences, medicine and surgery to create functional and viable bioproducts that can be used to repair or replace damaged or diseased tissues in the human body. The complexity of tissue engineering can affect the prospects of efficiently translating scientific discoveries in the field into scalable clinical approaches that could benefit patients. Organizational challenges may play a key role in the clinical translation of tissue engineering for the benefit of patients.

To gain insight into the organizational aspects of tissue engineering that may create impediments to efficient clinical translation, we conducted a retrospective qualitative case study of one tissue engineering multi-site translational project on knee cartilage engineered tissue grafts. We collected qualitative data using a set of different methods: semi-structured interviews, documentary research and audio-visual content analysis.

Our study identified various challenges associated to first-in-human trials in tissue engineering particularly related to: logistics and communication; research participant recruitment; clinician and medical student participation; study management; and regulation.

Conclusions

While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.

Introduction

Tissue engineering is a multidisciplinary field that combines principles from cell biology, bioengineering, material sciences, medicine and surgery to create functional and viable bioproducts that can be used to repair or replace damaged or diseased tissues in the human body [ 1 ]. Tissue engineering involves designing and fabricating artificial scaffolds, cultivating cells in vitro, and then integrating the cells and scaffolds into a functional tissue construct that can be implanted into the body. It has to potential to advance regenerative medicine, providing new treatments for a wide array of medical conditions, from organ failure to damaged tissue repair [ 2 ]. Cell sources for tissue engineering purposes include pluripotent and multipotent stem cells, progenitor cells, induced pluripotent stem cells as well as fully differentiated ones. Such cells can be sourced from donors, be retrieved in the course of biopsies, surgery and other medical procedures, or derived from embryos donated or generated for research purposes.

In the European Union, tissue engineering products are regulated by the European Medicines Agency (EMA) as advanced therapy medicinal products (ATMPs) via Regulation 1394/2007/EC [ 3 , 4 ]. Between 2009 and 2022, EMA has approved only 21 ATMPs, but for 7 of them marketing authorization was either withdrawn or not renewed [ 5 ]. Of the remaining 14 ATMPs, 11 are gene therapy products, 1 is a cell therapy product and 2 are tissue engineering products, namely Holoclar (an autologous therapy to repair damaged corneal surface) and Spherox (an autologous therapy to repair knee cartilage) [ 6 ].

These figures show that the process of efficiently translating tissue engineering approaches to clinical use is challenging. Many factors have been identified as impediments to clinical translation including insufficient scientific knowledge, lack of dedicated funding, inadequate regulatory frameworks, ethical barriers and intellectual property roadblocks [ 7 ]. However, it is not clear what specific impediments impinge on clinical translation in the field of regenerative medicine and in tissue engineering in particular [ 8 ].

To elucidate this issue and to gain insight into organizational barriers to clinical translation in tissue engineering, we conducted a retrospective qualitative case study based on a tissue engineering multi-site translational project on knee cartilage engineered tissue grafts.

This study aims to explore organizational impediments to the clinical translation of tissue engineering medicinal products. Given the complexity of the issue and the relative lack of published literature on such a specific topic, we decided to conduct a retrospective qualitative case study supported by a multimethod strategy of data access and analysis. The research protocol received approval from the Ethics Commission of ETH Zurich (2021-N-71).

Case study research is a kind of investigation consisting of a focused analysis of a single case aimed at shedding light on complex issues and at fostering understanding of key features of a given complex phenomenon [ 9 ]. Qualitative case studies are by their nature focused on the specific features of the case, they tend to be descriptive, and they favor heuristic interpretation over generalization of study results [ 10 ].

The choice of methods in qualitative case studies reflects researchers’ intuitions about which sources of knowledge are more likely to provide valuable insight about the case and, more in general, about the phenomenon under study [ 11 ]. Such sources can include people, documents, and ethnographic observations, to name those that are more frequently used.

Our case study is a publicly funded tissue engineering multi-site translational project on autologous cell-based engineered tissue grafts.

For the purpose of this paper, we have pseudonymized our primary data. Furthermore, we have made sure that neither participants, nor the analyzed project per se are identifiable.

This study employed a combined set of qualitative methods to analyze the practices, research behaviors, and organizational considerations in tissue engineering and translational research on engineered-cartilage implant and tissue repair, with a focus on ethical implications of development and clinical trials with ATMPs for regenerative medicine purposes.

The methods include the examination of transcripts generated from over than 200 min of interviews applied with the project’s Principal Investigator and two senior project managers (a scientific coordinator, responsible for the development of the tissue grafts, and the leader of Surgery, responsible for the replacement surgical procedure with participants); a review of twelve reports, and articles bringing project’s outcomes available on the website of the study or in the funder’s webpage, and an audiovisual content analysis of seven project presentations done by the researchers in which they explain in detail the organizational issues faced during the study.

Three researchers (a University Professor, a Senior Scientist and a Senior Surgeon) were selected for interviews, representing different roles within a multicentered clinical study. The interviews were conducted remotely between June and November 2021. The participants included a Principal Investigator/Professor of Tissue Engineering, a Senior Scientist/head of autologous cell-based engineered-cartilage research and development – also manager of clinical trial data and information, and a Physician/head of surgery and tissue graft implant.

The interviews aimed to gather insights into the project’s management, organizational challenges and the configuration of research processes. Data and personal information have been fully anonymized. Table  1 provides an overview of interviewees’ characteristics, including their roles within the multicentered clinical study.

Documentary research

Qualified data about this case is available in official websites and sources, such as reports, project description, case presentations and publications. Aiming to complement data from interviews, and to provide data robustness through diverse materials’ sources we selected twelve documents to compose a data package to be analyzed and triangulated with data from interviews.

The package consisted of official reports, scientific publications, conference proceedings, and relevant informational pieces from clinical blogs. These documents specifically discussed practices, research behaviors, and organizational considerations related to tissue engineering and translational research on engineered-cartilage implant and tissue repair. The analysis of these documents provided a comprehensive understanding of the research field. Table  2 presents the details of the twelve selected documents, including the original research articles, reports and other project outcomes. Data about publications were fully anonymized to avoid participant identification.

Audiovisual content analysis

Much evidence about the organizational challenges and emerging questions associated with first-in-human clinical trials in tissue engineering are available online in the format of videos and audiovisual content. The use of materials available digitally has gained space in multimethod qualitative studies that have recently introduced audiovisual content analysis as a mechanism to access reliable information about cases that deal with a scarce amount of data due to its novelty, restricted access or because it is a field under development [ 12 ].

Seven recorded videos (publicly available) were examined as part of the audiovisual content analysis. These videos were uploaded to the official channels of the project and funders and were fully available on streaming platforms. The audiovisual content analysis was fundamental in gaining insights into the project presentations, highlighting key aspects of the research, methodologies, and outcomes. The analysis of these materials complemented the findings from the interviews and documentary research.

To ensure confidentiality and protect the privacy of the individuals involved in the research, all information related to the researchers’ identity, institutional affiliation, and funders was anonymized. This anonymization process was in accordance with the consent forms signed by the participants and agreed upon by all parties involved. Table  3 outlines the characteristics of the seven presentations analyzed in the audiovisual content analysis, including the video source and key themes addressed.

The combination of these qualitative methods provided a multiperspective analysis of the tissue engineering clinical translation, with a specific focus on organizational aspects. While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.

Confounding variables and missing data are crucial considerations in our study. Although we did not address confounding variables, they could significantly impact the scope and conclusions of our analysis. Factors such as the geographical locations of participants and research/clinical staff, the level of technological novelty in first-in-human tissue engineering clinical translation (which may differ from other similar translational agendas), and contextual considerations within the research project, including the expertise of the team of scientists and clinicians, and years of experience in tissue engineering, are examples. We did not access data on these potential variables because our study aims to provide a broader overview of challenges and how stakeholders approach solutions.

Our study identified various challenges associated with first-in-human trials in tissue engineering, particularly related to five themes: (1) logistics and communication, (2) research participant recruitment, (3) clinicians and medical student participation, (4) study management, and (5) regulation.

Logistics and communication

Logistics and communicational issues emerged as a common concern between researchers and clinic stakeholders. It was noted that the coordination and effective exchange of information among various parties involved in the research process posed challenges.

For a participant leading the management of clinical trial’s data for over than a decade, problems derived from persistent difficulties in coordinating time and availability of both scientists and surgeons that advance the clinical trial in parallel with their current professional activities and commitments.

None of us have this trial as our exclusive activity or work responsibility. We all do it in parallel with teaching, supervising students, other projects and publishing results from previous projects. And the management of such a study takes a lot of time. To me, part of the challenges relate to this issue, and would be great to have a research team dedicated full-time to the trial, but this is not possible (Participant 2).

In this trial, time was directly related to regulations to bring results from the lab to the bedside, and with communication issues among scientists and healthcare professionals from different fields of expertise. A participant stated that time is a relevant variable in clinical trials in tissue engineering, and that to implement the study in accordance with all the rules and protocols takes long that demands better strategies of time allocation and mechanisms to push trials as routine of clinical practice.

Things take a lot of time in this kind of [clinical] study (…) Just to show you, for instance, we start this research back in 2000 and the first applicable standard operating procedure (SOP) for GMP production was examined in 2010.” (AvC 1). I think it’s important to start as complicated a necessary to understand the system, to design it. But then simplify it. Because otherwise it will not make it into the routine clinical practice (Participant 3).

The problem of time expenditure in covering regulatory demands was reinforced by a researcher during a presentation in 2022, framed as “challenges associated with moving lab results to translational studies”. They explained the logistics needed to set the laboratory to run such a first in human trial.

We went from a research lab to clinical studies. So, we had to move our lab to translational studies. And for that, you need to change your research protocol. You have to go for GMP (Good manufacturing parties) production and GMP compliant reagents, so, a lot of things to change in the end. To be compliant with this, we needed a quality management system composed by plenty of documentation… In our group we do both product manufacturing following GMP and also to deal with the paperwork for the clinical studies together with the surgeons, like study protocols, inform consent, etc. all this things… (AvC3).

The problem of logistics is also seen as result of the implementation of best practices and standards, which require acts of interpretation to fit local conditions and to guarantee that protocols will be respected accordingly by a team of researchers and clinicians spread in multiple countries:

We have a full team which is working on this. Because yes, there are some documentation that gives the guidelines. These are huge packs of documentations which are not simple to decipher and to interpret. So it requires experts. And I can say only with research culture, I would have trouble to address these issues… We cannot trust that a scientist will just read an article and understand what necessary. (Participant 2)

The communication issue was framed by a clinical study manager as the challenge “to make people to speak the same language” (Doc4). Researchers expressed the need for improved communication protocols to facilitate smooth collaboration and streamline the progress of the trial. A participant said it demands a clear communication between styles of thinking from science, engineering and clinics. To translate engineering principles into clinical practice, for this team member, entailed the need to become more scientific, and to master the most up-to-date scientific advances in a particular field.

For me it’s really dedication of being like a scientific surgeon. And I narrowed my clinical field to be more specialized, and to be able to cover all (AvC4).

Research participant recruitment

Effective management of participant recruitment also appeared as a notable organizational challenge in first-in-human trials of tissue engineering, requiring improved strategies and procedures. One interviewee stressed the relevance of being clear about safety to effectively recruit research participants.

In patient recruitment, a crucial issue of the clinical study is to demonstrate safety and efficacy, which should be given special attention already during the planning of the trial. (Doc3)

Skepticism among patients and their preference for similar tissue grafts already available on the market were identified as significant challenges in candidate selection. Researchers found that patients often had reservations and hesitations towards participating in trials involving novel tissue grafts.

(…) some people would not take the risk to get something new. They say, I go for what is already on the market (…) they want the new treatment instead of a prosthesis (…) I mean people think twice about whether they want to try something new or if they go for what is already available in the market for 10 years. (Participant 2).

Tissue grafts and biomaterials’ manufacturers work can, sometimes, clash with clinical priorities. From the point of view of tissue engineers, producing a tissue graft takes time, and many problems might emerge in this process. However, on the other hand, an interviewee points out that clinical workload (time) and lack of scientific skills affect recruitment’s efficiency due to technical issues placed beyond the clinical expertise.

The main problem is clinical workload. So time for research. I would also say it is related to the lack of research skills. There’s a lack of scientific knowledge on those methods. And also not only the scientific methods but creativity, ideas or innovation (Participant 3).

Transparency issues pertaining to participant recruitment and the communication of risks associated with first-in-human trials were identified as crucial concerns by researchers.

De facto, when they have for example a patient that does not entirely qualify for the inclusion criteria let’s say, then the tendency would be, well ‘why don’t we change the inclusion criteria so that we fit this patient’. And I must say that it never reaches a clash because we say, ‘well no’. Because otherwise we cannot address with the same powered design in this clinical trial with this scientific question. And so they accept it. But the tendency would be again to introduce always this level of flexibility (Participant 2).

The challenge of participant recruitment also relates to issues of transparency among groups of researchers working in the study. For a PI of the study, it is hard to control all variables emerging at the clinical side in multi-centered trials due to different approaches adopted by researcher to recruit participants.

I feel privileged to work with illuminated surgeons and clinicians. But from what I see in the international context, some [clinicians] offer an experimental procedure to a patient as a praxis [participant meant without fully discuss its risks and implications]. So new [protocols] have to be developed, have to be introduced in the clinic, but in the context of well-designed and transparently communicated trials. (Participant 1).

Clinician and medical student participation

The participation of clinicians and medical students in first-in-human trials was observed to be lower than initially anticipated by principal investigators (PIs) and project managers.

Clinician-researchers often take on multiple roles in translational research studies. Other than relying on themselves for recruitment, the team member also goes on to explain that they also rely on relationships and networks of co-workers, peers, and potential collaborators to recruit patients:

I have my outpatient service. So I see lots of patients myself. But if something is launched I inform colleagues to also watch out for possible patients. And we have a certain program of research education in the hospital. And every now and then I present, and then I also mention the ongoing projects so that people are informed. And it’s more or less the same in the lab. So we have progress reports, and where we have meetings. And maybe, sometimes it’s also just when having a coffee that you talk about such things. So very informal sometimes” (Participant 3).

Another researcher-clinician on the team also reports the importance of informal ties: “For instance [our team leader], if he know some surgeon who are interested in other clinic, it often starts like this. If you know someone, because then you know if people are motivated, if they work seriously, and everything. It’s a bit easier” (Participant 1). Informal ties thus not only help recruit potential patients, but also helps identify suitable collaborators.

Despite efforts to engage medical professionals in these trials, their involvement was below the expected levels. This limited participation raised concerns regarding the overall effectiveness and feasibility of the trials, as well as the potential impact on data collection and analysis. Then, to facilitate translational research, hospitals and universities can also implement organizational strategies of proximity and relation-work to facilitate exchanges in knowledge and ideas. As an interviewee responded:

Lots of surgeons were going into the lab for research year to learn basic science, to understand what is happening there, and also maybe giving back with this knowledge into the clinic. So there’s was a quite intense exchange. This is quite was quite key. And this was also supported by the department that you get the position and that you get a salary. Which is not the standard as a clinician, that you’re going to the lab and you receive a salary… So I was supported and was with overarching structure of the surgery and the university” (Participant 2).

Study management

As a multidisciplinary team engaged in the translation of engineering principles to the clinical context, there were moments when respondents highlighted potentials for clashes and conflicts in priorities, goals, and approaches between different team members.

If we want this science translated to a clinical setting, the challenge will be in my view to streamline and in most cases simplify processes to make them practical. I think some of the approaches that are being pursued are fantastic, are just conceptually so sophisticated and advanced. But the possibility to implement them into simple protocols that can be adopted by manufacturing groups and that can be transferable into the clinic is the main challenge (Participant 1).

The standardization of routines, availability of surgeons, the non-rare change of protocols for first-in-human trials in tissue engineering, and the management of patient participation were highlighted as key issues of the study management by PIs. A surgeon member of the clinical study pointed out the implementation of a standardized routine as a critical collective practice for the success of a clinical trial in tissue engineering, once it improves the reliability of procedures from the lab to the surgical table.

This is the requirement for scientific advances to be introduced clinically: a standardized routine. Because if we do not understand systems, we cannot control them. And people used to say, that the best way of understanding something is to is to create it. Because then you have a grasp on it (…) Standardization and reliability are necessary for clinical trials [and] for entering the routine practice for certain therapies (Participant 3).

A participant notes the need for standardization across organizations involved in the trial:

For this large multicenter study we are the ones who provide all the documentation to all the other centers. For instance, we write patient information, all those things, and they are translated to other languages if necessary of course. We have a standard operating procedure, so protocols, and try to make sure that everyone is following the same protocol in each country. We kind of centralize all the information when they send it back as well, if patients had problems, adverse events, everything… (Participant 2).

While strategies of proximity and relation-work may help with local regulators, regulators further away may be yet another challenge that researchers face when attempting to seek approval for their new projects.

Restrictive regulations due to the absence of protocols, limited patient availability, and translational lag in certain national contexts were identified as factors that compelled researchers to seek collaborations with international partners, as mentioned in a study report “At the same time, regulatory issues have become more complex, and there is no clear road map.” (Doc5).

The absence of established protocols specific to first-in-human trials in tissue engineering created uncertainty and hindered the overall efficiency of the research process. Since protocols in this area are constantly in change, it was framed by a scientist as a key challenge involved in the management of the clinical study.

You always need to continuous the development of your product, because clinical indications of our products are constantly changing. For example, sometimes the patients have larger defects to be treated. Then, we need to provide larger (tissue) grafts, so we need more cells. At the beginning we use to culture our cells with blood from the patient, so, no foreign product, so then we realized we would need to much blood from the patient to go for a larger production (laughs), so, not really nice as well… So then we changed products, for instance. Then, for that, you have to validate changing in raw material (replace autologous serum by hPL) and do a comparability study to show it is going to be the same.” (AvC1).

But the relationship between research teams with regulatory authorities also differs depending on the locale. As the project leader explained:

“We have received a lot of support and a lot of signals of flexibility to help us enter the early phases of the clinical trial. Clearly from a pilot trial, you want to reach marketing authorization for a product, then everything becomes more stringent. But in academic settings, to have an investigatory initiated clinical trial in [named the country], we have found the trajectory, the pathway is indeed facilitated by the regulatory agency. Which is less at the [international] level, and absolutely not the case at the [named third country] level… So we can consider ourselves privileged” (Participant 1).

According to an article cited by an interviewee (Doc9), the regulatory issues among scientists and physicians in multi-centered trials are directly associated to the lack of harmonization of regulations in the field internationally.

“A challenge for academia can arise not only from the regulations themselves, but also, in multi-centric studies, from the lack of harmonization between different countries. This becomes apparent in the different interpretation of European regulations, different implementation of directives in the national law of each country, requirements for qualification of personnel as well as in requirements for the manufacturing processes regarding quality of reagents and testing. This may lead to acceptance of a clinical trial in one country, but not in another, requiring several submissions until all authorities are satisfied.” (Doc9).

Due to regulatory constraints and inadequate patient pool in some countries, researchers faced difficulties in conducting the trials solely within national boundaries. As a result, international collaborations became imperative for overcoming these challenges and ensuring the progress and success of the research (Doc6 and AvC3).

Aside from external organizations, proximity and relation-work also aides in the management of regulatory oversight and scrutiny of research. As the surgical research member points out:

I recommend to contact the authorities early and keep in touch with them. (…) For research groups [that] have no experience with regulators, I tell to contact or collaborate with groups with experience on this. Those might have some ideas about good platforms for translation, that helps with regulation because it is quite a big field and takes a lot of work and time. And also lots of money. It is difficult for a small research lab to cover this (Participant 2).

Tissue engineering offers great prospects in the field of regenerative medicine to heal and repair tissue and bodily structures damaged by injury or disease. The clinical advantage of tissue engineering is that it offers biocompatible solutions that can be customized to the specific needs of patients, by harnessing the natural healing capacities of the human body while sustaining such process through bio-engineered scaffolds that greatly enhance the prospects of healing damage. Nevertheless, due to its technical complexity, tissue engineering poses critical challenges that demand a holistic approach to organizational management. Some organizational issues inherent to first-in-human clinical trials have been documented in the literature, especially regarding problems associated to market authorization and the regulatory processes [ 13 ].

In our study, researchers have also pointed persistent challenges of tissue engineering trials, as those also identified in our empirical analysis regarding to study management, clinician and medical student participation, recruitment and transparency. We highlight roles played by expertise access, resilient public engagement and efficient dialogue with patients, translational education and training, routines, and early consideration to ethics and regulation of new technologies as potential strategies to address challenges in tissue engineering trials. In Table  4 we summarize key challenges and its corresponding solutions as highlighted by participants of the study.

A recurrent theme discussed by the literature on translational research’s management deals with the importance of “expertise access” in such trials. The involvement of diverse specialists, including clinical researchers, cell biologists, surgeons and other healthcare professionals is integral to comprehensively assess the safety and potential efficacy of novel compounds. Wilkinson et al. (2017) [ 14 ] highlight the significance of early engagement of cross-disciplinary teams to facilitate robust trial design and ensure efficient execution. Similarly, Jones and Smith (2019) access to specialized expertise is important in identifying and addressing potential risks, thereby safeguarding the well-being of trial participants [ 15 ].

Simultaneously, the literature shows the critical role of organizational change in overcoming the challenges posed by first-in-human trials. Klim et al. (2020) advocate for the establishment of dedicated translational research units that facilitate streamlined decision-making processes and foster collaboration among stakeholders [ 16 ]. Such organizational innovations encompass adaptive trial designs, which allow flexibility in protocols based on emerging data, leading to more efficient resource allocation (time and expertise included), and quicker identification of compound attributes. Additionally, organizations should consider more efficient dialogue with patients as part of institutional mechanisms to both facilitate communication of benefits of new biotechnologies and to enhance access to future study participants.

The implications of organizational innovation extend beyond trial execution and influence the broader landscape of healthcare innovation. As noted by Brown et al. (2021), effective collaboration facilitates more accurate translation of preclinical data, reducing the likelihood of trial failures and optimizing resource allocation [ 17 ]. Innovative organizational approaches can expedite trial timelines and contribute to cost savings [ 18 ].

Overcoming logistical barriers, such as the availability of specialized professionals, can be particularly challenging in emerging areas of therapeutic intervention such new bioengineered tissue grafts and other biotechnologies holding higher levels of risk and translational failure [ 19 ]. Addressing these challenges is essential to fully realize the potential benefits a translational interface between science, engineering and medicine in clinical trials.

Finally, early ethical and regulatory considerations are a central component of first-in-human trials. Ensuring access to relevant expertise aligns with the ethical obligation to minimize risks to participants [ 20 ]. Furthermore, organizational innovations contribute to transparency and participants’ autonomy through enhanced communication, enabling participants to make better informed decisions about their involvement in trials. This ethical dimension adds weight to the relevance of both expertise access and organizational change in first in human trials.

Our study has limitations. The small number of participants might lead to questions about the statistical significance and relevance of the data used to formulate our hypotheses and considerations regarding the challenges and solutions to improve tissue engineering clinical translation. However, the limited number of research and clinical staff in the field has been highlighted by interviewees as a significant challenge within this realm of research and development. Additional limitations could arise from the anonymization of study participants, which may obscure potentially pertinent information concerning technical and organizational aspects related to the clinical translation of a specific biotechnology.

Our study illustrates the intricacy of organizational challenges in first-in-human clinical trials in tissue engineering and highlights the pivotal roles played by study management and interdisciplinary expertise to accommodate translational research competences and new knowledge. By harnessing specialized expertise and embracing innovative trial design approaches, stakeholders can navigate the complexity of clinical translation in tissue engineering more effectively, ultimately contributing to improved tissue engineering clinical translation.

These findings shed light on the complexities needed to conduct first-in-human trials in tissue engineering and underscore the need for effective strategies, standardized protocols, and international collaborations to overcome these challenges and advance the field.

While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering. The processes of clinical translation in tissue engineering have significantly advanced over the last decade.

Enhancing organizational tools, refining funding mechanisms, and incentivizing early ethical and regulatory scrutiny of new biotechnologies to tackle the issues outlined in our study could significantly reduce translational lag and prevent delays in promising tissue engineering clinical translation.

Data availability

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

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Acknowledgements

The authors acknowledge all the respondents of the interview study for their valuable input. We would also like to thank Shannon Hubbs for proofreading the final version of this manuscript.

This study is a result of the research project ‘Ethical and Regulatory Questions Related to Engineered Molecular Systems’, which was funded by the Swiss National Science Foundation through the National Centre of Competence in Research “Molecular Systems Engineering” (NCCR-MSE), grant n. 205608.

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Health Ethics and Policy Lab, Department of Health Sciences and Technology, ETH Zurich, Hottingerstrasse 10, Zurich, 8092, Switzerland

Renan Gonçalves Leonel da Silva & Alessandro Blasimme

Department of Sociology, Colin Powell School for Civic and Global Leadership, The City College of New York, New York, NY, USA

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RD accessed study participants, applied interviews, collected, transcribed, coded and analyzed the data regarding the organizational issues of first-in-human trial of tissue engineering clinical translation, as well as drafted the first version of this manuscript. LA assisted in data analysis, writing, drafting and reviewed all versions of the manuscript. AB analyzed the data, and actively worked on drafting all versions of the manuscript, as well as provided expert review, funding, supervision and lead the development of the manuscript to improve methodological accuracy and clarity. All authors read and approved the final manuscript.

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Correspondence to Renan Gonçalves Leonel da Silva .

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This research received the approval of the Ethics Commission of ETH Zurich (2021-N-71).

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da Silva, R.G.L., Au, L. & Blasimme, A. Organizational aspects of tissue engineering clinical translation: insights from a qualitative case study. transl med commun 9 , 17 (2024). https://doi.org/10.1186/s41231-024-00179-7

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Received : 23 January 2024

Accepted : 22 May 2024

Published : 30 May 2024

DOI : https://doi.org/10.1186/s41231-024-00179-7

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