guidelines for qualitative case study

Criteria for Good Qualitative Research: A Comprehensive Review

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• Published: 18 September 2021
• Volume 31 , pages 679–689, ( 2022 )

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This review aims to synthesize a published set of evaluative criteria for good qualitative research. The aim is to shed light on existing standards for assessing the rigor of qualitative research encompassing a range of epistemological and ontological standpoints. Using a systematic search strategy, published journal articles that deliberate criteria for rigorous research were identified. Then, references of relevant articles were surveyed to find noteworthy, distinct, and well-defined pointers to good qualitative research. This review presents an investigative assessment of the pivotal features in qualitative research that can permit the readers to pass judgment on its quality and to condemn it as good research when objectively and adequately utilized. Overall, this review underlines the crux of qualitative research and accentuates the necessity to evaluate such research by the very tenets of its being. It also offers some prospects and recommendations to improve the quality of qualitative research. Based on the findings of this review, it is concluded that quality criteria are the aftereffect of socio-institutional procedures and existing paradigmatic conducts. Owing to the paradigmatic diversity of qualitative research, a single and specific set of quality criteria is neither feasible nor anticipated. Since qualitative research is not a cohesive discipline, researchers need to educate and familiarize themselves with applicable norms and decisive factors to evaluate qualitative research from within its theoretical and methodological framework of origin.

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Introduction

“… It is important to regularly dialogue about what makes for good qualitative research” (Tracy, 2010 , p. 837)

To decide what represents good qualitative research is highly debatable. There are numerous methods that are contained within qualitative research and that are established on diverse philosophical perspectives. Bryman et al., ( 2008 , p. 262) suggest that “It is widely assumed that whereas quality criteria for quantitative research are well‐known and widely agreed, this is not the case for qualitative research.” Hence, the question “how to evaluate the quality of qualitative research” has been continuously debated. There are many areas of science and technology wherein these debates on the assessment of qualitative research have taken place. Examples include various areas of psychology: general psychology (Madill et al., 2000 ); counseling psychology (Morrow, 2005 ); and clinical psychology (Barker & Pistrang, 2005 ), and other disciplines of social sciences: social policy (Bryman et al., 2008 ); health research (Sparkes, 2001 ); business and management research (Johnson et al., 2006 ); information systems (Klein & Myers, 1999 ); and environmental studies (Reid & Gough, 2000 ). In the literature, these debates are enthused by the impression that the blanket application of criteria for good qualitative research developed around the positivist paradigm is improper. Such debates are based on the wide range of philosophical backgrounds within which qualitative research is conducted (e.g., Sandberg, 2000 ; Schwandt, 1996 ). The existence of methodological diversity led to the formulation of different sets of criteria applicable to qualitative research.

Among qualitative researchers, the dilemma of governing the measures to assess the quality of research is not a new phenomenon, especially when the virtuous triad of objectivity, reliability, and validity (Spencer et al., 2004 ) are not adequate. Occasionally, the criteria of quantitative research are used to evaluate qualitative research (Cohen & Crabtree, 2008 ; Lather, 2004 ). Indeed, Howe ( 2004 ) claims that the prevailing paradigm in educational research is scientifically based experimental research. Hypotheses and conjectures about the preeminence of quantitative research can weaken the worth and usefulness of qualitative research by neglecting the prominence of harmonizing match for purpose on research paradigm, the epistemological stance of the researcher, and the choice of methodology. Researchers have been reprimanded concerning this in “paradigmatic controversies, contradictions, and emerging confluences” (Lincoln & Guba, 2000 ).

In general, qualitative research tends to come from a very different paradigmatic stance and intrinsically demands distinctive and out-of-the-ordinary criteria for evaluating good research and varieties of research contributions that can be made. This review attempts to present a series of evaluative criteria for qualitative researchers, arguing that their choice of criteria needs to be compatible with the unique nature of the research in question (its methodology, aims, and assumptions). This review aims to assist researchers in identifying some of the indispensable features or markers of high-quality qualitative research. In a nutshell, the purpose of this systematic literature review is to analyze the existing knowledge on high-quality qualitative research and to verify the existence of research studies dealing with the critical assessment of qualitative research based on the concept of diverse paradigmatic stances. Contrary to the existing reviews, this review also suggests some critical directions to follow to improve the quality of qualitative research in different epistemological and ontological perspectives. This review is also intended to provide guidelines for the acceleration of future developments and dialogues among qualitative researchers in the context of assessing the qualitative research.

The rest of this review article is structured in the following fashion: Sect.  Methods describes the method followed for performing this review. Section Criteria for Evaluating Qualitative Studies provides a comprehensive description of the criteria for evaluating qualitative studies. This section is followed by a summary of the strategies to improve the quality of qualitative research in Sect.  Improving Quality: Strategies . Section  How to Assess the Quality of the Research Findings? provides details on how to assess the quality of the research findings. After that, some of the quality checklists (as tools to evaluate quality) are discussed in Sect.  Quality Checklists: Tools for Assessing the Quality . At last, the review ends with the concluding remarks presented in Sect.  Conclusions, Future Directions and Outlook . Some prospects in qualitative research for enhancing its quality and usefulness in the social and techno-scientific research community are also presented in Sect.  Conclusions, Future Directions and Outlook .

For this review, a comprehensive literature search was performed from many databases using generic search terms such as Qualitative Research , Criteria , etc . The following databases were chosen for the literature search based on the high number of results: IEEE Explore, ScienceDirect, PubMed, Google Scholar, and Web of Science. The following keywords (and their combinations using Boolean connectives OR/AND) were adopted for the literature search: qualitative research, criteria, quality, assessment, and validity. The synonyms for these keywords were collected and arranged in a logical structure (see Table 1 ). All publications in journals and conference proceedings later than 1950 till 2021 were considered for the search. Other articles extracted from the references of the papers identified in the electronic search were also included. A large number of publications on qualitative research were retrieved during the initial screening. Hence, to include the searches with the main focus on criteria for good qualitative research, an inclusion criterion was utilized in the search string.

From the selected databases, the search retrieved a total of 765 publications. Then, the duplicate records were removed. After that, based on the title and abstract, the remaining 426 publications were screened for their relevance by using the following inclusion and exclusion criteria (see Table 2 ). Publications focusing on evaluation criteria for good qualitative research were included, whereas those works which delivered theoretical concepts on qualitative research were excluded. Based on the screening and eligibility, 45 research articles were identified that offered explicit criteria for evaluating the quality of qualitative research and were found to be relevant to this review.

Figure  1 illustrates the complete review process in the form of PRISMA flow diagram. PRISMA, i.e., “preferred reporting items for systematic reviews and meta-analyses” is employed in systematic reviews to refine the quality of reporting.

PRISMA flow diagram illustrating the search and inclusion process. N represents the number of records

Criteria for Evaluating Qualitative Studies

Fundamental criteria: general research quality.

Various researchers have put forward criteria for evaluating qualitative research, which have been summarized in Table 3 . Also, the criteria outlined in Table 4 effectively deliver the various approaches to evaluate and assess the quality of qualitative work. The entries in Table 4 are based on Tracy’s “Eight big‐tent criteria for excellent qualitative research” (Tracy, 2010 ). Tracy argues that high-quality qualitative work should formulate criteria focusing on the worthiness, relevance, timeliness, significance, morality, and practicality of the research topic, and the ethical stance of the research itself. Researchers have also suggested a series of questions as guiding principles to assess the quality of a qualitative study (Mays & Pope, 2020 ). Nassaji ( 2020 ) argues that good qualitative research should be robust, well informed, and thoroughly documented.

Qualitative Research: Interpretive Paradigms

All qualitative researchers follow highly abstract principles which bring together beliefs about ontology, epistemology, and methodology. These beliefs govern how the researcher perceives and acts. The net, which encompasses the researcher’s epistemological, ontological, and methodological premises, is referred to as a paradigm, or an interpretive structure, a “Basic set of beliefs that guides action” (Guba, 1990 ). Four major interpretive paradigms structure the qualitative research: positivist and postpositivist, constructivist interpretive, critical (Marxist, emancipatory), and feminist poststructural. The complexity of these four abstract paradigms increases at the level of concrete, specific interpretive communities. Table 5 presents these paradigms and their assumptions, including their criteria for evaluating research, and the typical form that an interpretive or theoretical statement assumes in each paradigm. Moreover, for evaluating qualitative research, quantitative conceptualizations of reliability and validity are proven to be incompatible (Horsburgh, 2003 ). In addition, a series of questions have been put forward in the literature to assist a reviewer (who is proficient in qualitative methods) for meticulous assessment and endorsement of qualitative research (Morse, 2003 ). Hammersley ( 2007 ) also suggests that guiding principles for qualitative research are advantageous, but methodological pluralism should not be simply acknowledged for all qualitative approaches. Seale ( 1999 ) also points out the significance of methodological cognizance in research studies.

Table 5 reflects that criteria for assessing the quality of qualitative research are the aftermath of socio-institutional practices and existing paradigmatic standpoints. Owing to the paradigmatic diversity of qualitative research, a single set of quality criteria is neither possible nor desirable. Hence, the researchers must be reflexive about the criteria they use in the various roles they play within their research community.

Improving Quality: Strategies

Another critical question is “How can the qualitative researchers ensure that the abovementioned quality criteria can be met?” Lincoln and Guba ( 1986 ) delineated several strategies to intensify each criteria of trustworthiness. Other researchers (Merriam & Tisdell, 2016 ; Shenton, 2004 ) also presented such strategies. A brief description of these strategies is shown in Table 6 .

It is worth mentioning that generalizability is also an integral part of qualitative research (Hays & McKibben, 2021 ). In general, the guiding principle pertaining to generalizability speaks about inducing and comprehending knowledge to synthesize interpretive components of an underlying context. Table 7 summarizes the main metasynthesis steps required to ascertain generalizability in qualitative research.

Figure  2 reflects the crucial components of a conceptual framework and their contribution to decisions regarding research design, implementation, and applications of results to future thinking, study, and practice (Johnson et al., 2020 ). The synergy and interrelationship of these components signifies their role to different stances of a qualitative research study.

Essential elements of a conceptual framework

In a nutshell, to assess the rationale of a study, its conceptual framework and research question(s), quality criteria must take account of the following: lucid context for the problem statement in the introduction; well-articulated research problems and questions; precise conceptual framework; distinct research purpose; and clear presentation and investigation of the paradigms. These criteria would expedite the quality of qualitative research.

How to Assess the Quality of the Research Findings?

The inclusion of quotes or similar research data enhances the confirmability in the write-up of the findings. The use of expressions (for instance, “80% of all respondents agreed that” or “only one of the interviewees mentioned that”) may also quantify qualitative findings (Stenfors et al., 2020 ). On the other hand, the persuasive reason for “why this may not help in intensifying the research” has also been provided (Monrouxe & Rees, 2020 ). Further, the Discussion and Conclusion sections of an article also prove robust markers of high-quality qualitative research, as elucidated in Table 8 .

Quality Checklists: Tools for Assessing the Quality

Numerous checklists are available to speed up the assessment of the quality of qualitative research. However, if used uncritically and recklessly concerning the research context, these checklists may be counterproductive. I recommend that such lists and guiding principles may assist in pinpointing the markers of high-quality qualitative research. However, considering enormous variations in the authors’ theoretical and philosophical contexts, I would emphasize that high dependability on such checklists may say little about whether the findings can be applied in your setting. A combination of such checklists might be appropriate for novice researchers. Some of these checklists are listed below:

The most commonly used framework is Consolidated Criteria for Reporting Qualitative Research (COREQ) (Tong et al., 2007 ). This framework is recommended by some journals to be followed by the authors during article submission.

Standards for Reporting Qualitative Research (SRQR) is another checklist that has been created particularly for medical education (O’Brien et al., 2014 ).

Also, Tracy ( 2010 ) and Critical Appraisal Skills Programme (CASP, 2021 ) offer criteria for qualitative research relevant across methods and approaches.

Further, researchers have also outlined different criteria as hallmarks of high-quality qualitative research. For instance, the “Road Trip Checklist” (Epp & Otnes, 2021 ) provides a quick reference to specific questions to address different elements of high-quality qualitative research.

Conclusions, Future Directions, and Outlook

This work presents a broad review of the criteria for good qualitative research. In addition, this article presents an exploratory analysis of the essential elements in qualitative research that can enable the readers of qualitative work to judge it as good research when objectively and adequately utilized. In this review, some of the essential markers that indicate high-quality qualitative research have been highlighted. I scope them narrowly to achieve rigor in qualitative research and note that they do not completely cover the broader considerations necessary for high-quality research. This review points out that a universal and versatile one-size-fits-all guideline for evaluating the quality of qualitative research does not exist. In other words, this review also emphasizes the non-existence of a set of common guidelines among qualitative researchers. In unison, this review reinforces that each qualitative approach should be treated uniquely on account of its own distinctive features for different epistemological and disciplinary positions. Owing to the sensitivity of the worth of qualitative research towards the specific context and the type of paradigmatic stance, researchers should themselves analyze what approaches can be and must be tailored to ensemble the distinct characteristics of the phenomenon under investigation. Although this article does not assert to put forward a magic bullet and to provide a one-stop solution for dealing with dilemmas about how, why, or whether to evaluate the “goodness” of qualitative research, it offers a platform to assist the researchers in improving their qualitative studies. This work provides an assembly of concerns to reflect on, a series of questions to ask, and multiple sets of criteria to look at, when attempting to determine the quality of qualitative research. Overall, this review underlines the crux of qualitative research and accentuates the need to evaluate such research by the very tenets of its being. Bringing together the vital arguments and delineating the requirements that good qualitative research should satisfy, this review strives to equip the researchers as well as reviewers to make well-versed judgment about the worth and significance of the qualitative research under scrutiny. In a nutshell, a comprehensive portrayal of the research process (from the context of research to the research objectives, research questions and design, speculative foundations, and from approaches of collecting data to analyzing the results, to deriving inferences) frequently proliferates the quality of a qualitative research.

Prospects : A Road Ahead for Qualitative Research

Irrefutably, qualitative research is a vivacious and evolving discipline wherein different epistemological and disciplinary positions have their own characteristics and importance. In addition, not surprisingly, owing to the sprouting and varied features of qualitative research, no consensus has been pulled off till date. Researchers have reflected various concerns and proposed several recommendations for editors and reviewers on conducting reviews of critical qualitative research (Levitt et al., 2021 ; McGinley et al., 2021 ). Following are some prospects and a few recommendations put forward towards the maturation of qualitative research and its quality evaluation:

In general, most of the manuscript and grant reviewers are not qualitative experts. Hence, it is more likely that they would prefer to adopt a broad set of criteria. However, researchers and reviewers need to keep in mind that it is inappropriate to utilize the same approaches and conducts among all qualitative research. Therefore, future work needs to focus on educating researchers and reviewers about the criteria to evaluate qualitative research from within the suitable theoretical and methodological context.

There is an urgent need to refurbish and augment critical assessment of some well-known and widely accepted tools (including checklists such as COREQ, SRQR) to interrogate their applicability on different aspects (along with their epistemological ramifications).

Efforts should be made towards creating more space for creativity, experimentation, and a dialogue between the diverse traditions of qualitative research. This would potentially help to avoid the enforcement of one's own set of quality criteria on the work carried out by others.

Moreover, journal reviewers need to be aware of various methodological practices and philosophical debates.

It is pivotal to highlight the expressions and considerations of qualitative researchers and bring them into a more open and transparent dialogue about assessing qualitative research in techno-scientific, academic, sociocultural, and political rooms.

Frequent debates on the use of evaluative criteria are required to solve some potentially resolved issues (including the applicability of a single set of criteria in multi-disciplinary aspects). Such debates would not only benefit the group of qualitative researchers themselves, but primarily assist in augmenting the well-being and vivacity of the entire discipline.

To conclude, I speculate that the criteria, and my perspective, may transfer to other methods, approaches, and contexts. I hope that they spark dialog and debate – about criteria for excellent qualitative research and the underpinnings of the discipline more broadly – and, therefore, help improve the quality of a qualitative study. Further, I anticipate that this review will assist the researchers to contemplate on the quality of their own research, to substantiate research design and help the reviewers to review qualitative research for journals. On a final note, I pinpoint the need to formulate a framework (encompassing the prerequisites of a qualitative study) by the cohesive efforts of qualitative researchers of different disciplines with different theoretic-paradigmatic origins. I believe that tailoring such a framework (of guiding principles) paves the way for qualitative researchers to consolidate the status of qualitative research in the wide-ranging open science debate. Dialogue on this issue across different approaches is crucial for the impending prospects of socio-techno-educational research.

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Yadav, D. Criteria for Good Qualitative Research: A Comprehensive Review. Asia-Pacific Edu Res 31 , 679–689 (2022). https://doi.org/10.1007/s40299-021-00619-0

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Methodology or method? A critical review of qualitative case study reports

Despite on-going debate about credibility, and reported limitations in comparison to other approaches, case study is an increasingly popular approach among qualitative researchers. We critically analysed the methodological descriptions of published case studies. Three high-impact qualitative methods journals were searched to locate case studies published in the past 5 years; 34 were selected for analysis. Articles were categorized as health and health services ( n= 12), social sciences and anthropology ( n= 7), or methods ( n= 15) case studies. The articles were reviewed using an adapted version of established criteria to determine whether adequate methodological justification was present, and if study aims, methods, and reported findings were consistent with a qualitative case study approach. Findings were grouped into five themes outlining key methodological issues: case study methodology or method, case of something particular and case selection, contextually bound case study, researcher and case interactions and triangulation, and study design inconsistent with methodology reported. Improved reporting of case studies by qualitative researchers will advance the methodology for the benefit of researchers and practitioners.

Case study research is an increasingly popular approach among qualitative researchers (Thomas, 2011 ). Several prominent authors have contributed to methodological developments, which has increased the popularity of case study approaches across disciplines (Creswell, 2013b ; Denzin & Lincoln, 2011b ; Merriam, 2009 ; Ragin & Becker, 1992 ; Stake, 1995 ; Yin, 2009 ). Current qualitative case study approaches are shaped by paradigm, study design, and selection of methods, and, as a result, case studies in the published literature vary. Differences between published case studies can make it difficult for researchers to define and understand case study as a methodology.

Experienced qualitative researchers have identified case study research as a stand-alone qualitative approach (Denzin & Lincoln, 2011b ). Case study research has a level of flexibility that is not readily offered by other qualitative approaches such as grounded theory or phenomenology. Case studies are designed to suit the case and research question and published case studies demonstrate wide diversity in study design. There are two popular case study approaches in qualitative research. The first, proposed by Stake ( 1995 ) and Merriam ( 2009 ), is situated in a social constructivist paradigm, whereas the second, by Yin ( 2012 ), Flyvbjerg ( 2011 ), and Eisenhardt ( 1989 ), approaches case study from a post-positivist viewpoint. Scholarship from both schools of inquiry has contributed to the popularity of case study and development of theoretical frameworks and principles that characterize the methodology.

The diversity of case studies reported in the published literature, and on-going debates about credibility and the use of case study in qualitative research practice, suggests that differences in perspectives on case study methodology may prevent researchers from developing a mutual understanding of practice and rigour. In addition, discussion about case study limitations has led some authors to query whether case study is indeed a methodology (Luck, Jackson, & Usher, 2006 ; Meyer, 2001 ; Thomas, 2010 ; Tight, 2010 ). Methodological discussion of qualitative case study research is timely, and a review is required to analyse and understand how this methodology is applied in the qualitative research literature. The aims of this study were to review methodological descriptions of published qualitative case studies, to review how the case study methodological approach was applied, and to identify issues that need to be addressed by researchers, editors, and reviewers. An outline of the current definitions of case study and an overview of the issues proposed in the qualitative methodological literature are provided to set the scene for the review.

Definitions of qualitative case study research

Case study research is an investigation and analysis of a single or collective case, intended to capture the complexity of the object of study (Stake, 1995 ). Qualitative case study research, as described by Stake ( 1995 ), draws together “naturalistic, holistic, ethnographic, phenomenological, and biographic research methods” in a bricoleur design, or in his words, “a palette of methods” (Stake, 1995 , pp. xi–xii). Case study methodology maintains deep connections to core values and intentions and is “particularistic, descriptive and heuristic” (Merriam, 2009 , p. 46).

As a study design, case study is defined by interest in individual cases rather than the methods of inquiry used. The selection of methods is informed by researcher and case intuition and makes use of naturally occurring sources of knowledge, such as people or observations of interactions that occur in the physical space (Stake, 1998 ). Thomas ( 2011 ) suggested that “analytical eclecticism” is a defining factor (p. 512). Multiple data collection and analysis methods are adopted to further develop and understand the case, shaped by context and emergent data (Stake, 1995 ). This qualitative approach “explores a real-life, contemporary bounded system (a case ) or multiple bounded systems (cases) over time, through detailed, in-depth data collection involving multiple sources of information … and reports a case description and case themes ” (Creswell, 2013b , p. 97). Case study research has been defined by the unit of analysis, the process of study, and the outcome or end product, all essentially the case (Merriam, 2009 ).

The case is an object to be studied for an identified reason that is peculiar or particular. Classification of the case and case selection procedures informs development of the study design and clarifies the research question. Stake ( 1995 ) proposed three types of cases and study design frameworks. These include the intrinsic case, the instrumental case, and the collective instrumental case. The intrinsic case is used to understand the particulars of a single case, rather than what it represents. An instrumental case study provides insight on an issue or is used to refine theory. The case is selected to advance understanding of the object of interest. A collective refers to an instrumental case which is studied as multiple, nested cases, observed in unison, parallel, or sequential order. More than one case can be simultaneously studied; however, each case study is a concentrated, single inquiry, studied holistically in its own entirety (Stake, 1995 , 1998 ).

Researchers who use case study are urged to seek out what is common and what is particular about the case. This involves careful and in-depth consideration of the nature of the case, historical background, physical setting, and other institutional and political contextual factors (Stake, 1998 ). An interpretive or social constructivist approach to qualitative case study research supports a transactional method of inquiry, where the researcher has a personal interaction with the case. The case is developed in a relationship between the researcher and informants, and presented to engage the reader, inviting them to join in this interaction and in case discovery (Stake, 1995 ). A postpositivist approach to case study involves developing a clear case study protocol with careful consideration of validity and potential bias, which might involve an exploratory or pilot phase, and ensures that all elements of the case are measured and adequately described (Yin, 2009 , 2012 ).

Current methodological issues in qualitative case study research

The future of qualitative research will be influenced and constructed by the way research is conducted, and by what is reviewed and published in academic journals (Morse, 2011 ). If case study research is to further develop as a principal qualitative methodological approach, and make a valued contribution to the field of qualitative inquiry, issues related to methodological credibility must be considered. Researchers are required to demonstrate rigour through adequate descriptions of methodological foundations. Case studies published without sufficient detail for the reader to understand the study design, and without rationale for key methodological decisions, may lead to research being interpreted as lacking in quality or credibility (Hallberg, 2013 ; Morse, 2011 ).

There is a level of artistic license that is embraced by qualitative researchers and distinguishes practice, which nurtures creativity, innovation, and reflexivity (Denzin & Lincoln, 2011b ; Morse, 2009 ). Qualitative research is “inherently multimethod” (Denzin & Lincoln, 2011a , p. 5); however, with this creative freedom, it is important for researchers to provide adequate description for methodological justification (Meyer, 2001 ). This includes paradigm and theoretical perspectives that have influenced study design. Without adequate description, study design might not be understood by the reader, and can appear to be dishonest or inaccurate. Reviewers and readers might be confused by the inconsistent or inappropriate terms used to describe case study research approach and methods, and be distracted from important study findings (Sandelowski, 2000 ). This issue extends beyond case study research, and others have noted inconsistencies in reporting of methodology and method by qualitative researchers. Sandelowski ( 2000 , 2010 ) argued for accurate identification of qualitative description as a research approach. She recommended that the selected methodology should be harmonious with the study design, and be reflected in methods and analysis techniques. Similarly, Webb and Kevern ( 2000 ) uncovered inconsistencies in qualitative nursing research with focus group methods, recommending that methodological procedures must cite seminal authors and be applied with respect to the selected theoretical framework. Incorrect labelling using case study might stem from the flexibility in case study design and non-directional character relative to other approaches (Rosenberg & Yates, 2007 ). Methodological integrity is required in design of qualitative studies, including case study, to ensure study rigour and to enhance credibility of the field (Morse, 2011 ).

Case study has been unnecessarily devalued by comparisons with statistical methods (Eisenhardt, 1989 ; Flyvbjerg, 2006 , 2011 ; Jensen & Rodgers, 2001 ; Piekkari, Welch, & Paavilainen, 2009 ; Tight, 2010 ; Yin, 1999 ). It is reputed to be the “the weak sibling” in comparison to other, more rigorous, approaches (Yin, 2009 , p. xiii). Case study is not an inherently comparative approach to research. The objective is not statistical research, and the aim is not to produce outcomes that are generalizable to all populations (Thomas, 2011 ). Comparisons between case study and statistical research do little to advance this qualitative approach, and fail to recognize its inherent value, which can be better understood from the interpretive or social constructionist viewpoint of other authors (Merriam, 2009 ; Stake, 1995 ). Building on discussions relating to “fuzzy” (Bassey, 2001 ), or naturalistic generalizations (Stake, 1978 ), or transference of concepts and theories (Ayres, Kavanaugh, & Knafl, 2003 ; Morse et al., 2011 ) would have more relevance.

Case study research has been used as a catch-all design to justify or add weight to fundamental qualitative descriptive studies that do not fit with other traditional frameworks (Merriam, 2009 ). A case study has been a “convenient label for our research—when we ‘can't think of anything ‘better”—in an attempt to give it [qualitative methodology] some added respectability” (Tight, 2010 , p. 337). Qualitative case study research is a pliable approach (Merriam, 2009 ; Meyer, 2001 ; Stake, 1995 ), and has been likened to a “curious methodological limbo” (Gerring, 2004 , p. 341) or “paradigmatic bridge” (Luck et al., 2006 , p. 104), that is on the borderline between postpositivist and constructionist interpretations. This has resulted in inconsistency in application, which indicates that flexibility comes with limitations (Meyer, 2001 ), and the open nature of case study research might be off-putting to novice researchers (Thomas, 2011 ). The development of a well-(in)formed theoretical framework to guide a case study should improve consistency, rigour, and trust in studies published in qualitative research journals (Meyer, 2001 ).

Assessment of rigour

The purpose of this study was to analyse the methodological descriptions of case studies published in qualitative methods journals. To do this we needed to develop a suitable framework, which used existing, established criteria for appraising qualitative case study research rigour (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ). A number of qualitative authors have developed concepts and criteria that are used to determine whether a study is rigorous (Denzin & Lincoln, 2011b ; Lincoln, 1995 ; Sandelowski & Barroso, 2002 ). The criteria proposed by Stake ( 1995 ) provide a framework for readers and reviewers to make judgements regarding case study quality, and identify key characteristics essential for good methodological rigour. Although each of the factors listed in Stake's criteria could enhance the quality of a qualitative research report, in Table I we present an adapted criteria used in this study, which integrates more recent work by Merriam ( 2009 ) and Creswell ( 2013b ). Stake's ( 1995 ) original criteria were separated into two categories. The first list of general criteria is “relevant for all qualitative research.” The second list, “high relevance to qualitative case study research,” was the criteria that we decided had higher relevance to case study research. This second list was the main criteria used to assess the methodological descriptions of the case studies reviewed. The complete table has been preserved so that the reader can determine how the original criteria were adapted.

Framework for assessing quality in qualitative case study research.

Adapted from Stake ( 1995 , p. 131).

Study design

The critical review method described by Grant and Booth ( 2009 ) was used, which is appropriate for the assessment of research quality, and is used for literature analysis to inform research and practice. This type of review goes beyond the mapping and description of scoping or rapid reviews, to include “analysis and conceptual innovation” (Grant & Booth, 2009 , p. 93). A critical review is used to develop existing, or produce new, hypotheses or models. This is different to systematic reviews that answer clinical questions. It is used to evaluate existing research and competing ideas, to provide a “launch pad” for conceptual development and “subsequent testing” (Grant & Booth, 2009 , p. 93).

Qualitative methods journals were located by a search of the 2011 ISI Journal Citation Reports in Social Science, via the database Web of Knowledge (see m.webofknowledge.com). No “qualitative research methods” category existed in the citation reports; therefore, a search of all categories was performed using the term “qualitative.” In Table II , we present the qualitative methods journals located, ranked by impact factor. The highest ranked journals were selected for searching. We acknowledge that the impact factor ranking system might not be the best measure of journal quality (Cheek, Garnham, & Quan, 2006 ); however, this was the most appropriate and accessible method available.

International Journal of Qualitative Studies on Health and Well-being.

Search strategy

In March 2013, searches of the journals, Qualitative Health Research , Qualitative Research , and Qualitative Inquiry were completed to retrieve studies with “case study” in the abstract field. The search was limited to the past 5 years (1 January 2008 to 1 March 2013). The objective was to locate published qualitative case studies suitable for assessment using the adapted criterion. Viewpoints, commentaries, and other article types were excluded from review. Title and abstracts of the 45 retrieved articles were read by the first author, who identified 34 empirical case studies for review. All authors reviewed the 34 studies to confirm selection and categorization. In Table III , we present the 34 case studies grouped by journal, and categorized by research topic, including health sciences, social sciences and anthropology, and methods research. There was a discrepancy in categorization of one article on pedagogy and a new teaching method published in Qualitative Inquiry (Jorrín-Abellán, Rubia-Avi, Anguita-Martínez, Gómez-Sánchez, & Martínez-Mones, 2008 ). Consensus was to allocate to the methods category.

Outcomes of search of qualitative methods journals.

In Table III , the number of studies located, and final numbers selected for review have been reported. Qualitative Health Research published the most empirical case studies ( n= 16). In the health category, there were 12 case studies of health conditions, health services, and health policy issues, all published in Qualitative Health Research . Seven case studies were categorized as social sciences and anthropology research, which combined case study with biography and ethnography methodologies. All three journals published case studies on methods research to illustrate a data collection or analysis technique, methodological procedure, or related issue.

The methodological descriptions of 34 case studies were critically reviewed using the adapted criteria. All articles reviewed contained a description of study methods; however, the length, amount of detail, and position of the description in the article varied. Few studies provided an accurate description and rationale for using a qualitative case study approach. In the 34 case studies reviewed, three described a theoretical framework informed by Stake ( 1995 ), two by Yin ( 2009 ), and three provided a mixed framework informed by various authors, which might have included both Yin and Stake. Few studies described their case study design, or included a rationale that explained why they excluded or added further procedures, and whether this was to enhance the study design, or to better suit the research question. In 26 of the studies no reference was provided to principal case study authors. From reviewing the description of methods, few authors provided a description or justification of case study methodology that demonstrated how their study was informed by the methodological literature that exists on this approach.

The methodological descriptions of each study were reviewed using the adapted criteria, and the following issues were identified: case study methodology or method; case of something particular and case selection; contextually bound case study; researcher and case interactions and triangulation; and, study design inconsistent with methodology. An outline of how the issues were developed from the critical review is provided, followed by a discussion of how these relate to the current methodological literature.

Case study methodology or method

A third of the case studies reviewed appeared to use a case report method, not case study methodology as described by principal authors (Creswell, 2013b ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). Case studies were identified as a case report because of missing methodological detail and by review of the study aims and purpose. These reports presented data for small samples of no more than three people, places or phenomenon. Four studies, or “case reports” were single cases selected retrospectively from larger studies (Bronken, Kirkevold, Martinsen, & Kvigne, 2012 ; Coltart & Henwood, 2012 ; Hooghe, Neimeyer, & Rober, 2012 ; Roscigno et al., 2012 ). Case reports were not a case of something, instead were a case demonstration or an example presented in a report. These reports presented outcomes, and reported on how the case could be generalized. Descriptions focussed on the phenomena, rather than the case itself, and did not appear to study the case in its entirety.

Case reports had minimal in-text references to case study methodology, and were informed by other qualitative traditions or secondary sources (Adamson & Holloway, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nagar-Ron & Motzafi-Haller, 2011 ). This does not suggest that case study methodology cannot be multimethod, however, methodology should be consistent in design, be clearly described (Meyer, 2001 ; Stake, 1995 ), and maintain focus on the case (Creswell, 2013b ).

To demonstrate how case reports were identified, three examples are provided. The first, Yeh ( 2013 ) described their study as, “the examination of the emergence of vegetarianism in Victorian England serves as a case study to reveal the relationships between boundaries and entities” (p. 306). The findings were a historical case report, which resulted from an ethnographic study of vegetarianism. Cunsolo Willox, Harper, Edge, ‘My Word’: Storytelling and Digital Media Lab, and Rigolet Inuit Community Government (2013) used “a case study that illustrates the usage of digital storytelling within an Inuit community” (p. 130). This case study reported how digital storytelling can be used with indigenous communities as a participatory method to illuminate the benefits of this method for other studies. This “case study was conducted in the Inuit community” but did not include the Inuit community in case analysis (Cunsolo Willox et al., 2013 , p. 130). Bronken et al. ( 2012 ) provided a single case report to demonstrate issues observed in a larger clinical study of aphasia and stroke, without adequate case description or analysis.

Case study of something particular and case selection

Case selection is a precursor to case analysis, which needs to be presented as a convincing argument (Merriam, 2009 ). Descriptions of the case were often not adequate to ascertain why the case was selected, or whether it was a particular exemplar or outlier (Thomas, 2011 ). In a number of case studies in the health and social science categories, it was not explicit whether the case was of something particular, or peculiar to their discipline or field (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson, Botelho, Welch, Joseph, & Tennstedt, 2012 ; Mawn et al., 2010 ; Snyder-Young, 2011 ). There were exceptions in the methods category ( Table III ), where cases were selected by researchers to report on a new or innovative method. The cases emerged through heuristic study, and were reported to be particular, relative to the existing methods literature (Ajodhia-Andrews & Berman, 2009 ; Buckley & Waring, 2013 ; Cunsolo Willox et al., 2013 ; De Haene, Grietens, & Verschueren, 2010 ; Gratton & O'Donnell, 2011 ; Sumsion, 2013 ; Wimpenny & Savin-Baden, 2012 ).

Case selection processes were sometimes insufficient to understand why the case was selected from the global population of cases, or what study of this case would contribute to knowledge as compared with other possible cases (Adamson & Holloway, 2012 ; Bronken et al., 2012 ; Colón-Emeric et al., 2010 ; Jackson et al., 2012 ; Mawn et al., 2010 ). In two studies, local cases were selected (Barone, 2010 ; Fourie & Theron, 2012 ) because the researcher was familiar with and had access to the case. Possible limitations of a convenience sample were not acknowledged. Purposeful sampling was used to recruit participants within the case of one study, but not of the case itself (Gallagher et al., 2013 ). Random sampling was completed for case selection in two studies (Colón-Emeric et al., 2010 ; Jackson et al., 2012 ), which has limited meaning in interpretive qualitative research.

To demonstrate how researchers provided a good justification for the selection of case study approaches, four examples are provided. The first, cases of residential care homes, were selected because of reported occurrences of mistreatment, which included residents being locked in rooms at night (Rytterström, Unosson, & Arman, 2013 ). Roscigno et al. ( 2012 ) selected cases of parents who were admitted for early hospitalization in neonatal intensive care with a threatened preterm delivery before 26 weeks. Hooghe et al. ( 2012 ) used random sampling to select 20 couples that had experienced the death of a child; however, the case study was of one couple and a particular metaphor described only by them. The final example, Coltart and Henwood ( 2012 ), provided a detailed account of how they selected two cases from a sample of 46 fathers based on personal characteristics and beliefs. They described how the analysis of the two cases would contribute to their larger study on first time fathers and parenting.

Contextually bound case study

The limits or boundaries of the case are a defining factor of case study methodology (Merriam, 2009 ; Ragin & Becker, 1992 ; Stake, 1995 ; Yin, 2009 ). Adequate contextual description is required to understand the setting or context in which the case is revealed. In the health category, case studies were used to illustrate a clinical phenomenon or issue such as compliance and health behaviour (Colón-Emeric et al., 2010 ; D'Enbeau, Buzzanell, & Duckworth, 2010 ; Gallagher et al., 2013 ; Hooghe et al., 2012 ; Jackson et al., 2012 ; Roscigno et al., 2012 ). In these case studies, contextual boundaries, such as physical and institutional descriptions, were not sufficient to understand the case as a holistic system, for example, the general practitioner (GP) clinic in Gallagher et al. ( 2013 ), or the nursing home in Colón-Emeric et al. ( 2010 ). Similarly, in the social science and methods categories, attention was paid to some components of the case context, but not others, missing important information required to understand the case as a holistic system (Alexander, Moreira, & Kumar, 2012 ; Buzzanell & D'Enbeau, 2009 ; Nairn & Panelli, 2009 ; Wimpenny & Savin-Baden, 2012 ).

In two studies, vicarious experience or vignettes (Nairn & Panelli, 2009 ) and images (Jorrín-Abellán et al., 2008 ) were effective to support description of context, and might have been a useful addition for other case studies. Missing contextual boundaries suggests that the case might not be adequately defined. Additional information, such as the physical, institutional, political, and community context, would improve understanding of the case (Stake, 1998 ). In Boxes 1 and 2 , we present brief synopses of two studies that were reviewed, which demonstrated a well bounded case. In Box 1 , Ledderer ( 2011 ) used a qualitative case study design informed by Stake's tradition. In Box 2 , Gillard, Witt, and Watts ( 2011 ) were informed by Yin's tradition. By providing a brief outline of the case studies in Boxes 1 and 2 , we demonstrate how effective case boundaries can be constructed and reported, which may be of particular interest to prospective case study researchers.

Article synopsis of case study research using Stake's tradition

Ledderer ( 2011 ) used a qualitative case study research design, informed by modern ethnography. The study is bounded to 10 general practice clinics in Denmark, who had received federal funding to implement preventative care services based on a Motivational Interviewing intervention. The researcher question focussed on “why is it so difficult to create change in medical practice?” (Ledderer, 2011 , p. 27). The study context was adequately described, providing detail on the general practitioner (GP) clinics and relevant political and economic influences. Methodological decisions are described in first person narrative, providing insight on researcher perspectives and interaction with the case. Forty-four interviews were conducted, which focussed on how GPs conducted consultations, and the form, nature and content, rather than asking their opinion or experience (Ledderer, 2011 , p. 30). The duration and intensity of researcher immersion in the case enhanced depth of description and trustworthiness of study findings. Analysis was consistent with Stake's tradition, and the researcher provided examples of inquiry techniques used to challenge assumptions about emerging themes. Several other seminal qualitative works were cited. The themes and typology constructed are rich in narrative data and storytelling by clinic staff, demonstrating individual clinic experiences as well as shared meanings and understandings about changing from a biomedical to psychological approach to preventative health intervention. Conclusions make note of social and cultural meanings and lessons learned, which might not have been uncovered using a different methodology.

Article synopsis of case study research using Yin's tradition

Gillard et al. ( 2011 ) study of camps for adolescents living with HIV/AIDs provided a good example of Yin's interpretive case study approach. The context of the case is bounded by the three summer camps of which the researchers had prior professional involvement. A case study protocol was developed that used multiple methods to gather information at three data collection points coinciding with three youth camps (Teen Forum, Discover Camp, and Camp Strong). Gillard and colleagues followed Yin's ( 2009 ) principles, using a consistent data protocol that enhanced cross-case analysis. Data described the young people, the camp physical environment, camp schedule, objectives and outcomes, and the staff of three youth camps. The findings provided a detailed description of the context, with less detail of individual participants, including insight into researcher's interpretations and methodological decisions throughout the data collection and analysis process. Findings provided the reader with a sense of “being there,” and are discovered through constant comparison of the case with the research issues; the case is the unit of analysis. There is evidence of researcher immersion in the case, and Gillard reports spending significant time in the field in a naturalistic and integrated youth mentor role.

This case study is not intended to have a significant impact on broader health policy, although does have implications for health professionals working with adolescents. Study conclusions will inform future camps for young people with chronic disease, and practitioners are able to compare similarities between this case and their own practice (for knowledge translation). No limitations of this article were reported. Limitations related to publication of this case study were that it was 20 pages long and used three tables to provide sufficient description of the camp and program components, and relationships with the research issue.

Researcher and case interactions and triangulation

Researcher and case interactions and transactions are a defining feature of case study methodology (Stake, 1995 ). Narrative stories, vignettes, and thick description are used to provoke vicarious experience and a sense of being there with the researcher in their interaction with the case. Few of the case studies reviewed provided details of the researcher's relationship with the case, researcher–case interactions, and how these influenced the development of the case study (Buzzanell & D'Enbeau, 2009 ; D'Enbeau et al., 2010 ; Gallagher et al., 2013 ; Gillard et al., 2011 ; Ledderer, 2011 ; Nagar-Ron & Motzafi-Haller, 2011 ). The role and position of the researcher needed to be self-examined and understood by readers, to understand how this influenced interactions with participants, and to determine what triangulation is needed (Merriam, 2009 ; Stake, 1995 ).

Gillard et al. ( 2011 ) provided a good example of triangulation, comparing data sources in a table (p. 1513). Triangulation of sources was used to reveal as much depth as possible in the study by Nagar-Ron and Motzafi-Haller ( 2011 ), while also enhancing confirmation validity. There were several case studies that would have benefited from improved range and use of data sources, and descriptions of researcher–case interactions (Ajodhia-Andrews & Berman, 2009 ; Bronken et al., 2012 ; Fincham, Scourfield, & Langer, 2008 ; Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Snyder-Young, 2011 ; Yeh, 2013 ).

Study design inconsistent with methodology

Good, rigorous case studies require a strong methodological justification (Meyer, 2001 ) and a logical and coherent argument that defines paradigm, methodological position, and selection of study methods (Denzin & Lincoln, 2011b ). Methodological justification was insufficient in several of the studies reviewed (Barone, 2010 ; Bronken et al., 2012 ; Hooghe et al., 2012 ; Mawn et al., 2010 ; Roscigno et al., 2012 ; Yeh, 2013 ). This was judged by the absence, or inadequate or inconsistent reference to case study methodology in-text.

In six studies, the methodological justification provided did not relate to case study. There were common issues identified. Secondary sources were used as primary methodological references indicating that study design might not have been theoretically sound (Colón-Emeric et al., 2010 ; Coltart & Henwood, 2012 ; Roscigno et al., 2012 ; Snyder-Young, 2011 ). Authors and sources cited in methodological descriptions were inconsistent with the actual study design and practices used (Fourie & Theron, 2012 ; Hooghe et al., 2012 ; Jorrín-Abellán et al., 2008 ; Mawn et al., 2010 ; Rytterström et al., 2013 ; Wimpenny & Savin-Baden, 2012 ). This occurred when researchers cited Stake or Yin, or both (Mawn et al., 2010 ; Rytterström et al., 2013 ), although did not follow their paradigmatic or methodological approach. In 26 studies there were no citations for a case study methodological approach.

The findings of this study have highlighted a number of issues for researchers. A considerable number of case studies reviewed were missing key elements that define qualitative case study methodology and the tradition cited. A significant number of studies did not provide a clear methodological description or justification relevant to case study. Case studies in health and social sciences did not provide sufficient information for the reader to understand case selection, and why this case was chosen above others. The context of the cases were not described in adequate detail to understand all relevant elements of the case context, which indicated that cases may have not been contextually bounded. There were inconsistencies between reported methodology, study design, and paradigmatic approach in case studies reviewed, which made it difficult to understand the study methodology and theoretical foundations. These issues have implications for methodological integrity and honesty when reporting study design, which are values of the qualitative research tradition and are ethical requirements (Wager & Kleinert, 2010a ). Poorly described methodological descriptions may lead the reader to misinterpret or discredit study findings, which limits the impact of the study, and, as a collective, hinders advancements in the broader qualitative research field.

The issues highlighted in our review build on current debates in the case study literature, and queries about the value of this methodology. Case study research can be situated within different paradigms or designed with an array of methods. In order to maintain the creativity and flexibility that is valued in this methodology, clearer descriptions of paradigm and theoretical position and methods should be provided so that study findings are not undervalued or discredited. Case study research is an interdisciplinary practice, which means that clear methodological descriptions might be more important for this approach than other methodologies that are predominantly driven by fewer disciplines (Creswell, 2013b ).

Authors frequently omit elements of methodologies and include others to strengthen study design, and we do not propose a rigid or purist ideology in this paper. On the contrary, we encourage new ideas about using case study, together with adequate reporting, which will advance the value and practice of case study. The implications of unclear methodological descriptions in the studies reviewed were that study design appeared to be inconsistent with reported methodology, and key elements required for making judgements of rigour were missing. It was not clear whether the deviations from methodological tradition were made by researchers to strengthen the study design, or because of misinterpretations. Morse ( 2011 ) recommended that innovations and deviations from practice are best made by experienced researchers, and that a novice might be unaware of the issues involved with making these changes. To perpetuate the tradition of case study research, applications in the published literature should have consistencies with traditional methodological constructions, and deviations should be described with a rationale that is inherent in study conduct and findings. Providing methodological descriptions that demonstrate a strong theoretical foundation and coherent study design will add credibility to the study, while ensuring the intrinsic meaning of case study is maintained.

The value of this review is that it contributes to discussion of whether case study is a methodology or method. We propose possible reasons why researchers might make this misinterpretation. Researchers may interchange the terms methods and methodology, and conduct research without adequate attention to epistemology and historical tradition (Carter & Little, 2007 ; Sandelowski, 2010 ). If the rich meaning that naming a qualitative methodology brings to the study is not recognized, a case study might appear to be inconsistent with the traditional approaches described by principal authors (Creswell, 2013a ; Merriam, 2009 ; Stake, 1995 ; Yin, 2009 ). If case studies are not methodologically and theoretically situated, then they might appear to be a case report.

Case reports are promoted by university and medical journals as a method of reporting on medical or scientific cases; guidelines for case reports are publicly available on websites ( http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/case_report.html ). The various case report guidelines provide a general criteria for case reports, which describes that this form of report does not meet the criteria of research, is used for retrospective analysis of up to three clinical cases, and is primarily illustrative and for educational purposes. Case reports can be published in academic journals, but do not require approval from a human research ethics committee. Traditionally, case reports describe a single case, to explain how and what occurred in a selected setting, for example, to illustrate a new phenomenon that has emerged from a larger study. A case report is not necessarily particular or the study of a case in its entirety, and the larger study would usually be guided by a different research methodology.

This description of a case report is similar to what was provided in some studies reviewed. This form of report lacks methodological grounding and qualities of research rigour. The case report has publication value in demonstrating an example and for dissemination of knowledge (Flanagan, 1999 ). However, case reports have different meaning and purpose to case study, which needs to be distinguished. Findings of our review suggest that the medical understanding of a case report has been confused with qualitative case study approaches.

In this review, a number of case studies did not have methodological descriptions that included key characteristics of case study listed in the adapted criteria, and several issues have been discussed. There have been calls for improvements in publication quality of qualitative research (Morse, 2011 ), and for improvements in peer review of submitted manuscripts (Carter & Little, 2007 ; Jasper, Vaismoradi, Bondas, & Turunen, 2013 ). The challenging nature of editor and reviewers responsibilities are acknowledged in the literature (Hames, 2013 ; Wager & Kleinert, 2010b ); however, review of case study methodology should be prioritized because of disputes on methodological value.

Authors using case study approaches are recommended to describe their theoretical framework and methods clearly, and to seek and follow specialist methodological advice when needed (Wager & Kleinert, 2010a ). Adequate page space for case study description would contribute to better publications (Gillard et al., 2011 ). Capitalizing on the ability to publish complementary resources should be considered.

Limitations of the review

There is a level of subjectivity involved in this type of review and this should be considered when interpreting study findings. Qualitative methods journals were selected because the aims and scope of these journals are to publish studies that contribute to methodological discussion and development of qualitative research. Generalist health and social science journals were excluded that might have contained good quality case studies. Journals in business or education were also excluded, although a review of case studies in international business journals has been published elsewhere (Piekkari et al., 2009 ).

The criteria used to assess the quality of the case studies were a set of qualitative indicators. A numerical or ranking system might have resulted in different results. Stake's ( 1995 ) criteria have been referenced elsewhere, and was deemed the best available (Creswell, 2013b ; Crowe et al., 2011 ). Not all qualitative studies are reported in a consistent way and some authors choose to report findings in a narrative form in comparison to a typical biomedical report style (Sandelowski & Barroso, 2002 ), if misinterpretations were made this may have affected the review.

Case study research is an increasingly popular approach among qualitative researchers, which provides methodological flexibility through the incorporation of different paradigmatic positions, study designs, and methods. However, whereas flexibility can be an advantage, a myriad of different interpretations has resulted in critics questioning the use of case study as a methodology. Using an adaptation of established criteria, we aimed to identify and assess the methodological descriptions of case studies in high impact, qualitative methods journals. Few articles were identified that applied qualitative case study approaches as described by experts in case study design. There were inconsistencies in methodology and study design, which indicated that researchers were confused whether case study was a methodology or a method. Commonly, there appeared to be confusion between case studies and case reports. Without clear understanding and application of the principles and key elements of case study methodology, there is a risk that the flexibility of the approach will result in haphazard reporting, and will limit its global application as a valuable, theoretically supported methodology that can be rigorously applied across disciplines and fields.

Conflict of interest and funding

The authors have not received any funding or benefits from industry or elsewhere to conduct this study.

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Designing and Conducting Case Studies

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

Definition and Overview

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

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

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

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

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

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

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

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

Educational Applications

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

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

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

Types and Design Concerns

Researchers use multiple methods and approaches to conduct case studies.

Types of Case Studies

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

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

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

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

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

Identifying a Theoretical Perspective

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

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

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

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

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

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

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

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

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

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

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

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

Designing a Case Study

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

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

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

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

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

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

Conducting Case Studies

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

Method: Single or Multi-modal?

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

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

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

Participant Selection

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

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

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

Data Collection

There are six types of data collected in case studies:

• Archival records.
• Interviews.
• Direct observation.
• Participant observation.

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

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

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

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

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

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

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

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

Data Analysis

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

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

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

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

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

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

Composing the Case Study Report

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

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

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

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

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

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

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

Issues of Validity and Reliability

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

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

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

Commentary on Case Studies

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

Strengths and Weaknesses of Case Studies

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

Flexibility

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

Emphasis on Context

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

Inherent Subjectivity

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

High Investment

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

Ethical Considerations

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

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

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

Concerns about Reliability, Validity, and Generalizability

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

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

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

Annotated Bibliography

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

No abstract available.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This article provides tips for writing more effective case studies.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Related Links

Consider the following list of related Web sites for more information on the topic of case study research. Note: although many of the links cover the general category of qualitative research, all have sections that address issues of case studies.

• Sage Publications on Qualitative Methodology: Search here for a comprehensive list of new books being published about "Qualitative Methodology" http://www.sagepub.co.uk/
• The International Journal of Qualitative Studies in Education: An on-line journal "to enhance the theory and practice of qualitative research in education." On-line submissions are welcome. http://www.tandf.co.uk/journals/tf/09518398.html
• Qualitative Research Resources on the Internet: From syllabi to home pages to bibliographies. All links relate somehow to qualitative research. http://www.nova.edu/ssss/QR/qualres.html

Becker, Bronwyn, Patrick Dawson, Karen Devine, Carla Hannum, Steve Hill, Jon Leydens, Debbie Matuskevich, Carol Traver, & Mike Palmquist. (2005). Case Studies. Writing@CSU . Colorado State University. https://writing.colostate.edu/guides/guide.cfm?guideid=60

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

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

Research question

• Conceptual framework
• Conceptual vs. theoretical framework

Data collection

• Qualitative research methods
• Focus groups
• Observational research

What is a case study?

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

• Ethnographical research
• Ethical considerations
• Confidentiality and privacy
• Power dynamics
• Reflexivity

Case studies

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

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

Definition of a case study

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

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

Characteristics of case studies

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

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

The role of case studies in research

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

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

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

What is the purpose of a case study?

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

Why use case studies in qualitative research?

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

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

The explanatory, exploratory, and descriptive roles of case studies

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

The impact of case studies on knowledge development

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

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

Types of case studies

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

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

Exploratory case studies

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

Descriptive case studies

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

Explanatory case studies

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

Intrinsic, instrumental, and collective case studies

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

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

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

Critical information systems research

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

Health research

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

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

Asthma research studies

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

Other fields

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

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

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

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

Propositions

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

Units of analysis

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

Argumentation

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

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

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

Defining the research question

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

Selecting and defining the case

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

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

Developing a detailed case study protocol

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

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

Collecting data

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

Analyzing and interpreting data

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

Writing the case study report

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

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

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

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

Observations

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

Documents and artifacts

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

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

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

Ensuring the quality of data collection

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

Data analysis

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

Organizing the data

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

Categorizing and coding the data

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

Identifying patterns and themes

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

Interpreting the data

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

Verification of the data

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

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

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

Benefits include the following:

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

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

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

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

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• Standards for reporting qualitative research: a synthesis of recommendations
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SRQR and COREQ Reporting Guidelines for Qualitative Studies

• 1 Department of Surgery, University of Michigan, Ann Arbor
• 2 Institute for Health Policy and Innovation, University of Michigan, Ann Arbor
• 3 Department of Emergency Medicine, UCLA David Geffen School of Medicine, Los Angeles, California
• 4 Statistical Editor, JAMA Surgery
• 5 Web and Social Media Editor, JAMA Surgery
• Editorial Effective Use of Reporting Guidelines to Improve the Quality of Surgical Research Benjamin S. Brooke, MD, PhD; Amir A. Ghaferi, MD, MSc; Melina R. Kibbe, MD JAMA Surgery
• Guide to Statistics and Methods SQUIRE Reporting Guidelines for Quality Improvement Studies Rachel R. Kelz, MD, MSCE, MBA; Todd A. Schwartz, DrPH; Elliott R. Haut, MD, PhD JAMA Surgery
• Guide to Statistics and Methods STROBE Reporting Guidelines for Observational Studies Amir A. Ghaferi, MD, MS; Todd A. Schwartz, DrPH; Timothy M. Pawlik, MD, MPH, PhD JAMA Surgery
• Guide to Statistics and Methods CHEERS Reporting Guidelines for Economic Evaluations Oluwadamilola M. Fayanju, MD, MA, MPHS; Jason S. Haukoos, MD, MSc; Jennifer F. Tseng, MD, MPH JAMA Surgery
• Guide to Statistics and Methods TRIPOD Reporting Guidelines for Diagnostic and Prognostic Studies Rachel E. Patzer, PhD, MPH; Amy H. Kaji, MD, PhD; Yuman Fong, MD JAMA Surgery
• Guide to Statistics and Methods ISPOR Reporting Guidelines for Comparative Effectiveness Research Nader N. Massarweh, MD, MPH; Jason S. Haukoos, MD, MSc; Amir A. Ghaferi, MD, MS JAMA Surgery
• Guide to Statistics and Methods PRISMA Reporting Guidelines for Meta-analyses and Systematic Reviews Shipra Arya, MD, SM; Amy H. Kaji, MD, PhD; Marja A. Boermeester, MD, PhD JAMA Surgery
• Guide to Statistics and Methods AAPOR Reporting Guidelines for Survey Studies Susan C. Pitt, MD, MPHS; Todd A. Schwartz, DrPH; Danny Chu, MD JAMA Surgery
• Guide to Statistics and Methods MOOSE Reporting Guidelines for Meta-analyses of Observational Studies Benjamin S. Brooke, MD, PhD; Todd A. Schwartz, DrPH, MS; Timothy M. Pawlik, MD, MPH, PhD JAMA Surgery
• Guide to Statistics and Methods TREND Reporting Guidelines for Nonrandomized/Quasi-Experimental Study Designs Alex B. Haynes, MD, MPH; Jason S. Haukoos, MD, MSc; Justin B. Dimick, MD, MPH JAMA Surgery
• Guide to Statistics and Methods The CONSORT Framework Ryan P. Merkow, MD, MS; Amy H. Kaji, MD, PhD; Kamal M. F. Itani, MD JAMA Surgery

Appropriate criteria for evaluating rigor in qualitative research depend on the specifics of the approach and methods used, but inadequate reporting hinders the ability of readers to interpret and assess the strength of any qualitative study. 1 - 5 The Standards for Reporting Qualitative Research (SRQR) 5 and the Consolidated Criteria for Reporting Qualitative Research (COREQ) 4 are 2 attempts to improve transparency in qualitative health research through standardizing study reporting ( Box ). Both guidelines were derived by comparing, synthesizing, and supplementing previously published recommendations. The COREQ checklist was published in 2007, synthesized 22 original sources, and is a 32-item checklist. The SRQR was published in 2014, synthesized 40 original sources (including the COREQ), incorporated a review by 5 independent experts, and resulted in a 21-item list of standards.

• Editorial Effective Use of Reporting Guidelines to Improve the Quality of Surgical Research JAMA Surgery

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Dossett LA , Kaji AH , Cochran A. SRQR and COREQ Reporting Guidelines for Qualitative Studies. JAMA Surg. 2021;156(9):875–876. doi:10.1001/jamasurg.2021.0525

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• Volume 29, Issue 3
• Rapid reviews methods series: guidance on rapid qualitative evidence synthesis
• Article Text
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• http://orcid.org/0000-0003-4808-3880 Andrew Booth 1 , 2 ,
• Isolde Sommer 3 , 4 ,
• http://orcid.org/0000-0003-4238-5984 Jane Noyes 2 , 5 ,
• Catherine Houghton 2 , 6 ,
• Fiona Campbell 1 , 7
• The Cochrane Rapid Reviews Methods Group and Cochrane Qualitative and Implementation Methods Group (CQIMG)
• 1 EnSyGN Sheffield Evidence Synthesis Group , University of Sheffield , Sheffield , UK
• 2 Cochrane Qualitative and Implementation Methods Group (CQIMG) , London , UK
• 3 Department for Evidence-based Medicine and Evaluation , University for Continuing Education Krems , Krems , Austria
• 4 Cochrane Rapid Reviews Group & Cochrane Austria , Krems , Austria
• 5 Bangor University , Bangor , UK
• 6 University of Galway , Galway , Ireland
• 7 University of Newcastle upon Tyne , Newcastle upon Tyne , UK
• Correspondence to Professor Andrew Booth, Univ Sheffield, Sheffield, UK; a.booth{at}sheffield.ac.uk

This paper forms part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group and addresses rapid qualitative evidence syntheses (QESs), which use modified systematic, transparent and reproducible methodsu to accelerate the synthesis of qualitative evidence when faced with resource constraints. This guidance covers the review process as it relates to synthesis of qualitative research. ‘Rapid’ or ‘resource-constrained’ QES require use of templates and targeted knowledge user involvement. Clear definition of perspectives and decisions on indirect evidence, sampling and use of existing QES help in targeting eligibility criteria. Involvement of an information specialist, especially in prioritising databases, targeting grey literature and planning supplemental searches, can prove invaluable. Use of templates and frameworks in study selection and data extraction can be accompanied by quality assurance procedures targeting areas of likely weakness. Current Cochrane guidance informs selection of tools for quality assessment and of synthesis method. Thematic and framework synthesis facilitate efficient synthesis of large numbers of studies or plentiful data. Finally, judicious use of Grading of Recommendations Assessment, Development and Evaluation approach for assessing the Confidence of Evidence from Reviews of Qualitative research assessments and of software as appropriate help to achieve a timely and useful review product.

• Systematic Reviews as Topic
• Patient Care

Data availability statement

No data are available. Not applicable. All data is from published articles.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjebm-2023-112620

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Rapid Qualitative Evidence Synthesis (QES) is a relatively recent innovation in evidence synthesis and few published examples currently exists.

Guidance for authoring a rapid QES is scattered and requires compilation and summary.

WHAT THIS STUDY ADDS

This paper represents the first attempt to compile current guidance, illustrated by the experience of several international review teams.

We identify features of rapid QES methods that could be accelerated or abbreviated and where methods resemble those for conventional QESs.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

This paper offers guidance for researchers when conducting a rapid QES and informs commissioners of research and policy-makers what to expect when commissioning such a review.

Introduction

This paper forms part of a series from the Cochrane Rapid Reviews Methods Group providing methodological guidance for rapid reviews. While other papers in the series 1–4 focus on generic considerations, we aim to provide in-depth recommendations specific to a resource-constrained (or rapid) qualitative evidence synthesis (rQES). 5 This paper is accompanied by recommended resources ( online supplemental appendix A ) and an elaboration with practical considerations ( online supplemental appendix B ).

Supplemental material

The role of qualitative evidence in decision-making is increasingly recognised. 6 This, in turn, has led to appreciation of the value of qualitative evidence syntheses (QESs) that summarise findings across multiple contexts. 7 Recognition of the need for such syntheses to be available at the time most useful to decision-making has, in turn, driven demand for rapid qualitative evidence syntheses. 8 The breadth of potential rQES mirrors the versatility of QES in general (from focused questions to broad overviews) and outputs range from descriptive thematic maps through to theory-informed syntheses (see table 1 ).

• View inline

Glossary of important terms (alphabetically)

As with other resource-constrained reviews, no one size fits all. A team should start by specifying the phenomenon of interest, the review question, 9 the perspectives to be included 9 and the sample to be determined and selected. 10 Subsequently, the team must finalise the appropriate choice of synthesis. 11 Above all, the review team should consider the intended knowledge users, 3 including requirements of the funder.

An rQES team, in particular, cannot afford any extra time or resource requirements that might arise from either a misunderstanding of the review question, an unclear picture of user requirements or an inappropriate choice of methods. The team seeks to align the review question and the requirements of the knowledge user with available time and resources. They also need to ensure that the choice of data and choice of synthesis are appropriate to the intended ‘knowledge claims’ (epistemology) made by the rQES. 11 This involves the team asking ‘what types of data are meaningful for this review question?’, ‘what types of data are trustworthy?’ and ‘is the favoured synthesis method appropriate for this type of data?’. 12 This paper aims to help rQES teams to choose methods that best fit their project while understanding the limitations of those choices. Our recommendations derive from current QES guidance, 5 evidence on modified QES methods, 8 13 and practical experience. 14 15

This paper presents an overview of considerations and recommendations as described in table 2 . Supplemental materials including additional resources details of our recommendations and practical examples are provided in online supplemental appendices A and B .

Recommendations for resource-constrained qualitative evidence synthesis (rQES)

Setting the review question and topic refinement

Rapid reviews summarise information from multiple research studies to produce evidence for ‘the public, researchers, policymakers and funders in a systematic, resource-efficient manner’. 16 Involvement of knowledge users is critical. 3 Given time constraints, individual knowledge users could be asked only to feedback on very specific decisions and tasks or on selective sections of the protocol. Specifically, whenever a QES is abbreviated or accelerated, a team should ensure that the review question is agreed by a minimum number of knowledge users with expertise or experience that reflects all the important review perspectives and with authority to approve the final version 2 5 11 ( table 2 , item R1).

Involvement of topic experts can ensure that the rQES is responsive to need. 14 17 One Cochrane rQES saved considerable time by agreeing the review topic within a single meeting and one-phase iteration. 9 Decisions on topics to be omitted are also informed by a knowledge of existing QESs. 17

An information specialist can help to manage the quantity and quality of available evidence by setting conceptual boundaries and logistic limits. A structured question format, such as Setting-Perspective-Interest, phenomenon of-Comparison-Evaluation or Population-Interest, phenomenon of-Context helps in communicating the scope and, subsequently, in operationalising study selection. 9 18

Scoping (of review parameters) and mapping (of key types of evidence and likely richness of data) helps when planning the review. 5 19 The option to choose purposive sampling over comprehensive sampling approaches, as offered by standard QES, may be particularly helpful in the context of a rapid QES. 8 Once a team knows the approximate number and distribution of studies, perhaps mapping them against country, age, ethnicity, etc), they can decide whether or not to use purposive sampling. 12 An rQES for the WHO combined purposive with variation sampling. Sampling in two stages started by reducing the initial number of studies to a more manageable sampling frame and then sampling approximately a third of the remaining studies from within the sampling frame. 20

Sampling may target richer studies and/or privilege diversity. 8 21 A rich qualitative study typically illustrates findings with verbatim extracts from transcripts from interviews or textual responses from questionnaires. Rich studies are often found in specialist qualitative research or social science journals. In contrast, less rich studies may itemise themes with an occasional indicative text extract and tend to summarise findings. In clinical or biomedical journals less rich findings may be placed within a single table or box.

No rule exists on an optimal number of studies; too many studies makes it challenging to ‘maintain insight’, 22 too few does not sustain rigorous analysis. 23 Guidance on sampling is available from the forthcoming Cochrane-Campbell QES Handbook.

A review team can use templates to fast-track writing of a protocol. The protocol should always be publicly available ( table 2 , item R2). 24 25 Formal registration may require that the team has not commenced data extraction but should be considered if it does not compromise the rQES timeframe. Time pressures may require that methods are left suitably flexible to allow well-justified changes to be made as a detailed picture of the studies and data emerge. 26 The first Cochrane rQES drew heavily on text from a joint protocol/review template previously produced within Cochrane. 24

Setting eligibility criteria

An rQES team may need to limit the number of perspectives, focusing on those most important for decision-making 5 9 27 ( table 2 , item R3). Beyond the patients/clients each additional perspective (eg, family members, health professionals, other professionals, etc) multiplies the additional effort involved.

A rapid QES may require strict date and setting restrictions 17 and language restrictions that accommodate the specific requirements of the review. Specifically, the team should consider whether changes in context over time or substantive differences between geographical regions could be used to justify a narrower date range or a limited coverage of countries and/or languages. The team should also decide if ‘indirect evidence’ is to substitute for the absence of direct evidence. An rQES typically focuses on direct evidence, except when only indirect evidence is available 28 ( table 2 , item R4). Decisions on relevance are challenging—precautions for swine influenza may inform precautions for bird influenza. 28 A smoking ban may operate similarly to seat belt legislation, etc. A review team should identify where such shared mechanisms might operate. 28 An rQES team must also decide whether to use frameworks or models to focus the review. Theories may be unearthed within the topic search or be already known to team members, fro example, Theory of Planned Behaviour. 29

Options for managing the quantity and quality of studies and data emerge during the scoping (see above). In summary, the review team should consider privileging rich qualitative studies 2 ; consider a stepwise approach to inclusion of qualitative data and explore the possibility of sampling ( table 2 , item R5). For example, where data is plentiful an rQES may be limited to qualitative research and/or to mixed methods studies. Where data is less plentiful then surveys or other qualitative data sources may need to be included. Where plentiful reviews already exist, a team may decide to conduct a review of reviews 5 by including multiple QES within a mega-synthesis 28 29 ( table 2 , item R6).

Searching for QES merits its own guidance, 21–23 30 this section reinforces important considerations from guidance specific to qualitative research. Generic guidance for rapid reviews in this series broadly applies to rapid QESs. 1

In addition to journal articles, by far the most plentiful source, qualitative research is found in book chapters, theses and in published and unpublished reports. 21 Searches to support an rQES can (a) limit the number of databases searched, deliberately selecting databases from diverse disciplines, (b) use abbreviated study filters to retrieve qualitative designs and (c) employ high yield complementary methods (eg, reference checking, citation searching and Related Articles features). An information specialist (eg, librarian) should be involved in prioritising sources and search methods ( table 2 , item R7). 11 14

According to empirical evidence optimal database combinations include Scopus plus CINAHL or Scopus plus ProQuest Dissertations and Theses Global (two-database combinations) and Scopus plus CINAHL plus ProQuest Dissertations and Theses Global (three-database combination) with both choices retrieving between 89% and 92% of relevant studies. 30

If resources allow, searches should include one or two specialised databases ( table 2 , item R8) from different disciplines or contexts 21 (eg, social science databases, specialist discipline databases or regional or institutional repositories). Even when resources are limited, the information specialist should factor in time for peer review of at least one search strategy ( table 2 , item R9). 31 Searches for ‘grey literature’ should selectively target appropriate types of grey literature (such as theses or process evaluations) and supplemental searches, including citation chaining or Related Articles features ( table 2 , item R10). 32 The first Cochrane rQES reported that searching reference lists of key papers yielded an extra 30 candidate papers for review. However, the team documented exclusion of grey literature as a limitation of their review. 15

Study selection

Consistency in study selection is achieved by using templates, by gaining a shared team understanding of the audience and purpose, and by ongoing communication within, and beyond, the team. 2 33 Individuals may work in parallel on the same task, as in the first Cochrane rQES, or follow a ‘segmented’ approach where each reviewer is allocated a different task. 14 The use of machine learning in the specific context of rQES remains experimental. However, the possibility of developing qualitative study classifiers comparable to those for randomised controlled trials offers an achievable aspiration. 34

Title and abstract screening

The entire screening team should use pre-prepared, pretested title and abstract templates to limit the scale of piloting, calibration and testing ( table 2 , item R11). 1 14 The first Cochrane rQES team double-screened titles and abstracts within Covidence review software. 14 Disagreements were resolved with reference to a third reviewer achieving a shared understanding of the eligibility criteria and enhancing familiarity with target studies and insight from data. 14 The team should target and prioritise identified risks of either over-zealous inclusion or over-exclusion specific to each rQES ( table 2 , item R12). 14 The team should maximise opportunities to capture divergent views and perspectives within study findings. 35

Full-text screening

Full-text screening similarly benefits from using a pre-prepared pretested standardised template where possible 1 14 ( table 2 , item R11). If a single reviewer undertakes full-text screening, 8 the team should identify likely risks to trustworthiness of findings and focus quality control procedures (eg, use of additional reviewers and percentages for double screening) on specific threats 14 ( table 2 , item R13). The Cochrane rQES team opted for double screening to assist their immersion within the topic. 14

Data extraction

Data extraction of descriptive/contextual data may be facilitated by review management software (eg, EPPI-Reviewer) or home-made approaches using Google Forms, or other survey software. 36 Where extraction of qualitative findings requires line-by-line coding with multiple iterations of the data then a qualitative data management analysis package, such as QSR NVivo, reaps dividends. 36 The team must decide if, collectively, they favour extracting data to a template or coding direct within an electronic version of an article.

Quality control must be fit for purpose but not excessive. Published examples typically use a single reviewer for data extraction 8 with use of two independent reviewers being the exception. The team could limit data extraction to minimal essential items. They may also consider re-using descriptive details and findings previously extracted within previous well-conducted QES ( table 2 , item R14). A pre-existing framework, where readily identified, may help to structure the data extraction template. 15 37 The same framework may be used to present the findings. Some organisations may specify a preferred framework, such as an evidence-to-decision-making framework. 38

Assessment of methodological limitations

The QES community assess ‘methodological limitations’ rather than use ‘risk of bias’ terminology. An rQES team should pick an approach appropriate to their specific review. For example, a thematic map may not require assessment of individual studies—a brief statement of the generic limitations of the set of studies may be sufficient. However, for any synthesis that underpins practice recommendations 39 assessment of included studies is integral to the credibility of findings. In any decision-making context that involves recommendations or guidelines, an assessment of methodological limitations is mandatory. 40 41

Each review team should work with knowledge users to determine a review-specific approach to quality assessment. 27 While ‘traffic lights’, similar to the outputs from the Cochrane Risk of Bias tool, may facilitate rapid interpretation, accompanying textual notes are invaluable in highlighting specific areas for concern. In particular, the rQES team should demonstrate that they are aware (a) that research designs for qualitative research seek to elicit divergent views, rather than control for variation; (b) that, for qualitative research, the selection of the sample is far more informative than the size of the sample; and (c) that researchers from primary research, and equally reviewers for the qualitative synthesis, need to be thoughtful and reflexive about their possible influences on interpretation of either the primary data or the synthesised findings.

Selection of checklist

Numerous scales and checklists exist for assessing the quality of qualitative studies. In the absence of validated risk of bias tools for qualitative studies, the team should choose a tool according to Cochrane Qualitative and Implementation Methods Group (CQIMG) guidance together with expediency (according to ease of use, prior familiarity, etc) ( table 2 , item R15). 41 In comparison to the Critical Appraisal Skills Programme checklist which was never designed for use in synthesis, 42 the Cochrane qualitative tool is similarly easy to use and was designed for QES use. Work is underway to identify an assessment process that is compatible with QESs that support decision-making. 41 For now the choice of a checklist remains determined by interim Cochrane guidance and, beyond this, by personal preference and experience. For an rQES a team could use a single reviewer to assess methodological limitations, with verification of judgements (and support statements) by a second reviewer ( table 2 , item R16).

The CQIMG endorses three types of synthesis; thematic synthesis, framework synthesis and meta-ethnography ( box 1 ). 43 44 Rapid QES favour descriptive thematic synthesis 45 or framework synthesis, 46 47 except when theory generation (meta-ethnography 48 49 or analytical thematic synthesis) is a priority ( table 2 , item R17).

Choosing a method for rapid qualitative synthesis

Thematic synthesis: first choice method for rQES. 45 For example, in their rapid QES Crooks and colleagues 44 used a thematic synthesis to understand the experiences of both academic and lived experience coresearchers within palliative and end of life research. 45

Framework synthesis: alternative where a suitable framework can be speedily identified. 46 For example, Bright and colleagues 46 considered ‘best-fit framework synthesis’ as appropriate for mapping study findings to an ‘a priori framework of dimensions measured by prenatal maternal anxiety tools’ within their ‘streamlined and time-limited evidence review’. 47

Less commonly, an adapted meta-ethnographical approach was used for an implementation model of social distancing where supportive data (29 studies) was plentiful. 48 However, this QES demonstrates several features that subsequently challenge its original identification as ‘rapid’. 49

Abbrevations: QES, qualitative evidence synthesis; rQES, resource-constrained qualitative evidence synthesis.

The team should consider whether a conceptual model, theory or framework offers a rapid way for organising, coding, interpreting and presenting findings ( table 2 , item R18). If the extracted data appears rich enough to sustain further interpretation, data from a thematic or framework synthesis can subsequently be explored within a subsequent meta-ethnography. 43 However, this requires a team with substantial interpretative expertise. 11

Assessments of confidence in the evidence 4 are central to any rQES that seeks to support decision-making and the QES-specific Grading of Recommendations Assessment, Development and Evaluation approach for assessing the Confidence of Evidence from Reviews of Qualitative research (GRADE-CERQual) approach is designed to assess confidence in qualitative evidence. 50 This can be performed by a single reviewer, confirmed by a second reviewer. 26 Additional reviewers could verify all, or a sample of, assessments. For a rapid assessment a team must prioritise findings, using objective criteria; a WHO rQES focused only on the three ‘highly synthesised findings’. 20 The team could consider reusing GRADE-CERQual assessments from published QESs if findings are relevant and of demonstrable high quality ( table 2 , item R19). 50 No rapid approach to full application of GRADE-CERQual currently exists.

Reporting and record management

Little is written on optimal use of technology. 8 A rapid review is not a good time to learn review management software or qualitative analysis management software. Using such software for all general QES processes ( table 2 , item R20), and then harnessing these skills and tools when specifically under resource pressures, is a sounder strategy. Good file labelling and folder management and a ‘develop once, re-use multi-times’ approach facilitates resource savings.

Reporting requirements include the meta-ethnography reporting guidance (eMERGe) 51 and the Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement. 52 An rQES should describe limitations and their implications for confidence in the evidence even more thoroughly than a regular QES; detailing the consequences of fast-tracking, streamlining or of omitting processes all together. 8 Time spent documenting reflexivity is similarly important. 27 If QES methodology is to remain credible rapid approaches must be applied with insight and documented with circumspection. 53 54 (56)

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Patient consent for publication.

Not applicable.

Ethics approval

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

Correction notice Since this paper first published, updates have been made to the left hand column of table 2.

Contributors All authors (AB, IS, JN, CH, FC) have made substantial contributions to the conception and design of the guidance document. AB led on drafting the work and revising it critically for important intellectual content. All other authors (IS, JN, CH, FC) contributed to revisions of the document. All authors (AB, IS, JN, CH, FC) have given final approval of the version to be published. As members of the Cochrane Qualitative and Implementation Methods Group and/or the Cochrane Rapid Reviews Methods Group all authors (AB, IS, JN, CH, FC) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests AB is co-convenor of the Cochrane Qualitative and Implementation Methods Group. In the last 36 months, he received royalties from Systematic Approaches To a Successful Literature Review (Sage 3rd edition), honoraria from the Agency for Healthcare Research and Quality, and travel support from the WHO. JN is lead convenor of the Cochrane Qualitative and Implementation Methods Group. In the last 36 months, she has received honoraria from the Agency for Healthcare Research and Quality and travel support from the WHO. CH is co-convenor of the Cochrane Qualitative and Implementation Methods Group.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; internally peer reviewed.

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

Read the full text or download the PDF:

• 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.

Availability of data and materials

Some documents cited in this paper are either freely available from the Centre for Trials Research website or can be requested from the author for correspondence.

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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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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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A case study of online discussion boards for first year college students: a qualitative case study.

Eric Cummings , Liberty University Follow

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first-year students, online learning, higher education, sociocultural theory, community of inquiry

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Cummings, Eric, "A Case Study of Online Discussion Boards for First Year College Students: A Qualitative Case Study" (2024). Doctoral Dissertations and Projects . 5646. https://digitalcommons.liberty.edu/doctoral/5646

The purpose of this case study was to understand first-year college students’ perspectives on online discussion boards in the context of learning, via the community of inquiry framework. The theory guiding this study is Lev Vygotsky’s sociocultural theory, which identifies how learners create their own learning experiences in the classroom. The theory’s value comes from it being used to understand student thought in discussion boards, which is the study’s focus. A case study was the design, and the goal was to gather empirical data from discussion board experiences from students. The central research question was What are the experiences of a group of first-year nontraditional students engaged in a discussion board for a virtual English composition course? Fourteen students, 13 females and one male, made up the sample. Their discussion board responses, individual interviews, and group study recordings represent the qualitative data. All data were collected in a virtual setting via the online classroom, as well as Zoom. Interpretational phenomenological analysis was employed to analyze student interview responses, the group study, and discussion board responses to uncover themes in the data. The study found four significant themes during the analysis phase. First, the participants took little satisfaction in the social presence in the discussion board due to a lack of social opportunities. However, the participants did enjoy instructor presence, thanks to quick, encouraging, and critical responses. In addition, the participants did not exhibit a sense of critical thinking and seemed to participate with mostly the minimum requirement. It is hoped this research will act as a foundation for additional exploration into the community of inquiry’s relationship with online learning by providing starting points for answers to the issue of online student engagement.

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CRO Guide   >  Chapter 3.1

Qualitative Research: Definition, Methodology, Limitation & Examples

Qualitative research is a method focused on understanding human behavior and experiences through non-numerical data. Examples of qualitative research include:

• One-on-one interviews,
• Focus groups, Ethnographic research,
• Case studies,
• Record keeping,
• Qualitative observations

In this article, we’ll provide tips and tricks on how to use qualitative research to better understand your audience through real world examples and improve your ROI. We’ll also learn the difference between qualitative and quantitative data.

Table of Contents

Marketers often seek to understand their customers deeply. Qualitative research methods such as face-to-face interviews, focus groups, and qualitative observations can provide valuable insights into your products, your market, and your customers’ opinions and motivations. Understanding these nuances can significantly enhance marketing strategies and overall customer satisfaction.

What is Qualitative Research

Qualitative research is a market research method that focuses on obtaining data through open-ended and conversational communication. This method focuses on the “why” rather than the “what” people think about you. Thus, qualitative research seeks to uncover the underlying motivations, attitudes, and beliefs that drive people’s actions. 

Let’s say you have an online shop catering to a general audience. You do a demographic analysis and you find out that most of your customers are male. Naturally, you will want to find out why women are not buying from you. And that’s what qualitative research will help you find out.

In the case of your online shop, qualitative research would involve reaching out to female non-customers through methods such as in-depth interviews or focus groups. These interactions provide a platform for women to express their thoughts, feelings, and concerns regarding your products or brand. Through qualitative analysis, you can uncover valuable insights into factors such as product preferences, user experience, brand perception, and barriers to purchase.

Types of Qualitative Research Methods

Qualitative research methods are designed in a manner that helps reveal the behavior and perception of a target audience regarding a particular topic.

The most frequently used qualitative analysis methods are one-on-one interviews, focus groups, ethnographic research, case study research, record keeping, and qualitative observation.

1. One-on-one interviews

Conducting one-on-one interviews is one of the most common qualitative research methods. One of the advantages of this method is that it provides a great opportunity to gather precise data about what people think and their motivations.

Spending time talking to customers not only helps marketers understand who their clients are, but also helps with customer care: clients love hearing from brands. This strengthens the relationship between a brand and its clients and paves the way for customer testimonials.

• A company might conduct interviews to understand why a product failed to meet sales expectations.
• A researcher might use interviews to gather personal stories about experiences with healthcare.

These interviews can be performed face-to-face or on the phone and usually last between half an hour to over two hours. 

When a one-on-one interview is conducted face-to-face, it also gives the marketer the opportunity to read the body language of the respondent and match the responses.

2. Focus groups

Focus groups gather a small number of people to discuss and provide feedback on a particular subject. The ideal size of a focus group is usually between five and eight participants. The size of focus groups should reflect the participants’ familiarity with the topic. For less important topics or when participants have little experience, a group of 10 can be effective. For more critical topics or when participants are more knowledgeable, a smaller group of five to six is preferable for deeper discussions.

The main goal of a focus group is to find answers to the “why”, “what”, and “how” questions. This method is highly effective in exploring people’s feelings and ideas in a social setting, where group dynamics can bring out insights that might not emerge in one-on-one situations.

• A focus group could be used to test reactions to a new product concept.
• Marketers might use focus groups to see how different demographic groups react to an advertising campaign.

One advantage that focus groups have is that the marketer doesn’t necessarily have to interact with the group in person. Nowadays focus groups can be sent as online qualitative surveys on various devices.

Focus groups are an expensive option compared to the other qualitative research methods, which is why they are typically used to explain complex processes.

3. Ethnographic research

Ethnographic research is the most in-depth observational method that studies individuals in their naturally occurring environment.

This method aims at understanding the cultures, challenges, motivations, and settings that occur.

• A study of workplace culture within a tech startup.
• Observational research in a remote village to understand local traditions.

Ethnographic research requires the marketer to adapt to the target audiences’ environments (a different organization, a different city, or even a remote location), which is why geographical constraints can be an issue while collecting data.

This type of research can last from a few days to a few years. It’s challenging and time-consuming and solely depends on the expertise of the marketer to be able to analyze, observe, and infer the data.

4. Case study research

The case study method has grown into a valuable qualitative research method. This type of research method is usually used in education or social sciences. It involves a comprehensive examination of a single instance or event, providing detailed insights into complex issues in real-life contexts.  

• Analyzing a single school’s innovative teaching method.
• A detailed study of a patient’s medical treatment over several years.

Case study research may seem difficult to operate, but it’s actually one of the simplest ways of conducting research as it involves a deep dive and thorough understanding of the data collection methods and inferring the data.

5. Record keeping

Record keeping is similar to going to the library: you go over books or any other reference material to collect relevant data. This method uses already existing reliable documents and similar sources of information as a data source.

• Historical research using old newspapers and letters.
• A study on policy changes over the years by examining government records.

This method is useful for constructing a historical context around a research topic or verifying other findings with documented evidence.

6. Qualitative observation

Qualitative observation is a method that uses subjective methodologies to gather systematic information or data. This method deals with the five major sensory organs and their functioning, sight, smell, touch, taste, and hearing.

• Sight : Observing the way customers visually interact with product displays in a store to understand their browsing behaviors and preferences.
• Smell : Noting reactions of consumers to different scents in a fragrance shop to study the impact of olfactory elements on product preference.
• Touch : Watching how individuals interact with different materials in a clothing store to assess the importance of texture in fabric selection.
• Taste : Evaluating reactions of participants in a taste test to identify flavor profiles that appeal to different demographic groups.
• Hearing : Documenting responses to changes in background music within a retail environment to determine its effect on shopping behavior and mood.

Below we are also providing real-life examples of qualitative research that demonstrate practical applications across various contexts:

Qualitative Research Real World Examples

Let’s explore some examples of how qualitative research can be applied in different contexts.

1. Online grocery shop with a predominantly male audience

Method used: one-on-one interviews.

Let’s go back to one of the previous examples. You have an online grocery shop. By nature, it addresses a general audience, but after you do a demographic analysis you find out that most of your customers are male.

One good method to determine why women are not buying from you is to hold one-on-one interviews with potential customers in the category.

Interviewing a sample of potential female customers should reveal why they don’t find your store appealing. The reasons could range from not stocking enough products for women to perhaps the store’s emphasis on heavy-duty tools and automotive products, for example. These insights can guide adjustments in inventory and marketing strategies.

2. Software company launching a new product

Method used: focus groups.

Focus groups are great for establishing product-market fit.

Let’s assume you are a software company that wants to launch a new product and you hold a focus group with 12 people. Although getting their feedback regarding users’ experience with the product is a good thing, this sample is too small to define how the entire market will react to your product.

So what you can do instead is holding multiple focus groups in 20 different geographic regions. Each region should be hosting a group of 12 for each market segment; you can even segment your audience based on age. This would be a better way to establish credibility in the feedback you receive.

3. Alan Pushkin’s “God’s Choice: The Total World of a Fundamentalist Christian School”

Method used: ethnographic research.

Moving from a fictional example to a real-life one, let’s analyze Alan Peshkin’s 1986 book “God’s Choice: The Total World of a Fundamentalist Christian School”.

Peshkin studied the culture of Bethany Baptist Academy by interviewing the students, parents, teachers, and members of the community alike, and spending eighteen months observing them to provide a comprehensive and in-depth analysis of Christian schooling as an alternative to public education.

The study highlights the school’s unified purpose, rigorous academic environment, and strong community support while also pointing out its lack of cultural diversity and openness to differing viewpoints. These insights are crucial for understanding how such educational settings operate and what they offer to students.

Even after discovering all this, Peshkin still presented the school in a positive light and stated that public schools have much to learn from such schools.

Peshkin’s in-depth research represents a qualitative study that uses observations and unstructured interviews, without any assumptions or hypotheses. He utilizes descriptive or non-quantifiable data on Bethany Baptist Academy specifically, without attempting to generalize the findings to other Christian schools.

4. Understanding buyers’ trends

Method used: record keeping.

Another way marketers can use quality research is to understand buyers’ trends. To do this, marketers need to look at historical data for both their company and their industry and identify where buyers are purchasing items in higher volumes.

For example, electronics distributors know that the holiday season is a peak market for sales while life insurance agents find that spring and summer wedding months are good seasons for targeting new clients.

5. Determining products/services missing from the market

Conducting your own research isn’t always necessary. If there are significant breakthroughs in your industry, you can use industry data and adapt it to your marketing needs.

The influx of hacking and hijacking of cloud-based information has made Internet security a topic of many industry reports lately. A software company could use these reports to better understand the problems its clients are facing.

As a result, the company can provide solutions prospects already know they need.

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Qualitative Research Approaches

Once the marketer has decided that their research questions will provide data that is qualitative in nature, the next step is to choose the appropriate qualitative approach.

The approach chosen will take into account the purpose of the research, the role of the researcher, the data collected, the method of data analysis , and how the results will be presented. The most common approaches include:

• Narrative : This method focuses on individual life stories to understand personal experiences and journeys. It examines how people structure their stories and the themes within them to explore human existence. For example, a narrative study might look at cancer survivors to understand their resilience and coping strategies.
• Phenomenology : attempts to understand or explain life experiences or phenomena; It aims to reveal the depth of human consciousness and perception, such as by studying the daily lives of those with chronic illnesses.
• Grounded theory : investigates the process, action, or interaction with the goal of developing a theory “grounded” in observations and empirical data. 
• Ethnography : describes and interprets an ethnic, cultural, or social group;
• Case study : examines episodic events in a definable framework, develops in-depth analyses of single or multiple cases, and generally explains “how”. An example might be studying a community health program to evaluate its success and impact.

How to Analyze Qualitative Data

Analyzing qualitative data involves interpreting non-numerical data to uncover patterns, themes, and deeper insights. This process is typically more subjective and requires a systematic approach to ensure reliability and validity. 

1. Data Collection

Ensure that your data collection methods (e.g., interviews, focus groups, observations) are well-documented and comprehensive. This step is crucial because the quality and depth of the data collected will significantly influence the analysis.

2. Data Preparation

Once collected, the data needs to be organized. Transcribe audio and video recordings, and gather all notes and documents. Ensure that all data is anonymized to protect participant confidentiality where necessary.

3. Familiarization

Immerse yourself in the data by reading through the materials multiple times. This helps you get a general sense of the information and begin identifying patterns or recurring themes.

Develop a coding system to tag data with labels that summarize and account for each piece of information. Codes can be words, phrases, or acronyms that represent how these segments relate to your research questions.

• Descriptive Coding : Summarize the primary topic of the data.
• In Vivo Coding : Use language and terms used by the participants themselves.
• Process Coding : Use gerunds (“-ing” words) to label the processes at play.
• Emotion Coding : Identify and record the emotions conveyed or experienced.

5. Thematic Development

Group codes into themes that represent larger patterns in the data. These themes should relate directly to the research questions and form a coherent narrative about the findings.

6. Interpreting the Data

Interpret the data by constructing a logical narrative. This involves piecing together the themes to explain larger insights about the data. Link the results back to your research objectives and existing literature to bolster your interpretations.

7. Validation

Check the reliability and validity of your findings by reviewing if the interpretations are supported by the data. This may involve revisiting the data multiple times or discussing the findings with colleagues or participants for validation.

8. Reporting

Finally, present the findings in a clear and organized manner. Use direct quotes and detailed descriptions to illustrate the themes and insights. The report should communicate the narrative you’ve built from your data, clearly linking your findings to your research questions.

Limitations of qualitative research

The disadvantages of qualitative research are quite unique. The techniques of the data collector and their own unique observations can alter the information in subtle ways. That being said, these are the qualitative research’s limitations:

1. It’s a time-consuming process

The main drawback of qualitative study is that the process is time-consuming. Another problem is that the interpretations are limited. Personal experience and knowledge influence observations and conclusions.

Thus, qualitative research might take several weeks or months. Also, since this process delves into personal interaction for data collection, discussions often tend to deviate from the main issue to be studied.

2. You can’t verify the results of qualitative research

Because qualitative research is open-ended, participants have more control over the content of the data collected. So the marketer is not able to verify the results objectively against the scenarios stated by the respondents. For example, in a focus group discussing a new product, participants might express their feelings about the design and functionality. However, these opinions are influenced by individual tastes and experiences, making it difficult to ascertain a universally applicable conclusion from these discussions.

3. It’s a labor-intensive approach

Qualitative research requires a labor-intensive analysis process such as categorization, recording, etc. Similarly, qualitative research requires well-experienced marketers to obtain the needed data from a group of respondents.

4. It’s difficult to investigate causality

Qualitative research requires thoughtful planning to ensure the obtained results are accurate. There is no way to analyze qualitative data mathematically. This type of research is based more on opinion and judgment rather than results. Because all qualitative studies are unique they are difficult to replicate.

5. Qualitative research is not statistically representative

Because qualitative research is a perspective-based method of research, the responses given are not measured.

Comparisons can be made and this can lead toward duplication, but for the most part, quantitative data is required for circumstances that need statistical representation and that is not part of the qualitative research process.

While doing a qualitative study, it’s important to cross-reference the data obtained with the quantitative data. By continuously surveying prospects and customers marketers can build a stronger database of useful information.

Quantitative vs. Qualitative Research

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Quantitative and qualitative research are two distinct methodologies used in the field of market research, each offering unique insights and approaches to understanding consumer behavior and preferences.

As we already defined, qualitative analysis seeks to explore the deeper meanings, perceptions, and motivations behind human behavior through non-numerical data. On the other hand, quantitative research focuses on collecting and analyzing numerical data to identify patterns, trends, and statistical relationships.  

Let’s explore their key differences: 

Nature of Data:

• Quantitative research : Involves numerical data that can be measured and analyzed statistically.
• Qualitative research : Focuses on non-numerical data, such as words, images, and observations, to capture subjective experiences and meanings.

Research Questions:

• Quantitative research : Typically addresses questions related to “how many,” “how much,” or “to what extent,” aiming to quantify relationships and patterns.
• Qualitative research: Explores questions related to “why” and “how,” aiming to understand the underlying motivations, beliefs, and perceptions of individuals.

Data Collection Methods:

• Quantitative research : Relies on structured surveys, experiments, or observations with predefined variables and measures.
• Qualitative research : Utilizes open-ended interviews, focus groups, participant observations, and textual analysis to gather rich, contextually nuanced data.

Analysis Techniques:

• Quantitative research: Involves statistical analysis to identify correlations, associations, or differences between variables.
• Qualitative research: Employs thematic analysis, coding, and interpretation to uncover patterns, themes, and insights within qualitative data.

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• Last modified: January 3, 2023
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• Published: 28 May 2024

Parental experiences of caring for preterm infants in the neonatal intensive care unit, Limpopo Province: a descriptive qualitative study exploring the cultural determinants

• Madimetja J. Nyaloko 1 ,
• Welma Lubbe 1 ,
• Salaminah S. Moloko-Phiri 1 &
• Khumoetsile D. Shopo 1  

BMC Health Services Research volume  24 , Article number:  669 ( 2024 ) Cite this article

Metrics details

Parent-infant interaction is highly recommended during the preterm infant hospitalisation period in the Neonatal Intensive Care Unit (NICU). Integrating culturally sensitive healthcare during hospitalisation of preterm infants is critical for positive health outcomes. However, there is still a paucity of evidence on parental experience regarding cultural practices that can be integrated into preterm infant care in the NICU. The study explored and described the cultural determinants of parents that can be integrated into the care of preterm infants in the NICU.

A descriptive qualitative research design was followed where twenty ( n =20) parents of preterm infants were purposively selected. The study was conducted in the NICU in Limpopo using in-depth individual interviews. Taguette software and a thematic analysis framework were used to analyse the data. The COREQ guidelines and checklist were employed to ensure reporting standardisation.

Four themes emerged from the thematic analysis: 1) Lived experienced by parents of preterm infants, 2) Interactions with healthcare professionals, 3) Cultural practices concerning preterm infant care, and 4) Indigenous healthcare practices for preterm infants.

Conclusions

The study emphasised a need for healthcare professionals to understand the challenges parents of preterm infants face in NICU care. Furthermore, healthcare professionals should know indigenous healthcare practices to ensure relevant, culturally sensitive care.

Peer Review reports

Introduction and background

Parenting is an intricate process involving the upbringing and caring for a child from infancy to adulthood through promoting and supporting the child’s physical, emotional, social, and intellectual development [ 1 ]. This process becomes challenging, particularly when it involves preterm infants admitted to the hospital [ 2 ]. The birth of a preterm infant can be an epoch-making, evocative, and occasionally devastating parental experience [ 3 ]. A preterm infant is defined as a child born before the 37 th week of pregnancy is completed [ 4 ]. Annually, approximately 15 million preterm births are documented out of 160 million live births, accounting for an 11.5% global preterm birth rate [ 5 ]. Between 2010 and 2020, more than 60% of global preterm births occurred in South Asia and Sub-Saharan Africa [ 5 ]. One in every seven infants in South Africa was born before their due date and required NICU admission [ 5 ].

The NICU is typically a foreign and intimidating environment for parents, due to the need for continuous monitoring and medical intervention for infants who are fragile and sick. Parents can experience stress, guilt, anxiety, and sadness due to the infant's uncertain health prognosis [ 6 ]. The active involvement of parents in preterm infant care activities in the NICU is crucial for infant developmental outcomes [ 7 ]. Healthcare professionals should comprehend the parental experience of caring for a preterm infant in the NICU to address parental needs and enhance parent-infant interaction and attachment [ 8 ]. This interaction may in turn increase parental satisfaction, thus promoting more appropriate parent-infant interaction, including attachment and bonding [ 9 ].

Although parent-infant interaction is beneficial, cultural variables need to be acknowledged. Parenting is deeply rooted in a culture characterized by ideologies concerning how an individual should act, feel and think as an in-group member [ 10 ]. Therefore, the parental involvement and parent-infant interaction might be disrupted if the parental cultural practice is not considered. Cultural practices influence the parents' infant care approach [ 11 , 12 ]. The values and ideals of culture are conveyed to the next generation through child-rearing practices, which implies that cultures are contextually sensitive parenting guidelines [ 13 ].

Parents of preterm infants in Limpopo Province, South Africa, come from various cultural backgrounds, which may influence how they understand and react to the care provided to their preterm infant in the NICU. Various childrearing practices associated with culture influence the health of preterm infants [ 14 ]. These practices include massaging the baby, applying oil to the eyes and ears, burping the baby, applying black carbon to the eyes, and trimming the nails. Parental involvement in preterm infant care in the NICU may also be influenced by culture [ 15 ]. The cultural views and ideas of healthcare professionals can potentially affect the standard of care offered to preterm infants and their parents in the NICU. These cultural views and ideas are health beliefs that explain the cause of illness, its prevention or treatment methods, and the appropriate individuals who should participate in the healing process [ 16 ].

Healthcare professionals who have a comprehensive understanding of the parental cultural determinants can facilitate the nurturing and promoting of adequate parental-infant care and interaction, which is the foundation for developing preterm infants [ 17 ]. Lack of support from healthcare professionals regarding the cultural aspects of parent-infant interaction may negate parents' cultural practices, and increase negative perceptions and dissatisfaction with the healthcare service provided in the NICU [ 17 ]. Consequently, this may result in a lack of parental awareness or responsiveness to the infant, associated with delayed infant cognitive development and multiple behavioural problems [ 18 ].

Despite the recognition of the importance of parental involvement in NICU care and the documented emotional challenges experienced by parents, there is a gap in the literature regarding the specific experiences and cultural practices of parents caring for preterm infants which can be integrated in NICU in settings, such as Limpopo Province in South Africa. The province has seen a significant increase in the number of newborn babies weighing under 2,500 grams in recent years [ 19 ]. The study aimed to explore and describe the cultural determinants of parents that can be integrated into the care of preterm infants admitted to the NICU in Limpopo Province to ensure culturally sensitive care. This study is unique due to its focus on South Africa, specifically Limpopo Province, which is the centre of cultural practices due to its rurality. The main research question was: 'What are the cultural determinants which influence the parental experience that can be integrated into the care of preterm infants in the NICU in Limpopo Province?

The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was followed to ensure standardisation in reporting the study type, design, execution, analysis, and results [ 20 ].

The study applied a qualitative research design following a descriptive approach [ 21 ]. In-depth individual interviews were used to explore and describe the experiences of parents of preterm infants admitted to the NICU in Limpopo Province through a cultural determinant lens.

The current study was conducted in the NICU of a tertiary hospital in Limpopo Province, South Africa. Limpopo Province was selected based on two grounds: 1) Cultural practices are more evident in rural villages than in semi-urban or urban settings [ 22 ], 84.2% of the study population live in rural areas [ 23 ]; and 2) one in every seven infants is born before its due date in South Africa [ 5 ], the Limpopo Province accounts for high preterm birth rates [ 19 ].

Participants and sample

The population comprised mothers of a preterm infant admitted to the NICU. For this study, a parent was defined as the mother of a preterm infant in the NICU. Purposive sampling was used to select twenty ( n =20) participants from the NICU in a tertiary hospital [ 24 ]. The inclusion criteria required that 1) the participant be the parent of a preterm infant; 2) the parent had a preterm infant in the NICU for a minimum of two weeks (As set out by the researcher, the contextually relevant time for an immersive experience was two weeks); 3) the parent be able to speak either Sepedi, Xitsonga, Tshivenda, or English (the common local languages). Mothers of preterm infants who were in critical condition were excluded. There were no refusals to participate. The sample size was determined based on data saturation, which was reached with n =20 participants [ 25 ].

Recruitment

The first author (Ph.D.) and an independent person recruited the participants face-to-face by distributing recruitment material such as flyers and asynchronously by displaying posters on the noticeboards in the selected hospital's NICU and a place where the mother lodge in the hospital. Recruitment was conducted after ethical approvals and permission from the hospital were granted. Participants who expressed interest in the study notified the first author through a phone call, SMS, or WhatsApp text message. The first author then contacted the potential participants to provide detailed information regarding the study aim and data collection method, including audio recordings of interviews, confidentiality agreements, written informed consent, and voluntary participation. Potential participants who showed interest were given an informed consent form and a minimum of 48 hours to consult and inform their partners or family members. The first author was accessible telephonically for any clarity-seeking questions. The first author contacted the agreed participants to schedule the hospital-based interviews on the agreed-upon dates. All consented mothers participated and there were no withdrawals.

Data collection

The interview guide was developed for this current study in English, and translated to local languages (Sepedi, Xitsonga, and Tshivenda) by assistant researchers who are fluent with these respective languages. Three bilingual speakers (Sepedi, Xitsonga, and Tshivenda) checked the translations from English to these local languages for accuracy, which was endorsed. Furthermore, the interview schedule was piloted with two participants to assess its effectiveness and suitability (See supplementary document 1). Pilot study was instrumental in refining the interview guide and ensuring that it would yield the desired data during the primary study. The in-depth interview began with an open-ended question, as shown in Table 1 below.

The data was collected between August and September 2022. In-depth individual interviews were conducted by the first author and assistant researcher using Sepedi, Xitsonga, Tshivenda, or English in a private room in the hospital to ensure confidentiality. COVID-19 precautionary measures were followed to protect the health and safety of participants and interviewers. Furniture was wiped with a 70% based-alcohol solution before and after each interview, chairs were spaced 1.5 meters apart to ensure adequate social distance and researchers and participants sanitised their hands before entering and exiting the room. Participants and the interviewer wore a surgical facial mask covering the nose and mouth throughout the interview.

The first author served as the lead interviewer, the assistant researcher functioned as a support system in case of a language barrier. The interviews were conducted in the participant's preferred language (Sepedi, Xitsonga, Tshivenda, or English). The interviewer used probing questions to encourage the participants to elaborate, and all other questions arose from the dialogue. The duration of each interview was between 45 and 65 minutes.

With the participants' permission, two audio recording devices were used to record each interview, whereby one served as a backup in case the main one defaulted. During each interview, the first author compiled field notes regarding the context, non-communication cues, and impressions to complement the recorded audio. Data collection continued until no new data emerged, whereby data saturation was declared. All the interviews were conducted at the hospital.

After data collection, the first author and assistant researchers transcribed the data verbatim, including field notes in English. The researchers' subjective experiences regarding the explored phenomenon were described to avoid influencing data analysis: a process termed bracketing [ 26 ]. Three bilingual speakers (Sepedi, Xitsonga, and Tshivenda) checked the translations to English transcriptions for accuracy against the audio recordings. Additionally, two transcripts (10% of the sample) were back translated, and accuracy was verified by an independent co-coder and two co-authors [SSM, KDS]. No substantial linguistic issues were identified during the translation process.

Data analysis

Giorgi's data analysis method [ 27 , 28 ] was applied to comprehend the essence of the experiences of parents of preterm infants in the NICU. The data analysis process constituted five steps: understanding raw data, constructing a constituent profile, forming a theme index, merging participants' theme indexes, and searching the thematic index to develop interpretive themes.

Trustworthiness

The four criteria of Lincoln and Guba [ 29 ] were applied to establish the trustworthiness of the current study. Credibility was established by member checking with 10% of the sample ( n =2) by sending the transcript and developed themes. The supervisors (experts) conducted a confirmability audit of the study project by checking and rechecking the collected raw-, coded- and interpreted data to affirm neutrality. Additionally, the study followed a rigorous descriptive qualitative method and underwent a peer review process that confirmed the consistency of the data, and the findings ensured dependability, while data saturation and a detailed description of the methodology ensured transferability.

Demographic data

Twenty ( n =20) mothers of preterm infants admitted to the NICU in a tertiary hospital participated in this study. The participants’ ages ranged from 18 to 39 years, with the majority being between 18 and 25. The majority of parents had three children. Regarding education, nine participants had a secondary-level education, and 11 had a tertiary education. Of the 20 participants, nine were unemployed, two were self-employed, one was fully employed, one was employed part-time, and seven were students (Refer to Table 2 ).

Emerging themes and sub-themes

Four main themes emerged from the data analysis. These were: lived experienced by parents of preterm infants, interactions with healthcare professionals, cultural practices concerning preterm infant care, and indigenous healthcare practices for preterm infants. These themes, supported by sub-themes, are outlined in Table 3 .

Theme 1 lived experienced by parents of preterm infants

The current study's first theme emerged as the lived experienced by parents of preterm infants. Parents experienced considerable challenges while caring for the preterm infants in the NICU. Lived difficulties experiences by parents are further explored through the sub-themes: stress and exhaustion, and longing for home.

Sub-theme 1.1 stress and exhaustion

Participants felt an overwhelming sense of exhaustion and stress, as they cared for their infants in the NICU. Participant responses revealed a pervasive fear of the unknown, coupled with emotional turmoil and physical strain. The uncertainty surrounding the health of their infants exacerbates their distress, leading to heightened anxiety and feelings of helplessness. This emotional burden is compounded by the challenges of navigating complex medical information and coping with unexpected health complications. Participants expressed shock, describing the unexpected event of preterm birth and the overwhelming emotions following the delivery of a preterm infant.

One participant reported:

We are always scared when we go to see babies because we don't know what it is, especially when you leave the baby without the tube; you think she may vomit when you are not around, and the next thing you will be receiving a call saying your baby is no more. (P1, 18-year-old)

Participant 1's expression of fear illustrates the constant apprehension experienced by mothers in the NICU, highlighting the emotional strain of anticipating potential emergencies and adverse outcomes. Another participant indicated the overwhelming uncertainty faced by the mothers upon entering the NICU, emphasizing the need for clear communication and reassurance from healthcare providers. The following quote supports the participant’s experience:

What if they tell me the situation is like this when I enter there? Honestly speaking, it frightens us. We just wish that it didn't ring so that when you get there, they tell you that they needed you so and so . (P2, 25-year-old)

Another participant highlighted the shock and fear induced by the sight of an extremely premature infant, illustrating the emotional toll of witnessing their vulnerability.

This baby, she was too small, like it was the first time seeing a small child like this. I once saw premature, but it was not like this, this one was so small, so I was scared. (P4, 24-year-old)

Another participant described her emotional response to distressing news about her baby's health which underscores the profound impact of medical uncertainties on maternal well-being, emphasizing the need for sensitive communication and support.

When they told me that my baby was like this and this, I even cried. (P10, 39-year-old)

Additionally, other participant’s narrative reflected the overwhelming fear and uncertainty experienced by mothers in the NICU, highlighting the emotional toll of constantly anticipating adverse outcomes and navigating complex medical situations. The following quotes reflect the participants’ experiences:

What I'm dealing with, because I was very broken and did not know what it is, will the baby survive, what will she do, what's going to happen. The answer is not right, as, for us, we are always afraid, we don't know what it is when you are here. (P17, 23-year-old)

Sub-theme 1.2 longing for home

The emotional strain and challenges faced by mothers while caring for their infants in the hospital setting evoke a profound yearning for the sense of security, comfort and belonging that home provides. The participants described their experience of not getting enough rest and sleep while caring for their preterm infant in the NICU which would not happen if they were home. Contributing factors include the time required to visit the NICU for the infant’s care routine, time spent walking from the mother's lodge to the NICU and back, and the separation of mother and infant.

The participant reflected on the contrast between hospital practices and what would have been done if she were at home:

Yes, here in the hospital, they want you to bathe the baby like this while at home they want you to do this and this or at home, you would do this when you see him doing that. It's things I want to know. (P5, 38-year-old)

This quote encapsulates the longing for the familiar routines and comforts of home amidst the unfamiliarity of hospital protocols. It highlights the sense of control and autonomy associated with home, where individuals adhere to their own customs and practices, as opposed to the regulated environment of the hospital. Another participant reminisces about cultural practices that would have been observed in her home environment:

Yeah, like mostly, like back at home, in our culture, we believe that a baby less than a month old must be bathed by the mother or grandmother... If I was at home, I will be feeding her with soft porridge without giving her any medications because this medication makes her defecate twice a day or so and this makes her lose weight. (P7, 32-year-old)

This excerpt emphasises the role of cultural traditions and familial support in shaping caregiving practices. It underlines the interconnectedness between home and cultural identity, where adherence to traditional customs provides a sense of security and belonging, particularly in the context of new-born care. Furthermore, another participant described the traditional approach to newborn care back home:

No, after birth when I come home, we don’t bathe the baby right away, we dampen the cloth in lukewarm water and just wipe the baby where he is dirty. We wash the head because the hair traps a lot of dirty things (blood and birth secretions), we avoid the full bath so that we don’t expose the baby to flu. (P18, 20-year-old)

Other participants compared hospital feeding methods with traditional practices at home. The participants reported that:

Here we feed the baby with breast milk using pipes (NG tubes and syringes) but at home, we do a light and very soft porridge. (P16, 38-year-old)

This comparison highlights the adaptation to different environments and the longing for familiar routines. It shows how home serves as a sanctuary where individuals adhere to their preferred methods of infant care, reinforcing the notion of home as a place of comfort and familiarity. Other participants expressed a longing for the comforts of home and the familiar routines:

So, the first challenge is that we wake up. We only sleep two hours. Most of the time we spend on the way, we do not have time to rest. Like when you are going that way, you may find that you are going for a long time in the baby’s room. When you are coming here, and you try to sleep, time is gone, you must go back. (P14, 39-year-old)

This statement reflects the desire for a sense of normalcy and routine amidst the challenges of hospitalisation. It highlights the idea that home represents a heaven of rest and recuperation, where individuals can adhere to their preferred practices and routines, particularly during significant life events such as childrearing.

Theme 2 interactions with healthcare professionals

In this study, interaction is perceived as communication and involvement in preterm infant care among healthcare professionals and parents of preterm infants in the NICU. The sub-themes included NICU care, communication, and healthcare professional attitudes.

Sub-theme 2.1 care in NICU

This sub-theme concerns how healthcare professionals cared for preterm infants and their parents in the NICU. Some indicated that they received adequate care from nurses and doctors in the NICU.

One participant indicated that:

The doctors are mostly here; they used to come only to check and update [us] about the baby's condition. The people who take part mostly are the nurses. Okay, looking at the ICU there is no problems, all is right. (P02, 25-year-old)

A similar view was echoed by another participant who stated:

Yes, they help me take care of the baby, and the doctors are nearby if there is something the doctor and nurses can help with. (P13, 22-year-old)

Another participant shared that she had only seen good things and is at peace with the care that she is receiving in the NICU:

In [N]ICU I have not seen any bad things; I only noticed the good things. My baby was in troubles, but she is not well, nurses are checking her every time so does the doctors. So up to so far, I never had any problems with nurses and doctors. I am at peace. (P18, 20-year-old)

However, one participant expressed dissatisfaction with the care she received in the NICU. The following quote confirms this:

They end up swearing at us and to be treated this way, been shouted, it ends up affecting our minds since I already have a problem with my baby’s condition. (P12, 28-year-old)

The participants’ responses highlight that they experienced positive and negative care while looking after their preterm infants in NICU; it appears that they appreciated the care, although some were unhappy.

Sub-theme 2.2 communication in NICU

Nearly all parents mentioned the importance of healthcare professionals practising effective communication as clinicians. In this context, communication is the exchange of information between parents of preterm infants and healthcare professionals in the NICU. The parents indicated that they had experienced satisfactory communication with healthcare professionals while caring for their preterm infant in the NICU. This includes comprehensive explanations; for instance, the doctor offered information regarding the baby's weight decrease in terms that parents could comprehend, giving them relief. The following quotes support the experience:

Yes, is not it that when we come here, we are under stress? So, if we want to say sister (nurse), may I ask, how is my baby doing? She can answer me; if she does not know, she must go and ask or tell me that I do not know about this one. I can ask someone who knows, like have good communication. (P17, 23-year-old)

Yes, the same doctor that I ask him regarding the baby’s weight loss. He explained to me well and now I understand, am free because the weight is no longer 0.8 kg, it is now around 1.0 kg. The support is good because when you ask something they quickly actioned it, so there is support. (P18, 20-year-old)

The above participants highlighted the importance of efficient communication in interactions between parents and healthcare professionals in the NICU and its positive effects on parents’ experiences and well-being. Nevertheless, other participants expressed dissatisfaction with the communication they received from the healthcare professionals in the NICU. One of the cited reasons for their dissatisfaction was that healthcare professionals discussed the infant's condition in a language the parents did not understand.

One participant mentioned that:

They asked me if I knew why my baby went to the theatre? What is the reason he came here? I said yes; I just heard them saying it is the authority which I do not know what they meant. (P06, 23-year-old)

Similarly, other participants expressed disappointment that healthcare professionals were not informing them about the interventions/procedures before implementation. The following quotes support the parental disappointment:

We do want to know because when we arrive in the ward, we just see that intravenous lines were inserted, and blood sample were collected, and we also see that the infant was pricked several times on the extremities hence do not even know where the samples are taken to. (P16, 38-year-old)

It is the same as when he was in high care because after labour, my baby was sent to high care, and the next morning he was in ICU without informing me. (P19, 23-year-old)

Moreover, another participant mentioned feeling confused because of the conflicting communication from healthcare professionals. The following quote supports this confusion:

The other one enters tells you the baby should change sides and give you reasons. When you tell them one said I should not change sides, they end up swearing at us end up confusing us. (P12, 28-year-old)

Participants highlighted the negative impact that poor communication could have on their experience in the NICU, as well as the significance of simple and consistent communication with healthcare professionals. They expressed a desire for precise, reliable information to understand what was happening to their preterm infants and to feel more involved in the care of their infants.

Sub-theme 2.3 attitude of healthcare professionals in NICU

The participants in the study expressed dissatisfaction with the attitudes of healthcare professionals in the NICU, as illustrated by the two quotes below:

When you go to the nurse and tell her that the tube is disconnected from the baby and the secretions are coming out through the nose, so the response will be like, what do you want me to do because your baby did that (mother rolling the eyes)? (P01, 18-year-old)

Okay there was this nurse who was on a night shift yesterday and she was busy with files, and when we wanted to ask her to collect some of the things for us, and she would say to us that we must go collect those things for ourselves because she is busy. So, when we got there to collect for ourselves, we found another nurse who asked us as to where our nurse is because we should not be doing this for ourselves. So, when we called her, she showed to me that she does not like her job. (P08, 31-year-old)

Another participant further mentioned that:

There is a nurse that seemed to have an advanced age, whenever we ask her to assist our babies, or asking some supplies to help our babies she is rude. She once told me that [my] babies are ugly such like me. (P20, 19-year-old)

More so, some mothers lamented the lack of communication from the nurses. For example

Their communication is not good because they hide things from us, sometimes you will find that they had taken your baby’s blood and not tell you about the results or what the results implies, and even when you ask the nurses, they would tell you that they are doing what they have been instructed to do. Sometimes you also find your baby inserted with drip, and when you ask, they do not say or explain the reason for all of these. (P08, 31-year-old)

Even though other participants expressed their dissatisfaction regarding the attitude of the healthcare professionals, other participants felt the opposite. One participant mentioned that she had a satisfactory relationship with the healthcare professionals expressed in the quote:

I am pleased with how the hospital is providing her with milk, yes, I am happy they help. (P12, 28-year-old)

Similarly, another participant added that she has only observed good things concerning the level of service provided to her infant:

In [N]ICU I haven’t seen any bad things; I only noticed the good things. (P18, 20-year-old)

Most parents expressed satisfaction with the level of support provided by the healthcare professionals in the NICU. The participants describe the support as encouraging and helping them to understand that challenges are a normal part of the process, as indicated by the below quotes:

Yes, their support is good. It is the kind of support that encourages you to understand that things like this are there and there are these kinds of challenges. (P07, 32-year-old)

Additionally, another participant alluded that:

The support from the nurses is very good, each one of them know me because I have been here for a long time. When they arrive, they call and ask how is the baby [doing]? Initially it was scary because my baby was the smallest one in the unit, and I was new but now am used to the nurses and the unit. (P18, 20-year-old)

Theme 3 cultural practice concerning preterm infant care

The third main theme was the cultural practices concerning preterm infant care. This study's concepts associated with this theme include practices and behaviours conducted after childbirth. This includes the infant naming practice, infant access restrictions, family involvement, and religious practice observance.

Sub-theme 3.1 infant naming by senior family members

Participants indicated that they adhere to the cultural practices of naming the preterm infant after birth. These cultural practices include understanding who is responsible for naming the infant, introducing the infant to the ancestors, and the meaning associated with the name given. The quotes show that senior family members, particularly grandmothers, are responsible for naming the infant and performing ancestral veneration to introduce the infant to the ancestors after birth.

One participant shared that:

If the granny [was] still alive, she [would be] the right [person] to appoint my parent to name the infant. (P02, 25-year-old)

Another participant supported the preceding statement by stating:

Well, when I call them at home regarding the name, my grandmother would want her name to be passed down to the child. (P08, 31-year-old)

The above data highlight that the grandmothers are responsible for naming the infants. This is because naming a preterm infant in Limpopo Province is culturally associated with the practice of ancestral communication, which grandmothers perform. Furthermore, one participant indicated that the infants are named based on various events in life. The following quotation illustrates this:

Because they used a dead person's name, so they are informing the owner of the name that there is someone who will use it. (P02, 25-year-old)

The above quote highlights the belief that a preterm infant is given the name of a deceased person to keep their memory alive and to ensure the continuation of a family legacy. Also, ancestral communication rituals should be performed to inform the name's owner. In addition, another participant indicated that infant naming is culturally essential and that a misnamed infant will continuously cry. The following quotation evidences this belief:

They do that; for example, they can call a baby by name like Sara, and if the baby stops crying, it means that is the name she wanted. And these things happen because they can call her by her name; the baby then stops crying and is healed instantly. (P01, 18-year-old)

The above data suggest that naming a preterm infant may positively affect the infant’s health and well-being when culturally informed. The beliefs and practices related to naming a preterm infant reflect the cultural values and traditions of the parents, which are essential considerations in providing culturally sensitive care in the NICU.

Sub-theme 3.2 infant access restrictions

Participants indicated that everyone is not permitted access to the room where the preterm infant is kept. Access restrictions include funeral attendees, pregnant women and individuals who recently engaged in sexual activities. The following section further explores how participants perceived these restricted individuals as harmful to the infant through a cultural lens based on their experiences during preterm infant care. A common experience for many participants was that individuals who participated in funeral services should perform cultural rituals with ashes and some aloes when entering, as illustrated in the following quotes.

They [those attended the funeral] enter the baby's room, they bath the baby with aloe and ashes a little bit and even on the joints so that she must never get sick. (P01, 18-year-old)

Usually, when they are from a funeral, they take ashes, apply them to the baby and make her swallow a bit of it so that they do not suppress her. (P02, 25-year-old)

An additional participant concurred with the preceding participants and elaborated that:

According to culture all babies from newborn to a child aged 6 to 7, when one person at home goes to the funeral, when that person comes back home takes ashes and rub it on the tummies of all these age group so that none of them can get suppressed or have negative auras. (P20, 19-year-old)

The data highlight the cultural belief that there are diseases and negative auras that can be acquired from funeral services and that precautionary measures must be taken to prevent the spread of these harmful elements to the preterm infant. In addition to the precautionary measures highlighted above, other participants explained that people who attend funerals should be isolated from the infant for some period before regaining access to the infant's room, as illustrated by the two quotes below:

I am staying with my grandmother, but if they are from the funeral, it means only I will nurse the baby. They will take seven days without entering the baby's room. (P04, 24-year-old)

She [person attended the funeral] must stay there for seven days before she returns, and after that, she can come back and help me with the baby. (P11, 27-year-old)

The above quotes indicate that isolating individuals who attended the funeral service for seven days will allow the acquired diseases and negative auras from the funeral to clear up and minimize the chances of transmission to the infant. Pregnant women were the second restriction. The following quotes illustrate beliefs and practices surrounding the presence and interactions of preterm infants and pregnant women:

Traditionally, we think she will suppress the baby. If a pregnant person carries the baby, she will delay the baby's growth. You find that at around six months, the baby is still unable to sit, so they believe it is because a pregnant person carried the baby. She is not supposed to enter the baby's room until the baby gets out. (P02, 25-year-old)

Another participant said:

If someone is pregnant, she is not supposed to hold a baby in such a way that the legs of the baby are on [her-pregnant woman] abdomen because we believe that if the baby's legs are stepping on top of the pregnant person's abdomen, the baby won't walk until the pregnant woman give birth, she will wait for the unborn baby to be born before she can walk. (P01, 18-year-old)

The first quote highlights the complete restriction of pregnant women from gaining access to the infant due to the negative impact (slow growth) that she can have on the infant. However, the second quote indicated that a pregnant woman can be granted access to the infant’s room and can even carry the infant, although with precautions not to allow the infant’s leg to come in contact with the abdomen. Through this analysis, it becomes clear that cultural beliefs and practices play a substantial role in shaping the experiences of pregnant women and their interaction with preterm infants. The final restriction was holding the infant after sexual intercourse. Most participants revealed a common belief that sexual intercourse could lead to the transfer of a negative aura to the infant. The following quote exemplifies this belief:

When the cord has not yet fallen, my grandmother is the only person who is allowed to enter because she has passed that stage of sexual intercourse. The rest of them are not allowed because we are trying to avoid negative aura to be passed on to the child, and if that happen, he will cry a lot. So, no one is allowed except my grandmother. (P08, 31-year-old)

Other participants stated, in support of the preceding statement:

They [siblings] might be coming from their partners and you would find that they were intimate in a way, so their energies will affect the baby negatively. (P09, 30-year-old)

Because they [grandmothers] do not have sexual intercourse anymore and they have experience. Culturally, it is believed that people who had sexual intercourse had negative aura. (P16, 38-year-old)

The data suggest that the role of grandmothers in caring for preterm infants is essential and safe as they are free of negative energies due to their age, experience, and abstinence from sexual intercourse. Furthermore, the data highlights that individuals who engage in sexual intercourse bring negative auras to the baby and are, therefore, not allowed to be in close proximity to the newborn. This cultural practice aims to ensure the well-being and health of the preterm infant by avoiding contact with individuals who have recently engaged in sexual intercourse.

Sub-theme 3.3 family involvement

Cultural practices concerning preterm infant care restrict infant access and allow family members to assist in caring for the infant. The following quotations illustrate participants' experience regarding family involvement while caring for the infant.

One participant stated that:

When I am here, the nurses help me, which is the same when you are at home. There is no difference. (P11, 27-year-old)

Another participant expressed a similar view:

It is very important because when you get help as a new mom you also get time to rest, in my family they would bathe the infant and massage you. (P12, 28-year-old)

In support of the above participants, another participant added that:

At home it is better because we have people who are assisting us, and we have time to rest (P16, 38-year-old)

The conclusion that can be drawn from these findings is that the involvement of family members in caring for the infant enabled the mothers to rest rather than continuously caring for the infant alone, which may be exhausting.

Sub-theme 3.4 religious practices observance/beliefs

In context of this study, most parents were religious and observed religious practices in terms of prayer and using ditaelo (church prescriptions - the church practices believed to be effective in curing the patient and preventing misfortune). This is connected to the belief that their infants would be protected from illness and be healthy, parents would be strengthened, and healthcare professionals would be granted wisdom to care for the infants. Most parents prayed to God for their preterm infant to get better and be healed. The following quotes illustrate this:

I just thought my baby is going to die but because God is present, I prayed I got baby boy. Now I thank God because of my faith and even the doctors had confidence that the baby will be okay. (P18, 20-year-old)

I pray every time I go to the ward for God to give her life and when I leave, I do not know what they will do to her, to not be affected when a lot of activities are done to her body. (P02, 25-year-old) Furthermore, parents also prayed for themselves and drew strength from their spiritual anchor to overcome the challenges they experienced while caring for their preterm infant in the NICU.

I have a way of overcoming my fears and sadness through prayer so that I can be able to receive strength . (P11, 27-year-old)

Other participants also highlighted this. For example, one participant indicated that:

When I am down, I pray for 2 minutes and ask God for strength. Then after, I feel okay. (P02, 25-year-old)

Moreover, participants did not only pray for themselves and their infants but also for healthcare professionals to have wisdom while caring for their infants. The following quotes demonstrate this intercession:

I believe that is the reason I prayed, because evil spirits can block the doctors view for them not see anything. (P12, 28-year-old)

Until now I just pray to God to give wisdom to doctors so that they treat my baby well then, I can go home. (P18, 20-year-old)

Lastly, one participant believed that prayer is more effective when performed in person, in the presence of others, rather than done alone. The participant stated that:

I prefer that when I pray, I must be there with two or more people because the prayer becomes more powerful when you are many. (P11, 27-year-old)

These findings highlights that the communal aspect of religious practices is vital for some individuals and that they believe that the power of prayer is amplified when performed with others. The quotes in this analysis indicate that the participants view prayer as connecting with a higher power, seeking strength, wisdom, and healing for themselves and the preterm infant in their care. Another aspect of religious practice, observance/practice called ditaelo , was also used to protect their infants from evil spirits and heal them.

Theme 4 indigenous healthcare practices for preterm infants

The final theme from the data analysis was “indigenous healthcare practices for preterm infants,” which parents described as the beliefs, knowledge, and habits about health passed down from generation to generation in a specific community. This theme is further explored through the following four subthemes.

Sub-theme 4.1 cultural practices used for cleaning the umbilical cord

Most participants believed that the indigenous care method for the umbilical cord is a vital cultural practice related to preterm infant care. Although the participants used surgical spirit in the NICU, they expressed the practices of using various herbal formulations that they would like to incorporate in the NICU during umbilical cord care. The following quotes reflect this.

I take table salt with that powdered wood soot and apply it [umbilical cord] on the cord every time you bathe the baby until it dries. (P10, 39-year-old)

We took soil from termite mound, chickens’ manure and placed them there for it to fall. (P12, 28-year-old)

Additionally, the same view was echoed by other participants, explaining that:

The herbs will shrink the cord, which will eventually fall off. After that, they will give you herbs to spread over the cord area, which will help the cord to close from inside. I was using the ashes to mix with Vaseline, then spread the mixture over the cord. (P15, 32-year-old)

We clean the cord with surgical spirit. Then we also use the head from the ‘matches’ stick and mix with the mouse poo and crush it down until is a fine powder. Then we apply the fine powder on the cord area. (P20, 19-year-old)

In addition to the various preferred herbal formulations, other participants mentioned that they apply breastmilk on the umbilical cord to increase the rate at which it dries. This is evident in the following quotes:

We do a full bath after two days with warm water, then clean the cord with the spirit, and apply breast milk so that the cord can dry and fall fast. (P18, 20-year-old)

They say we pour breast milk on the cord, like basically the newborn baby we need to apply the breast milk when I wake up in the morning, on the belly button. (P17, 23-year-old)

Furthermore, despite using surgical spirit in the NICU, participants were dissatisfied with its effectiveness. Most mothers felt that the delayed umbilical cord drying, and detachment were caused using surgical spirits.

One participant mentioned:

The way of taking care of children here is different; for instance, the surgical spirit is not so effective in cleaning and making the cord dry. The cord would have fallen by now if I was home. (P05, 38-year-old)

Another participant expressed that:

With home remedies it takes up to three days but with the surgical spirit, it takes seven days. It is fast if you do it traditionally. (P13, 22-year-old)

In support of the above participant, another participant further explained that:

We are staying with elderly people at our homes, so immediately after the baby is born, we start by treating her umbilical cord, which, culturally or religion-wise, is much faster than what we use here at the hospital, because even here at the hospital, they treat the cord by spreading spirit on the cord, but it takes time. (P14, 39-year-old)

Sub-theme 4.2 treatment of dehydration “ phogwana or lebalana ”

Some illnesses experienced by newborns are deemed to be not-for-hospital treatment but require indigenous healthcare practices or treatment. For example, dehydration is an indigenous childhood illness called phogwana, which traditionalists treat through herbal formulations. Other participants were concerned that their infant might suffer from phogwana while admitted to the NICU.

Maybe if I do things the way I am used to doing on the baby, he might recover, or maybe the baby has phogwana, and the doctor thinks it is something they can treat. (P06, 23-year-old)

The following participant echoed a similar notion in support:

When the baby is sick with lebalana, you do not take the baby to the hospital because they do not know how to treat that. You take her to someone. In Tshivenda, we say when the baby has lebalana, they must cut, burn things that came out of it, and then come to the baby… then the baby heals at the same time. (P17, 23-year-old)

Furthermore, participants shared that phogwana needs to be treated by a traditional healer or with traditional medicine. This is evident in the following quote.

If the phogwana is not beating well, there is a traditional medicine that we apply to make sure that it does not affect the baby. (P16, 38-year-old)

Sub-theme 4.3 care of eyes, ears, and nose

The subtheme of "care of eyes, ears, and nose " within the major theme of indigenous healthcare practices for preterm infants is represented by traditional methods of addressing issues related to the eyes, ears, and nose. Most participants reported using breast milk to clean and treat minor ailments of the eyes, ears, and nose.

Most of the time we use breast milk to take care of their eyes, and that even allows them to sleep peacefully, we take few drops of our breast milk and pour them inside his eyes. (P08, 31-year-old)

Another participant added that:

If the eyes are having discharge, we express breast milk inside the eyes and wipes it using the tongue to remove the discharges. (P16, 38-year-old)

In addition to using breast milk for eyes, it was reported to treat blocked nostrils and common flu and clean the umbilical cord, as reflected in the following quotes.

Breast milk works especially when the eyes are white or having the discharges. Same as the nose, when the baby is having a flu, we put few drops of breast milk that is our culture. (P18, 20-year-old)

Participants believe that the non-nutritional use of breast milk as a remedy or treatment for minor ailments of the eyes, sinuses, and ears is effective. This traditional belief may be because breast milk contains antibacterial and anti-inflammatory properties.

Sub-theme 4.4 infant bathing practices

The current study further revealed that preterm infant bathing was not only done for hygiene-related reasons but was also seen as serving to stimulate weight, for physical strengthening, and to protect the infant against evil spirits. These reasons are reflected in the following quotes.

Traditionally we bathe her with sehlapišo (traditional medicine) used to bathe infants to stimulate weight gain. (P13, 22-year-old)

Another participant also shared that:

We use leaves from the Baobab tree to bathe the baby; it is a medication. It is responsible for making the baby strong. (P10, 39-year-old)

In addition to herbal medicines that stimulate infant weight, other participants reported using herbal formulations to protect the infant against evil spirits and negative auras. The usage of herbal formulations is evident in the following quotes:

They use mogato (a traditional form of medicine to protect the baby from being suppressed) for bathing her. They put mogato inside the water and then just bath her, more especially if there is someone from the extended family coming to visit. (P02, 25-year-old)

I use the mixture, add it to the water, and bathe the baby to remove the negative spirits and aura, and some is for weight-gaining stimulation because young babies are difficult to hold due to their size. (P14, 39-year-old)

Lastly, other participants also shared the same notion; however, they indicated that this kind of herbal formulation called sehlapišo should not be used on the infant’s head during bathing as it is believed that the infant’s head will grow at an expedited rate should it come in contact with sehlapišo . The following quotes demonstrate this point:

When we use ‘sehlapišo’ for two days, we keep the water and then the next day we dilute it with hot water so that it becomes warm, and then after bathing we rinse him. we only bath his arms and legs because if we bath his head and neck they will grow too as this is used for growing or gaining weight. (P08, 31-year-old)

You do not touch the baby’s head when using ‘sehlapišo’ you only bath him from the neck to his toes, because they say if it happens that you touch the baby’s head while bathing him, [otherwise] the head and face becomes swollen and changes size. (P09, 30-year-old)

This study highlights parents' experiences caring for their preterm infants and the cultural determinants that can be integrated into preterm care to ensure culturally sensitive care. Four major themes and related sub-themes emphasise the importance of healthcare professionals respecting and acknowledging cultural practices, beliefs, and customs relevant to parents of preterm infants admitted to their facilities.

Participants in the current study experienced a range of negative feelings, including shock, fear, and anxiety, concerning the unexpected event of preterm birth, consistent with the literature. For instance, studies conducted in Sweden [ 30 ] and Denmark [ 31 ] reported that the abruptness of preterm birth, combined with the physical environment of the NICU, evokes feelings of shock and overwhelm in parents. Furthermore, the fear and anxiety experienced by the participants in this study while caring for their preterm infant in the NICU corroborate the findings in existing literature [ 32 , 33 ]. Both studies reported that parents often oscillate between hope and fear, particularly regarding their infant's survival and the possible long-term health complications associated with preterm birth. This correlation could be explained by the fact that preterm birth is traumatic and a potential stressor because it occurs mostly under emergency conditions, often threatening both the parents and the infant's well-being.

The current study's findings revealed that most participants acknowledged receiving satisfactory care from the nurses and doctors, as they were regularly present and helpful in tending to the infants' needs. This finding mirrors those of a study which noted that parents appreciate the quality of care provided by healthcare professionals in the NICU [ 34 ]. However, some participants felt that the nurses were often not friendly and mistreated them in the NICU. The findings are similar to the study which reported that some parents were dissatisfied with the care they received, which often stemmed from perceived rude behavior or negligence [ 35 ]. While technical, medical treatment and care are vital, the current data highlight how such care significantly influences parents' experiences in the NICU.

Communication, both in content and manner, is essential in the NICU setting, as it profoundly impacts parental experiences [ 36 ]. In addition, communication was also identified as a critical component in providing quality care to a diverse population concerning incorporating culturally competent care [ 37 ]. The current findings showed that many parents were satisfied with the communication they received from healthcare professionals, particularly when they were given clear explanations about their infants' condition. However, specific communication issues, including using incomprehensible medical jargon, insufficient intervention information, and conflicting advice from different professionals, were pointed out. These issues align with previous research, highlighting the need for improved communication strategies in the NICU to better inform and support parents [ 38 ].

Regarding the attitude of healthcare professionals, our findings revealed a mixed perception among parents. Some parents expressed dissatisfaction with the perceived negative attitudes of healthcare professionals, echoing similar findings by Shields et al. [ 39 ]. Negative attitudes from healthcare professionals can lead to mistrust and increased stress among parents [ 40 ]. Conversely, other parents in our study reported positive attitudes and felt well-supported and valued by the NICU staff. This positive perception aligns with the previous study which suggested that positive interactions with healthcare professionals can improve parental satisfaction [ 41 ]. While the current findings corroborate existing literature, the heightened perception of both positive and negative aspects of care, communication, and attitude might be attributed to cultural diversity in Limpopo Province.

The current study found that naming preterm infants is the domain of senior family members, particularly grandmothers. This finding aligns with previous work which asserted that grandmothers play a crucial role in naming infants and performing associated rituals in African cultures [ 42 ]. This role could be because the naming process is closely related to ancestral communication, which grandmothers frequently facilitate. Furthermore, the study indicates that infants' names often carry important cultural meanings or memorials, reflecting events or individuals in the family's history. The belief in the power of naming to affect an infant's well-being corroborates with the previous study’s assertion that names in most African cultures bear profound significance, carrying the family's hopes, aspirations, and legacies [ 43 ]. Additionally, names help individuals understand who they are and the community to which they belong. Such findings underscore the importance of cultural considerations concerning naming preterm infants in the NICU to promote culturally sensitive care and enhance parents' experiences.

In this study, three cultural restrictions on infant access aimed at safeguarding preterm infants' health were revealed. These restrictions primarily concern those who attended funerals, pregnant women, and people who recently engaged in sexual intercourse. First, funeral attendants: participants believed they could introduce diseases or negative auras to preterm infants, so precautionary measures needed to be taken before access could be granted again. The precautionary measure, which includes isolating funeral attendants for several days and having them wash their hands with aloe and ashes before touching the infant, aligns with a study by McAdoo [ 44 ], which reported similar customs among various African cultures. The use of aloe and ashes might stem from the fact that they contain some antibacterial properties, which may kill or lessen bacteria.

Second, according to our findings, pregnant women were also viewed as potentially harmful to preterm infants. This finding is unique as no other similar study could be located regarding the harm that could be brought by pregnant women. Third, individuals who recently engaged in sexual intercourse were deemed to have negative auras that could harm infants, particularly from parents' perspectives. This restriction echoes findings of previous study which revealed that newborns are isolated from young girls who engage in sexual activities as they can delay umbilical cord falling off [ 45 ]. This finding highlights the need for open dialogue and understanding regarding sexual practices in NICU care.

This study's findings underline the key role of family members in caring for preterm infants, which aligns with previous research in the field. Particularly, participant responses corroborated the evidence of family involvement as crucial to maternal well-being and infant care, as shown in a study conducted in the United States [ 46 ]. The responses reflect an appreciation for the support offered by extended family, primarily in providing mothers with rest and recovery time, mirroring previous findings [ 47 ]. The significance of family engagement in this study can be linked to cultural norms and values in the Limpopo Province and South Africa.

Most South African tribes, particularly indigenous ones, strongly believe in communal assistance and interdependence, particularly at significant life events such as childbirth. This is frequently characterised by extended family members stepping in to aid and support the new mother, allowing her time to relax and heal while contributing to the infant's care. Additionally, the similarity in support between NICU nurses and family members emphasized by participants resonates with the notion of family-centred care advocated by other scholars [ 48 ]. This approach, which suggests that healthcare providers can emulate a sense of familial support, highlights the importance of aligning clinical practices with the socio-cultural context of care.

Most participants expressed a reliance on prayer for the health of their infants, personal strength, and wisdom for healthcare professionals, which aligns with other studies that demonstrated the importance of spiritual beliefs in health outcomes and coping mechanisms [ 49 , 50 , 51 ]. Moreover, the idea of communal prayer being more potent than individual prayer, as pointed out by one participant, echoes classic sociological theory on the collective effervescence and emotional energy generated in communal religious rituals [ 52 ]. This finding accentuates the importance of understanding and integrating spiritual needs and beliefs in the NICU environment.

Interestingly, participants in the current study also invoked ' ditaelo ', or church prescriptions, in protecting and healing their infants. This practice, not extensively documented in the existing literature, appears to be a distinct element of religious observance in this cultural context. It may relate to African traditional healing practices, as discussed in the previous studies which indicated a unique fusion of Christianity and indigenous beliefs [ 53 , 54 ]. This practice underscores the cultural and spiritual complexity surrounding NICU care in the Limpopo Province and calls for further research to better comprehend these practices and their implications for infant care.

The participants’ experiences in the current study regarding umbilical cord care revealed that most parents reported using and believing in traditional cord care practices. These participants further described using ashes, powdered wood soot, breast milk, and soil from termite mounds topically to dry off and heal the umbilical cord. The use of herbs to treat and care for the umbilical cord was not unique to the participants in this study. In Sub-Saharan countries including South Africa [ 45 ], Zambia [ 55 ], Nigeria [ 56 ], Pakistan [ 57 ], and Uganda [ 58 ], the topical application of substances to the umbilical cord to hasten its detachment has been reported. It is important to acknowledge that while these traditional practices hold cultural significance and have been used for generations, their efficacy and safety may differ. In some cases, such practices may carry risks, such as infection or irritation. Healthcare providers should be aware of these cultural practices and engage in open and respectful conversation with families to understand their beliefs and preferences while also providing safe evidence-based care.

Moreover, participants also expressed dissatisfaction with modern procedures, such as surgical spirits, which they perceived as less effective than traditional practices because it makes the cord detach after seven days. This perception echoes the findings of study which revealed that some cultures believe traditional practices provide superior results compared to modern medical care, particularly for infants [ 59 ]. Although the herbal formulation was preferred over modern medical care, it has not been scientifically evaluated and studied; therefore, there is a potential risk of infection and other complications. Further research is needed to understand the scientific functionality of herbal formulations used to treat and dry off the umbilical cord.

This study showed that there are perceptions that certain medical conditions affecting newborns do not necessitate hospital care but rather require indigenous healthcare practices or treatment. For instance, phogwana was mentioned as a condition that needs out-of-hospital treatment by traditionalists. Similarly, this finding supports the previous literature which documented that the treatment of phogwana requires a traditional healer [ 44 , 60 ]. In addition, the literature indicated that the characteristics, prevention, and treatment of phogwana correspond to specific cultural contexts [ 61 ]. Providing medical care for premature infants outside of the hospital, under the guidance of traditionalists, may pose result risks, such as adverse responses to herbal therapy and metabolic poisoning. The immature organs of preterm newborns may have limited ability to efficiently remove metabolites of herbal medicines, which could potentially cause more health complications and death [ 62 ].

Furthermore, regarding the care of eyes, ears, and nose, participants reported using breast milk as a treatment for minor ailments. The belief in the antibacterial effects and healing properties of breast milk in traditional medicine is further substantiated by this finding, aligning with existing literature. These studies reinforce the multifunctional uses of breast milk beyond nutrition, including its application in treating eye infections [ 63 ] and alleviating nasal congestion, among others [ 64 ]. Although the benefits of breast milk are recognised, it is crucial to follow proper hygiene protocols when dealing with it. This includes washing your hands before handling breast milk and using sterile containers and applicators. Neglecting to maintain good hygiene can potentially introduce infections to the ears, nose, and eyes.

The participants in the current study reported that infant bathing was performed with different herbs for several purposes, such as stimulation of weight, warding off the evil spirit, and strengthening and protecting the infant. Herbal formulations used for bathing included sehlapišo , mogato , and baobab tree leaves. This study's findings agree with several studies on the African continent. In Uganda, infants were bathed with kyogero to attract fortunes [ 65 ], and in South Africa [ 44 ], India [ 66 ] and Nigeria [ 67 ], herbal medicine was also used during infant bathing for strengthening and spiritual protection purposes. One possible reason for the similarity could be that all studies reporting indigenous infant bathing were conducted on the African continent, which has overlapping cultural practices. It is clear from this finding that bathing practices are not merely physiologically functional but are often symbolic, serving various socio-cultural purposes and highlighting the intersection of cultural belief and healthcare. Preterm infants are vulnerable to health risks such as hypothermia, skin irritation, and infection due to their underdeveloped thermoregulatory system, delicate skin, and immature immune system [ 68 ]. Ritual bathing, particularly if not performed carefully, has the potential to worsen these health risks. It is recommended that healthcare professionals should ensures measures to guarantee that the ritual bathing environment for preterm newborns is secure, hygienic, and at a suitable temperature to reduce these dangers.

Limitations and strengths of the study

This study explored the cultural determinants of parents that can be incorporated into preterm infant care to ensure culturally sensitive care as part of maternal and childcare routine in the NICU in Limpopo Province. Although the qualitative design was the most appropriate to explore the phenomenon in this study, it limited the study's findings as it was not generalizable. Additionally, the primary investigator’s unconscious biases and perceptions could have influenced data analysis, however bracketing was applied to limit bias. Furthermore, to limit biases, the experts conducted a confirmability audit of the study project by checking and rechecking the collected raw-, coded- and interpreted data. The current study was conducted in a public hospital in Limpopo Province to explore the experiences of parents of preterm infants in the NICU, which may differ substantially from those in private hospitals and other provinces. Therefore, future research is recommended to explore this phenomenon in private hospitals and other provinces in South Africa.

The current study provides an understanding of parents' experiences caring for preterm infants in the NICU. The study offered meaningful insights into indigenous healthcare practices, emphasizing their crucial role in preterm infant care in specific cultural contexts. The cultural determinants included various topics, such as caring for the umbilical cord, treating phogwana , caring for the eyes, ears, and nose, and infant bathing customs. These practices showed a deeply ingrained belief system and a rich cultural heritage that have a meaningful impact on healthcare behaviours. However, these cultural determinants might have both positive and negative implications.

The findings demonstrated a strong reliance on traditional methods and herbal formulations in caring for preterm infants. Parents emphasised the advantages of these practices over current medical procedures, notably in treating disorders not frequently recognised by modern medicine and the care of the umbilical cord. This discontent with contemporary practices, highlights the need for culturally sensitive healthcare which can be conducted by conducting cultural assessments to understand the beliefs, values, and practices of the families in the NICU.

Overall, the findings of this study highlight the profound role of indigenous healthcare practices for preterm infants, reinforcing the need for a culturally sensitive approach in healthcare.

Availability of data and materials

The dataset materials generated and analysed during this study are accessible upon justified request from the corresponding author [MN].

Abbreviations

Neonatal Intensive Care Unit

North-West University

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Acknowledgements

The authors would like to extend their gratitude to all the parents of preterm infants who participated in this study and the assistant researchers who assisted in collecting the data.

Open access funding provided by North-West University. This manuscript was extracted from a funded research project by the NWU postgraduate bursary and Faculty of Health Sciences bursary (Funding code/number: not applicable).

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Madimetja J. Nyaloko, Welma Lubbe, Salaminah S. Moloko-Phiri & Khumoetsile D. Shopo

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M.N. conceptualised and developed the research protocol, conducted research (gathered, analysed, interpreted, and managed the data), and wrote the initial draft. W.L., S.S.M., and K.D.S. supervised the research and provided inputs and guidance for the research protocol development, data collection, analysis, and interpretations. All authors have read and approved the manuscript.

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Correspondence to Madimetja J. Nyaloko .

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The current study was executed in accordance with the Declaration of Helsinki and approved by North-West University Health Research Ethical committee [NWU-00267-21-S1]. Limpopo Province [LP-2021-08-027] granted permission to conduct the study through the National Health Research Database website. The management of the tertiary hospital granted goodwill permission for the study to be undertaken in their NICU. All the parents of preterm infants who participated in the study provided written informed consent. Participants were informed that participation in the study was voluntary and that they could withdraw anytime without penalty.

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Nyaloko, M.J., Lubbe, W., Moloko-Phiri, S.S. et al. Parental experiences of caring for preterm infants in the neonatal intensive care unit, Limpopo Province: a descriptive qualitative study exploring the cultural determinants. BMC Health Serv Res 24 , 669 (2024). https://doi.org/10.1186/s12913-024-11117-6

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Received : 11 October 2023

Accepted : 17 May 2024

Published : 28 May 2024

DOI : https://doi.org/10.1186/s12913-024-11117-6

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