qualitative research frameworks

• Correspondence
• Open access
• Published: 18 September 2013

Using the framework method for the analysis of qualitative data in multi-disciplinary health research

• Nicola K Gale 1 ,
• Gemma Heath 2 ,
• Elaine Cameron 3 ,
• Sabina Rashid 4 &
• Sabi Redwood 2  

BMC Medical Research Methodology volume  13 , Article number:  117 ( 2013 ) Cite this article

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The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations.

The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study.

Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

The Framework Method for the management and analysis of qualitative data has been used since the 1980s [ 1 ]. The method originated in large-scale social policy research but is becoming an increasingly popular approach in medical and health research; however, there is some confusion about its potential application and limitations. In this article we discuss when it is appropriate to use the Framework Method and how it compares to other qualitative analysis methods. In particular, we explore how it can be used in multi-disciplinary health research teams. Multi-disciplinary and mixed methods studies are becoming increasingly commonplace in applied health research. As well as disciplines familiar with qualitative research, such as nursing, psychology and sociology, teams often include epidemiologists, health economists, management scientists and others. Furthermore, applied health research often has clinical representation and, increasingly, patient and public involvement [ 2 ]. We argue that while leadership is undoubtedly required from an experienced qualitative methodologist, non-specialists from the wider team can and should be involved in the analysis process. We then present a step-by-step guide to the application of the Framework Method, illustrated using a worked example (See Additional File 1 ) from a published study [ 3 ] to illustrate the main stages of the process. Technical terms are included in the glossary (below). Finally, we discuss the strengths and limitations of the approach.

Glossary of key terms used in the Framework Method

Analytical framework: A set of codes organised into categories that have been jointly developed by researchers involved in analysis that can be used to manage and organise the data. The framework creates a new structure for the data (rather than the full original accounts given by participants) that is helpful to summarize/reduce the data in a way that can support answering the research questions.

Analytic memo: A written investigation of a particular concept, theme or problem, reflecting on emerging issues in the data that captures the analytic process (see Additional file 1 , Section 7).

Categories: During the analysis process, codes are grouped into clusters around similar and interrelated ideas or concepts. Categories and codes are usually arranged in a tree diagram structure in the analytical framework. While categories are closely and explicitly linked to the raw data, developing categories is a way to start the process of abstraction of the data (i.e. towards the general rather than the specific or anecdotal).

Charting: Entering summarized data into the Framework Method matrix (see Additional File 1 , Section 6).

Code: A descriptive or conceptual label that is assigned to excerpts of raw data in a process called ‘coding’ (see Additional File 1 , Section 3).

Data: Qualitative data usually needs to be in textual form before analysis. These texts can either be elicited texts (written specifically for the research, such as food diaries), or extant texts (pre-existing texts, such as meeting minutes, policy documents or weblogs), or can be produced by transcribing interview or focus group data, or creating ‘field’ notes while conducting participant-observation or observing objects or social situations.

Indexing: The systematic application of codes from the agreed analytical framework to the whole dataset (see Additional File 1 , Section 5).

Matrix: A spreadsheet contains numerous cells into which summarized data are entered by codes (columns) and cases (rows) (see Additional File 1 , Section 6).

Themes: Interpretive concepts or propositions that describe or explain aspects of the data, which are the final output of the analysis of the whole dataset. Themes are articulated and developed by interrogating data categories through comparison between and within cases. Usually a number of categories would fall under each theme or sub-theme [ 3 ].

Transcript: A written verbatim (word-for-word) account of a verbal interaction, such as an interview or conversation.

The Framework Method sits within a broad family of analysis methods often termed thematic analysis or qualitative content analysis. These approaches identify commonalities and differences in qualitative data, before focusing on relationships between different parts of the data, thereby seeking to draw descriptive and/or explanatory conclusions clustered around themes. The Framework Method was developed by researchers, Jane Ritchie and Liz Spencer, from the Qualitative Research Unit at the National Centre for Social Research in the United Kingdom in the late 1980s for use in large-scale policy research [ 1 ]. It is now used widely in other areas, including health research [ 3 – 12 ]. Its defining feature is the matrix output: rows (cases), columns (codes) and ‘cells’ of summarised data, providing a structure into which the researcher can systematically reduce the data, in order to analyse it by case and by code [ 1 ]. Most often a ‘case’ is an individual interviewee, but this can be adapted to other units of analysis, such as predefined groups or organisations. While in-depth analyses of key themes can take place across the whole data set, the views of each research participant remain connected to other aspects of their account within the matrix so that the context of the individual’s views is not lost. Comparing and contrasting data is vital to qualitative analysis and the ability to compare with ease data across cases as well as within individual cases is built into the structure and process of the Framework Method.

The Framework Method provides clear steps to follow and produces highly structured outputs of summarised data. It is therefore useful where multiple researchers are working on a project, particularly in multi-disciplinary research teams were not all members have experience of qualitative data analysis, and for managing large data sets where obtaining a holistic, descriptive overview of the entire data set is desirable. However, caution is recommended before selecting the method as it is not a suitable tool for analysing all types of qualitative data or for answering all qualitative research questions, nor is it an ‘easy’ version of qualitative research for quantitative researchers. Importantly, the Framework Method cannot accommodate highly heterogeneous data, i.e. data must cover similar topics or key issues so that it is possible to categorize it. Individual interviewees may, of course, have very different views or experiences in relation to each topic, which can then be compared and contrasted. The Framework Method is most commonly used for the thematic analysis of semi-structured interview transcripts, which is what we focus on in this article, although it could, in principle, be adapted for other types of textual data [ 13 ], including documents, such as meeting minutes or diaries [ 12 ], or field notes from observations [ 10 ].

For quantitative researchers working with qualitative colleagues or when exploring qualitative research for the first time, the nature of the Framework Method is seductive because its methodical processes and ‘spreadsheet’ approach seem more closely aligned to the quantitative paradigm [ 14 ]. Although the Framework Method is a highly systematic method of categorizing and organizing what may seem like unwieldy qualitative data, it is not a panacea for problematic issues commonly associated with qualitative data analysis such as how to make analytic choices and make interpretive strategies visible and auditable. Qualitative research skills are required to appropriately interpret the matrix, and facilitate the generation of descriptions, categories, explanations and typologies. Moreover, reflexivity, rigour and quality are issues that are requisite in the Framework Method just as they are in other qualitative methods. It is therefore essential that studies using the Framework Method for analysis are overseen by an experienced qualitative researcher, though this does not preclude those new to qualitative research from contributing to the analysis as part of a wider research team.

There are a number of approaches to qualitative data analysis, including those that pay close attention to language and how it is being used in social interaction such as discourse analysis [ 15 ] and ethnomethodology [ 16 ]; those that are concerned with experience, meaning and language such as phenomenology [ 17 , 18 ] and narrative methods [ 19 ]; and those that seek to develop theory derived from data through a set of procedures and interconnected stages such as Grounded Theory [ 20 , 21 ]. Many of these approaches are associated with specific disciplines and are underpinned by philosophical ideas which shape the process of analysis [ 22 ]. The Framework Method, however, is not aligned with a particular epistemological, philosophical, or theoretical approach. Rather it is a flexible tool that can be adapted for use with many qualitative approaches that aim to generate themes.

The development of themes is a common feature of qualitative data analysis, involving the systematic search for patterns to generate full descriptions capable of shedding light on the phenomenon under investigation. In particular, many qualitative approaches use the ‘constant comparative method’ , developed as part of Grounded Theory, which involves making systematic comparisons across cases to refine each theme [ 21 , 23 ]. Unlike Grounded Theory, the Framework Method is not necessarily concerned with generating social theory, but can greatly facilitate constant comparative techniques through the review of data across the matrix.

Perhaps because the Framework Method is so obviously systematic, it has often, as other commentators have noted, been conflated with a deductive approach to qualitative analysis [ 13 , 14 ]. However, the tool itself has no allegiance to either inductive or deductive thematic analysis; where the research sits along this inductive-deductive continuum depends on the research question. A question such as, ‘Can patients give an accurate biomedical account of the onset of their cardiovascular disease?’ is essentially a yes/no question (although it may be nuanced by the extent of their account or by appropriate use of terminology) and so requires a deductive approach to both data collection and analysis (e.g. structured or semi-structured interviews and directed qualitative content analysis [ 24 ]). Similarly, a deductive approach may be taken if basing analysis on a pre-existing theory, such as behaviour change theories, for example in the case of a research question such as ‘How does the Theory of Planned Behaviour help explain GP prescribing?’ [ 11 ]. However, a research question such as, ‘How do people construct accounts of the onset of their cardiovascular disease?’ would require a more inductive approach that allows for the unexpected, and permits more socially-located responses [ 25 ] from interviewees that may include matters of cultural beliefs, habits of food preparation, concepts of ‘fate’, or links to other important events in their lives, such as grief, which cannot be predicted by the researcher in advance (e.g. an interviewee-led open ended interview and grounded theory [ 20 ]). In all these cases, it may be appropriate to use the Framework Method to manage the data. The difference would become apparent in how themes are selected: in the deductive approach, themes and codes are pre-selected based on previous literature, previous theories or the specifics of the research question; whereas in the inductive approach, themes are generated from the data though open (unrestricted) coding, followed by refinement of themes. In many cases, a combined approach is appropriate when the project has some specific issues to explore, but also aims to leave space to discover other unexpected aspects of the participants’ experience or the way they assign meaning to phenomena. In sum, the Framework Method can be adapted for use with deductive, inductive, or combined types of qualitative analysis. However, there are some research questions where analysing data by case and theme is not appropriate and so the Framework Method should be avoided. For instance, depending on the research question, life history data might be better analysed using narrative analysis [ 19 ]; recorded consultations between patients and their healthcare practitioners using conversation analysis [ 26 ]; and documentary data, such as resources for pregnant women, using discourse analysis [ 27 ].

It is not within the scope of this paper to consider study design or data collection in any depth, but before moving on to describe the Framework Method analysis process, it is worth taking a step back to consider briefly what needs to happen before analysis begins. The selection of analysis method should have been considered at the proposal stage of the research and should fit with the research questions and overall aims of the study. Many qualitative studies, particularly ones using inductive analysis, are emergent in nature; this can be a challenge and the researchers can only provide an “imaginative rehearsal” of what is to come [ 28 ]. In mixed methods studies, the role of the qualitative component within the wider goals of the project must also be considered. In the data collection stage, resources must be allocated for properly trained researchers to conduct the qualitative interviewing because it is a highly skilled activity. In some cases, a research team may decide that they would like to use lay people, patients or peers to do the interviews [ 29 – 32 ] and in this case they must be properly trained and mentored which requires time and resources. At this early stage it is also useful to consider whether the team will use Computer Assisted Qualitative Data Analysis Software (CAQDAS), which can assist with data management and analysis.

As any form of qualitative or quantitative analysis is not a purely technical process, but influenced by the characteristics of the researchers and their disciplinary paradigms, critical reflection throughout the research process is paramount, including in the design of the study, the construction or collection of data, and the analysis. All members of the team should keep a research diary, where they record reflexive notes, impressions of the data and thoughts about analysis throughout the process. Experienced qualitative researchers become more skilled at sifting through data and analysing it in a rigorous and reflexive way. They cannot be too attached to certainty, but must remain flexible and adaptive throughout the research in order to generate rich and nuanced findings that embrace and explain the complexity of real social life and can be applied to complex social issues. It is important to remember when using the Framework Method that, unlike quantitative research where data collection and data analysis are strictly sequential and mutually exclusive stages of the research process, in qualitative analysis there is, to a greater or lesser extent depending on the project, ongoing interplay between data collection, analysis, and theory development. For example, new ideas or insights from participants may suggest potentially fruitful lines of enquiry, or close analysis might reveal subtle inconsistencies in an account which require further exploration.

Procedure for analysis

Stage 1: transcription.

A good quality audio recording and, ideally, a verbatim (word for word) transcription of the interview is needed. For Framework Method analysis, it is not necessarily important to include the conventions of dialogue transcriptions which can be difficult to read (e.g. pauses or two people talking simultaneously), because the content is what is of primary interest. Transcripts should have large margins and adequate line spacing for later coding and making notes. The process of transcription is a good opportunity to become immersed in the data and is to be strongly encouraged for new researchers. However, in some projects, the decision may be made that it is a better use of resources to outsource this task to a professional transcriber.

Stage 2: Familiarisation with the interview

Becoming familiar with the whole interview using the audio recording and/or transcript and any contextual or reflective notes that were recorded by the interviewer is a vital stage in interpretation. It can also be helpful to re-listen to all or parts of the audio recording. In multi-disciplinary or large research projects, those involved in analysing the data may be different from those who conducted or transcribed the interviews, which makes this stage particularly important. One margin can be used to record any analytical notes, thoughts or impressions.

Stage 3: Coding

After familiarization, the researcher carefully reads the transcript line by line, applying a paraphrase or label (a ‘code’) that describes what they have interpreted in the passage as important. In more inductive studies, at this stage ‘open coding’ takes place, i.e. coding anything that might be relevant from as many different perspectives as possible. Codes could refer to substantive things (e.g. particular behaviours, incidents or structures), values (e.g. those that inform or underpin certain statements, such as a belief in evidence-based medicine or in patient choice), emotions (e.g. sorrow, frustration, love) and more impressionistic/methodological elements (e.g. interviewee found something difficult to explain, interviewee became emotional, interviewer felt uncomfortable) [ 33 ]. In purely deductive studies, the codes may have been pre-defined (e.g. by an existing theory, or specific areas of interest to the project) so this stage may not be strictly necessary and you could just move straight onto indexing, although it is generally helpful even if you are taking a broadly deductive approach to do some open coding on at least a few of the transcripts to ensure important aspects of the data are not missed. Coding aims to classify all of the data so that it can be compared systematically with other parts of the data set. At least two researchers (or at least one from each discipline or speciality in a multi-disciplinary research team) should independently code the first few transcripts, if feasible. Patients, public involvement representatives or clinicians can also be productively involved at this stage, because they can offer alternative viewpoints thus ensuring that one particular perspective does not dominate. It is vital in inductive coding to look out for the unexpected and not to just code in a literal, descriptive way so the involvement of people from different perspectives can aid greatly in this. As well as getting a holistic impression of what was said, coding line-by-line can often alert the researcher to consider that which may ordinarily remain invisible because it is not clearly expressed or does not ‘fit’ with the rest of the account. In this way the developing analysis is challenged; to reconcile and explain anomalies in the data can make the analysis stronger. Coding can also be done digitally using CAQDAS, which is a useful way to keep track automatically of new codes. However, some researchers prefer to do the early stages of coding with a paper and pen, and only start to use CAQDAS once they reach Stage 5 (see below).

Stage 4: Developing a working analytical framework

After coding the first few transcripts, all researchers involved should meet to compare the labels they have applied and agree on a set of codes to apply to all subsequent transcripts. Codes can be grouped together into categories (using a tree diagram if helpful), which are then clearly defined. This forms a working analytical framework. It is likely that several iterations of the analytical framework will be required before no additional codes emerge. It is always worth having an ‘other’ code under each category to avoid ignoring data that does not fit; the analytical framework is never ‘final’ until the last transcript has been coded.

Stage 5: Applying the analytical framework

The working analytical framework is then applied by indexing subsequent transcripts using the existing categories and codes. Each code is usually assigned a number or abbreviation for easy identification (and so the full names of the codes do not have to be written out each time) and written directly onto the transcripts. Computer Assisted Qualitative Data Analysis Software (CAQDAS) is particularly useful at this stage because it can speed up the process and ensures that, at later stages, data is easily retrievable. It is worth noting that unlike software for statistical analyses, which actually carries out the calculations with the correct instruction, putting the data into a qualitative analysis software package does not analyse the data; it is simply an effective way of storing and organising the data so that they are accessible for the analysis process.

Stage 6: Charting data into the framework matrix

Qualitative data are voluminous (an hour of interview can generate 15–30 pages of text) and being able to manage and summarize (reduce) data is a vital aspect of the analysis process. A spreadsheet is used to generate a matrix and the data are ‘charted’ into the matrix. Charting involves summarizing the data by category from each transcript. Good charting requires an ability to strike a balance between reducing the data on the one hand and retaining the original meanings and ‘feel’ of the interviewees’ words on the other. The chart should include references to interesting or illustrative quotations. These can be tagged automatically if you are using CAQDAS to manage your data (N-Vivo version 9 onwards has the capability to generate framework matrices), or otherwise a capital ‘Q’, an (anonymized) transcript number, page and line reference will suffice. It is helpful in multi-disciplinary teams to compare and contrast styles of summarizing in the early stages of the analysis process to ensure consistency within the team. Any abbreviations used should be agreed by the team. Once members of the team are familiar with the analytical framework and well practised at coding and charting, on average, it will take about half a day per hour-long transcript to reach this stage. In the early stages, it takes much longer.

Stage 7: Interpreting the data

It is useful throughout the research to have a separate note book or computer file to note down impressions, ideas and early interpretations of the data. It may be worth breaking off at any stage to explore an interesting idea, concept or potential theme by writing an analytic memo [ 20 , 21 ] to then discuss with other members of the research team, including lay and clinical members. Gradually, characteristics of and differences between the data are identified, perhaps generating typologies, interrogating theoretical concepts (either prior concepts or ones emerging from the data) or mapping connections between categories to explore relationships and/or causality. If the data are rich enough, the findings generated through this process can go beyond description of particular cases to explanation of, for example, reasons for the emergence of a phenomena, predicting how an organisation or other social actor is likely to instigate or respond to a situation, or identifying areas that are not functioning well within an organisation or system. It is worth noting that this stage often takes longer than anticipated and that any project plan should ensure that sufficient time is allocated to meetings and individual researcher time to conduct interpretation and writing up of findings (see Additional file 1 , Section 7).

The Framework Method has been developed and used successfully in research for over 25 years, and has recently become a popular analysis method in qualitative health research. The issue of how to assess quality in qualitative research has been highly debated [ 20 , 34 – 40 ], but ensuring rigour and transparency in analysis is a vital component. There are, of course, many ways to do this but in the Framework Method the following are helpful:

Summarizing the data during charting, as well as being a practical way to reduce the data, means that all members of a multi-disciplinary team, including lay, clinical and (quantitative) academic members can engage with the data and offer their perspectives during the analysis process without necessarily needing to read all the transcripts or be involved in the more technical parts of analysis.

Charting also ensures that researchers pay close attention to describing the data using each participant’s own subjective frames and expressions in the first instance, before moving onto interpretation.

The summarized data is kept within the wider context of each case, thereby encouraging thick description that pays attention to complex layers of meaning and understanding [ 38 ].

The matrix structure is visually straightforward and can facilitate recognition of patterns in the data by any member of the research team, including through drawing attention to contradictory data, deviant cases or empty cells.

The systematic procedure (described in this article) makes it easy to follow, even for multi-disciplinary teams and/or with large data sets.

It is flexible enough that non-interview data (such as field notes taken during the interview or reflexive considerations) can be included in the matrix.

It is not aligned with a particular epistemological viewpoint or theoretical approach and therefore can be adapted for use in inductive or deductive analysis or a combination of the two (e.g. using pre-existing theoretical constructs deductively, then revising the theory with inductive aspects; or using an inductive approach to identify themes in the data, before returning to the literature and using theories deductively to help further explain certain themes).

It is easy to identify relevant data extracts to illustrate themes and to check whether there is sufficient evidence for a proposed theme.

Finally, there is a clear audit trail from original raw data to final themes, including the illustrative quotes.

There are also a number of potential pitfalls to this approach:

The systematic approach and matrix format, as we noted in the background, is intuitively appealing to those trained quantitatively but the ‘spreadsheet’ look perhaps further increases the temptation for those without an in-depth understanding of qualitative research to attempt to quantify qualitative data (e.g. “13 out of 20 participants said X). This kind of statement is clearly meaningless because the sampling in qualitative research is not designed to be representative of a wider population, but purposive to capture diversity around a phenomenon [ 41 ].

Like all qualitative analysis methods, the Framework Method is time consuming and resource-intensive. When involving multiple stakeholders and disciplines in the analysis and interpretation of the data, as is good practice in applied health research, the time needed is extended. This time needs to be factored into the project proposal at the pre-funding stage.

There is a high training component to successfully using the method in a new multi-disciplinary team. Depending on their role in the analysis, members of the research team may have to learn how to code, index, and chart data, to think reflexively about how their identities and experience affect the analysis process, and/or they may have to learn about the methods of generalisation (i.e. analytic generalisation and transferability, rather than statistical generalisation [ 41 ]) to help to interpret legitimately the meaning and significance of the data.

While the Framework Method is amenable to the participation of non-experts in data analysis, it is critical to the successful use of the method that an experienced qualitative researcher leads the project (even if the overall lead for a large mixed methods study is a different person). The qualitative lead would ideally be joined by other researchers with at least some prior training in or experience of qualitative analysis. The responsibilities of the lead qualitative researcher are: to contribute to study design, project timelines and resource planning; to mentor junior qualitative researchers; to train clinical, lay and other (non-qualitative) academics to contribute as appropriate to the analysis process; to facilitate analysis meetings in a way that encourages critical and reflexive engagement with the data and other team members; and finally to lead the write-up of the study.

We have argued that Framework Method studies can be conducted by multi-disciplinary research teams that include, for example, healthcare professionals, psychologists, sociologists, economists, and lay people/service users. The inclusion of so many different perspectives means that decision-making in the analysis process can be very time consuming and resource-intensive. It may require extensive, reflexive and critical dialogue about how the ideas expressed by interviewees and identified in the transcript are related to pre-existing concepts and theories from each discipline, and to the real ‘problems’ in the health system that the project is addressing. This kind of team effort is, however, an excellent forum for driving forward interdisciplinary collaboration, as well as clinical and lay involvement in research, to ensure that ‘the whole is greater than the sum of the parts’, by enhancing the credibility and relevance of the findings.

The Framework Method is appropriate for thematic analysis of textual data, particularly interview transcripts, where it is important to be able to compare and contrast data by themes across many cases, while also situating each perspective in context by retaining the connection to other aspects of each individual’s account. Experienced qualitative researchers should lead and facilitate all aspects of the analysis, although the Framework Method’s systematic approach makes it suitable for involving all members of a multi-disciplinary team. An open, critical and reflexive approach from all team members is essential for rigorous qualitative analysis.

Acceptance of the complexity of real life health systems and the existence of multiple perspectives on health issues is necessary to produce high quality qualitative research. If done well, qualitative studies can shed explanatory and predictive light on important phenomena, relate constructively to quantitative parts of a larger study, and contribute to the improvement of health services and development of health policy. The Framework Method, when selected and implemented appropriately, can be a suitable tool for achieving these aims through producing credible and relevant findings.

The Framework Method is an excellent tool for supporting thematic (qualitative content) analysis because it provides a systematic model for managing and mapping the data.

The Framework Method is most suitable for analysis of interview data, where it is desirable to generate themes by making comparisons within and between cases.

The management of large data sets is facilitated by the Framework Method as its matrix form provides an intuitively structured overview of summarised data.

The clear, step-by-step process of the Framework Method makes it is suitable for interdisciplinary and collaborative projects.

The use of the method should be led and facilitated by an experienced qualitative researcher.

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Acknowledgments

All authors were funded by the National Institute for Health Research (NIHR) through the Collaborations for Leadership in Applied Health Research and Care for Birmingham and Black Country (CLAHRC-BBC) programme. The views in this publication expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

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Health Services Management Centre, University of Birmingham, Park House, 40 Edgbaston Park Road, Birmingham, B15 2RT, UK

Nicola K Gale

School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

Gemma Heath & Sabi Redwood

School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, UK

Elaine Cameron

East and North Hertfordshire NHS Trust, Lister hospital, Coreys Mill Lane, Stevenage, SG1 4AB, UK

Sabina Rashid

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Correspondence to Nicola K Gale .

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The authors declare that they have no competing interests.

Authors’ contributions

All authors were involved in the development of the concept of the article and drafting the article. NG wrote the first draft of the article, GH and EC prepared the text and figures related to the illustrative example, SRa did the literature search to identify if there were any similar articles currently available and contributed to drafting of the article, and SRe contributed to drafting of the article and the illustrative example. All authors read and approved the final manuscript.

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Additional file 1: illustrative example of the use of the framework method.(docx 167 kb), authors’ original submitted files for images.

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Gale, N.K., Heath, G., Cameron, E. et al. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 13 , 117 (2013). https://doi.org/10.1186/1471-2288-13-117

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Received : 17 December 2012

Accepted : 06 September 2013

Published : 18 September 2013

DOI : https://doi.org/10.1186/1471-2288-13-117

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The Oxford Handbook of Qualitative Research (2nd edn)

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The Oxford Handbook of Qualitative Research, second edition, presents a comprehensive retrospective and prospective review of the field of qualitative research. Original, accessible chapters written by interdisciplinary leaders in the field make this a critical reference work. Filled with robust examples from real-world research; ample discussion of the historical, theoretical, and methodological foundations of the field; and coverage of key issues including data collection, interpretation, representation, assessment, and teaching, this handbook aims to be a valuable text for students, professors, and researchers. This newly revised and expanded edition features up-to-date examples and topics, including seven new chapters on duoethnography, team research, writing ethnographically, creative approaches to writing, writing for performance, writing for the public, and teaching qualitative research.

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Qualitative Research Bridging the Conceptual, Theoretical, and Methodological

• Sharon M. Ravitch - University of Pennsylvania, USA
• Nicole Mittenfelner Carl - University of Pennsylvania, USA
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Offering useful context to the cohort, who are mainly engaged in degree work for vocational purposes but who need to understand the context of the academic work they do

This book gives the student great general knowledge of qualitative reserch and it's different possibilities. THe book has been written understandable, thank you for writers!

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Will be very helpful for my students undertaking their research projects

This book will provide the content for my online qualitative methodology course. It is an excellent source. Dr. Ballenger

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• Updated organization  addresses ethics earlier in the research process       
• A more cohesive discussion of  research design  helps students see the design process within one main chapter
• Additional resources and examples for developing questionnaires  provide more thorough coverage
• Expanded discussions of qualitative coding and analysis  over several chapters provide more student support for this crucial aspect of research
• Recommended Practices  for each memo or document guide students in their creation and development
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• Appendices  with new and updated examples from real student research including memos, protocols, forms, displays, and conference, grant, and dissertation proposals

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Chapter 1: Qualitative Research An Opening Orientation

Chapter 2: Conceptual Frameworks in Research

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• 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

Metrics details

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.

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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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An investigation into the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companionship in Tehran: a qualitative inquiry on mitigating mistreatment of women during childbirth

• Marjan Mirzania 1 ,
• Elham Shakibazadeh 1 , 2 ,
• Sedigheh Hantoushzadeh 3 ,
• Zahra Panahi 4 ,
• Meghan A. Bohren 5 &
• Abdoljavad Khajavi 6  

BMC Public Health volume  24 , Article number:  1292 ( 2024 ) Cite this article

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A birth companion is a powerful mechanism for preventing mistreatment during childbirth and is a key component of respectful maternity care (RMC). Despite a growing body of evidence supporting the benefits of birth companions in enhancing the quality of care and birth experience, the successful implementation of this practice continues to be a challenge, particularly in developing countries. Our aim was to investigate the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companions to mitigate the mistreatment of women during childbirth in Tehran.

This exploratory descriptive qualitative study was conducted between April and August 2023 at Valiasr Hospital in Tehran, Iran. Fifty-two face-to-face in-depth interviews were conducted with a purposive sample of women, birth companions, and maternity healthcare providers. Interviews were audio-recorded, transcribed verbatim, and analyzed using content analysis, with a deductive approach based on the Implementation Outcomes Framework in the MAXQDA 18.

Participants found the implemented program to be acceptable and beneficial, however the implementation team noticed that some healthcare providers were initially reluctant to support it and perceived it as an additional burden. However, its adoption has increased over time. Healthcare providers felt that the program was appropriate and feasible, and it improved satisfaction with care and the birth experience. Participants, however, highlighted several issues that need to be addressed. These include the need for training birth companions prior to entering the maternity hospital, informing women about the role of birth companions, assigning a dedicated midwife to provide training, and addressing any physical infrastructure concerns.

Despite some issues raised by the participants, the acceptability, adoption, appropriateness, feasibility, and fidelity of the implementation strategies for birth companions to mitigate the mistreatment of women during childbirth were well received. Future research should explore the sustainability of this program. The findings of this study can be used to support the implementation of birth companions in countries with comparable circumstances.

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Despite every woman’s right to have a positive birth experience, the mistreatment during childbirth has been documented worldwide in health facilities [ 1 , 2 , 3 , 4 ]. Recent studies from Iran have reported a high rate of mistreatment, including verbal abuse, frequent and painful vaginal examinations, neglect and abandonment, lack of supportive care, physical abuse [ 5 ], denial of mobility [ 5 , 6 , 7 ], and pain relief [ 5 , 8 ]. Additionally, women are typically not allowed to choose their labour positions [ 6 ] or have a birth companion [ 7 ].

A powerful mechanism to prevent mistreatment during childbirth, as demonstrated in previous research, is the presence of a birth companion [ 6 , 9 , 10 ]. The World Health Organization (WHO) recommends ensuring the presence of a chosen companion during labour and childbirth, as outlined in three guidelines [ 11 , 12 , 13 ]. This practice is recognized as a significant strategy for enhancing the quality of care and the birthing experience [ 12 ], and is considered a crucial element of respectful maternity care (RMC) [ 14 ]. Evidence shows that having birth companions is associated with reduced pain intensity and duration of labour, increased likelihood of spontaneous vaginal birth, decreased need for analgesia, episiotomy, and cesarean section, improved birth experience, early initiation of breastfeeding, and reduced postpartum depression [ 15 , 16 , 17 ]. Despite recognizing these benefits, the successful implementation of birth companions remains a challenge. Many women in health facilities across the world, particularly in developing countries, are denied this right [ 18 , 19 , 20 , 21 , 22 , 23 ].

Addressing the research-to-practice gap and scaling up evidence-based interventions (EBIs) are key goals of implementation science (IS). IS is a multidisciplinary field defined as “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and hence, to improve the quality and effectiveness of health services” [ 24 ]. A wide range of implementation frameworks has been published. The implementation outcomes framework, introduced by Proctor et al. (2011), is one of these frameworks. This evaluation framework includes eight outcomes that serve as indicators of successful implementation: acceptability, adoption, appropriateness, feasibility, fidelity, implementation costs, penetration, and sustainability [ 25 ].

In Iran, the Ministry of Health and Medical Education (MOHME) implemented a policy in 2014 to promote maternal and newborn health by encouraging vaginal childbirth in public hospitals. One strategy of this policy to enhance the childbirth experience is the redesign of maternity wards to allow for the presence of birth companions [ 26 ]. However, public hospitals do not always support the implementation of birth companionship. As part of a large implementation research project, we have identified the challenges of implementing a birth companion as a formative research. The results showed that the major challenges include the lack of knowledge of companions, interference of companions in the clinical duties of staff, cultural issues, staff unwillingness, lack of supervision, and structural characteristics such as lack of physical space [ 27 ]. To address these issues, we developed and implemented strategies for birth companions. To the best of our knowledge, no comprehensive study has examined the implementation outcomes of birth companions in Iran. Therefore, this study aimed to investigate the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companions to mitigate the mistreatment of women during childbirth in Tehran.

Study design and setting

This study was part of a larger implementation research project examining the development and implementation of a context-specific intervention to reduce disrespectful maternity care and evaluation of strategies to improve implementation. This project, initiated in October 2021, consists of five phases: (1) needs assessment, (2) identifying the interventions to reduce mistreatment of women during childbirth, (3) identifying the implementation challenges of interventions, (4) designing implementation strategies for the intervention, and (5) testing implementation strategies in a real-life setting. The results of phases 1 and 3 of the project are presented in detail elsewhere [ 5 , 27 , 28 ]. This study used an exploratory descriptive qualitative design. It employed face-to-face in-depth interviews as data collection methods. Data was analyzed according to content analysis with a deductive approach.

Study context

This study was conducted between April and August 2023 at Valiasr Hospital in Tehran, Iran. We selected this hospital because it is a major, tertiary referral hospital in Tehran that offers a wide range of obstetric services to diverse groups of women. The maternity ward, which supports approximately 200 women giving birth per month, consists of a 12-bed hall for the first stage of labour and a separate room with one bed for the active stage of labour.

Designing implementation strategies of birth companions

In response to the challenges identified for the presence of birth companions in phase 3 of the project, we designed implementation strategies. These strategies include: (1) determining the implementation team, (2) training midwives, (3) conducting orientation sessions for obstetricians and residents, (4) training birth companions, (5) allowing birth companions to accompany women during labour and childbirth, and (6) continuously monitoring the implementation process. The implementation of these strategies spanned an 8-week period from April to June 2023. Our study focused on the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companions during the early implementation phase. These indicators are crucial for the initial stages of implementing health interventions [ 25 ]. According to the implementation outcomes framework of Proctor et al. (2011), acceptability is defined as “the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory”; adoption as “the intention, initial decision, or action to employ an innovation”; appropriateness as “the degree of compatibility or perceived fit of the innovation”; feasibility as “the degree of successful implementation of the innovation in a setting”; and fidelity as “the degree of implementation of the innovation as intended” [ 25 ]. The details of implementation strategies of birth companions are provided below.

Determining the implementation team

The team consisted of members of the study team, the head of obstetrics, and maternity healthcare providers (MHCPs). The members of the study team (first and second authors) held a meeting with the head of obstetrics and the matron-in-charge to explain the purpose of the study.

Training midwives

All midwives received training from the matron-in-charge ( n  = 30, five midwives in each session). The training focused on the purpose of the study, the benefits of having birth companions during labour and childbirth, and specifically on providing training to birth companions. A member of the study team (the lead researcher) participated in the sessions.

Conducting orientation sessions for obstetricians and residents

The head of obstetrics held a meeting with obstetricians and residents to explain the purpose of the study and the benefits of having birth companions during labour and childbirth.

Training birth companions

Each birth companion received a 10-minute training session from midwives on supportive labour techniques, their roles and responsibilities during labour and childbirth, and the maternity regulations upon arrival at the maternity hospital for birth.

Allowing birth companions to accompany women during labour and childbirth

Any female birth companion that labouring women wanted was allowed to stay with her during labour and childbirth.

Continuously monitoring the implementation process

Supervisory visits to the maternity hospital were conducted by the study team, the matron-in-charge, and a team from the MOHME to oversee the implementation. The first author was present at the maternity hospital every day during both morning and evening shifts. The matron-in-charge visited the maternity hospital daily, and the third author visited the maternity hospital on a weekly basis, specifically on Fridays.

Recruitment and participants

Three groups of participants were identified for this study: (a) women, (b) birth companions, and (c) MHCPs (midwives, residents, and head of obstetrics). The eligibility criteria were as follows: women who had a vaginal birth, regardless of the outcome; female birth companions stayed with women during labour and childbirth; residents who had completed at least one semester (six months) in the maternity hospital; and midwives and head of obstetrics with at least one year of work experience in their role and involvement in the birth companion study. Women who had a labour progress disorder and cesarean section were excluded from this study. A purposive sampling technique with maximum variation was used to recruit participants. This technique aimed to include individuals with diverse characteristics, such as age, education, socioeconomic status for women and birth companions, and age, work experience, and shift for MHCPs.

Following prior coordination and permission from the hospital authorities, the first author (M.M.) invited participants to contribute in person. The purpose and reasons for conducting the study were explained to participants. All participants provided written consent to participate in the study and audio recordings p the interviews. They were also aware that their participation was voluntary, and that they could decline or stop the interviews at any time without facing any consequences.

Data collection

A semi-structured interview guide and face-to-face in-depth interviews were used to collect data. The interview guides were developed based on the framework of Proctor et al. [ 25 ] and then pilot-tested by conducting three initial interviews with participants, but were not analyze (Additional file 1 : Interview guides). For women and birth companions, the study examined the acceptability and adoption of having a birth companion. Meanwhile the MHCPS were asked about the acceptability, adoption, appropriateness, feasibility, and fidelity of having a birth companion. Each interview started with an overarching question such as “Please describe your overall experience with the implementation of the birth companion program at this hospital”. The interview process continued with questions such as “Are you satisfied or dissatisfied with the current implementation of the program or intervention?”, “How appropriate is the implementation of this program or intervention in the hospital?”, “What are your thoughts on integrating this program or intervention into your hospital?”. Probing questions, such as ‘“Can you explain more?”, “Why do you think that is?” and ‘What would need to change?, were used. All interviews were conducted in Persian by the first author (M.M.), a PhD candidate in Health Education and Promotion with experience in conducting qualitative research. No prior relationships existed between her and any of the other participants. Interviews with the women and birth companions were conducted before discharge in a quiet and private place in the postpartum ward. Interviews with MHCPs were conducted in a private room with no one else present at the maternity hospital. The interviews lasted approximately 30–40 minutes, and field notes were taken. Each participant was contacted once during the study. At the end of each interview, demographic information of the participants was collected. Data saturation was achieved through interviews with 22 women, 14 birth companions, and 16 MHCPs, after which, no new major themes emerged.

Data analysis

Data analysis was conducted simultaneously with data collection, using content analysis with a deductive approach [ 29 ]. First, M.M. listened to the recorded interviews repeatedly and transcribed them verbatim in Persian. Anonymity was ensured using numerical labels for each transcript file. The transcripts were checked for accuracy by the second author (E.Sh., a female professor in health education and promotion with experience in qualitative research). They were then independently coded by M.M. and E.Sh. We marked the segments of interest in the text and color-coded them. We then put these color-coded text segments together and assigned codes to them. We grouped the various codes according to their similarities and differences and linked them to pre-determined categorizations in different themes and sub-themes. The differences among coders regarding coding were discussed until a consensus was reached. Data management and analysis were performed using MAXQDA 18 software [ 30 ]. The selected quotations were translated into English to complement the findings of the study.

The trustworthiness of the study was assessed using Lincoln and Guba’s criteria [ 31 ]. Credibility was ensured through the triangulation of participants, including women, birth companions, and MHCPs. Additionally, the initially extracted codes were provided to three participants for approval, further enhancing credibility. Confirmability ensured by utilizing multiple data sources such as field notes, observations, audio recordings, and transcripts. Additionally, the data analysis process was reviewed and confirmed by an expert qualitative researcher who was not involved in the study. To enhance dependability, two authors independently analyzed the interviews. Furthermore, a detailed description of the research process was provided to ensure the transferability of the results. This allows for the evaluation and application of the study in different contexts. The study was reported according to the consolidated criteria for reporting qualitative research (COREQ) checklist [ 32 ] (Additional file 2 : COREQ Checklist).

Review author reflexivity

The authors maintained a reflexive stance throughout the study from study selection to data synthesis. The author team represents diverse international academic and professional backgrounds (health education and promotion, reproductive health, obstetrics and gynecology, and health services management) with a range of research focus areas and expertise. We are mindful that the authors’ perspectives might have affected the manner in which the data were collected, analyzed, and interpreted. The different perspectives of the authors could be related to their subject expertise, professional backgrounds, and knowledge of birth companionship and respectful care. As a multidisciplinary team, the authors challenged and critiqued their preconceived assumptions through reflective dialogue and supported each other to understand how these assumptions affected the analysis or interpretation of the findings. We believe that the diversity in our team helped us to critique and challenge our biases and develop the findings of the study.

Socio-demographic characteristics of participants

A total of 52 interviews were conducted, including 22 with women, 14 with birth companions and 16 with MHCPs. The socio-demographic characteristics of the participants are summarized in Tables  1 and 2 . None potential participants declined to participate in this study. Most of the women in this study were Iranians housewives with secondary education. More than one-third of the birth companions were mothers of women and most of the support was provided only during labour. We reported on the acceptability, adoption, appropriateness, feasibility, and fidelity of birth companions’ implementation strategies, using direct quotations from the participants (Table  3 ).

Acceptability

Participants shared opinions on the acceptability of implementing birth companion strategies in three sub-themes: perceived value of birth companions, relative advantage, and credibility.

Perceived value of birth companions

Women and birth companions had overall positive experiences with the implementation of birth companions. They believed that the implementation of the program was a good idea, which resulted in continuous support from companions, satisfaction with care, and an improved birth experience. As one woman explained:

“It was my first delivery, and I was feeling very stressed. The healthcare providers were busy and unable to give me the attention I needed, but having my sister there made a significant difference. She massaged my back, used a hot water bag, assisted me with walking and exercising, and contacted healthcare providers when I required assistance. If my companion was not there, I would have had a difficult birth.” (Woman 2, 25 years old).

Another person noted that: “It was a positive experience for me, and I am content with how everything went, particularly because my mother was present in the delivery room. For example, when I was in pain, she would hold my hand and say, ‘send blessings’ or during childbirth, she would say, ‘well done, push, it’s great, I can see the baby’s head’, and it was encouraging … Thank you for making it possible for companions to be with us even during childbirth.” (Woman 19, 16 years old)

“The presence of birth companions at this hospital was a good idea; we were satisfied with this program. In the public hospitals of our city, the companions are not allowed to enter the maternity hospital. However, here I had no barrier to my presence …” (Birth companion 7, 26 years old).

Relative advantage

Women were asked if they would be more inclined to choose a hospital for giving birth if it offered birth companions as a standard practice in the maternity ward, and all of them responded affirmatively. One woman stated:

“When I gave birth a few years ago, they did not allow me to have a companion. This hospital was recommended to me by a friend. She said that last week, my sister gave birth there, and she had a companion… I came here only because I could have a companion, and I was satisfied with having a companion by my side.” (Woman 14, 21 years old).

Credibility

Both women and their companions described the quality of program implementation and training provided by midwives as beneficial:

“I think this program is being implemented well… The midwife taught me support techniques. I did them for my daughter and tried not to interfere with the clinical work of the providers… They were effective in relieving her pain.” (Birth companion 14, 50 years old).

“When I was in pain, my companion used a hot water bag, asked me to take deep breaths, or used Entonox gas… They were very helpful.” (Woman 12, 24 years old).

While providers also acknowledged the usefulness of implementing birth companions, the implementation team felt that some were initially reluctant to support the program and perceived it as an added burden. However, this reluctance changed over time due to positive outcomes, such as increasing women’s satisfaction, greater participation of companions, and reducing the workload of providers. Several providers also mentioned concerns about limited physical space, violation of women’s privacy, overcrowding, and the transmission of infection:

“Some of us initially did not support the implementation of this program, because it was perceived as an additional burden. However, after some time of implementation of the program, we observed positive outcomes, such as increased satisfaction among women during childbirth, participation of companions, and a reduction in workload… Now I can confidently say that all the providers have accepted it.” (Midwife 1, 40 years old).

In this study, adoption of implementation of birth companion strategies was discussed in two sub-themes: uptake and actual use.

The providers’ responses to the program were positive. They stated that they allow companions to accompany women during labour and childbirth. Upon entering, they provided explanations about the regulations of the maternity hospital, the role and responsibilities of the companion during labour and childbirth. They also taught emotional support techniques such as praying, using calming verbal expressions, encouraging, and comforting. Additionally, they taught physical support techniques including helping with walking, feeding, massaging, and breathing exercises.

“Upon entering, we ask women if they would like to have a companion. If they wish, we allow their companion to enter the maternity hospital. We teach her (companion)… Finally, we ask her to sign the form to receive training from the midwife.” (Midwife 14, 29 years old).

“We allow the companion to be present. We offer training to birth companions led by midwives. The midwife teaches… Most companions also perform well, according to the training they receive.” (Resident 10, 31 years old).

Providers’ adoption of the program increased over time as they gained a clearer understanding of how the program was intended to work. However, a few providers also raised concerns that the program may not be sustainable after its initial phase ends. These concerns have contributed to doubts about the program’s full adoption.

“This program cannot be expected to be sustainable within a few months of implementation… I believe it requires additional time and ongoing monitoring to be effectively integrated into the work tasks of our providers.” (Head of obstetrics, 49 years old).

Appropriateness

Participants reported three sub-themes related to the appropriateness of implementation of birth companion strategies, including perceived usefulness, integration into existing workflows, and informing women about the possibility of having a birth companion.

Perceived usefulness

Most of the participants agreed that implementation of the program in this maternity hospital was appropriate. One birth companion stated:

“I believe it is necessary to have a companion in this maternity hospital due to the overcrowding and insufficient staff. The healthcare providers do not have enough time to provide back massages of comfort a woman in labour. As companions, we can fulfil this role for them.” (Birth companion 4, 46 years old).

Integration into existing workflows

Some providers agreed that birth companions could be integrated into the existing workflows:

“I think that these implementation strategies for birth companions can be very helpful… they are simple and low cost. If we use these strategies correctly, there will be no problems in our workflow.” (Midwife 3, 41 years old).

Informing women about the possibility of having a birth companion

Some women mentioned that if they had been informed in advance (e.g., in childbirth preparation classes) about the possibility of having a birth companion, they could have chosen a more suitable person to accompany them.

“… If I had known that I could have a companion, I would have brought someone with me who would be more comfortable, trained, or at least had experience with vaginal delivery.” (Woman 1, 43 years old).

Feasibility

The providers felt that the routine use of birth companions was feasible in this maternity hospital and described three sub-themes that would contribute to improving feasibility: training birth companions in prenatal care, recruiting a fixed midwife, and improving the physical infrastructure.

Training birth companions in prenatal care

The providers commented on the importance of training birth companions and preparing them to play a role in prenatal care. Most providers stated that in order for the few minutes of training upon entering the maternity hospital to be more effective, it is important to give attention to the training of birth companions in childbirth preparation classes.

“I think the important thing is to train… It is necessary to provide training for labouring women and their companions before they enter maternity hospitals.” (Midwife 8, 40 years old).

“… Unfortunately, most of the companions were not trained here. Well, how much time do I have to explain to her during labour?” (Midwife 13, 37 years old).

“I believe that training at the maternity hospital can be more effective if the companion is already trained, and our training includes a review component.” (Resident 11, 30 years old).

Recruiting a fixed midwife

Similarly, providers discussed the importance of recruiting a fixed midwife to improve the feasibility of birth companions in maternity hospitals. The majority of providers stated that, in light of the overcrowding and understaffing, successful implementation of the program relied on recruit a fixed midwife who could provide training to labouring women and their companions.

“… I believe it is necessary to have a permanent midwife for training in order to consistently implement this program.” (Head of obstetrics, 49 years old).

Improving the physical infrastructure

Improving the physical infrastructure of maternity hospitals was also suggested by some providers as a factor related to feasibility:

“… Yes, routine use of this program is possible, but it is also important to ensure that the physical environment is suitable. We have limited physical space here. The burden of visiting is also high, and we are concerned about overcrowding and the transmission of infection.” (Resident 2, 30 years old).

Two sub-themes related to the fidelity of implementation of birth companion strategies were identified: adherence and participant responsiveness.

Almost all providers agreed that they had implemented the program as intended by the project developers. However, several of them stated that as the implementation progressed, other women (those who were scheduled for a caesarean section or had an abortion) also requested the presence of their companions, which posed a challenge at times. This is because providers had to spend time explaining and justifying their decisions.

“I believe the providers implemented the program according to the original protocol. I noticed a significant improvement in the conditions at the maternity hospital after the implementation of this program.” (Midwife 15, 34 years old).

“… The women who were scheduled for a caesarean section or had an abortion also requested the presence of their companions. If there are also companions, the maternity hospital will become very crowded, which will hinder the provision of proper care.” (Resident 16, 28 years old).

“Anyway, when a program starts to reach the ideal, it faces challenges. However, I believe that the providers who were directly involved in the implementation process adhered to the plan…” (Head of obstetrics, 49 years old).

Participant responsiveness

The level of participant engagement in the program was reported to be high, as one provider remarked:

“I think almost all providers were involved in this program. We may not have had a good participation at the beginning of the program, but it increased over time …” (Midwife 8, 40 years old).

Furthermore, providers’ statements showed that the reception of women and their companions in the presence of a birth companion was positive:

“Both women and their companions were receptive to this program. When we informed women that they could have a companion, even during their childbirth, they would be happy…” (Midwife 4, 41 years old).

This was the first qualitative study in Iran to examine the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies of birth companions based on the experience of women, birth companions, and MHCPs. In summary, the findings of this study indicated strategies for effectively implementing birth companions in public hospitals in Tehran.

In our study, the sub-themes associated with the acceptability of implementing birth companion strategies from the participants’ perspectives included perceived value, relative advantage, and credibility. We found that the implementation strategies used by the birth companion were acceptable to most participants. Our findings are consistent with those of previous studies [ 33 , 34 ]. Overall, women and their companions greatly appreciated the provision of a birth companion in the hospital, as it improved satisfaction with care and the birth experience [ 22 , 33 , 35 , 36 ]. Similarly, providers have described the benefits of implementing birth companions, such as continuous support and a reduced workload [ 16 , 20 , 34 , 37 ]. Furthermore, in our study, women and their companions mentioned the benefits of the quality of the program implementation and training provided by midwives. Similar findings have been reported by Kabakian-Khasholian et al. [ 34 ].

Our findings showed that although the presence of birth companions was not initially supported by some providers, its acceptance grew over time with an increased understanding of the program as well as the positive outcomes that followed for both women and providers. Another study on birth companions in the labour ward of a center in India showed that providers were initially hesitant to allow birth companions due to overcrowding and the potential disruption of their duties and decision-making [ 20 ]. The experience reported by our providers is not surprising. This is an important finding for implementation, and demonstrates that immediate acceptance of new programs after introduction cannot be expected, as research has shown that the acceptability of any program increases with knowledge of that program [ 25 ]. A possible explanation for the higher acceptability of birth companions in our study could be attributed to the continuous monitoring of the implementation team and the provision of feedback throughout the implementation process.

The uptake and actual use were perceived as important aspects of adoption of implementing birth companion strategies. Despite the fact that providers adopted the program and responded positively to its use, a few expressed doubts about the program’s sustainability beyond the initial phase. Our findings are consistent with those of a previous study conducted in Arab countries, which reported that obstetric residents expressed uncertainty regarding about the long-term viability of the labour companionship model [ 34 ]. Although examining the sustainability of the program was not the goal of our study, it is important to note this issue, which should be explored in the future.

Our study findings showed that the appropriateness of implementation of birth companion strategies refers to the perceived usefulness, integration into existing workflows, and informing women about the possibility of having a birth companion. Providers found that birth companions could be integrated into workflows. Though studies in LIMCs show that providers were reluctant to incorporate birth companions into routine maternity services for reasons such as women’s disobedience to provider instructions, companion interference in care, and the transmission of infections [ 36 , 38 , 39 ]. Some women in our study expressed the desire to be informed about the option of having a birth companion during antenatal care. This finding aligns with a study on birth companionship in Tanzania [ 33 ].

This study suggests that the implementation of birth companion strategies in this maternity hospital is feasible, but several potential factors should be considered. Some of our providers pointed out the importance of training birth companions through childbirth preparation classes for the effectiveness of their support upon entering maternity hospitals, as highlighted by Kabakian-Khasholian et al. [ 34 ]. Providers also emphasized that recruiting fixed midwives to provide training to women and their birth companions in the maternity hospital was important to support the feasibility of the program. Women and companions have also criticized the infrastructure of the maternity hospital. It is important to note that in this study, any strategy for the reconstruction of physical space (such as the lack of suitable space for the accommodation of companions) was considered but opposed by the management of the maternity hospital, despite it being an important component in the implementation of birth companions.

Our study has several practical implications. Despite the recommendations of the WHO regarding the choice of a companion during labour and childbirth, as well as existing policies, there is a need for the presence of a birth companion in Iran. Increased efforts by policy-makers and managers of maternal health programs are necessary to ensure women’s access to this right and to effectively and sustainably implement it in maternity hospitals. This will help to improve the quality of maternity care and enhance positive childbirth experiences. Furthermore, the collaboration of MHCPs in the implementation of birth companions and the establishment of continuous monitoring systems in maternity hospitals is important. It is also necessary to include training for birth companions in childbirth preparation classes, educating them about their expected role in supporting women.

Strengths and limitations

To our knowledge, this is the first study to examine the implementation outcomes of birth companions in Iran. This study encompasses a wide range of perspectives and experiences from women, birth companions, and MHCPs. This study has several limitations. First, due to the sensitive nature of the mistreatment issue, participants may have underreported some of their experiences with the companionship program possibly influenced by social desirability bias. We attempted to reduce this bias by conducting interviews in a private room and ensuring the anonymity of the participants’ identities. Second, this study was conducted solely at a public teaching hospital in Tehran, which restricts the generalizability of the findings to private hospitals in Iran. Nonetheless, this study adds to the literature on implementation strategies for birth companion’s support by incorporating implementation research (IR). The findings of this study will be useful for health policymakers in supporting the implementation of birth companions to reduce mistreatment of women during labour and childbirth. However, we recommend continuous monitoring of the actual collaboration among MHCPs during the program implementation process.

Our study found that the implementation strategies for birth companions in Tehran public hospitals are acceptable, appropriate, and feasible. These strategies improve satisfaction with care and the birth experience, seek continuous support from companions, and reduce provider workloads. However, there are several issues that need to be addressed regarding birth companions in maternity hospitals. These include training birth companions prior to the arrival, informing women about the presence of birth companions, assigning a dedicated midwife to provide training, and improving the physical infrastructure. The findings of this study can be utilized to support the implementation of birth companions in countries with comparable circumstances.

Data availability

The datasets generated and analyzed during the current study are not publicly available due to privacy restrictions of the participants but are available from the corresponding author on reasonable request.

Abbreviations

World Health Organizaion

Respectful Maternity Care

Evidence-Based Interventions

Implementation Science

Ministry of Health and Medical Education

Maternity Healthcare Providers

Consolidated Criteria for Reporting Qualitative Research

Implementation Research

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Acknowledgements

This study was part of a PhD dissertation. The authors would like to thank the officials and maternity healthcare providers of Valiasr Hospital in Tehran as well as all the women and birth companions for their valuable contribution to this study.

This study was funded by the Health Information Management Research Center, Tehran University of Medical Sciences, Iran (grant number 1401-3-208-62407). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Marjan Mirzania & Elham Shakibazadeh

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Elham Shakibazadeh

Department of Obstetrics and Gynecology, School of Medicine, Vali-E-Asr Reproductive Health research Center, Family Health Research Institute, Tehran University of Medical Sciences, Tehran, Iran

Sedigheh Hantoushzadeh

Department of Obstetrics and Gynecology, Maternal-Fetal Neonatal Research Center, Tehran University of Medical Sciences, Valiasr Hospital, Tehran, Iran

Zahra Panahi

Gender and Women’s Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Carlton, VIC, Australia

Meghan A. Bohren

Department of Social Medicine, School of Medicine, Gonabad University of Medical Sciences, Gonabad, Iran

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E.Sh., M.M., S.H., M.B., A.Kh., and Z.P. designed the study. M.M. and E.Sh. developed the interview guide. M.M. conducted the interviews. M.M. and E.Sh. analyzed the data. M.M. drafted the manuscript, and E.Sh. reviewed and edited it. All authors have read and approved the final manuscript. All authors have agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.

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This study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval for this study was obtained from the Tehran University of Medical Sciences Ethics Committee (code number: IR.TUMS.SPH.REC.1400.169). Participation was voluntary, and all participants provided written informed consent. For any participant under 16 years of age, we obtained informed consent to participate in the study from parents or legal guardians.

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Mirzania, M., Shakibazadeh, E., Hantoushzadeh, S. et al. An investigation into the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companionship in Tehran: a qualitative inquiry on mitigating mistreatment of women during childbirth. BMC Public Health 24 , 1292 (2024). https://doi.org/10.1186/s12889-024-18751-z

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INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

[80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier . Stanford University Press.

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

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Using the framework method for the analysis of qualitative data in multi-disciplinary health research

Nicola k gale.

1 Health Services Management Centre, University of Birmingham, Park House, 40 Edgbaston Park Road, Birmingham B15 2RT, UK

Gemma Heath

2 School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

Elaine Cameron

3 School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham B4 7ET, UK

Sabina Rashid

4 East and North Hertfordshire NHS Trust, Lister hospital, Coreys Mill Lane, Stevenage SG1 4AB, UK

Sabi Redwood

Associated data.

The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations.

The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study.

Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

The Framework Method for the management and analysis of qualitative data has been used since the 1980s [ 1 ]. The method originated in large-scale social policy research but is becoming an increasingly popular approach in medical and health research; however, there is some confusion about its potential application and limitations. In this article we discuss when it is appropriate to use the Framework Method and how it compares to other qualitative analysis methods. In particular, we explore how it can be used in multi-disciplinary health research teams. Multi-disciplinary and mixed methods studies are becoming increasingly commonplace in applied health research. As well as disciplines familiar with qualitative research, such as nursing, psychology and sociology, teams often include epidemiologists, health economists, management scientists and others. Furthermore, applied health research often has clinical representation and, increasingly, patient and public involvement [ 2 ]. We argue that while leadership is undoubtedly required from an experienced qualitative methodologist, non-specialists from the wider team can and should be involved in the analysis process. We then present a step-by-step guide to the application of the Framework Method, illustrated using a worked example (See Additional File 1 ) from a published study [ 3 ] to illustrate the main stages of the process. Technical terms are included in the glossary (below). Finally, we discuss the strengths and limitations of the approach.

Glossary of key terms used in the Framework Method

Analytical framework: A set of codes organised into categories that have been jointly developed by researchers involved in analysis that can be used to manage and organise the data. The framework creates a new structure for the data (rather than the full original accounts given by participants) that is helpful to summarize/reduce the data in a way that can support answering the research questions.

Analytic memo: A written investigation of a particular concept, theme or problem, reflecting on emerging issues in the data that captures the analytic process (see Additional file 1 , Section 7).

Categories: During the analysis process, codes are grouped into clusters around similar and interrelated ideas or concepts. Categories and codes are usually arranged in a tree diagram structure in the analytical framework. While categories are closely and explicitly linked to the raw data, developing categories is a way to start the process of abstraction of the data (i.e. towards the general rather than the specific or anecdotal).

Charting: Entering summarized data into the Framework Method matrix (see Additional File 1 , Section 6).

Code: A descriptive or conceptual label that is assigned to excerpts of raw data in a process called ‘coding’ (see Additional File 1 , Section 3).

Data: Qualitative data usually needs to be in textual form before analysis. These texts can either be elicited texts (written specifically for the research, such as food diaries), or extant texts (pre-existing texts, such as meeting minutes, policy documents or weblogs), or can be produced by transcribing interview or focus group data, or creating ‘field’ notes while conducting participant-observation or observing objects or social situations.

Indexing: The systematic application of codes from the agreed analytical framework to the whole dataset (see Additional File 1 , Section 5).

Matrix: A spreadsheet contains numerous cells into which summarized data are entered by codes (columns) and cases (rows) (see Additional File 1 , Section 6).

Themes: Interpretive concepts or propositions that describe or explain aspects of the data, which are the final output of the analysis of the whole dataset. Themes are articulated and developed by interrogating data categories through comparison between and within cases. Usually a number of categories would fall under each theme or sub-theme [ 3 ].

Transcript: A written verbatim (word-for-word) account of a verbal interaction, such as an interview or conversation.

The Framework Method sits within a broad family of analysis methods often termed thematic analysis or qualitative content analysis. These approaches identify commonalities and differences in qualitative data, before focusing on relationships between different parts of the data, thereby seeking to draw descriptive and/or explanatory conclusions clustered around themes. The Framework Method was developed by researchers, Jane Ritchie and Liz Spencer, from the Qualitative Research Unit at the National Centre for Social Research in the United Kingdom in the late 1980s for use in large-scale policy research [ 1 ]. It is now used widely in other areas, including health research [ 3 - 12 ]. Its defining feature is the matrix output: rows (cases), columns (codes) and ‘cells’ of summarised data, providing a structure into which the researcher can systematically reduce the data, in order to analyse it by case and by code [ 1 ]. Most often a ‘case’ is an individual interviewee, but this can be adapted to other units of analysis, such as predefined groups or organisations. While in-depth analyses of key themes can take place across the whole data set, the views of each research participant remain connected to other aspects of their account within the matrix so that the context of the individual’s views is not lost. Comparing and contrasting data is vital to qualitative analysis and the ability to compare with ease data across cases as well as within individual cases is built into the structure and process of the Framework Method.

The Framework Method provides clear steps to follow and produces highly structured outputs of summarised data. It is therefore useful where multiple researchers are working on a project, particularly in multi-disciplinary research teams were not all members have experience of qualitative data analysis, and for managing large data sets where obtaining a holistic, descriptive overview of the entire data set is desirable. However, caution is recommended before selecting the method as it is not a suitable tool for analysing all types of qualitative data or for answering all qualitative research questions, nor is it an ‘easy’ version of qualitative research for quantitative researchers. Importantly, the Framework Method cannot accommodate highly heterogeneous data, i.e. data must cover similar topics or key issues so that it is possible to categorize it. Individual interviewees may, of course, have very different views or experiences in relation to each topic, which can then be compared and contrasted. The Framework Method is most commonly used for the thematic analysis of semi-structured interview transcripts, which is what we focus on in this article, although it could, in principle, be adapted for other types of textual data [ 13 ], including documents, such as meeting minutes or diaries [ 12 ], or field notes from observations [ 10 ].

For quantitative researchers working with qualitative colleagues or when exploring qualitative research for the first time, the nature of the Framework Method is seductive because its methodical processes and ‘spreadsheet’ approach seem more closely aligned to the quantitative paradigm [ 14 ]. Although the Framework Method is a highly systematic method of categorizing and organizing what may seem like unwieldy qualitative data, it is not a panacea for problematic issues commonly associated with qualitative data analysis such as how to make analytic choices and make interpretive strategies visible and auditable. Qualitative research skills are required to appropriately interpret the matrix, and facilitate the generation of descriptions, categories, explanations and typologies. Moreover, reflexivity, rigour and quality are issues that are requisite in the Framework Method just as they are in other qualitative methods. It is therefore essential that studies using the Framework Method for analysis are overseen by an experienced qualitative researcher, though this does not preclude those new to qualitative research from contributing to the analysis as part of a wider research team.

There are a number of approaches to qualitative data analysis, including those that pay close attention to language and how it is being used in social interaction such as discourse analysis [ 15 ] and ethnomethodology [ 16 ]; those that are concerned with experience, meaning and language such as phenomenology [ 17 , 18 ] and narrative methods [ 19 ]; and those that seek to develop theory derived from data through a set of procedures and interconnected stages such as Grounded Theory [ 20 , 21 ]. Many of these approaches are associated with specific disciplines and are underpinned by philosophical ideas which shape the process of analysis [ 22 ]. The Framework Method, however, is not aligned with a particular epistemological, philosophical, or theoretical approach. Rather it is a flexible tool that can be adapted for use with many qualitative approaches that aim to generate themes.

The development of themes is a common feature of qualitative data analysis, involving the systematic search for patterns to generate full descriptions capable of shedding light on the phenomenon under investigation. In particular, many qualitative approaches use the ‘constant comparative method’ , developed as part of Grounded Theory, which involves making systematic comparisons across cases to refine each theme [ 21 , 23 ]. Unlike Grounded Theory, the Framework Method is not necessarily concerned with generating social theory, but can greatly facilitate constant comparative techniques through the review of data across the matrix.

Perhaps because the Framework Method is so obviously systematic, it has often, as other commentators have noted, been conflated with a deductive approach to qualitative analysis [ 13 , 14 ]. However, the tool itself has no allegiance to either inductive or deductive thematic analysis; where the research sits along this inductive-deductive continuum depends on the research question. A question such as, ‘Can patients give an accurate biomedical account of the onset of their cardiovascular disease?’ is essentially a yes/no question (although it may be nuanced by the extent of their account or by appropriate use of terminology) and so requires a deductive approach to both data collection and analysis (e.g. structured or semi-structured interviews and directed qualitative content analysis [ 24 ]). Similarly, a deductive approach may be taken if basing analysis on a pre-existing theory, such as behaviour change theories, for example in the case of a research question such as ‘How does the Theory of Planned Behaviour help explain GP prescribing?’ [ 11 ]. However, a research question such as, ‘How do people construct accounts of the onset of their cardiovascular disease?’ would require a more inductive approach that allows for the unexpected, and permits more socially-located responses [ 25 ] from interviewees that may include matters of cultural beliefs, habits of food preparation, concepts of ‘fate’, or links to other important events in their lives, such as grief, which cannot be predicted by the researcher in advance (e.g. an interviewee-led open ended interview and grounded theory [ 20 ]). In all these cases, it may be appropriate to use the Framework Method to manage the data. The difference would become apparent in how themes are selected: in the deductive approach, themes and codes are pre-selected based on previous literature, previous theories or the specifics of the research question; whereas in the inductive approach, themes are generated from the data though open (unrestricted) coding, followed by refinement of themes. In many cases, a combined approach is appropriate when the project has some specific issues to explore, but also aims to leave space to discover other unexpected aspects of the participants’ experience or the way they assign meaning to phenomena. In sum, the Framework Method can be adapted for use with deductive, inductive, or combined types of qualitative analysis. However, there are some research questions where analysing data by case and theme is not appropriate and so the Framework Method should be avoided. For instance, depending on the research question, life history data might be better analysed using narrative analysis [ 19 ]; recorded consultations between patients and their healthcare practitioners using conversation analysis [ 26 ]; and documentary data, such as resources for pregnant women, using discourse analysis [ 27 ].

It is not within the scope of this paper to consider study design or data collection in any depth, but before moving on to describe the Framework Method analysis process, it is worth taking a step back to consider briefly what needs to happen before analysis begins. The selection of analysis method should have been considered at the proposal stage of the research and should fit with the research questions and overall aims of the study. Many qualitative studies, particularly ones using inductive analysis, are emergent in nature; this can be a challenge and the researchers can only provide an “imaginative rehearsal” of what is to come [ 28 ]. In mixed methods studies, the role of the qualitative component within the wider goals of the project must also be considered. In the data collection stage, resources must be allocated for properly trained researchers to conduct the qualitative interviewing because it is a highly skilled activity. In some cases, a research team may decide that they would like to use lay people, patients or peers to do the interviews [ 29 - 32 ] and in this case they must be properly trained and mentored which requires time and resources. At this early stage it is also useful to consider whether the team will use Computer Assisted Qualitative Data Analysis Software (CAQDAS), which can assist with data management and analysis.

As any form of qualitative or quantitative analysis is not a purely technical process, but influenced by the characteristics of the researchers and their disciplinary paradigms, critical reflection throughout the research process is paramount, including in the design of the study, the construction or collection of data, and the analysis. All members of the team should keep a research diary, where they record reflexive notes, impressions of the data and thoughts about analysis throughout the process. Experienced qualitative researchers become more skilled at sifting through data and analysing it in a rigorous and reflexive way. They cannot be too attached to certainty, but must remain flexible and adaptive throughout the research in order to generate rich and nuanced findings that embrace and explain the complexity of real social life and can be applied to complex social issues. It is important to remember when using the Framework Method that, unlike quantitative research where data collection and data analysis are strictly sequential and mutually exclusive stages of the research process, in qualitative analysis there is, to a greater or lesser extent depending on the project, ongoing interplay between data collection, analysis, and theory development. For example, new ideas or insights from participants may suggest potentially fruitful lines of enquiry, or close analysis might reveal subtle inconsistencies in an account which require further exploration.

Procedure for analysis

Stage 1: transcription.

A good quality audio recording and, ideally, a verbatim (word for word) transcription of the interview is needed. For Framework Method analysis, it is not necessarily important to include the conventions of dialogue transcriptions which can be difficult to read (e.g. pauses or two people talking simultaneously), because the content is what is of primary interest. Transcripts should have large margins and adequate line spacing for later coding and making notes. The process of transcription is a good opportunity to become immersed in the data and is to be strongly encouraged for new researchers. However, in some projects, the decision may be made that it is a better use of resources to outsource this task to a professional transcriber.

Stage 2: Familiarisation with the interview

Becoming familiar with the whole interview using the audio recording and/or transcript and any contextual or reflective notes that were recorded by the interviewer is a vital stage in interpretation. It can also be helpful to re-listen to all or parts of the audio recording. In multi-disciplinary or large research projects, those involved in analysing the data may be different from those who conducted or transcribed the interviews, which makes this stage particularly important. One margin can be used to record any analytical notes, thoughts or impressions.

Stage 3: Coding

After familiarization, the researcher carefully reads the transcript line by line, applying a paraphrase or label (a ‘code’) that describes what they have interpreted in the passage as important. In more inductive studies, at this stage ‘open coding’ takes place, i.e. coding anything that might be relevant from as many different perspectives as possible. Codes could refer to substantive things (e.g. particular behaviours, incidents or structures), values (e.g. those that inform or underpin certain statements, such as a belief in evidence-based medicine or in patient choice), emotions (e.g. sorrow, frustration, love) and more impressionistic/methodological elements (e.g. interviewee found something difficult to explain, interviewee became emotional, interviewer felt uncomfortable) [ 33 ]. In purely deductive studies, the codes may have been pre-defined (e.g. by an existing theory, or specific areas of interest to the project) so this stage may not be strictly necessary and you could just move straight onto indexing, although it is generally helpful even if you are taking a broadly deductive approach to do some open coding on at least a few of the transcripts to ensure important aspects of the data are not missed. Coding aims to classify all of the data so that it can be compared systematically with other parts of the data set. At least two researchers (or at least one from each discipline or speciality in a multi-disciplinary research team) should independently code the first few transcripts, if feasible. Patients, public involvement representatives or clinicians can also be productively involved at this stage, because they can offer alternative viewpoints thus ensuring that one particular perspective does not dominate. It is vital in inductive coding to look out for the unexpected and not to just code in a literal, descriptive way so the involvement of people from different perspectives can aid greatly in this. As well as getting a holistic impression of what was said, coding line-by-line can often alert the researcher to consider that which may ordinarily remain invisible because it is not clearly expressed or does not ‘fit’ with the rest of the account. In this way the developing analysis is challenged; to reconcile and explain anomalies in the data can make the analysis stronger. Coding can also be done digitally using CAQDAS, which is a useful way to keep track automatically of new codes. However, some researchers prefer to do the early stages of coding with a paper and pen, and only start to use CAQDAS once they reach Stage 5 (see below).

Stage 4: Developing a working analytical framework

After coding the first few transcripts, all researchers involved should meet to compare the labels they have applied and agree on a set of codes to apply to all subsequent transcripts. Codes can be grouped together into categories (using a tree diagram if helpful), which are then clearly defined. This forms a working analytical framework. It is likely that several iterations of the analytical framework will be required before no additional codes emerge. It is always worth having an ‘other’ code under each category to avoid ignoring data that does not fit; the analytical framework is never ‘final’ until the last transcript has been coded.

Stage 5: Applying the analytical framework

The working analytical framework is then applied by indexing subsequent transcripts using the existing categories and codes. Each code is usually assigned a number or abbreviation for easy identification (and so the full names of the codes do not have to be written out each time) and written directly onto the transcripts. Computer Assisted Qualitative Data Analysis Software (CAQDAS) is particularly useful at this stage because it can speed up the process and ensures that, at later stages, data is easily retrievable. It is worth noting that unlike software for statistical analyses, which actually carries out the calculations with the correct instruction, putting the data into a qualitative analysis software package does not analyse the data; it is simply an effective way of storing and organising the data so that they are accessible for the analysis process.

Stage 6: Charting data into the framework matrix

Qualitative data are voluminous (an hour of interview can generate 15–30 pages of text) and being able to manage and summarize (reduce) data is a vital aspect of the analysis process. A spreadsheet is used to generate a matrix and the data are ‘charted’ into the matrix. Charting involves summarizing the data by category from each transcript. Good charting requires an ability to strike a balance between reducing the data on the one hand and retaining the original meanings and ‘feel’ of the interviewees’ words on the other. The chart should include references to interesting or illustrative quotations. These can be tagged automatically if you are using CAQDAS to manage your data (N-Vivo version 9 onwards has the capability to generate framework matrices), or otherwise a capital ‘Q’, an (anonymized) transcript number, page and line reference will suffice. It is helpful in multi-disciplinary teams to compare and contrast styles of summarizing in the early stages of the analysis process to ensure consistency within the team. Any abbreviations used should be agreed by the team. Once members of the team are familiar with the analytical framework and well practised at coding and charting, on average, it will take about half a day per hour-long transcript to reach this stage. In the early stages, it takes much longer.

Stage 7: Interpreting the data

It is useful throughout the research to have a separate note book or computer file to note down impressions, ideas and early interpretations of the data. It may be worth breaking off at any stage to explore an interesting idea, concept or potential theme by writing an analytic memo [ 20 , 21 ] to then discuss with other members of the research team, including lay and clinical members. Gradually, characteristics of and differences between the data are identified, perhaps generating typologies, interrogating theoretical concepts (either prior concepts or ones emerging from the data) or mapping connections between categories to explore relationships and/or causality. If the data are rich enough, the findings generated through this process can go beyond description of particular cases to explanation of, for example, reasons for the emergence of a phenomena, predicting how an organisation or other social actor is likely to instigate or respond to a situation, or identifying areas that are not functioning well within an organisation or system. It is worth noting that this stage often takes longer than anticipated and that any project plan should ensure that sufficient time is allocated to meetings and individual researcher time to conduct interpretation and writing up of findings (see Additional file 1 , Section 7).

The Framework Method has been developed and used successfully in research for over 25 years, and has recently become a popular analysis method in qualitative health research. The issue of how to assess quality in qualitative research has been highly debated [ 20 , 34 - 40 ], but ensuring rigour and transparency in analysis is a vital component. There are, of course, many ways to do this but in the Framework Method the following are helpful:

•Summarizing the data during charting, as well as being a practical way to reduce the data, means that all members of a multi-disciplinary team, including lay, clinical and (quantitative) academic members can engage with the data and offer their perspectives during the analysis process without necessarily needing to read all the transcripts or be involved in the more technical parts of analysis.

•Charting also ensures that researchers pay close attention to describing the data using each participant’s own subjective frames and expressions in the first instance, before moving onto interpretation.

•The summarized data is kept within the wider context of each case, thereby encouraging thick description that pays attention to complex layers of meaning and understanding [ 38 ].

•The matrix structure is visually straightforward and can facilitate recognition of patterns in the data by any member of the research team, including through drawing attention to contradictory data, deviant cases or empty cells.

•The systematic procedure (described in this article) makes it easy to follow, even for multi-disciplinary teams and/or with large data sets.

•It is flexible enough that non-interview data (such as field notes taken during the interview or reflexive considerations) can be included in the matrix.

•It is not aligned with a particular epistemological viewpoint or theoretical approach and therefore can be adapted for use in inductive or deductive analysis or a combination of the two (e.g. using pre-existing theoretical constructs deductively, then revising the theory with inductive aspects; or using an inductive approach to identify themes in the data, before returning to the literature and using theories deductively to help further explain certain themes).

•It is easy to identify relevant data extracts to illustrate themes and to check whether there is sufficient evidence for a proposed theme.

•Finally, there is a clear audit trail from original raw data to final themes, including the illustrative quotes.

There are also a number of potential pitfalls to this approach:

•The systematic approach and matrix format, as we noted in the background, is intuitively appealing to those trained quantitatively but the ‘spreadsheet’ look perhaps further increases the temptation for those without an in-depth understanding of qualitative research to attempt to quantify qualitative data (e.g. “13 out of 20 participants said X). This kind of statement is clearly meaningless because the sampling in qualitative research is not designed to be representative of a wider population, but purposive to capture diversity around a phenomenon [ 41 ].

•Like all qualitative analysis methods, the Framework Method is time consuming and resource-intensive. When involving multiple stakeholders and disciplines in the analysis and interpretation of the data, as is good practice in applied health research, the time needed is extended. This time needs to be factored into the project proposal at the pre-funding stage.

•There is a high training component to successfully using the method in a new multi-disciplinary team. Depending on their role in the analysis, members of the research team may have to learn how to code, index, and chart data, to think reflexively about how their identities and experience affect the analysis process, and/or they may have to learn about the methods of generalisation (i.e. analytic generalisation and transferability, rather than statistical generalisation [ 41 ]) to help to interpret legitimately the meaning and significance of the data.

While the Framework Method is amenable to the participation of non-experts in data analysis, it is critical to the successful use of the method that an experienced qualitative researcher leads the project (even if the overall lead for a large mixed methods study is a different person). The qualitative lead would ideally be joined by other researchers with at least some prior training in or experience of qualitative analysis. The responsibilities of the lead qualitative researcher are: to contribute to study design, project timelines and resource planning; to mentor junior qualitative researchers; to train clinical, lay and other (non-qualitative) academics to contribute as appropriate to the analysis process; to facilitate analysis meetings in a way that encourages critical and reflexive engagement with the data and other team members; and finally to lead the write-up of the study.

We have argued that Framework Method studies can be conducted by multi-disciplinary research teams that include, for example, healthcare professionals, psychologists, sociologists, economists, and lay people/service users. The inclusion of so many different perspectives means that decision-making in the analysis process can be very time consuming and resource-intensive. It may require extensive, reflexive and critical dialogue about how the ideas expressed by interviewees and identified in the transcript are related to pre-existing concepts and theories from each discipline, and to the real ‘problems’ in the health system that the project is addressing. This kind of team effort is, however, an excellent forum for driving forward interdisciplinary collaboration, as well as clinical and lay involvement in research, to ensure that ‘the whole is greater than the sum of the parts’, by enhancing the credibility and relevance of the findings.

The Framework Method is appropriate for thematic analysis of textual data, particularly interview transcripts, where it is important to be able to compare and contrast data by themes across many cases, while also situating each perspective in context by retaining the connection to other aspects of each individual’s account. Experienced qualitative researchers should lead and facilitate all aspects of the analysis, although the Framework Method’s systematic approach makes it suitable for involving all members of a multi-disciplinary team. An open, critical and reflexive approach from all team members is essential for rigorous qualitative analysis.

Acceptance of the complexity of real life health systems and the existence of multiple perspectives on health issues is necessary to produce high quality qualitative research. If done well, qualitative studies can shed explanatory and predictive light on important phenomena, relate constructively to quantitative parts of a larger study, and contribute to the improvement of health services and development of health policy. The Framework Method, when selected and implemented appropriately, can be a suitable tool for achieving these aims through producing credible and relevant findings.

•The Framework Method is an excellent tool for supporting thematic (qualitative content) analysis because it provides a systematic model for managing and mapping the data.

•The Framework Method is most suitable for analysis of interview data, where it is desirable to generate themes by making comparisons within and between cases.

•The management of large data sets is facilitated by the Framework Method as its matrix form provides an intuitively structured overview of summarised data.

•The clear, step-by-step process of the Framework Method makes it is suitable for interdisciplinary and collaborative projects.

•The use of the method should be led and facilitated by an experienced qualitative researcher.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

All authors were involved in the development of the concept of the article and drafting the article. NG wrote the first draft of the article, GH and EC prepared the text and figures related to the illustrative example, SRa did the literature search to identify if there were any similar articles currently available and contributed to drafting of the article, and SRe contributed to drafting of the article and the illustrative example. All authors read and approved the final manuscript.

Pre-publication history

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

http://www.biomedcentral.com/1471-2288/13/117/prepub

Supplementary Material

Illustrative Example of the use of the Framework Method.

Acknowledgments

All authors were funded by the National Institute for Health Research (NIHR) through the Collaborations for Leadership in Applied Health Research and Care for Birmingham and Black Country (CLAHRC-BBC) programme. The views in this publication expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

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• Open access
• Published: 06 May 2024

Drivers of district-level differences in outpatient antibiotic prescribing in Germany: a qualitative study with prescribers

• Benjamin Schüz 1 ,
• Oliver Scholle 2 ,
• Ulrike Haug 2 , 3 ,
• Roland Tillmann 4 &
• Christopher Jones 1 , 5  

BMC Health Services Research volume  24 , Article number:  589 ( 2024 ) Cite this article

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Previous studies have identified substantial regional variations in outpatient antibiotic prescribing in Germany, both in the paediatric and adult population. This indicates inappropriate antibiotic prescribing in some regions, which should be avoided to reduce antimicrobial resistance and potential side effects. The reasons for regional variations in outpatient antibiotic prescribing are not yet completely understood; socioeconomic and health care density differences between regions do not fully explain such differences. Here, we apply a behavioural perspective by adapting the Theoretical Domains Framework (TDF) to examine regional factors deemed relevant for outpatient antibiotic prescriptions by paediatricians and general practitioners.

Qualitative study with guideline-based telephone interviews of 40 prescribers (paediatricians and general practitioners) in outpatient settings from regions with high and low rates of antibiotic prescriptions, stratified by urbanity. TDF domains formed the basis of an interview guide to assess region-level resources and barriers to rational antibiotic prescription behaviour. Interviews lasted 30–61 min (M = 45 min). Thematic analysis was used to identify thematic clusters, and relationships between themes were explored through proximity estimation.

Both paediatricians and general practitioners in low-prescribing regions reported supporting contextual factors (in particular good collegial networks, good collaboration with laboratories) and social factors (collegial support and low patient demand for antibiotics) as important resources. In high-prescribing regions, poor coordination between in-patient and ambulatory health services, lack of region-level information on antimicrobial resistance, few professional development opportunities, and regional variations in patient expectations were identified as barriers to rational prescribing behaviour.

Conclusions

Interventions targeting professional development, better collaboration structures with laboratories and clearer and user-friendly guidelines could potentially support rational antibiotic prescribing behaviour. In addition, better networking and social support among physicians could support lower prescription rates.

Peer Review reports

Antimicrobial resistance is a major threat to global health systems [ 1 ]. Despite improvements in international surveillance programs [ 2 ], for example in the WHO European region in 2019 alone, around 541,000 deaths were associated with and 133,000 deaths were directly attributable to antimicrobial resistance [ 3 ]. One of the key drivers of antimicrobial resistance in humans is previous exposure to antibiotics [ 4 ]. To reduce the development of antimicrobial resistance, improving rational antibiotic prescription practices (i.e. avoiding unnecessary prescriptions) is crucial [ 5 , 6 ]. Most antibiotic prescriptions in outpatient settings in Europe are for respiratory and urinary tract infections [ 7 , 8 ]. In Germany, the setting of this study, most outpatient prescriptions for antibiotics are issued by general practitioners and paediatricians [ 8 , 9 ].

Germany consistently ranks among the European countries with the lowest community consumption of antibiotics, for example, in the 2021 surveillance report of the European Centre for Disease Prevention and Control [ 10 ], Germany has the 3rd lowest community consumption of antibiotics for systemic use. Still, there is considerable regional variation in outpatient prescription rates across regions in Germany [ 11 ]. International research suggests that such regional differences in outpatient prescriptions cannot be fully explained by regional differences in infectious disease prevalence [ 12 ]. Instead, socioeconomic, demographic and cultural differences have been highlighted as additional key determinants [ 13 ].

A recent small-area analysis based on health insurance claims data [ 11 ], breaking down differences between the 401 administrative districts in Germany, found up to 4-fold differences in outpatient prescription rates for children (between 188 and 710 age- and sex-standardized outpatient prescriptions per 1000 persons/year), and more than 2-fold differences in adults (between 300 and 693 prescriptions per 1000 persons/year). These substantial regional variations in prescription rates continue to raise concern about the appropriateness of antibiotic prescribing practices in Germany [ 8 ].

At the same time, reasons for the observed regional differences in outpatient antibiotic prescription rates are not fully understood. On the one hand, urban-rural differences in prescription patterns might be due to differences in health care access and socioeconomic differences in populations such as age or deprivation status [ 14 ]. Proximity to animal breeding or fattening farms has also been associated with variations in antibiotic prescriptions [ 15 ]. Further regional differences exist in the quality and accessibility of out-of-hours emergency primary care settings, which have both been associated with an increase in antibiotic prescriptions [ 16 ].

On the other hand, non-clinical factors such as demographic and socioeconomic differences [ 13 ], or differences in patient demand and prescription practices have been suggested to underlie regional variations [ 17 ], and the influence of patient demand on inappropriate antibiotic prescriptions is well documented [ 18 , 19 ]. Supporting small-area differences, calls have been made to take into account small-area regional factors in devising targeted interventions to support rational prescription practices [ 20 ].

Together, this suggests that a better understanding of the reasons underlying regional variations in outpatient antibiotic prescriptions is vital, especially for the development and implementation of better interventions to avoid inappropriate antibiotic prescriptions. The present study is based on a mixed methods research project commissioned by the German Federal Ministry of Health (SARA; “Studie zur Analyse der Regionalen Unterschiede bei der Antibiotika-Verordnung” [Study to analyse regional variations in antibiotic prescriptions]). Previous publications from this research project include the abovementioned small-area analysis of health insurance claims data [ 11 ] and a conference presentation containing some of the present data [ 21 ]. The current study focuses on the qualitative part of the project and reports results from interviews with prescribers in outpatient settings.

To this end, it builds on the patterns of regional differences identified in the previous quantitative study [ 11 ] to better understand the drivers of these regional differences in prescription behaviour based on perceptions of prescribers (general practitioners and paediatricians) in districts differing by outpatient antibiotic prescription rates.

In order to do so, an established framework of determinants of health care professional behaviours, the Theoretical Domains Framework (TDF; [ 22 , 23 ]) was used to guide qualitative interviews with prescribers.

The TDF is a psychological model developed for healthcare and behaviour change research and is based on comprehensive reviews of behavioural theories [ 22 , 24 ]. It comprises 14 key individual, social and contextual domains influencing human behaviour: knowledge, skills, social/professional role/identity, beliefs about capabilities, optimism, beliefs about consequences, reinforcement, intentions, goals, memory/attention/decision processes, environmental context/resources, social influences, emotion, and behavioural regulation. Both main effects of and interactions between domains are possible.

The TDF has been instrumental in examining individual determinants of antibiotic prescribing behaviour [ 25 , 26 , 27 , 28 ], and most studies show the domain of environmental context and resources to be influential for antibiotic prescriptions. However, which contextual aspects are particularly relevant is poorly understood to date.

The degree to which contextual resources and barriers as well as their interactions are specific to small-area districts and regions is vital to understand the observed variations in prescription rates and improve future intervention efforts. This study will therefore apply the TDF to understand differences in contextual determinants of antibiotic prescriptions and map these onto established small-area differences in paediatricians and general practitioners in Germany.

Participants and procedure

To identify region-level determinants of differences in outpatient antibiotic prescribing, semi-structured interviews were conducted with general practitioners and paediatricians working in outpatient settings. The protocol for this study was approved by the University of Bremen Ethics committee (AZ 2021-03).

Data collection materials

An interview guide (supplementary file 1 ) based on the Theoretical Domains Framework (TDF) [ 22 , 23 ] and previous studies using the TDF in antibiotic prescription contexts [ 25 , 28 ] was designed with input from a paediatrician (RT) and pharmacoepidemiologists (UH, OS) and was pilot-tested with GP representatives known to the researchers. The interview guide started with informing participants about the status of their district as high-or low-prescribing and subsequently asked an open question on prescribers’ ideas on reasons for this. Following this, we asked prescribers for their perceptions on regional levels of TDF domains relevant for prescribing antibiotics [ 25 , 28 ]; (i) knowledge, (ii) social support, (iii) environmental context and resources (and perceived differences to other districts), (iv) social and professional role, (v) social influences (patients), (vi) goals, (vii) beliefs about capabilities (patient expectation management), (viii) beliefs about consequences, (ix) optimism, (x) intentions, (xi) memory and attention processes.

Recruitment

We employed purposive sampling and stratified potential participants based on our previous quantitative analysis of regional differences in medical claims data of outpatient antimicrobial prescriptions in Germany [ 11 ]. Here, differences in prescriptions were compared between administrative districts (“Landkreise” or “kreisfreie Städte”; Nomenclature of Territorial Units for Statistics NUTS level-3 subdivision [ 29 ]).

In order to compare and contrast health care providers’ perspectives on regional differences, we selected, separately for paediatricians and GPs, 5 districts each that were within the 5% highest antibiotic prescription rates per 1,000 insured persons, and 5 districts that were within the 5% lowest antibiotic prescription rates. Within each district group, we further selected rural and urban districts (classification based on official regional statistics in Germany; [ 30 ]) to account for potential differences in settlement structure.

Contact information for paediatrician and GP practices in the respective districts were obtained through the regional representations of the respective medical councils, and were contacted through email and phone calls. Snowball recruitment was used during which participants recommended further colleagues within the respective districts, and a total of 1,444 contact attempts were made. Participants received €75 (approximately US$80) for their participation.

Prescribers who had expressed interest in the study were emailed a participant information sheet and were asked to suggest a date and time for a phone interview. Semi-structured telephone interviews were subsequently conducted by experienced female and male qualitative researchers (CJ, BS, PK), audio recorded and were transcribed verbatim. Interviews lasted a mean of 45 min (range 30–61 min) and started with an introduction, brief overview of the study goals, and verbal informed consent was obtained prior to interview commencement. The interviewed prescribers had no personal or professional connection to the researchers before the interviews.

Data analysis

Starting with the TDF domains in the interview guide, data analysis utilized an deductive approach and was based on thematic analysis [ 31 ]. Two researchers (CJ, BS) independently coded the material using MaxQDA data management software. Initial codes were reviewed between the two researchers, and saturation was achieved with both the paediatrician and GP interviews. All codes were mapped onto at least one of the TDF domains. Relationships between codes were examined looking at code overlaps in coded segments and analysing the relative proximity of coded segments in the transcribed text. The more frequently two codes appear in the same segment or in relative proximity, the more substantial overlaps between the codes are assumed. The relative positions of codes in this two-dimensional space were operationalized using multidimensional scaling implemented in MaxQDA. Here, a solution is estimated which replicates the distance between elements in the two-dimensional space between codes as well as possible relationships. Assigning of a code to a cluster of codes is estimated using the Unweighted Average Linkage method [ 32 ]. Disagreements were resolved through discussion between the researchers.

Results of the thematic analyses are presented separately for GPs and paediatricians.

Participants

A total of 40 interviews (17 paediatricians; 10 from high-prescription and 7 from low-prescription districts, 23 GPs; 10 from high-prescription and 13 from low-prescription districts) were conducted. Participants had between 1 and 35 years of experience in their current positions (mean 13.4 years, SD 9.9 years). Interviews lasted an average of 44.8 min (SD 7.1 min, range 30–61 min).

Paediatricians

TDF domains on region levels mentioned as influencing paediatricians’ prescribing behaviour (Fig.  1 ) included context and resources (86 mentions), social influences (56 mentions), knowledge (36 mentions), skills (22 mentions), social/professional role (15 mentions), beliefs about consequences (15 mentions), beliefs about capabilities (9 mentions), goals (9 mentions), behavioural regulation (6 mentions), optimism (3 mentions) and emotions (2 mentions).

TDF domains mentioned as barriers (red) or resources (blue) by paediatricians

Context and resources

Regional context and resources can affect prescribing behaviour through multiple, direct and indirect pathways, according to the participating paediatricians. The distinction between contextual (i.e., factors specific to the region) and composition effects (i.e., factors resulting from the composition of the population within a region; [ 33 ]) is particularly relevant.

Paediatricians mainly mentioned contextual factors, e.g., air pollution as a risk factor:

This area here is a former working-class area, air quality is poor, and this means we have more respiratory illnesses which are the most frequent reasons for antimicrobial prescriptions.

(A, paediatrician, urban area, high prescription rate)

Similar direct contextual effects are evident in the density of paediatricians:

…This means service provision for children in an emergency is limited, and they are rather seen by GPs. And the GPs are fantastic, […], but they don’t have our special training and might be a bit more anxious if they see a child with a high fever….

(B, paediatrician, rural area, high prescription rate)

This low density then results in overload of the paediatricians, which in turn can increase antimicrobial prescriptions:

I mean on a Monday in February I have seen about 200 children, or thereabouts. And then I can’t start discussing for ages, this just doesn’t work.

(C, paediatrician, rural area, high prescription rates)

Suboptimal transition from in-patient to out-patient care were also seen to increase antimicrobial prescriptions in districts with higher prescription rates:

…in the hospitals, they prescribe broad-spectrum antibiotics. And I have to say, after we have sat down together a year ago and have talked about outpatient antibiotic therapies, we had agreed on not prescribing some particular antibiotics. And now I see that these exact antibiotics are still being used in the hospital.

(D, paediatrician, rural area, high prescription rates)

Contextual effects however also can constitute resources for lower prescription rates, for example in high-quality laboratories and quick turnaround times:

This means we can get samples to them three or four times a day and are not dependent on pickups once a day like in the practices out there. This really is a resource I think .

(E, paediatrician, rural area, low prescription rates)

Social influences

Social influences have been mentioned frequently, both as social influences through patients and through other health care providers. In particular where patient characteristics are being discussed, such influences could also be classified as compositional context resources (see above). However, as most of the quotes illustrate, these compositional factors also contain social influences.

Social influences as factors affecting high prescription rates are mainly located on patient level, illustrated in the following quote referring to patients with Middle-Eastern migration history:

This is a totally different culture, also affecting ideas about illnesses. Their ideas are totally different, and antibiotics are seen as miracle drugs – they are over the moon if they can get an antibiotic.

(F, paediatrician, urban area, high prescription rates)

However, the demand by patients is also being attributed to context effects such as dominating agricultural influences:

I think that there are lots of expectations for antibiotics by patients. For example, I do have a mother who generally insists on getting an antibiotic for her child, and I wouldn’t prescribe it. And I tell you how she says it: ‘I also give this to my pigs, so it can’t be bad for my kids’. So I think that antibiotic practices in the farms around here, I think that this means they (antibiotics) are applied liberally and happily, and the parents have experience and want them for their kids as well.

At the same time, social influences are seen as malleable influences, in particular in combination with skills and knowledge which can then contribute to improvements in prescription practice:

It has become much better, yes. They (patients) now understand it, they have gotten used to it. And now we have, when the doctor says, you don’t need an antimicrobial, then more than half of them don’t go and see another doctor immediately and say ‘I need an antibiotic’.

(G, paediatrician, urban area, low prescription rates)

Knowledge included both information on current recommendations for antimicrobial prescribing, information on local resistance prevalence, information on local and personal prescription rates, and training content relevant to prescribing antimicrobials.

Participants from low-prescription districts mentioned knowledge on current recommendations as a resource and linked this knowledge to lower prescription rates within their districts:

We feel quite well informed. And everyone builds on that through individual research, further training and talking to colleagues. And I think, else we wouldn’t see these numbers.

(H, paediatrician, rural area, low prescription rates)

In contrast, paediatricians from high-prescription areas mentioned increased effort in obtaining relevant information:

[…] There is no information in the district, you always have to look after this yourself.

(I, paediatrician, rural area, high prescription rates).

In districts that had employed a paediatrician-initiated education programme (AnTiB; [ 34 ]), this programme was mentioned as an explicit resource:

We used to have this little informal guideline here in (city), which is also lying around in out-of-hours paediatric services and which every paediatrician here is likely to have in their practice. It is very useful and if you are doing emergency shifts, you pull it out of the drawer, look at the dosage and then prescribe.

(J, paediatrician, urban area, low prescription rate).

In contrast, the lack of specific knowledge in paediatric emergency services is seen as a barrier to effective prescribing:

We live in one of the areas with the most children in Germany, and, you can’t make this stuff up, we don’t have a paediatric out-of-hours service. This means out-of-hours is staffed by colleagues, e.g., urologists who have no clue, who start googling first – and then quickly prescribe an antibiotic.

Skills as mentioned by the paediatricians include both discipline-specific and generic skills such as language skills or interpersonal skills.

Lack of specific treatment skills are mentioned as barriers to lower prescription rates by paediatricians in high-prescribing districts:

Perhaps the experience that as a urologist, you might not have that much experience with these really high fever temperatures in toddlers under two years.

(K, paediatrician, rural area, high prescription rate).

Similarly, a lack of language skills both on the side of the prescribers and patients is being seen as a barrier, both to non-prescribing and to instructing parents to monitor their children’s health:

… there is such a large language barrier which prevents you from explaining what the parents have to look out for, what are the signs of deteriorations, when do they need to come back, well, that this is a problem overall.

(L, paediatrician, urban area, high prescription rate)

Social and professional role

Social and professional role are mainly seen as a resource for low prescription rates. The main effects are seen to be indirect, via social norms and better professional networks. In some areas, this professional role is a relevant part of paediatricians’ identity which is used to be a role model to other paediatricians.

I think there are these lighthouse or role model practices here, the bigger ones. And they do this on purpose, to set standards and blaze a trail, and the younger colleagues or others then orient themselves on them.

(M, paediatrician, urban area, low prescription rates)

In addition, the social influence through networks is being seen as strengthened through social and professional roles and identity:

So we do have quite a number of colleagues who are really well connected. They always participate in our quality groups, participate very reliably, and have good contact amongst themselves.

Beliefs about consequences

Beliefs about consequences tend to be related to contextual and environmental resources or barriers as well as regional outcomes. A particularly strong motive seems to be using antibiotics to prevent potential risks.

Paediatricians from districts with high prescription rates discuss avoiding consequences in particular with regards to patient overload:

My personal record in winter was 209 children a day. […] I have briefly checked them and then prescribed an antibiotic, because even if most of it is viral, you have children with whooping cough and I tend to be generous, because the hospitals are full of pneumonia.

Paediatricians from districts with low prescription rates on the other hand discuss low beliefs about negative consequences such as patients changing doctors due to low competition pressure:

So we don’t really have a competitive mindset here, because changes from one paediatrician to the other are really, really rare.

Interestingly, beliefs about consequences in terms of developing resistant microbes differ between paediatricians from low- and high-prescribing districts. Whereas those from high-prescribing districts argue that the responsibility for resistances is mainly located in the agricultural sector:

I think that resistant microbes develop if the farms in the area use lots of antibiotics […] So the kids who have MRSA here, they are all from farms. So they didn’t get MRSA because we gave them antibiotics but because the farms at home use lots of antibiotics.

(C, paediatrician, rural area, high prescription rates),

Those from low-prescription districts tend to attribute resistance development to health care professional behaviour:

The less antibiotics one prescribes, and if this happens everywhere, then we can expect, that the development of resistances will be less bad than elsewhere.

Beliefs about competences

Beliefs about competences mainly revolved around perceptions of competence to influence local resistance developments and largely mirror those exemplified in the beliefs about consequences section.

Both paediatricians from low- and high-prescribing districts explicitly mentioned goals to prescribe less antimicrobials, and mention that these goals are also shared by colleagues in the respective districts. Differences exist in the context within goals are mentioned – paediatricians from low-prescription districts mention the goal of lower prescriptions as part of a combinations of goals (e.g., optimal therapy or limiting resistance development), paediatricians from high-prescription districts concentrate on potentially more relevant goals than lower prescription rates:

…I think I can speak for most of my colleagues here, one tries to prescribe as little as possible. But if they really all read the reports, do they change their prescription behaviour, I doubt that. There are quite some other problems here that need solving as well.

Behavioural regulation

Behavioural regulation had only six mentions, but these were mainly together with contextual factors in districts with high prescription prevalence to highlight that contextual factors can pose barriers which also affect the low likelihood to change through impeding behavioural regulation:

And I think that these are basically deeply rooted, historic, ritualized prescription patterns, which then manifest regionally such that it is really difficult to change this.

General Practitioners (GPs)

TDF domains on district level that affected GP prescribing behaviour (Fig.  2 ) included context and resources (159 mentions), social influence (60 mentions), knowledge (41 mentions), beliefs about consequences (29 mentions), social/professional role (16 mentions), skills (16 mentions), goals (6 mentions), and behavioural regulation (4 mentions).

TDF domains mentioned as barriers (red) or resources (blue) by GPs

Similar to the paediatric participants, GPs reported on a range of regional contextual factors that influenced prescribing behaviour. These can also be differentiated along contextual and compositional factors [ 33 ].

A combination of contextual (main industry in the region) and compositional (migrant workers in the main industry) is a good example for these influences:

With the (migrant) workers in the meat industry, we do have a lot of people who might have potentially problems in dental hygiene, infections due to cuts for example. This happens a lot, and then increases the prescription of (antimicrobials).

(N, GP, rural area, high prescription rates).

GPs also report on regional differences in the influence of pharmaceutical representatives in their practices. For example, a GP from a low-prescription rural district mentioned that their local quality circles “will not invite pharmaceutical representatives if possible”.

Social influence

Social influences differ between districts, according to GP participants, and similar to paediatricians, these influences come through colleagues and patients.

One example for a local social influence could be long established GPs who influence local quality circles:

…as a young and newly arrived doctor, I quit going to the quality circles because the old guard was so present and influenced communication, work and thinking about practices. However, we do have now a new generation of GPs and things change.

(O, GP, rural area, low prescription rates)

Patient-level influences are also perceived to differ between districts, with some of the differences in expectations to be prescribed antibiotics being attributed to cultural factors:

There is a group of patients who are really eager to get antibiotics and who are incredibly demanding. Germans from the former Soviet Republics, and we do have many of them in this district. For them, it (not being prescribed antibiotics) is not a real therapy, even if it is viral….

(P, GP, rural area, high prescription rates)

Similar to cultural factors, the age distribution in a district is perceived to affect prescription, with more older adults in a district being associated with higher antibiotic demand.

Similar to this influence on higher prescriptions, specific regional social influences are also perceived as being influential for low prescription rates:

I mean, (city) is a very special city. It’s an administrative centre, a big university city, so I think there are a lot of people with a relatively high educational attainment, relatively little industry and I guess it’s also related to the fact that people have a bit of a different attitude. .

(Q, GP, urban area, low prescription rates)

Similar to the results in paediatricians, knowledge about current recommendations, information on local resistance, and training content relevant to prescribing antimicrobials were seen as relevant resources. One particular additional factor was that in one of the participating districts, the local university was seen as influential for particularly rational prescribing behaviour:

I think that this is due to the fact that here in (city) there are many doctors who have studied in (city). And I remember from my studies that antibiotic prescriptions were an important topic, and that in microbiology et cetera we were always being reminded that one does not just prescribe antibiotics but needs to justify this really well.

(R, GP, rural area, low prescription rates)

At the same time, similar to the paediatricians, a lack of knowledge in out-of-hours services is seen as a relevant factor for high prescription rates:

But there are many colleagues working in the out-of-hours primary care and doing GP tasks who have for example an anesthesia background, or something else from the hospital, they don’t know it any better.

(N, GP, rural area, high prescription rates)

These knowledge factors interact with resources and barriers on context level.

Similar to paediatricians, beliefs about consequences include beliefs about having to avoid liabilities, which are often mentioned in combination with structural and contextual factors:

And if something does go wrong, and that’s always a problem in outpatient settings, you are the one who screwed it up. That’s what all the colleagues are afraid of. So the fear of making a mistake and not prescribing the antibiotic is always bigger than the fear of damaging something with the antibiotic.

(S, GP, rural area, high prescription rates)

Losing patients to other practices in situations with strong competition was a strong belief about consequences in districts with high prescriptions:

You can say, No I am not going to prescribe this, but then you lose the patient, they are just going somewhere else.

(T, GP, urban area, high prescription rates).

At the same time, a lack of such perceived consequences has been perceived as a resource for lower prescriptions:

…at least we don’t have to bow to patient demands too much. It is very different here compared to (city) where I was before, in the inner city, where there was a lot of competition due to too many GPs. You are much more likely to give in to irrational demands then.

(U, GP, rural area, low prescription rates)

Social / professional role

Specific regional ideas on the professional roles are perceived to influence prescription behaviour, in particular in combination with specific aspects of rurality that could affect the composition of the local GP structure:

I just see what kind of colleagues – to say it cautiously – are coming to this region, who take over old practices or establish new ones. They are not necessarily the most committed doctors.

(V, GP, rural area, high prescription rates)

In districts with low prescription rates, skills were mainly being mentioned with regards to interpersonal skills regarding expectation management with patients, which were perceived to be higher in the respective districts:

…in fact, skills training in multiple areas. General communication skills, difficult patients, bad prognosis, diagnosis, or making the patients understand why a particular therapy is indicated – these are all key skills and have always been emphasized during our studies.

Similar to paediatricians, GPs from both low- and high-prescription districts mention the goal of low prescription rates, and assume that their colleagues in the district have similar goals. GPs in low-prescription districts mention this goal as part of multiple goals (ideal therapy, avoid resistance) in low-prescription districts, GPs in high-prescription districts mention this goal as having lower priority compared to competing demands.

Similar to the paediatricians, a lack of behavioural regulation in combination with contextual measures such as relatively old GPs in the district was seen as a risk factor for higher prescriptions:

Prescription behaviour by older colleagues plays a role I think. You can see this when you look at the age structure of the GPs here. They tend to prescribe antibiotics quickly whenever there are respiratory infections.

(W, GP, rural area, high prescription rates)

This study examined prescribers’ perceptions of region-specific drivers of outpatient antibiotic prescriptions. We conducted 40 interviews in districts stratified by antibiotic prescription rates, and mapped these perceptions on dimensions of the Theoretical Domains Framework [ 22 , 23 ]. A total of 11 domains were identified, and these served as, partially interacting, barriers against and resources for low antibiotic prescription rates. Most barriers and facilitators were similar between paediatricians and GPs. However, while GPs mentioned the age and workforce structure in districts as additional barrier, paediatricians emphasized a lack of skills and knowledge of GP colleagues treating young children as a barrier in districts with only few paediatricians.

We could link differences in the perception of TDF domains and their interactions to differences in prescribing behaviour in the districts to identify overarching barriers and resources for appropriate prescription practices.

Overarching barriers to low prescription rates

Both paediatric and GPs mentioned a lack of knowledge on district-level resistance developments as particular barrier to rational prescribing. This knowledge factor overlaps with a lack of contextual and environmental resources which could provide this information such as routine information flows between laboratories and health care providers.

Similarly, a lack of collaboration and coordination of knowledge in out-of-hours services was perceived to be associated with higher prescription rates – partly also due to a perception to avoid liabilities if prescribing antibiotics.

Lower health care provider density as contextual factor has been associated with higher prescription rates in previous international studies [ 35 , 36 ]. In the present study, lower prescriber density has only indirectly been associated with higher prescription rates – in the cases where lower density correlates with suboptimal emergency services prescription guidelines [ 16 ].

Participants also associated specific regional industries in rural districts (pig farming and meat factories) with higher patient demands due to either antibiotic practices in farming [ 15 ] or an increased demand for antibiotics by migrant workers and due to cuts in meat factories.

Social influences included culture-specific expectations about the effectiveness of antibiotics leading to higher patient demand for antibiotics, which together with time pressure from high patient load increased pressure on prescribers during consultations. This finding replicates findings from other European studies on antibiotic prescribing behaviour [ 18 , 19 ].

Overarching resources for low prescription rates

Overarching resources for low prescription rates that were mentioned by both paediatricians and GPs included environmental context and resources . Here in particular existing local networks supporting quality control were perceived as supportive of appropriate prescribing, both through the provision of information, best-practice examples and social norms. This replicates an earlier study suggesting that well-functioning local or regional primary care networks in Germany are associated with more appropriate antibiotic prescribing [ 37 ]. In addition, laboratories routinely providing information on local resistance data were perceived as resources for rational prescribing, which is in line with previous studies in Germany outlining the lack of local resistance information as a barrier to appropriate prescribing [ 38 ] and, similarly, showing that practitioners perceive information on local resistance as beneficial [ 39 ]. Low local population demand for antibiotics was also perceived as resource, as participants reported this to positively impact their prescription practice.

Implications

Most barriers and resources to rational outpatient prescribing in this study were contextual factors. However, contextual factors such as the local population, the main local branches of industry or (at least in Germany), or the free choice of practitioners to open practices anywhere within a district are not directly modifiable. This means that interventions should in particular target local collaboration structures and the availability of locally adapted guidelines.

If collaborations between local medical councils and laboratories can be improved to routinely provide local antimicrobial resistance data to prescribers, this information can readily be included into the prescription decision-making process [ 39 ]. In particular since both German and international studies [ 40 ] show that there is substantial variation in the degree to which individual practices take local resistance data into consideration, routine approaches are warranted. Germany has implemented a standardized surveillance program for multiresistant microbes such as MSRA [ 2 ], but the degree to which these surveillance findings are broken down locally and are available to practices varies considerably between districts, suggesting policies to standardise practice. If these findings are then included into local prescription guidelines such as the AnTiB guidelines [ 34 ], local prescription practices can be improved.

Routine antibiotic stewardship programmes that support paediatric and general practices could also help facilitating such closer collaborations and in turn build on some of the networking aspects mentioned as resources in the interviews. At the moment, antibiotic stewardship programs for outpatient settings in Germany are supported through national professional and scientific associations and are eligible for training credits, but implementation depends on local initiatives [ 5 ]. National policies to mandate such programmes would help to reduce the current regional disparities in antibiotic prescription practices, and the current antibiotic strategy of the German government DART 2030 [ 41 ] plans to explore compulsory training.

In terms of knowledge resources, participants mentioned that easy-to-use recommendations for emergency practice services are an important resource in particular if there is no paediatric emergency service, and children are seen by non-paediatrician practitioners. In Germany, initiatives such as Antibiotic Therapy in Bielefeld (AnTiB; [ 34 ]) provide such guidelines, but a systems-wide implementation of easy-to-follow guidelines such as e.g., NICE guidelines for upper respiratory tract infections [ 42 ] is currently lacking and would likely improve prescription practices in Germany.

Patient information such as leaflets might lead to increased patient knowledge about the role of antibiotics in managing infections and lower patient demand [ 43 ] without increased reconsultations [ 44 ]. At the same time, the role of involving audiences in the design of such leaflets and ensuring their understandability is crucial [ 45 ].

Strengths and limitations

A particular strength of the study lies in using the TDF to examine district-level differences in prescription behaviour, which allowed us to identify and interpret the impact of the factors mentioned by GPs and paediatricians. This deductive approach allowed mapping key themes on an established framework, which can in turn be used to determine and develop potential intervention applications. Our study complements previous work applying the TDF to understand antibiotic prescribing behaviour [ 25 ] by extending the perspective of the TDF on individual determinants onto characteristics of the district.

At the same time, the perceptions of participants regarding district-level TDF-based characteristics are subjective perceptions and do not necessarily correspond to the actual level of resources and barriers in the districts. Compared to face-to-face interviews, telephone interviews miss out on nonverbal information, but have allowed us to accommodate prescribers’ schedules. Due to the self-report nature of interviews, demand characteristics might affect responses such that participants exaggerate or downplay relevant factors.

Saturation in that no new codes emerged was achieved in all study cells (defined by practitioner group, urban/rural practice site and prescription rates) apart from GPs from high-prescribing urban areas, where only one interview could be realised. It is thus possible that additional interviews could have provided additional barriers and resources.

Substantial district-level differences in outpatient antibiotic prescriptions in paediatric and general practices can be mapped on differences in prescriber perceptions of district-level barriers and resources to rational prescribing. Given the regional variation in underlying reasons for inappropriate prescribing of antibiotics, similar qualitative studies in all districts in Germany with high prescription rates could be a promising approach to design targeted interventions. According to the results of interviews conducted in this study, routine provision of local antibiotic resistance data, better and clearer guidelines for paediatric patients in ambulatory emergency services, patient information and a wider implementation of standardised antibiotic stewardship programs could be promising targets for interventions.

Data availability

The qualitative data collected for this study was de-identified before analysis. Consent was not obtained to use or publish individual-level data from the participants and therefore may not be shared publicly. The de-identified (German) data can be obtained from the corresponding author upon reasonable request.

Change history

09 may 2024.

A typesetting mistake in the figure formatting in the HTML version of the article was corrected.

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Acknowledgements

The support of Paula Kinzel during data assessment is gratefully acknowledged.

Open Access funding enabled and organized by Projekt DEAL.

The SARA project—on which this publication is based—was commissioned by the Federal Ministry of Health (grant number ZMVI1-2519FSB115).

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Benjamin Schüz & Christopher Jones

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Praxis für Kinder- und Jugendmedizin Roland Tillmann, Ärztenetz Bielefeld, Bielefeld, Germany

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Contributions

BS conceived of the study, analysed and interpreted data and wrote the first draft of the manuscript. OS contributed to design of the study, interpretation of data. UH contributed to acquisition, concept and design of the study as well as interpretation of data. RT contributed to design and acquisition of the study as well as interpretation of data. CJ contributed to design and concept of the study as well as assessment, analysis and interpretation of the data. All authors critically reviewed the manuscript.

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Ethics approval was obtained through the University of Bremen ethics committee (AZ 2021-03). All methods and procedures were performed in accordance with the relevant guidelines. All participants provided informed consent including before being interviewed for this study.

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Competing interests

OS and UH are working at an independent, non-profit research institute, the Leibniz Institute for Prevention Research and Epidemiology – BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. These are post-authorization safety studies (PASS) requested by health authorities. The design and conduct of these studies as well as the interpretation and publication are not influenced by the pharmaceutical industry. The study presented was not funded by the pharmaceutical industry. The Federal Ministry of Health specified the research question and the main content of the study concept and regularly participated in discussions on the implementation of the study. The authors were independent in the specific design, execution, interpretation, and writing of the study. The Federal Ministry of Health has authorized the publication of the results. BS, RT and CJ declare no conflicts of interest.

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Schüz, B., Scholle, O., Haug, U. et al. Drivers of district-level differences in outpatient antibiotic prescribing in Germany: a qualitative study with prescribers. BMC Health Serv Res 24 , 589 (2024). https://doi.org/10.1186/s12913-024-11059-z

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Received : 09 November 2023

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Published : 06 May 2024

DOI : https://doi.org/10.1186/s12913-024-11059-z

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