qualitative research framework

• 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

519k Accesses

4724 Citations

101 Altmetric

Metrics details

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.

Ritchie J, Lewis J: Qualitative research practice: a guide for social science students and researchers. 2003, London: Sage

Google Scholar  

Ives J, Damery S, Redwod S: PPI, paradoxes and Plato: who's sailing the ship?. J Med Ethics. 2013, 39 (3): 181-185. 10.1136/medethics-2011-100150.

Article   Google Scholar  

Heath G, Cameron E, Cummins C, Greenfield S, Pattison H, Kelly D, Redwood S: Paediatric ‘care closer to home’: stake-holder views and barriers to implementation. Health Place. 2012, 18 (5): 1068-1073. 10.1016/j.healthplace.2012.05.003.

Elkington H, White P, Addington-Hall J, Higgs R, Petternari C: The last year of life of COPD: a qualitative study of symptoms and services. Respir Med. 2004, 98 (5): 439-445. 10.1016/j.rmed.2003.11.006.

Murtagh J, Dixey R, Rudolf M: A qualitative investigation into the levers and barriers to weight loss in children: opinions of obese children. Archives Dis Child. 2006, 91 (11): 920-923. 10.1136/adc.2005.085712.

Barnard M, Webster S, O’Connor W, Jones A, Donmall M: The drug treatment outcomes research study (DTORS): qualitative study. 2009, London: Home Office

Ayatollahi H, Bath PA, Goodacre S: Factors influencing the use of IT in the emergency department: a qualitative study. Health Inform J. 2010, 16 (3): 189-200. 10.1177/1460458210377480.

Sheard L, Prout H, Dowding D, Noble S, Watt I, Maraveyas A, Johnson M: Barriers to the diagnosis and treatment of venous thromboembolism in advanced cancer patients: a qualitative study. Palliative Med. 2012, 27 (2): 339-348.

Ellis J, Wagland R, Tishelman C, Williams ML, Bailey CD, Haines J, Caress A, Lorigan P, Smith JA, Booton R, et al: Considerations in developing and delivering a nonpharmacological intervention for symptom management in lung cancer: the views of patients and informal caregivers. J Pain Symptom Manag (0). 2012, 44 (6): 831-842. 10.1016/j.jpainsymman.2011.12.274.

Gale N, Sultan H: Telehealth as ‘peace of mind’: embodiment, emotions and the home as the primary health space for people with chronic obstructive pulmonary disorder. Health place. 2013, 21: 140-147.

Rashidian A, Eccles MP, Russell I: Falling on stony ground? A qualitative study of implementation of clinical guidelines’ prescribing recommendations in primary care. Health policy. 2008, 85 (2): 148-161. 10.1016/j.healthpol.2007.07.011.

Jones RK: The unsolicited diary as a qualitative research tool for advanced research capacity in the field of health and illness. Qualitative Health Res. 2000, 10 (4): 555-567. 10.1177/104973200129118543.

Pope C, Ziebland S, Mays N: Analysing qualitative data. British Med J. 2000, 320: 114-116. 10.1136/bmj.320.7227.114.

Pope C, Mays N: Critical reflections on the rise of qualitative research. British Med J. 2009, 339: 737-739.

Fairclough N: Critical discourse analysis: the critical study of language. 2010, London: Longman

Garfinkel H: Ethnomethodology’s program. Soc Psychol Quarter. 1996, 59 (1): 5-21. 10.2307/2787116.

Merleau-Ponty M: The phenomenology of perception. 1962, London: Routledge and Kegan Paul

Svenaeus F: The phenomenology of health and illness. Handbook of phenomenology and medicine. 2001, Netherlands: Springer, 87-108.

Reissmann CK: Narrative methods for the human sciences. 2008, London: Sage

Charmaz K: Constructing grounded theory: a practical guide through qualitative analysis. 2006, London: Sage

Glaser A, Strauss AL: The discovery of grounded theory. 1967, Chicago: Aldine

Crotty M: The foundations of social research: meaning and perspective in the research process. 1998, London: Sage

Boeije H: A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002, 36 (4): 391-409. 10.1023/A:1020909529486.

Hsieh H-F, Shannon SE: Three approaches to qualitative content analysis. Qual Health Res. 2005, 15 (9): 1277-1288. 10.1177/1049732305276687.

Redwood S, Gale NK, Greenfield S: ‘You give us rangoli, we give you talk’: using an art-based activity to elicit data from a seldom heard group. BMC Med Res Methodol. 2012, 12 (1): 7-10.1186/1471-2288-12-7.

Mishler EG: The struggle between the voice of medicine and the voice of the lifeworld. The sociology of health and illness: critical perspectives. Edited by: Conrad P, Kern R. 1990, New York: St Martins Press, Third

Hodges BD, Kuper A, Reeves S: Discourse analysis. British Med J. 2008, 337: 570-572. 10.1136/bmj.39370.701782.DE.

Sandelowski M, Barroso J: Writing the proposal for a qualitative research methodology project. Qual Health Res. 2003, 13 (6): 781-820. 10.1177/1049732303013006003.

Ellins J: It’s better together: involving older people in research. HSMC Newsletter Focus Serv Users Publ. 2010, 16 (1): 4-

Phillimore J, Goodson L, Hennessy D, Ergun E: Empowering Birmingham’s migrant and refugee community organisations: making a difference. 2009, York: Joseph Rowntree Foundation

Leamy M, Clough R: How older people became researchers. 2006, York: Joseph Rowntree Foundation

Glasby J, Miller R, Ellins J, Durose J, Davidson D, McIver S, Littlechild R, Tanner D, Snelling I, Spence K: Final report NIHR service delivery and organisation programme. Understanding and improving transitions of older people: a user and carer centred approach. 2012, London: The Stationery Office

Saldaña J: The coding manual for qualitative researchers. 2009, London: Sage

Lincoln YS: Emerging criteria for quality in qualitative and interpretive research. Qual Inquiry. 1995, 1 (3): 275-289. 10.1177/107780049500100301.

Mays N, Pope C: Qualitative research in health care: assessing quality in qualitative research. BMJ British Med J. 2000, 320 (7226): 50-10.1136/bmj.320.7226.50.

Seale C: Quality in qualitative research. Qual Inquiry. 1999, 5 (4): 465-478. 10.1177/107780049900500402.

Dingwall R, Murphy E, Watson P, Greatbatch D, Parker S: Catching goldfish: quality in qualitative research. J Health serv Res Policy. 1998, 3 (3): 167-172.

Popay J, Rogers A, Williams G: Rationale and standards for the systematic review of qualitative literature in health services research. Qual Health Res. 1998, 8 (3): 341-351. 10.1177/104973239800800305.

Morse JM, Barrett M, Mayan M, Olson K, Spiers J: Verification strategies for establishing reliability and validity in qualitative research. Int J Qual Methods. 2008, 1 (2): 13-22.

Smith JA: Reflecting on the development of interpretative phenomenological analysis and its contribution to qualitative research in psychology. Qual Res Psychol. 2004, 1 (1): 39-54.

Polit DF, Beck CT: Generalization in quantitative and qualitative research: Myths and strategies. Int J Nurs Studies. 2010, 47 (11): 1451-1458. 10.1016/j.ijnurstu.2010.06.004.

Pre-publication history

The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2288/13/117/prepub

Download references

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.

Author information

Authors and affiliations.

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

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Nicola K Gale .

Additional information

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.

Electronic supplementary material

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

Below are the links to the authors’ original submitted files for images.

Authors’ original file for figure 1

Authors’ original file for figure 2, authors’ original file for figure 3, authors’ original file for figure 4, authors’ original file for figure 5, authors’ original file for figure 6, rights and permissions.

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and permissions

About this article

Cite this article.

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

Download citation

Received : 17 December 2012

Accepted : 06 September 2013

Published : 18 September 2013

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

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Qualitative research
• Qualitative content analysis
• Multi-disciplinary research

BMC Medical Research Methodology

ISSN: 1471-2288

• General enquiries: [email protected]

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

Chapter 4: Theoretical frameworks for qualitative research

Tess Tsindos

Learning outcomes

Upon completion of this chapter, you should be able to:

• Describe qualitative frameworks.
• Explain why frameworks are used in qualitative research.
• Identify various frameworks used in qualitative research.

What is a Framework?

A framework is a set of broad concepts or principles used to guide research.  As described by Varpio and colleagues 1 , a framework is a logically developed and connected set of concepts and premises – developed from one or more theories – that a researcher uses as a scaffold for their study. The researcher must define any concepts and theories that will provide the grounding for the research and link them through logical connections, and must relate these concepts to the study that is being carried out. In using a particular theory to guide their study, the researcher needs to ensure that the theoretical framework is reflected in the work in which they are engaged.

It is important to acknowledge that the terms ‘theories’ ( see Chapter 3 ), ‘frameworks’ and ‘paradigms’ are sometimes used interchangeably. However, there are differences between these concepts. To complicate matters further, theoretical frameworks and conceptual frameworks are also used. In addition, quantitative and qualitative researchers usually start from different standpoints in terms of theories and frameworks.

A diagram by Varpio and colleagues demonstrates the similarities and differences between theories and frameworks, and how they influence research approaches. 1(p991) The diagram displays the objectivist or deductive approach to research on the left-hand side. Note how the conceptual framework is first finalised before any research is commenced, and it involves the articulation of hypotheses that are to be tested using the data collected. This is often referred to as a top-down approach and/or a general (theory or framework) to a specific (data) approach.

The diagram displays the subjectivist or inductive approach to research on the right-hand side. Note how data is collected first, and through data analysis, a tentative framework is proposed. The framework is then firmed up as new insights are gained from the data analysis. This is referred to as a specific (data) to general (theory and framework) approach .

Why d o w e u se f rameworks?

A framework helps guide the questions used to elicit your data collection. A framework is not prescriptive, but it needs to be suitable for the research question(s), setting and participants. Therefore, the researcher might use different frameworks to guide different research studies.

A framework informs the study’s recruitment and sampling, and informs, guides or structures how data is collected and analysed. For example, a framework concerned with health systems will assist the researcher to analyse the data in a certain way, while a framework concerned with psychological development will have very different ways of approaching the analysis of data. This is due to the differences underpinning the concepts and premises concerned with investigating health systems, compared to the study of psychological development. The framework adopted also guides emerging interpretations of the data and helps in comparing and contrasting data across participants, cases and studies.

Some examples of foundational frameworks used to guide qualitative research in health services and public health:

• The Behaviour Change Wheel 2
• Consolidated Framework for Implementation Research (CFIR) 3
• Theoretical framework of acceptability 4
• Normalization Process Theory 5
• Candidacy Framework 6
• Aboriginal social determinants of health 7(p8)
• Social determinants of health 8
• Social model of health 9,10
• Systems theory 11
• Biopsychosocial model 12
• Discipline-specific models
• Disease-specific frameworks

E xamples of f rameworks

In Table 4.1, citations of published papers are included to demonstrate how the particular framework helps to ‘frame’ the research question and the interpretation of results.

Table 4.1. Frameworks and references

As discussed in Chapter 3, qualitative research is not an absolute science. While not all research may need a framework or theory (particularly descriptive studies, outlined in Chapter 5), the use of a framework or theory can help to position the research questions, research processes and conclusions and implications within the relevant research paradigm. Theories and frameworks also help to bring to focus areas of the research problem that may not have been considered.

• Varpio L, Paradis E, Uijtdehaage S, Young M. The distinctions between theory, theoretical framework, and conceptual framework. Acad Med . 2020;95(7):989-994. doi:10.1097/ACM.0000000000003075
• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci .  2011;6:42. doi:10.1186/1748-5908-6-42
• CFIR Research Team. Consolidated Framework for Implementation Research (CFIR). Center for Clinical Management Research. 2023. Accessed February 15, 2023. https://cfirguide.org/
• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res . 2017;17:88. doi:10.1186/s12913-017-2031-8
• Murray E, Treweek S, Pope C, et al. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med .  2010;8:63. doi:10.1186/1741-7015-8-63
• Tookey S, Renzi C, Waller J, von Wagner C, Whitaker KL. Using the candidacy framework to understand how doctor-patient interactions influence perceived eligibility to seek help for cancer alarm symptoms: a qualitative interview study. BMC Health Serv Res . 2018;18(1):937. doi:10.1186/s12913-018-3730-5
• Lyon P. Aboriginal Health in Aboriginal Hands: Community-Controlled Comprehensive Primary Health Care @ Central Australian Aboriginal Congress; 2016. Accessed February 15, 2023. https://nacchocommunique.com/wp-content/uploads/2017/09/cphc-congress-final-report.pdf
• Solar O., Irwin A. A Conceptual Framework for Action on the Social Determinants of Health:   Social Determinants of Health Discussion Paper 2 (Policy and Practice); 2010. Accessed February 22, 2023. https://www.who.int/publications/i/item/9789241500852
• Yuill C, Crinson I, Duncan E. Key Concepts in Health Studies . SAGE Publications; 2010.
• Germov J. Imagining health problems as social issues. In: Germov J, ed. Second Opinion: An Introduction to Health Sociology . Oxford University Press; 2014.
• Laszlo A, Krippner S. Systems theories: their origins, foundations, and development. In: Jordan JS, ed. Advances in Psychology . Science Direct; 1998:47-74.
• Engel GL. From biomedical to biopsychosocial: being scientific in the human domain. Psychosomatics . 1997;38(6):521-528. doi:10.1016/S0033-3182(97)71396-3
• Schmidtke KA, Drinkwater KG. A cross-sectional survey assessing the influence of theoretically informed behavioural factors on hand hygiene across seven countries during the COVID-19 pandemic. BMC Public Health . 2021;21:1432. doi:10.1186/s12889-021-11491-4
• Graham-Wisener L, Nelson A, Byrne A, et al. Understanding public attitudes to death talk and advance care planning in Northern Ireland using health behaviour change theory: a qualitative study. BMC Public Health . 2022;22:906. doi:10.1186/s12889-022-13319-1
• Walker R, Quong S, Olivier P, Wu L, Xie J, Boyle J. Empowerment for behaviour change through social connections: a qualitative exploration of women’s preferences in preconception health promotion in the state of Victoria, Australia. BMC Public Health . 2022;22:1642. doi:10.1186/s12889-022-14028-5
• Ayton DR, Barker AL, Morello RT, et al. Barriers and enablers to the implementation of the 6-PACK falls prevention program: a pre-implementation study in hospitals participating in a cluster randomised controlled trial. PLOS ONE . 2017;12(2):e0171932. doi:10.1371/journal.pone.0171932
• Pratt R, Xiong S, Kmiecik A, et al. The implementation of a smoking cessation and alcohol abstinence intervention for people experiencing homelessness. BMC Public Health . 2022;22:1260. doi:10.1186/s12889-022-13563-5
• Bossert J, Mahler C, Boltenhagen U, et al. Protocol for the process evaluation of a counselling intervention designed to educate cancer patients on complementary and integrative health care and promote interprofessional collaboration in this area (the CCC-Integrativ study). PLOS ONE . 2022;17(5):e0268091. doi:10.1371/journal.pone.0268091
• Lwin KS, Bhandari AKC, Nguyen PT, et al. Factors influencing implementation of health-promoting interventions at workplaces: protocol for a scoping review. PLOS ONE . 2022;17(10):e0275887. doi:10.1371/journal.pone.0275887
• Wilhelm AK, Schwedhelm M, Bigelow M, et al. Evaluation of a school-based participatory intervention to improve school environments using the Consolidated Framework for Implementation Research. BMC Public Health . 2021;21:1615. doi:10.1186/s12889-021-11644-5
• Timm L, Annerstedt KS, Ahlgren JÁ, et al. Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes. PLOS ONE . 2022;17(10):e0275576. doi:10.1371/journal.pone.0275576
• Laing L, Salema N-E, Jeffries M, et al. Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: a qualitative exploration using the Theoretical Framework of Acceptability. PLOS ONE . 2022;17(10):e0275633. doi:10.1371/journal.pone.0275633
• Renko E, Knittle K, Palsola M, Lintunen T, Hankonen N. Acceptability, reach and implementation of a training to enhance teachers’ skills in physical activity promotion. BMC Public Health . 2020;20:1568. doi:10.1186/s12889-020-09653-x
• Alexander SM, Agaba A, Campbell JI, et al. A qualitative study of the acceptability of remote electronic bednet use monitoring in Uganda. BMC Public Health . 2022;22:1010. doi:10.1186/s12889-022-13393
• May C, Rapley T, Mair FS, et al. Normalization Process Theory On-line Users’ Manual, Toolkit and NoMAD instrument. 2015. Accessed February 15, 2023. https://normalization-process-theory.northumbria.ac.uk/
• Davis S. Ready for prime time? Using Normalization Process Theory to evaluate implementation success of personal health records designed for decision making. Front Digit  Health . 2020;2:575951. doi:10.3389/fdgth.2020.575951
• Durand M-A, Lamouroux A, Redmond NM, et al. Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial. BMC Public Health . 2021;21:1684. doi:10.1186/s12889-021-11565
• Jones SE, Hamilton S, Bell R, Araújo-Soares V, White M. Acceptability of a cessation intervention for pregnant smokers: a qualitative study guided by Normalization Process Theory. BMC Public Health . 2020;20:1512. doi:10.1186/s12889-020-09608-2
• Ziegler E, Valaitis R, Yost J, Carter N, Risdon C. “Primary care is primary care”: use of Normalization Process Theory to explore the implementation of primary care services for transgender individuals in Ontario. PLOS ONE . 2019;14(4):e0215873. doi:10.1371/journal.pone.0215873
• Mackenzie M, Conway E, Hastings A, Munro M, O’Donnell C. Is ‘candidacy’ a useful concept for understanding journeys through public services? A critical interpretive literature synthesis. Soc Policy Adm . 2013;47(7):806-825. doi:10.1111/j.1467-9515.2012.00864.x
• Adeagbo O, Herbst C, Blandford A, et al. Exploring people’s candidacy for mobile health–supported HIV testing and care services in rural KwaZulu-Natal, South Africa: qualitative study. J Med Internet Res . 2019;21(11):e15681. doi:10.2196/15681
• Mackenzie M, Turner F, Platt S, et al. What is the ‘problem’ that outreach work seeks to address and how might it be tackled? Seeking theory in a primary health prevention programme. BMC Health Serv Res . 2011;11:350. doi:10.1186/1472-6963-11-350
• Liberati E, Richards N, Parker J, et al. Qualitative study of candidacy and access to secondary mental health services during the COVID-19 pandemic. Soc Sci Med. 2022;296:114711. doi:10.1016/j.socscimed.2022.114711
• Pearson O, Schwartzkopff K, Dawson A, et al. Aboriginal community controlled health organisations address health equity through action on the social determinants of health of Aboriginal and Torres Strait Islander peoples in Australia. BMC Public Health . 2020;20:1859. doi:10.1186/s12889-020-09943-4
• Freeman T, Baum F, Lawless A, et al. Revisiting the ability of Australian primary healthcare services to respond to health inequity. Aust J Prim  Health . 2016;22(4):332-338. doi:10.1071/PY14180
• Couzos S. Towards a National Primary Health Care Strategy: Fulfilling Aboriginal Peoples Aspirations to Close the Gap . National Aboriginal Community Controlled Health Organisation. 2009. Accessed February 15, 2023. https://researchonline.jcu.edu.au/35080/
• Napier AD, Ancarno C, Butler B, et al. Culture and health. Lancet . 2014;384(9954):1607-1639. doi:10.1016/S0140-6736(14)61603-2
• WHO. COVID-19 and the Social Determinants of Health and Health Equity: Evidence Brief . 2021. Accessed February 15, 2023. https://www.who.int/publications/i/item/9789240038387
• WHO. Social Determinants of Health . 2023. Accessed February 15, 2023. https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1
• McCrae JS, Robinson JAL, Spain AK, Byers K, Axelrod JL. The Mitigating Toxic Stress study design: approaches to developmental evaluation of pediatric health care innovations addressing social determinants of health and toxic stress. BMC Health Serv Res . 2021;21:71. doi:10.1186/s12913-021-06057-4
• Hosseinpoor AR, Stewart Williams J, Jann B, et al. Social determinants of sex differences in disability among older adults: a multi-country decomposition analysis using the World Health Survey. Int J  Equity   Health . 2012;11:52. doi:10.1186/1475-9276-11-52
• Kabore A, Afriyie-Gyawu E, Awua J, et al. Social ecological factors affecting substance abuse in Ghana (West Africa) using photovoice. Pan Afr Med J . 2019;34:214. doi:10.11604/pamj.2019.34.214.12851
• Bíró É, Vincze F, Mátyás G, Kósa K. Recursive path model for health literacy: the effect of social support and geographical residence. Front Public Health . 2021;9. doi:10.3389/fpubh.2021.724995
• Yuan B, Zhang T, Li J. Family support and transport cost: understanding health service among older people from the perspective of social-ecological model. Arch Public Health . 2022;80:173. doi:10.1186/s13690-022-00923-1
• Mahmoodi Z, Karimlou M, Sajjadi H, Dejman M, Vameghi M, Dolatian M. A communicative model of mothers’ lifestyles during pregnancy with low birth weight based on social determinants of health: a path analysis. Oman Med J . 2017 ;32(4):306-314. doi:10.5001/omj.2017.59
• Vella SA, Schweickle MJ, Sutcliffe J, Liddelow C, Swann C. A systems theory of mental health in recreational sport. Int J Environ Res Public Health . 2022;19(21):14244. doi:10.3390/ijerph192114244
• Henning S. The wellness of airline cabin attendants: A systems theory perspective. African Journal of Hospitality, Tourism and Leisure . 2015;4(1):1-11. Accessed February 15, 2023. http://www.ajhtl.com/archive.html
• Sutphin ST, McDonough S, Schrenkel A. The role of formal theory in social work research: formalizing family systems theory. Adv Soc Work . 2013;14(2):501-517. doi:10.18060/7942
• Colla R, Williams P, Oades LG, Camacho-Morles J. “A new hope” for positive psychology: a dynamic systems reconceptualization of hope theory. Front Psychol .  2022;13. doi:10.3389/fpsyg.2022.809053
• Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977;196(4286):129–136. doi:10.1126/science.847460
• Wade DT, HalliganPW. The biopsychosocial model of illness: a model whose time has come. Clin Rehabi l. 2017;31(8):995–1004. doi:10.1177/0269215517709890
• Ip L, Smith A, Papachristou I, Tolani E. 3 Dimensions for Long Term Conditions – creating a sustainable bio-psycho-social approach to healthcare.  J Integr Care . 2019;19(4):5. doi:10.5334/ijic.s3005
• FrameWorks Institute. A Matter of Life and Death: Explaining the Wider Determinants of Health in the UK . FrameWorks Institute; 2022. Accessed February 15, 2023. https://www.frameworksinstitute.org/wp-content/uploads/2022/03/FWI-30-uk-health-brief-v3a.pdf
• Zemed A, Nigussie Chala K, Azeze Eriku G, Yalew Aschalew A. Health-related quality of life and associated factors among patients with stroke at tertiary level hospitals in Ethiopia. PLOS ONE . 2021;16(3):e0248481. doi:10.1371/journal.pone.0248481
• Finch E, Foster M, Cruwys T, et al. Meeting unmet needs following minor stroke: the SUN randomised controlled trial protocol. BMC Health Serv Res . 2019;19:894. doi:10.1186/s12913-019-4746-1

Qualitative Research – a practical guide for health and social care researchers and practitioners Copyright © 2023 by Tess Tsindos is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License , except where otherwise noted.

Share This Book

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Int J Prev Med

Qualitative Methods in Health Care Research

Vishnu renjith.

School of Nursing and Midwifery, Royal College of Surgeons Ireland - Bahrain (RCSI Bahrain), Al Sayh Muharraq Governorate, Bahrain

Renjulal Yesodharan

1 Department of Mental Health Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Judith A. Noronha

2 Department of OBG Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Elissa Ladd

3 School of Nursing, MGH Institute of Health Professions, Boston, USA

Anice George

4 Department of Child Health Nursing, Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Healthcare research is a systematic inquiry intended to generate robust evidence about important issues in the fields of medicine and healthcare. Qualitative research has ample possibilities within the arena of healthcare research. This article aims to inform healthcare professionals regarding qualitative research, its significance, and applicability in the field of healthcare. A wide variety of phenomena that cannot be explained using the quantitative approach can be explored and conveyed using a qualitative method. The major types of qualitative research designs are narrative research, phenomenological research, grounded theory research, ethnographic research, historical research, and case study research. The greatest strength of the qualitative research approach lies in the richness and depth of the healthcare exploration and description it makes. In health research, these methods are considered as the most humanistic and person-centered way of discovering and uncovering thoughts and actions of human beings.

Introduction

Healthcare research is a systematic inquiry intended to generate trustworthy evidence about issues in the field of medicine and healthcare. The three principal approaches to health research are the quantitative, the qualitative, and the mixed methods approach. The quantitative research method uses data, which are measures of values and counts and are often described using statistical methods which in turn aids the researcher to draw inferences. Qualitative research incorporates the recording, interpreting, and analyzing of non-numeric data with an attempt to uncover the deeper meanings of human experiences and behaviors. Mixed methods research, the third methodological approach, involves collection and analysis of both qualitative and quantitative information with an objective to solve different but related questions, or at times the same questions.[ 1 , 2 ]

In healthcare, qualitative research is widely used to understand patterns of health behaviors, describe lived experiences, develop behavioral theories, explore healthcare needs, and design interventions.[ 1 , 2 , 3 ] Because of its ample applications in healthcare, there has been a tremendous increase in the number of health research studies undertaken using qualitative methodology.[ 4 , 5 ] This article discusses qualitative research methods, their significance, and applicability in the arena of healthcare.

Qualitative Research

Diverse academic and non-academic disciplines utilize qualitative research as a method of inquiry to understand human behavior and experiences.[ 6 , 7 ] According to Munhall, “Qualitative research involves broadly stated questions about human experiences and realities, studied through sustained contact with the individual in their natural environments and producing rich, descriptive data that will help us to understand those individual's experiences.”[ 8 ]

Significance of Qualitative Research

The qualitative method of inquiry examines the 'how' and 'why' of decision making, rather than the 'when,' 'what,' and 'where.'[ 7 ] Unlike quantitative methods, the objective of qualitative inquiry is to explore, narrate, and explain the phenomena and make sense of the complex reality. Health interventions, explanatory health models, and medical-social theories could be developed as an outcome of qualitative research.[ 9 ] Understanding the richness and complexity of human behavior is the crux of qualitative research.

Differences between Quantitative and Qualitative Research

The quantitative and qualitative forms of inquiry vary based on their underlying objectives. They are in no way opposed to each other; instead, these two methods are like two sides of a coin. The critical differences between quantitative and qualitative research are summarized in Table 1 .[ 1 , 10 , 11 ]

Differences between quantitative and qualitative research

Qualitative Research Questions and Purpose Statements

Qualitative questions are exploratory and are open-ended. A well-formulated study question forms the basis for developing a protocol, guides the selection of design, and data collection methods. Qualitative research questions generally involve two parts, a central question and related subquestions. The central question is directed towards the primary phenomenon under study, whereas the subquestions explore the subareas of focus. It is advised not to have more than five to seven subquestions. A commonly used framework for designing a qualitative research question is the 'PCO framework' wherein, P stands for the population under study, C stands for the context of exploration, and O stands for the outcome/s of interest.[ 12 ] The PCO framework guides researchers in crafting a focused study question.

Example: In the question, “What are the experiences of mothers on parenting children with Thalassemia?”, the population is “mothers of children with Thalassemia,” the context is “parenting children with Thalassemia,” and the outcome of interest is “experiences.”

The purpose statement specifies the broad focus of the study, identifies the approach, and provides direction for the overall goal of the study. The major components of a purpose statement include the central phenomenon under investigation, the study design and the population of interest. Qualitative research does not require a-priori hypothesis.[ 13 , 14 , 15 ]

Example: Borimnejad et al . undertook a qualitative research on the lived experiences of women suffering from vitiligo. The purpose of this study was, “to explore lived experiences of women suffering from vitiligo using a hermeneutic phenomenological approach.” [ 16 ]

Review of the Literature

In quantitative research, the researchers do an extensive review of scientific literature prior to the commencement of the study. However, in qualitative research, only a minimal literature search is conducted at the beginning of the study. This is to ensure that the researcher is not influenced by the existing understanding of the phenomenon under the study. The minimal literature review will help the researchers to avoid the conceptual pollution of the phenomenon being studied. Nonetheless, an extensive review of the literature is conducted after data collection and analysis.[ 15 ]

Reflexivity

Reflexivity refers to critical self-appraisal about one's own biases, values, preferences, and preconceptions about the phenomenon under investigation. Maintaining a reflexive diary/journal is a widely recognized way to foster reflexivity. According to Creswell, “Reflexivity increases the credibility of the study by enhancing more neutral interpretations.”[ 7 ]

Types of Qualitative Research Designs

The qualitative research approach encompasses a wide array of research designs. The words such as types, traditions, designs, strategies of inquiry, varieties, and methods are used interchangeably. The major types of qualitative research designs are narrative research, phenomenological research, grounded theory research, ethnographic research, historical research, and case study research.[ 1 , 7 , 10 ]

Narrative research

Narrative research focuses on exploring the life of an individual and is ideally suited to tell the stories of individual experiences.[ 17 ] The purpose of narrative research is to utilize 'story telling' as a method in communicating an individual's experience to a larger audience.[ 18 ] The roots of narrative inquiry extend to humanities including anthropology, literature, psychology, education, history, and sociology. Narrative research encompasses the study of individual experiences and learning the significance of those experiences. The data collection procedures include mainly interviews, field notes, letters, photographs, diaries, and documents collected from one or more individuals. Data analysis involves the analysis of the stories or experiences through “re-storying of stories” and developing themes usually in chronological order of events. Rolls and Payne argued that narrative research is a valuable approach in health care research, to gain deeper insight into patient's experiences.[ 19 ]

Example: Karlsson et al . undertook a narrative inquiry to “explore how people with Alzheimer's disease present their life story.” Data were collected from nine participants. They were asked to describe about their life experiences from childhood to adulthood, then to current life and their views about the future life. [ 20 ]

Phenomenological research

Phenomenology is a philosophical tradition developed by German philosopher Edmond Husserl. His student Martin Heidegger did further developments in this methodology. It defines the 'essence' of individual's experiences regarding a certain phenomenon.[ 1 ] The methodology has its origin from philosophy, psychology, and education. The purpose of qualitative research is to understand the people's everyday life experiences and reduce it into the central meaning or the 'essence of the experience'.[ 21 , 22 ] The unit of analysis of phenomenology is the individuals who have had similar experiences of the phenomenon. Interviews with individuals are mainly considered for the data collection, though, documents and observations are also useful. Data analysis includes identification of significant meaning elements, textural description (what was experienced), structural description (how was it experienced), and description of 'essence' of experience.[ 1 , 7 , 21 ] The phenomenological approach is further divided into descriptive and interpretive phenomenology. Descriptive phenomenology focuses on the understanding of the essence of experiences and is best suited in situations that need to describe the lived phenomenon. Hermeneutic phenomenology or Interpretive phenomenology moves beyond the description to uncover the meanings that are not explicitly evident. The researcher tries to interpret the phenomenon, based on their judgment rather than just describing it.[ 7 , 21 , 22 , 23 , 24 ]

Example: A phenomenological study conducted by Cornelio et al . aimed at describing the lived experiences of mothers in parenting children with leukemia. Data from ten mothers were collected using in-depth semi-structured interviews and were analyzed using Husserl's method of phenomenology. Themes such as “pivotal moment in life”, “the experience of being with a seriously ill child”, “having to keep distance with the relatives”, “overcoming the financial and social commitments”, “responding to challenges”, “experience of faith as being key to survival”, “health concerns of the present and future”, and “optimism” were derived. The researchers reported the essence of the study as “chronic illness such as leukemia in children results in a negative impact on the child and on the mother.” [ 25 ]

Grounded Theory Research

Grounded theory has its base in sociology and propagated by two sociologists, Barney Glaser, and Anselm Strauss.[ 26 ] The primary purpose of grounded theory is to discover or generate theory in the context of the social process being studied. The major difference between grounded theory and other approaches lies in its emphasis on theory generation and development. The name grounded theory comes from its ability to induce a theory grounded in the reality of study participants.[ 7 , 27 ] Data collection in grounded theory research involves recording interviews from many individuals until data saturation. Constant comparative analysis, theoretical sampling, theoretical coding, and theoretical saturation are unique features of grounded theory research.[ 26 , 27 , 28 ] Data analysis includes analyzing data through 'open coding,' 'axial coding,' and 'selective coding.'[ 1 , 7 ] Open coding is the first level of abstraction, and it refers to the creation of a broad initial range of categories, axial coding is the procedure of understanding connections between the open codes, whereas selective coding relates to the process of connecting the axial codes to formulate a theory.[ 1 , 7 ] Results of the grounded theory analysis are supplemented with a visual representation of major constructs usually in the form of flow charts or framework diagrams. Quotations from the participants are used in a supportive capacity to substantiate the findings. Strauss and Corbin highlights that “the value of the grounded theory lies not only in its ability to generate a theory but also to ground that theory in the data.”[ 27 ]

Example: Williams et al . conducted a grounded theory research to explore the nature of relationship between the sense of self and the eating disorders. Data were collected form 11 women with a lifetime history of Anorexia Nervosa and were analyzed using the grounded theory methodology. Analysis led to the development of a theoretical framework on the nature of the relationship between the self and Anorexia Nervosa. [ 29 ]

Ethnographic research

Ethnography has its base in anthropology, where the anthropologists used it for understanding the culture-specific knowledge and behaviors. In health sciences research, ethnography focuses on narrating and interpreting the health behaviors of a culture-sharing group. 'Culture-sharing group' in an ethnography represents any 'group of people who share common meanings, customs or experiences.' In health research, it could be a group of physicians working in rural care, a group of medical students, or it could be a group of patients who receive home-based rehabilitation. To understand the cultural patterns, researchers primarily observe the individuals or group of individuals for a prolonged period of time.[ 1 , 7 , 30 ] The scope of ethnography can be broad or narrow depending on the aim. The study of more general cultural groups is termed as macro-ethnography, whereas micro-ethnography focuses on more narrowly defined cultures. Ethnography is usually conducted in a single setting. Ethnographers collect data using a variety of methods such as observation, interviews, audio-video records, and document reviews. A written report includes a detailed description of the culture sharing group with emic and etic perspectives. When the researcher reports the views of the participants it is called emic perspectives and when the researcher reports his or her views about the culture, the term is called etic.[ 7 ]

Example: The aim of the ethnographic study by LeBaron et al . was to explore the barriers to opioid availability and cancer pain management in India. The researchers collected data from fifty-nine participants using in-depth semi-structured interviews, participant observation, and document review. The researchers identified significant barriers by open coding and thematic analysis of the formal interview. [ 31 ]

Historical research

Historical research is the “systematic collection, critical evaluation, and interpretation of historical evidence”.[ 1 ] The purpose of historical research is to gain insights from the past and involves interpreting past events in the light of the present. The data for historical research are usually collected from primary and secondary sources. The primary source mainly includes diaries, first hand information, and writings. The secondary sources are textbooks, newspapers, second or third-hand accounts of historical events and medical/legal documents. The data gathered from these various sources are synthesized and reported as biographical narratives or developmental perspectives in chronological order. The ideas are interpreted in terms of the historical context and significance. The written report describes 'what happened', 'how it happened', 'why it happened', and its significance and implications to current clinical practice.[ 1 , 10 ]

Example: Lubold (2019) analyzed the breastfeeding trends in three countries (Sweden, Ireland, and the United States) using a historical qualitative method. Through analysis of historical data, the researcher found that strong family policies, adherence to international recommendations and adoption of baby-friendly hospital initiative could greatly enhance the breastfeeding rates. [ 32 ]

Case study research

Case study research focuses on the description and in-depth analysis of the case(s) or issues illustrated by the case(s). The design has its origin from psychology, law, and medicine. Case studies are best suited for the understanding of case(s), thus reducing the unit of analysis into studying an event, a program, an activity or an illness. Observations, one to one interviews, artifacts, and documents are used for collecting the data, and the analysis is done through the description of the case. From this, themes and cross-case themes are derived. A written case study report includes a detailed description of one or more cases.[ 7 , 10 ]

Example: Perceptions of poststroke sexuality in a woman of childbearing age was explored using a qualitative case study approach by Beal and Millenbrunch. Semi structured interview was conducted with a 36- year mother of two children with a history of Acute ischemic stroke. The data were analyzed using an inductive approach. The authors concluded that “stroke during childbearing years may affect a woman's perception of herself as a sexual being and her ability to carry out gender roles”. [ 33 ]

Sampling in Qualitative Research

Qualitative researchers widely use non-probability sampling techniques such as purposive sampling, convenience sampling, quota sampling, snowball sampling, homogeneous sampling, maximum variation sampling, extreme (deviant) case sampling, typical case sampling, and intensity sampling. The selection of a sampling technique depends on the nature and needs of the study.[ 34 , 35 , 36 , 37 , 38 , 39 , 40 ] The four widely used sampling techniques are convenience sampling, purposive sampling, snowball sampling, and intensity sampling.

Convenience sampling

It is otherwise called accidental sampling, where the researchers collect data from the subjects who are selected based on accessibility, geographical proximity, ease, speed, and or low cost.[ 34 ] Convenience sampling offers a significant benefit of convenience but often accompanies the issues of sample representation.

Purposive sampling

Purposive or purposeful sampling is a widely used sampling technique.[ 35 ] It involves identifying a population based on already established sampling criteria and then selecting subjects who fulfill that criteria to increase the credibility. However, choosing information-rich cases is the key to determine the power and logic of purposive sampling in a qualitative study.[ 1 ]

Snowball sampling

The method is also known as 'chain referral sampling' or 'network sampling.' The sampling starts by having a few initial participants, and the researcher relies on these early participants to identify additional study participants. It is best adopted when the researcher wishes to study the stigmatized group, or in cases, where findings of participants are likely to be difficult by ordinary means. Respondent ridden sampling is an improvised version of snowball sampling used to find out the participant from a hard-to-find or hard-to-study population.[ 37 , 38 ]

Intensity sampling

The process of identifying information-rich cases that manifest the phenomenon of interest is referred to as intensity sampling. It requires prior information, and considerable judgment about the phenomenon of interest and the researcher should do some preliminary investigations to determine the nature of the variation. Intensity sampling will be done once the researcher identifies the variation across the cases (extreme, average and intense) and picks the intense cases from them.[ 40 ]

Deciding the Sample Size

A-priori sample size calculation is not undertaken in the case of qualitative research. Researchers collect the data from as many participants as possible until they reach the point of data saturation. Data saturation or the point of redundancy is the stage where the researcher no longer sees or hears any new information. Data saturation gives the idea that the researcher has captured all possible information about the phenomenon of interest. Since no further information is being uncovered as redundancy is achieved, at this point the data collection can be stopped. The objective here is to get an overall picture of the chronicle of the phenomenon under the study rather than generalization.[ 1 , 7 , 41 ]

Data Collection in Qualitative Research

The various strategies used for data collection in qualitative research includes in-depth interviews (individual or group), focus group discussions (FGDs), participant observation, narrative life history, document analysis, audio materials, videos or video footage, text analysis, and simple observation. Among all these, the three popular methods are the FGDs, one to one in-depth interviews and the participant observation.

FGDs are useful in eliciting data from a group of individuals. They are normally built around a specific topic and are considered as the best approach to gather data on an entire range of responses to a topic.[ 42 Group size in an FGD ranges from 6 to 12. Depending upon the nature of participants, FGDs could be homogeneous or heterogeneous.[ 1 , 14 ] One to one in-depth interviews are best suited to obtain individuals' life histories, lived experiences, perceptions, and views, particularly while exporting topics of sensitive nature. In-depth interviews can be structured, unstructured, or semi-structured. However, semi-structured interviews are widely used in qualitative research. Participant observations are suitable for gathering data regarding naturally occurring behaviors.[ 1 ]

Data Analysis in Qualitative Research

Various strategies are employed by researchers to analyze data in qualitative research. Data analytic strategies differ according to the type of inquiry. A general content analysis approach is described herewith. Data analysis begins by transcription of the interview data. The researcher carefully reads data and gets a sense of the whole. Once the researcher is familiarized with the data, the researcher strives to identify small meaning units called the 'codes.' The codes are then grouped based on their shared concepts to form the primary categories. Based on the relationship between the primary categories, they are then clustered into secondary categories. The next step involves the identification of themes and interpretation to make meaning out of data. In the results section of the manuscript, the researcher describes the key findings/themes that emerged. The themes can be supported by participants' quotes. The analytical framework used should be explained in sufficient detail, and the analytic framework must be well referenced. The study findings are usually represented in a schematic form for better conceptualization.[ 1 , 7 ] Even though the overall analytical process remains the same across different qualitative designs, each design such as phenomenology, ethnography, and grounded theory has design specific analytical procedures, the details of which are out of the scope of this article.

Computer-Assisted Qualitative Data Analysis Software (CAQDAS)

Until recently, qualitative analysis was done either manually or with the help of a spreadsheet application. Currently, there are various software programs available which aid researchers to manage qualitative data. CAQDAS is basically data management tools and cannot analyze the qualitative data as it lacks the ability to think, reflect, and conceptualize. Nonetheless, CAQDAS helps researchers to manage, shape, and make sense of unstructured information. Open Code, MAXQDA, NVivo, Atlas.ti, and Hyper Research are some of the widely used qualitative data analysis software.[ 14 , 43 ]

Reporting Guidelines

Consolidated Criteria for Reporting Qualitative Research (COREQ) is the widely used reporting guideline for qualitative research. This 32-item checklist assists researchers in reporting all the major aspects related to the study. The three major domains of COREQ are the 'research team and reflexivity', 'study design', and 'analysis and findings'.[ 44 , 45 ]

Critical Appraisal of Qualitative Research

Various scales are available to critical appraisal of qualitative research. The widely used one is the Critical Appraisal Skills Program (CASP) Qualitative Checklist developed by CASP network, UK. This 10-item checklist evaluates the quality of the study under areas such as aims, methodology, research design, ethical considerations, data collection, data analysis, and findings.[ 46 ]

Ethical Issues in Qualitative Research

A qualitative study must be undertaken by grounding it in the principles of bioethics such as beneficence, non-maleficence, autonomy, and justice. Protecting the participants is of utmost importance, and the greatest care has to be taken while collecting data from a vulnerable research population. The researcher must respect individuals, families, and communities and must make sure that the participants are not identifiable by their quotations that the researchers include when publishing the data. Consent for audio/video recordings must be obtained. Approval to be in FGDs must be obtained from the participants. Researchers must ensure the confidentiality and anonymity of the transcripts/audio-video records/photographs/other data collected as a part of the study. The researchers must confirm their role as advocates and proceed in the best interest of all participants.[ 42 , 47 , 48 ]

Rigor in Qualitative Research

The demonstration of rigor or quality in the conduct of the study is essential for every research method. However, the criteria used to evaluate the rigor of quantitative studies are not be appropriate for qualitative methods. Lincoln and Guba (1985) first outlined the criteria for evaluating the qualitative research often referred to as “standards of trustworthiness of qualitative research”.[ 49 ] The four components of the criteria are credibility, transferability, dependability, and confirmability.

Credibility refers to confidence in the 'truth value' of the data and its interpretation. It is used to establish that the findings are true, credible and believable. Credibility is similar to the internal validity in quantitative research.[ 1 , 50 , 51 ] The second criterion to establish the trustworthiness of the qualitative research is transferability, Transferability refers to the degree to which the qualitative results are applicability to other settings, population or contexts. This is analogous to the external validity in quantitative research.[ 1 , 50 , 51 ] Lincoln and Guba recommend authors provide enough details so that the users will be able to evaluate the applicability of data in other contexts.[ 49 ] The criterion of dependability refers to the assumption of repeatability or replicability of the study findings and is similar to that of reliability in quantitative research. The dependability question is 'Whether the study findings be repeated of the study is replicated with the same (similar) cohort of participants, data coders, and context?'[ 1 , 50 , 51 ] Confirmability, the fourth criteria is analogous to the objectivity of the study and refers the degree to which the study findings could be confirmed or corroborated by others. To ensure confirmability the data should directly reflect the participants' experiences and not the bias, motivations, or imaginations of the inquirer.[ 1 , 50 , 51 ] Qualitative researchers should ensure that the study is conducted with enough rigor and should report the measures undertaken to enhance the trustworthiness of the study.

Conclusions

Qualitative research studies are being widely acknowledged and recognized in health care practice. This overview illustrates various qualitative methods and shows how these methods can be used to generate evidence that informs clinical practice. Qualitative research helps to understand the patterns of health behaviors, describe illness experiences, design health interventions, and develop healthcare theories. The ultimate strength of the qualitative research approach lies in the richness of the data and the descriptions and depth of exploration it makes. Hence, qualitative methods are considered as the most humanistic and person-centered way of discovering and uncovering thoughts and actions of human beings.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

• Privacy Policy

Home » Qualitative Research – Methods, Analysis Types and Guide

Qualitative Research – Methods, Analysis Types and Guide

Table of Contents

Qualitative Research

Qualitative research is a type of research methodology that focuses on exploring and understanding people’s beliefs, attitudes, behaviors, and experiences through the collection and analysis of non-numerical data. It seeks to answer research questions through the examination of subjective data, such as interviews, focus groups, observations, and textual analysis.

Qualitative research aims to uncover the meaning and significance of social phenomena, and it typically involves a more flexible and iterative approach to data collection and analysis compared to quantitative research. Qualitative research is often used in fields such as sociology, anthropology, psychology, and education.

Qualitative Research Methods

Qualitative Research Methods are as follows:

One-to-One Interview

This method involves conducting an interview with a single participant to gain a detailed understanding of their experiences, attitudes, and beliefs. One-to-one interviews can be conducted in-person, over the phone, or through video conferencing. The interviewer typically uses open-ended questions to encourage the participant to share their thoughts and feelings. One-to-one interviews are useful for gaining detailed insights into individual experiences.

Focus Groups

This method involves bringing together a group of people to discuss a specific topic in a structured setting. The focus group is led by a moderator who guides the discussion and encourages participants to share their thoughts and opinions. Focus groups are useful for generating ideas and insights, exploring social norms and attitudes, and understanding group dynamics.

Ethnographic Studies

This method involves immersing oneself in a culture or community to gain a deep understanding of its norms, beliefs, and practices. Ethnographic studies typically involve long-term fieldwork and observation, as well as interviews and document analysis. Ethnographic studies are useful for understanding the cultural context of social phenomena and for gaining a holistic understanding of complex social processes.

Text Analysis

This method involves analyzing written or spoken language to identify patterns and themes. Text analysis can be quantitative or qualitative. Qualitative text analysis involves close reading and interpretation of texts to identify recurring themes, concepts, and patterns. Text analysis is useful for understanding media messages, public discourse, and cultural trends.

This method involves an in-depth examination of a single person, group, or event to gain an understanding of complex phenomena. Case studies typically involve a combination of data collection methods, such as interviews, observations, and document analysis, to provide a comprehensive understanding of the case. Case studies are useful for exploring unique or rare cases, and for generating hypotheses for further research.

Process of Observation

This method involves systematically observing and recording behaviors and interactions in natural settings. The observer may take notes, use audio or video recordings, or use other methods to document what they see. Process of observation is useful for understanding social interactions, cultural practices, and the context in which behaviors occur.

Record Keeping

This method involves keeping detailed records of observations, interviews, and other data collected during the research process. Record keeping is essential for ensuring the accuracy and reliability of the data, and for providing a basis for analysis and interpretation.

This method involves collecting data from a large sample of participants through a structured questionnaire. Surveys can be conducted in person, over the phone, through mail, or online. Surveys are useful for collecting data on attitudes, beliefs, and behaviors, and for identifying patterns and trends in a population.

Qualitative data analysis is a process of turning unstructured data into meaningful insights. It involves extracting and organizing information from sources like interviews, focus groups, and surveys. The goal is to understand people’s attitudes, behaviors, and motivations

Qualitative Research Analysis Methods

Qualitative Research analysis methods involve a systematic approach to interpreting and making sense of the data collected in qualitative research. Here are some common qualitative data analysis methods:

Thematic Analysis

This method involves identifying patterns or themes in the data that are relevant to the research question. The researcher reviews the data, identifies keywords or phrases, and groups them into categories or themes. Thematic analysis is useful for identifying patterns across multiple data sources and for generating new insights into the research topic.

Content Analysis

This method involves analyzing the content of written or spoken language to identify key themes or concepts. Content analysis can be quantitative or qualitative. Qualitative content analysis involves close reading and interpretation of texts to identify recurring themes, concepts, and patterns. Content analysis is useful for identifying patterns in media messages, public discourse, and cultural trends.

Discourse Analysis

This method involves analyzing language to understand how it constructs meaning and shapes social interactions. Discourse analysis can involve a variety of methods, such as conversation analysis, critical discourse analysis, and narrative analysis. Discourse analysis is useful for understanding how language shapes social interactions, cultural norms, and power relationships.

Grounded Theory Analysis

This method involves developing a theory or explanation based on the data collected. Grounded theory analysis starts with the data and uses an iterative process of coding and analysis to identify patterns and themes in the data. The theory or explanation that emerges is grounded in the data, rather than preconceived hypotheses. Grounded theory analysis is useful for understanding complex social phenomena and for generating new theoretical insights.

Narrative Analysis

This method involves analyzing the stories or narratives that participants share to gain insights into their experiences, attitudes, and beliefs. Narrative analysis can involve a variety of methods, such as structural analysis, thematic analysis, and discourse analysis. Narrative analysis is useful for understanding how individuals construct their identities, make sense of their experiences, and communicate their values and beliefs.

Phenomenological Analysis

This method involves analyzing how individuals make sense of their experiences and the meanings they attach to them. Phenomenological analysis typically involves in-depth interviews with participants to explore their experiences in detail. Phenomenological analysis is useful for understanding subjective experiences and for developing a rich understanding of human consciousness.

Comparative Analysis

This method involves comparing and contrasting data across different cases or groups to identify similarities and differences. Comparative analysis can be used to identify patterns or themes that are common across multiple cases, as well as to identify unique or distinctive features of individual cases. Comparative analysis is useful for understanding how social phenomena vary across different contexts and groups.

Applications of Qualitative Research

Qualitative research has many applications across different fields and industries. Here are some examples of how qualitative research is used:

• Market Research: Qualitative research is often used in market research to understand consumer attitudes, behaviors, and preferences. Researchers conduct focus groups and one-on-one interviews with consumers to gather insights into their experiences and perceptions of products and services.
• Health Care: Qualitative research is used in health care to explore patient experiences and perspectives on health and illness. Researchers conduct in-depth interviews with patients and their families to gather information on their experiences with different health care providers and treatments.
• Education: Qualitative research is used in education to understand student experiences and to develop effective teaching strategies. Researchers conduct classroom observations and interviews with students and teachers to gather insights into classroom dynamics and instructional practices.
• Social Work : Qualitative research is used in social work to explore social problems and to develop interventions to address them. Researchers conduct in-depth interviews with individuals and families to understand their experiences with poverty, discrimination, and other social problems.
• Anthropology : Qualitative research is used in anthropology to understand different cultures and societies. Researchers conduct ethnographic studies and observe and interview members of different cultural groups to gain insights into their beliefs, practices, and social structures.
• Psychology : Qualitative research is used in psychology to understand human behavior and mental processes. Researchers conduct in-depth interviews with individuals to explore their thoughts, feelings, and experiences.
• Public Policy : Qualitative research is used in public policy to explore public attitudes and to inform policy decisions. Researchers conduct focus groups and one-on-one interviews with members of the public to gather insights into their perspectives on different policy issues.

How to Conduct Qualitative Research

Here are some general steps for conducting qualitative research:

• Identify your research question: Qualitative research starts with a research question or set of questions that you want to explore. This question should be focused and specific, but also broad enough to allow for exploration and discovery.
• Select your research design: There are different types of qualitative research designs, including ethnography, case study, grounded theory, and phenomenology. You should select a design that aligns with your research question and that will allow you to gather the data you need to answer your research question.
• Recruit participants: Once you have your research question and design, you need to recruit participants. The number of participants you need will depend on your research design and the scope of your research. You can recruit participants through advertisements, social media, or through personal networks.
• Collect data: There are different methods for collecting qualitative data, including interviews, focus groups, observation, and document analysis. You should select the method or methods that align with your research design and that will allow you to gather the data you need to answer your research question.
• Analyze data: Once you have collected your data, you need to analyze it. This involves reviewing your data, identifying patterns and themes, and developing codes to organize your data. You can use different software programs to help you analyze your data, or you can do it manually.
• Interpret data: Once you have analyzed your data, you need to interpret it. This involves making sense of the patterns and themes you have identified, and developing insights and conclusions that answer your research question. You should be guided by your research question and use your data to support your conclusions.
• Communicate results: Once you have interpreted your data, you need to communicate your results. This can be done through academic papers, presentations, or reports. You should be clear and concise in your communication, and use examples and quotes from your data to support your findings.

Examples of Qualitative Research

Here are some real-time examples of qualitative research:

• Customer Feedback: A company may conduct qualitative research to understand the feedback and experiences of its customers. This may involve conducting focus groups or one-on-one interviews with customers to gather insights into their attitudes, behaviors, and preferences.
• Healthcare : A healthcare provider may conduct qualitative research to explore patient experiences and perspectives on health and illness. This may involve conducting in-depth interviews with patients and their families to gather information on their experiences with different health care providers and treatments.
• Education : An educational institution may conduct qualitative research to understand student experiences and to develop effective teaching strategies. This may involve conducting classroom observations and interviews with students and teachers to gather insights into classroom dynamics and instructional practices.
• Social Work: A social worker may conduct qualitative research to explore social problems and to develop interventions to address them. This may involve conducting in-depth interviews with individuals and families to understand their experiences with poverty, discrimination, and other social problems.
• Anthropology : An anthropologist may conduct qualitative research to understand different cultures and societies. This may involve conducting ethnographic studies and observing and interviewing members of different cultural groups to gain insights into their beliefs, practices, and social structures.
• Psychology : A psychologist may conduct qualitative research to understand human behavior and mental processes. This may involve conducting in-depth interviews with individuals to explore their thoughts, feelings, and experiences.
• Public Policy: A government agency or non-profit organization may conduct qualitative research to explore public attitudes and to inform policy decisions. This may involve conducting focus groups and one-on-one interviews with members of the public to gather insights into their perspectives on different policy issues.

Purpose of Qualitative Research

The purpose of qualitative research is to explore and understand the subjective experiences, behaviors, and perspectives of individuals or groups in a particular context. Unlike quantitative research, which focuses on numerical data and statistical analysis, qualitative research aims to provide in-depth, descriptive information that can help researchers develop insights and theories about complex social phenomena.

Qualitative research can serve multiple purposes, including:

• Exploring new or emerging phenomena : Qualitative research can be useful for exploring new or emerging phenomena, such as new technologies or social trends. This type of research can help researchers develop a deeper understanding of these phenomena and identify potential areas for further study.
• Understanding complex social phenomena : Qualitative research can be useful for exploring complex social phenomena, such as cultural beliefs, social norms, or political processes. This type of research can help researchers develop a more nuanced understanding of these phenomena and identify factors that may influence them.
• Generating new theories or hypotheses: Qualitative research can be useful for generating new theories or hypotheses about social phenomena. By gathering rich, detailed data about individuals’ experiences and perspectives, researchers can develop insights that may challenge existing theories or lead to new lines of inquiry.
• Providing context for quantitative data: Qualitative research can be useful for providing context for quantitative data. By gathering qualitative data alongside quantitative data, researchers can develop a more complete understanding of complex social phenomena and identify potential explanations for quantitative findings.

When to use Qualitative Research

Here are some situations where qualitative research may be appropriate:

• Exploring a new area: If little is known about a particular topic, qualitative research can help to identify key issues, generate hypotheses, and develop new theories.
• Understanding complex phenomena: Qualitative research can be used to investigate complex social, cultural, or organizational phenomena that are difficult to measure quantitatively.
• Investigating subjective experiences: Qualitative research is particularly useful for investigating the subjective experiences of individuals or groups, such as their attitudes, beliefs, values, or emotions.
• Conducting formative research: Qualitative research can be used in the early stages of a research project to develop research questions, identify potential research participants, and refine research methods.
• Evaluating interventions or programs: Qualitative research can be used to evaluate the effectiveness of interventions or programs by collecting data on participants’ experiences, attitudes, and behaviors.

Characteristics of Qualitative Research

Qualitative research is characterized by several key features, including:

• Focus on subjective experience: Qualitative research is concerned with understanding the subjective experiences, beliefs, and perspectives of individuals or groups in a particular context. Researchers aim to explore the meanings that people attach to their experiences and to understand the social and cultural factors that shape these meanings.
• Use of open-ended questions: Qualitative research relies on open-ended questions that allow participants to provide detailed, in-depth responses. Researchers seek to elicit rich, descriptive data that can provide insights into participants’ experiences and perspectives.
• Sampling-based on purpose and diversity: Qualitative research often involves purposive sampling, in which participants are selected based on specific criteria related to the research question. Researchers may also seek to include participants with diverse experiences and perspectives to capture a range of viewpoints.
• Data collection through multiple methods: Qualitative research typically involves the use of multiple data collection methods, such as in-depth interviews, focus groups, and observation. This allows researchers to gather rich, detailed data from multiple sources, which can provide a more complete picture of participants’ experiences and perspectives.
• Inductive data analysis: Qualitative research relies on inductive data analysis, in which researchers develop theories and insights based on the data rather than testing pre-existing hypotheses. Researchers use coding and thematic analysis to identify patterns and themes in the data and to develop theories and explanations based on these patterns.
• Emphasis on researcher reflexivity: Qualitative research recognizes the importance of the researcher’s role in shaping the research process and outcomes. Researchers are encouraged to reflect on their own biases and assumptions and to be transparent about their role in the research process.

Advantages of Qualitative Research

Qualitative research offers several advantages over other research methods, including:

• Depth and detail: Qualitative research allows researchers to gather rich, detailed data that provides a deeper understanding of complex social phenomena. Through in-depth interviews, focus groups, and observation, researchers can gather detailed information about participants’ experiences and perspectives that may be missed by other research methods.
• Flexibility : Qualitative research is a flexible approach that allows researchers to adapt their methods to the research question and context. Researchers can adjust their research methods in real-time to gather more information or explore unexpected findings.
• Contextual understanding: Qualitative research is well-suited to exploring the social and cultural context in which individuals or groups are situated. Researchers can gather information about cultural norms, social structures, and historical events that may influence participants’ experiences and perspectives.
• Participant perspective : Qualitative research prioritizes the perspective of participants, allowing researchers to explore subjective experiences and understand the meanings that participants attach to their experiences.
• Theory development: Qualitative research can contribute to the development of new theories and insights about complex social phenomena. By gathering rich, detailed data and using inductive data analysis, researchers can develop new theories and explanations that may challenge existing understandings.
• Validity : Qualitative research can offer high validity by using multiple data collection methods, purposive and diverse sampling, and researcher reflexivity. This can help ensure that findings are credible and trustworthy.

Limitations of Qualitative Research

Qualitative research also has some limitations, including:

• Subjectivity : Qualitative research relies on the subjective interpretation of researchers, which can introduce bias into the research process. The researcher’s perspective, beliefs, and experiences can influence the way data is collected, analyzed, and interpreted.
• Limited generalizability: Qualitative research typically involves small, purposive samples that may not be representative of larger populations. This limits the generalizability of findings to other contexts or populations.
• Time-consuming: Qualitative research can be a time-consuming process, requiring significant resources for data collection, analysis, and interpretation.
• Resource-intensive: Qualitative research may require more resources than other research methods, including specialized training for researchers, specialized software for data analysis, and transcription services.
• Limited reliability: Qualitative research may be less reliable than quantitative research, as it relies on the subjective interpretation of researchers. This can make it difficult to replicate findings or compare results across different studies.
• Ethics and confidentiality: Qualitative research involves collecting sensitive information from participants, which raises ethical concerns about confidentiality and informed consent. Researchers must take care to protect the privacy and confidentiality of participants and obtain informed consent.

Also see Research Methods

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

You may also like

Questionnaire – Definition, Types, and Examples

Case Study – Methods, Examples and Guide

Observational Research – Methods and Guide

Quantitative Research – Methods, Types and...

Qualitative Research Methods

Explanatory Research – Types, Methods, Guide

Home > HCAS > HCAS_PUBS > HCAS_JOURNALS > TQR Home > TQR > Vol. 26 > No. 6 (2021)

Using Framework Analysis in Applied Qualitative Research

Laurie J. Goldsmith , GoldQual Consulting and Simon Fraser University Follow

Framework analysis and applied qualitative research can be a perfect match, in large part because framework analysis was developed for the explicit purpose of analyzing qualitative data in applied policy research. Framework analysis is an inherently comparative form of thematic analysis which employs an organized structure of inductively- and deductively-derived themes (i.e., a framework) to conduct cross-sectional analysis using a combination of data description and abstraction. The overall objective of framework analysis is to identify, describe, and interpret key patterns within and across cases of and themes within the phenomenon of interest. This flexible and powerful method of analysis has been applied to a variety of data types and used in a range of ways in applied research. Framework analysis consists of two major components: creating an analytic framework and applying this analytic framework. This paper details the five steps in framework analysis (data familiarization, framework identification, indexing, charting, and mapping and interpretation) through conducting secondary analysis on this special issue’s common dataset. This worked example adds to the existing framework analysis methodology literature both through describing the analysis specifics and through highlighting the importance of multiple considerations of units of analysis. This paper also includes reflection on the myriad reasons that framework analysis is valuable for applied research.

analytic framework, applied qualitative research, framework analysis

Author Bio(s)

Laurie J. Goldsmith, PhD, is the Founder and Principal of GoldQual Consulting, a qualitative and mixed methods health services research company, and an Adjunct Professor in Simon Fraser University’s Faculty of Health Sciences. Her research interests include access to health care and documenting and advancing the use of research methods. Please direct correspondence to [email protected].

Publication Date

Creative commons license.

10.46743/2160-3715/2021.5011

Recommended APA Citation

Goldsmith, L. J. (2021). Using Framework Analysis in Applied Qualitative Research. The Qualitative Report , 26 (6), 2061-2076. https://doi.org/10.46743/2160-3715/2021.5011

Since June 22, 2021

Included in

Quantitative, Qualitative, Comparative, and Historical Methodologies Commons , Social Statistics Commons

https://doi.org/10.46743/2160-3715/2021.5011

To view the content in your browser, please download Adobe Reader or, alternately, you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.

• The Qualitative Report
• About This Journal
• Aims & Scope
• Editorial Board
• Open Access

TQR Publications

• The Qualitative Report Conference
• TQR Weekly Newsletter
• Submit Article
• Most Popular Papers
• Receive Email Notices or RSS

Special Issues:

• Volume 25 - Issue 13 - 4th World Conference on Qualitative Research Special Issue
• World Conference on Qualitative Research Special Issue
• Reflecting on the Future of QDA Software
• Volume 22, Number 13: Asian Qualitative Research Association Special Issue - December 2017

Advanced Search

Print ISSN: 1052-0147

E-ISSN: 2160-3715

Follow TQR on:

Submission Locations

• View submissions on map
• View submissions in Google Earth

Home | About | FAQ | My Account | Accessibility Statement

Privacy Copyright

• Open access
• Published: 16 May 2024

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

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

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

1 Altmetric

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.

O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. BMJ Open. 2013;3(6):e002889.

Article   PubMed   PubMed Central   Google Scholar  

O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Goode J, Hewison J. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study – a mixed methods study. Health Technol Assess. 2014;18(38):1–197.

Clement C, Edwards SL, Rapport F, Russell IT, Hutchings HA. Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review. Trials. 2018;19(1):589.

Hennessy M, Hunter A, Healy P, Galvin S, Houghton C. Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study. Trials. 2018;19:584.

Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350(mar19 6):h1258.

Bonell C, Fletcher A, Morton M, Lorenc T, Moore L. Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Soc Sci Med. 2012;75(12):2299–306.

Article   PubMed   Google Scholar  

O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.

Cooper C, O’Cathain A, Hind D, Adamson J, Lawton J, Baird W. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls. Contemp Clin Trials. 2014;38(2):338–43.

Rapport F, Storey M, Porter A, Snooks H, Jones K, Peconi J, et al. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit. Trials. 2013;14:54.

Cardiff University. Centre for Trials Research. Available from: https://www.cardiff.ac.uk/centre-for-trials-research . Accessed 10 May 2024.

Pell B, Williams D, Phillips R, Sanders J, Edwards A, Choy E, et al. Using visual timelines in telephone interviews: reflections and lessons learned from the star family study. Int J Qual Methods. 2020;19:160940692091367.

Thomas-Jones E, Lloyd A, Roland D, Sefton G, Tume L, Hood K, et al. A prospective, mixed-methods, before and after study to identify the evidence base for the core components of an effective Paediatric Early Warning System and the development of an implementation package containing those core recommendations for use in th. BMC Pediatr. 2018;18:244.

May C, Finch T, Mair F, Ballini L, Dowrick C, Eccles M, et al. Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res. 2007;7:148.

May C, Finch T. Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology. 2009;43(3):535–54.

Article   Google Scholar  

May CR, Mair F, Finch T, Macfarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009;4:29.

Ogrinc G, Davies L, Goodman D, Batalden PB, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality and Safety. 2016;25:986-92.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.

Jamal F, Fletcher A, Shackleton N, Elbourne D, Viner R, Bonell C. The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example. Trials. 2015;16(1):466.

Download references

Acknowledgements

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

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

Author information

Authors and affiliations.

Centre for Trials Research, DECIPHer Centre, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK

Jeremy Segrott

Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK

Sue Channon, Eleni Glarou, Jacqueline Hughes, Nina Jacob, Sarah Milosevic, Yvonne Moriarty, Mike Robling, Heather Strange, Julia Townson & Lucy Brookes-Howell

Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK

Eleni Glarou

Wales Centre for Public Policy, Cardiff University, Sbarc I Spark, Maindy Road, Cardiff, CF24 4HQ, UK

School of Social Sciences, Cardiff University, King Edward VII Avenue, Cardiff, CF10 3WA, UK

Josie Henley

DECIPHer Centre, School of Social Sciences, Cardiff University, Sbarc I Spark, Maindy Road, Cardiff, CF24 4HQ, UK

Bethan Pell

You can also search for this author in PubMed   Google Scholar

Qualitative Research Group

• , D. Gillespie
• , J. Latchem-Hastings
• , R. Milton
• , V. Shepherd
• , K. Smallman
•  & H. Stanton

Contributions

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

Corresponding author

Correspondence to Jeremy Segrott .

Ethics declarations

Ethics approval and consent to participate.

Ethical approval was not sought as no personal or identifiable data was collected.

Consent for publication

Competing interests.

All authors are or were members of staff or students in the Centre for Trials Research. JS is an associate editor of Trials .

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Supplementary material 1., rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

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

Download citation

Received : 20 October 2023

Accepted : 17 April 2024

Published : 16 May 2024

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

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Qualitative research
• Qualitative methods
• Trials units
• Normalisation Process Theory
• Randomised controlled trials

ISSN: 1745-6215

• Submission enquiries: Access here and click Contact Us
• General enquiries: [email protected]

• Open access
• Published: 13 May 2024

“ We might not have been in hospital, but we were frontline workers in the community ”: a qualitative study exploring unmet need and local community-based responses for marginalised groups in Greater Manchester during the COVID-19 pandemic

• Stephanie Gillibrand 1 ,
• Ruth Watkinson 2 ,
• Melissa Surgey 2 ,
• Basma Issa 3 &
• Caroline Sanders 2 , 4  

BMC Health Services Research volume  24 , Article number:  621 ( 2024 ) Cite this article

60 Accesses

2 Altmetric

Metrics details

The response to the COVID-19 pandemic saw a significant increase in demand for the voluntary, community, faith and social enterprise (VCFSE) sector to provide support to local communities. In Greater Manchester (GM), the VCFSE sector and informal networks provided health and wellbeing support in multiple ways, culminating in its crucial supportive role in the provision of the COVID-19 vaccination rollout across the GM city region. However, the support provided by the VCFSE sector during the pandemic remains under-recognised. The aims of the study were to: understand the views and experiences of marginalised communities in GM during the COVID-19 pandemic; explore how community engagement initiatives played a role during the pandemic and vaccine rollout; assess what can be learnt from the work of key stakeholders (community members, VCFSEs, health-system stakeholders) for future health research and service delivery.

The co-designed study utilised a participatory approach throughout and was co-produced with a Community Research Advisory Group (CRAG). Focus groups and semi-structured interviews were conducted remotely between September-November 2021, with 35 participants from local marginalised communities, health and care system stakeholders and VCFSE representatives. Thematic framework analysis was used to analyse the data.

Local communities in GM were not supported sufficiently by mainstream services during the course of the COVID-19 pandemic, resulting in increased pressure onto the VCFSE sector to respond to local communities’ need. Community-based approaches were deemed crucial to the success of the vaccination drive and in providing support to local communities more generally during the pandemic, whereby such approaches were in a unique position to reach members of diverse communities to boost uptake of the vaccine. Despite this, the support delivered by the VCFSE sector remains under-recognised and under-valued by the health system and decision-makers.

Conclusions

A number of challenges associated with collaborative working were experienced by the VSCE sector and health system in delivering the vaccination programme in partnership with the VCFSE sector. There is a need to create a broader, more inclusive health system which allows and promotes inter-sectoral working. Flexibility and adaptability in ongoing and future service delivery should be championed for greater cross-sector working.

Peer Review reports

The response to the COVID-19 pandemic saw a significant increase in demand for the voluntary, community, faith and social enterprise (VCFSE) sector to provide support to local communities [ 1 , 2 ]. The role of communities was seen as crucial to supporting the pandemic response, to better mobilise public health pandemic responses and supportive health services [ 3 ]. VCFSE organisations nationally had to quickly mobilise to adapt their service offer to meet increased demand, new gaps in service provision and deliver services in different ways to address the challenges faced by local communities. These included loss of income and financial hardship, closure of schools and childcare, increased social isolation, digital exclusion, and increased mental health issues [ 4 ]. However, previous research has concluded that support provided by the voluntary sector during the pandemic has been under-recognised [ 5 ]. Some authors have explored the role that VCFSEs played at the national level, in supporting communities during the pandemic [ 4 , 5 , 6 ]. Yet, whilst it is well-known that tens of thousands of UK volunteers supported local vaccine delivery [ 7 ], no existing academic literature has explored the role of VCFSEs in supporting the vaccination rollout.

We focus on Greater Manchester (GM), where increased support from VCFSE organisations, including smaller, community-based networks, responded to increased demand from local communities and the NHS to provide key health and wellbeing-related services, including food and care packages for clinically vulnerable households, food bank services, support for people experiencing homelessness, mental health and domestic violence services and support to local community organisations [ 8 ]. This support culminated in the sector’s supportive role in the delivery of the COVID-19 vaccination rollout, in response to the need for mass immunisation across the region.

Over the last decade, the English health and care system has been evolving to integrate health and social care. A key focus is building closer working relationships between the NHS, local authorities and other providers– including the VCFSE sector– to deliver joined up care for communities [ 9 , 10 ]. To aid integration, a new model for organising health and care on different geographical footprints has been developed: Integrated Care Systems (ICSs), place-based partnerships and neighbourhood models. These collaborative partnerships bring together existing health and care organisations to coordinate health and care planning and delivery in a more integrated way and include councils, NHS provider trusts, Primary Care Networks, GP federations and health and care commissioners [ 11 ]. These new geographically-based partnerships have an emphasis on collaborative working beyond traditional health and care partners. This includes acknowledging the role that VCFSE organisations can have in supporting wider population wellbeing, particularly as part of multi-disciplinary neighbourhood teams embedded in local communities [ 12 ]. National guidance on the development of ICSs and place-based partnerships strongly encourages health and care leaders to include VCFSE organisations in partnership arrangements and embed them into service delivery [ 12 ]. In GM, the partnership working approach pre-dates the formal mandating of ICSs, with a combined authority which brings together the ten local authorities and an association of Clinical Commissioning Groups (CCGs) which represented health commissioners, and a VCFSE umbrella group which also operates as a joint venture to represent the sector’s interests at a GM level Footnote 1 . However, reorganisation to the ICS system may present new local challenges for the VCFSE sector to find a meaningful ‘seat at the table’. That withstanding, the COVID-19 pandemic coincided with the development of ICSs and place-based partnerships as arguably one of the earliest and most intense tests of partnership working across health and care organisations within the current policy landscape.

Here, we present findings from a co-designed qualitative research project, drawing on insights from 35 participants, including members of diverse communities in GM, VCFSE participants, and key decision-making health and care system stakeholders. The aims of the study were to: understand the views and experiences of marginalised communities in GM during the COVID-19 pandemic; explore how community engagement initiatives played a role during the pandemic and vaccine rollout; assess what can be learnt from the work of key stakeholders (including community members, VCFSEs, health and care system stakeholders) for future health research and service delivery. The rationale for the study developed from a related piece of work assessing inequalities in the COVID-19 vaccine uptake in GM [ 13 ]. At that time, there was little research on the experiences of under-served communities during the pandemic. As such, the public and stakeholder engagement for the related project identified a need for a qualitative workstream to explore more fully the drivers behind and context surrounding the vaccination programme in GM, centring also local communities’ experiences during the pandemic (explored in a related paper [ 14 ]).

In this paper, we examine the role the VCFSE sector played in supporting unmet needs for marginalised groups in GM during the COVID-19 pandemic and as part of the rapid rollout of the COVID-19 vaccination programme. We consider the opportunities and barriers that may influence the full integration of the VCFSE sector into health and care services in the future. This paper provides additional evidence around the role of local community-led support in the context of identified unmet needs from marginalised local communities. Whilst focused on GM, it provides an exemplar of the role of VCFSEs and community networks during the pandemic, with relevant learning for other regions and international settings with place-based partnerships.

Study design

The study utilised a participatory approach throughout and was co-designed and co-produced with a diverse Community Research Advisory Group (CRAG). The CRAG were members of local community groups who were disproportionately impacted by the COVID-19 pandemic, including one member who is a co-author on this paper. This included members of three VCFSE organisations working with specific ethnic minority communities including Caribbean and African, South Asian and Syrian communities.

CRAG members acted as champions for the research, supporting design of appropriate information and fostering connections for recruitment via their existing community networks. The strong partnerships built through our approach were crucial to enabling a sense of trust and legitimacy for the research amongst underserved communities invited to participate.

Interviews and focus groups took place between September-November 2021 and sought to explore: the context surrounding the rollout of the vaccination programme; key aspects of support delivered as part of the vaccination programme; the use of localised approaches to support vaccine delivery including engagement initiatives, as well as broader community-level responses to the COVID-19 pandemic; perceptions around barriers to vaccine uptake Footnote 2 ; experiences of local communities (including healthcare) during the pandemic Footnote 3 . During the data collection period, national pandemic restrictions were largely lifted with no restrictions on social distancing or limits to gatherings, and all public venues reopened. A self-isolation period of 10 days after a positive COVID-19 test remained a legal requirement, but self-isolation after contact with a positive case was not required if fully vaccinated [ 15 ]. By July 2021, every UK adult had been offered their first dose of the COVID-19 vaccine, with every adult offered both doses by mid-September 2021 [ 16 ]. By early September 2021, more than 92 million doses had been administered in the UK [ 15 ].

Interviews and focus groups were conducted by one member of the research team (SG) and were conducted remotely due to the pandemic, via Zoom and telephone calls. The limitations of undertaking remote qualitative research interviews are acknowledged in academic literature, including potential restrictions to expressing compassion and assessing the participant’s environment [ 17 , 18 ]. However, given the remaining prevalence of COVID-19 at the time of interview, it was judged that the ensuing risk posed by COVID-19 to both researchers and participants outweighed the potential drawbacks. Nevertheless, participants were offered face-to-face options if they were unable to participate remotely to maximise inclusion (although no participants chose to participate face-to-face).

Interviews and focus groups were audio recorded with an encrypted recorder and transcribed by a professional transcription service. Informed written consent to participate was taken prior to the interviews and focus groups. The average length of the interviews was 34 min and average length of the focus groups was 99 min. Two focus groups were co-facilitated by a CRAG member, a member of the local community who works for a mental health charity that supports local South Asian communities, who also provided translation support. In respect to authors positionality, coauthors SG, RW, MS and CS are university researchers in academic roles and had prior links to the CRAG members via a wider community forum (co-ordinated by the NIHR funded Applied Research Collaboration for Greater Manchester). The wider group met regularly to discuss and share learning regarding community experiences, community action and related research during the pandemic. BI is a member of the CRAG and a member of a local Syrian community.

Sampling & recruitment

The sampling strategy for community participants centred around groups that had been disproportionately affected by the COVID-19 pandemic in England, including ethnic minority groups, young adults, and those with long-term physical and mental health conditions. VCFSE participants included community and religious leaders, members of local community VCFSE organisations and smaller, informal community networks and groups from local communities. Health and care system stakeholders included local council workers and health and care system stakeholders (e.g. those organising the vaccination response in CCGs and GP Federations). Characteristics of the sample are provided in Table  1 . Overall, the study achieved a diverse sample of participants on the basis of gender and ethnicity.

A combination of purposive and snowballing sampling was used to recruit via pre-established links and connections to community networks and stakeholders to ensure the inclusion of specific seldom-heard groups. For example, members of African and Caribbean communities were recruited via a charity which supports the health of these groups, and members of South Asian communities were recruited via a mental health charity.

Quotes are described by respondent type (community member, VCFSE participant, health and care system stakeholder) and participant identifier number to maintain anonymity whilst providing important contextual detail.

Data analysis

We analysed the data using an adapted framework approach [ 19 ]. We adopted a framework approach to analysis as this is viewed as a helpful method when working within large multidisciplinary teams or when not all members of the team have experience of qualitative data analysis, as was the case within our team. This structured thematic approach is also considered valuable when handling large volumes of data [ 20 , 21 ] and was found to be a helpful way to present, discuss and refine the themes within the research team and CRAG meetings. We created an initial list of themes from coding four transcripts, and discussions with CRAG members: personal or family experiences/stories; work/education experiences; racism and racialised experiences; trust and mistrust; fear and anxiety; value of community/community approaches; access to services including healthcare; operational and logistical factors around vaccine rollout; communication and (mis)information. We used this set of themes and sub themes to code the remaining transcripts, including further inductively generated codes as analysis progressed, regularly discussing within the team.

We shared transcript coding amongst the study team, with one team member responsible for collating coded transcripts into a charting framework of themes/subthemes with illustrative transcript extracts. The themes were refined throughout the analysis period (November 2021-March 2022) with the research team and CRAG and were sense-checked with CRAG members and the wider study team, to synthesise a final iteration of the themes and sub-themes (see supplementary material). We present findings related to five overarching themes: (1) unmet needs of local communities during the pandemic: inaccessible care and distrust; (2) community-led approaches: social support and leadership to support services; (3) community led support to COVID-19 vaccination delivery; (4) operational and logistical barriers to community-based pandemic responses: challenges faced by the voluntary and community sector; (5) learning from the pandemic response in GM: trust building and harnessing community assets. Themes are discussed in more detail below.

Ethical approval

This study was approved by University of Manchester Ethics Committee (Proportionate University Research Ethics Committee) 24/06/21. Ref 2021-11646-19665.

Unmet needs of local communities during the pandemic: inaccessible care and distrust

The COVID-19 pandemic brought an unprecedented shift in the way NHS services could function due to social distancing and lockdown measures. Pressures included unprecedented demand on hospital capacity and infection control measures (within hospitals and across the NHS) which reduced workforce capacity. There were also staff shortages due to high levels of COVID-19 infection amongst NHS staff, and shortages in non-acute capacity due to staff re-deployment [ 22 , 23 ]. In an effort to reduce pressure on the NHS, the policy mantra “Protect the NHS” was coined as a keynote slogan from the early stages of the pandemic [ 24 ].

It is within this context that many community participants raised (spontaneously) that there was a general inability to access health services during the pandemic, including GP and specialist services.

when I tried to contact my doctor’s surgery I was on the call for over an hour, number 20, number 15. Then by the time I’m under ten I get cut off. And it happened continuously. I just couldn’t get through and I just gave up really…now it’s like a phone consultation before you can even go and see someone, and even for that you’re waiting two, three weeks. (1029, VCFSE participant)

This resulted in frustration amongst some community participants, who questioned the logic of “protecting the NHS”, seemingly at the expense of their health-related needs. This led to sentiments that other health needs were de-prioritised by decision-makers during the pandemic. It was felt that this logic was counter-productive and fell short of the principles of protecting the most vulnerable.

We were like it just didn’t matter, it could have been much more serious than just a cough or a cold, [] but the help was just not there” (1028, community participant). what about people who actually need to see a doctor so the very vulnerable ones that we’re supposed to be protecting. Yes, we’re protecting the NHS, I understand that, I said, but we’ve also got to protect all those vulnerable people that are out there that are actually isolated (1011, community participant).

Community participants described their fear of accessing healthcare service because of potential risks of catching the virus in these settings, and fear of insufficient care due to well-publicised pressures in NHS settings. Some VCFSE participants noted that the widely publicised pressures faced by the NHS, and heightened media and political attention around COVID-19 cases in health settings led to fear and anxiety Footnote 4 .

I didn’t go to the hospital because I was scared shitless whether I was going to come out alive from hospital.” (1023, community participant). …the number of people who didn’t access services when they should have done… They were either terrified they were going to go into hospital and catch COVID straightaway and die, or they were terrified that they were taking [the hospital space] away from someone else (2003, VCFSE participant).

Overall, this led to a strong sense that mainstream services were not supporting the needs of local communities. This was especially felt for those requiring specialist services (e.g. mental health or secondary services), and for those who had faced intersecting inequalities, such as health issues, language and digital/IT barriers, and newly settled refugees and immigrants.

Community-led approaches: social support and leadership to support services

As a consequence of this unmet need, VCFSE and community participants identified that local communities themselves increased activities to provide community support. Participants felt strongly that this increased support provided by the VCFSE sector and community networks remains under-recognised and under-valued by the health system and wider public.

BAME organisations were going around door to door, giving hand sanitisers, giving masks to everybody [ ]. And it was the BAME community that was the most active during COVID delivering medication, delivering food to houses, doing the shopping. [ ] Nobody gave credit to that. Nobody talks about the good work that the BAME community has done. (1020, community participant)

A number of community and VCFSE sector participants highlighted the work done at the community level, by either themselves or other networks to support local communities. This included providing support packages, running errands for vulnerable community members, cooking and food shopping services, a helpline and communication networks for local communities, and online wellbeing and support groups.

We might not have been in hospital, but we were frontline workers in the community. (1028, community participant)

Support was provided by formal VCFSE organisations and by smaller, sometimes informal, community networks and channels, in which support mechanisms included mental health support and wellbeing focused communications to combat loneliness and boost wellbeing. This was often focused around outreach and the provision of community-based support to the most marginalised and vulnerable groups that had been disproportionately impacted during the pandemic, e.g. recently settled refugees and asylum seekers, older individuals.

We have an Iranian group in Salford…And one of them spotted this young woman in the queue and she thought she looked Iranian, you know….anyway she started a conversation, and this person had been an asylum seeker at the beginning of the pandemic and had been in a detention centre during the pandemic. And then, finally got their leave to remain and then were just basically dumped in Salford. [ ] just having that friendly face and someone was trying to start that conversation, she was able to be linked into this group of women who support other refugees and asylum seekers from the Middle East. (2014, VCFSE participant)

Community led support to COVID-19 vaccination delivery

The VCFSE sector and community networks also played a crucial part in supporting the COVID-19 vaccine delivery. Community, VCFSE and system-sector participants recognised the unique role that the VCFSE sector had played in reaching diverse communities and sections of communities not reached by the mainstream vaccination programme. For example, VCFSE groups aided vaccine delivery by helping run vaccine ‘pop-up’ sites in community spaces including mosques and other religious sites, children’s centres, and local specialist charities (e.g.: refugee and sex worker charities).

The use of community ‘champions’ and community ‘connectors’ to convey messaging around the vaccination drive were deemed especially vital in this regard. Trusted members of communities (e.g. community leaders) who had crucial pre-existing communication channels were able to effectively interact with different parts of communities to advocate for the vaccine and address misinformation. Situated within communities themselves, these ‘champions’ held established trust within communities, allowing conversations surrounding the vaccine to be held on the basis of shared experiences, honesty, openness, compassion and understanding.

So, as with any ethnic minority community, unless you’re part of it, it’s almost impossible to completely dig out all its norms and its very, very fine distinctions…[ ] what is acceptable, what is not acceptable[ ]? Unless you’re part of it, or you’ve really immersed yourself in the culture for decades, it’s almost impossible to get it (2015, VCFSE participant) One of the strongest approaches that you can take to increase uptake in any community, whether it be pregnant women or a faith group or a geographical area or a cultural group, is that if you’ve got a representative from that community leading on and advocating for the vaccine, you’re going to have the best impact (2011, health and care system stakeholder participant). unless Imams or significant people in the community were coming out for them and saying, it’s absolutely fine, it’s safe, and culturally it’s the right thing to do, there was a bit of uncertainty there (2010, health and care system stakeholder participant).

Health and care system stakeholders also emphasised the importance of “community ownership” of vaccination approaches, and of system responsiveness to identified needs and priorities at the community level. Health and care system stakeholders recognised that they were able to utilise community links to have better on-the-ground knowledge, provided in real time, to supplement locally held data to inform targeted efforts to boost uptake. This included council led initiatives including door-knocking with council staff, local health improvement practitioners, and VCFSE representatives working together to provide information about vaccine clinics and register people for vaccine appointments.

if messages went out and they didn’t land right they [the VCFSE sector] could be the first people [that] would hear about that and they could feed that back to us. [ ]….we were able to regularly go to them and say, look from a geographical perspective we can see these key areas…[ ] the people aren’t coming for vaccinations, [ ] what more can you tell us. Or, we can say, from these ethnicities in this area we’re not getting the numbers, what more can you tell us. And when we’ve fed them that intelligence then they could then use that to go and gain further insight for us, so they were a kind of, key mechanism (2010, health and care system participant).

Operational and logistical barriers to community-based pandemic responses: challenges faced by the voluntary and community sector

VCFSE sector and health and care system stakeholder participants reported significant logistical barriers to partnership working to support communities during the pandemic. Barriers included red tape and bureaucracy, which delayed responses to communities’ health and wellbeing needs.

whilst we were buying masks and hand sanitisers and going door to door, [ ] the council were still getting their paperwork in order, their policies in order, it was meeting after meeting. It took them seven to eight weeks for them to say [ ] we’ve got masks, would you like to help dish them out. (1029, VCFSE participant)

VCFSE and health and care system participants also raised challenges with respect to the VCFSE sector supporting the vaccination programme. This resulted in frustration amongst both VCFSE and health and care system participants who recognised the value of these community-based approaches.

The time that trickles through to the council and the time that the council turn around and say all right, we’ll actually let you do it was weeks later, and the community is turning round to us and saying to us well, what’s going on? We don’t like being messed around like this… (2008, VCFSE participant).

Participants highlighted the numerous health-related bodies with various roles which comprise a complex system for VCFSE partners to navigate, in part due to organisational and cultural clashes. Frustration was felt by both VCFSE and health and care system stakeholder participants (from local councils) in this respect. One VCFSE participant discussing the vaccine rollout noted:

We hit dead end after dead end within the council and there was literally very little response….You’ve got so many departments within this massive organisation called the council…[ ].it’s very difficult to navigate all that and deal with all that bureaucracy… (2008, VCFSE participant).

Broader institutional and organisational barriers to VCFSE support were identified, where cultural clashes between differing values and ways of working emerged, including ethos surrounding risk aversion and the system-level commitment to privilege value-for-money during the vaccination rollout. More practical issues around information governance and training were also raised as barriers to collaborative working.

I don’t think that they understand the power of community and the way community works. I don’t think that at a governmental level they understand what it means to penetrate into a community and actually understand what needs to be done to help a community…[ ] If they did and they had better links and ties into understanding that and helping that then we likely wouldn’t have had so many hurdles to get through (2008, VCFSE participant). ….in terms of public money, this is a public programme, we need to get value for the public pound. So we’re saying to [VCFSE organisation], how much is it going to cost? And [VCFSE organisation] are like, well, we don’t really know, until we deliver it. And we’re like, well, we can’t really approve it, until we know what it’s going to cost…. (2006, health and care system stakeholder participant)

Overall, these issues surmounted to difficulties of power-sharing between public sector organisations and VCFSEs during a time of rapid response to a public health crisis, political, institutional, and other external pressures. This was echoed amongst VCFSE and health and care system stakeholder participants, where frustration towards this was felt from both sides.

the public sector [ ] need to get better at letting go of some of the control. So even still, after I said, so many times, [VCFSE organisation] are delivering this, [VCFSE organisation] are doing everything, [ ] I still got the comms team going, are we doing a leaflet? No, [VCFSE organisation] are doing it, this is a [VCFSE organisation] programme, this isn’t a Council programme. (2006, local authority participant) it is difficult sometimes working with organisations, I find myself very much stuck in the middle sometimes [ ] I engage with [community groups] and ask them how best we do it and then we put things in place that they’ve asked for, and then they’ve told us it’s not working why have you done it like that. [ ] I think it’s acknowledgement to do it right, it takes time, and it takes effort, it takes resource. (2010, local authority participant)

Health and care system stakeholders also highlighted the importance of accessibility and localised vaccination hubs to reach different parts of diverse local communities e.g. sites in local mosques and sites near local supermarkets to reach different demographics. For instance, having mobile vaccination sites to reduce accessibility barriers, alongside dialogue-based initiatives to answer questions and respond to concerns from local communities about the vaccine, with the view to building trust without explicit pressure to receive the vaccine. Describing their efforts to engage with a member of the local community over the vaccine, two local health and care system stakeholders detailed the following example of how localised, communication-based approaches were deemed successful:

She came to the clinic and there were a lot of tears. It was very emotional. She’d been through a very difficult journey and had got pregnant by IVF, so it was a big decision for her, a big risk that she thought she was taking. Whether she took the vaccine or not, it felt like a risk to her, [ ] we were able to sit down and talk to her. We had some peers there. So we had other pregnant women there who’d had the vaccine, that were able to give her some confidence. We had the specialist multicultural midwife there, [ ] And we literally just sat and drank coffee with her and let her talk and she ended up agreeing to have the vaccine [ ] (2011, system-level stakeholder). …And the feedback from that lady was amazing. A couple of weeks ago I contacted her to make sure she was going to come down for her booster and she was just so grateful. [ ] she’d had backlash from her family and people within her community for taking up the vaccine and they still thought it was a massive risk. But she had no doubts that she’d done absolutely the right thing… (2012, system-level stakeholder).

Learning from the pandemic response in GM: trust building and harnessing community assets

Taking these findings from health and care system stakeholders, community and VCFSE participants, several learning points were identified.

In terms of vaccine delivery, some health and care system stakeholder participants reflected the need for more joined-up ways of working, across existing services and amongst VCFSE partners, to ensure efficiency and maximise uptake by embedding the vaccination programmes into other health services. For example, offering vaccination through health visiting or health checks, or offering COVID-19 vaccine boosters and flu vaccinations in single visits at care homes. These settings could also provide opportunities for dialogue with local communities where there is pushback against vaccination. Another health and care system stakeholder identified the need for greater joined up delivery of services; utilising the VCFSE sector to deliver multiple services simultaneously, including the vaccine, to improve vaccine uptake and access to other healthcare services:

the sex worker clinic is a good example of that. [ ] People were coming in for another reason, to get their health check and to get their support from the advisors there at that voluntary organisation, [ ]…if there’s a multiple purpose at the site, for people to attend, you can start to engage them in the conversation and then take the opportunity and vaccinate them. So I’m really interested in looking at that a little bit more, about how that can help to increase uptake. (2011, health and care system stakeholder participant)

A VCFSE participant suggested using educational settings such as schools as a channel to disseminate public health and vaccine-related information, as trusted settings which have wide-reach to many different communities.

A number of health and care system stakeholders, VCFSE and community participants noted that long-term, continuous, meaningful engagement is crucial to build longer-term trust between institutions and communities, and to improve the efficacy of public health measures. It was felt that more concentrated efforts were required from the NHS and other statutory organisations to reach the most marginalised and minoritised communities, for example through door-knocking and welfare calls. Participants highlighted that this was required not solely at times of public health crises, but as part of continued engagement efforts, in order to adequately engage with the most marginalised groups and effectively build long-term trust. This may be done most effectively by building on existing links to marginalised communities, for example using education liaison staff to understand traveller communities’ perspectives on the vaccine.

proactive engagement with communities both locally and nationally to say, [the health system] are looking at this, what’s people’s thoughts, views, you know, is there any issues with this, what more can we do, what do you need to know to make an informed decision. This is what we were thinking of, how would this land…I think we could learn by, [ ] doing that insight work, spending more time working with communities at a kind of, national, regional, and local level (2010, health and care system stakeholder participant). [the health system] could have engaged better with communities, I think bringing them in at the beginning. So, having them sat around the table, representatives from different groups, understanding how to engage with them from the very beginning…I think they could have used the data very very early on to inform who were engaging. We didn’t quite get it right at the beginning, we didn’t link the public health data teams with the comms and engagement teams (2013, health and care system stakeholder participant).

The tone of communications was also seen to be important. One health and care system stakeholder participant noted that the strategy of pushing communications and public health messaging aimed at behavioural change did not achieve the desired effect as these did not engage effectively with the communities to alleviate or address key concerns about the vaccine. These were deemed less successful than starting from a place of understanding and openness to generate constructive dialogue which could foster trust and respect.

There was also more specific learning identified in terms of collaboration between public sector institutions, VCFSEs and community links, with this seen as vital to build strong, long-term relationships between sectors based on trust and mutual respect. This should also involve working to share knowledge between sectors in real-time.

Health and care system stakeholder and VCFSE participants both suggested a failure to further develop partnerships fostered during the pandemic would be a lost opportunity that could potentially create distrust and additional barriers between communities, VCFSEs and public organisations, perhaps further marginalising seldom-heard groups.

we need to find ways which we have ongoing engagement, and I think it needs to be more informal. People don’t want to be just constantly asked and asked and asked (2010, health and care system stakeholder participant). a network of just sharing information and insight, rather than just engaging when you’ve got something specific to engage about. (2010, health and care system stakeholder participant) We were then thinking to ourselves, well, maybe we shouldn’t be doing this. If it’s going to cause us damage, if the council can’t work with us properly maybe we just shouldn’t do it. We’ve got to weigh up. We don’t want to lose our trust within the community (2008, VCFSE participant).

In terms of dynamics and working arrangements between sectors, participants thought it important to allow community organisations and VCFSEs to lead on their areas of speciality, e.g.: community organisations leading on outreach and communications within and to communities. This relates to the identified need of pursuing adaptable and flexible approaches to vaccine delivery. Moreover, there is a need to allow more joined-up decision-making between the health system and VCFSEs to ensure better use of local intelligence and improved planning.

Discussion & policy implications

Unmet need and the role of communities during the pandemic.

Our findings clearly demonstrate that local communities were not supported sufficiently by mainstream services during the COVID-19 pandemic. This in turn led to frustration, fear and loss of faith in the healthcare system as a whole, evidenced also in responses to the COVID-19 vaccination programme in which distrust results from wider experiences of historical marginalisation and structural inequalities [ 14 ]. In the absence of mainstream service support, our findings demonstrate how VCFSE organisations and community networks mobilised to support local communities to fulfil unmet health, social care, and wellbeing needs. This supports emerging evidence from across England which finds that the VCFSE sector played a key role in supporting communities during the pandemic [ 6 , 8 , 25 ].

The importance of community-based, localised approaches, community-led and community owned initiatives, ‘community champions’ and community connectors’ were also highlighted as crucial to the success of the COVID-19 vaccination drive. Participants noted that community-led approaches were uniquely positioned to reach some communities when mainstream approaches were unsuccessful. This is echoed in existing literature, where the role of localised community responses was deemed important to reach marginalised groups, as part of the wider pandemic response [ 26 ].

Operational and logistical barriers

Operational and logistical barriers created dissonance between communities and the system. These barriers included difficulties with decision-making and power-sharing between VCFSE and commissioning or clinical organisations, organisational cultural clashes, red-tape and bureaucracy, and complex systems and power structures to navigate. This builds on existing evidence of barriers to partnership working during the pandemic, including cultural clashes and bureaucracy/red tape [ 5 , 27 ]. The VCFSE sector also suffered from the closure of services, and reduced funding and resources due to increased demand for services and needing to adapt service provision [ 8 ].

These factors hindered collaborative working and created risk for VCFSEs, including putting tension on relationships with local communities resulting from delays implementing services. In most VCFSE-health system partnerships, participants noted that power is generally held by the health system partner, but reputational risk and additional resource-based costs lie with VCFSE partners. Supporting capacity building and workforce resource within the voluntary sector will strengthen this [ 28 ].

Inadequate processes to establish collaborative working enhance distrust between the health system and VCFSE sector, which in turn enhances difficulties for collaborative working. Trust is an important factor in how the system interacts with VCFSEs, with a lack of trust leading to further bottlenecks in VCFSE activities [ 29 ]. Alongside this, is the need for greater health system appreciation for the VCFSE sector, with VSCE partners reporting they faced greater scrutiny and more arduous administrative processes than private sector partners [ 2 , 29 ].

Learning from the pandemic: service prioritisation

All sectors of the health and care system face pressures from resource shortages, internal and external targets [ 30 , 31 ]. This is often linked to drives to increase the value-for-money of services, but key questions remain as to how to assimilate the goals of achieving health equity within value-for-money objectives [ 32 ]. To this end, prioritising value-for-money may come at odds with reducing health inequities. For example, during the rollout of the vaccination programme, additional resources and innovative approaches were required to reach marginalised communities [ 33 , 34 ]. This is supported by emerging evidence from England and internationally that efforts to drive vaccination uptake and reduce inequities in uptake amongst marginalised populations require significant resources and a breadth of approaches to maximise uptake [ 34 ]. Our findings suggest that changes in vaccine uptake were smaller and slower to be realised in these populations, resulting in a “slow burn” in terms of demonstrating quantifiable outcomes. Given the NHS principles of equity [ 10 , 35 ], reaching these groups should remain a public health priority, and failure to prioritise these groups may incur greater long-term financial costs resulting from greater health service needs. Our findings support that challenging entrenched attitudes and frameworks for how success is measured and adapting structures to better incentivise targeted interventions for marginalised or high-risk groups is essential to prioritising addressing unmet needs amongst marginalised communities.

The changing commissioning landscape

The development of ICSs and place-based partnerships has changed how health and care services are commissioned. National guidance encourages health and care leaders to include VCFSE organisations in partnership arrangements and embed them into service delivery [ 12 ], with ‘alliance models’ between ICSs and the VCFSE sector [ 36 ] established in certain regions (see for example [ 37 ]. However, this rests on “a partnership of the willing” [ 37 ] between ICS partners and VCFSE sector players, and concrete guidance for achieving collaborative working in practice, is lacking. As the findings in this paper point to, evolving decision-making processes may add to resource burdens for VCFSE organisations. Traditional health and care partners such as the NHS and local authorities should consider how their ways of working may need to change to foster full VCFSE inclusion on an equal standing, otherwise only the VCFSE stakeholders with sufficient capacity and resource may be able to be meaningfully involved.

Creating a VCFSE-accessible health and care system

In terms of fostering relationships between different sectors, participants acknowledged that pre-pandemic efforts to engage communities and community networks and VCFSEs were insufficient, with more meaningful, well-resourced engagement required going forward. It was also identified by participants the importance of avoiding tokenistic involvement of the VCFSE sector, which may be counter-productive for developing meaningful long-term partnerships. More equal relationships between statutory and VCFSE sectors are needed to foster improved collaborative working [ 5 , 38 ], and this is identified already at the GM level [ 28 ]. Central to this is actioned principles of co-design, including power-sharing, community ownership and trust. In order for co-design strategies to be successful, recognition of the role of the VCFSE sector and their ownership of approaches must be championed within co-design strategies and the enactment of co-designed activities.

Relatedly, greater trust of the VCFSE sector to deliver services effectively and efficiently is needed from health and social care decision-makers to ensure that funding compliance measures and processes are proportionate and not overly burdensome, to avoid funding bottlenecks which in turn impact service delivery [ 2 ]. Currently at the national level, VCFSE applicants typically only become aware of funding through existing networks, leaving less-connected organisations to find out ‘by chance’, thereby limiting reach amongst other organisations [ 2 ]. This may be especially true for smaller or ad-hoc VCFSE networks and groups. Our findings support that bottlenecks to applying for funding should be removed, and more streamlined processes for accessing funding championed [ 2 ].

Our findings also suggest that health systems should engage with the full breadth of the VCFSE sector, creating space for the involvement of smaller scale and less formal organisations as partners. Sharing of best practice and advice for adapting to local contexts should be promoted, alongside evaluation of collaborative models.

Finally, the pandemic period saw unprecedented state-sponsored investment into the VCFSE sector [ 29 ]. Within the GM context, this funding enabled VCFSEs to develop organisational capacity and systems, develop new partnerships, and better respond to the (unmet) needs of local communities [ 39 ]. Currently there are no clear plans to maintain this investment, but sustained inter-sector partnership working will require continued investment in the VCFSE sector.

Strengths & limitations

There are two main limitations to this study. Firstly, whilst the study achieved diversity in its sample, we could not achieve representation across all marginalised communities and therefore could not cover the experiences of all marginalised communities in-depth. As such, whilst the analyses provides valuable insights, such insights may not be transferrable and do not reflect all communities in GM. Secondly, whilst other studies focused on multiple city-regions or areas, our study is limited to the city region of GM. However, this focus provides an in-depth analysis on one region, and, as we discuss in the framing of the paper, we contend that the analysis presented in this paper serves as an exemplar to explore further at the national and international level. It should also be noted that co-design approaches are inevitably time and resource-heavy, and this was challenging in the context of this study, as local stakeholders wanted timely insights to inform the vaccination programme. However, one of the key strengths of our participatory approach was that this enabled a direct connection with the experiences of communities as relevant to the research, in order to shape the research questions, as well as the design and conduct of the study.

Overall, the contribution of the VCFSE sector during the pandemic is clear, with significant support provided in respect to community health and wellbeing and vaccination delivery. Nevertheless, there remains much to learn from the pandemic period, with the potential to harness capacity to tackle inequalities and build trust through shared learning and greater collaborative working. Maintaining an environment in which VCFSE partners are under-recognised, under-valued, and seemingly face further bureaucratic barriers will only exacerbate issues to collaborative working. There are also significant questions around systemic issues and sustainability, which must be addressed to overcome existing barriers to collaborative working between sectors. For instance, our findings identify the importance of flexibility and adaptability, in ongoing and future service delivery. Where this is not pursued this may not only impact service delivery but also create roadblocks to collaboration between sectors, creating divisions between entities whilst ultimately trying to effect change on similar goals (i.e. improved population health). ICS–VCFSE Alliances and community connectors may be a mechanism to promote this, but clear, actionable guidance will be required to translate rhetoric to real-world progress.

Data availability

Data for this research data will not be made publicly available as individual privacy could be compromised. Please contact Stephanie Gillibrand ([email protected]) for further information.

10 GM is an umbrella group which seeks to represent the VCSE sector in GM. More information is available here: https://10gm.org.uk/ .

These themes are explored in a related paper by Gillibrand et al. [ 14 ].

Topic guides are provided as supplementary material.

Distrust was also raised in relation to fear and anxiety in NHS settings, and this is discussed in detail in a related paper from this study by Gillibrand et al. [ 14 ].

Abbreviations

Clinical Commissioning Groups

Community Research Advisory Group

Greater Manchester

Integrated Care Systems

Voluntary, Community and Social Enterprise

Craston MRB. Susan Mackay, Daniel Cameron, Rebecca Writer-Davies, Dylan Spielman. Impact Evaluation of the Coronavirus Community Support Fund. 2021.

NatCen Social Research. Evaluation of VCSE COVID-19 Emergency Funding Package. Department for Digital, Culture, Media & Sport (DCMS); 2022. 27 April 2022.

Marston CRA, Miles S. Community participation is crucial in a pandemic. Lancet. 2020;395(10238):1676–8.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Frost S, Rippon S, Gamsu M, Southby K, Bharadwa M, Chapman J. Space to Connect Keeping in Touch sessions: A summary write up (unpublished). Leeds: Leeds Beckett University; 2021 2021.

Pilkington G, Southby K, Gamsu M, Bagnall AM, Bharadwa M, Chapman J, Freeman C. Through different eyes: How different stakeholders have understood the contribution of the voluntary sector to connecting and supporting people in the pandemic.; 2021.

Dayson CaW A. Capacity through crisis: The role and contribution of the VCSE Sector in Sheffield during the COVID-19 pandemic; 2021.

Timmins B. The COVID-19 vaccination programme: trials, tribulations and successes. The Kings Fund; 2022.

Howarth M, Martin P, Hepburn P, Sheriff G, Witkam R. A Realist evaluation of the state of the Greater Manchester Voluntary, Community and Social Enterprise Sector 2021. GMCVO/University of Salford; 2021.

NHS England. Five Year Forward View. Leeds. 2014 October 2014.

NHS England. The NHS Long Term Plan. NHS England. 2019 January 2019.

Surgey M. With great power: Taking responsibility for integrated care. 2022.

NHS England. Integrating care: next steps to building strong and effective integrated care systems across England. Leeds: NHS England; 2020.

Google Scholar  

RE W. Ethnic inequalities in COVID-19 vaccine uptake and comparison to seasonal influenza vaccine uptake in Greater Manchester, UK: a cohort study. PLoS Med. 2022;19(3).

Gillibrand S, Kapadia D, Watkinson R, Issa B, Kwaku-Odoi C, Sanders C. Marginalisation and distrust in the context of the COVID-19 vaccination programme: experiences of communities in a northern UK city region. BMC Public Health. 2024;24(1):853.

Article   PubMed   PubMed Central   Google Scholar  

Cabinet Office. COVID-19 response: autumn and Winter Plan 2021. Guidance: GOV.UK; 2021.

Department of Health and Social Care. Every adult in UK offered COVID-19 vaccine [press release]. GOV.UK, 19 July 2021 2021.

Irani E. The Use of Videoconferencing for qualitative interviewing: opportunities, challenges, and considerations. Clin Nurs Res. 2019;28(1):3–8.

Article   PubMed   Google Scholar  

Seitz S. Pixilated partnerships, overcoming obstacles in qualitative interviews via Skype: a research note. Qualitative Res. 2016;16(2):229–35.

Article   Google Scholar  

Gale NK. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):1–8.

Castleberry A, Nolen A. Thematic analysis of qualitative research data: is it as easy as it sounds? Curr Pharm Teach Learn. 2018;10(6):807–15.

Braun V, Clarke V. Thematic analysis. APA handbook of research methods in psychology, Vol 2: Research designs: Quantitative, qualitative, neuropsychological, and biological2012. pp. 57–71.

Burn S, Propper C, Stoye G, Warner M, Aylin P, Bottle A. What happened to English NHS hospital activity during the COVID-19 pandemic? Brief Note IFS; 2021 13th May 2021.

NHS. COVID-19: Deploying our people safely. 2020 [updated 30th April 2020. https://www.england.nhs.uk/coronavirus/documents/COVID-19-deploying-our-people-safely/ .

Department of Health and Social Care. New TV advert urges public to stay at home to protect the NHS and save lives. [press release]. Department of Health and Social Care, 21st. January 2021 2021.

McCabe A, Wilson M, Macmillian R. Stronger than anyone thought: communities responding to COVID-19. Local Trust. Sheffieldn Hallam University. TSRC.; 2020.

McCabe A, Afridi A, Langdale E. Community responses to COVID-19: connecting communities? How relationships have mattered in community responses to COVID-19 Local Trust. TSRC, Sheffield Hallam University; 2022. January 2022.

Carpenter J. Exploring lessons from Covid-19 for the role of the voluntary sector in Integrated Care Systems. July 2021. Oxford Brookes University; 2021.

Greater Manchester Combined Authority. GM VCSE Accord Agreement. 2021 [ https://www.greatermanchester-ca.gov.uk/media/5207/gm-vcse-accord-2021-2026-final-signed-october-2021-for-publication.pdf .

Department for Digital, Culture, Media & Sport. Financial support for voluntary, community and social enterprise (VCSE) organisations to respond to coronavirus (COVID-19).: Department for Digital, Culture, Media & Sport and Office for Civil Society. 2020 [updated 20th may 2020. https://www.gov.uk/guidance/financial-support-for-voluntary-community-and-social-enterprise-vcse-organisations-to-respond-to-coronavirus-COVID-19 .

Smee C. Improving value for money in the United Kingdom National Health Service: performance measurement and improvement in a centralised system. Measuring Up: Improving Health Systems Performance in OECD Countries; 2002.

McCann L, Granter E, Hassard J, Hyde P. You can’t do both—something will give: limitations of the targets culture in managing UK health care workforces. Hum Resour Manag. 2015;54(5):773–91.

Smith P. Measuring value for money in healthcare: concepts and tools. London: Centre for Health Economics, University of York. The Health Foundation; 2009 September 2009.

Ekezie W, Awwad S, Krauchenberg A, Karara N, Dembiński Ł, Grossman Z, et al. Access to Vaccination among Disadvantaged, isolated and difficult-to-Reach communities in the WHO European Region: a systematic review. Vaccines. 2022;10(7):1038.

British Academy. Vaccine equity in Multicultural Urban settings: a comparative analysis of local government and community action, contextualised political economies and moral frameworks in Marseille and London. London: The British Academy; 2022.

England NHS. Core20PLUS5 (adults)– an approach to reducing healthcare inequalities 2023. https://www.england.nhs.uk/about/equality/equality-hub/national-healthcare-inequalities-improvement-programme/core20plus5/ .

NHS England. Building strong integrated care systems everywhere 2021. Available from here: https://www.england.nhs.uk/wp-content/uploads/2021/06/B0664-ics-clinical-and-care-professional-leadership.pdf .

Anfilogoff T, Marovitch J. Who Creates Health in Herts and West Essex? Presentation to NHS Confederation Seminar: Who Creates Health? 8 November 2022. 2022.

Bergen JWS. Pandemic pressures: how Greater Manchester equalities organisations have responded to the needs of older people during the covid-19 crisis. GMCVO; 2021.

Graham M. Learning from Covid-19 pandemic grant programmes lessons for funders and support agencies. May 2022. GMCVO; 2022.

Download references

Acknowledgements

The research team would like to thank ARC-GM PCIE team (Sue Wood, Aneela McAvoy, & Joanna Ferguson) and the Caribbean and African Health Network for their support in this study. We would also like to thank the Advisory Group members: Nasrine Akhtar, Basma Issa and Charles Kwaku-Odoi for their dedicated time, commitment, and valuable inputs into this research project and to partners who contributed to the early inception of this work, including members of the ARC-GM PCIE Panel & Forum & Nick Filer. We would also like to extend our thanks to the study participants for their participation in this research.

The project was funded by an internal University of Manchester grant and supported by the National Institute for Health and Care (NIHR) Applied Research Collaboration for Greater Manchester. Melissa Surgey’s doctoral fellowship is funded by the Applied Research Collaboration for Greater Manchester. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.

Author information

Authors and affiliations.

Centre for Primary Care and Health Services Research, University of Manchester, Greater Manchester, England, UK

Stephanie Gillibrand

NIHR Applied Research Collaboration for Greater Manchester, Greater Manchester, England, UK

Ruth Watkinson, Melissa Surgey & Caroline Sanders

Independent (public contributor), Greater Manchester, England, UK

Greater Manchester Patient Safety Research Centre, University of Manchester, Greater Manchester, England, UK

Caroline Sanders

You can also search for this author in PubMed   Google Scholar

Contributions

SG, lead writer/editor, design of the work, RW, design of the work, drafting of article, review and revise suggestionsMS, draft of the article, review and revise suggestionsBI, design of the work, review and revise suggestionsCS, design of the work, draft of the article, review and revise suggestionsAll authors read and approved the final manuscript.

Corresponding author

Correspondence to Stephanie Gillibrand .

Ethics declarations

Ethics approval and consent to participate.

This study was approved by University of Manchester Ethics Committee (Proportionate UREC) 24/06/21. Ref 2021-11646-19665. Informed consent to participate in the research was taken from all research participants ahead of their participation in the study. Consent to participate in the study was taken from each participant by a member of the research team. All experiments were performed in accordance with relevant guidelines and regulations.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Supplementary material 2, supplementary material 3, supplementary material 4, supplementary material 5, supplementary material 6, rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Gillibrand, S., Watkinson, R., Surgey, M. et al. “ We might not have been in hospital, but we were frontline workers in the community ”: a qualitative study exploring unmet need and local community-based responses for marginalised groups in Greater Manchester during the COVID-19 pandemic. BMC Health Serv Res 24 , 621 (2024). https://doi.org/10.1186/s12913-024-10921-4

Download citation

Received : 10 November 2023

Accepted : 28 March 2024

Published : 13 May 2024

DOI : https://doi.org/10.1186/s12913-024-10921-4

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Marginalised groups

BMC Health Services Research

ISSN: 1472-6963

• General enquiries: [email protected]

Cookies on GOV.UK

We use some essential cookies to make this website work.

We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.

We also use cookies set by other sites to help us deliver content from their services.

You have accepted additional cookies. You can change your cookie settings at any time.

You have rejected additional cookies. You can change your cookie settings at any time.

• Education, training and skills
• Further and higher education, skills and vocational training
• Sector-based Work Academy Programme: qualitative case study research
• Department for Work & Pensions

SWAP Qualitative Case Study Research: Annexes

Updated 16 May 2024

© Crown copyright 2024

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected] .

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/sector-based-work-academy-programme-qualitative-case-study-research/swap-qualitative-case-study-research-annexes

Annex 1: SWAP Theory of Change Logic Model

The flow diagram presents the following information:.

Inputs mainly under the heading ‘Government (Continued benefits, training costs, barriers to participation, analytical resources)’:

‘Employer -Time for set up/management/ feedback’

‘Training Provider - Time for set up/management’

‘Employer Advisor’, ‘Work Coach’

These inputs flow into the following activities:

• ‘Local Labour market analysis’
• ‘Arrange SWAP ’
• ‘Disseminate available SWAP with JCP ’
• ‘Awareness of available SWAP ’
• ‘Sell SWAP to claimant’
• ‘Refer claimant’

These activities flow to the output: ‘Claimant agrees to participate in SWAP ’. The claimant agreement flows on to the claimant input: ‘Investment of time and initial travel costs (reimbursable)’ and the following work coach activities:

• ‘Barrier Assessment’
• ‘Record referral’

Then the following employer activities:

• ‘Background checks (if applicable)’
• ‘Workplace adjustment (if applicable)’ 

These all flow into the output ‘Claimant starts SWAP ’.

The main SWAP portion of the theory of change starts here with the activities:

• ‘Pre-employment Training’ (with side flow to ‘Claimant gains certification (if applicable)’)
• ‘Work placement’
• ‘Guaranteed Interview’

The main SWAP activities flow to the following three possible outputs:

• ‘Claimant completes SWAP : Interview successful’
• ‘Claimant completes SWAP : Interview unsuccessful’
• ‘Claimant does not complete SWAP ’)

Regardless of which output, the diagram shows a flow to the activity ‘WC completes SWAP Tracker’. 

If Claimant completes SWAP with an unsuccessful interview, or the Claimant does not complete the SWAP , these outputs flow into the short term outcome of ‘additional needs identified’. The unsuccessful interview also flows into the short term outcome ‘interview feedback from employer’.

Both of these short term outcomes flow into the activity ‘Reflection with WC’ and this can flow into the activity ‘Claimant applies for other jobs in sector’. Claimant applies for other jobs in sector can flow into a successful short term outcome ‘claimant gains employment in new sector’ or an unsuccessful short term outcome, in which case ‘claimant reengages with WC’. 

Claimants unsuccessful at SWAP or subsequent interviews (through engagement with WC activities) flow into either:

• the short-term outcome ‘Increased employability’
• the medium term outcome ‘improve claimants employability’.

Collectively the short and medium term outcomes flow into the impact ‘Value for unsuccessful claimants’. 

If the claimant is successful at either the guaranteed or subsequent interview, these flow into the output ‘ Claimant enters work in new sector’ which flows onto the following four short-term outcomes:

• ‘Change in attitude towards working in new sector’
• ‘Claimant has skills to succeed at new job’
• ‘Increased earning’
• ‘Reduced UC /benefit’

This may flow into the following medium term outcomes:

• ‘ UC ends (or is maintained at reduced level)’
• ‘Sustained employment (18 months)’
• ‘Career progression’

These medium term outcomes flow into the impacts:

• ‘Increased employment’
• ‘Reduced UC costs’

If the claimant is successful at the guaranteed interview, and subject to the assumption ‘Employer outputs and outcomes are dependent on the SWAP meeting employer expectations’, the following employer outputs are recorded:

• ‘Reduced vacancies’
• ‘Employer social responsibility goals met’
• ‘Development of local workforce’ 

‘Reduced vacancies’ and ‘Employer social responsibility goals met’ flow to the short-term outcome ‘Employer satisfied with SWAP experience’. This then flows to the activity ‘ DWP gathers feedback from claimants and employers’ and the short-term outcome ‘Collated employer success stories’.

These short-term outcomes flow to the medium term outcomes:

• ‘Businesses return for additional SWAP ’
• ‘Increased employer uptake in SWAP or other provisions’
• ‘Improved Attitudes towards hiring DWP claimants’
• ‘Employers approaching DWP with vacancies more readily’ 

‘Development of local workforce’ output flows to the following short-term outcomes:

• ‘ SWAP aligns with local market need including sector shortages’
• ‘Sector pathways identified’
• ‘Change in attitude towards working in new sector’, which flow to the medium term outcome ‘Improved fit between employers and claimants’. 

Medium term outcomes in this employer focussed part of the theory of change flow to the impacts ‘Improved DWP relationship with business sector’ and ‘increased employment’.

Annex 2: Participant characteristics

Table 3: employer, training provider and claimant participants by swap sector, table 4: claimant participant characteristics, annex 3: additional methodology details.

This annex includes additional information about how the case study research was conducted.

Contacting claimants

A random sample of 150 claimants was drawn for each case study area (600 claimants in total across the four areas) in order to achieve 10 claimant interviews in each district. This sample size was in line with previous, similar research (in terms of mode, length and recruitment approach), which achieved a response rate of approximately 1 in 15 claimants. The sample was sourced from the SWAP manual trackers completed by each district which detail which claimants are referred each week to the programme. Claimant identification numbers were then linked to centrally held contact information (for example, postal address and telephone number).

The stratification of the sample was limited by the quality of data DWP holds on certain claimant characteristics (for example, ethnicity and disability information was not available) as well as claimants’ SWAP journey (only claimant start dates on the pre-employment training ( PET ) were consistently recorded by all areas). As a result, it was impossible to identify in advance claimants who had dropped out of a SWAP part-way through, or claimants who were successful at the guaranteed interview stage, which limited the study’s ability to explore these aspects in detail. The sample drawn was, therefore, broadly reflective (rather than representative) of the claimant population who started on a SWAP in terms of gender and sector of SWAP , and consisted of individuals who had started the SWAP PET within the previous 12 weeks of the sample being drawn. This time period was agreed in order to ensure the feasibility of obtaining a sample of 150 claimants from each area, while minimising as much as possible the risk of recall bias within claimant accounts of their experience.

It is important to note the claimant sample was delivered in two separate stages, to reflect the gap in fieldwork between Area 2 and Area 3. The samples for Areas 3 and 4, was additionally stratified by age (18 to 24 years vs. 25+ years) to account for the small number of potential participants aged 18 to 24 years provided in the sample for Areas 1 and 2.

All claimants in the sample were sent an advance letter to the address held on DWP ’s central records. This letter provided further information about the research, what their participation would involve, data processing information and an email address to which they could write if they wanted to opt-out. Claimants were called using the telephone numbers provided in each sample, and while formal quotas for recruiting participants were not used, calls were targeted to achieve a spread in terms of claimant gender, age and sector of SWAP (the latter was obtained from the SWAP manual trackers and was therefore dependent on DWP staff interpretations of this at the local level). Claimants were called up to three times without a response before they were not contacted any further. During the calls, researchers emphasised their independence from benefits processing and that decisions regarding participation would not affect claimants’ benefits in any way. Each interview lasted approximately 30 to 45 minutes and claimants received a £20 voucher for their time.

In Area 4, fieldwork was terminated early due to an underlying issue with this sample in which few claimants could be contacted (many claimants did not pick up the phone) and of those who did, few recalled the programme or had actually started the SWAP to which they had been referred. Only two interviews were completed from 207 recruitment calls, compared to 10 interviews completed from 88 recruitment calls in Area 3. The study team attempted to unpick the reasoning for the issues with the underlying sample in subsequent meetings and interviews with the local operational contacts, however, it was difficult to pinpoint this exactly. The information gathered suggested that the issue was likely a result of error(s) completing the local manual SWAP trackers. As a result, fieldwork was terminated early so that the findings could be reported to the timetable agreed.

Contacting employers and training providers

As described in the main report, the study was reliant on the case study areas to supply the contact details of employers and training providers who had taken part in a SWAP in their districts, as there was no alternative way of identifying these organisations. Within each area, the study aimed to interview a total of 7 employers, and 3 training providers, and so local contacts were asked to provide approximately 15 to 20 employer contacts and 5 to 10 training provider contacts to account for uncertainty in likely response rates. Obtaining contacts was more difficult in some of the case study areas and was affected by factors such as local record keeping of this information (for example, some training providers were listed as employers, and other contact information was out of date), and busyness of the staff involved. In all areas, subsequent samples of employers were requested due to poor response rates for this participant group.

To counter the risk of staff supplying only contacts for similar organisations, and therefore similar experiences of the programme, contact information for a range of organisations in terms of key characteristics (size, sector of SWAP , length of SWAP , number of SWAPs involved in, and how the SWAP was initiated) was requested. Organisations were then approached by researchers to ensure a spread across these characteristics, although achieving this was limited by response rates, particularly among employers.

Organisations were initially emailed using a template which explained the purpose of the research and asked if they were able to participate. Where organisations agreed to take part, they were then sent an additional information sheet and booked in for an interview at a convenient date and time. Where no response was received, a follow-up email was sent a few days later prompting them about the study. Finally, where the target number of interviews had not yet been reached, organisations were contacted by telephone for up to a maximum of two attempts. Where this was the case, the researcher verbally communicated the key information about the study contained in the initial emails.

For most areas, the first time employers and training providers heard about the research was when they were contacted via email about the study. In Area 4, however, DWP staff approached employers in advance before handing contact details over to the study team. This approach was taken as DWP staff in this area felt it would be beneficial in securing employer participation and minimised any risk to their relationships with these contacts if the study team were to contact them without warning. It should be noted that this may have increased the risk that some employers may have felt obligated to take part in the research and/or restricted their feedback due to a perceived lack of separation between DWP researchers and operational staff leading on SWAPs . As with all areas, researchers in Area 4 emphasised their independence from jobcentres ( JCPs ) and SWAP policy decision-making during each contact with participants, and the questions asked during data collection were framed in a way to encourage and enable participants to be honest about their experience. Despite this, it’s likely that a certain level of bias related to this aspect remains in the dataset obtained.

Each interview lasted approximately 30 minutes to an hour, depending on how much each organisation wanted to share. To ensure the most appropriate person was spoken to, the information shared during the recruitment stages requested that the participant was an individual who had knowledge of, or was responsible for, the SWAP that their organisation had been involved in.

Contacting staff

Once JCP Service Leaders had agreed for fieldwork to take place in their district areas, the study team were signposted to operational staff who would be able to facilitate the research. These individuals became key contacts for the study team during fieldwork. In initial meetings, these local contacts provided a broad overview of the SWAP set-up in their district, and the types of staff involved in delivery, from which a list of different staff roles to speak to as part of the fieldwork was agreed. Due to the varying nature of the local staffing models, it was easier to understand how SWAP delivery was organised in some areas more than others.

The project manager and case study leads maintained regular contact with these local contacts while fieldwork took place in each area. In Areas 1 and 2 this mostly consisted of contact via email, whereas for Areas 3 and 4 this took the form of a weekly scheduled meeting. In Areas 2, 3 and 4, a follow-up meeting took place with the local contacts to check the study team’s understanding of local SWAP delivery obtained through data collection, and to clarify any aspects of delivery that remained unclear.

The local contacts provided a list of suggested staff who could be approached for the fieldwork based on their role and involvement in local SWAP delivery. The study team then arranged the interviews and focus groups for these staff around their availability. In setting up the interviews and focus groups, an information sheet was provided about the research, and it was emphasised that their participation was voluntary. Despite this, some staff may have only participated in the study because they felt obligated to. As with other participant groups, the independence of the study team was emphasised, and participants were offered the opportunity to withdraw from the study if they wanted to.

Piloting [footnote 1] interviews were conducted with two members of DWP staff, one employer and one training provider who agreed to this. These interviews were conducted to test the length and appropriateness of the topic guides for these participant groups, and the quality of the data obtained. These individuals were recruited from a separate JCP district to the case study areas and so the information collected was not used in the analysis and reporting of this study. The topic guides were amended following these pilots.

For claimants, the first week of fieldwork was considered a pilot. Minimal changes were made to the topic guide following these interviews, and so, unlike the other fieldwork strands, the data collected during these interviews was analysed and reported on. It should, however, be noted that the topic guides and fieldwork processes were continually reviewed and modified throughout the data collection periods to ensure they were as efficient and effective as possible. The study team met multiple times a week to reflect on interviews, and formal debrief sessions were held within the study team, and separately with wider supporting researchers, following the end of data collection in each study area. This process allowed learning from each area to be implemented in subsequent fieldwork.

Analysis and Reporting

Once all interviews had been conducted, the interview notes formed the final dataset. The dataset was explored using a thematic analysis approach. As there were multiple researchers involved in the coding of the data, a coding framework (Annex 4) was developed to ensure consistency in coding across the study team. The research questions were used as a guide to ensure the framework aligned with the objectives of the research, and the framework was tested with an initial sample of interviews before a final version was agreed for coding the rest of the data (although this was still subject to ongoing tweaks as coding progressed).

Members of the study team were paired up to code a specific strand of data (for example, employers) and each pair coded the same initial set of notes to check alignment in their coding approach, before separately coding the remaining data. A separate member of the study team then examined a selection of coded notes from each pair to quality assure the completed coding. Feedback on the coding approach, particularly inconsistencies within each pair, was provided to the coders so that this could be incorporated into the analysis of future notes.

The project team met multiple times to discuss and agree the themes identified within the coded data. The themes identified via this process of analysis structured the findings within this report. When analysing the data, findings were explored by participant group (for example, claimants vs. employers) as well as by case study area (for example, Area 1 vs. Area 2), and these were included in the reporting where relevant.

A Quality Assurance ( QA ) panel was established to review the work of the research team during the analysis stage. The panel included researchers external to the project, senior researchers, and a fieldworker external to the study team, who was involved in conducting the research. This panel was engaged to review the initial coding framework that had been developed, and again to review how the codes had been applied to a sample of the data collected. This ensured that the approach taken to analysis had been peer reviewed, and that the data analysis conducted was of good quality. The final report was separately quality assured by an academic on secondment to the In-House Research Unit ( IHRU ), as well as senior researchers in the unit.

Annex 4: Initial coding framework

A pilot is a small-scale, preliminary study that is used as a test run for a particular research instrument to ensure its efficacy.  ↩

Is this page useful?

• Yes this page is useful
• No this page is not useful

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.

To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab) .

Barriers and enablers in the implementation of a quality improvement program for acute coronary syndromes in hospitals: a qualitative analysis using the consolidated framework for implementation research

Add to collection, downloadable content.

• Other Affiliation: Department of Global Health, School of Public Health, Peking University, Haidian District, Beijing, China
• Other Affiliation: Department of Global Health, School of Public Health, Peking University, Beijing, China
• Other Affiliation: RTI International, Waltham, MA, United States
• Affiliation: School of Medicine, Division of Cardiology, Department of Medicine
• Background: Ischemic heart disease causes a high disease burden globally and numerous challenges in treatment, particularly in developing countries such as China. The National Chest Pain Centers Program (NCPCP) was launched in China as the first nationwide, hospital-based, comprehensive, continuous quality improvement (QI) program to improve early diagnosis and standardized treatment of acute coronary syndromes (ACS) and improve patients’ clinical outcomes. With implementation and scaling up of the NCPCP, we investigated barriers and enablers in the NCPCP implementation process and provided examples and ideas for overcoming such barriers. Methods: We conducted a nationally representative survey in six cities in China. A total of 165 key informant interviewees, including directors and coordinators of chest pain centers (CPCs) in 90 hospitals, participated in semi-structured interviews. The interviews were transcribed verbatim, translated into English, and analyzed in NVivo 12.0. We used the Consolidated Framework for Implementation Research (CFIR) to guide the codes and themes. Results: Barriers to NCPCP implementation mainly arose from nine CFIR constructs. Barriers included the complexity of the intervention (complexity), low flexibility of requirements (adaptability), a lack of recognition of chest pain in patients with ACS (patient needs and resources), relatively low government support (external policies and incentives), staff mobility in the emergency department and other related departments (structural characteristics), resistance from related departments (networks and communications), overwhelming tasks for CPC coordinators (compatibility), lack of available resources for regular CPC operations (available resources), and fidelity to and sustainability of intervention implementation (executing). Enablers of intervention implementation were inner motivation for change (intervention sources), evidence strength and quality of intervention, relatively low cost (cost), individual knowledge and beliefs regarding the intervention, pressure from other hospitals (peer pressure), incentives and rewards of the intervention, and involvement of hospital leaders (leadership engagement, engaging). Conclusion: Simplifying the intervention to adapt routine tasks for medical staff and optimizing operational mechanisms between the prehospital emergency system and in-hospital treatment system with government support, as well as enhancing emergency awareness among patients with chest pain are critically important to NCPCP implementation. Clarifying and addressing these barriers is key to designing a sustainable QI program for acute cardiovascular diseases in China and similar contexts across developing countries worldwide. Trial registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR 2100043319), registered 10 February 2021.
• Quality improvement
• Qualitative study
• https://doi.org/10.17615/ectv-0k43
• https://doi.org/10.1186/s13012-022-01207-6
• Attribution 4.0 International
• Implementation Science
• China Medical Board, CMB: 20-376
• National Natural Science Foundation of China, NSFC: 71904004
• BioMed Central Ltd

This work has no parents.

Select type of work

Master's papers.

Deposit your masters paper, project or other capstone work. Theses will be sent to the CDR automatically via ProQuest and do not need to be deposited.

Scholarly Articles and Book Chapters

Deposit a peer-reviewed article or book chapter. If you would like to deposit a poster, presentation, conference paper or white paper, use the “Scholarly Works” deposit form.

Undergraduate Honors Theses

Deposit your senior honors thesis.

Scholarly Journal, Newsletter or Book

Deposit a complete issue of a scholarly journal, newsletter or book. If you would like to deposit an article or book chapter, use the “Scholarly Articles and Book Chapters” deposit option.

Deposit your dataset. Datasets may be associated with an article or deposited separately.

Deposit your 3D objects, audio, images or video.

Poster, Presentation, Protocol or Paper

Deposit scholarly works such as posters, presentations, research protocols, conference papers or white papers. If you would like to deposit a peer-reviewed article or book chapter, use the “Scholarly Articles and Book Chapters” deposit option.

• Open access
• Published: 15 May 2024

Sacred space: a qualitative interpretive meta-synthesis of women’s experiences of supportive birthing environments

• December Maxwell 1 ,
• Sarah R. Leat 2 ,
• Toni Gallegos 3 &
• Regina T. Praetorius 3  

BMC Pregnancy and Childbirth volume  24 , Article number:  372 ( 2024 ) Cite this article

Metrics details

In the United States there are roughly three million births a year, ranging from cesarean to natural births. A major aspect of the birthing process is related to the healing environment, and how that helps or harms healing for the mother and child. Using the theoretical framework, Theory of Supportive Care Settings (TSCS), this study aimed to explore what is necessary to have a safe and sacred healing environment for mothers.

This study utilized an updated Qualitative Interpretive Meta-synthesis (QIMS) design called QIMS-DTT [deductive theory testing] to answer the research question, What are mother’s experiences of environmental factors contributing to a supportive birthing environment within healthcare settings?

Key terms were run through multiple databases, which resulted in 5,688 articles. After title and abstract screening, 43 were left for full-text, 12 were excluded, leaving 31 to be included in the final QIMS. Five main themes emerged from analysis: 1) Service in the environment, 2) Recognizing oneself within the birthing space, 3) Creating connections with support systems, 4) Being welcomed into the birthing space, and 5) Feeling safe within the birthing environment.

Conclusions

Providing a warm and welcoming birth space is crucial for people who give birth to have positive experiences. Providing spaces where the person can feel safe and supported allows them to find empowerment in the situation where they have limited control.

Peer Review reports

Introduction

In 2021, there were 3,664,292 births in the United States. Of those birth, 98.3% took place in hospitals [ 1 ]. In hospital settings, medical interventions such as induction of labor, cesarean sections, and the use of instruments like forceps or vacuum extractors may be more common [ 2 ]. These interventions can carry risks such as increased likelihood of complications for both the birthing person and the baby [ 2 , 3 ]. Some women may feel stressed or anxious in a hospital setting, which could potentially slow down labor or lead to other complications. This stress can be due to various factors such as unfamiliar surroundings, medical procedures, or concerns about interventions [ 2 ]. In a hospital setting, decisions about the birth process may be influenced by hospital policies, medical protocols, and the preferences of healthcare providers, potentially leading to a loss of autonomy for the birthing person in decision-making about their own birth experience [ 4 ]. The experience of giving birth in a hospital, especially if it involves unexpected interventions or complications, can contribute to postpartum depression or anxiety in some women [ 5 ]. Hospital routines and policies may not always be conducive to establishing breastfeeding immediately after birth, which can lead to challenges in breastfeeding initiation and continuation [ 6 ].

Birthing requires healing and a supportive environment at every stage of the birthing process, consisting of holistic support and agency [ 7 ]. This involves “constant emotional, physical, spiritual, and psychosocial” support [ 8 ]. Experiencing birthing trauma has shown to result in postpartum post-traumatic stress disorder (P-PTSD) and postpartum depression (PPD) [ 9 , 10 , 11 ]. Likewise, disempowering births can have long term impacts of maternal self-esteem [ 12 , 13 ]. Maternal mental health issues have resulted in numerous public health concerns, specifically regarding the decreased safety and negative health outcomes that the infant faces [ 14 , 15 ]. Postpartum mental health disorders can also have lasting impacts on family outcomes [ 16 , 17 ]. As such, understanding how to improve the birth experience has the potential to reduce postpartum mental health issues, as well as reduce maternal morbidities, which can improve outcomes for both mother and child.

Of note is the influence of the built environment on healing. Given that thoughtfully designed healthcare facilities can influence the amount of privacy and control a patient perceives [ 18 ], the built environment plays an integral part in healing. Ample daylight, thermal comfort, color, and noise control all contribute to environmental healing within a hospital [ 19 ]. Furthermore, patient health outcomes have been linked to the built environment of hospitals in multiple studies [ 13 , 20 , 21 ]. More specific to birthing, women have indicated that perceived hominess and control in the environment relate to their birthing experience [ 20 , 22 , 23 ].

Control over the birthing environment, including comfort and perceived healing also have mental health impacts for birthing mothers, and the birth environment can have an impact on the mother’s perception of the birth which in turn can influence maternal mental health outcomes [ 24 , 25 ]. Given that approximately 1 in 7 mothers will experience postpartum depression (PPD) in the United States [ 26 , 27 ] and 0.05%-60% of mothers will experience PPD globally [ 28 , 29 ], understanding the impact of birthing environment on maternal morbidities and mental health can create holistic approaches to birthing environment design.

Given the impacts of the birthing environment on maternal mental health, learning what is necessary to have a safe and sacred healing environment for mothers is an important endeavor and the purpose of this qualitative interpretive meta-synthesis (QIMS). A QIMS is a method that is specific to the social work field. It was created to review and analyze qualitative data to identify and synthesize themes surrounding different phenomena found in existing qualitative research [ 30 ]. QIMS has previously been used to synthesize existing data regarding social justice concerns around minority police encounters [ 31 ] and children’s exposure to intimate partner violence [ 32 ]. Concerning the topic of birthing and motherhood, one QIMS explored marginalized women’s experiences of postpartum depression [ 33 ] and another explored the experience of suicidality postpartum [ 34 ]. To date, no QIMS has considered the experiences of the birth environment for birthing mothers and the impact on maternal mental health. A synthesis of the literature qualitatively evaluating women’s perspectives on what is necessary to have a safe and sacred healing environment for mothers could bolster understanding of how hospitals could better support birthing mothers. As such, this study uses QIMS to answer the following research question: what is necessary to have a safe and sacred healing environment for mothers?

Theoretical framework

This study sought to understand how birthing mothers experienced the birthing environment and which environmental factors contributed to a safe and sacred healing environment for mothers. As such, the Theory of Supportive Care Settings (TSCS) was used to frame this synthesis [ 35 ].

Theory of supportive care settings

Theory of Supportive Care Settings (TSCS) was created through research to have a theoretical understanding of which “processes supported a supportive care setting” [ 35 ]. TSCS was developed using three different care settings–a hospice, geriatric, and acute care ward, through qualitative interviews with patients, significant others, and care staff’s experiences. Although TSCS was not developed within the birthing environment, given the raise of childbirth induced P-PTSD, it is appropriate to apply the concepts to the birthing environment. One aspect of this synthesis is to assess the utility of the application of TSCS to the birthing environment using it as the main theoretical approach. There are five main processes the theory addresses as creating a supportive care environment: experiencing welcoming in the environment, recognizing oneself in the environment, creating and maintaining social relations in the environment, experiencing a willingness to serve in the environment, and experiencing safety in the environment. An applied theoretical framework was created (Fig.  1 ).

Framework of theory of supportive birth settings

Experiencing welcoming in the environment

Experiencing welcoming in the environment has three properties which are intensely experienced when the patient first enters the healthcare setting [ 35 ]. Being expected is the first property that involves the care setting knowing the patient is coming. This happens by having the patient’s name displayed and knowing pertinent information about the person before the beginning of care [ 35 ]. Being seen entails a warm welcome upon entering the care setting, having personal introductions, and care staff showing an interest [ 35 ]. Lastly, being invited consists of being shown around the care setting for the patient to become familiar with the environment and the people within [ 35 ].

Certainly, experiencing welcoming in a care setting, such as a hospital, heightens mood among patients and increases their satisfaction with their experience of the care setting [ 36 ]. Within a birthing environment, there is also evidence that being believed and welcomed upon arrival to the hospital increases the satisfaction of mothers as well as enhances their birthing experience [ 37 ].

Recognizing oneself in the environment

Within TSCS, recognizing oneself in the environment encapsulates the intensity of which patients recognize themselves within the care environment [ 35 ]. For example, environments that are perceived as too sterile do not allow the patient to recognize themselves in the environment. Being able to recognize oneself in the care setting includes being in a familiar and calm environment [ 35 ]. A familiar environment includes objects that are familiar to the patients, as well as beauty in the environment that includes windows and warm colors [ 35 ]. Further, a calm environment has minimal loud noises from machines, phones, and patients are allowed to move freely [ 35 ]. Features of familiarity in the birthing environment can reduce the length of labor and reduce pain intensity [ 38 ].

Creating and maintaining social relations in the environment

Creating and maintaining social relations in the environment within TSCS describes the social relations a patient develops that create ease within the environment [ 35 ]. Within this concept, there are two processes: staying in contact with social relations and creating new social relations. Staying in contact entails the patient’s ability to stay in contact with those in their social circles while undergoing care and can include environmental factors that facilitate this such as access to a personal phone and privacy to visit with social relations while in care. Creating new social relations explains the way patients can create new social relationships through positive interactions such as those that include laughter and support from care staff or others in the care setting. The process further includes the structural environment and facilitation of such connections, including openness of concept, support places, and comfortable furniture in private and common areas of the care setting [ 35 ].

This process of TSCS is again supported in literature regarding birthing environments. Availability of social support is integral to the birthing experience and increased access to social support creates better birthing outcomes and perceptions of birth [ 39 ]. Similarly, those supporting the birth need to feel welcomed and included in the birth environment, and there are specific aspects of the built environment that facilitate increased support during birth such as familial alcoves in birthing rooms and increased attempts at including the supporter by care setting providers [ 40 ].

Experiencing a willingness to serve in the environment

The willingness to serve in the environment from TCSC involves both care staff and patients. In TSCS doing a little extra and receiving a little extra are the processes that promote a willingness to serve. To the patients, seeing the care staff demonstrate thoughtful actions shows the staff’s willingness to serve. These actions can include things like remembering a patient’s preferences for their pillow or water temperature or arranging food in an appealing way. The willingness to serve can also come from patients though; some patients reaching out to other patients to give support or even just showing caring attitudes towards either nurses or other patients. For patients, an environment which demonstrates the willingness to serve is one when care staff do things without being asked, are intuitive in their approaches, and do not make the patient feel like a burden [ 35 ].

Within the birthing environment, willingness to serve can look like staff providing welcome distractions from the birthing process through music or aromatherapy, dimming lights, changing ambient temperature, and ensuring loud sounds are minimal. Further, care staff can exhibit willingness to serve by advocating for the birthing mother to have less people in the room, creating a familiar space, and providing comfort [ 38 ].

Experiencing safety in the environment

TSCA defines safety in the birthing environment as the safe feelings that arise from knowing what is happening, feeling informed, being comforted, and feeling trustful of care providers. Understanding what is happening includes, knowing what is happening, having information in an accessible language, and being aware of the course of events. For the patient, being is safe hands means having trust in the providers through honest conversations, knowing that their needs and requests are honored, and that the physical environment is clean, organized, and aesthetically pleasing rather than chaotic and messy [ 35 ].

The safety in the birthing environment often ties honest conversations and knowing needs and requests will be met to feel in control over the birth and the experience. Feeling in control of the birth environment can also include creating a familiar, homey space by being allowed to personalize the space with music, design elements like personal photos, pillows, or plants, and controlling the temperature and lighting [ 40 ]. In addition, knowing that healthcare providers are respecting the birth plan as much as possible and supporting freedom to move and move through the birth process in their own way [ 38 ]. Furthermore, machinery that ties the mother down, inhibiting freedom to move, can be distracting and reduce the time midwives or nurses spend in the birthing room, diminishing the birthing mother’s trust in care providers [ 41 ].

Despite the lack of use of TCSC in birthing environment literature, all five concepts from TCSC are found within the existing literature to be recommended for use in birthing environments. That said, there is not a synthesis to date utilizing the framework to evaluate qualitative perspectives of the birthing environment. This review aims to organize the existing qualitative literature within TCSC to provide a roadmap for birthing space design that aligns with a supportive care environment, with the hopes of creating more functional birthing spaces which may reduce the rates of maternal mental health challenges following the birth of a child.

Ethics, consent for publication, availability of data and materials

The data used in this study are derived from publicly available, published research articles and thus, in the public domain. Similarly, Institutional Review Board approval was not required since all data used were in the public domain in publicly available, published research articles. Informed consent was not required as no participants were recruited to participate in this study. There is no identifiable information of participants used in this method nor do we as consumers of previously published qualitative research have access to the original data.

QIMS is a method that lets researchers find a deeper understanding of a phenomenon or shared experience using qualitative journal articles as secondary data. QIMS is focused on researchers synthesizing previously published qualitative findings on a topic across the literature to reveal insights of participants’ experiences with a phenomenon [ 30 ]. This process includes creating a research question, conducting a systematic search of existing literature, and finally analyzing identified articles through theme extraction, synthesis, and triangulation [ 30 ].

QIMS has a set analysis process that involves reviewing the original authors’ published themes, as well as the participant's quotations in the manuscript. Themes and quotations are extracted and compiled into a new dataset to capture participants’ experiences of shared phenomenon across literature, providing a larger, more diverse sample size.

Sometimes, the analysis ends with a methodological reduction as well. Methodological reduction is an accepted method within phenomenological inquiry that permits researchers to understand the phenomena being observed through a new contextual lens allowing for further abstraction [ 42 ]. That said, due to the paucity of research evaluating what is necessary to have a safe and sacred healing environment for mothers, this study utilized a rare approach to QIMS wherein the theoretical framework was provided at the outset of the study to guide the entirety of the synthesis. This deviates from the more inductive approach of traditional QIMS, but this deductive approach allows for a more pointed answer to a specific research question that seeks to operationalize a construct within a distinctive context or population and has been used previously [ 30 ]. Essentially, this analysis approach used a combination of both QIMS and theory-testing deductive analysis methods. The theory guides each step of the QIMS process, and specific steps have been applied (see Fig.  2 ). This combined approach is formalized here and is called QIMS-DTT [deductive theory testing].

Associations of birthing environment to Theory of Supportive Care Settings 

First, in line with theory-testing deductive analysis [ 43 ], a qualitative question was posed with a specific theoretical lens in mind, in this case, Edvardsson’s Theory of Supportive Care Setting. Then, following QIMS, a systematic search of the literature was conducted using PRISMA guidelines [ 44 ]. The keywords for the initial search included “birth or childbirth or labour or labor or delivery or birthing” as subject terms. The key terms “experiences or experience” and “qualitative” were added to “in abstract” as well as “birthing experiences” and “birthing perceptions.” Key terms were searched within the following databases: ERIC, Academic Search Complete, APA PsycInfo, CINAHL Complete, Family Studies Abstracts, MedicLatina, MEDLINE, Psychology and Behavioral Sciences Collection, Alt HealthWatch. This initial search yielded 5,688 articles. After duplicates were removed 5,167 articles remained. The title and abstract screened for content relating to the desired topic, and inclusion and exclusion criteria were applied.

Inclusion criteria were that the studies were U.S. based only, included pregnant women’s experiences of hospital or birthing center birth, and were qualitative research with quotations presented in the article. Inclusion was limited to U.S. based studies given that birthing practices differ vastly across the world; focusing on the U.S. provides homogeneity of context for understanding the birthing environment impact. Furthermore, even though the U.S. is a high resource country, the perinatal care system is considered unique as requires private pay insurance and not every woman has access to Medicaid or Medicare federal and state funded health insurance programs [ 45 ]. Furthermore, among 11 high resourced countries, the U.S. has the highest maternal mortality rate, which some scholars attribute to how the U.S. has the lowest supply of obstetricians and heavily lacks midwives and insurance coverage for midwifery care [ 46 ]. Theory was incorporated here as well as an inclusion criterion, and the results were filtered through the operationalization of Edvardsson’s Theory of Supportive Care Setting used for this study. Using the five constructs of the theory that were operationalized for this study, the articles were included if authors discussed at least one construct from the theory (the constructs that articles discussed can be found in Table  1 ). Articles not discussing at least one of the five constructs of the theory were excluded. In addition, other exclusion criteria included articles discussing future births or expectations about future births, choice of location for birth, mode of delivery, labor pain, healthcare providers’ perspectives, existing reviews or syntheses, and articles discussing techniques of or towards birthing [e.g., acupuncture, Lamaze, education]. After title and abstract screening, 3,178 articles were excluded, leaving 43 articles to be screened full text. During the full-text screen, 12 articles were excluded, leaving 31 total articles to be included in the QIMS.

Following this approach (inclusive of both QIMS and theory-testing deductive analysis) we have formalized within this study, the original themes (Table  2 ) from the articles were organized by one researcher into appropriate theoretical assumptions that most aligned with the constructs of TSCS (See Table  1 –providing theoretical triangulation). Then, the quotations from each article were extracted and uploaded to qualitative software, atlas.ti (v.8.1). The quotations were coded deductively by the first two authors using the theoretical framework as a guide for thematic development. The themes were then aligned with each of the five theoretical constructs by unanimous rating. This process provided a layer of analyst triangulation additional to the triangulation inherent in QIMS design resulting from triangulation in the individual studies prior to the QIMS.

Instrumentation

In addition to the analysis process, it is also important for researchers to bracket, or disclose, their experiences with a phenomenon to increase the trustworthiness of the synthesis. The authors are the main instruments of this study, as is frequently the case in qualitative research. To further lend credibility and transparency to the QIMS process, brief descriptions of the authors can be found in Table  3 . The authors purposefully include two mothers–one who experienced Postpartum Mood and Anxiety Disorders (PMADs) and one who did not, and two women who were not mothers at the time of this writing. This intentionally focused toward balancing any biases the two mothers might have brought to the analyses given their experiences further explained in Table  3 .

The final sample included 30 qualitative studies giving ear to the voices of 1,802 postpartum mothers. These mothers ranged in age from 12 to 71 and represented a wide range of races and ethnicities. For more demographic information including data collection methods and settings, see Table  4 .

Using a theory-testing deductive analysis process in conjunction with QIMS, the analysis results in five themes with various subthemes. The supporting quotations can be found in Table  5 . In addition, thematic constructs of TSCS were found across the included articles and the theoretical deduction was sound. Evidence of theoretical constructs can be found in Table  1 .

Theme 1: service in the environment

The first theme consists of ways that participants experienced service within the birthing environment. This service can be either from the healthcare team or the woman themselves and can be expressed in ways more encompassing than just direct labor. Participants described providers who exhibited exceptional care as a memorable part of their birthing experience. This aspect of service within the environment contributed to warm feelings towards their providers and allowed them to feel important and cared for. Many described how taking time out of their busy schedules to focus on the woman one-on-one, accommodating disabilities or medical conditions without being asked, and going out of their way to encourage and empower women was how a provider demonstrated “above and beyond” care.

Theme 2: recognizing oneself within the birthing space

The second theme described how birthing persons saw themselves within the birthing space. This included their personhood being acknowledged and their maternal role being validated by providers.

Subtheme 2A: acknowledging personhood

Recognizing oneself within the environment should be facilitated by feeling acknowledged as persons with dignity. For participants in these studies, this was expressed in their experiences of not having their personhood acknowledged and valued during the birthing process. One participant was not allowed to walk to the bathroom and was also not clearly told why. Her dignity was wounded, and the situation introduced emotional trauma into her birth story. Other women had a similarly emotionally traumatic experience that compromised their dignity and devalued their personhood.

Subtheme 2B: validating maternal role

Validation in becoming a mother is an important step in a woman’s transition into motherhood. The birth is an experience that will forever impact how the person views their maternal role. Many participants felt that their role as mother was overlooked by providers or not validated in a way that made them feel unequipped to mother their children. Often, participants described how providers made decisions for their newborns for them without consulting or trusting them to make such decisions.

Theme 3: creating connections with support systems

The third theme describes the ability of participants to forge or maintain social connection while experiencing birth. This could be availability of social support through communication from providers or through inclusion of support persons. Furthermore, disrespect hampered the formation of social connections.

Subtheme 3A: communication is key

This subtheme revolved around the necessity of communication to forge a strong, trusting social connection between provider and women. This communication included informing the women of medically necessary interventions and allowing them to understand the necessity of them before consenting when medically possible. Communication also included introducing themselves and accepting a patient introduction genuinely through learning womens’ names and making eye contact and gathering consent before touching the client. When providers communicated in this fashion, the participants indicated that they felt a stronger social bond to the providers and their trust and satisfaction with them was increased.

Subtheme 3B: team effort among providers

Relationships required a team effort, which meant that multiple providers needed to be on the same page and operating in good communication with one another to support mothers. Participants in the included studies described how both providers and the birthing person, as well as their support people could work together to ensure the birthing process was a positive one. Others explained that when providers did not work together or communicate among each other the birthing process felt chaotic and disjointed, leaving them feeling unsatisfied and unsafe.

Subtheme 3C: respect forges social connection

This sub theme describes how care providers can forge social connection with their patients through respecting the wishes of the birthing person. Examples included respecting their birthing plan even when it was not medically necessary, allowing the birthing person to make choices about pain interventions, and not respecting the minimal birthing requests that were not related to medical interventions. Conversely, not hearing or respecting the birthing person created a negative experience which was detrimental to social connection in the birthing space.

Theme 4: being welcomed into the birthing space

The fourth theme that emerged encompassed participants’ desires to be welcomed into the birthing space. This involved experiences of being admitted into the maternity ward or birthing suite upon arrival at the hospital and being made to feel comfortable in the space.

Subtheme 4A: being believed and admitted

Participants within the included articles discussed the importance of being believe when they presented to the hospital in what they perceived as active labor. Participants described being unsure if the sensations they were feeling were in labor and expressed anxiety as to whether they would be admitted into the maternity ward. Participants worried that if they arrived at the hospital too early, they would be treated poorly for “over-reacting” and be sent home, even though they were in pain. Participants also described the feeling of being rejected as failure. Being admitted into the birthing space was crucial for participants in the included articles to feel supported and validated.

Subtheme 4B: comfortable birthing space

In addition to being admitted, having the birthing space be comfortable was also necessary for participants to feel welcomed. Participants described spaces that had enough room for all their family members, single-occupancy rooms that allowed the birthing mother to have the whole room to herself, and rooms that had calming items present to be the most comfortable. In addition, participants in the included articles described experiences of uncomfortable spaces. Several participants expressed discomfort at having to be moved to multiple locations within the hospital. Participants also found hospitals challenging to navigate which caused stress on the family and the laboring mothering. Some participants described how the temperature of the space affected them as well, with the ability to control the temperature helping them to feel comfortable, both themselves and their families.

Theme 5: feeling safe within the birthing environment

The fifth theme encompasses various ways birthing persons felt or did not feel safety in the birthing environment. Either through consent in procedures, being able to follow birth plans, having freedom to move, and having trust and confidence in the healthcare team, there were many ways participants expressed their perceptions of safety in the birthing environment.

Subtheme 5A: interpersonal safety

This theme described how interpersonal relationships contributed to feeling safety in the birthing environment. Participants in the original studies talked about how they took action to ensure they had interpersonal safety through choosing obstetricians that felt safe to them, either due to gender or validation tactics. Others described how having continuity of care when possible created safe feeling interpersonal relationships, such as having the same nurse throughout or when they did change shifts- the outgoing nurse took extra steps to introduce the new nurse and supported the forging of an interpersonal relationship between birthing person and new nurse. Having a familiar face consistently throughout the birthing process was comforting. In addition, many quotations described how a provider could focus on the woman in a way that was comforting and forged and interpersonal connection by ensuring they knew they were being heard and supported.

Subtheme 5B: Confidence in the healthcare team

Feeling safe in the birthing environment was also influenced by how much confidence the women had in their healthcare team. Some participants in the original study described how they trust doctors because they know better through education, while others felt like their care providers were not listening to their concerns, eroding their trust and making them feel unsafe. Others explained actions the healthcare team took to ruin the trust between them, either by not sharing the full truth of the current process or by giving false information. When the providers were not honest with their patients, the birthing person was less likely to feel safe and therefore it tainted their birthing experience with anxious feelings.

Subtheme 5C: Feeling in control of the birth

Participants also described feeling in control of the space allowed them to feel safe within the birthing space. Participants who were given the ability to make decisions about positions, movements, and even presented with a way to watch the birth felt in control and supported by staff. Conversely, participants who were restricted in their movement felt trapped.

The findings of this QIMS-DTT highlight what is necessary to have a safe and sacred healing environment for mothers. Filtered through the adapted Theory of Supportive Care Settings, the findings of this deductive theory-testing study found multiple overlaps with the theoretical approach and as such, propose the importance of utilizing a Theory of Supportive Birthing Environments when evaluating birthing care environments. The five main components of Edvardsson’s theory can be found across all included articles and in the findings of this QIMS-DTT, making the findings unique in the application of the theory as a framework to approach environmental birth design.

For instance, a novel finding was the participant-described need for a welcoming birthing environment, including their initial admission to the hospital, being believed, and validated about their labor process, and the birthing environment itself being welcoming to them and their support persons. The initial moments upon arrival at the birthing facility or the presence of the healthcare team can significantly impact the birthing person's emotional well-being, comfort, and sense of security. Indeed, research does indicate that a warm welcome can help alleviate these feelings by making the birthing person feel valued, respected, and cared for from the moment they arrive. A positive and supportive atmosphere can contribute to a more relaxed state of mind [ 47 ]. Although the findings illuminate that a warm welcome into the birthing environment is critically important as it sets the tone for the entire childbirth experience, there is scant literature on this phenomenon as an attribute of the birth environment experience. A warm welcome also fosters trust and rapport between the birthing person and the healthcare team [ 46 ] which is essential for effective communication and cooperation throughout labor and childbirth. When trust is established early on, it can lead to a more collaborative and positive birthing experience. Beyond alleviating stress, feeling welcomed and respected empowers the birthing person to actively engage in their care and decision-making [ 47 ]. When they are treated with kindness and dignity, they are more likely to voice their preferences, concerns, and questions, leading to informed decision-making [ 47 , 77 ]. As many participants shared, the birthing environment itself was responsible for the welcoming feeling and contributed to a positive and comfortable birthing environment. In this study, this included friendly greetings, a clean and inviting room, soft lighting, and soothing sounds. Such an environment can promote relaxation and facilitate a smoother labor and birth [ 77 ].

The findings also illuminate the importance of social connection within the birthing space, through feeling respected and heard, clear communication, and acknowledgment and validation. Social relationships, including those with partners, family members, friends, and healthcare providers, offer emotional support during a time that can be physically and emotionally challenging. Previous literature has supported these findings, indicating that when there are people who care about the birthing person's well-being and provide comfort and encouragement, it can reduce stress and anxiety for the birthing person [ 40 ]. Trust is a critical component of any healthcare relationship, especially during childbirth [ 52 ]. Unique within these findings, however, is the importance of social connection between the women and providers on the recounting of birth stories and satisfaction with the birth environment. Furthermore, although support by providers is well documented, the findings here offer a unique approach as establishing these relationships as a facet of the birth environment. Establishing trust with healthcare providers and support staff is essential for effective communication, which, in turn, leads to better decision-making and a more positive birthing experience.

Safety in the environment was a salient finding of this study, and with good reason. Participants expressed that having interpersonal safety, seeing a good team effort among healthcare providers, and confidence in that healthcare team all contributed to their perceptions of safety in the birthing environment. Creating feelings of safety in the birthing environment is of paramount importance for several reasons. A safe and supportive birthing environment not only ensures the physical well-being of the birthing person and baby but also has a profound impact on the overall childbirth experience. Feelings of safety help reduce stress and anxiety during labor and childbirth [ 78 ]. Perceived safety benefits medical providers as well- when the birthing environment is perceived as safe, it can facilitate the release of endorphins, the body's natural pain relief hormones, and contribute to a smoother labor and birth process without unnecessary medical interventions [ 79 ].

Another important, but already substantiated, finding within safety in the environment was the element of control and agency within the birthing environment that was necessary to have positive birth experiences. Participants engaged in self-advocacy and described the importance of feeling in control over the birthing process to their well-being. Agency and control in the birthing environment are documented crucial aspects of the childbirth experience, as they can significantly impact the physical and emotional well-being of the birthing person and their overall satisfaction with the process [ 45 ]. When birthing people have a sense of agency and control over their birth experience, they report higher levels of satisfaction with the process, regardless of whether their birth unfolds as planned or not [ 45 ]. Agency and control also empower the birthing person to make informed decisions about their birth plan and medical interventions and endorse their maternal role. Informed decision-making allows individuals to choose the options that align with their values, preferences, and health needs. Notably, the findings in this study indicate that when birthing persons do not feel in control of their birth, they had poor retrospective memories about their birth and sometimes felt shame or anger about it. Indeed, a lack of agency and control during childbirth can sometimes lead to feelings of trauma or dissatisfaction [ 80 ]. Although this phenomenon is well documented, the findings from this review contextualize the need for agency and control within the theoretical approach and creates a more comprehensive look at birth environment attributes.

Implications for providers and research

The findings of this study illuminate numerous implications for providers and researchers. For providers, the knowledge that a warm welcome extends beyond them to the entire birthing team, including nurses, midwives, doulas, and support persons. A cohesive and supportive team that welcomes the birthing person with open arms can enhance the overall birthing experience. Furthermore, welcoming includes initial contact and the way a birthing person is received and treated upon arrival can significantly influence their overall perception of their birth experience. A warm welcome contributes to positive birth memories and can have long-lasting emotional and psychological benefits [ 47 ].

Empowering birthing people to have control over their experience can help reduce the risk of trauma. Establishing trust and effective communication between the birthing person, their support team, and healthcare providers is essential for maintaining agency and control. When there is open dialogue and mutual respect, the birthing person is more likely to feel comfortable expressing their preferences and concerns. In some cases, having control over the birthing environment can lead to better physical outcomes. For example, a birthing person who can move freely, choose their birthing position, and have access to comfort measures may experience shorter labor and fewer complications [ 77 ]. In addition, providers should recognize that every birthing experience is unique and respecting cultural and individual differences is essential for promoting agency and control. What one person values or finds empowering in their birthing experience may differ from another, and healthcare providers should strive to accommodate these variations. More research may be needed to understand the prevalence of agency and control better quantitatively in the birthing environment and its relationship to maternal mental health outcomes using measurements surveying the birth environment that combine the attributes of the framework presented in the findings.

Building social relationships in the birthing environment can create a supportive and celebratory atmosphere. The birthing person, their partner, and their support network can share in the joy and excitement of welcoming a new life into the world, enhancing the overall experience.

Social relationships formed during childbirth can extend into the postpartum period, providing ongoing emotional support, advice, and assistance as the birthing person navigates the challenges of early parenthood. Social relationships in the birthing environment can also be a source of valuable information and education. Healthcare providers and support persons can share knowledge about the birthing process, available options, and potential interventions, empowering the birthing person to make informed decisions.

Another implication for providers is building a culture of safety within the environment. When the birthing environment feels unsafe or traumatic, it can have long-lasting negative effects on the birthing person's mental and emotional well-being. Feelings of trauma during childbirth can lead to post-traumatic stress disorder [PTSD] and have a significant impact on future pregnancies [ 80 , 81 ]. Safety also includes trust. Trust is a cornerstone of the birthing experience and when the birthing person trusts their healthcare providers and the birthing environment, they are more likely to follow recommendations, cooperate with care plans, and have a positive overall experience. More research is needed to better understand how women experience trust in the birthing environment specifically, including better understanding of the frequencies of agency, consent, and control over their environments. In addition, research surveying the use of interdisciplinary communication and communication mechanisms with women regarding birth plans might illuminate fragmented communication in the birth environment.

Limitations

Within this study there were some primary limitations related to sampling of studies. When identifying studies through databases and services such as GoogleScholar, embargoes and artificial intelligence interference [e.g., search algorithms] create challenges in replicating and updating searches. For this study, the search was initially conducted then redone to ensure all studies were identified since sufficient time had passed since the initial search. Although exact keywords and procedures were followed from search one to search two, algorithms and embargoes may have led to some key studies not emerging in the search. A second limitation is that given the breadth of birthing environments and cultural orientations to birthing, despite the number of studies analyzed, it is likely that some experiences are not represented in this study.

While the experiences of the participants appeared to range, the scope of the search did not include birthing person experiences outside of the US. Consequently, this leaves the results of this study to only be applicable to what is needed in the small context of the US. Problems that are faced by participants in this study may not be seen as harmful to others. Likewise, since QIMS-DTT is a social work focused method, it can limit how the researchers approached the material from the participants. This can be related to the complex nature of constraints that are often faced in the health-care field. Furthermore, there is a limitation related to the relevancy of applying the TSCS to the birthing space. A key difference between the concept of service in birthing space is that mothers only spend an average of 24 to 48 h in the birthing space, whereas those in nursing care, the environmental in which TSCS originated, could spend an extended period of time in the environment.

In conclusion, a new framework using the Theory of Supportive Care Settings can be applied to evaluate a sacred and healing birthing experience. This new framework includes a balance of already documented phenomenon such as agency and control during birth, as well as integrates new findings, such as the necessity of a warm welcome into the birthing environment to promote trust, comfort, and empowerment. Indeed, the importance of a welcoming environment cannot be overstated. It sets the initial tone for the birthing experience, influencing the individual's stress levels and emotional state, which, in turn, can affect the physiological aspects of childbirth. This study supports the hypothesis from applying TSCS to the birth environment that when individuals feel welcomed, they are more likely to experience a sense of calm and readiness for birth, which can lead to more positive outcomes.

Our study contributes to the growing body of literature that underscores the significance of the birth environment in shaping birth experiences. It calls for a reevaluation of current practices and environments in which childbirth takes place, advocating for a more holistic approach that encompasses emotional, psychological, and physical well-being. The implications of our findings extend beyond the individual, suggesting that by improving birth experiences, we can foster better early bonding experiences, potentially leading to long-term benefits for both the mother and child.

Authors’contributions

Authors DM and SL contributed to the initial design and concept. DM, SL, RT, and TG all performed data collection, data analysis, interpretation of results, and drafting of the article. All authors made substantial contributions to the initial and revised manuscript. All authors have read and approved the final version and are accountable for all aspects of the work.

Availability of data and materials

The data used in this study are from publicly available existing literature, therefore the data is available within this article from the data tables.

Grünebaum A, Bornstein E, McLeod-Sordjan R, Lewis T, Wasden S, Combs A, et al. The impact of birth settings on pregnancy outcomes in the United States. Am J Obstet Gynecol. 2023;228(5):S965–76.

Article   PubMed   Google Scholar  

Çalik KY, Karabulutlu Ö, Yavuz C. First do no harm - interventions during labor and maternal satisfaction: a descriptive cross-sectional study. BMC Pregnancy Childbirth. 2018;18(1):415.

Article   PubMed   PubMed Central   Google Scholar  

Lothian JA. Healthy birth practice #4: avoid interventions unless they are medically necessary. J Perinat Educ. 2014;23(4):198–206.

Zolkefli ZHH, Mumin KHA, Idris DR. Autonomy and its impact on midwifery practice. Br J Midwifery. 2020;28(2):120–9.

Article   Google Scholar  

Ahmadpour P, Faroughi F, Mirghafourvand M. The relationship of childbirth experience with postpartum depression and anxiety: a cross-sectional study. BMC Psychol. 2023;11(1):58. https://doi.org/10.1186/s40359-023-01105-6 .

George EK. Birth Center Breastfeeding Rates. MCNAm J Matern Child Nurs. 2022;47(6):310–7.

Parratt J, Fahy K. Creating a ‘safe’ place for birth: an empirically grounded theory. New Zealand College Midwives J. 2004;30. [cited 2020 Apr 17]. Available from: https://epubs.scu.edu.au/hahs_pubs/1657

Akbaş P, ÖzkanŞat S, Yaman SŞ. The effect of holistic birth support strategies on coping with labor pain, birth satisfaction, and fear of childbirth: a randomized, triple-blind. Controlled Trial Clin Nurs Res. 2022;31(7):1352–61.

Soet JE, Brack GA, DiIorio C. Prevalence and Predictors of Women’s Experience of Psychological Trauma During Childbirth. Birth. 2003;30(1):36–46. https://doi.org/10.1046/j.1523-536X.2003.00215.x . [cited 2017 Sep 7].

Moran Vozar TE, Van Arsdale A, Gross LA, Hoff E, Pinch S. The elephant in the delivery room: Enhancing awareness of the current literature and recommendations for perinatal PTSD. Pract Innov. 2021;6(1):1–16.

Orovou E, Eskitzis P, Mrvoljak-Theodoropoulou I, Tzitiridou-Chatzopoulou M, Dagla M, Arampatzi C, et al. The Relation between Neonatal Intensive Care Units and Postpartum Post-Traumatic Stress Disorder after Cesarean Section. Healthcare. 2023;11(13):1877.

Forssén ASK. Lifelong significance of disempowering experiences in prenatal and maternity care. Qual Health Res. 2012;22(11):1535–46.

Olwanda E, Opondo K, Oluoch D, Croke K, Maluni J, Jepkosgei J, et al. Women’s autonomy and maternal health decision making in Kenya: implications for service delivery reform - a qualitative study. BMC Womens Health. 2024;24(1):181.

Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, et al. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues Ment Health Nurs. 2012;33(7):445–57.

Tripathy P. A public health approach to perinatal mental health: Improving health and wellbeing of mothers and babies. J Gynecol Obstet Hum Reprod. 2020;49(6).

VanderKruik R, Barreix M, Chou D, Allen T, Say L, Cohen LS, et al. The global prevalence of postpartum psychosis: a systematic review. BMC Psychiatry. 2017;17(1):272. [cited 2017 Sep 7]. Available from:  http://www.ncbi.nlm.nih.gov/pubmed/28754094 .

Walker AL, Peters PH, de Rooij SR, Henrichs J, Witteveen AB, Verhoeven CJM, et al. The long-term impact of maternal anxiety and depression postpartum and in early childhood on child and paternal mental health at 11–12 years follow-up. Front Psychiatry. 2020;15:11.

Google Scholar  

Huisman ERCM, Morales E, van Hoof J, Kort HSM. Healing environment: A review of the impact of physical environmental factors on users. Build Environ. 2012;1(58):70–80.

Simonsen T, Sturge J, Duff C. Healing Architecture in Healthcare: A Scoping Review. HERD: Health Environ Res Design J. 2022;15(3):315–28.

Asadi Z, Shahcheraghi A, Zare L, Gharehbaglou M. The effect of supportive care environment on the treatment process in hospitals: a qualitative study. Crescent J Med Biol Sci. 2023;10(2):81–92.

Nielsen JH, Overgaard C. Healing architecture and Snoezelen in delivery room design: a qualitative study of women’s birth experiences and patient-centeredness of care. BMC Pregnancy Childbirth. 2020;20(1):283.

Shin JH. Hospital Birthing Room Design: A Study Of Mothers’ Perception Of Hominess. J Inter Des. 2004;30(1):23–36. [cited 2020 Apr 17] Available from: https://doi.org/10.1111/j.1939-1668.2004.tb00397.x

Kuipers YJ, Thomson G, Goberna-Tricas J, Zurera A, Hresanová E, Temesgenová N, et al. The social conception of space of birth narrated by women with negative and traumatic birth experiences. Women and Birth. 2023;36(1):e78–85.

Borquez HA, Wiegers TA. A comparison of labour and birth experiences of women delivering in a birthing centre and at home in the Netherlands. Midwifery. 2006;22[4]:339–47. [cited 2019 Feb 21]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16647170

Preis H, Lobel M, Benyamini Y. Between Expectancy and Experience. Psychol Women Q. 2018;036168431877953. [cited 2019 Jan 19].  https://doi.org/10.1177/0361684318779537

Ko JY, Rockhill KM, Tong VT, Morrow B, Farr SL. Trends in Postpartum Depressive Symptoms — 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66(6):153–8. [cited 2019 May 14] Available from: http://www.cdc.gov/mmwr/volumes/66/wr/mm6606a1.htm

Mughal S, Azhar Y, Siddiqui W. Postpartum Depression. 2024.

Abdollahi F, Lye MS, Zain AM, Ghazali SS, Zarghami M. Postnatal depression and its associated factors in women from different cultures. Iran J Psychiatry Behav Sci. Kowsar Medical Publishing Company; 2011;5(2):5–11.

Abenova M, Myssayev A, Kanya L, Turliuc MN, Jamedinova U. Prevalence of postpartum depression and its associated factors within a year after birth in Semey, Kazakhstan: A cross sectional study. Clin Epidemiol Glob Health. 2022;16:101103.

Aguirre RT, Bolton KW. Qualitative interpretive meta-synthesis in social work research: Uncharted territory. J Soc Work. 2014;14(3):279–94. [cited 2019 Jan 14].  https://doi.org/10.1177/1468017313476797

Nordberg A, Marcus Crawford BR, Regina Praetorius BT, Smith Hatcher S. Exploring Minority Youths’ Police Encounters: A Qualitative Interpretive Meta-synthesis. Adolescent Soc Work J. 2016;33(2):137–49. [cited 2018 Feb 20]. Available from: https://search-proquest-com.ezproxy.uta.edu/docview/1772422660?pq-origsite=summon

Ravi KE, Casolaro TE. Children’s Exposure to Intimate Partner Violence: A Qualitative Interpretive Meta-synthesis. Child Adolescent Soc Work J. 2017;1–13. [cited 2018 Feb 20]. https://doi.org/10.1007/s10560-017-0525-1

Maxwell D, Robinson SR, Rogers K. “I keep it to myself”: a qualitative meta-interpretive synthesis of experiences of postpartum depression among marginalised women. Health Soc Care Community. 2019;27(3):e23–6.

Praetorius R, Maxwell D, Alam K. Wearing a happy mask: mother’s expressions of suicidality with postpartum depression. Soc Work Ment Health. 2020;18(4):429–59.

Edvardsson JD, Sandman PO, Rasmussen BH. Sensing an atmosphere of ease: A tentative theory of supportive care settings. Scand J Caring Sci. 2005;19(4):344–53. [cited 2021 May 27]. Available from: https://pubmed.ncbi.nlm.nih.gov/16324058/

Leather P, Beale D, Santos A, Watts J, Lee L. Outcomes of environmental appraisal of different hospital waiting areas. Environ Behav. 2003;35(6):842–69.

Vedam S, Stoll K, Khemet Taiwo T, Rubashkin N, Cheyney M, Strauss N, et al. The Giving Voice to Mothers study: inequity and mistreatment during pregnancy and childbirth in the United States. Reprod Health. 2019;16(1):77. [cited 2020 May 4]. Available from: https://doi.org/10.1186/s12978-019-0729-2

Nilsson C, Wijk H, Höglund L, Sjöblom H, Hessman E, Berg M. Effects of birthing room design on maternal and neonate outcomes: a systematic review. HERD. SAGE Publications Inc.; 2020;13(3):198–214.

Reid KM, Taylor MG. Social support, stress, and maternal postpartum depression: A comparison of supportive relationships. Soc Sci Res. 2015;54:246–62.

Harte JD, Sheehan A, Stewart SC, Foureur M. Childbirth supporters’ experiences in a built hospital birth environment: exploring inhibiting and facilitating factors in negotiating the supporter role. Health Environ Res Design J. 2016;9(3):135–61.

Hodnett E, Stremler R, Weston J, McKeever P. Re-conceptualizing the hospital labor room: the PLACE [Pregnant and Laboring in an Ambient Clinical Environment] pilot trial. Birth. 2009;36(2):159–66.

Van Maanen J. Ethnography as work: some rules of engagement. J Manage Stud. 2011;48(1):218–34.

Vargas-Bianchi L. Qualitative theory testing by deductive design and pattern matching analysis. SocArxiv. https://doi.org/10.31235/osf.io/w4gxe . Published online July 30, 2020.

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;29: n71.

Scrimshaw SC, Backes EP, editors. Birth Settings in America. Washington, D.C.: National Academies Press; 2020.

Admon LK, Dalton VK, Kolenic GE, et al. Trends in suicidality 1 year before and after birth among commercially insured childbearing individuals in the United States, 2006–2017. JAMA Psychiatry. Published online November 18, 2020. https://doi.org/10.1001/jamapsychiatry.2020.3550

Attanasio LB, McPherson ME, Kozhimannil KB. Positive childbirth experiences in US hospitals: a mixed methods analysis. Matern Child Health J. 2014;18(5):1280–90.

Beebe KR, Humphreys J. Expectations, perceptions, and management of labor in nulliparas prior to hospitalization. J Midwifery Womens Health. 2006;51(5):347–53.

Bernhard C, Zielinski R, Ackerson K, English J. Home birth after hospital birth: women’s choices and reflections. J Midwifery Womens Health. 2014;59(2):160–6.

Boucher D, Bennett C, McFarlin B, Freeze R. Staying home to give birth: why women in the United States choose home birth. J Midwifery Womens Health. 2009;54(2):119–26.

Brooks JL, Holdtich-Davis D, Docherty SL, Theodorou CS. Birthing and parenting a premature infant in a cultural context. Qual Health Res. 2016;26(3):387–98.

Fair CD, Morrison T. “I felt part of the decision-making process”: a qualitative study on techniques used to enhance maternal control during labor and delivery. Int J Childbirth Educ. 2011;26(3):21–5.

Finn JM. Culture care of euro-american women during childbirth: using leininger’s theory. J Transcult Nurs. 1994;5(2):25–37.

Article   CAS   PubMed   Google Scholar  

Fowles ER. Labor concerns of women two months after delivery. Birth. 1998;25(4):235–40.

Gardner M, Suplee PD, Bloch J, Lecks K. Exploratory study of childbearing experiences of women with asperger syndrome. Nurs Womens Health. 2016;20(1):28–37.

Hall PJ, Foster JW, Yount KM, Jennings BM. Keeping it together and falling apart: Women’s dynamic experience of birth. Midwifery. 2018;58:130–6.

Hill N, Hunt E, Hyrkäs K. Somali immigrant women’s health care experiences and beliefs regarding pregnancy and birth in the United States. J Transcult Nurs. 2012;23(1):72–81.

Lipson JG, Rogers J. Pregnancy, birth, and disability: women’s health care experiences. Health Care Women Int. 2000;21(1):11–26.

Low LK, Martin K, Sampselle C, Guthrie B, Oakley D. Adolescents’ experiences of childbirth: contrasts with adults 1, 2 . J Midwifery Womens Health. 2003;48(3):192–8.

Low LK, Moffat A. Every Labor is Unique. MCN Am J Matern Child Nurs. 2006;31(5):307???312.

Lynch TA, Cheyney M, Chan M, Walia J, Burcher P. Temporal themes in periviable birth: a qualitative analysis of patient experiences. Matern Child Health J. 2019;23(3):422–30.

Lyndon A, Malana J, Hedli LC, Sherman J, Lee HC. Thematic analysis of women’s perspectives on the meaning of safety during hospital-based birth. J Obstet Gynecol Neonatal Nurs. 2018;47(3):324–32.

McKinney D. A Qualitative Study of the Bradley Method of Childbirth Education. International Journal of Childbirth Education. 2006;21(3).

Qureshi R, Pacquiao DF. Ethnographic study of experiences of Pakistani women immigrants with pregnancy, birthing, and postpartum care in the United States and Pakistan. J Transcult Nurs. 2013;24(4):355–62.

Raines DA, Morgan Z. Culturally sensitive care during childbirth. Appl Nurs Res. 2000;13(4):167–72.

Sauls DJ. Promoting a positive childbirth experience for adolescents. J Obstet Gynecol Neonatal Nurs. 2010;39(6):703–12.

Seo JY, Kim W, Dickerson SS. Korean immigrant women’s lived experience of childbirth in the United States. J Obstet Gynecol Neonatal Nurs. 2014;43(3):305–17.

Sheffield SM, Liddell JL. “If I Had a Choice, I’d Do It Natural”: Gulf South indigenous women’s preferences and experiences in childbirth. Int J Childbirth. 2023;13(1):23–36.

Smeltzer SC, Wint AJ, Ecker JL, Iezzoni LI. Labor, delivery, and anesthesia experiences of women with physical disability. Birth. 2017;44(4):315–24.

Taniguchi H, Baruffi G. Childbirth overseas: The experience of Japanese women in Hawaii. Nurs Health Sci. 2007;9(2):90–5.

Tiedje LB, Price E, You M. Childbirth Is Changing What Now? MCN Am J Matern Child Nurs. 2008;33(3):144–50.

VandeVusse L. Decision making in analyses of women’s birth stories. Birth. 1999;26(1):43–50.

Yeo S, Fetters M, Maeda Y. Japanese couples’ childbirth experiences in michigan: implications for care. Birth. 2000;27(3):191–8.

LoGiudice JA, Beck CT. The lived experience of childbearing from survivors of sexual abuse: “It Was the Best of Times, It Was the Worst of Times.” J Midwifery Womens Health. 2016;61(4):474–81.

Mackey MC. Women’s evaluation of the labor and delivery experience. Nursingconnections. 1998;11(3):19–32.

CAS   PubMed   Google Scholar  

Matthews R, Callister LC. Childbearing women’s perceptions of nursing care that promotes dignity. J Obstet Gynecol Neonatal Nurs. 2004;33(4):498–507.

Ayerle GM, Schäfers R, Mattern E, Striebich S, Haastert B, Vomhof M, et al. Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial. Trials. 2018 Nov 19;19(1):NA-NA.

Hollins Martin C, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 2011;24(2):124–35.

Uvnäs-Moberg K. The physiology and pharmacology of oxytocin in labor and in the peripartum period. Am J Obstet Gynecol. 2024;230(3):S740–58.

Tatano BC. A metaethnography of traumatic childbirth and its aftermath: amplifying causal looping. Qual Health Res. 2011;21(3):301–11.

Beck CT. Birth trauma and its sequelae. J Trauma Dissociation. 2009;10(2):189–203.

Download references

Financial support for publication was provided by the University of Oklahoma Libraries’ Open Access Fund.

Author information

Authors and affiliations.

The University of Oklahoma, Norman, OK, USA

December Maxwell

The University of Memphis, Memphis, TN, USA

Sarah R. Leat

The University of Texas at Arlington, Arlington, TX, USA

Toni Gallegos & Regina T. Praetorius

You can also search for this author in PubMed   Google Scholar

Contributions

Corresponding author.

Correspondence to Regina T. Praetorius .

Ethics declarations

Ethics approval and consent to participate.

Not Applicable.

Consent for publication

Competing interests.

The authors declare no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Maxwell, D., Leat, S.R., Gallegos, T. et al. Sacred space: a qualitative interpretive meta-synthesis of women’s experiences of supportive birthing environments. BMC Pregnancy Childbirth 24 , 372 (2024). https://doi.org/10.1186/s12884-024-06544-6

Download citation

Received : 06 November 2023

Accepted : 25 April 2024

Published : 15 May 2024

DOI : https://doi.org/10.1186/s12884-024-06544-6

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Qualitative Interpretive Meta-Synthesis (QIMS)
• Birthing process
• Becoming a mother
• Built environment

BMC Pregnancy and Childbirth

ISSN: 1471-2393

• Submission enquiries: [email protected]
• General enquiries: [email protected]

• Open access
• Published: 13 May 2024

Sexual and reproductive health implementation research in humanitarian contexts: a scoping review

• Alexandra Norton 1 &
• Hannah Tappis 2  

Reproductive Health volume  21 , Article number:  64 ( 2024 ) Cite this article

85 Accesses

Metrics details

Meeting the health needs of crisis-affected populations is a growing challenge, with 339 million people globally in need of humanitarian assistance in 2023. Given one in four people living in humanitarian contexts are women and girls of reproductive age, sexual and reproductive health care is considered as essential health service and minimum standard for humanitarian response. Despite growing calls for increased investment in implementation research in humanitarian settings, guidance on appropriate methods and analytical frameworks is limited.

A scoping review was conducted to examine the extent to which implementation research frameworks have been used to evaluate sexual and reproductive health interventions in humanitarian settings. Peer-reviewed papers published from 2013 to 2022 were identified through relevant systematic reviews and a literature search of Pubmed, Embase, PsycInfo, CINAHL and Global Health databases. Papers that presented primary quantitative or qualitative data pertaining to a sexual and reproductive health intervention in a humanitarian setting were included.

Seven thousand thirty-six unique records were screened for inclusion, and 69 papers met inclusion criteria. Of these, six papers explicitly described the use of an implementation research framework, three citing use of the Consolidated Framework for Implementation Research. Three additional papers referenced other types of frameworks used in their evaluation. Factors cited across all included studies as helping the intervention in their presence or hindering in their absence were synthesized into the following Consolidated Framework for Implementation Research domains: Characteristics of Systems, Outer Setting, Inner Setting, Characteristics of Individuals, Intervention Characteristics, and Process.

This review found a wide range of methodologies and only six of 69 studies using an implementation research framework, highlighting an opportunity for standardization to better inform the evidence for and delivery of sexual and reproductive health interventions in humanitarian settings. Increased use of implementation research frameworks such as a modified Consolidated Framework for Implementation Research could work toward both expanding the evidence base and increasing standardization.

Plain English summary

Three hundred thirty-nine million people globally were in need of humanitarian assistance in 2023, and meeting the health needs of crisis-affected populations is a growing challenge. One in four people living in humanitarian contexts are women and girls of reproductive age, and provision of sexual and reproductive health care is considered to be essential within a humanitarian response. Implementation research can help to better understand how real-world contexts affect health improvement efforts. Despite growing calls for increased investment in implementation research in humanitarian settings, guidance on how best to do so is limited. This scoping review was conducted to examine the extent to which implementation research frameworks have been used to evaluate sexual and reproductive health interventions in humanitarian settings. Of 69 papers that met inclusion criteria for the review, six of them explicitly described the use of an implementation research framework. Three used the Consolidated Framework for Implementation Research, a theory-based framework that can guide implementation research. Three additional papers referenced other types of frameworks used in their evaluation. This review summarizes how factors relevant to different aspects of implementation within the included papers could have been organized using the Consolidated Framework for Implementation Research. The findings from this review highlight an opportunity for standardization to better inform the evidence for and delivery of sexual and reproductive health interventions in humanitarian settings. Increased use of implementation research frameworks such as a modified Consolidated Framework for Implementation Research could work toward both expanding the evidence base and increasing standardization.

Peer Review reports

Over the past few decades, the field of public health implementation research (IR) has grown as a means by which the real-world conditions affecting health improvement efforts can be better understood. Peters et al. put forward the following broad definition of IR for health: “IR is the scientific inquiry into questions concerning implementation – the act of carrying an intention into effect, which in health research can be policies, programmes, or individual practices (collectively called interventions)” [ 1 ].

As IR emphasizes real-world circumstances, the context within which a health intervention is delivered is a core consideration. However, much IR implemented to date has focused on higher-resource settings, with many proposed frameworks developed with particular utility for a higher-income setting [ 2 ]. In recognition of IR’s potential to increase evidence across a range of settings, there have been numerous reviews of the use of IR in lower-resource settings as well as calls for broader use [ 3 , 4 ]. There have also been more focused efforts to modify various approaches and frameworks to strengthen the relevance of IR to low- and middle-income country settings (LMICs), such as the work by Means et al. to adapt a specific IR framework for increased utility in LMICs [ 2 ].

Within LMIC settings, the centrality of context to a health intervention’s impact is of particular relevance in humanitarian settings, which present a set of distinct implementation challenges [ 5 ]. Humanitarian responses to crisis situations operate with limited resources, under potential security concerns, and often under pressure to relieve acute suffering and need [ 6 ]. Given these factors, successful implementation of a particular health intervention may require different qualities than those that optimize intervention impact under more stable circumstances [ 7 ]. Despite increasing recognition of the need for expanded evidence of health interventions in humanitarian settings, the evidence base remains limited [ 8 ]. Furthermore, despite its potential utility, there is not standardized guidance on IR in humanitarian settings, nor are there widely endorsed recommendations for the frameworks best suited to analyze implementation in these settings.

Sexual and reproductive health (SRH) is a core aspect of the health sector response in humanitarian settings [ 9 ]. Yet, progress in addressing SRH needs has lagged far behind other services because of challenges related to culture and ideology, financing constraints, lack of data and competing priorities [ 10 ]. The Minimum Initial Service Package (MISP) for SRH in Crisis Situations is the international standard for the minimum set of SRH services that should be implemented in all crisis situations [ 11 ]. However, as in other areas of health, there is need for expanded evidence for planning and implementation of SRH interventions in humanitarian settings. Recent systematic reviews of SRH in humanitarian settings have focused on the effectiveness of interventions and service delivery strategies, as well as factors affecting utilization, but have not detailed whether IR frameworks were used [ 12 , 13 , 14 , 15 ]. There have also been recent reviews examining IR frameworks used in various settings and research areas, but none have explicitly focused on humanitarian settings [ 2 , 16 ].

Given the need for an expanded evidence base for SRH interventions in humanitarian settings and the potential for IR to be used to expand the available evidence, a scoping review was undertaken. This scoping review sought to identify IR approaches that have been used in the last ten years to evaluate SRH interventions in humanitarian settings.

This review also sought to shed light on whether there is a need for a common framework to guide research design, analysis, and reporting for SRH interventions in humanitarian settings and if so, if there are any established frameworks already in use that would be fit-for-purpose or could be tailored to meet this need.

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews was utilized to guide the elements of this review [ 17 ]. The review protocol was retrospectively registered with the Open Science Framework ( https://osf.io/b5qtz ).

Search strategy

A two-fold search strategy was undertaken for this review, which covered the last 10 years (2013–2022). First, recent systematic reviews pertaining to research or evaluation of SRH interventions in humanitarian settings were identified through keyword searches on PubMed and Google Scholar. Four relevant systematic reviews were identified [ 12 , 13 , 14 , 15 ] Table 1 .

Second, a literature search mirroring these reviews was conducted to identify relevant papers published since the completion of searches for the most recent review (April 2017). Additional file 1 includes the search terms that were used in the literature search [see Additional file 1 ].

The literature search was conducted for papers published from April 2017 to December 2022 in the databases that were searched in one or more of the systematic reviews: PubMed, Embase, PsycInfo, CINAHL and Global Health. Searches were completed in January 2023 Table 2 .

Two reviewers screened each identified study for alignment with inclusion criteria. Studies in the four systematic reviews identified were considered potentially eligible if published during the last 10 years. These papers then underwent full-text review to confirm satisfaction of all inclusion criteria, as inclusion criteria were similar but not fully aligned across the four reviews.

Literature search results were exported into a citation manager (Covidence), duplicates were removed, and a step-wise screening process for inclusion was applied. First, all papers underwent title and abstract screening. The remaining papers after abstract screening then underwent full-text review to confirm satisfaction of all inclusion criteria. Title and abstract screening as well as full-text review was conducted independently by both authors; disagreements after full-text review were resolved by consensus.

Data extraction and synthesis

The following content areas were summarized in Microsoft Excel for each paper that met inclusion criteria: publication details including author, year, country, setting [rural, urban, camp, settlement], population [refugees, internally displaced persons, general crisis-affected], crisis type [armed conflict, natural disaster], crisis stage [acute, chronic], study design, research methods, SRH intervention, and intervention target population [specific beneficiaries of the intervention within the broader population]; the use of an IR framework; details regarding the IR framework, how it was used, and any rationale given for the framework used; factors cited as impacting SRH interventions, either positively or negatively; and other key findings deemed relevant to this review.

As the focus of this review was on the approach taken for SRH intervention research and evaluation, the quality of the studies themselves was not assessed.

Twenty papers underwent full-text review due to their inclusion in one or more of the four systematic reviews and meeting publication date inclusion criteria. The literature search identified 7,016 unique papers. After full-text screening, 69 met all inclusion criteria and were included in the review. Figure  1 illustrates the search strategy and screening process.

Flow chart of paper identification

Papers published in each of the 10 years of the review timeframe (2013–2022) were included. 29% of the papers originated from the first five years of the time frame considered for this review, with the remaining 71% papers coming from the second half. Characteristics of included publications, including geographic location, type of humanitarian crisis, and type of SRH intervention, are presented in Table  3 .

A wide range of study designs and methods were used across the papers, with both qualitative and quantitative studies well represented. Twenty-six papers were quantitative evaluations [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 ], 17 were qualitative [ 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 ], and 26 used mixed methods [ 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 ]. Within the quantitative evaluations, 15 were observational, while five were quasi-experimental, five were randomized controlled trials, and one was an economic evaluation. Study designs as classified by the authors of this review are summarized in Table  4 .

Six papers (9%) explicitly cited use of an IR framework. Three of these papers utilized the Consolidated Framework for Implementation Research (CFIR) [ 51 , 65 , 70 ]. The CFIR is a commonly used determinant framework that—in its originally proposed form in 2009—is comprised of five domains, each of which has constructs to further categorize factors that impact implementation. The CFIR domains were identified as core content areas influencing the effectiveness of implementation, and the constructs within each domain are intended to provide a range of options for researchers to select from to “guide diagnostic assessments of implementation context, evaluate implementation progress, and help explain findings.” [ 87 ] To allow for consistent terminology throughout this review, the original 2009 CFIR domains and constructs are used.

Guan et al. conducted a mixed methods study to assess the feasibility and effectiveness of a neonatal hepatitis B immunization program in a conflict-affected rural region of Myanmar. Guan et al. report mapping data onto the CFIR as a secondary analysis step. They describe that “CFIR was used as a comprehensive meta-theoretical framework to examine the implementation of the Hepatitis B Virus vaccination program,” and implementation themes from multiple study data sources (interviews, observations, examination of monitoring materials) were mapped onto CFIR constructs. They report their results in two phases – Pre-implementation training and community education, and Implementation – with both anchored in themes that they had mapped onto CFIR domains and constructs. All but six constructs were included in their analysis, with a majority summarized in a table and key themes explored further in the narrative text. They specify that most concerns were identified within the Outer Setting and Process domains, while elements identified within the Inner Setting domain provided strength to the intervention and helped mitigate against barriers [ 70 ].

Sarker et al. conducted a qualitative study to assess provision of maternal, newborn and child health services to Rohingya refugees residing in camps in Cox’s Bazar, Bangladesh. They cite using CFIR as a guide for thematic analysis, applying it after a process of inductive and deductive coding to index these codes into the CFIR domains. They utilized three of the five CFIR domains (Outer Setting, Inner Setting, and Process), stating that the remaining two domains (Intervention Characteristics and Characteristics of Individuals) were not relevant to their analysis. They then proposed two additional CFIR domains, Context and Security, for use in humanitarian contexts. In contrast to Guan et al., CFIR constructs are not used nor mentioned by Sarker et al., with content under each domain instead synthesized as challenges and potential solutions. Regarding the CFIR, Sarker et al. write, “The CFIR guided us for interpretative coding and creating the challenges and possible solutions into groups for further clarification of the issues related to program delivery in a humanitarian crisis setting.” [ 51 ]

Sami et al. conducted a mixed methods case study to assess the implementation of a package of neonatal interventions at health facilities within refugee and internally displaced persons camps in South Sudan. They reference use of the CFIR earlier in the study than Sarker et al., basing their guides for semi-structured focus group discussions on the CFIR framework. They similarly reference a general use of the CFIR framework as they conducted thematic analysis. Constructs are referenced once, but they do not specify whether their application of the CFIR framework included use of domains, constructs, or both. This may be in part because they then applied an additional framework, the World Health Organization (WHO) Health System Framework, to present their findings. They describe a nested approach to their use of these frameworks: “Exploring these [CFIR] constructs within the WHO Health Systems Framework can identify specific entry points to improve the implementation of newborn interventions at critical health system building blocks.” [ 65 ]

Three papers cite use of different IR frameworks. Bolan et al. utilized the Theoretical Domains Framework in their mixed methods feasibility study and pilot cluster randomized trial evaluating pilot use of the Safe Delivery App by maternal and newborn health workers providing basic emergency obstetric and newborn care in facilities in the conflict-affected Maniema province of the Democratic Republic of the Congo (DRC). They used the Theroetical Domains Framework in designing interview questions, and further used it as the coding framework for their analysis. Similar to the CFIR, the Theoretical Domains Framework is a determinant framework that consists of domains, each of which then includes constructs. Bolan et al. utilized the Theoretical Domains Framework at the construct level in interview question development and at the domain level in their analysis, mapping interview responses to eight of the 14 domains [ 83 ]. Berg et al. report using an “exploratory design guided by the principles of an evaluation framework” developed by the Medical Research Council to analyze the implementation process, mechanisms of impact, and outcomes of a three-pillar training intervention to improve maternal and neonatal healthcare in the conflict-affected South Kivu province of the DRC [ 67 , 88 ]. Select components of this evaluation framework were used to guide deductive analysis of focus group discussions and in-depth interviews [ 67 ]. In their study of health workers’ knowledge and attitudes toward newborn health interventions in South Sudan, before and after training and supply provision, Sami et al. report use of the Conceptual Framework of the Role of Attitudes in Evidence-Based Practice Implementation in their analysis process. The framework was used to group codes following initial inductive coding analysis of in-depth interviews [ 72 ].

Three other papers cite use of specific frameworks in their intervention evaluation [ 19 , 44 , 76 ]. As a characteristic of IR is the use of an explicit framework to guide the research, the use of the frameworks in these three papers meets the intention of IR and serves the purpose that an IR framework would have in strengthening the analytical rigor. Castle et al. cite use of their program’s theory of change as a framework for a mixed methods evaluation of the provision of family planning services and more specifically uptake of long-acting reversible contraception use in the DRC. They describe use of the theory of change to “enhance effectiveness of [long-acting reversible contraception] access and uptake.” [ 76 ] Thommesen et al. cite use of the AAAQ (Availability, Accessibility, Acceptability and Quality) framework in their qualitative study assessing midwifery services provided to pregnant women in Afghanistan. This framework is focused on the “underlying elements needed for attainment of optimum standard of health care,” but the authors used it in this paper to evaluate facilitators and barriers to women accessing midwifery services [ 44 ]. Jarrett et al. cite use of the Centers for Disease Control and Prevention’s (CDC) Guidelines for Evaluating Public Health Surveillance Systems to explore the characteristics of a population mobility, mortality and birth surveillance system in South Kivu, DRC. Use of these CDC guidelines is cited as one of four study objectives, and commentary is included in the Results section pertaining to each criteria within these guidelines, although more detail regarding use of these guidelines or the authors’ experience with their use in the study is not provided [ 19 ].

Overall, 22 of the 69 papers either explicitly or implicitly identified IR as relevant to their work. Nineteen papers include a focus on feasibility (seven of which did not otherwise identify the importance of exploring questions concerning implementation), touching on a common outcome of interest in implementation research [ 89 ].

While a majority of papers did not explicitly or implicitly use an IR framework to evaluate their SRH intervention of focus, most identified factors that facilitated implementation when they were present or served as a barrier when absent. Sixty cite factors that served as facilitators and 49 cite factors that served as barriers, with just three not citing either. Fifty-nine distinct factors were identified across the papers.

Three of the six studies that explicitly used an IR framework used the CFIR, and the CFIR is the only IR framework that was used by multiple studies. As previously mentioned, Means et al. put forth an adaptation of the CFIR to increase its relevance in LMIC settings, proposing a sixth domain (Characteristics of Systems) and 11 additional constructs [ 2 ]. Using the expanded domains and constructs as proposed by Means et al., the 59 factors cited by papers in this review were thematically grouped into the six domains: Characteristics of Systems, Outer Setting, Inner Setting, Characteristics of Individuals, Intervention Characteristics, and Process. Within each domain, alignment with CFIR constructs was assessed for, and alignment was found with 29 constructs: eight of Means et al.’s 11 constructs, and 21 of the 39 standard CFIR constructs. Three factors did not align with any construct (all fitting within the Outer Setting domain), and 14 aligned with a construct label but not the associated definition. Table 5 synthesizes the mapping of factors affecting SRH intervention implementation to CFIR domains and constructs, with the construct appearing in italics if it is considered to align with that factor by label but not by definition.

Table 6 lists the CFIR constructs that were not found to have alignment with any factor cited by the papers in this review.

This scoping review sought to assess how IR frameworks have been used to bolster the evidence base for SRH interventions in humanitarian settings, and it revealed that IR frameworks, or an explicit IR approach, are rarely used. All four of the systematic reviews identified with a focus on SRH in humanitarian settings articulate the need for more research examining the effectiveness of SRH interventions in humanitarian settings, with two specifically citing a need for implementation research/science [ 12 , 13 ]. The distribution of papers across the timeframe included in this review does suggest that more research on SRH interventions for crisis-affected populations is taking place, as a majority of relevant papers were published in the second half of the review period. The papers included a wide range of methodologies, which reflect the differing research questions and contexts being evaluated. However, it also invites the question of whether there should be more standardization of outcomes measured or frameworks used to guide analysis and to facilitate increased comparison, synthesis and application across settings.

Three of the six papers that used an IR framework utilized the CFIR. Guan et al. used the CFIR at both a domain and construct level, Sarker et al. used the CFIR at the domain level, and Sami et al. did not specify which CFIR elements were used in informing the focus group discussion guide [ 51 , 65 , 70 ]. It is challenging to draw strong conclusions about the applicability of CFIR in humanitarian settings based on the minimal use of CFIR and IR frameworks within the papers reviewed, although Guan et al. provides a helpful model for how analysis can be structured around CFIR domains and constructs. It is worth considering that the minimal use of IR frameworks, and more specifically CFIR constructs, could be in part because that level of prescriptive categorization does not allow for enough fluidity in humanitarian settings. It also raises questions about the appropriate degree of standardization to pursue for research done in these settings.

The mapping of factors affecting SRH intervention implementation provides an example of how a modified CFIR framework could be used for IR in humanitarian contexts. This mapping exercise found factors that mapped to all five of the original CFIR domains as well as the sixth domain proposed by Means et al. All factors fit well within the definition for the selected domain, indicating an appropriate degree of fit between these existing domains and the factors identified as impacting SRH interventions in humanitarian settings. On a construct level, however, the findings were more variable, with one-quarter of factors not fully aligning with any construct. Furthermore, over 40% of the CFIR constructs (including the additional constructs from Means et al.) were not found to align with any factors cited by the papers in this review, also demonstrating some disconnect between the parameters posed by the CFIR constructs and the factors cited as relevant in a humanitarian context.

It is worth noting that while the CFIR as proposed in 2009 was used in this assessment, as well as in the included papers which used the CFIR, an update was published in 2022. Following a review of CFIR use since its publication, the authors provide updates to construct names and definitions to “make the framework more applicable across a range of innovations and settings.” New constructs and subconstructs were also added, for a total of 48 constructs and 19 subconstructs across the five domains [ 90 ]. A CFIR Outcomes Addendum was also published in 2022, based on recommendations for the CFIR to add outcomes and intended to be used as a complement to the CFIR determinants framework [ 91 ]. These expansions to the CFIR framework may improve applicability of the CFIR in humanitarian settings. Several constructs added to the Outer Setting domain could be of particular utility – critical incidents, local attitudes, and local conditions, each of which could help account for unique challenges faced in contexts of crisis. Sub-constructs added within the Inner Setting domain that seek to clarify structural characteristics and available resources would also be of high utility based on mapping of the factors identified in this review to the original CFIR constructs. As outcomes were not formally included in the CFIR until the 2022 addendum, a separate assessment of implementation outcomes was not undertaken in this review. However, analysis of the factors cited by papers in this review as affecting implementation was derived from the full text of the papers and thus captures content relevant to implementation determinants that is contained within the outcomes.

Given the demonstrated need for additional flexibility within an IR framework for humanitarian contexts, while not a focus of this review, it is worth considering whether a different framework could provide a better fit than the CFIR. Other frameworks have differing points of emphasis that would create different opportunities for flexibility but that do not seem to resolve the challenges experienced in applying the CFIR to a humanitarian context. As one example, the EPIS (Exploration, Preparation, Implementation, Sustainment) Framework considers the impact of inner and outer context on each of four implementation phases; while the constructs within this framework are broader than the CFIR, an emphasis on the intervention characteristics is missing, a domain where stronger alignment within the CFIR is also needed [ 92 ]. Alternatively, the PRISM (Practical, Robust Implementation and Sustainability Model) framework is a determinant and evaluation framework that adds consideration of context factors to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) outcomes framework. It has a stronger emphasis on intervention aspects, with sub-domains to account for both organization and patient perspectives within the intervention. While PRISM does include aspects of context, external environment considerations are less robust and intentionally less comprehensive in scope, which would not provide the degree of alignment possible between the Characteristics of Systems and Outer Setting CFIR domains for the considerations unique to humanitarian environments [ 93 ].

Reflecting on their experience with the CFIR, Sarker et al. indicate that it can be a “great asset” in both evaluating current work and developing future interventions. They also encourage future research of humanitarian health interventions to utilize the CFIR [ 51 ]. The other papers that used the CFIR do not specifically reflect on their experience utilizing it, referring more generally to having felt that it was a useful tool [ 65 , 70 ]. On their use of an evaluation framework, Berg et al. reflected that it lent useful structure and helped to identify aspects affecting implementation that otherwise would have gone un-noticed [ 67 ]. The remaining studies that utilized an IR framework did not specifically comment on their experience with its use [ 72 , 83 ]. While a formal IR framework was not engaged by other studies, a number cite a desire for IR to contribute further detail to their findings [ 21 , 37 ].

In their recommendations for strengthening the evidence base for humanitarian health interventions, Ager et al. speak to the need for “methodologic innovation” to develop methodologies with particular applicability in humanitarian settings [ 7 ]. As IR is not yet routinized for SRH interventions, this could be opportune timing for the use of a standardized IR framework to gauge its utility. Using an IR framework to assess factors influencing implementation of the MISP in initial stages of a humanitarian response, and interventions to support more comprehensive SRH service delivery in protracted crises, could lend further rigor and standardization to SRH evaluations, as well as inform strategies to improve MISP implementation over time. Based on categorizing factors identified by these papers as relevant for intervention evaluation, there does seem to be utility to a modified CFIR approach. Given the paucity of formal IR framework use within SRH literature, it would be worth conducting similar scoping exercises to assess for explicit use of IR frameworks within the evidence base for other health service delivery areas in humanitarian settings. In the interim, the recommended approach from this review for future IR on humanitarian health interventions would be a modified CFIR approach with domain-level standardization and flexibility for constructs that may standardize over time with more use. This would enable use of a common analytical framework and vocabulary at the domain level for stakeholders to describe interventions and the factors influencing the effectiveness of implementation, with constructs available to use and customize as most appropriate for specific contexts and interventions.

This review had a number of limitations. As this was a scoping review and a two-part search strategy was used, the papers summarized here may not be comprehensive of those written pertaining to SRH interventions over the past 10 years. Papers from 2013 to 2017 that would have met this scoping review’s inclusion criteria may have been omitted due to being excluded from the systematic reviews. The review was limited to papers available in English. Furthermore, this review did not assess the quality of the papers included or seek to assess the methodology used beyond examination of the use of an IR framework. It does, however, serve as a first step in assessing the extent to which calls for implementation research have been addressed, and identify entry points for strengthening the science and practice of SRH research in humanitarian settings.

With one in 23 people worldwide in need of humanitarian assistance, and financing required for response plans at an all-time high, the need for evidence to guide resource allocation and programming for SRH in humanitarian settings is as important as ever [ 94 ]. Recent research agenda setting initiatives and strategies to advance health in humanitarian settings call for increased investment in implementation research—with priorities ranging from research on effective strategies for expanding access to a full range of contraceptive options to integrating mental health and psychosocial support into SRH programming to capturing accurate and actionable data on maternal and perinatal mortality in a wide range of acute and protracted emergency contexts [ 95 , 96 ]. To truly advance guidance in these areas, implementation research will need to be conducted across diverse humanitarian settings, with clear and consistent documentation of both intervention characteristics and outcomes, as well as contextual and programmatic factors affecting implementation.

Conclusions

Implementation research has potential to increase impact of health interventions particularly in crisis-affected settings where flexibility, adaptability and context-responsive approaches are highlighted as cornerstones of effective programming. There remains significant opportunity for standardization of research in the humanitarian space, with one such opportunity occurring through increased utilization of IR frameworks such as a modified CFIR approach. Investing in more robust sexual and reproductive health research in humanitarian contexts can enrich insights available to guide programming and increase transferability of learning across settings.

Availability of data and materials

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Availability, Accessibility, Acceptability and Quality

Centers for Disease Control and Prevention

Consolidated Framework for Implementation Research

Democratic Republic of the Congo

Exploration, Preparation, Implementation, Sustainment

• Implementation research

Low and middle income country

Minimum Initial Service Package

Practical, Robust Implementation and Sustainability Model

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

Reach, Effectiveness, Adoption, Implementation, Maintenance

• Sexual and reproductive health

World Health Organization

Peters DH, et al. Implementation research: what it is and how to do it. RESEARCH METHODS. 2013;347:7.

Means AR, et al. Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review. Implement Sci. 2020;15(1):17.

Article   PubMed   PubMed Central   Google Scholar  

Alonge O, et al. How is implementation research applied to advance health in low-income and middle-income countries? BMJ Glob Health. 2019;4(2):e001257.

Ridde V, Pérez D, Robert E. Using implementation science theories and frameworks in global health. BMJ Glob Health. 2020;5(4):e002269.

Gaffey MF, et al. Delivering health and nutrition interventions for women and children in different conflict contexts: a framework for decision making on what, when, and how. Lancet (London, England). 2021;397(10273):543–54.

Article   PubMed   Google Scholar  

Singh NS, et al. Delivering health interventions to women, children, and adolescents in conflict settings: what have we learned from ten country case studies? The Lancet. 2021;397(10273):533–42.

Article   Google Scholar  

Ager A, et al. Strengthening the evidence base for health programming in humanitarian crises. Science. 2014;345(6202):1290–2.

Article   CAS   PubMed   Google Scholar  

Blanchet K, et al. Evidence on public health interventions in humanitarian crises. The Lancet. 2017;390(10109):2287–96.

Sphere A. The Sphere Handbook | Standards for quality humanitarian response. 2018.

Google Scholar  

Barot S. In a State of Crisis: Meeting the Sexual and Reproductive Health Needs of Women in Humanitarian Situations. Guttmacher Policy Rev. 2017;20:7.

Crisis, I.-A.W.G.f.R.H.i., Minimum Initial Service Package. 2020: https://www.unfpa.org/resources/minimum-initial-service-package-misp-srh-crisis-situations .

Casey SE. Evaluations of reproductive health programs in humanitarian settings: a systematic review. Confl Heal. 2015;9(1):S1.

Singh NS, et al. A long way to go: a systematic review to assess the utilisation of sexual and reproductive health services during humanitarian crises. BMJ Glob Health. 2018;3(2):e000682.

Singh NS, et al. Evaluating the effectiveness of sexual and reproductive health services during humanitarian crises: A systematic review. PLoS ONE. 2018;13(7):e0199300.

Warren E, et al. Systematic review of the evidence on the effectiveness of sexual and reproductive health interventions in humanitarian crises. BMJ Open. 2015;5(12):e008226.

Dadich A, Piper A, Coates D. Implementation science in maternity care: a scoping review. Implement Sci. 2021;16(1):16.

Tricco AC, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018;169(7):467–73.

Devine A, et al. Strategies for the prevention of perinatal hepatitis B transmission in a marginalized population on the Thailand-Myanmar border: a cost-effectiveness analysis. BMC Infect Dis. 2017;17(1):552.

Jarrett P, et al. Evaluation of a population mobility, mortality, and birth surveillance system in South Kivu. Democratic Republic of the Congo Disasters. 2020;44(2):390–407.

PubMed   Google Scholar  

Logie CH, et al. A Psycho-Educational HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti: Results from a Non-Randomized Cohort Pilot Study. PLoS ONE. 2014;9(2):e89836.

O’Laughlin KN, et al. A cohort study to assess a communication intervention to improve linkage to HIV care in Nakivale Refugee Settlement. Uganda Glob Public Health. 2021;16(12):1848–55.

Adam I. The influence of maternal health education on the place of delivery in conflict settings of Darfur. Sudan Conflict and Health. 2015;9:31.

Adam IF, et al. Relationship between implementing interpersonal communication and mass education campaigns in emergency settings and use of reproductive healthcare services: evidence from Darfur, Sudan. BMJ Open. 2015;5(9):e008285.

Edmond K, et al. Mobile outreach health services for mothers and children in conflict-affected and remote areas: a population-based study from Afghanistan. Arch Dis Child. 2020;105(1):18–25.

Nasir S, et al. Dissemination and implementation of the e-MCHHandbook, UNRWA’s newly released maternal and child health mobile application: a cross-sectional study. BMJ Open. 2020;10(3):e034885.

O’Laughlin KN, et al. Feasibility and acceptability of home-based HIV testing among refugees: a pilot study in Nakivale refugee settlement in southwestern Uganda. BMC Infect Dis. 2018;18(1):332.

Adam I. Evidence from cluster surveys on the association between home-based counseling and use of family planning in conflict-affected Darfur. Int J Gynecol Obstet. 2016;133(2):221–5.

Casey S, et al. Availability of long-acting and permanent family-planning methods leads to increase in use in conflict-affected northern Uganda: Evidence from cross-sectional baseline and endline cluster surveys. Glob Public Health. 2013;8(3):284–97.

Corna F, et al. Supporting maternal mental health of Rohingya refugee women during the perinatal period to promote child health and wellbeing: a field study in Cox’s Bazar. Intervention, the Journal of Mental Health & Psychosocial Support in Conflict Affected Areas. 2019;17(2):160–8.

Glass N, et al. Effectiveness of the Communities Care programme on change in social norms associated with gender-based violence (GBV) with residents in intervention compared with control districts in Mogadishu, Somalia. BMJ Open. 2019;9(3):e023819.

James LE, et al. Development and Testing of a Community-Based Intervention to Address Intimate Partner Violence among Rohingya and Syrian Refugees: A Social Norms-Based Mental Health-Integrated Approach. Int J Environ Res Public Health. 2021;18(21):11674.

Le Roux E, et al. Engaging with faith groups to prevent VAWG in conflict-affected communities: results from two community surveys in the DRC. BMC Int Health Hum Rights. 2020;20(1):27.

Morris CN, et al. When political solutions for acute conflict in Yemen seem distant, demand for reproductive health services is immediate: a programme model for resilient family planning and post-abortion care services. Sex Reprod Health Matters. 2019;27(2):1610279.

Anibueze AU, et al. Impact of counseling visual multimedia on use of family planning methods among displaced Nigerian families. Health Promot Int. 2022;37(3):daac060.

Doocy S, et al. Cash-based assistance and the nutrition status of pregnant and lactating women in the Somalia food crisis: A comparison of two transfer modalities. PLoS ONE. 2020;15(4):e0230989.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Draiko CV, et al. The effect of umbilical cord cleansing with chlorhexidine gel on neonatal mortality among the community births in South Sudan: a quasi-experimental study. Pan Afr Med J. 2021;38:78.

Edmond KM, et al. Can community health worker home visiting improve care-seeking and maternal and newborn care practices in fragile states such as Afghanistan? A population-based intervention study. BMC Med. 2018;16(1):106.

Edmond KM, et al. Conditional cash transfers to improve use of health facilities by mothers and newborns in conflict affected countries, a prospective population based intervention study from Afghanistan. BMC Pregnancy Childbirth. 2019;19(1):193.

Bakesiima R, et al. Effect of peer counselling on acceptance of modern contraceptives among female refugee adolescents in northern Uganda: A randomised controlled trial. PLoS ONE. 2021;16(9):e0256479.

Greene MC, et al. Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial. PLoS ONE. 2021;16(6):e0252982.

Gupta J, et al. Gender norms and economic empowerment intervention to reduce intimate partner violence against women in rural Côte d’Ivoire: a randomized controlled pilot study. BMC Int Health Hum Rights. 2013;13(1):46.

Hossain M, et al. Working with men to prevent intimate partner violence in a conflict-affected setting: a pilot cluster randomized controlled trial in rural Côte d’Ivoire. BMC Public Health. 2014;14(1):339.

Vaillant J, et al. Engaging men to transform inequitable gender attitudes and prevent intimate partner violence: a cluster randomised controlled trial in North and South Kivu, Democratic Republic of Congo. BMJ Glob Health. 2020;5(5):e002223.

Thommesen T, et al. “The midwife helped me … otherwise I could have died”: women’s experience of professional midwifery services in rural Afghanistan - a qualitative study in the provinces Kunar and Laghman. BMC Pregnancy Childbirth. 2020;20(1):140.

Awasom-Fru A, et al. Doctors’ experiences providing sexual and reproductive health care at Catholic Hospitals in the conflict-affected North-West region of Cameroon: a qualitative study. Reprod Health. 2022;19(1):126.

Kabakian-Khasholian T, Makhoul J, Ghusayni A. “A person who does not have money does not enter”: a qualitative study on refugee women’s experiences of respectful maternity care. BMC Pregnancy and Childbirth. 2022;22(1):748.

Lilleston P, et al. Evaluation of a mobile approach to gender-based violence service delivery among Syrian refugees in Lebanon. Health Policy Plan. 2018;33(7):767–76.

Mugo NS, et al. Barriers Faced by the Health Workers to Deliver Maternal Care Services and Their Perceptions of the Factors Preventing Their Clients from Receiving the Services: A Qualitative Study in South Sudan. Matern Child Health J. 2018;22(11):1598–606.

Persson M, et al. A qualitative study on health care providers’ experiences of providing comprehensive abortion care in Cox’s Bazar, Bangladesh. Conflict and Health. 2021;15(1):6.

Phanwichatkul T, et al. The perceptions and practices of Thai health professionals providing maternity care for migrant Burmese women: An ethnographic study. Women Birth. 2022;35(4):e356–68.

Sarker M, et al. Effective maternal, newborn and child health programming among Rohingya refugees in Cox’s Bazar, Bangladesh: Implementation challenges and potential solutions. PLoS ONE. 2020;15(3):e0230732.

Tousaw E, et al. “Without this program, women can lose their lives”: migrant women’s experiences with the Safe Abortion Referral Programme in Chiang Mai. Thailand Reprod Health Matters. 2017;25(51):58–68.

Tousaw E, et al. “It is just like having a period with back pain”: exploring women’s experiences with community-based distribution of misoprostol for early abortion on the Thailand-Burma border. Contraception. 2018;97(2):122–9.

West L, et al. Factors in use of family planning services by Syrian women in a refugee camp in Jordan. Journal of Family Planning and Reproductive Health Care. 2017;43(2):96–102.

O’Connell KA, et al. Meeting the Sexual and Reproductive Health Needs of Internally Displaced Persons in Ethiopia’s Somali Region: A Qualitative Process Evaluation. Glob Health Sci Pract. 2022;10(5):e2100818.

Orya E, et al. Strengthening close to community provision of maternal health services in fragile settings: an exploration of the changing roles of TBAs in Sierra Leone and Somaliland. BMC Health Serv Res. 2017;17(1):460.

Perera SM, et al. Barriers to seeking post-abortion care in Paktika Province, Afghanistan: a qualitative study of clients and community members. BMC Womens Health. 2021;21(1):390.

Tanabe M, et al. Piloting community-based medical care for survivors of sexual assault in conflict-affected Karen State of eastern Burma. Confl Heal. 2013;7(1):12.

Tran NT, et al. Clinical outreach refresher trainings in crisis settings (S-CORT): clinical management of sexual violence survivors and manual vacuum aspiration in Burkina Faso, Nepal, and South Sudan. Reprod Health Matters. 2017;25(51):103–13.

Yankah E, et al. Feasibility and acceptability of mobile phone platforms to deliver interventions to address gender-based violence among Syrian adolescent girls and young women in Izmir. Turkey Vulnerable Children and Youth Studies. 2020;15(2):133–43.

Muuo S, et al. Barriers and facilitators to care-seeking among survivors of gender-based violence in the Dadaab refugee complex. Sex Reprod Health Matters. 2020;28(1):1722404.

Amsalu R, et al. Essential newborn care practice at four primary health facilities in conflict affected areas of Bossaso, Somalia: a cross-sectional study. Conflict and Health. 2019;13(13):27.

Myers A, et al. Facilitators and barriers in implementing the Minimum Initial Services Package (MISP) for reproductive health in Nepal post-earthquake. Conflict and Health. 2018;12:35.

Santo L.C.d, et al. Feasibility and acceptability of a video library tool to support community health worker counseling in rural Afghan districts: a cross-sectional assessment. Conflict and Health. 2020;14:56.

Sami S, et al. Understanding health systems to improve community and facility level newborn care among displaced populations in South Sudan: a mixed methods case study. BMC Pregnancy Childbirth. 2018;18(1):325.

Amsalu R, et al. Effectiveness of clinical training on improving essential newborn care practices in Bossaso, Somalia: a pre and postintervention study. BMC Pediatr. 2020;20(1):215.

Berg M, Mwambali SN, Bogren M. Implementation of a three-pillar training intervention to improve maternal and neonatal healthcare in the Democratic Republic Of Congo: a process evaluation study in an urban health zone. Glob Health Action. 2022;15(1):2019391.

Castillo M, et al. Turning Disaster into an Opportunity for Quality Improvement in Essential Intrapartum and Newborn Care Services in the Philippines: Pre- to Posttraining Assessments. Biomed Res Int. 2016;2016:1–9.

Foster AM, Arnott G, Hobstetter M. Community-based distribution of misoprostol for early abortion: evaluation of a program along the Thailand-Burma border. Contraception. 2017;96(4):242–7.

Guan TH, et al. Implementation of a neonatal hepatitis B immunization program in rural Karenni State, Myanmar: A mixed-methods study. PLoS ONE. 2021;16(12):e0261470.

Logie, C.H., et al., Mixed-methods findings from the Ngutulu Kagwero (agents of change) participatory comic pilot study on post-rape clinical care and sexual violence prevention with refugee youth in a humanitarian setting in Uganda. Global Public Health, 2022((Logie C.H., [email protected]) Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Canada(Logie C.H., [email protected]) Women’s College Research Institute, Women’s College Hospital, Toronto, Canada(Logie C.H., carmen.l).

Sami S, et al. “You have to take action”: changing knowledge and attitudes towards newborn care practices during crisis in South Sudan. Reprod Health Matters. 2017;25(51):124–39.

Smith JR, et al. Clinical care for sexual assault survivors multimedia training: a mixed-methods study of effect on healthcare providers’ attitudes, knowledge, confidence, and practice in humanitarian settings. Confl Heal. 2013;7(1):14.

Stevens A, et al. Folate supplementation to prevent birth abnormalities: evaluating a community-based participatory action plan for refugees and migrant workers on the Thailand-Myanmar border. Public Health. 2018;161:83–9.

Nguyen Toan T, et al. Strengthening healthcare providers’ capacity for safe abortion and postabortion care services in humanitarian settings: lessons learned from the clinical outreach refresher training model (S-CORT) in Uganda, Nigeria, and the Democratic Republic of Congo. Conflict and Health. 2021;15(1):20.

Castle S, et al. Successful programmatic approaches to facilitating IUD uptake: CARE’s experience in DRC. BMC Womens Health. 2019;19(1):104.

Deitch J, et al. “They Love Their Patients”: Client Perceptions of Quality of Postabortion Care in North and South Kivu, the Democratic Republic of the Congo. Global health, science and practice. 2019;7(Suppl 2):S285–98.

Ferreyra C, et al. Evaluation of a community-based HIV test and start program in a conflict affected rural area of Yambio County, South Sudan. PLoS ONE. 2021;16(7):e0254331.

Ho LS, Wheeler E. Using Program Data to Improve Access to Family Planning and Enhance the Method Mix in Conflict-Affected Areas of the Democratic Republic of the Congo. Glob Health Sci Pract. 2018;6(1):161–77.

Klabbers RE, et al. Health Worker Perspectives on Barriers and Facilitators of Assisted Partner Notification for HIV for Refugees and Ugandan Nationals: A Mixed Methods Study in West Nile Uganda. AIDS Behav. 2021;25(10):3206–22.

Turner C, et al. Neonatal Intensive Care in a Karen Refugee Camp: A 4 Year Descriptive Study. PLoS ONE. 2013;8(8):e72721.

Vries Id, et al. Key lessons from a mixed-method evaluation of a postnatal home visit programme in the humanitarian setting of Gaza. Eastern Mediterr Health J. 2021;27(6):546–52.

Bolan NE, et al. mLearning in the Democratic Republic of the Congo: A Mixed-Methods Feasibility and Pilot Cluster Randomized Trial Using the Safe Delivery App. Global health, science and practice. 2018;6(4):693–710.

Khan MN, et al. Evaluating feasibility and acceptability of a local psycho-educational intervention for pregnant women with common mental problems affected by armed conflict in Swat, Pakistan: A parallel randomized controlled feasibility trial. Int J Soc Psychiatry. 2017;63(8):724–35.

Hynes M, et al. Using a quality improvement approach to improve maternal and neonatal care in North Kivu, Democratic Republic of Congo. Reprod Health Matters. 2017;25(51):140–50.

Gibbs A, et al. The impacts of combined social and economic empowerment training on intimate partner violence, depression, gender norms and livelihoods among women: an individually randomised controlled trial and qualitative study in Afghanistan. BMJ Glob Health. 2020;5(3):e001946.

Damschroder L, et al. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation science: IS; 2009.

Moore GF, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.

Proctor E, et al. Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda. Adm Policy Ment Health. 2011;38(2):65–76.

Damschroder LJ, et al. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022;17(1):75.

Damschroder LJ, et al. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum. Implement Sci. 2022;17(1):7.

Aarons GA, Hurlburt M, Horwitz SM. Advancing a Conceptual Model of Evidence-Based Practice Implementation in Public Service Sectors. Administration and Policy in Mental Health and Mental Health Services Research. 2011;38(1):4–23.

Feldstein AC, Glasgow RE. A Practical, Robust Implementation and Sustainability Model (PRISM) for Integrating Research Findings into Practice. The Joint Commission Journal on Quality and Patient Safety. 2008;34(4):228–43.

OCHA. Global Humanitarian Overview 2023. 2022 [cited 2023 8/3/2023]; Available from: https://humanitarianaction.info/node/13073/article/glance-0 . Accessed 8 Mar 2023.

Kobeissi L, et al. Setting research priorities for sexual, reproductive, maternal, newborn, child and adolescent health in humanitarian settings. Confl Heal. 2021;15(1):16.

Save the, C., et al. Roadmap to Accelerate Progress for Every Newborn in Humanitarian Settings 2020 – 2024. 2020. p. 52.

Inter-Agency Working Group on Reproductive Health in, C. Inter-Agency Field Manual on Reproductive Health in Humanitarian Settings. 2018.

Download references

Acknowledgements

Not applicable.

The authors received no funding for this study.

Author information

Authors and affiliations.

Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA

Alexandra Norton

Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21205, USA

Hannah Tappis

You can also search for this author in PubMed   Google Scholar

Contributions

AN and HT designed the scoping review. AN conducted the literature search. AN and HT screened records for inclusion. AN extracted data from included studies. Both authors contributed to synthesis of results. AN drafted the manuscript and both authors contributed to editorial changes.

Corresponding author

Correspondence to Alexandra Norton .

Ethics declarations

Ethics approval and consent to participate, consent for publication, competing interests.

The authors declare no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Additional file 1.

. Literature search terms: Exact search terms used in literature search, with additional detail on the methodology to determine search terms and definitions used for each component of the search

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Norton, A., Tappis, H. Sexual and reproductive health implementation research in humanitarian contexts: a scoping review. Reprod Health 21 , 64 (2024). https://doi.org/10.1186/s12978-024-01793-2

Download citation

Received : 06 November 2023

Accepted : 12 April 2024

Published : 13 May 2024

DOI : https://doi.org/10.1186/s12978-024-01793-2

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Humanitarian settings

Reproductive Health

ISSN: 1742-4755

• General enquiries: [email protected]