qualitative research examples in public health

Collecting and Analyzing Qualitative Data

Brent Wolff, Frank Mahoney, Anna Leena Lohiniva, and Melissa Corkum

• Choosing When to Apply Qualitative Methods
• Commonly Used Qualitative Methods in Field Investigations
• Sampling and Recruitment for Qualitative Research
• Managing, Condensing, Displaying, and Interpreting Qualitative Data
• Coding and Analysis Requirements

Qualitative research methods are a key component of field epidemiologic investigations because they can provide insight into the perceptions, values, opinions, and community norms where investigations are being conducted ( 1,2 ). Open-ended inquiry methods, the mainstay of qualitative interview techniques, are essential in formative research for exploring contextual factors and rationales for risk behaviors that do not fit neatly into predefined categories. For example, during the 2014–2015 Ebola virus disease outbreaks in parts of West Africa, understanding the cultural implications of burial practices within different communities was crucial to designing and monitoring interventions for safe burials ( Box 10.1 ). In program evaluations, qualitative methods can assist the investigator in diagnosing what went right or wrong as part of a process evaluation or in troubleshooting why a program might not be working as well as expected. When designing an intervention, qualitative methods can be useful in exploring dimensions of acceptability to increase the chances of intervention acceptance and success. When performed in conjunction with quantitative studies, qualitative methods can help the investigator confirm, challenge, or deepen the validity of conclusions than either component might have yielded alone ( 1,2 ).

Qualitative research was used extensively in response to the Ebola virus disease outbreaks in parts of West Africa to understand burial practices and to design culturally appropriate strategies to ensure safe burials. Qualitative studies were also used to monitor key aspects of the response.

In October 2014, Liberia experienced an abrupt and steady decrease in case counts and deaths in contrast with predicted disease models of an increased case count. At the time, communities were resistant to entering Ebola treatment centers, raising the possibility that patients were not being referred for care and communities might be conducting occult burials.

To assess what was happening at the community level, the Liberian Emergency Operations Center recruited epidemiologists from the US Department of Health and Human Services/Centers for Disease Control and Prevention and the African Union to investigate the problem.

Teams conducted in-depth interviews and focus group discussions with community leaders, local funeral directors, and coffin makers and learned that communities were not conducting occult burials and that the overall number of burials was less than what they had experienced in previous years. Other key findings included the willingness of funeral directors to cooperate with disease response efforts, the need for training of funeral home workers, and considerable community resistance to cremation practices. These findings prompted the Emergency Operations Center to open a burial ground for Ebola decedents, support enhanced testing of burials in the private sector, and train private-sector funeral workers regarding safe burial practices.

Source: Melissa Corkum, personal communication.

Similar to quantitative approaches, qualitative research seeks answers to specific questions by using rigorous approaches to collecting and compiling information and producing findings that can be applicable beyond the study population. The fundamental difference in approaches lies in how they translate real-life complexities of initial observations into units of analysis. Data collected in qualitative studies typically are in the form of text or visual images, which provide rich sources of insight but also tend to be bulky and time-consuming to code and analyze. Practically speaking, qualitative study designs tend to favor small, purposively selected samples ideal for case studies or in-depth analysis ( 1 ). The combination of purposive sampling and open-ended question formats deprive qualitative study designs of the power to quantify and generalize conclusions, one of the key limitations of this approach.

Qualitative scientists might argue, however, that the generalizability and precision possible through probabilistic sampling and categorical outcomes are achieved at the cost of enhanced validity, nuance, and naturalism that less structured approaches offer ( 3 ). Open-ended techniques are particularly useful for understanding subjective meanings and motivations underlying behavior. They enable investigators to be equally adept at exploring factors observed and unobserved, intentions as well as actions, internal meanings as well as external consequences, options considered but not taken, and unmeasurable as well as measurable outcomes. These methods are important when the source of or solution to a public health problem is rooted in local perceptions rather than objectively measurable characteristics selected by outside observers ( 3 ). Ultimately, such approaches have the ability to go beyond quantifying questions of how much or how many to take on questions of how or why from the perspective and in the words of the study subjects themselves ( 1,2 ).

Another key advantage of qualitative methods for field investigations is their flexibility ( 4 ). Qualitative designs not only enable but also encourage flexibility in the content and flow of questions to challenge and probe for deeper meanings or follow new leads if they lead to deeper understanding of an issue (5). It is not uncommon for topic guides to be adjusted in the course of fieldwork to investigate emerging themes relevant to answering the original study question. As discussed herein, qualitative study designs allow flexibility in sample size to accommodate the need for more or fewer interviews among particular groups to determine the root cause of an issue (see the section on Sampling and Recruitment in Qualitative Research). In the context of field investigations, such methods can be extremely useful for investigating complex or fast-moving situations where the dimensions of analysis cannot be fully anticipated.

Ultimately, the decision whether to include qualitative research in a particular field investigation depends mainly on the nature of the research question itself. Certain types of research topics lend themselves more naturally to qualitative rather than other approaches ( Table 10.1 ). These include exploratory investigations when not enough is known about a problem to formulate a hypothesis or develop a fixed set of questions and answer codes. They include research questions where intentions matter as much as actions and “why?” or “why not?” questions matter as much as precise estimation of measured outcomes. Qualitative approaches also work well when contextual influences, subjective meanings, stigma, or strong social desirability biases lower faith in the validity of responses coming from a relatively impersonal survey questionnaire interview.

The availability of personnel with training and experience in qualitative interviewing or observation is critical for obtaining the best quality data but is not absolutely required for rapid assessment in field settings. Qualitative interviewing requires a broader set of skills than survey interviewing. It is not enough to follow a topic guide like a questionnaire, in order, from top to bottom. A qualitative interviewer must exercise judgment to decide when to probe and when to move on, when to encourage, challenge, or follow relevant leads even if they are not written in the topic guide. Ability to engage with informants, connect ideas during the interview, and think on one’s feet are common characteristics of good qualitative interviewers. By far the most important qualification in conducting qualitative fieldwork is a firm grasp of the research objectives; with this qualification, a member of the research team armed with curiosity and a topic guide can learn on the job with successful results.

Semi-Structured Interviews

Semi-structured interviews can be conducted with single participants (in-depth or individual key informants) or with groups (focus group discussions [FGDs] or key informant groups). These interviews follow a suggested topic guide rather than a fixed questionnaire format. Topic guides typically consist of a limited number ( 10– 15 ) of broad, open-ended questions followed by bulleted points to facilitate optional probing. The conversational back-and-forth nature of a semi-structured format puts the researcher and researched (the interview participants) on more equal footing than allowed by more structured formats. Respondents, the term used in the case of quantitative questionnaire interviews, become informants in the case of individual semi-structured in-depth interviews (IDIs) or participants in the case of FGDs. Freedom to probe beyond initial responses enables interviewers to actively engage with the interviewee to seek clarity, openness, and depth by challenging informants to reach below layers of self-presentation and social desirability. In this respect, interviewing is sometimes compared with peeling an onion, with the first version of events accessible to the public, including survey interviewers, and deeper inner layers accessible to those who invest the time and effort to build rapport and gain trust. (The theory of the active interview suggests that all interviews involve staged social encounters where the interviewee is constantly assessing interviewer intentions and adjusting his or her responses accordingly [ 1 ]. Consequently good rapport is important for any type of interview. Survey formats give interviewers less freedom to divert from the preset script of questions and formal probes.)

Individual In-Depth Interviews and Key-Informant Interviews

The most common forms of individual semi-structured interviews are IDIs and key informant interviews (KIIs). IDIs are conducted among informants typically selected for first-hand experience (e.g., service users, participants, survivors) relevant to the research topic. These are typically conducted as one-on-one face-to-face interviews (two-on-one if translators are needed) to maximize rapport-building and confidentiality. KIIs are similar to IDIs but focus on individual persons with special knowledge or influence (e.g., community leaders or health authorities) that give them broader perspective or deeper insight into the topic area ( Box 10.2 ). Whereas IDIs tend to focus on personal experiences, context, meaning, and implications for informants, KIIs tend to steer away from personal questions in favor of expert insights or community perspectives. IDIs enable flexible sampling strategies and represent the interviewing reference standard for confidentiality, rapport, richness, and contextual detail. However, IDIs are time-and labor-intensive to collect and analyze. Because confidentiality is not a concern in KIIs, these interviews might be conducted as individual or group interviews, as required for the topic area.

Focus Group Discussions and Group Key Informant Interviews

FGDs are semi-structured group interviews in which six to eight participants, homogeneous with respect to a shared experience, behavior, or demographic characteristic, are guided through a topic guide by a trained moderator ( 6 ). (Advice on ideal group interview size varies. The principle is to convene a group large enough to foster an open, lively discussion of the topic, and small enough to ensure all participants stay fully engaged in the process.) Over the course of discussion, the moderator is expected to pose questions, foster group participation, and probe for clarity and depth. Long a staple of market research, focus groups have become a widely used social science technique with broad applications in public health, and they are especially popular as a rapid method for assessing community norms and shared perceptions.

Focus groups have certain useful advantages during field investigations. They are highly adaptable, inexpensive to arrange and conduct, and often enjoyable for participants. Group dynamics effectively tap into collective knowledge and experience to serve as a proxy informant for the community as a whole. They are also capable of recreating a microcosm of social norms where social, moral, and emotional dimensions of topics are allowed to emerge. Skilled moderators can also exploit the tendency of small groups to seek consensus to bring out disagreements that the participants will work to resolve in a way that can lead to deeper understanding. There are also limitations on focus group methods. Lack of confidentiality during group interviews means they should not be used to explore personal experiences of a sensitive nature on ethical grounds. Participants may take it on themselves to volunteer such information, but moderators are generally encouraged to steer the conversation back to general observations to avoid putting pressure on other participants to disclose in a similar way. Similarly, FGDs are subject by design to strong social desirability biases. Qualitative study designs using focus groups sometimes add individual interviews precisely to enable participants to describe personal experiences or personal views that would be difficult or inappropriate to share in a group setting. Focus groups run the risk of producing broad but shallow analyses of issues if groups reach comfortable but superficial consensus around complex topics. This weakness can be countered by training moderators to probe effectively and challenge any consensus that sounds too simplistic or contradictory with prior knowledge. However, FGDs are surprisingly robust against the influence of strongly opinionated participants, highly adaptable, and well suited to application in study designs where systematic comparisons across different groups are called for.

Like FGDs, group KIIs rely on positive chemistry and the stimulating effects of group discussion but aim to gather expert knowledge or oversight on a particular topic rather than lived experience of embedded social actors. Group KIIs have no minimum size requirements and can involve as few as two or three participants.

Egypt’s National Infection Prevention and Control (IPC) program undertook qualitative research to gain an understanding of the contextual behaviors and motivations of healthcare workers in complying with IPC guidelines. The study was undertaken to guide the development of effective behavior change interventions in healthcare settings to improve IPC compliance.

Key informant interviews and focus group discussions were conducted in two governorates among cleaning staff, nursing staff, and physicians in different types of healthcare facilities. The findings highlighted social and cultural barriers to IPC compliance, enabling the IPC program to design responses. For example,

• Informants expressed difficulty in complying with IPC measures that forced them to act outside their normal roles in an ingrained hospital culture. Response: Role models and champions were introduced to help catalyze change.
• Informants described fatalistic attitudes that undermined energy and interest in modifying behavior. Response: Accordingly, interventions affirming institutional commitment to change while challenging fatalistic assumptions were developed.
• Informants did not perceive IPC as effective. Response: Trainings were amended to include scientific evidence justifying IPC practices.
• Informants perceived hygiene as something they took pride in and were judged on. Response: Public recognition of optimal IPC practice was introduced to tap into positive social desirability and professional pride in maintaining hygiene in the work environment.

Qualitative research identified sources of resistance to quality clinical practice in Egypt’s healthcare settings and culturally appropriate responses to overcome that resistance.

____________________ Source: Anna Leena Lohiniva, personal communication.

Visualization Methods

Visualization methods have been developed as a way to enhance participation and empower interviewees relative to researchers during group data collection ( 7 ). Visualization methods involve asking participants to engage in collective problem- solving of challenges expressed through group production of maps, diagrams, or other images. For example, participants from the community might be asked to sketch a map of their community and to highlight features of relevance to the research topic (e.g., access to health facilities or sites of risk concentrations). Body diagramming is another visualization tool in which community members are asked to depict how and where a health threat affects the human body as a way of understanding folk conceptions of health, disease, treatment, and prevention. Ensuing debate and dialogue regarding construction of images can be recorded and analyzed in conjunction with the visual image itself. Visualization exercises were initially designed to accommodate groups the size of entire communities, but they can work equally well with smaller groups corresponding to the size of FGDs or group KIIs.

Selecting a Sample of Study Participants

Fundamental differences between qualitative and quantitative approaches to research emerge most clearly in the practice of sampling and recruitment of study participants. Qualitative samples are typically small and purposive. In-depth interview informants are usually selected on the basis of unique characteristics or personal experiences that make them exemplary for the study, if not typical in other respects. Key informants are selected for their unique knowledge or influence in the study domain. Focus group mobilization often seeks participants who are typical with respect to others in the community having similar exposure or shared characteristics. Often, however, participants in qualitative studies are selected because they are exceptional rather than simply representative. Their value lies not in their generalizability but in their ability to generate insight into the key questions driving the study.

Determining Sample Size

Sample size determination for qualitative studies also follows a different logic than that used for probability sample surveys. For example, whereas some qualitative methods specify ideal ranges of participants that constitute a valid observation (e.g., focus groups), there are no rules on how many observations it takes to attain valid results. In theory, sample size in qualitative designs should be determined by the saturation principle , where interviews are conducted until additional interviews yield no additional insights into the topic of research ( 8 ). Practically speaking, designing a study with a range in number of interviews is advisable for providing a level of flexibility if additional interviews are needed to reach clear conclusions.

Recruiting Study Participants

Recruitment strategies for qualitative studies typically involve some degree of participant self-selection (e.g., advertising in public spaces for interested participants) and purposive selection (e.g., identification of key informants). Purposive selection in community settings often requires authorization from local authorities and assistance from local mobilizers before the informed consent process can begin. Clearly specifying eligibility criteria is crucial for minimizing the tendency of study mobilizers to apply their own filters regarding who reflects the community in the best light. In addition to formal eligibility criteria, character traits (e.g., articulate and interested in participating) and convenience (e.g., not too far away) are legitimate considerations for whom to include in the sample. Accommodations to personality and convenience help to ensure the small number of interviews in a typical qualitative design yields maximum value for minimum investment. This is one reason why random sampling of qualitative informants is not only unnecessary but also potentially counterproductive.

Analysis of qualitative data can be divided into four stages: data management, data condensation, data display, and drawing and verifying conclusions ( 9 ).

Managing Qualitative Data

From the outset, developing a clear organization system for qualitative data is important. Ideally, naming conventions for original data files and subsequent analysis should be recorded in a data dictionary file that includes dates, locations, defining individual or group characteristics, interviewer characteristics, and other defining features. Digital recordings of interviews or visualization products should be reviewed to ensure fidelity of analyzed data to original observations. If ethics agreements require that no names or identifying characteristics be recorded, all individual names must be removed from final transcriptions before analysis begins. If data are analyzed by using textual data analysis software, maintaining careful version control over the data files is crucial, especially when multiple coders are involved.

Condensing Qualitative Data

Condensing refers to the process of selecting, focusing, simplifying, and abstracting the data available at the time of the original observation, then transforming the condensed data into a data set that can be analyzed. In qualitative research, most of the time investment required to complete a study comes after the fieldwork is complete. A single hour of taped individual interview can take a full day to transcribe and additional time to translate if necessary. Group interviews can take even longer because of the difficulty of transcribing active group input. Each stage of data condensation involves multiple decisions that require clear rules and close supervision. A typical challenge is finding the right balance between fidelity to the rhythm and texture of original language and clarity of the translated version in the language of analysis. For example, discussions among groups with little or no education should not emerge after the transcription (and translation) process sounding like university graduates. Judgment must be exercised about which terms should be translated and which terms should be kept in vernacular because there is no appropriate term in English to capture the richness of its meaning.

Displaying Qualitative Data

After the initial condensation, qualitative analysis depends on how the data are displayed. Decisions regarding how data are summarized and laid out to facilitate comparison influence the depth and detail of the investigation’s conclusions. Displays might range from full verbatim transcripts of interviews to bulleted summaries or distilled summaries of interview notes. In a field setting, a useful and commonly used display format is an overview chart in which key themes or research questions are listed in rows in a word processer table or in a spreadsheet and individual informant or group entry characteristics are listed across columns. Overview charts are useful because they allow easy, systematic comparison of results.

Drawing and Verifying Conclusions

Analyzing qualitative data is an iterative and ideally interactive process that leads to rigorous and systematic interpretation of textual or visual data. At least four common steps are involved:

• Reading and rereading. The core of qualitative analysis is careful, systematic, and repeated reading of text to identify consistent themes and interconnections emerging from the data. The act of repeated reading inevitably yields new themes, connections, and deeper meanings from the first reading. Reading the full text of interviews multiple times before subdividing according to coded themes is key to appreciating the full context and flow of each interview before subdividing and extracting coded sections of text for separate analysis.
• Coding. A common technique in qualitative analysis involves developing codes for labeling sections of text for selective retrieval in later stages of analysis and verification. Different approaches can be used for textual coding. One approach, structural coding , follows the structure of the interview guide. Another approach, thematic coding , labels common themes that appear across interviews, whether by design of the topic guide or emerging themes assigned based on further analysis. To avoid the problem of shift and drift in codes across time or multiple coders, qualitative investigators should develop a standard codebook with written definitions and rules about when codes should start and stop. Coding is also an iterative process in which new codes that emerge from repeated reading are layered on top of existing codes. Development and refinement of the codebook is inseparably part of the analysis.
• Analyzing and writing memos. As codes are being developed and refined, answers to the original research question should begin to emerge. Coding can facilitate that process through selective text retrieval during which similarities within and between coding categories can be extracted and compared systematically. Because no p values can be derived in qualitative analyses to mark the transition from tentative to firm conclusions, standard practice is to write memos to record evolving insights and emerging patterns in the data and how they relate to the original research questions. Writing memos is intended to catalyze further thinking about the data, thus initiating new connections that can lead to further coding and deeper understanding.
• Verifying conclusions. Analysis rigor depends as much on the thoroughness of the cross-examination and attempt to find alternative conclusions as on the quality of original conclusions. Cross-examining conclusions can occur in different ways. One way is encouraging regular interaction between analysts to challenge conclusions and pose alternative explanations for the same data. Another way is quizzing the data (i.e., retrieving coded segments by using Boolean logic to systematically compare code contents where they overlap with other codes or informant characteristics). If alternative explanations for initial conclusions are more difficult to justify, confidence in those conclusions is strengthened.

Above all, qualitative data analysis requires sufficient time and immersion in the data. Computer textual software programs can facilitate selective text retrieval and quizzing the data, but discerning patterns and arriving at conclusions can be done only by the analysts. This requirement involves intensive reading and rereading, developing codebooks and coding, discussing and debating, revising codebooks, and recoding as needed until clear patterns emerge from the data. Although quality and depth of analysis is usually proportional to the time invested, a number of techniques, including some mentioned earlier, can be used to expedite analysis under field conditions.

• Detailed notes instead of full transcriptions. Assigning one or two note-takers to an interview can be considered where the time needed for full transcription and translation is not feasible. Even if plans are in place for full transcriptions after fieldwork, asking note-takers to submit organized summary notes is a useful technique for getting real-time feedback on interview content and making adjustments to topic guides or interviewer training as needed.
• Summary overview charts for thematic coding. (See discussion under “Displaying Data.”) If there is limited time for full transcription and/or systematic coding of text interviews using textual analysis software in the field, an overview chart is a useful technique for rapid manual coding.
• Thematic extract files. This is a slightly expanded version of manual thematic coding that is useful when full transcriptions of interviews are available. With use of a word processing program, files can be sectioned according to themes, or separate files can be created for each theme. Relevant extracts from transcripts or analyst notes can be copied and pasted into files or sections of files corresponding to each theme. This is particularly useful for storing appropriate quotes that can be used to illustrate thematic conclusions in final reports or manuscripts.
• Teamwork. Qualitative analysis can be performed by a single analyst, but it is usually beneficial to involve more than one. Qualitative conclusions involve subjective judgment calls. Having more than one coder or analyst working on a project enables more interactive discussion and debate before reaching consensus on conclusions.
• Systematic coding.
• Selective retrieval of coded segments.
• Verifying conclusions (“quizzing the data”).
• Working on larger data sets with multiple separate files.
• Working in teams with multiple coders to allow intercoder reliability to be measured and monitored.

The most widely used software packages (e.g., NVivo [QSR International Pty. Ltd., Melbourne, VIC, Australia] and ATLAS.ti [Scientific Software Development GmbH, Berlin, Germany]) evolved to include sophisticated analytic features covering a wide array of applications but are relatively expensive in terms of license cost and initial investment in time and training. A promising development is the advent of free or low-cost Web-based services (e.g., Dedoose [Sociocultural Research Consultants LLC, Manhattan Beach, CA]) that have many of the same analytic features on a more affordable subscription basis and that enable local research counterparts to remain engaged through the analysis phase (see Teamwork criteria). The start-up costs of computer-assisted analysis need to be weighed against their analytic benefits, which tend to decline with the volume and complexity of data to be analyzed. For rapid situational analyses or small scale qualitative studies (e.g. fewer than 30 observations as an informal rule of thumb), manual coding and analysis using word processing or spreadsheet programs is faster and sufficient to enable rigorous analysis and verification of conclusions.

Qualitative methods belong to a branch of social science inquiry that emphasizes the importance of context, subjective meanings, and motivations in understanding human behavior patterns. Qualitative approaches definitionally rely on open-ended, semistructured, non-numeric strategies for asking questions and recording responses. Conclusions are drawn from systematic visual or textual analysis involving repeated reading, coding, and organizing information into structured and emerging themes. Because textual analysis is relatively time-and skill-intensive, qualitative samples tend to be small and purposively selected to yield the maximum amount of information from the minimum amount of data collection. Although qualitative approaches cannot provide representative or generalizable findings in a statistical sense, they can offer an unparalleled level of detail, nuance, and naturalistic insight into the chosen subject of study. Qualitative methods enable investigators to “hear the voice” of the researched in a way that questionnaire methods, even with the occasional open-ended response option, cannot.

Whether or when to use qualitative methods in field epidemiology studies ultimately depends on the nature of the public health question to be answered. Qualitative approaches make sense when a study question about behavior patterns or program performance leads with why, why not , or how . Similarly, they are appropriate when the answer to the study question depends on understanding the problem from the perspective of social actors in real-life settings or when the object of study cannot be adequately captured, quantified, or categorized through a battery of closed-ended survey questions (e.g., stigma or the foundation of health beliefs). Another justification for qualitative methods occurs when the topic is especially sensitive or subject to strong social desirability biases that require developing trust with the informant and persistent probing to reach the truth. Finally, qualitative methods make sense when the study question is exploratory in nature, where this approach enables the investigator the freedom and flexibility to adjust topic guides and probe beyond the original topic guides.

Given that the conditions just described probably apply more often than not in everyday field epidemiology, it might be surprising that such approaches are not incorporated more routinely into standard epidemiologic training. Part of the answer might have to do with the subjective element in qualitative sampling and analysis that seems at odds with core scientific values of objectivity. Part of it might have to do with the skill requirements for good qualitative interviewing, which are generally more difficult to find than those required for routine survey interviewing.

For the field epidemiologist unfamiliar with qualitative study design, it is important to emphasize that obtaining important insights from applying basic approaches is possible, even without a seasoned team of qualitative researchers on hand to do the work. The flexibility of qualitative methods also tends to make them forgiving with practice and persistence. Beyond the required study approvals and ethical clearances, the basic essential requirements for collecting qualitative data in field settings start with an interviewer having a strong command of the research question, basic interactive and language skills, and a healthy sense of curiosity, armed with a simple open-ended topic guide and a tape recorder or note-taker to capture the key points of the discussion. Readily available manuals on qualitative study design, methods, and analysis can provide additional guidance to improve the quality of data collection and analysis.

• Patton MQ. Qualitative research and evaluation methods: integrating theory and practice . 4th ed. Thousand Oaks, CA: Sage; 2015.
• Hennink M, Hutter I, Bailey A. Qualitative research methods . Thousand Oaks, CA: Sage; 2010.
• Lincoln YS, Guba EG. The constructivist credo . Walnut Creek, CA: Left Coast Press; 2013.
• Mack N, Woodsong C, MacQueen KM, Guest G, Namey E. Qualitative research methods: a data collectors field guide. https://www.fhi360.org/sites/default/files/media/documents/Qualitative%20Research%20Methods%20-%20A%20Data%20Collector%27s%20Field%20Guide.pdf
• Kvale S, Brinkmann S. Interviews: learning the craft of qualitative research . Thousand Oaks, CA: Sage; 2009:230–43.
• Krueger RA, Casey MA. Focus groups: a practical guide for applied research . Thousand Oaks, CA: Sage; 2014.
• Margolis E, Pauwels L. The Sage handbook of visual research methods . Thousand Oaks, CA: Sage; 2011.
• Mason M. Sample size and saturation in PhD studies using qualitative interviews. Forum : Qualitative Social Research/Sozialforschung. 2010;11(3).
• Miles MB, Huberman AM, Saldana J. Qualitative data analysis: a methods sourcebook . 3rd ed. Thousand Oaks, CA: Sage; 2014.
• Silver C, Lewins A. Using software in qualitative research: a step-by-step guide . Thousand Oaks, CA; Sage: 2014.

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InterTASC ISSG Search Filter Resource A list of references describing filters to identify qualitative research MEDLINE (Ovid and PubMed), CINAHL, EMBASE, and PsycINFO. From Centre for Reviews and Dissemination, University of York and National Institute for Health Research, UK.

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• Use the following keywords to identify qualitative research. These keywprds will search the titles, abstracts and keywords of records held in the databases. Use quotations to search as a phrase:

Use controlled vocabulary

Databases use controlled vocabulary to categorize each record stored. The terms they use are known as  thesaurus terms or subject headings .  The thesaurus terms vary for each database according to their indexing system.

For example, qualitative research is indexed in PubMed as "Qualitative Research" or "Nursing Methodology Research", while in CINAHL their subject heading "Qualitative Studies" is complemented by more detailed terms, including "Phenomenological Research" and "Grounded Theory".

Tutorials for searching subject headings

Use qualitative research filters

Qualitative research filters are pre-formulated search strategies that have been constructed by librarians to help you retrieve articles in databases that deal with qualitative research. You can use the filter and then combine the results with your subject.

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PubMed Topic Specific Queries

• Go to  http://www.ncbi.nlm.nih.gov/pubmed/
• Under PubMed Tools , click Topic Specific Queries
• In the left column, click   Health Services Research (HSR) Queries
• Enter your search topic
• Under Category select Qualitative Research  
• Go to PsychINFO database in Database Finder .
• Enter your topic in the search box.
• In right column, under Methodoly, MATHEMATICAL MODEL , select Qualitative study .
• Under Refine Search section on the left, limit further your search under Methodology drop down menu.

Modify your search strategy accordingly by using thesaurus terms, such as qualitative research, grounded theory, interviews, observation methods, etc.

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Handbook of Global Health pp 213–238 Cite as

Qualitative Research in Global Health Research

• Pranee Liamputtong 5 &
• Zoe Sanipreeya Rice 6  
• Reference work entry
• First Online: 12 May 2021

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This chapter discusses the contribution of qualitative research and its value in global health. Qualitative research alludes to “a broad approach” that qualitative researchers adopt as a means to examine social circumstances. The inquiry posits that people use “what they see, hear, and feel” to make sense of social experiences. There are many features that differentiate qualitative research from the quantitative approach. Fundamentally, it is interpretive. The meanings and interpretation of the participants are the essence of qualitative inquiry. Qualitative research is valuable in many ways. It offers researchers to hear silenced voices, to work with marginalized and vulnerable people, to address social justice issue, and to contribute to the person-centered healthcare and the design of clinical trials and plays an important role in evidence-based global health. Qualitative researchers are seen as constructivists who attempt to find answers in the real world. Fundamentally, qualitative researchers look for meanings that people have constructed. In this chapter, we discuss the value of qualitative research, qualitative inquiry in global health, qualitative research, and evidence-based practice in global health. The chapter also discusses in great depth some distinctiveness of the qualitative research, in particular the inductive nature of qualitative research, methodological frameworks, purposive sampling technique, saturation concept, qualitative data analysis, and the trustworthiness of a qualitative study. We also provide a concrete example of how a qualitative study was undertaken using details from the research project that we have conducted.

• Qualitative inquiry
• Interpretation
• Evidence-based practice in health
• Methodological framework
• Trustworthiness
• Qualitative researcher

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Quantitative and Qualitative Methods for Public Health

This course focuses on quantitative methods, which are designed to precisely estimate population parameters and measure the association between biologic, social, environmental, and behavioral factors and health conditions in order to define the determinants of health and disease and, ultimately, to understand causal pathways.

However, it is important to acknowledge the importance of qualitative methods which provide a means of understanding public health problems in greater depth by providing contextual information regarding a population's beliefs, opinions, norms, and behaviors. This type of information is difficult to capture using traditional quantitative methods, yet it can be vitally important for understanding the "why" for many health problems and also the "how" in terms of how to achieve improvements in health outcomes.

These two approaches might be thought of as the positivist and the constructivist approaches. In positivist research data are more easily quantified, but they are disconnected from the context in which they occur. For example, people of lower socioeconomic status are more likely to smoke tobacco, but the data collected does not indicate why. However, with a constructivist approach, the exposures that people are subjected to (or choose) are better understood in the context of their personal circumstances and the significance that people attribute to things in their environment.

Qualitative methods provide a means of understanding health problems and potential barriers and solutions in greater detail, and they provide an opportunity to understand the "how" and "why" and to identify overlooked issues and themes.

The table below, from the introductory course on fundamentals of public health, highlights some of the major differences between quantitative and qualitative research.

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Content ©2020. All Rights Reserved. Date last modified: September 10, 2020. Wayne W. LaMorte, MD, PhD, MPH

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• Published: 04 April 2024

Use of qualitative research in World Health Organisation guidelines: a document analysis

• Melissa Taylor   ORCID: orcid.org/0009-0006-3506-0902 1 ,
• Paul Garner 1 ,
• Sandy Oliver 2 , 3 &
• Nicola Desmond 4  

Health Research Policy and Systems volume  22 , Article number:  44 ( 2024 ) Cite this article

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Guidelines depend on effect estimates, usually derived from randomised controlled trials, to inform their decisions. Qualitative research evidence may improve decisions made but where in the process and the methods to do this have not been so clearly established. We sought to describe and appraise how qualitative research has been used to inform World Heath Organization guidance since 2020.

We conducted a document analysis of WHO guidelines from 2020 to 2022. We purposely sampled guidelines on the topics of maternal and newborn health (MANH) and infectious diseases, as most of the qualitative synthesis to date has been conducted on these topics, likely representing the ‘best case’ scenario. We searched the in-built repository feature of the WHO website and used standardised search terms to identify qualitative reporting. Using deductive frameworks, we described how qualitative evidence was used to inform guidelines and appraised the standards of this use.

Of the 29 guidelines, over half used qualitative research to help guide decisions (18/29). A total of 8 of these used qualitative research to inform the guideline scope, all 18 to inform recommendations, and 1 to inform implementation considerations. All guidelines drew on qualitative evidence syntheses (QES), and five further supplemented this with primary qualitative research. Qualitative findings reported in guidelines were typically descriptive, identifying people’s perception of the benefits and harms of interventions or logistical barriers and facilitators to programme success. No guideline provided transparent reporting of how qualitative research was interpreted and weighed used alongside other evidence when informing decisions, and only one guideline reported the inclusion of qualitative methods experts on the panel. Only a few guidelines contextualised their recommendations by indicating which populations and settings qualitative findings could be applied.

Conclusions

Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH. However, the process often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.

Peer Review reports

Evidence-informed guidance usually includes a critical summary of one or more systematic reviews of reliable research findings to inform the decisions. For simple clinical questions which assess the efficacy of a new drug, systematic reviews of randomised control trials may provide the most appropriate information [ 1 ]. Making recommendations about drugs, vaccines and public health interventions all require reflection on the acceptability or appropriateness of an intervention, and this requires different forms of evidence and types of research [ 2 ]. The value of qualitative methods lies in their ability to pursue systematically ‘what’, ‘why’ or ‘how’ questions that are not easily answerable by experimental methods [ 3 ].

There is an increasing recognition of the importance of the social determinants of health in policy making, given the complex nature of most public health issues [ 4 ]. Qualitative research methods are particularly adept to explore these findings from the individual, community or broader system level [ 4 , 5 ]. Qualitative research may also range from descriptive to explanatory in nature [ 6 ]. Descriptive findings address people’s views or experiences, such as the perception of personal benefits and harms of interventions, and the trade-offs between these. Descriptive findings may also identify and describe unintended consequences of the proposed intervention. Finally, they may identify logistical barriers and facilitators to programme success [ 7 , 8 ]. These aspects are particularly valuable, as they bring forth the patient and health worker voice in decision making [ 9 ].

Explanatory findings, on the other hand, link descriptive perspectives or experiences to aspects of psychological, historical, cultural, economic, social, environmental and political context [ 6 ]. In doing so, they help generate a theoretical understanding of ‘why’ perceptions and experiences occur and may have broader applications to related contexts [ 6 ]. Here qualitative findings may be used to explain how personal attributes and lifestyle impact individuals, how local context impacts group choice to access treatment or diagnosis or how broad structural and health systems can impede their ability to access, benefit or trust health interventions [ 7 , 8 ].

Guideline developers such as the World Health Organisation (WHO) are beginning to draw on qualitative research to inform their decisions [ 2 ], aided by the methodological developments of systematic reviews of qualitative research, known as qualitative evidence syntheses (QES) and their appraisal [ 10 ]. Previous research has documented examples on how qualitative research has so far informed guideline processes, including identifying relevant outcomes, evaluating evidence to produce recommendations and developing implementation considerations [ 11 , 12 , 13 ]. However, it remains unclear how often qualitative research is actually used for these purposes. Further, it is thought that qualitative research does not always fit well within the ‘summary-based and compartmentalised structure’ of the guideline framework [ 12 ], given the wide range of aims of qualitative research, from describing people’s views to explaining the impact of structural barriers to treatment access. Documenting which of these the WHO has drawn on so far will help to further refine guidance for the uptake of qualitative research by Identifying areas of unmet potential.

Furthermore, as with any guideline development, those preparing the reviews and the panels using them need to provide transparent reporting and rigorous appraisal akin to those historically practised with quantitative research in decision-making [ 12 , 14 ]. However, so far, no methodological guidance exists on how best to systematically draw on and evaluate qualitative findings during guideline processes [ 9 ], and it is unclear how often these standards are achieved [ 11 , 12 , 13 ].

Our aim is to describe how qualitative evidence has been used in existing WHO guideline development procedures and appraise the standards of this inclusion.

We used a study design of document analysis to systematically describe and appraise WHO guidelines. Document analysis is a qualitative method commonly used in health policy analysis [ 15 ], which aims to synthesise and appraise textual data to elicit meaning, gain understanding and develop empirical knowledge [ 16 ]. This necessitates a systematic approach; however, standardised methodologies are lacking [ 15 ]. To ensure rigour, we drew on Kayesa and Shung-King [ 15 ], who identified the key steps reported in document analyses: adopting clear inclusion criteria for documents and clear procedures for identifying documents, coding them and extracting data; applying a clear analytical framework to analyse the role of qualitative research cited in policy documents; and presenting the findings of each stage of the process from searching for documents to answering the research question.

Guideline retrieval

A scoping search of the Cochrane Library [ 17 ] identified that QES were most frequently conducted on MANH (6/23 QES) and infectious disease topics (7/23 QES). For this reason, we chose to focus our analysis on these topic areas, as whilst not exhaustive, they may represent the ‘best case scenario’.

We used the in-built document repository feature on WHO’s website [ 18 ] to identify guideline documents. Therefore, only documents published on this web page were eligible for inclusion. Grey literature was not included. The web page allowed for filtering by publication type and year, which was restricted to ‘guideline’ in 2020 and 2021. A 2-year period was chosen to reflect the most current practices of qualitative research at the time of the search. The lead author (M.T.) then screened the guideline titles in the search results for topics relating to Maternal and Newborn Health (MANH) and infectious disease. MANH was defined as any topic covering the health of women during pregnancy, childbirth and the post-partum period and babies’ first month of life. Infectious disease was defined as any topic covering the prevention, diagnosis and treatment of all diseases acquired through human–human or animal–human transmission, including vector-borne diseases. A table detailing the excluded guidelines and justification for this exclusion can be found in Additional file 1: Excluded studies. The final list of included and excluded guidelines was approved by the entire author team.

The unit of analysis used in this study was the section of text describing a qualitative finding within a guideline document. As a result, we performed a second search within the included guideline documents to identify any qualitative reporting. We defined a qualitative study as one that collected data using qualitative methods such as ethnographic observations, in‐depth interviews, focus group discussions and open‐ended survey questions. Appropriate analysis methods included, for example, thematic analysis, narrative analysis, framework analysis, and grounded theory. While we acknowledge that mixed methods studies may contribute qualitative findings, for the purpose of this study they were excluded, as it was not possible to identify which findings had been derived from quantitative or qualitative methods. Initial reading of a sample of three guidelines in-depth identified terms that accompanied qualitative reporting. We then performed a key-word search for the following terms in all guidelines to identify qualitative reporting: ‘qualitative’, ‘accept*’, ‘value’, ‘equit*’, ‘feasib’, ‘interview’ or ‘focus-group discussion’. Sections of text containing the keywords were checked against their corresponding citation to ensure the findings were derived from qualitative studies.

Data extraction and analysis

Data analysis occurred in three phases. First, given the broad range of potential qualitative findings, we sought to understand what ‘type’ guidelines typically drew on. To achieve this, we developed a deductive framework informed by the literature. We crossed (1) the nested individual, community and broader system ecosystems within social determinants of health theory against (2) descriptive to explanatory qualitative research methodology. Within this, we populated the matrix with qualitative research aims derived from literature and discussed in the background of this paper. This provided us with a theoretical overview of the potential contribution of qualitative research (Fig.  1 ). We then coded each qualitative finding contained within guidelines with one of these aims. The framework was validated on a selection of guidelines, which led to the inclusion of one inductive aim of qualitative research: to understand information needs.

Matrix of how qualitative research can contribute to guideline development

We next sought to describe how qualitative research was identified by the guideline and how it was used to inform the scope of the guideline, the intervention recommendation and implementation considerations. Finally, we sought to appraise how qualitative research had been used using analogous standards expected and practised for quantitative methods in decision-making processes. Table 1 guided this process. Extraction domains and questions were initially identified a priori, and any new questions that arose during analysis were shared and discussed within the team to ensure they were appropriate. If new questions were added to the data extraction tool (Table  1 ), all guidelines were re-analysed to ensure a complete dataset.

Search results

Between 2020 and 2022, the WHO published 29 guidelines on the topics MANH and infectious diseases. Seven guidelines were excluded as they did not cover the chosen topics areas. Of the 29 included guidelines, 18 (62%) incorporated qualitative research to inform either the scope, recommendation or implementation considerations. Of the 18 guidelines that used qualitative research, 15/18 guidelines were on topics of MANH, in contrast to 3/18 on infectious diseases. An overview of the search results is shown in Fig.  2 below, and a summary of all included guidelines is detailed in Table  2 .

Overview of guideline search process

Below follows a narrative summary of where the 18 guidelines used qualitative evidence in informing their scope, decisions and implementation considerations. This is followed by an appraisal of this use according to the pre-specified domains of transparency, specificity, certainty and reflexivity.

How qualitative research was used

Overall, qualitative research summarised in guidelines typically provided descriptive understanding of logistical barriers and facilitators to programme success (133 quotations across 18 guidelines) or patient perception of benefits and harms (126 quotations across 18 guidelines). Less frequently, qualitative findings explained the influence of local context of health-seeking behaviours and the influence of local context (51 quotations across 18 guidelines); described information needs (42 quotations across 10 guidelines); explained the influence of personal attributes on health seeking behaviour (42 quotations across 10 guidelines); described unintended consequences (12 quotations across 5 guidelines); or explained how systems function and their impact on individuals (5 quotations across 1 guidelines). Figure  3 provides an overview of these findings with selected example quotations derived from the guidelines presented in this study. A cross comparison of how these roles fed into each stage of the decision-making process is presented below:

Illustration of how WHO guidelines used qualitative research according to their role

Retrieving qualitative research

Guideline documents either specifically commission research to inform their process or identify existing literature. Seven guidelines commissioned QES specifically for their guideline [ 22 , 25 , 28 , 29 , 30 , 31 , 32 ], while four guidelines performed a systematic search of published literature [ 19 , 20 , 33 , 34 ]. However, seven guidelines did not include any methods for how they obtained qualitative research.

Overall, the guidelines in our analysis drew on a total of 38 primary studies and 25 systematic reviews of qualitative research (QES) to inform their recommendations. Guidelines most often drew on 2 qualitative research studies and a maximum of 33 qualitative research studies [ 27 ].

All guidelines that used qualitative research drew on systematic reviews of qualitative evidence, known as QES to inform their process. No guidelines drew exclusively on primary qualitative studies, but five did include them alongside qualitative evidence synthesis data [ 22 , 24 , 25 , 27 , 31 ].

Informing guideline scope

Seven guidelines [ 19 , 20 , 21 , 22 , 23 , 24 , 25 ] on the topic of MANH drew on the same QES [ 26 ] to inform the addition of a quantitative ‘positive postnatal experience outcome’, defined as ‘ in which women, partners, parents, caregivers and families receive information and reassurance in a consistent manner from motivated health workers. Both the women’s and babies’ health, social and developmental needs are recognized, within a resourced and flexible health system that respects their cultural context ’ [ 25 ]. The inclusion of this outcome allowed for prioritising women’s psychosocial and emotional well-being alongside physical health outcomes, such as mortality or morbidity, when evaluating an intervention. One infectious disease guideline [ 27 ] drew on qualitative research to inform the background of 6/99 recommendations. Findings here were often coded as ‘to understand why programmes succeed or fail’, suggesting that qualitative research can be used in this context to detail challenges with current approaches and provide a rationale for the consideration of new interventions and service designs.

Informing the decision to recommend an intervention

All 18 guidelines drew on qualitative research to inform the decision. The frequency of use for this purpose likely reflects the standardisation of the research-to-decision-making framework (EtD) and pre-specified domains of ‘acceptability’, ‘values and preferences’, ‘feasibility’ or ‘equity’ of a proposed intervention. Table 2 provides an overview of which of these domains included qualitative research. Regarding the feasibility of the proposed intervention, 12 guidelines drew on qualitative research. Regarding the acceptability of the proposed intervention, 13 guidelines drew on qualitative research. Regarding the values and preferences relating to the proposed intervention, 17 guidelines drew on qualitative research. Finally, regarding the equity implications of the proposed intervention, five guidelines drew on qualitative research.

Findings that described people’s perception of benefits and harms were typically used in the ‘values and preferences’ domain, which helped to understand the importance patients place on guideline outcomes. They were also used to inform acceptability and feasibility, and it was noted that typically these findings often justified that interventions were acceptable or feasible. In contrast, unacceptable or unfeasible aspects of interventions drew on findings concerned with explaining the influence of local context on health seeking behaviour, understanding how programmes succeed or fail or identifying information needs. Qualitative research was rarely used to identify unintended consequences or to understand how systems function and its impact. These two roles may have important contributions to considerations of equity, yet few guidelines drew on qualitative research to inform this domain.

Depending on the information provided, all but one [ 27 ] of the guidelines then determined a judgement of ‘probably yes’, ‘variable’ or ‘probably no’ to each domain. Judgements of the former two were frequent, and we observed only one occasion in which the acceptability was judged to be ‘probably no’ [ 25 ]. However, ‘varied’ acceptability judgements did not appear to correspond to context specific recommendations or feed into implementation considerations. We found only one example where qualitative research had influenced the overall recommendation and was directly reported in the accompanying justification [ 25 ].

Informing the implementation considerations of an intervention

We found only one guideline where qualitative research had been clearly cited in the designated implementation considerations section for 1/99 recommendations [ 27 ]. This makes it difficult to assess the extent to which qualitative research is used for this component or to delineate considerations that are derived from panel opinion or other forms of research. The qualitative research finding used here stated ‘other challenges include lack of nutrition support’ in reference to adherence support required for children and infants. The reductive nature of the quotation makes it difficult to assess the intended purpose of the use of qualitative research.

Standards of qualitative research use

All MANH guidelines reported judgements about the certainty of evidence by applying the CERQual tool to their QES findings but did not conduct any formal quality assessment on stand-alone primary studies. None of the infectious disease guidelines reported judgements about the certainty of evidence or conducted quality assessments on primary studies.

Transparency

Readers should be able to understand the justification for each recommendation from the research presented [ 12 ]. However, we found that this information was often lacking. A rationale for why the guideline panel judged there to be ‘probably yes’, ‘varied’ or ‘probably no’ acceptability, feasibility, and equity was not provided in any guideline. For some recommendations, the judgement could be easily intuited. For example, a summary of qualitative research that only describes positive viewpoints under acceptability could be reasonably judged to be ‘probably yes’. Yet, when varied viewpoints were presented, it was unclear why acceptability had been labelled ‘probably yes’ as opposed to ‘varied’. Was this due to the relative proportions of conflicting viewpoints or the relative importance of viewpoints?

Some guidelines drew on a mixture of both qualitative and quantitative studies to inform their values, acceptability, feasibility and equity domains. When this occurred, it was not clear how this research was weighed and evaluated in the decision. For example, in one guideline [ 27 ], women were less accepting of the intervention in qualitative interviews in contrast to the surveys which reported high rates of acceptability. Yet the guideline summarised acceptability as ‘high’ and cited quantitative studies to support this. As no quality assessments were performed in any guideline, it is likely that weighting was not dependant on this.

Specificity

Qualitative research can allow for more tailored recommendations that moves beyond what intervention may work in a controlled setting, to which intervention may work in real-life settings and contexts. This is often referred to as the efficacy to effectiveness gap [ 35 ]. However, for this to happen contextualising of recommendations are necessary. This requires narrative summaries of qualitative research to retain sufficient information on the context of findings [ 12 ]. A total of 11 guidelines contextualised a finding at least once. However, overall contextualisation was infrequent and reductive as considerations were labelled as: LMIC settings (54 findings), low-resource settings (2 findings), rural settings (7 findings), HIC settings (3 findings), children (1 finding) and unequal gender relations (2 findings). We acknowledge there is likely to be some crossover between these considerations but have listed them as referred to in the guideline documents. Moreover, contextualised findings did not appear to lead to more nuanced recommendations, e.g. for which populations is this intervention acceptable, or implementation considerations, e.g. how should the implementation be adapted for specific populations.

Reflexivity

Three guidelines in the field of MANH health, but no guidelines in infectious diseases, included someone experienced in qualitative research on the panel. Meanwhile, we sought to understand whether summaries of qualitative research had been produced by the guideline author team, by the guideline panel or in close collaboration, yet no guidelines reported this.

Qualitative research was frequently used in WHO guidelines between 2020 and 2022, although had a larger role in informing MANH than infectious diseases. Within healthcare, qualitative research has its roots in nursing, due to the relative importance of social interventions [ 6 ], and it is likely that the frequent use of qualitative research in MANH is linked to its longer history here, given the similarities in the two fields. This may also explain why some of the MANH guidelines included qualitative expertise, compared with none of the infectious disease guidelines.

We found that qualitative research rarely informed the scope of the guideline or the implementation considerations. Instead, qualitative research most often informed the decision. A similar study reported that 86% of WHO and UK, US and Canadian national guidelines used qualitative research to inform decisions but only 20% to identify clinical questions and 19% to inform implementation considerations [ 36 ]. This may be due to lack of clear citing, which made it difficult to assess accurately the extent of use. However, qualitative research presented in guidelines were often found to touch on issues regarding implementation, and yet this information did not appear to track to the appropriate section. Given that qualitative methods are considered an integral component in wider implementation science, it is surprising to see the lack of qualitative research here [ 37 , 38 ].

Across the different theoretical aims of qualitative research, the most frequently used was ‘describing perception of benefits and harms’ and ‘describing barriers and facilitators to programme success’. In contrast, explanatory findings were less frequently used. Similarly, In National Institute of Health and Care Excellence (NICE) guidelines between 2015 and 2019, over half of qualitative research addressed one of two types of question: “What are the barriers and/or facilitators?” and “What are the information (and support) needs?”, and they were all descriptive in nature [ 39 ]. This may indicate a limited understanding of the potential of qualitative research particularly for more explanatory findings or simply reflect that they infrequently capture these findings to begin with. However, engaging with explanatory findings may allow guideline panels to indicate to national government which findings are likely to be transferable to their context and population groups.

We found that summaries of qualitative research and the process of transforming these into ‘yes’, ‘no’ or ‘varied’ judgments were often reductive, at the expense of the original case complexity and nuance [ 8 , 40 ]. There are several ways recommendations can be contextualised from the perspectives of: geographical, epidemiological, sociocultural, socioeconomic, ethical, legal and political [ 41 ]. Qualitative research may help in understanding how proposed interventions interact with these aspects of context, but this is currently poorly conducted. One driver of this may be in how domains such as ‘acceptability’ are framed and defined. Guideline developers drew on the following definition of acceptability: ‘the extent to which that intervention is considered to be reasonable among those receiving, delivering or affected by the intervention’ [ 13 ]. However, acceptability can include affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy [ 42 ].

We found that guidelines failed to address or consider quality when interpreting primary qualitative research. Similarly, national UK guidelines by the National Institute of Health and Care Excellence (NICE) between 2003 and 2019 rarely conducted quality appraisal [ 39 , 43 ]. High quality, rigorous evidence is central to the principles of evidence-based practice [ 1 ], and it is important that appropriate standards are applied to qualitative research, not only to ensure the usability of the findings but also to institutionalise the credibility of the methodology as a whole. The use of qualitative research also lacked transparency as it was often unclear how the information had been interpreted and evaluated. Aside from a transparency issue, it is possible that qualitative research was just not a key influencer in most decisions and mainly relegated to supportive roles in guideline processes [ 44 ].

Study limitations

This study has some limitations. First, we collected guideline documents from a relatively short time frame. The trends documented in this review may be an artefact of 2020–2022, specifically, and do not describe general trends in qualitative research use. Second, lack of clear and transparent reporting on the use of qualitative research does not necessarily mean that, for example, it did not directly feed into overall judgements, or implementation considerations. Document analysis is limited by the availability of public documents, and it may be that further information is contained within meeting notes, email exchanges and other private reports that we cannot access. Finally, we chose to focus on the topics of MANH and infectious disease as they account for a large portion of qualitative research, but the use of qualitative research may be different for other topic areas.

Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH and was rarely used to inform guidelines relating to infectious diseases. However, the process of how qualitative evidence was used and evaluated often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.

Availability of data and materials

The coded guideline documents and data extraction tables are available from the authors upon request.

Abbreviations

Maternal and newborn health

World Health Organisation

National Institute of Health and Care Excellence

• Qualitative evidence synthesis

Low-and middle-income country

High income country

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Melissa Taylor and Sandy Oliver are supported by the Research, Evidence and Development Initiative (READ‐It) project. READ‐It (project number 300342‐104) is funded by UK aid from the UK Government; however, the views expressed do not necessarily reflect the UK Government's official policies.

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Taylor, M., Garner, P., Oliver, S. et al. Use of qualitative research in World Health Organisation guidelines: a document analysis. Health Res Policy Sys 22 , 44 (2024). https://doi.org/10.1186/s12961-024-01120-y

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This is a compulsory subject in the Master of Public Health. Qualitative research plays an important role in public health as it can explain how people experience a particular health issue or why they perform a health-related behavior, taking into account specific social, political and economic contexts. Public health practitioners need to be able to undertake and interpret a range of published research (including qualitative research) in order to gather evidence for practice, identify gaps in evidence and evaluate current practice. This subject will introduce students to qualitative research in public health - both the principles underlying design and the strengths and weaknesses of different qualitative methodologies. It will cover a range of methods, such as individual interviews, group interviews, visual and participatory methods. Each element of research design will be covered, from recognising research paradigms and sampling strategies through to the different types of analysis. Students will learn how to design, plan and evaluate qualitative research as sources of evidence in public health.

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How to use and assess qualitative research methods

Loraine busetto.

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

Wolfgang Wick

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

Christoph Gumbinger

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

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

What is qualitative research?

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

Why conduct qualitative research?

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

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

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

How to conduct qualitative research?

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

Iterative research process

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

Data collection

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

Document study

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

Observations

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

Semi-structured interviews

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

Focus groups

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

Choosing the “right” method

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

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

Possible combination of data collection methods

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

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

Data analysis

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

From data collection to data analysis

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

How to report qualitative research?

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

How to combine qualitative with quantitative research?

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

Three common mixed methods designs

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

How to assess qualitative research?

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

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

Reflexivity

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

Sampling and saturation

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

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

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

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

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

Member checking

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

Stakeholder involvement

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

How not to assess qualitative research

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

Protocol adherence

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

Sample size

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

Randomisation

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

Interrater reliability, variability and other “objectivity checks”

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

Not being quantitative research

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

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

Take-away-points

Acknowledgements

Abbreviations, authors’ contributions.

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

no external funding.

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The authors declare no competing interests.

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• Open access
• Published: 05 April 2024

Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: a qualitative descriptive study

• Min Meng 1 , 2 , 3 , 4   na1 ,
• Jiale Hu 5   na1 ,
• Xiao Liu 6 ,
• Min Tian 4 ,
• Wenjuan Lei 4 ,
• Enmei Liu 2 , 3 ,
• Zhu Han 7 ,
• Qiu Li 2 , 3 , 8 &
• Yaolong Chen 1 , 2 , 3 , 9 , 10 , 11  

BMC Health Services Research volume  24 , Article number:  435 ( 2024 ) Cite this article

Metrics details

Despite being a global public health concern, there is a research gap in analyzing implementation strategies for managing off-label drug use in children. This study aims to understand professional health managers’ perspectives on implementing the Guideline in hospitals and determine the Guideline’s implementation facilitators and barriers.

Pediatric directors, pharmacy directors, and medical department directors from secondary and tertiary hospitals across the country were recruited for online interviews. The interviews were performed between June 27 and August 25, 2022. The Consolidated Framework for Implementation Research (CFIR) was adopted for data collection, data analysis, and findings interpretation to implement interventions across healthcare settings.

Individual interviews were conducted with 28 healthcare professionals from all over the Chinese mainland. Key stakeholders in implementing the Guideline for the Management of Pediatric Off-Label Use of Drugs in China (2021) were interviewed to identify 57 influencing factors, including 27 facilitators, 29 barriers, and one neutral factor, based on the CFIR framework. The study revealed the complexity of the factors influencing managing children’s off-label medication use. A lack of policy incentives was the key obstacle in external settings. The communication barrier between pharmacists and physicians was the most critical internal barrier.

To our knowledge, this study significantly reduces the implementation gap in managing children’s off-label drug use. We provided a reference for the standardized management of children’s off-label use of drugs.

Peer Review reports

Introduction

Off-label drug use in pediatrics is a global public health issue [ 1 ], particularly in China [ 2 , 3 ]. According to a systematic review, pediatric off-label medicine prescription rates ranged from 22.7% to 51.2% in outpatient settings and 40.48% to 78.96% in hospitalized children in China [ 4 ]. However, there are numerous unreasonable examples of off-label drug use in children, posing significant risks to children’s safety [ 5 , 6 ]. As a result, the Guideline for the Management of Pediatric Off-label Use of Drugs in China (i.e., the Guideline) was developed in 2021 by the Chinese Society of Pediatric Clinical Pharmacology, the Chinese Medical Association, and the National Clinical Research Center for Child Health and Disorders (Children’s Hospital of Chongqing Medical University), in collaboration with the Chinese GRADE Center [ 7 ].

However, translating evidence from clinical practice guidelines (i.e., CPG) into practice, also known as implementation [ 8 , 9 ], is a complex process influenced by various factors such as political and social, the health organizational system, the CPG context, healthcare professionals, and patients [ 10 ]. For example, only about half of Chinese healthcare professionals follow the recommendations and understand the clinical practice guidelines, which range from 3 to 86% [ 9 ].

To enhance guideline adherence among healthcare professionals, it is necessary to identify the facilitators and barriers to guideline implementation [ 11 ]. In addition, theory-based guideline implementation research can assist implementers in avoiding potential pitfalls that may hinder their effectiveness [ 12 ]. Consequently, identifying factors that influence the implementation of recommendations, that is, implementation barriers and facilitators [ 10 ], is essential for the early clinical translation of guidelines to implement strategies tailored to anticipated barriers [ 13 ] and to optimize the implementation of interventions [ 14 ].

Off-label use of drugs in children is a complex aspect of clinical practice [ 15 ]. Only a small number of studies have demonstrated that the following are obstacles to the management of pediatric off-label use in China: lack of time to offer sources of information and evidence of off-label use, no available expert panel on off-label use, no adverse drug reaction monitoring system, no database of off-label drugs, no ethics council or pharmacy administration committee, difficulties in gaining written agreement from parents or guardians, and absence of a unified regulatory framework [ 16 , 17 , 18 ]. In addition, doctors’ awareness prescription of off-label drugs [ 19 , 20 , 21 , 22 ], their fear of legal repercussions [ 23 ], and they are less of informing parents about off-label drugs [ 21 , 24 ] were obstacles to managing children’s off-label drug use. However, none of the present research is theoretically based on guideline implementation studies and hence may lack systematicity in identifying factors influencing off-label drug use management in children. In addition, implementation strategies for managing pediatric off-label drug use are understudied.

Implementation strategies tailed based on the implementation contextual factors can promote adherence among healthcare professionals [ 25 ]. The Consolidated Framework for Implementation Research (CFIR), a well-known implementation science framework, has been extensively used as a framework in recent research on strategies for implementing guidelines, and it has successfully identified the influencing factors for guidelines’ implementation [ 26 , 27 , 28 , 29 , 30 , 31 ].Therefore, this study used CFIR for guiding data collection, data analysis, and findings interpretation to implement interventions across healthcare settings and aimed to understand professional health managers’ perspectives on implementing the Guideline in hospitals and determine the Guideline’s implementation facilitators and barriers. Also, the suggestions for implementing the Guideline were created by mapping the identified barriers to the Expert Recommendations for Implementing Change (ERIC) and selecting the appropriate strategies for implementation [ 26 , 32 ].

Research design

A qualitative descriptive study design was used in this study to understand professional health managers’ perceived barriers and facilitators to implementing the Guideline in hospitals [ 33 ]. In the previous study, 896 healthcare professionals from mainland China were invited to complete a questionnaire to rate the urgency and difficulty of implementing each of the 21 recommendations in the Guideline, ranking the recommendations according to combined scores, and selecting the top five of them (See Table  1 ).

Setting and sample

The study was conducted collaboratively by the Clinical Pharmacology Group of the Pediatric Society of the Chinese Medical Association and the National Clinical Research Center for Child Health (Children’s Hospital of Chongqing Medical University). Pediatric directors, pharmacy directors, and medical department directors from secondary and tertiary hospitals across the country were recruited voluntarily through the members’ units for online interviews via Tencent Meeting ( https://meeting.tencent.com ).

Reading available studies and performing some initial research helped create an interview framework [ 16 , 17 , 34 , 35 , 36 ]. Before the formal interviews started, a pharmacy director was recruited to participate in the pretest, and the interview plan was modified to consider the pretest results. The formal interviews were performed between June 27 and August 25, 2022, and participants were recruited using the convenience sampling approach. All the professionals with at least one year of management experience in pediatric off-label drug use were included. All experts invited to present were encouraged to participate and were given comprehensive information on the study via WeChat. They were instructed to read the Guideline in detail and ask the guideline developers to explain any questions accordingly [ 7 ]. Detailed interview times and locations were negotiated after signing an electronic informed consent. The sample size for this investigation was determined based on data coding, data saturation, and study feasibility [ 37 ].

Data collection

A semi-structured interview outline was created, with all questions revolving around the CFIR. The conversation will focus on potential contributing elements and obstacles to the Guideline’s implementation (See Supplementary Material 2 ). The CFIR framework and pre-interview were used to determine the validity of a structured interview in this qualitative research.

Data collection and analysis were repeated to discover new insights from early interviews that would guide later interviews and data collection [ 33 ]. We used Tencent Conferences ( https://meeting.tencent.com ) for audio recording and Xunfeitingjian Software ( https://www.iflyrec.com/ ) for transcriptions. Each interview was recorded with a particular interviewer label and then transcribed verbatim. All interviewees had the chance to examine the interview recordings to increase credibility and reliability.

Data analysis

The facilitators and barriers of the Guideline were investigated explicitly in the qualitative content analysis of expert interview data [ 38 ]. Both inductive and deductive methods were used to identify facilitators, barriers, and neutral factors [ 39 ]. A neutral influence has no positive or negative consequences or both positive and negative consequences but is overall neutral [ 40 ]. Meaningful text units, such as sentences, paragraphs, and words, were inductively extracted into coding and then subjected to CFIR framework analysis. These codes were then classified into subcategories and generic categories for further evaluation [ 41 ]. Information extraction and coding in Chinese were carried out independently by two researchers (MM and LX), and any discrepancies were resolved through discussion. The final findings were translated into English and further discussed by the research team to enable researcher triangulation and to reach a consensus on the results [ 42 ].

Role of the funding sources

The funder provided support for expert consultation fees and research publication costs. The study’s design and execution were not influenced by the research funding.

Characteristics of participants

Individual interviews were conducted with 28 healthcare professionals. The interviews ranged from 21 to 56 min. Half of the participants had a bachelor’s degree, and 60.7% were male. Among the participants, pediatric directors, pharmacy directors, and medical department director were ten, nine, and nine, correspondingly. About 40% of participants had more than 20 years of experience, 27 were in senior positions, and one was in an intermediate position. There were 15 from tertiary hospitals and 13 from secondary hospitals, respectively. Twenty of the professionals interviewed were dissatisfied with the current management of off-label drug use in children. Participants came from all across the Chinese mainland (see Table  2 ).

Identified influencing factors

According to the findings of the interviews, there are 57 factors influencing the implementation of the Guideline in China, including 27 facilitators, 29 barriers, and one neutral factor. These contributing factors were spread throughout 29 constructs in the four CFIR domains studied for the guidelines (see Table  3 and Supplementary Material 1 ). The most influential factors were found in the internal setting, and the fewest influences were found in the intervention characteristics, which was 24 and ten, respectively. Following the CFIR framework, including intervention characteristics, external setting, internal setting and individual characteristics, we will present the following descriptions of all influential factors.

Intervention characteristics

In seven of the eight constructs in the CFIR domain of intervention characteristics, three facilitators and seven barriers were identified (see Table  3 and Supplementary Material 1 ). Many experts supported the implementation of the Guideline and praised the quality and strength of the evidence in terms of facilitators. The Guideline’s key relative strengths were the Guideline developed by a pediatric specialty hospital, which was in charge of developing pharmaceuticals for pediatrics, including national interdisciplinary specialists with more impact. It is more advantageous than comparable existing guidelines in China.

The barriers included a lack of practicality, unnecessary clinical practice, a need for context-specific adaptation, poor trialability in non-children’s hospitals, poor feasibility in primary hospitals, some complicated recommendations, and a need for some cost. The participant said, “With or without this guideline, it has little impact on clinical practice; it is just an additional option to consider.” which showed the Guideline is not particularly meaningful. The absence of emergency response capacity, the shortage of pediatricians, and the inability to accurately estimate adverse drug reactions are the key barriers to implementation in primary care facilities. The adaptations to the guidelines that are required to fit the implementing setting include suiting the primary level, renaming off-label drug use to expanded drug use, managing pediatric population subgroups differently (neonates, infants, children, and adolescents), improving process management, and simplifying clinical practice. The management of off-label use of drugs should be implemented for all patients while managing the pediatric population, according to the broad view of non-children’s hospital managers who believe that the pediatric population is too small. Costs that need to be considered include the cost of purchasing, maintaining, and updating the database, the cost of recruiting assessment experts, the cost of legislation, training, and dissemination, as well as the time clinicians must spend managing off-label drugs.

External setting

In the four constructs of the external setting, a total of 12 influencing factors were included, with five facilitating factors, six barrier factors, and one neutral factor (see Table  3 and Supplementary Material 1 ). In terms of facilitating factors, the Guideline can meet children’s treatment needs, pharmaceutical companies participate in and promote clinical trials, the Physicians Law of the People’s Republic of China encourages the management of off-label drug use in children, the occurrence of off-label drug use disputes in children raises concerns in this area, and unique improvement campaigns. Neutral influences include the Guangdong Pharmaceutical Society, the Shandong Pharmaceutical Society, and similar guidelines from other countries.

The barriers included a lack of patient understanding, pharmaceutical industry off-label promotion, too many choices, non-reimbursement by health insurance, risk of legal conflicts, and a lack of administrative or policy promotion. Although clinicians may have some authority, they will still have to deal with the problem and risk of off-label use of drugs because patients frequently lack comprehension of their use. " Well-known professionals collect a variety of evidence and then inform the patient of any potential adverse effects,, the parents will claim, ‘I signed the informed permission, but I do not know the medicine and saw the instructions did not include this use. You are a doctor, and you know whether to use it.' if the accident occurs.” In China, the health insurance reimbursement system has a direct impact on clinicians’ treatment behavior, and “there is a big problem with not being reimbursed for any medications that are used off-label. " In addition, the possibility of legal disputes arising from the off-label use of medications in children worries many doctors. A participant said,” After all, there is no particular legislation, and while the Physician Law specifies that off-label drug use is subject to standards and guidelines, there are still risks in practice. " Furthermore, the lack of administrative or policy impetus for the guideline is an essential barrier, “Regarding the current context of hospital medication use in China, the power of professionals is constantly pushed by the force of administration or policy. “

Internal setting

The 14 structures of the internal setting in CFIR contained the most influencing elements, with 15 facilitators and nine barriers (see Table  3 and Supplementary Material 1 ). The facilitators included graded management, a dedicated person to drive, the addition of prescription review rules, promotion by societies or associations, promotion by medical associations, cultural alignment with the hospital, high urgency, fitting firmly with the hospital’s management, availability of punishments, alignment with hospital management goals, a better learning environment, proper off-label drug coverage by the hospital, a team of off-label drug management, a database, and clinical pharmacists’ support of off-label drug use. Off-label drugs are not reimbursed by Medicare but are covered by some hospitals. " The hospital will pay for reasonable off-label drugs that are approved by the hospital but are not paid for by health insurance.” Furthermore, many hospitals are prepared to implement off-label management in children, and interview experts believe that clinical pharmacist support can help manage the off-label use of drugs. A participant said, “Our clinical pharmacists are our most important resource for explaining off-label drug use. The combination of clinicians and clinical pharmacists coming together to assess the safety and efficacy of the drugs is particularly good.”

The barriers included the low priority of pediatrics in non-children’s hospitals, the unfavorable social environment, the conflict between clinicians and patients, the lack of communication between pharmacists and clinicians, a lack of priority in comparison to other daily work, a lack of personal gain, low-level physician compliance, complex management procedures, a lack of attention from hospital leadership, and a lack of specialized training. According to many experts, managing pediatric off-label drug use does not prioritize daily work since it is only a small component of rational medication management or daily diagnosis and treatment. A participant said, " Off-label drugs for children are just a minor part of clinical treatment. In the arduous clinical work, I must always prioritize the patient, making off-label drugs impossible to focus on”. Additionally, especially in primary hospitals, there is a lack of specialized training in using off-label medications in children.

Individual characteristics

In the four constructs of the individual characteristics, a total of 11 influencing factors were included, with four facilitating factors and seven barrier factors (see Table  3 and Supplementary Material 1 ). The facilitators included an alignment with personal beliefs, physician confidence, a willingness to promote, and a high degree of professional restraint and self-defense of pediatric doctors. The transmission and promotion of guidelines with coworkers, classmates, and some network contacts were mentioned by experts as methods. Furthermore, some interviewers considered pediatricians more self-aware and disciplined than adult physicians.

The barriers included a lack of understanding of the Benefit and Risk Assessment framework, low titles, a lack of passion and innovation on the part of pharmacists, a wide range of technical competence, a few physicians’ poor ethical principles, an ignorance of physicians’ management of off-label use drugs, and a physicians’ empiricism with drug use. Recommendation 4.1’s benefit and risk assessment framework confused many medical professionals. They offered some solutions, such as “I hope to use it as a quantitative adjustment of a scale,” “make it a scoring system,” “make its voice recognizable,” or “make it as intelligent standard operating procedures.” The more considerable barriers are physicians’ empirical use of drugs and a lack of awareness about off-label drug management. “Clinically, there isn’t a clear line between right and wrong, and I think that after the recommendations are put into place, there will be a lot of resistance to changing doctors’ habits if they need to.”

Role differences

Conflicting views exist among experts on the interaction between clinical pharmacists and physicians. A pharmacist said, “The most challenging component of communicating with clinicians is clinical department chiefs, in particular. Some medical professionals will collect books, manuals, guidelines, and other information to prove their point to you. We must explain that any use not listed in the drug manual is considered off-label, but it may not be irrational. Additionally, you must carefully and exhaustively offer evidence when introducing each form of an off-label drug one at a time. With the medical department, communication is still quite simple.” In contrast, doctors contended that “prescriptions are frequently evaluated by the hospital’s pharmacy department, for example, in the case of incorrect dosage. Then a deduction is required, and much work and time must be spent on fighting and appealing each time.” Clinicians expect pharmacists to devote their time and energy as the driving force behind the off-label use of drugs for children, even though the varied feedback from the roles for communication may be related to the various goals of the different roles for managing off-label drugs for children. A participant said, “Pharmacy is expected by medical departments to offer a catalog or to advance scientific management, but their primary goal is self-preservation and minimizing dangers to clinicians during treatment. Clinicians are also extremely hopeful that pharmacies will become more clinically friendly through constant appeal and standardization, some actions to support the development of a reliable system, and a social environment. However, clinicians might not invest much time or effort in this area.”

Conflicting influential factors

Some interview experts viewed clinical pharmacists as facilitators, but some believed that they made managing children’s off-label drug use more difficult. “It is appropriate for clinical pharmacists to direct the clinical use of medications because they are more knowledgeable about drug toxicology and adverse effects. But the current situation of over-centralization of clinical pharmacist rights and restriction of clinical use of medications to clinicians, as well as the lack of personal competence of clinical pharmacists, may hinder the rational clinical use of medications, including off-label use in children,” one medical director stated.

Many experts regarded the Law on Doctors of the People's Republic of China as a facilitating factor, but some experts still think there are legal concerns involved in putting the Guidelines into practice. An expert said, “The Physicians’ Law contains 67 items, including four on the use of off-label drugs, which is considerable progress for the management of off-label use of drugs. However, there is no targeted legislation. Clinicians are at higher risk of experiencing adverse side effects from using off-label drugs.” The experts regard the guidelines’ implementation as urgent but not a priority. An interviewer said, “As a result of our current inadequate drug supply and the urgent demand for pediatric medications, experts stressed the urgent necessity to address the issue of off-label prescriptions for children.” However, according to experts, it is not given the highest priority for implementation, primarily due to the busy and complex clinical work and the concern about off-label use of drugs making up a tiny portion of daily work. Additionally, managing children’s off-label drug use is also not a standard component of hospital assessments, and medical staff typically puts the hospital’s assessment requirement first.

According to our knowledge, this is the first study conducted by Chinese guideline developers to tailor the implementation strategy of the guidelines. Key stakeholders in the implementation of the Guideline for the management of pediatric off-label use of drugs in China (2021) were interviewed to identify 57 influencing factors, including 27 facilitators, 29 barriers, and one neutral factor, based on the implementation science CFIR framework and using one-on-one expert in-depth interviews. Based on mapping the critical barriers to the CFIR-ERIC [ 26 , 32 ], recommendations for implementation strategies were made, such as tailoring strategies, encouraging adaptability, inquiring of national health administrations to promote recommendations, and establishing networks for communication between clinicians and pharmacists. The study revealed the complexity of the factors influencing managing children’s off-label medication use. We will update the Guideline to address the lack of patient awareness, and a lack of policy incentives (non-reimbursement by health insurance and a lack of administrative or policy promotion) were the key obstacles in external settings. The communication barriers between pharmacists and physicians were found to be the most critical internal barriers. Regarding individual characteristics, the main barriers were pharmacists’ varying technical competence and physicians’ empiricism with medication use. Additionally, this study discovered that even though the PRC Physicians Law’s enforcement helped implement and promote the Guideline, it still needs to relieve the issue of legal dangers for medical staff completely. The difference in the barriers to implementing the Guideline for different roles of medical staff is the communication barrier between pharmacists and physicians.

According to this qualitative study, the Guideline was viewed as having less applicability for primary hospitals by many experts. The findings were consistent with a 2017 study on managing children’s off-label drug use, which also found a significant difference between the management of children’s off-label drug use in secondary and tertiary hospitals [ 17 ]. In China, each hospital grade has a unique set of medical duties, and the higher the grade, the greater the capacity for treatment [ 43 , 44 ]. As map CFIR-ERIC suggests, we should tailor strategies [ 26 , 32 ]. It is advised that guideline developers should take into account the creation of implementation strategies for various hospital grades [ 14 ]. Additionally, many experts feel that the Benefit and Risk Assessment Framework in recommendation 4.1 is difficult to comprehend and would like to quantify and improve the framework’s operability to help physicians make speedy and accurate decision-making. Intelligent assisted decision-making technologies have been created globally and deployed in clinical practice [ 45 , 46 , 47 ]. Artificial intelligence-based and scientifically sound assisted decision-making systems for children’s off-label drug use to have some shortcomings [ 45 ]. As map CFIR-ERIC suggests, we should promote adaptability and suggest researchers should develop a more practical framework for monitoring the use of off-label drugs in children or a scientifically validated off-label medication-assisted decision-making system to make it easy to follow [ 26 , 32 ].

As our findings show, in China, the lack of policy incentives and Medicare not covering off-label medicine costs are severe barriers to managing off-label drug use in children [ 48 , 49 ], Belgium [ 50 ], the Czech Republic [ 51 ], Germany [ 52 ], Italy [ 53 ], Switzerland [ 53 ], the United States [ 54 , 55 ], Slovakia [ 55 ], Greece [ 5 ], and Poland [ 56 ], were currently capable of paying for certain off-label drugs by general health insurance. As a result, it is proposed that China’s health insurance department consider establishing a national essential specified reimbursement catalog for off-label drugs based on the relevant experience of the countries mentioned above. Also, we find that a lack of administrative & policy promotion is a barrier. Policies are the most influential drivers of medical practice improvement in China. For example, the Chinese Special Rectification Activity on Clinical Antibiotic Use (CSRA), launched in 2011, has been implemented by hospitals and promoted by policy. Numerous studies have demonstrated its rapid and long-term implementation effect [ 57 , 58 , 59 ]. Alter incentive/allowance structures, involve executive boards, and build a coalition were mapped by CFIR-ERIC [ 26 , 32 ]; consequently, the national health administration is called upon to promote implementing off-label drug use management in children.

Although the Law on Doctors of the People's Republic of China was a reasonable basis for off-label use, physicians and hospitals face potential legal risks in practice, according to our research, which may be because of its implementation challenges [ 59 ]. According to Chinese Physicians Law, “in special cases where effective therapies are not yet available, a physician may, after obtaining the patient’s explicit informed consent, use a drug that is not stated in the drug’s instructions but has evidence to support its use,” which indicates that there are two conditions for using drugs off-label. First, obtain the patient’s informed consent. Second, there is evidence supported. Clinical challenges exist in obtaining informed permission from parents of children, primarily because of their lack of comprehension of the concept of off-label use of drugs [ 19 , 60 ] and an increased risk of adverse reaction [ 60 ], which is further worsened by the crisis in doctor-patient trust crisis [ 61 ]. Additionally, the current inaccessibility of evidence, mainly because of the shortage of locally evidence-based data for pediatrics [ 62 , 63 ], the shortage of evidence-based specialists [ 64 ], and the ignorance of “evidence-based medicine” and its critical databases among doctors both domestically and internationally [ 65 ]. As a result, the following two suggestions are recommended: On the one hand, information sharing and disease-specific education [ 66 ] can help doctors and patients communicate more effectively. The Guideline’s developers should create patient and public versions of the Guidelines [ 67 , 68 ] to “translate” the rationale and recommendations into a format that patients and the general public can understand and use, as well as to assist parents of children in understanding the meaning and necessity of off-label drugs in a friendly manner. Parents will have a better grasp of why off-label drug use is necessary. On the other hand, the authors of the recommendations should invite evidence-based specialists to regularly update the “list of common types of pediatric off-label use of drugs, evidence levels, and recommendations” in Recommendation 1.2, making it easy for clinicians to access the evidence-based information regarding the use of drugs off-label in children.

Clinical pharmacists actively contribute to managing off-label drugs in children, as the experts indicated in their interviews [ 69 , 70 , 71 , 72 ]. However, the study identified communication barriers between pharmacists and physicians, which is consistent with the findings [ 73 ]. On the one hand, the idea of the doctor as a leader is ingrained in the medical profession. The power gap between doctors and pharmacists makes doctors seem unapproachable to pharmacists [ 74 , 75 ]. On the other, most clinical pharmacists in China originally trained as ordinary pharmacists and went on to finish a year of continuing clinical pharmacy education [ 76 , 77 ]. A need for more clarity of duty and role conflict among clinical pharmacists is frequently the result of shorter training programs and quick duty transitions [ 76 ]. The wide range mainly demonstrates this in clinical pharmacist competence [ 78 ], which has caused physicians to need more faith in their expertise [ 73 ]. In order to improve the communication effectiveness of pediatric off-label use of drug management, it is suggested to investigate appropriate communication strategies and establish networks for communication between doctors and pharmacists according to the CFIR-ERIC map [ 26 , 32 ]. For instance, physician-pharmacist-patient communication has become more effective and satisfying thanks to the situation-background-assessment-recommendation (SBAR) standardized communication model [ 79 , 80 ].

To our knowledge, this study significantly reduces the implementation gap in managing children’s off-label drug use. We systematically identified and analyzed the “Guideline for the Management of Pediatric Off-Label Use of Drugs in China” implementation challenges using the CFIR framework and gave suggestions for implementing the Guideline. In this study, we investigated the perspectives of healthcare professionals in various hospital roles on the management of children’s off-label drug use. We provided a reference for the standardized management of children’s off-label use of drugs.

Limitations

The study also has some limitations. Firstly, only the key stakeholders in the Guideline—the head of pediatrics, the head of the pharmacy, and the medical department director were included in the study, whichmeans that not all influencing factors were identified. Still, since all participants have rich experience in the field and experience managing off-label drug use in children, we believe they are more representative. Second, quotations with codes were translated into English from the expert interviews and data analysis done in Chinese. Although no researchers of the international collaborative team had read the original transcripts, a consensus was reached through an iterative process and triangulation to ensure the objectivity of the data collection and analysis.

Implications for further research and clinical practice

Planning the implementation of guidelines, including a good fit between implementation strategies, relevant interventions, and contexts, is more complicated and demanding [ 81 ]. The findings of this study indicate that future complex interventions for the Guideline will be necessary because of several influencing factors. It is advised that future intervention studies be designed using the new framework for complex interventions, which includes intervention development or identification, feasibility, assessment, and implementation [ 82 ]. Partnership, target population-centered, evidence, and theory-based, implementation-based, efficiency-based, stepped or phased, intervention-specific, and combination are currently recommended intervention development and design methodologies [ 83 ]. Combining the Chinese implementation settings will be possible concerning numerous implementation strategies, such as workflow and regulation optimization, assessment tool development, resource input, or multidisciplinary collaboration [ 84 ]. Consequently, complex interventions may be established to encourage the implementation of guidelines at various levels of the hospital setting. In addition, appropriate process evaluation methods should be adopted to comprehend and better understand the causal mechanisms and contextual factors associated with outcome change [ 85 , 86 ].

Despite being a global public health concern, there is a research gap in analyzing implementation strategies for managing off-label drug use in children. In the future, the Guideline will be updated based on facilitators and barriers, and interventions will be created in various settings to advance guidelines’ implementation by guideline developers. Additionally, the findings in this study are regarded as a baseline for comparison with the barriers and facilitators evaluated during and after implementing an intervention to improve the use of off-label drug management strategies.

Data availability

To preserve the anonymity of interviewees, the transcribed interviews are not available for sharing. The remaining data generated or analysed during this study are included in this published article and its supplementary information file.

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Acknowledgements

Thanks to Professor Fei Yin of Xiangya Hospital Central South University for his help in recruiting experts for the interviews.

This research was funded by the Chevidence Lab Child & Adolescent Health of Chongqing Medical University’s Children’s Hospital’s Key Project in 2022 (LY03007).

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Min Meng and Jiale Hu contribute equally.

Authors and Affiliations

Chevidence Lab of Child & Adolescent Health, Children’s Hospital of Chongqing Medical University, Chongqing, China

Min Meng & Yaolong Chen

National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, China

Min Meng, Enmei Liu, Qiu Li & Yaolong Chen

Chongqing Key Laboratory of Pediatrics, Chongqing, China

Department of Pharmacy, Gansu Provincial Hospital, Lanzhou, China

Min Meng, Min Tian & Wenjuan Lei

Department of Nurse Anesthesia, Virginia Commonwealth University, Richmond, USA

School of Public Health, Lanzhou University, Lanzhou, China

College of Pharmacy, Gansu University of Chinese Medicine, Lanzhou, China

Department of Nephrology, Children’s Hospital of Chongqing Medical University, Chongqing, China

Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences(2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou, China

Yaolong Chen

 WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou, China

Lanzhou University GRADE Center, Lanzhou, China

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MM and JH are joint first authors. YC and QL designed the study. MM organized all expert interviews with the help of JH and requested experts to examine the interview recordings. XL and MM extracted information and coded in Chinese.WL and XL analyzed the data. MT and ZH translated interview. MM and JH drafted the manuscript. YC and QL revised the article. All authors have read and approved the final manuscript.

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Correspondence to Qiu Li or Yaolong Chen .

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This study was approved by the Research Ethics Committees at Gansu Provincial People’s Hospital (approval number: 2022 − 152). All participants signed the informed consent form. All interviews were conducted anonymously, and all transcripts and other records were kept private. Participants were informed that they could start, refuse, or withdraw from the study without negative consequences.The study was performed in accordance with the Declaration of Helsinki.

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Meng, M., Hu, J., Liu, X. et al. Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: a qualitative descriptive study. BMC Health Serv Res 24 , 435 (2024). https://doi.org/10.1186/s12913-024-10860-0

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Development and implementation of a worksite-based intervention to improve mothers’ knowledge, attitudes, and skills in sharing information with their adolescent daughters on preventing sexual violence: lessons learned in a developing setting, Sri Lanka

• Dilini Mataraarachchi 1 ,
• P.K. Buddhika Mahesh 2 ,
• T.E.A. Pathirana 3 &
• P.V.S.C. Vithana 1  

BMC Public Health volume  24 , Article number:  983 ( 2024 ) Cite this article

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Sexual violence among adolescents has become a major public health concern in Sri Lanka. Lack of sexual awareness is a major reason for adverse sexual health outcomes among adolescents in Sri Lanka. This study was intended to explore the effectiveness of a worksite-based parent-targeted intervention to improve mothers’ knowledge, and attitudes on preventing sexual violence among their adolescent female offspring and to improve mother-daughter communication of sexual violence prevention with the family.

“My mother is my best friend” is an intervention designed based on previous research and behavioral theories, to help parents to improve their sexual communication skills with their adolescent daughters. A quasi-experimental study was conducted from August 2020 to March 2023 in randomly selected two Medical Officer of Health (MOH)areas in Kalutara district, Sri Lanka. Pre and post-assessments were conducted among a sample of 135 mothers of adolescent girls aged 14–19 years in both intervention and control areas.

Out of the 135 mothers who participated in the baseline survey, 127 mothers (94.1%) from the intervention area (IA) physically participated in at least one session of the intervention. The worksite-based intervention was effective in improving mothers’ knowledge about adolescent sexual abuse prevention (Difference in percentage difference of pre and post intervention scores in IA and CA = 4.3%, p  = 0.004), mother’s attitudes in communicating sexual abuse prevention with adolescent girls (Difference in percentage difference of pre and post intervention scores in IA and CA = 5.9%, p  = 0.005), and the content of mother-daughter sexual communication (Difference in percentage difference of pre and post intervention scores in IA and CA = 27.1%, p  < 0.001).

Conclusions and recommendations

Worksite-based parenting program was effective in improving mothers’ knowledge about sexual abuse prevention among adolescent daughters and in improving the content of mother-daughter communication about sexual abuse prevention. Developing appropriate sexual health programs for mothers of different ethnicities, and cultures using different settings is important. Conduction of need assessment programs to identify the different needs of mothers is recommended.

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Sexual violence and coercion involving children are seen in every part of society occurring in homes, workplaces, communities, and public spaces. World Health Organization defines sexual violence as “any unwanted sexual act, comment or advance encompassing various forms of abuse and exploitation” [ 1 ].

The UNICEF reports depict that worldwide, at least one in ten girls under the age of twenty are being forced into some form of sexual activity [ 2 ]. However, cases of sexual abuse and violence among children and adolescents in Sri Lanka are often under-reported due to stigma and ignorance [ 3 ]. A study reported that 14% of both male and female students in Sri Lanka suffered some form of sexual abuse [ 4 ]. A significant 23% of sexually active school adolescents experienced non-consensual sexual intercourse [ 5 ].

The literature shows that lack of awareness and poor life skills are the root causes of the higher incidence of sexual abuse among adolescents [ 6 ]. Despite more than three decades of school sexual health education, Sri Lankan adolescents lack adequate sexual health knowledge and receive conflicting messages [ 7 ].

Global research advocates family-based sexuality education, as this will create an open and comfortable environment for discussion about sexuality, relationships, and other related topics [ 8 , 9 ]. Family-based sex education enables children to have early access to quality information on sexual matters, develop healthy attitudes towards sex and relationships, reduce risky behaviors, and make informed decisions about their sexual health.

In a family, the role of the mother is more pronounced and can have an impact on the health of other members [ 10 ]. Literature indicates that well-informed and prepared mothers are one of the best sources of sexual health information for adolescent girls [ 11 ].

In Sri Lanka, the stigma around the topic, coupled with various religious and mythological beliefs, discourages the implementation of school or community-based sex education for children. Nevertheless, the ability to tailor sexual health messages to suit one’s family values, religious beliefs highlights family-based sex education as a suitable approach for South Asian settings like Sri Lanka [ 12 ]. However, parental discomfort and lack of awareness of adolescent sexual health and lack of skills on sexual health communication, pose significant challenges hindering the opportunity to family based sexual education in the country [ 12 ].

It was discovered that 67% of Sri Lankan parents lack knowledge about child sexual abuse [ 13 ].The objective of this study was to develop a comprehensive intervention for mothers of adolescent girls, to enhance their understanding and enable them to convey crucial information to their daughters about preventing child sexual. The study aimed to evaluate the potential for family-based sex education in the study context. This is the first ever study to explore the potential for family-based sex education in this study context.

Setting for the intervention

Intervention was carried out in seven randomly selected government work-sites in IA and CA in Kalutara district. A spacious room or the auditorium in the work place was chosen as the setting for the intervention.

Study period

The intervention was conducted in August 2020 while the baseline assessment was carried out one week prior to the intervention. Post-interventional assessment was carried out in March 2021.

Target audience

Target audience for the intervention was mothers of adolescent girls aged 14–19 years.

Planning of the intervention

The intervention development process involved technical experts, policymakers, practitioners, and representatives from the target population [ 14 ]. The intervention was based on the views and concerns of its users. Results of a descriptive-cross sectional study that was conducted among the adolescents in the study setting [ 15 ] and findings of a qualitative study carried out among mothers of adolescent girls to explore their views on providing sexual health information to their children [ 12 ] were taken into account during the intervention development.

The intervention in the present study was inspired by the information-motivation and behavioral skills model. Further, previous literature on similar parenting interventions to improve mothers’ knowledge, attitudes, and communication skills on adolescent sexual health matters was looked into.

Piloting the intervention

The intervention was piloted at a government work site in Colombo, involving fifteen eligible mothers. Two public health specialists and an adolescent psychiatrist supervised the sessions. Practical issues regarding the timing of each session and logistics were identified. Participant feedback was collected to pinpoint areas needing improvement. The intervention content, lecture timing, and interactive sessions were adjusted based on participant suggestions. Handbooks and materials were distributed, with follow-ups conducted after two weeks to assess participant’s engagement. Mothers were inquired about the material readability and clarity. Post-pilot experts discussed identified issues and made necessary corrections.

Intervention implementation

“My mother is my best friend” was carried out as two sessions one week apart, followed by a one-hour follow-up session six weeks apart. Trainer guide and all materials to be used during the session and material to be distributed among mothers following the session were developed with the expert opinion, while content and consensus generation among the experts on the content of the program was done using the Modified Delphi technique using electronic mail service.

The take-home materials were left at the workplace for the mothers who could not participate in the second session of the intervention. An online training program was carried out for the mothers who missed the sessions intervention. The online program was conducted in two separate sessions and the mothers who missed at least one session of the intervention were invited to participate.

Program content

The intervention for the mothers included;

Activity I - A short lecture presentation on physiological changes during adolescence.

Activity II - A short lecture presentation on parent guide to adolescent sexual violence prevention.

Activity III - A lecture presentation on how to communicate with your teen about protecting herself from sexual violence.

Activity IV - Two video presentations that showed how to catch up with teachable moments and initiate a sexual conversation with an adolescent girl, and the techniques that can be used when responding to difficult questions forwarded during such discussion.

Activity V - A handbook on preventing sexual violence among adolescent girls, to refer to after the program.

Activity VI - Case scenarios for role play.

All participant mothers were allocated into three small groups. Each group was provided with a case scenario. Each group was asked to narrate a brief role-play between a mother and a daughter about the given case scenario. Feedback from the audience was obtained after each role-play.

Activity VII - Table topics–

The table topics consisted of some questions, including general questions and a few sex and relationship-related questions. Mothers were expected to discuss each of the topics randomly with the children as a family game.

Activity VIII - Checklist–

A checklist was developed and given to all mothers for the self-assessment of the level of communication with adolescent daughters on preventing sexual violence. The checklist was assessed by the PI during the follow-up session, six weeks following the intervention.

Implementation fidelity of the intervention

All programs were facilitated by the principal investigator and one other medical officer, who had special training in adolescent health and experience in working with adolescents and their parents. The facilitators adhered to the trainer’s guide developed with expert opinion, to preserve the uniformity of the program when conducting each session.

Monitoring of the intervention

Three months following the implementation of the intervention, the PI carried out an online follow-up session with the mother participants where they were inquired about the progress of the communication with daughters and for any problems they had encountered while practicing communication at home. Those who were not available at the online follow-up session were followed up over the phone.

Control area - Intervention was not implemented in the control area until the post-interventional assessment was done. Following the post-interventional survey, one hour lecture on sexual violence prevention among adolescent girls was carried out with the distribution of IEC material.

Evaluation of the effectiveness of the intervention

Study design.

Quasi experimental study design was used.

Sample size calculation

Pre and post-interventional evaluation of the intervention was carried out among a sample of 135 mothers working in selected government worksites in both IA and CA. Pocock’s formula, a standard formula for sample size calculation of intervention studies was used to determine the sample size [ 16 ].

Inclusion criteria

Eligible participant were Sinhala mothers having an adolescent daughter aged 14–19 years, and is living with the daughter in the same household for at least two days per week.

Exclusion criteria

The following groups were excluded from the pre and post intervenion surveys, although they were allowed to participate in the intervention.

Mothers diagosed with any severe mental disability at the time of the intervention would prevent them from effectively engaging with the daughter.

Mothers with adolescent daughters who had cognitive or communication disabilities that would prevent her from effectively engaging with her mother.

Sampling procedure

Out of the 13 MOH areas in Kalutara district, two MOH areas that share similar socio-demographic characteristics were selected as IA and CA. A list of government working places with more than fifty female employees in both IA and CA were taken from the relevant Divisional Secretariat office. From each list 9 government working places were randomly selected. From each worksite fifteen female employees meeting the eligibility criteria were included in to the study.

Data collection

Data collectors visited the worksite one week prior to the intervention and six months after the implementation of the worksite intervention. Data was collected using an interviewer administered questionnaire. Trained interviewers made pre and post interventional visits to the worksites to collect data from study participants.

Data Analysis

All data were coded and entered into a database using a standard statistical package (SPSS 25). Data cleaning and checking were done by the PI. Socio-demographic information of the participants was presented in numbers and percentages.

The evaluation of the effectiveness of the intervention was carried out in 3 stages;

Comparison of pre-interventional scores between intervention and control areas.

Comparison of post-interventional scores between intervention and control areas.

Comparison of pre and post interventional scores within intervention and control area.

The total percentage scores were calculated for each subscale. Since the total percentage scores were not normally distributed (Shapiro-Wilk test p  < 0.05, Kolmogov-Smirnov test < 0.05), the analysis was carried-out using non-parametric tests. Between area comparison of knowledge, attitudes and communication practices of the mothers was carried out using Mann- Whitney U test, while Pre and post-test comparison within IA and CA area was done using Wilcoxon Signed Rank test.

The effect sizes were computed to determine the strength of the association. Since the outcomes were not normally distributed, the effect sizes were calculated using non-parametric effect size estimator, Cohen’s r.

Interpretation of effect size.

Effect size < 0.1 = no effect

Effect size 0.1–0.3 = Small effect

Effect size 0.3 = 0.5 = Medium effect

Effect size > 0.5 = Large effect

The percentage difference in pre and post intervention scores in IA and CA was calculated. Percentage Increase = [(Post-Intervention Score - Pre-Intervention Score) / Pre-Intervention Score] * 100

The response rate for the pre-intervention was 100% for the mothers in both IA and CA. Out of the mothers who participated in the baseline survey 127 mothers (94.1%) from the intervention area (IA), physically participated in at least one session of the intervention. Five out of eight participants who missed both sessions participated in the online session. Participants who did not participate in the intervention ( n  = 3) were considered lost-to-follow-ups (Fig.  1 ).

For the post-interventional assessment, 122 mothers from the IA, and 125 mothers from the Control area (CA) participated giving a final response rate of 90.3% (122/135) and 92.6% (125/135) respectively.

The reasons for loss-to-follow-up among IA mothers were later change of mind ( n  = 6),

the husband was against participating in the study ( n  = 4), and change of workplaces during the six months follow-up period ( n  = 3). Among the CA mothers, five changed their minds later in the course, while four mothers said their husbands were against the idea. One mother had shifted workplaces due to a change of residence.

Out of all 135 mothers recruited to the study in IA and CA, who participated in the baseline assessment, the number of mothers who responded to the six months post-interventional survey was 122 and 125 in IA and CA, respectively. Therefore, the loss to follow-up rate calculated was 9.6% ( n  = 13) for the mothers in IA and 7.4% ( n  = 10) for the mothers in CA (Fig.  1 ).

CONSORT diagram graphically describes the participant’s disposition throughout the study

At 95% confidence level, there was no significant difference between the participants who completed the study and the drop-outs, in their age, educational status, civil status, or the age of the adolescent daughter, which suggested random dropouts (Table  1 ).

Preliminary effects of the intervention

There was no significant difference between the IA and CA mothers in their knowledge, attitudes about adolescent sexual violence prevention or in the content and frequency of communication with their daughters on sexual violence prevention (Table  2 ).

According to the results mothers’ post-intervention knowledge, content, and frequency of communication with their daughters on sexual violence prevention was significantly higher compared to the baseline in the IA. In the IA the strength of association for mother’s knowledge improvement (0.3) and the content of communication (0.47) was moderate, while it was high for the frequency of communication. However, no such improvement could be seen in the control area. (Table  3 ).

The percentage increase in scores for mother’s knowledge, attitudes and communication on adolescent sexual abuse prevention pre and post intervention in IA and CA is shown in Table  4 .

Comparison of post-interventional scores between IA and CA indicated that there is a significant difference in the mother’s knowledge about preventing sexual violence in adolescent girls and in the content of mother-daughter communication on sexual violence prevention. However, no significant difference was observed in mother’s attitudes or in the frequency of communication (Table  5 ).

The intervention in this study was inspired by the information-motivation and behavioral skills model, a framework that has consistently demonstrated empirical support in the sexual and reproductive health risk reduction in various key populations including adolescents and youth [ 17 , 18 ]. The program structure was adapted from ‘Talking parents-healthy teens’, a successful worksite-based parenting program conducted in the US, which significantly increased parent-teen sexual health [ 19 ].

The intervention primarily focused on preventing sexual violence among adolescent girls. This emphasis stemmed from the previous research conducted among mothers of adolescent girls in the study setting, which revealed that mothers were more concerned about protecting their daughters from sexual violence [ 12 , 20 ]. To enhance engagement and effectiveness, the intervention incorporated interactive sessions such as role-plays, video presentations, and take-home activities as suggested by previous literature [ 21 , 22 , 23 ]. Additionally, interactive games were incorporated to enhance easy communication between mothers and adolescents about SRH matters [ 23 ].

The study recognized the efficacy of utilizing worksite settings as platforms to implement health programs for working mothers. The support received from the worksite administration in conducting the program affirmed the potential to expand health promoting initiatives at worksites, moving beyond routine health assessments. Unlike challenges reported in previous literature concerning recruiting and retaining parents in parenting interventions [ 24 ], the work setting in this study facilitated the parent participation without additional effort. The enthusiasm of the worksite management to implement the program was partly driven by the growing number of sexual violence cases in the study setting and their interest in employee-assistance programs as work-life balance initiatives. Similar health-promoting interventions such as weight reduction programs or smoking cessation programs had been proven effective when conducted in worksite setting [ 25 ]. Moreover, evidence suggests that interventions aimed at facilitating parent-child sexual communication and reducing sexual risk behaviors among adolescents, conducted at parent’s workplaces, can be effective [ 26 ]. For instance, Talking Parents-Healthy Teens, a parenting intervention conducted at thirteen worksites in Southern California led to significant positive outcomes [ 27 ].

The study revealed a significant improvement in mother’s knowledge about preventing adolescent sexual abuse and in the content and frequency of sexual communication with their daughters among IA mothers six months following the intervention compared to baseline. However, when comparing areas, the intervention proved more effective in improving mother’s knowledge about preventing adolescent sexual abuse and the content of mother-daughter sexual communication among IA mothers compared to CA but no significant difference was observed in the frequency of communication. This disparity could be attributed to the fact that CA mothers reported higher frequency of sexual health communication with their daughters even at the baseline compared to the IA, which can be due to some unknown external factors. The finding aligns with a US study, “Talking parent-healthy teens”, where intervention area mothers reported more discussion of new topics ( p  < 0.001) and more frequency of conversations about sex compared to the control group [ 27 ].

Although there was no significant difference between the pre and post interventional scores for mother’s attitudinal change in IA, the percentage score increase in IA was significantly higher compared to the CA. A review of studies that have been carried out between 1980 and 2010 to evaluate the effectiveness of parenting interventions to improve sex communication indicated that very few interventions successfully influenced mothers’ attitudes [ 28 ]. Adopting different socio-psychological approaches would be essential to unfreeze mothers’ attitudes, which is crucial for ensuing the long-term sustainability of the intervention’s impact.

Public Health implications of the study findings

According to the present study findings, parent-targeted interventions are an effective way of delivering sexual and reproductive health information to adolescents in Sri Lanka. The present intervention could be adopted with necessary modifications to the existing public health system to reduce sexual abuse among adolescent girls in the country.

Strengths and limitations

The parenting intervention was developed considering the views of both the mothers and daughters in the same study setting, giving a more comprehensive approach to the study problem. The quasi-experimental study design enabled identifying the actual effect of the parenting intervention on the mothers and adolescent girls. The use of government worksites as the setting for the study, was an advantage since as it improved parent participation, reducing attrition bias. Carrying out face-to-face intervention was a challenge due to the COVID-19 pandemic situation in the country. Hence, we were unable to gain the full effect of a face-to-face intervention and follow-up sessions.

Furthermore, the pandemic resulted in both the mothers and daughters to work from home and spend more time together than usual. This may limit the generalization of the findings to the population during the COVID-19 free times.

The study highlights the effectiveness of mother targeted interventions in enhancing mothers’ knowledge and communication with their adolescent daughters regarding sexual health. Mothers’ enthusiasm to learn about adolescent health, indicated the necessity for future parent-targeted programs. The success of worksite setting in engaging mothers suggests its effectiveness for parenting programs.

The study calls for policymakers to recognize parents as a primary source of sexual health information for adolescent girls. It recommends implementing parent awareness and skill-building sessions alongside the existing school-based sexual health education programs. Additionally, education sector is encouraged to conduct such sessions in parallel to the current school sexuality education, promoting mothers’ role as early sexual health educators for their children even before adolescence.

Future research

Future research should assess the effectiveness of a parenting intervention in improving mother-daughter sexual communication among unemployed mothers, considering potential difference between employed and unemployed groups. Additionally, it is crucial to include women who are employed in the private sector in these studies.

Furthermore, there is a need to develop interventions targeting fathers. The present intervention mainly focused on communicating sexual violence prevention with adolescents. Future interventions should encourage parent-adolescent communication on various sexual health topics.

The present intervention was implemented solely at large government worksites. Research should be conducted to evaluate the intervention’s effectiveness in small workplaces and private sector work settings.

Data availability

Data presented in this study are available with the corresponding author and can be produced on request.

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Acknowledgements

We acknowledge the support given by the administration of the worksite settings in which the interventions were taking place.

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A. Dilini Mataraarachchi- Study conception and design, Wrote the main manuscriptB. Buddhika Mahesh P.K- Reviewed the paperC. T.E.A.Pathirana- Supported the implementation of the intervention at the worksite settingD. P.V.S.C. Vithana- Reviewed the manuscript.

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Ethical approval to conduct the study was obtained from the Ethical Approval Committee, University of Colombo; Ethical approval no: EC-19-115. All mothers were allowed to participate in the study, irrespective of their daughter’s age, even though only mothers having a daughter aged 14–19 years were included in the assessment. Informed, written consent was obtained from all mothers before including them in the pre and post-assessment. Participants were given the freedom to decide on their participation in the intervention. Since the intervention was carried out during the times of COVID pandemic, all measures were taken to prevent infection transmission. Online sessions were conducted for the ones who were unable to participate in physical sessions. All methods used in the study were in accordance with the relevant ethical guidelines for research with human participants.

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Mataraarachchi, D., Buddhika Mahesh, P., Pathirana, T. et al. Development and implementation of a worksite-based intervention to improve mothers’ knowledge, attitudes, and skills in sharing information with their adolescent daughters on preventing sexual violence: lessons learned in a developing setting, Sri Lanka. BMC Public Health 24 , 983 (2024). https://doi.org/10.1186/s12889-024-18416-x

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Exploring the decision-making process of female genital cosmetic procedures in Iranian women and constructing and validating a results-based logic model for a healthy public policy: a study protocol

• Elham Azmoude 1 ,
• Samira Ebrahimzadeh Zagami 3 ,
• Elahe Hooshmand 4 ,
• Elham Taheri 5 &
• Nahid Jahani Shoorab 2 , 3  

Reproductive Health volume  21 , Article number:  46 ( 2024 ) Cite this article

Metrics details

Female genital cosmetic procedures have grown rapidly in most parts of the world. Professional organizations have issued warnings about the complications and long-term consequences of these practices. To be able to adopt the right health policies, it is necessary to know why women decide to perform these procedures. Therefore, the present study will be aim to discover the decision-making process involved in performing female genital cosmetic procedures for Iranian women and construct and validate a results-based logic model for healthy public policy.

The present study was conducted in three phases. In the initial phase, a qualitative study will be conducted with the Corbin and Strauss ground theory approach. The participants in the study will be healthy women who desire or have undergone female genital cosmetic procedures without medical indications. In this phase, purposive and theoretical sampling will guide recruitment and data collection. The data will be collected via semi-structured interviews, field notes and observations of individual interactions. The data will be analysed using the approach of Corbin and Strauss (2015). MAXQDA 2007 software was used for managing the process of data analysis. In the second phase, the development of a results-based logic model for a healthy public policy is performed based on the findings of the first phase of the study, interviews with key informants and a review of the results of the literature in this field. Finally, validation of the designed program will be performed by the nominal group technique with the presence of a group of experts in the third phase.

The findings of this study, by identifying women’s main concerns related to the studied phenomenon, the existing context, participants’ reactions and the consequences of the adopted reactions, can be very important in designing a program that fits Iran’s cultural characteristics. In this research, a program using a logical model will be presented that is suitable for policymakers, planners and healthcare service providers to be implemented in the social-cultural context of the study.

Plain English summary

Female genital cosmetic procedures refer to a group of cosmetic procedures that change the structure and healthy appearance of the female external genitalia to improve sexual performance or body image. The desire to perform these techniques has become popular in most parts of the world. However, scientific societies have warned about the efficiency, effectiveness and side effects of these techniques. According to these points, the present study aims to discover the decision-making process of performing FGCPs for Iranian women and to construct and validate a program for healthy public policy. This study will be performed in three stages. First, a qualitative study and interviews with healthy women who desire or have undergone female genital cosmetic procedures will be performed. In the following, based on the findings of the first stage, interviews with key informants and a review of literature, a program will be presented to reduce or prevent these procedures, and then this program will be validated. Using the designed program, healthcare practitioners will be able to provide women with more effective advice and guidance to make correct and informed decisions. In addition, this program will enable planners and policymakers to take steps to reduce the demand for these actions and make informed decisions by women by changing and adjusting the conditions and context.

The use of surgical knives on women’s bodies has a long history, ranging from unnecessary episiotomy and unnecessary caesarean section to female circumcision and, recently, female genital cosmetic procedures (FGCPs) [ 1 ]. FGCPs include various surgical and nonsurgical techniques, which are often performed to achieve a better genital appearance and improve women’s sexual performance without any medical indications. Labiaplasty, mons pubis liposuction, bleaching, and G-spot augmentation are among these procedures [ 2 ].

Despite insufficient evidence about the effectiveness and side effects of these techniques, the rate of these procedures has been increasing worldwide and in most Western and Eastern countries [ 3 ]. In 2016, the International Society of Cosmetic Surgery registered 138,033 cases of labiaplasty worldwide, which was a 46% increase compared to 2015, and its growth rate was much greater than that of other cosmetic surgeries [ 4 ]. The statistics published in the United States in 2018 also indicate 12,756 cases of labiaplasty, which is a 53% increase compared to the last 5 years [ 5 ]. A similar increase has been reported in Canada, some European countries, Australia, Brazil and parts of Asia from 2001 to 2016 [ 6 , 7 ].

Based on the available data, although exact statistics for performing these procedures in Iran are not available, it is thought that Iran is a country with high statistics for FGCPs, which has become a social concern in addition to a medical concern [ 8 ].

According to the opinion of experts, some FGCPs are similar to female genital mutilation in terms of applied anatomical changes as well as direct and indirect social pressures that lead women to perform these procedures [ 9 ]. On the other hand, public concern about the ethical foundations, safety and efficiency of these procedures has increased [ 10 ]. Despite the many goals that are expressed to perform these practices, there is limited evidence to support their efficiency and effectiveness in improving the perception of women’s bodies and sexual performance [ 11 ]. In this context, the American College of Obstetricians and Gynecologists (ACOG) points out that due to the limited information on the safety and effectiveness of genital cosmetic surgeries and the existence of potential complications does not support their use [ 12 ].

According to the literature, the desire to change the appearance of the genitals may be based on incorrect assumptions about the natural dimensions of the body. Accordingly, some studies attribute the demand for FGCPs to women’s desire to standardize the appearance of their genitalia, with the labia minora being narrow and not visible and the vaginal opening appearing too tight [ 13 , 14 ]. The decision to perform FGCPs is based on culture and is also affected by the development of internet pornography, the normalization of pubic hair removal and the uniform display of the female reproductive system on websites, magazines and journals [ 14 , 15 ]. Exposure to images of modified genitalia may change women’s perception of what is normal or desirable and influence their decision to undergo labiaplasty [ 12 ]. For example, in the case‒control study conducted by Sharp et al. (2016), the strongest motivation for Australian women to undergo labiaplasty was concern about their genital appearance [ 16 ].

One of the important issues in the pathology of the psychological and economic burden of these practices is knowing why women decide to perform these techniques. Most of the studies on the causes and factors related to women’s decision-making have been conducted in Western countries with quantitative and cross-sectional designs and based on a positivist paradigm [ 16 , 17 , 18 ]. Moreover, a deep understanding of why and how complex phenomena such as the tendency towards FGCPs can be achieved through qualitative studies [ 19 ]. This type of study is important because women’s tendency toward FGCPs is rooted in cultural and psychosocial factors, and women’s decision-making takes place during a multidimensional and complex interactive process [ 7 , 19 ]. In this regard, Locatelli et al. (2017) conducted a qualitative study with a grounded theory approach to explain the decision-making process and willingness to perform cosmetic surgeries (including general and genital cosmetic surgeries). Based on the results of the in-depth interviews, the two main factors identified that can lead to the decision to undergo cosmetic surgery include recent life events and psychological needs [ 19 ].

Among the various methods of qualitative research, grounded theory is used if the perception of the phenomenon in the context of society and the study of social processes embedded in human interactions are desired [ 20 ]. Therefore, explaining the decision-making process of FGCPs through a qualitative study with ground theory seems necessary due to the unavailability of a similar study.

The results of qualitative studies are very suitable for use in the design of health programs because they are based on the views of participants and beneficiaries. Among these methods, the use of the ground theory method, due to the provision of deep and comprehensive data about the various dimensions of phenomena, can be a very suitable methodology for planning effective programs [ 21 ]. Therefore, studies such as this one will be more effective when the results are used in the direction of policy-making and the formulation of health programs. One of the appropriate tools for designing health programs, especially in the field of reproductive health, is the logical model [ 22 ]. A logic model is a programming tool used to visualize the inputs and activities of a program and the expected results of the program. Logic models provide a framework that allows planners, evaluators, and other stakeholders to link program processes to program outcomes [ 23 ].

The results of ground theory studies can be very important in designing a suitable program by identifying the concerns of women about the studied phenomenon, context, individual reactions and consequences of the adopted reactions [ 21 ]. In this study, the emergence of the process in which women decide to perform FGCPs can be effective in the design of health programs. Therefore, the researchers will try to present a program logic model for healthy public policy based on the results of the qualitative section and using the points of view of key informants. According to the mentioned notes, this protocol will be designed to discover the decision-making process of performing FGCPs in Iranian women and construct and validate a results-based logic model for healthy public policy.

1- The discovery of the decision-making process for performing FGCPs among women.

2- Constructing a results-based logic model for a healthy public policy.

3- Validation of a results-based logic model for a healthy public policy using a nominal group technique.

The main research questions

How is the FGCPS decision-making process formed for women?

Methods/design

The first phase: a qualitative study.

In this phase, a qualitative study will be conducted based on the grounded theory approach to discover the decision-making process for performing FGCPs in Iranian women. Grounded theory, as an inductive qualitative approach, is a systematic approach for collecting and analysing qualitative data to construct theories that are grounded in the data [ 20 ].

Study setting

This study will be conducted in Mashhad, one of the largest cities in Iran and the capital of Khorasan-e Razavi Province. Participants will be recruited from healthcare centers, governmental and private hospitals and gynecology clinics. The most common FGCPs currently performed in this city are labiaplasty, perineoplasty, vaginoplasty, HIFU vaginal rejuvenation and vaginal carboxytherapy.

Inclusion criteria

In this study, the participants will be healthy women who desire or have undergone FGCPs without medical indications (such as stage 3 or 4 uterine prolapse or vaginismus). Having agreed to participate in the study, being Iranian, and having less than 5 years since FGCPs were among the other eligibility criteria for inclusion in this study. A history of psychological illness or the use of psychological drugs will exclude women from this study.

Participants will be identified using the documentation available in health centers, hospitals, and clinics. In addition, access to participants will be achieved by installing information posters in health centers and clinics.

Data collection method

The data will be collected through interviews, field notes and observations of individual interactions in the research environment. Semi-structured face-to-face in-depth interviews will be the main method of data collection. An interview guide with open-ended and possible follow-up questions will be designed to explore the experiences of each participant. The interview will begin with an open and general question such as “Please tell me about the first time you thought of using the procedure”. During the interviews, the questions gradually will be become more specific and focused. For example, the following question will be asked: “After taking action to use these procedures, what changes did you experience in your life?“. In addition, probing questions will be used if needed.

Data collection in this phase will begin after the research objectives are explained by the researchers and the written consent form is completed by the participants. The interviews will be conducted individually in private settings chosen by participants (e.g., their home or the public library or hospital).

Examples of the interview questions are as follows:

What made you think of FGCPs?

Can you talk about your experience of using FGCPs?

With whom did you discuss your decision to perform FGCPs, and how did you see their reaction?

Can you explain to me what happened that made you make the final decision to do FGCPs?

What changes did you experience in your life after FGCPs?

Sample size and sampling method

In this study, sampling continued until data saturation. This means that the data collection will continue until no new dimensions or features are added to the emerging categories and no new relationships appear between the categories [ 20 , 24 ].

In this study, purposive and theoretical sampling will guide recruitment and data collection. First, women who could express their in-depth feelings and experiences regarding FGCPs will be required purposefully based on the inclusion criteria.

Purposive sampling will be used to select participants by adopting a maximum variation strategy based on age, marital status, education, social class, occupation, motivation to perform the procedure, type of procedures, time elapsed from the procedures, and decision stage (including precontemplation, contemplation, preparation, action, maintenance and even people who have given up).

In addition, theoretical sampling will also be used to recruit additional participants to guide the depth of the theory. Theoretical sampling is a process of collecting data that helps researchers create a theory that is grounded in the data [ 20 , 24 ].

Along with theoretical sampling and to complete the theory, it may be necessary to include influential individuals in the decision-making process for FGCPs, such as health and medical professionals (such as reproductive health policymakers, gynecologists, midwives, plastic and cosmetic surgeons, psychologists, psychologists and nurses, etc.), women’s family members (for example, spouses) or even women who are not applying for FGCPs.

Data analysis

In this study, the data collection and analysis process will be performed continuously and simultaneously from the beginning of the research. In this study, the approach of Corbin and Strauss (2015) will be used for data analysis. The approach of Corbin and Strauss 2015 involves six steps, including analysing data for concepts, developing the concepts in terms of their properties and dimensions, analysing data for context, bringing the process into the analysis, and integrating categories.

In this study, according to Corbin and Strauss, analytical tools such as using questions (sensitizing questions, theory questions), comparing (continuous comparison, theoretical comparison), the Flip-flop technique and waving the red flag will be used used to analyse the data in terms of context, process and composition of categories [ 24 ]. The data analysis will be managed by MAXQDA10 software.

Rigor and trustworthiness

In this study, Lincoln and Guba’s criteria (1994), including credibility, dependability, confirmability, and transferability, will be used to assess the rigor and trustworthiness of the collected data [ 25 ].

The second phase: constructing a results-based logic model for a healthy public policy

In this phase of the research, the development of a results-based logic model for a healthy public policy is performed based on the findings of the first phase of the study, interviews with key informants and a review of the results of literature in this field.

A logic model is a visual representation of a program that maps the relationships between invested resources, ongoing activities, and direct as well as long-term outcomes of program activities [ 23 ].

The program logic model (PLM) has been used in reproductive health planning [ 26 , 27 , 28 ]. Both quantitative and qualitative research are appropriate for presenting the health program. However, the qualitative approach is more valuable for designing health programs because it provides information based on the experiences, values, and perspectives of the participants and is not affected by preprepared quantitative categories [ 29 ]. The results of studies with grounded theory methodology have often been used as qualitative research methods in health care planning [ 29 , 30 ]. Due to the provision of deep information based on the context and the relative coordination of its implementation steps with the logical model program, ground theory has turned it into a suitable and optimal source for designing and compiling a program logical model [ 21 ].

Examples of interview questions with key informants for developing the program are as follows:

What can be done to prevent the tendency of women to use these techniques?

In your opinion, what topics should the designed program include to be effective?

What organizations and at what level should be involved in the designed program?

Which organizations at the micro and macro levels should be in charge of these programs?

Regarding these women, what important points should be considered that have been neglected?

The third stage: validation of the designed program

In this phase, a nominal group technique (NGT) will be used to validate the designed program in the presence of a group of experts [ 22 , 31 ]. This technique is an important method for validating programs [ 32 ]. This method has been proposed as a valuable tool to facilitate group decision-making to make decisions and priorities, especially in the health system [ 33 ]. One of the advantages of this technique is that its results are determined at the end of a session, and it is possible to save time and provide immediate feedback [ 34 ]. In addition, in this method, it is not possible to influence a powerful person and induce their opinion [ 35 ].

To validate the program, a draft of the designed program will be provided to the key informants before the meeting to obtain deep insight into the program. The duration of a nominal group meeting is variable and depends on the size of the group, the number of questions and the type of participants.

According to the NGT, the meeting will be held according to the following steps:

Introductory statement, silent generation of ideas, choosing and prioritizing individual top lists, time out and icebreaker, discussion of group top issues, reranking and rating group top ideas, conclusion.

The present study will explore the decision-making process of FGCPs and will later design and validate a results-based logic model for a healthy public policy to reduce or prevent these procedures. In the review of literature, most of the studies conducted in this area were performed in Western countries, were performed quantitatively, and were guided by the paradigm of positivism [ 16 , 17 , 18 ]. For example, in a retrospective study of 163 French women who underwent labiaplasty, the motivations reported by women for performing this procedure were as follows: dissatisfaction with the appearance of the labia (87%), discomfort when wearing clothes (64%), discomfort when participating in sports (26%) and painful sexual intercourse (43%) [ 3 ].

There are limited qualitative studies in this field [ 17 , 18 , 19 , 36 ]. Moreover, a deep understanding of why and how complex phenomena such as the abovementioned issue can be achieved through qualitative studies. In this regard, Locatelli et al. (2017) conducted a qualitative study with a grounded theory approach to explain the decision-making process to perform cosmetic surgeries (including general and genital cosmetic surgeries). Based on the results of the in-depth interviews, the two main factors identified that can lead people to decide to undergo cosmetic surgery include recent life events and their psychological needs [ 19 ].

Sharp et al. [ 16 ], in a content analysis study, explored the reasons for doing labiaplasty and the expectations and experiences of Australian women. In this study, the emerging themes included “media influence”, “negative experiences and interpretations”, “physical reasons versus reasons for beautification”, “satisfaction with surgery” and “sexual health”. In other words, online media’s representation of genital appearance and past negative experiences, especially in sexual matters, led women to worry about their sexual appearance. In addition, issues related to physical discomfort were also commonly raised, and sometimes women emphasized it to legitimize surgery. Most women were generally satisfied with the results of their surgery, although some noted that their labia were not as small or symmetrical as they had hoped. Most women reported a significant improvement in their sexual health after surgery; however, some noted that their emotional distress during sex did not improve [ 18 ].

In a qualitative content analysis study with the participation of 9 women undergoing cosmetic genital surgery in the city of Erbil, Iraq, Pirro et al. (2022) explored women’s understanding of and experience performing cosmetic surgery. Based on the findings of this study, genital surgeries lead to improvements in body image, sexual performance and sexual satisfaction in couples, especially spouses [ 36 ].

In a qualitative study conducted by Bramwell et al. (2007) on six British women undergoing labiaplasty, all women reported abnormal genital appearance and stated that they were seeking a normal genital appearance through labiaplasty. They also reported that they received confusing messages about whether the genitals were normal and whether surgery was necessary when consulting health practitioners. Finally, all of them reported that the inappropriate appearance of their genitals hurts their sexual relationships. Finally, the results of this study showed that labiaplasty does not necessarily improve the quality of sexual life of all people [ 17 ].

As noted, the current literature review shows that most of the studies have focused on the reasons for and consequences of performing FGCPs rather than the decision-making process of women.

The findings of the present study are expected to present a theory based on the cultural and social context of Iran to explain the decision-making process of this group of women, considering the purpose of ground theory, which is to study social phenomena embedded in human interactions.

According to this theory, in addition to individual and cognitive factors, structural factors such as interpersonal and social factors, situations that put people under pressure, and structural factors such as physical, social, and cultural issues are expected to be used to design suitable interventions for reducing the demand for these techniques.

In the second part of the study, the researchers will try to provide a results-based logic model for a healthy public policy to reduce or prevent these procedures by understanding the decision-making process of women and using the points of view of key informants. The logical model is one of the successful tools for planning in health fields [ 22 ]. For example, this model has been used in the design of programs to prevent HIV, sexual violence, domestic violence, homelessness in drug addicts and obesity in teenagers [ 26 , 27 , 28 , 37 , 38 , 39 ]. Regarding the application of FGCPs, preventive measures have been sporadically recommended by different organizations. For example, not using nonscientific words for advertising by professionals, counselling women to determine the root of the problem and providing a specific solution and identifying women with psychological disorders or sexual dysfunction are among these suggestions [ 40 , 41 , 42 ]. However, a comperhensive program that is focused on the various dimensions of issues faced by these women during the long-term career decision process is not available.

Therefore, in this research, the researchers will present a program that is suitable for policymakers, planners and providers of healthcare services to be implemented in the social-cultural context of Iran. Using the designed program, healthcare practitioners will be able to provide more effective advice and guidance to women to make correct and informed decisions.

In the present study, the researchers predict several challenges. For example, women may be less willing to talk about their private and sexual issues. In addition, some of these women are not married and have sexual partners, which is considered taboo in the cultural and social context of Iran. Therefore, the importance of honesty in answering questions and gaining the participants’ trust in the confidentiality of the data will be emphasized. In addition, due to the low frequency of some procedures, such as G-spot augmentation, access to these women is limited. Therefore, with extensive advertising, it was possible to enter participants performing fewer common procedures to study. The present study, similar to other qualitative approaches, has limited generalizability, and the above limitations should be adjusted as much as possible by maximum variation in sampling.

Availability of data and materials

No datasets were generated or analysed during the current study.

Abbreviations

• Female genital cosmetic procedures

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Acknowledgements

We are grateful to all the volunteer participants who participated in this study. We are also grateful to the research assistant of Mashhad University of Medical Sciences for their support.

This study is funded by Mashhad University of Medical Sciences.

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Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran

Elham Azmoude

Nursing and Midwifery Care Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran

Nahid Jahani Shoorab

Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran

Samira Ebrahimzadeh Zagami & Nahid Jahani Shoorab

Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

Elahe Hooshmand

Department of Clinical Psychology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Elham Taheri

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Contributions

E.A, S.EZ, E.H, E.T and N.JS contributed to the design, implementation and analysis of the protocol. EA wrote the first draft of this protocol. S.EZ, E.H, E.T and N.JS critically reviewed the protocol for important intellectual content. All authors approved the final version.

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Correspondence to Nahid Jahani Shoorab .

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Written informed consent will be obtained from each participant. This protocol was reviewed and approved by the relevant Local Research Ethics Committee of Mashhad University of Medical Sciences (Code: IR.MUMS.NURSE.REC.1402.021).

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The authors declare no competing interests.

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Azmoude, E., Zagami, S.E., Hooshmand, E. et al. Exploring the decision-making process of female genital cosmetic procedures in Iranian women and constructing and validating a results-based logic model for a healthy public policy: a study protocol. Reprod Health 21 , 46 (2024). https://doi.org/10.1186/s12978-024-01788-z

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Received : 02 April 2024

Accepted : 05 April 2024

Published : 08 April 2024

DOI : https://doi.org/10.1186/s12978-024-01788-z

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Qualitative evidence synthesis has become a particular growth area within evidence synthesis and systematic reviews. It is becoming increasingly difficult to explore a health or social care topic without encountering one or more qualitative evidence syntheses (QESs). At the same time there is increasing pressure from decision-makers in policy or practice to provide timely answers to issues that relate to the acceptability, feasibility and meaningfulness of health and social care interventions. This workshop will explore three different but related routes to providing qualitative evidence within resource-limited contexts – the rapid QES, the overview of multiple QESs and the update of one or more QESs.

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