General practitioners’ and women’s experiences of perimenopause consultations: A qualitative evidence synthesis protocol

Phase 1: Getting started

This stage of meta-ethnography involves identifying an area of interest and providing a rationale for conducting the study. To the best of our knowledge, through preliminary searching, no meta-ethnography has synthesized general practitioners' and women’s lived experiences of perimenopausal consultations in general practice. A meta-ethnography was chosen as the most suitable approach to enable the development of a conceptual understanding of the experiences of perimenopausal consultations as experienced by both GPs and women in the context of general practice. Given the surge of attention given to menopause and perimenopause in the media^20,21,34 as well as primary qualitative research^25,35–37 conducting this qualitative evidence synthesis is timely. As recommended^32,38 a research team with suitable expertise and skills has been established to conduct this meta-ethnography.

Phase 2: Deciding what is relevant

Once the topic of interest has been established, the next four steps as described by Sattar et al.³² will be completed:

Phase 2a. Defining the focus of the synthesis

Finding the balance between having a qualitative evidence synthesis with a broad scope, yet a focus that provides an appropriate but manageable number of studies can be a challenge in the meta-ethnographic approach³². It is suggested that if there is little literature published on the chosen topic, a wider search of the literature should be conducted³⁹. Given the paucity of research on the phenomenon of perimenopause in isolation from menopause, it has been decided that the search strategy should be wider than perimenopause alone, so as not to miss research that reports perimenopause as a theme of menopause. Moreover, with such varied definitions of perimenopause and pre-menopause in the literature as highlighted by Ambikairajah et al. (2022)⁴⁰ it has been decided that the best approach to disentangle studies that report perimenopause as a concept of menopause is to search for perimenopause more broadly.

Phase 2b: Locating relevant studies

Currently, there is little consensus on how studies should be included in meta-ethnographic synthesis, nor is there agreement regarding the necessity of exhaustive literature searching³⁹. As there is little qualitative research that explores perimenopause consultations from the perspective of GPs and women our search will be expansive yet systematic. We will conduct an extensive search strategy of seven databases: Medline (via PubMed), Web of Science Core Collection, Scopus, CINAHL, Embase (Elsevier), PsycINFO and Academic Search Complete.

A comprehensive search strategy was developed guided by the Sample, Phenomenon of interest, Design, Evaluation, Research type (SPIDER) tool⁴¹. A search strategy was first formulated in Medline (via PubMed) and consists of three major concepts: general practice, perimenopause and qualitative research. Search terms include a combination of Medical Subject Headings (MeSH), specific database headings, keywords, and synonymous with the following: “perimenopause” “general practice” and “qualitative research”. Boolean operators (OR, AND) were used to widen and narrow searches where appropriate. Proximity searches of keywords were also included. An academic support librarian from University College Cork was consulted and offered guidance on search strategy development.

Searches in subsequent databases will be amended as appropriate depending on database specifications. The reference list of identified studies will also be searched. The search strategy as conducted in Medline (via PubMed) is presented in Table 1 below. Given the extensive search of seven databases, grey literature sources will not be searched. Grey literature searching can be a time-consuming process with “minimally productive follow-up of the unpublished literature”^{42 (p.83)}.

Phase 2c: Decisions to include studies

The SPIDER framework⁴¹ will inform inclusion and exclusion criteria for screening and selection of studies. Table 2 outlines each aspect of the SPIDER tool and the corresponding inclusion and exclusion criteria.

Sample: Studies must include either general practitioners or equivalents (including family physicians, and primary care physicians) and/or women with lived experience of attending general practice (or equivalent, family practice) for management of symptoms during perimenopause. Studies conducted in secondary care settings will be excluded.

Phenomenon of Interest: Studies that explore GPs’ and women’s lived experience of perimenopause consultations will be included. Studies that investigate consultations for other clinical conditions, menopause for example, will be included if data regarding perimenopausal symptom management can be isolated and extracted. Studies that report on wider women’s health issues that report perimenopause as a theme will be included. Studies that investigate clinical management of post-menopausal symptoms only will not be included in the review, as the phenomenon of interest is perimenopause. Studies that investigate the management of iatrogenic menopause will not be included.

The experiences of perimenopause consultations as experienced by women and GPs could include experiences of the treatment and management of symptoms including menopause hormone therapy or non-hormonal alternative medications, confidence in managing perimenopause, feelings of satisfaction or dissatisfaction, and how decisions regarding the management of symptoms are made.

Design and Research Type:

All primary qualitative and mixed methods studies that meet the eligibility criteria (Table 2) will be included. Qualitative or mixed-methods studies must report primary qualitative data with recognised methods of qualitative analysis (thematic synthesis, grounded theory etc.) to be included. Studies that provide free text responses to questionnaires that have been analyzed qualitatively will be included. Studies that employ quantitative methods only will be excluded. Mixed methods studies without any recognised qualitative components will be excluded. The year of publication will be restricted to studies published after 2014 to include the most up-to-date literature and to capture studies published after the publication of NICE Guidelines: Diagnosis and Management of the Menopause (NG23)⁴ in 2015 for healthcare professionals who care for menopausal and perimenopausal women. Due to time constraints and availability of translation services studies must be published in the English language. Studies must be peer-reviewed to be included.

Following the completion of searching all seven databases, identified articles will be imported into the bibliographic software EndNote - Clarivate^TM and duplicates removed. Articles will then be exported to Rayyan – Intelligent Systematic Review - Rayyan a systematic review software tool. Further deduplication will be carried out before the screening of articles. Title/abstract screening and full-text screening will be conducted by two reviewers (LJM and AOM) independently. Where consensus cannot be reached through discussion a third review author will be consulted (AJ). A PRISMA⁴³ flow diagram will be provided to illustrate the screening and inclusion process and will outline reasons for exclusion at the full-text screening stage.

Phase 2d: Quality appraisal

Quality assessment will be conducted using CASP (Critical Appraisal Skills Programme)⁴⁴ tools for qualitative studies. Qualitative data from mixed methods studies will also be assessed using this tool. The CASP tool for qualitative studies is used widely in qualitative evidence synthesis and consists of ten questions that consider the methodological aspects of a qualitative research study⁴⁵. No studies will be excluded based upon quality appraisal as studies with a lower quality appraisal rating can still make a valuable contribution to qualitative evidence synthesis³². Quality appraisal will be assessed by the main review author and a random sample of 20% will be checked by a second review author. Studies with lower-quality assessment scores will be included but will be highlighted in methodological limitations. Furthermore, a quality appraisal is a required step that must be completed before applying the Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) tool³².

Phase 3: Reading the studies

Included studies will be read in-depth, with repeated reading. First order constructs (participants’ quotations) and second order constructs (authors’ themes) presented in the results or the discussion of included primary studies will be considered the raw data for this meta-ethnography⁴⁶. PDFs of included studies will be uploaded at this stage to NVivo - Lumivero 14 to facilitate coding of conceptual findings as they appear in the studies. Contextual data will be extracted in a data extraction form in a Microsoft Excel spreadsheet and will include author, year of publication, country of origin, study aims and objectives, study design, study setting, sample, characteristics of participants, data collection methodology, coding approaches, analysis, themes, and subthemes.

Phase 4: Determining how the studies are related

During this stage studies will be “put together”^31(p.28) through constant comparison a commonly used method in qualitative research⁴⁷. The relationships between studies and key concepts of included studies will be explored. A list of themes will be created to allow for comparison and identify reoccurring commonalities and concepts between studies. Concepts should not just describe the data but should explain it. A concept is a ‘meaningful idea that develops by comparing particular instances’^{46(p. 7)}

Phase 5: Translating the studies into one another

Concepts from each paper will be compared to identify the presence of similarities, or the absence of similarities. In doing so, it will be possible to identify differences or commonalities between concepts and will enable us to further organize them into conceptual groupings, thus creating third order constructs. Codes that have been created will be sorted into categories based on common concepts and labeled using appropriate terms that capture the key concepts that contain and express relationships that exist between and within categories. Reference to study characteristics (completed during stage 3: reading the studies) is important at this stage to give context to comparisons and to the papers themselves³².

Phase 6: Synthesising the translations: as described by Sattar et al.³² this phase will be divided into the following stages

(a) Reciprocal and refutational synthesis

Third order constructs, i.e. the review authors’ interpretation of first and second order concepts will be established. At this stage studies are no longer viewed as individual studies but as a whole, in an attempt to develop a conceptual framework that may explain the phenomenon of interest⁴⁸. This stage involves ascertaining if studies are similar to allow for reciprocal translation synthesis or refutational synthesis whereby studies refute each other.

(b) A line of argument synthesis

The themes that are common across the studies will be summarized and juxtaposed to interpret a line of argument synthesis. This process will enable ‘making a whole into something more than the parts alone imply’^31(p.28) As this QES aims to synthesize the experiences of general practitioners and women, two separate syntheses will be conducted. This phase will be conducted by the main study author (LJM) and findings will be merged to create the final line of argument. Findings will be presented to the wider research team and reviewed.

Phase 7: Expressing the synthesis

To ensure transparency and robustness in conducting this meta-ethnography the eMERGe³³ reporting guidelines will be adhered to, and a record will be provided. Findings will be disseminated through publication in a peer-reviewed journal and will also be presented at academic conferences.

Confidence

A GRADE-CERQual assessment will be conducted to assess the confidence of our review findings based on methodological limitations, data adequacy, coherence and relevance⁴⁹. The iSoQ :: Grade-CERQual, a free online tool will be used to assist conducting and applying the GRADE-CERQual approach to findings of this qualitative evidence synthesis. The iSoQ tool⁵⁰ will be used to present a summary of qualitative findings table. Applying the GRADE-CERQual approach to findings that emerge from a meta-ethnography is considered a challenging process and is not well described in the literature⁵¹, nonetheless, it is also considered an important step.

Reflexivity statement

It is important to acknowledge the review authors' expertise and background, to be transparent in how these may influence findings, thus increasing rigor⁵². LJM is a full-time PhD candidate, with a background in general nursing with a strong interest in women’s health and health equity. As the main review author, LJM will keep a journal throughout all stages of the review process, to keep note of decisions made and why decisions were made. Discussions with the wider review team will also be documented throughout. AOM is a postdoctoral researcher with a background in psychology and a strong interest in evidence synthesis and research integrity. She has not previously worked on research regarding women’s health. AJ is an academic GP. Within her clinical practice, AJ has an interest in female health. SMH is a health services researcher with a background in health psychology and interest in implementation science. SMH has carried out research on the management of chronic conditions in general practice however she has not previously conducted research on women’s health topics.

Strengths and limitations

To the best of our knowledge, this review will be the first qualitative evidence synthesis to present the experiences of both women who have attended general practice for the treatment of perimenopausal symptoms and the GPs managing them. Moreover, there is no QES that gathers the evidence on experiences of GP delivering perimenopausal care. Given the dearth of research published specific to perimenopause in the context of general practice, results from this QES will add to the empirical literature and generate evidence for GPs, women, and researchers. The findings of this QES will provide a greater understanding of how GPs and women experience perimenopause consultations, aspects of these consultations that work well, and areas that may need improvement. It is important to acknowledge that meta-ethnography does have limitations. It should be acknowledged that findings from this meta-ethnography will offer just one interpretation and given the subjective nature of this methodology, the representativeness of findings may also be affected³². Nonetheless, despite its challenges, meta-ethnography is invaluable in providing evidence to support practice and policy³³.