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. 2025 Jul 1;9(1):79.
doi: 10.1186/s41687-025-00914-0.

Qualitative exploration of women's experiences of vasomotor symptoms to support the content validity of patient-reported outcomes

Claudia Haberland  1 , Melissa Barclay  2 , Sophie Whyman  2 , Asha Lehane  2 , Adam Gater  2 , Christoph Gerlinger  3   4 , Christian Seitz  3   5 , Maja Francuski  3 , Nils Schoof  3 , Andrew Trigg  6 , Helena Bradley  7
Affiliations

Qualitative exploration of women's experiences of vasomotor symptoms to support the content validity of patient-reported outcomes

Claudia Haberland et al. J Patient Rep Outcomes. .

Abstract

Background: Frequency and severity of vasomotor symptoms (VMS; hot flashes) associated with menopause significantly impact women's health-related quality of life (HRQoL). Treatment benefit in VMS clinical trials is assessed using patient-reported outcome (PRO) measures, which must demonstrate evidence of content validity. This research aimed to establish a conceptual model in VMS and evaluate content validity of the Hot Flash Daily Diary (HFDD), PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), and Menopause-Specific Quality of Life (MENQOL) questionnaire for use in VMS clinical trials.

Methods: Targeted searches were conducted to identify qualitative literature documenting women's VMS experiences. Qualitative concept elicitation (CE) and cognitive interviews (CI) were then conducted with 20 US participants experiencing VMS (n = 10 postmenopause; n = 10 AET-treated). Literature and CE findings were used to develop a conceptual model and confirm conceptual coverage of PRO measures selected for assessing efficacy in VMS clinical trials. CIs assessed the content validity of PRO measures.

Results: Findings from the literature and CE interviews informed a conceptual model depicting women's experiences of VMS. Thirty-three symptom concepts were identified with key symptoms including sweating, cold sweats/chills and tiredness/fatigue. Impacts of VMS on HRQoL were categorized into seven domains: sleep, emotional wellbeing, activities of daily living, social wellbeing, work/education, cognitive and physical functioning. The concepts assessed by the HFDD (VMS severity and frequency), PROMIS SD SF 8b (sleep disturbance) and MENQOL (menopause-related quality of life) aligned with those endorsed by women as relevant to their VMS experience. Instructions, recall periods and response options of the measures were understood. A reduction of one moderate or one severe hot flash in 24-hours (assessed by the HFDD) was considered a meaningful improvement by participants. Similar observations were made across study samples.

Conclusions: Findings provide detailed insights into women's experience of VMS, supporting the development of a conceptual model and assessment of conceptual coverage of selected PRO measures. Content validity of the HFDD, PROMIS SD SF 8b, and MENQOL for use in VMS clinical trials was supported. CI results suggest that a reduction of one moderate or one severe hot flash in 24-hours is meaningful to women with VMS.

Keywords: Conceptual model; Content validity; Hot flashes; Meaningful change; Menopause; Patient-reported outcome; Vasomotor symptoms.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Ethical approval and oversight were obtained from Western Copernicus Group Independent Review Board (WCG; reference: 20222753). Written informed consent was obtained from all participants. Consent for publication: All participants provided informed consent indicating their data will be used for medical research purposes and the study results may be published. Competing interests: CH, CG, CS, MF, NS and AT are Bayer employees. MB, SW, AL, AG and HB are Adelphi Values employees.

Figures

Fig. 1
Fig. 1
Conceptual model based on literature review and qualitative CE interviews
Fig. 2
Fig. 2
Meaningful change in moderate hot flashes. Note *n = 1 reported that a reduction of two moderate hot flashes would be meaningful to her but did not report how many moderate hot flashes this would be a reduced from when thinking about a previous 24-hour period
Fig. 3
Fig. 3
Meaningful change in severe hot flashes. Note *n = 6 reported that a reduction of one severe hot flash would be meaningful to them but did not report how many severe hot flashes this would be reduced from when thinking about a previous 24-hour period. The remaining n = 1 participant did not provide a response when asked
See this image and copyright information in PMC

References

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