OBJECTIVES: Vasomotor symptoms (VMS; hot flashes) significantly impact the health-related quality of life (HRQoL) of women and are a patient priority for treatment. Qualitative literature in this context of use is limited. Therefore, this study assessed women’s experience of VMS and the content validity of patient-reported outcome (PRO) measures: the Hot Flash Daily Diary (HFDD), PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), and Menopause-Specific Quality of Life (MENQOL) questionnaire.

METHODS: Semi-structured, qualitative concept elicitation and cognitive debriefing telephone interviews were conducted in line with regulatory and industry standards with 20 US participants experiencing VMS at four study sites. The participants included postmenopausal women (n=10) and women treated with adjuvant endocrine therapy (AET; n=10). Interview transcripts were analysed using thematic and framework analysis.

RESULTS: VMS, associated symptoms and impacts on HRQoL were explored in-depth. Key symptoms relevant to VMS (hot flashes) included sweating (n=19/20), cold sweats/chills (n=18/20) and tiredness/fatigue (n=18/20). Various impacts of VMS on HRQoL were identified, including sleep (n=20/20), activities of daily living (n=20/20), emotional wellbeing (n=19/20) and work/education (n=15/20). A draft conceptual model was refined. The HFDD, PROMIS SD SF 8b, and MENQOL instructions, recall periods and response options were well-understood and item concepts considered relevant by the participants in general. A reduction of one moderate or one severe hot flash in 24-hours, as assessed by the HFDD, was considered a meaningful improvement with treatment to most participants. No notable differences in findings were observed across postmenopausal and AET-treated women.

CONCLUSIONS: Findings provide detailed insights into women’s experience of VMS and add to existing published qualitative research literature. The content validity of the HFDD, PROMIS SD SF 8b, and MENQOL for use in VMS clinical trials was confirmed. Future research will evaluate psychometric properties of the instruments in women with VMS using clinical trial data.