Qualitative Assessment of Women’s Experiences of Sleep Disturbances Associated With Menopause to Evaluate Content Validity of Patient-Reported Outcomes
Author(s)
Huda Shalhoub, PhD1, Melissa Lucy Barclay, BSc, MSc2, Rowena Jones, BSc (Hons)2, Heidi Wikstrom, TBC3, Andrew Trigg, MSc4, Kathleen O'Sullivan, MS5, Asha Lehane, MSc2, Christian Seitz, PhD1, Frank Kramer, PhD6, Mauminah Chaudry, MSc2, Helena Bradley, BSc2.
1Bayer AG, Berlin, Germany, 2Adelphi Values Ltd, Bollington, United Kingdom, 3Bayer Oy, Espoo, Finland, 4Bayer plc, Reading, United Kingdom, 5Bayer US LLC, Whippany, NJ, USA, 6Bayer AG, Wuppertal, Germany.
1Bayer AG, Berlin, Germany, 2Adelphi Values Ltd, Bollington, United Kingdom, 3Bayer Oy, Espoo, Finland, 4Bayer plc, Reading, United Kingdom, 5Bayer US LLC, Whippany, NJ, USA, 6Bayer AG, Wuppertal, Germany.
OBJECTIVES: Sleep disturbances are one of the most bothersome symptoms occurring during menopause, significantly impacting women's health-related quality of life. This study explored women’s experiences of sleep disturbances associated with menopause and assessed content validity of several patient-reported outcome (PRO) measures, including the PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), Insomnia Severity Index (ISI), and a Sleep Diary (SD).
METHODS: Semi-structured, qualitative concept elicitation and cognitive interviews were conducted with 20 women experiencing sleep disturbances associated with menopause in the United States (US). Interviews were transcribed and analysed using qualitative thematic and framework analytical methods. Input was also obtained through discussion sessions with three clinical experts with experience in the treatment of sleep disturbances associated with menopause from the US and Canada.
RESULTS: Six sleep disturbance concepts associated with menopause were identified, including nighttime awakenings, unrefreshing sleep, reduced sleep quality, difficulty falling back to sleep, reduced sleep quantity, and difficulty initially falling asleep. Primary impacts of sleep disturbances included tiredness, fatigue, daytime sleepiness/drowsiness, and wanting/needing to nap. Secondary impacts on emotional and social wellbeing, physical and cognitive functioning, daily activities, and work were also identified. Vasomotor symptoms (VMS; hot flashes), sweating (including night sweats), and musculoskeletal pain were commonly associated with sleep disturbances, though sleep disturbances were experienced irrespective of these symptoms. Findings informed refinement of a conceptual model depicting women’s experiences of sleep disturbances. The PROMIS SD SF 8b, ISI, and SD were considered appropriate and relevant by clinical experts and the instructions, recall periods, and response options were well-understood and item concepts considered relevant by women, in general.
CONCLUSIONS: Results provide in-depth insights into women’s experiences of sleep disturbances associated with menopause and support content validity of the PROMIS SD SF 8b, ISI, and SD for use in future clinical trials involving women experiencing menopause.
METHODS: Semi-structured, qualitative concept elicitation and cognitive interviews were conducted with 20 women experiencing sleep disturbances associated with menopause in the United States (US). Interviews were transcribed and analysed using qualitative thematic and framework analytical methods. Input was also obtained through discussion sessions with three clinical experts with experience in the treatment of sleep disturbances associated with menopause from the US and Canada.
RESULTS: Six sleep disturbance concepts associated with menopause were identified, including nighttime awakenings, unrefreshing sleep, reduced sleep quality, difficulty falling back to sleep, reduced sleep quantity, and difficulty initially falling asleep. Primary impacts of sleep disturbances included tiredness, fatigue, daytime sleepiness/drowsiness, and wanting/needing to nap. Secondary impacts on emotional and social wellbeing, physical and cognitive functioning, daily activities, and work were also identified. Vasomotor symptoms (VMS; hot flashes), sweating (including night sweats), and musculoskeletal pain were commonly associated with sleep disturbances, though sleep disturbances were experienced irrespective of these symptoms. Findings informed refinement of a conceptual model depicting women’s experiences of sleep disturbances. The PROMIS SD SF 8b, ISI, and SD were considered appropriate and relevant by clinical experts and the instructions, recall periods, and response options were well-understood and item concepts considered relevant by women, in general.
CONCLUSIONS: Results provide in-depth insights into women’s experiences of sleep disturbances associated with menopause and support content validity of the PROMIS SD SF 8b, ISI, and SD for use in future clinical trials involving women experiencing menopause.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR199
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Reproductive & Sexual Health