Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

Marci English,Boyka Stoykova,Lynda Doward,Christina Slota,Rebecca Crawford,Emad Siddiqui,Dana Dibenedetti

doi:10.1186/s41687-021-00289-y

Abstract

PurposeWe evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS.MethodsCross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40–64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing.ResultsThirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct.ConclusionVMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS.

Highlights

Vasomotor symptoms (VMS) associated with menopause can negatively affect quality of life and cause nocturnal awakenings that result in poor sleep [1, 2]
Plain English summary Vasomotor symptoms (VMS) associated with menopause have consistently been linked with poor sleep
The Patient-Reported Outcomes Measurement Information System (PROMIS) measure of sleep quality has been validated in the general population and in people with sleep issues, but not in women with VMS associated with menopause

Summary

Introduction

Vasomotor symptoms (VMS) associated with menopause ( known as hot flashes, hot flushes, and night sweats) can negatively affect quality of life and cause nocturnal awakenings that result in poor sleep [1, 2]. A metaanalysis of seven placebo-controlled trials concluded that menopausal hormone therapy results in moderately improved sleep quality in women with VMS (standardized mean difference vs placebo: − 0.54; 95% CI: − 0.91 to − 0.18; P < 0.007) [3]. These studies used six sleep assessment tools, resulting in a range of sleep outcomes. The authors concluded that standardized scales should be used to assess self-reported sleep quality in future trials of VMS treatments

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