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

Journal of Patient-Reported Outcomes

Marci English¹  Emad Siddiqui²  Boyka Stoykova²  Lynda Doward³  Rebecca Crawford³  Christina Slota⁴  Dana DiBenedetti⁴ 

[1] Astellas Pharma Inc., Pharma Global Development, 1 Astellas Way, 60062-6111, Northbrook, IL, USA;Astellas Pharma Inc., Surrey, Chertsey, UK;RTI Health Solutions, Manchester, UK;RTI Health Solutions, Patient-Centered Outcomes Assessment Group, Research Triangle Park, NC, USA;

关键词: Menopause;    Vasomotor symptoms;    Sleep;    Quality of life;    PRO;    Content validity;   

DOI  :  10.1186/s41687-021-00289-y

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY