OBJECTIVE: Vasomotor symptoms (VMS) associated with menopause (hot flashes, night sweats) negatively impact quality of life and sleep. Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures have been validated in the general population and those with sleep issues but not in women with menopause-associated VMS. We sought to evaluate the impact of VMS, especially on sleep patterns, and establish content validity of PROMIS Short Form Sleep-Related Impairment 8a and Sleep Disturbance 8b measures in menopausal women with moderate/severe VMS.
DESIGN: Cross-sectional, in-person, 60-min, qualitative interviews were conducted in the US (Dallas, TX; Chicago, IL) and EU (Manchester, UK; Paris, France) with women aged 40‒64 years experiencing moderate/severe VMS (≥35/wk). The main outcome measures were patient-reported impact of VMS based on concept elicitation and content validity of PROMIS 8a/8b via cognitive debriefing.
RESULTS: Thirty-two women (16 US; 16 EU) participated. A majority (US 93.8%; EU 93.8%) said VMS affected their sleep; specifically, they had sleep interrupted by physical discomfort (eg, sweating, overheating) and difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US 75%; EU 50%). Menopause-associated VMS led women to lift bed covers on/off and to change clothes, wash bedding, shower, and apply deodorant/perfume more often. VMS also affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found PROMIS sleep measures easy to understand and answer and relevant to evaluating their sleep pattern. On PROMIS 8a (sleep-related impairment), ≥50% of US respondents said VMS had an impact ranging from a little bit to very much on alertness, tiredness, daytime problems due to poor sleep, and daytime sleepiness; 50% of EU respondents said VMS at least somewhat affected alertness, concentration, irritability, and ability to get things done because of daytime sleepiness. PROMIS 8b (sleep disturbance) items most affected by VMS were “trouble staying asleep” and “sleep quality was restless.”
CONCLUSION: VMS associated with menopause significantly interfere with sleep and next-day functioning (eg, work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with VMS found that the PROMIS short form sleep measures 8a/8b assessed constructs important to management of menopause-associated VMS.
