ArticleJournal of patient-reported outcomes2021
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.
Article in Journal of patient-reported outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Systematic Review of the Effect of a One-Day Versus Seven-Day Recall Duration on Patient Reported Outcome Measures (PROMs).The patient · 2023Pooled it
- Trial
- Psychometric evaluation of the HFDD, PROMIS SD SF 8b, and MENQOL questionnaire in women experiencing vasomotor symptoms associated with menopause.Journal of patient-reported outcomes · 2025Trial
- Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial.The Journal of international medical research · 2024Trial
- Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT.The Journal of clinical endocrinology and metabolism · 2023Trial
- Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms Associated with Menopause: Insights from the WARMER Study.The patient · 2026Article
- Targeted literature review of concepts related to women's experiences and perceptions of vasomotor symptoms associated with menopause.Menopause (New York, N.Y.) · 2026Review
- Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross-sectional survey.Acta obstetricia et gynecologica Scandinavica · 2025Article
- Lifetime history of hypertensive disorders of pregnancy is associated with shorter sleep duration and more sleep disturbance in midlife: results from the Project Viva women's health cohort.Biology of sex differences · 2025Article
- Qualitative exploration of women's experiences of vasomotor symptoms to support the content validity of patient-reported outcomes.Journal of patient-reported outcomes · 2025Article
- Comparative performance of PROMIS Sleep Disturbance computerized adaptive testing algorithms and static short form in postmenopausal women.Journal of patient-reported outcomes · 2025Article
- An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects.Drug design, development and therapy · 2025Article
- Article
- Shining a spotlight on sleep disturbance-related cognitive impairment and relevance to menopause.Sleep · 2024Article
- Associations of adverse childhood and lifetime experiences with sleep quality and duration among women in midlife.Sleep health · 2023Article
- Psychometric evaluation of the PROMIS SD-SF-8b instrument in individuals experiencing vasomotor symptoms due to menopause.Health and quality of life outcomes · 2023Article
- A survey of medical cannabis use during perimenopause and postmenopause.Menopause (New York, N.Y.) · 2022Article
- The relationship between sleep quality and menopausal symptoms among postmenopausal women in Saudi Arabia.Saudi medical journal · 2022Article
- Correction to: 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 · 2021Article
- Test-Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia.Frontiers in pain research (Lausanne, Switzerland) · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.