Trial reportJournal of patient-reported outcomes2025
Psychometric evaluation of the HFDD, PROMIS SD SF 8b, and MENQOL questionnaire in women experiencing vasomotor symptoms associated with menopause.
Trial report in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
1 citing paper in PubMed.
- Qualitative exploration of women's experiences of vasomotor symptoms to support the content validity of patient-reported outcomes.Journal of patient-reported outcomes · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundVasomotor symptoms (VMS; hot flashes) associated with menopause have significant impacts on health-related quality of life and are a leading cause for women seeking medical attention. Patient-reported outcome (PRO) instruments are commonly used to assess treatment benefit in VMS clinical trials and must demonstrate supportive evidence of measurement properties within the context of use. This study evaluated the measurement properties of scores from the Hot Flash Daily Diary (HFDD), PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) and Menopause-Specific Quality of Life (MENQOL) for measuring treatment efficacy in VMS clinical trials.
methodsMeasurement properties of the HFDD, PROMIS SD SF 8b, and MENQOL scores were assessed using data (n = 400 participants) from a randomized, placebo-controlled, phase 3 study evaluating the efficacy and safety of elinzanetant for the treatment of VMS in postmenopausal women (OASIS 2). Analyses assessed distributional properties, reliability, validity, responsiveness, and thresholds for meaningful change.
resultsMinimal floor and ceiling effects were found across the instruments at baseline. Inter-item correlations, and confirmatory factor analysis or item-response theory supported dimensionality and scoring for the MENQOL and PROMIS SD SF 8b, respectively. Test-retest reliability between Weeks 8 and 12 was good to excellent for HFDD Frequency and Severity of moderate-to-severe hot flashes scores, PROMIS SD SF 8b T-score and MENQOL Total score (intra-class correlation coefficients 0.835-0.971). Convergent and divergent correlations with instruments assessing similar or distinct constructs were consistent with pre-specified hypotheses. Known-groups validity was supported by significant differences (p < 0.0001) between subgroups hypothesized a priori as being clinically distinct. Responsiveness was indicated by consistent and statistically significant differences (p < 0.0001) in mean changes from baseline to Week 4 and 12 between groups of participants classified as 'improved', 'stable' and 'worsened' (effect sizes for improvement 0.81-4.62). Triangulation of estimates from multiple anchor-based analyses derived meaningful within-individual change thresholds for the HFDD, PROMIS SD SF 8b and MENQOL scores that were likely to exceed measurement error.
conclusionsFindings provide evidence that HFDD, PROMIS SD SF 8b, and MENQOL scores are valid, reliable and responsive to change, supporting their use for assessing key efficacy endpoints in VMS clinical trials.
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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 Socratic graph.