Menopause. 2023 Nov 14. doi: 10.1097/GME.0000000000002280. Online ahead of print.
OBJECTIVE: This study aimed to advance understanding of vasomotor symptom (VMS) outcomes measurement using pooled data from three Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) trials.
METHODS: Participants self-reported VMS frequency, severity, and bother using daily diaries; completed standardized measures of VMS interference, insomnia severity, and sleep quality/disturbance; and completed four treatment satisfaction items. Analyses included descriptive statistics, Pearson correlations (baseline pooled sample, posttreatment pooled sample, posttreatment placebo only), t tests, and analysis of variance.
RESULTS: Participants were mostly postmenopausal (82.9%) and a mean of 54.5 years old. VMS frequency was fairly correlated with severity, bother, and interference for pooled baseline and placebo posttreatment samples (r values = 0.21-0.39, P values < 0.001) and moderately correlated with severity, bother, and interference for pooled posttreatment (r values = 0.40-0.44, P values < 0.001). VMS severity, bother, and interference were moderately correlated (r values = 0.37-0.48, P values < 0.001), with one exception. VMS severity and bother were strongly correlated (r values = 0.90-0.92, P values < 0.001). VMS interference was moderately correlated with insomnia (r values = 0.45-0.54, P values < 0.001) and fairly to moderately correlated with sleep quality/disturbance (r values = 0.31-0.44, P values < 0.001). Other VMS outcomes were weakly to fairly correlated with insomnia (r values = 0.07-0.33, P values < 0.001 to < 0.05) and sleep quality/disturbance (r values = 0.06-0.26, P values < 0.001 to > 0.05). Greater improvement in VMS and sleep over time was associated with higher treatment satisfaction (P values < 0.001).
CONCLUSIONS: This pooled analysis advances understanding of VMS outcomes measurement and has implications for selecting measures and creating future research.