Correlations among Core Outcomes in Menopause-recommended vasomotor symptom outcomes in MsFLASH trials
Year: 2023
Type: article
Abstract: 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.
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Menopausal Symptoms Initiative-Finding Lasting Answers for Sweats and Hot Flashes, MSI-FLASH: An Exercise Intervention for Women with Menopausal Symptoms, Efficacy of an SSRI for Menopausal Symptoms in Perimenopausal Women, MSI FLASH: An RCT of Yoga and Ultra Low-Dose Estrogen Gel for Vasomotor Symptoms, Indiana Clinical and Translational Science Institute (UL1), MSI-FLASH: Relative Efficacy of Hormonal and Non-Hormonal Interventions for VMS, MSI-FLASH: Paced Respiration for Breast Cancer Survivors
OpenAlex ID: W4388662550