Affiliation:
1. Indiana University School of Nursing, Indianapolis, IN
2. MsFLASH Data Coordinating Center, Fred Hutchinson Cancer Center, Seattle, WA
3. Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Guy's Campus, London, United Kingdom
4. Obstetrics and Gynaecology, Royal Women's Hospital, The University of Melbourne, Melbourne, Australia.
Abstract
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.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Obstetrics and Gynecology,General Medicine