OBJECTIVE: Our objective was to identify symptom clusters using standardized measures completed by @entity1 in the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health clinical trial at baseline, including hot flash interference, and sleep, @entity308 , @entity148 , and @entity158 symptoms. METHODS: Data from all @entity1 randomized to interventions and controls from Menopausal Strategies: Finding Lasting Answers to Symptoms and Health studies 1, 2, and 3 (N=899) were included; 797 with complete data were used in the analyses. Scores from standardized measures obtained at baseline included the following: Hot Flash-Related Daily Interference Scale, @entity22 Severity Index, Pittsburgh Sleep Quality Index, @entity1 Health Questionnaire-9 measure of @entity308 mood, Generalized @entity148 , and Brief Pain Inventory PEG scores ( @entity158 intensity [P], interference with enjoyment of life [E], and interference with daily activity [G]). Latent class analysis was used to identify symptom clusters using standardized scale scores and their established cut points. RESULTS: We identified five classes using the Bayesian Information Criterion and the Akaike Information Criterion. @entity1 in classes 1 and 2 had high hot flash interference levels relative to the others, and class 1 (10.5% of total) included severe hot flash interference, severe @entity25 , and moderately severe @entity158 symptoms (hot flash, sleep, @entity158 ). In class 2 (14.1%), severe hot flash interference was paired with the severe @entity25 , and moderate to severe @entity308 and @entity1316 and @entity158 (hot flash, sleep, mood, @entity158 ). In class 3 (39.6%), @entity1 reported moderately severe @entity25 with moderate hot flash interference, and low severity mood and @entity158 symptoms (hot flash, sleep). Those in class 4 (7.0%) reported moderate hot flash interference with severe levels of @entity148 and @entity308 , but low levels of other symptoms (hot flash, mood). @entity1 in class 5 (28.7%) reported the lowest levels of all the five symptoms (low severity symptoms). CONCLUSIONS: @entity1 meeting hot flash frequency criteria for inclusion in clinical trials exhibited multiple co-occurring symptoms that clustered into identifiable groups according to symptom interference and severity. Variability of symptom profiles between the classes was evident, indicating that the classes were composed of differing symptom types and not simply differing severity levels. These symptom clusters may be useful phenotypes for differentiating treatment effects or evaluating associations with biomarkers or genes.

Symptom clusters among MsFLASH clinical trial XXXX .

@entity1 :: ('9606', 'Species') :: ['participants', 'women', 'Women', 'Patient'] @entity308 :: ('MESH:D003866', 'Disease') :: ['depressed mood symptoms', 'depressed', 'depressive'] @entity1316 :: ('MESH:D019964', 'Disease') :: ['anxious mood symptoms'] @entity148 :: ('MESH:D001008', 'Disease') :: ['anxiety', 'Anxiety Disorder'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity25 :: ('MESH:D012893', 'Disease') :: ['sleep symptoms'] @entity22 :: ('MESH:D007319', 'Disease') :: ['Insomnia']
@entity1 :: (9606,Species) :: ['participants']
