Objective: The aim of this study was to evaluate monitors for assessing vasomotor symptoms (VMS) in laboratory and ambulatory settings before use in the Menopause Strategies Finding Lasting Answers for Symptoms and Health network clinical trials testing VMS therapies.
Methods: This was a three-phase study. Phase 1 included laboratory testing of the Freedman and prototype Bahr Monitor, phase 2 included laboratory testing of the commercial Bahr Monitor and Biolog, and phase 3 included ambulatory testing of the commercial Bahr Monitor and Biolog. All phases enrolled midlife women with VMS, midlife women without VMS, and young women without VMS. The participants self-reported VMS by pressing event marker buttons. Questionnaires assessed demographics (all phases) and monitor acceptability (phases 2 and 3).
Results: Phase I testing was stopped because of sensitivity of the Freedman device to ambient humidity changes and lack of analytic software for the prototype Bahr Monitor. In phases 2 and 3, agreement between event-marked and commercial Bahr Monitor or Biolog-recorded VMS was higher in the laboratory than in the ambulatory setting; however, agreement between monitors was poor in two of three laboratory groups (midlife no VMS and young no VMS) and in all ambulatory groups. During ambulatory monitoring, the mean number of Bahr Monitor VMS was 16.33 in midlife women with VMS, 9.61 in midlife women without VMS, and 14.63 in young women without VMS (software version, March 2011). The Bahr Monitor was more acceptable than the larger Biolog, but feedback reflected annoyance at having to wear a device that itched and was visible under clothing.
Conclusions: The Bahr Monitor and Biolog seem suitable for use in controlled laboratory conditions during short periods of time. However, the current versions of these monitors may not be suitable for ambulatory clinical trials at this time.
From the 1Department of Adult Health, School of Nursing, Indiana University, Indianapolis, IN; 2Group Health Research Institute, Seattle, WA; 3Division of Research, Kaiser Permanente, Oakland, CA; 4Massachusetts General Hospital, Boston, MA; 5University of Washington School of Medicine, Seattle,WA; 6VA Medical Center/University of Minnesota, Minneapolis, MN; and 7Center for Nursing Research and Scholarship, School of Nursing, Indiana University, Indianapolis, IN.
Received July 14, 2011; revised and accepted October 18, 2011.
Funding/support: This study was supported by a cooperative agreement issued by the National Institute on Aging (NIA), in collaborationwith theEunice Kennedy Shriver National Institute of Child Health and Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM), and the Office of ResearchandWomen’s Health (ORWH) and NIA grants U01AG032659, U01AG032669, U01AG032682, U01AG032699, and U01AG032700. In Indiana, the project was supported by the Indiana Clinical and Translational Sciences Institute and funded, in part, by grant UL1 RR025761 from the National Institutes of Health, National Center for Research Resources, Clinical and Translational Sciences Award.
Financial disclosure/conflicts of interest: Hadine Joffe provides researchsupport (to the Center for Women’s Mental Health at Massachusetts General Hospital where she participates in protocols as a co-investigator) toBayer HealthCare Pharmaceuticals, Forest Laboratories, and GlaxoSmithKline. She also provides advisory/consulting services to Sanofi-Aventis/Sunovion.
Address correspondence to: Janet S. Carpenter, PhD, RN, FAAN, Professor and Sally Reahard Chair, Indiana University School of Nursing, 1111 Middle Drive, Indianapolis, IN, USA 46202. E-mail: firstname.lastname@example.org