Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network

Abstract

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.

Figure 1

Field Study Day 7 Monitor Acceptability Ratings Responses shown are valid percentages of answers to each question accounting for missing data. On day 7, 35 of 35 participants rated the Biolog™ monitor items and 11-14 of 15 participants rated the Bahr Monitor™. The Biolog™ was worn in the ambulatory study only for the first 24 hours by Indianapolis site participants. Solid lines are responses for Biolog™. Dashed lines are responses for Bahr Monitor™.

Figure 2

Photo of VMS Monitoring Systems The photo shows the monitoring systems used in the study. From left to right are the (1) Freedman FlashMark Pro minitiarized hygrometer with (2) double sided tape ring to adhere the device to the skin; (3) prototype Bahr Monitor™ resembling a small green circuit board, (4) production version Bahr Monitor™, (5) electrode used to adhere the Bahr Monitor™ to the skin; and (6) Biolog™ with electrode lead wires.