Measuring Menses: Issues with Patient-Reported Menstrual Cycle Assessment

• Activity Number: 536
• Type: Contributed
• Date/Time: Thursday, August 10, 2006 : 10:30 AM to 12:20 PM
• Sponsor: Section on Health Policy Statistics
• Author(s): Stephanie Land*+ and Gina Sucato and Marcie Ritter and Reena Cecchini and Sandra Swain and Patricia Ganz
• Companies: University of Pittsburgh and Children's Hospital and University of Pittsburgh and University of Pittsburgh and National Cancer Institute and University of California, Los Angeles
• Keywords: patient-reported outcomes ; clinical trials ; questionnaire ; quality of life

Abstract

The assessment of the timing and duration of menstrual cycles arises in several areas of medical research, but an ideal approach to collecting this information from patients has yet to be developed. In this presentation, I will discuss measurement issues that have arisen in two studies. In the first, a multi-center breast cancer clinical trial, menstrual history was collected with questionnaires in order to assess the effect of chemotherapy on menopausal status, and the effect of menopausal status on survival. In the second, an observational study regarding adolescent birth control use, menses were recorded on patient calendars. Both designs resulted in intermittent missingness and uncertainty in the measures of interest (such as time to resumption of menses). I will describe alternative approaches presented in medical literature, and make recommendations for future studies.