Overview
This study evaluated the prevalence and burden of menopause-related symptoms among women aged 45 to 65 who had evidence of HT use. EMR data from a regional healthcare organization were analyzed for prevalence of menopausal symptoms. Women were selected for potential inclusion if they were enrolled in the Fallon Community Health Plan for one year prior to and one year following the first observed prescription for HT.
Data source
Data from the Reliant Medical Group, Worcester, Massachusetts, USA were used to explore the prevalence of menopausal symptoms among women undergoing HT. The Reliant Medical Group is a multispecialty group practice with a predominantly managed-care population of approximately 200,000 patients. Data covering the six-year period from January 1, 2006 through December 31, 2011 (the study period) were analyzed.
The study data set consisted of combined patient medical claims and EMR data. Patients’ data were de-identified, with a unique, encrypted identifier available to link claims and EMR information. The study protocol and data collection forms were approved by the Reliant Medical Group-Fallon Community Health Plan-Saint Vincent Hospital Institutional Review Board.
Patient selection
Patient IDs for EMR review were identified based on a filled prescription for HT, using administrative claims data from the Reliant Medical Group. Patients selected for study inclusion were first identified using the following claims-based eligibility criteria: female patients, fill of at least one month’s supply of HT anytime between January 1, 2007 and December 31, 2010 (with the first date of HT deemed the “index date” for analysis), and aged 45 to 65 years of age as of the index date. Patients were additionally required to have no history of breast cancer, venous thromboembolism, stroke, gynecological cancer, or total hysterectomy, and be continuously enrolled in the health plan for 12 months pre- and 12 months post-index. HT consisted of oral or transdermal estrogen or estrogen and progestin combination therapies, excluding HT rings and creams.
From the full list of patients meeting eligibility criteria in claims data, a random sample of patients was generated to serve as the cohort for the EMR review. Study inclusion criteria, as first identified via claims data, were confirmed through the EMR chart review by clinical professionals from the Reliant Medical Group until approximately 100 patients met eligibility criteria, representing approximately one-third of patients meeting claims eligibility criteria.
Menopausal symptom identification
All patient visits in the EMR (excluding behavioral management visits) occurring within the two-year study period were analyzed. Data variables extracted from the EMR data set included: visit date, reason for the visit, provider specialty, and whether any menopausal symptoms were listed during the visit. All symptoms were required to have menopause referenced in the physician notes of the EMR as the cause of the symptom. Symptoms could have been self-reported by the patient or elicited by the healthcare provider. Specific menopause symptoms evaluated included: hot flushes (used interchangeably with hot flashes), night sweats, insomnia, vaginal dryness, loss of sexual desire, weight gain, hair loss, fatigue, major depression, anxiety, or mood disorders (including mention of episodic mood disorder and/or mood swings). VMS was defined based on the presence of hot flushes and/or night sweats, which is consistent with the National Institute of Health (NIH) definition of VMS [7].
Data analysis
The prevalence of all identified symptoms was analyzed descriptively at both the patient and visit levels. Descriptive analyses of all patient characteristics were conducted. Binary variables were summarized using percentages of patients and continuous variables were summarized using mean, SD, and median values. All analyses were conducted with SAS v9.3, Cary, North Carolina, USA.