This study describes women's experiences of the genitourinary syndrome of menopause (GSM) elicited through focus groups and cognitive debriefing sessions during development of a novel patient-reported outcome measure (PROM) designed for use in both clinical care and research.
A draft questionnaire to identify and assess bothersome genitourinary symptoms associated with estrogen deficiency in menopausal women was developed in five discrete phases from multiple sources of information in accordance with standards for PROM development. GSM was confirmed by report of symptoms in conjunction with a confirmatory pelvic examination and laboratory assessments.
Qualitative content interviews were completed in 36 menopausal women with GSM. Cognitive testing of draft PROM items was performed in nine focus groups, including 26 menopausal women with and 15 without GSM. Participants reported a range of symptoms and described associated impacts on more than 15 quality-of-life domains. The majority of women reported that their symptoms impacted their sexual functioning and had a negative effect on their overall quality of life. GSM affected many aspects of menopausal women's lives beyond sexual function, with descriptions of pain when walking, urinating, wearing tight clothes, and with other activities of daily living.
Women's own words methodically recorded and analyzed during qualitative interviews and cognitive debriefing focus groups illuminate the subjective experience of women with GSM. It is hoped that the PROM currently in development will provide an effective tool for increasing our understanding of the prevalence, predictors, and impact of GSM in menopausal women's lives.
1Massachusetts General Hospital, Boston, MA
2New England Research Institutes, Inc., Watertown, MA
3Sermonix Pharmaceuticals, Columbus, OH
4Southern California Center for Sexual Health Survivorship Medicine, Newport Beach, CA
5Women's Health and Consultants, Washington, DC
6University Hospitals Cleveland Medical Center, Cleveland, OH.
Address correspondence to: Jan L. Shifren, MD, Vincent Trustees Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, Director, Midlife Women's Health Center, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114. E-mail: firstname.lastname@example.org
Received 9 August, 2018
Revised 9 October, 2018
Accepted 9 October, 2018
This work was presented in part as an abstract at the 28th Annual Meeting of The North American Menopause Society; Oct 11-14, 2017; Philadelphia, PA.
Funding/support: Support for research discussed in this work was received from the Vulvovaginal Aging Research Group, whose members included The North American Menopause Society, the Massachusetts General Hospital Midlife Women's Health Center, Pfizer, Shionogi, and Allergan. Industry partners had no role in the design or conduct of the research.
Financial disclosure/conflicts of interest: JLS: Research consultant, New England Research Institutes; MLK: Speakers Bureau: AMAG, Duchesney, Lupin; Consultant/Advisory Board: AMAG, Lupin Pharmaceuticals, Duchesney, Viveve Medical, Materna, Exeltis, Applied Biology, Palatin Technologies, TherapeuticsMD; DJP: Sermonix Pharmaceuticals—Employee, Stockholder; AMAG Pharmaceuticals—Advisory Board, Consultant, Speakers bureau; TherapeuticsMD—Speakers bureau; Duchesnay- Consultant; Endoceutics—Consultant; JAS: Advisory Board/Consultant: AbbVie, Inc., Allergan, Plc, AMAG Pharmaceuticals, Inc., Amgen, Ascend Therapeutics, Azure Biotech, Inc., Bayer HealthCare Pharmaceuticals Inc., CEEK Enterprises, LLC, Covance Inc., Millendo Therapeutics, Inc., Mitsubishi Tanabe Pharma Development America, Inc., ObsEva SA, Radius Health, Inc., Sanofi S.A., Sebela Pharmaceuticals, Inc., Sermonix Pharmaceuticals, Inc., Shionogi Inc., Symbiotec Pharmalab, TherapeuticsMD, Valeant Pharmaceuticals. Speaker: Duchesnay USA, Novo Nordisk, Shionogi Inc., Valeant Pharmaceuticals. Grants/Research: AbbVie, Inc., Allergan, Plc, Agile Therapeutics, Bayer Healthcare LLC., Myovant Sciences, New England Research Institute, Inc., ObsEva SA, Palatin Technologies, Symbio Research, Inc., TherapeuticsMD. Stock Shareholder: Sermonix Pharmaceuticals; SAK: Consultant, Investigator, or Scientific Advisory Board: AMAG, Sprout, Emotional Brain, Valeant, Endoceutics, Novo Nordisk, Palatin Technologies, Pfizer, Duchesney, Materna, Lupin, GTx, IVIX, TherapeuticsMD, Viveve; RZ: Pfizer, Shionogi, and Allergan; ELC, AM, and RCR: Pfizer, Shionogi, and Actavis.