This application proposes a Research Design and Methodology conference to assess existing outcome measures for pelvic organ prolapse (POP) surgical and clinical care. POP is a chronic condition particularly affecting older women, with 1 in 8 women undergoing surgery for POP over her lifetime. Symptoms range from mild to debilitating bladder, bowel and sexual dysfunction, and corresponding treatment plans are available. However, few existing measures facilitate a clinician's ability to longitudinally track outcomes, and even fewer consider outcomes from a patient perspective. Similarly, without a standard set of measures, research on outcomes of POP surgery such as comparisons with conservative therapies can be difficult to interpret. The goal of this conference is to rectify this issue by recommending a standard set of measures for use in research and begin the process of developing new measures to fill existing gaps. The proposed conference will be held immediately prior to the American Urogynecologic Society's (AUGS) June 2019 Strategic Planning and Board of Directors meeting in Baltimore, Maryland. An initial consensus conference recommended improvement in patient-reported outcome measures for POP and agreement on a standardized group of prolapse outcomes to be used routinely in large trials, community-based research, and quality metric development. The proposed conference will be attended by clinicians from multiple professional societies representing tertiary care centers as well as private practice, researchers, patients and patient advocates as well as FDA and industry representatives. Inclusion of diverse voices from all aspects of POP treatment is critical to the success of this conference. Over two days the participants will form workgroups that assess existing outcomes in several broad categories such as provider-based, quality, and patient-reported outcomes measurement, and make recommendations toward a consensus set of measures for use in clinical trials as well as list patient-reported outcome measures to development with prioritization among different societies. At the end of the conference, the Steering Committee will begin dissemination activities including a manuscript for publication in the Female Pelvic Medicine and Reconstructive Surgery journal and an abstract to be submitted to AUGS annual meeting and the annual meetings of participating societies. Provider-reported and patient-reported outcomes will be incorporated into AUGS existing registries and shared with the Women's Health Technologies Coordinated Registry Network, a project of MDEpiNet and the FDA. Conference deliverables will also be available to the public on AUGS website.
The purpose of the proposed conference is to recommend a standardized group of pelvic organ prolapse (POP) outcome measures that multiple stakeholders and societies agree to use for future research and clinical ventures. Standardization of outcomes will not only improve clinical care for women with POP, a condition that affects 1 in 8 women during their lifetime, but also strengthen POP research and reduce unexpected complications such as those seen recently with urogynecologic surgical mesh. Furthermore, the proposed conference will for the first time utilize significant patient input to assess weaknesses in existing POP surgery outcome measures and identify patient priorities to aid in developing new patient-reported outcome measures.
