Conference for Prolapse Outcome Measurement

项目总结/摘要 本申请提出了一个研究设计和方法会议，以评估 盆腔器官脱垂（POP）手术和临床护理的现有结局指标。POP是一 慢性疾病特别影响老年妇女，八分之一的妇女接受手术， 在她的一生中流行。症状从轻微到使膀胱、肠道和性功能衰弱不等。 功能障碍，并有相应的治疗方案。然而，现有的措施很少 促进临床医生纵向跟踪结果的能力，甚至更少考虑结果 从病人的角度来看。同样，如果没有一套标准的衡量标准， POP手术与保守治疗的比较可能难以解释。 本次会议的目标是通过建议一套标准措施来纠正这一问题 供研究使用，并开始制定新措施以填补现有空白的进程。 拟议的会议将在美国泌尿妇科大会之前举行 协会（AUGS）2019年6月在巴尔的摩举行的战略规划和董事会会议， 马里兰州。最初的共识会议建议改善患者报告的 POP的结局指标，并就标准化脱垂结局组达成一致， 常规用于大型试验、社区研究和质量指标开发。 拟议的会议将由来自多个专业协会的临床医生参加 代表三级保健中心以及私人诊所、研究人员、患者和 以及FDA和行业代表。包容所有人的不同声音 持久性有机污染物处理的各个方面对本次会议的成功至关重要。两天多来， 与会者将组成工作组，评估几大类现有成果 例如基于提供者、质量和患者报告结果测量， 对临床试验中使用的一组共识措施的建议，以及清单 患者报告的结局指标与不同社会之间的优先发展有关。 会议结束时，指导委员会将开始宣传活动 包括一篇发表在《女性盆腔医学》和《重建医学》上的手稿。 外科杂志和摘要将提交给AUGS年会和年度 参加社团的会议。提供者报告和患者报告的结局将 纳入AUGS现有登记册，并与妇女健康技术共享 协调注册网络，MDEPiNet和FDA的一个项目。会议可交付成果 也将在AUGS网站上向公众提供。

Project Summary/Abstract 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.