Pelvic floor Disorders Network-Data Coordinating Center

描述(申请人提供)：盆底疾病，如尿失禁、盆腔器官脱垂和大便失禁，是美国女性常见的和重大的健康相关问题。盆底疾病手术和非手术干预后的结果还没有得到充分的评估。因此，无法获得充分告知患者和做出重要决策所需的数据。盆底疾病网络(PFDN)的长期目标是系统地评估这些结果。该应用程序将成为盆底疾病网络的数据协调中心(DCC)，汇集了来自生物统计学、泌尿外科、泌尿外科、生活质量和卫生服务研究的经验丰富的研究人员，以前瞻性地评估女性盆底疾病的各种外科干预措施的结果。DCC的具体目标是：1.通过在PFDN进行的临床试验的设计、实施和分析方面提供专业知识，协助制定方案。2.在衡量生活质量方面提供专门知识，并选择适当的工具来评估治疗结果，并在适当时进行面谈。3.协调执行指导委员会核准的研究方案，包括设计病例报告表和面谈方案，编写操作手册，通过集中或远程数据输入进行中央数据库管理，必要时向食品和药物管理局提交IND，并根据需要组织培训和认证会议。4.为人阵开展的每项研究建立一个数据库。5.实施集中式或基于网络的数据录入和核查。6.监控临床站点的数据质量。7.为监测不良事件和监管网络提供基础设施。8.为指导委员会、咨询委员会和战略和预算问题协调机构提供面对面会议和电话会议的后勤支助。9.为人阵维护一个网站，其中包括带有面向公众的内容的网页，以及一个有密码保护的网站，其中有所有研究文件和数据库。10.管理和分配方案资金给临床中心。为了说明DCC的工作，提出了一项随机临床试验，以比较使用阴道入路治疗盆腔器官脱垂的手术方式。

DESCRIPTION (provided by applicant): Pelvic floor disorders, such as urinary incontinence, pelvic organ prolapse, and fecal incontinence, are common and significant health-related problems for women in the United States. Outcomes following surgical and non-surgical intervention for pelvic floor disorders have not been adequately evaluated. As a result, data necessary to fully inform patients and to make important policy decisions are unavailable. The long-term objective of the Pelvic Floor Disorders Network (PFDN) is to systematically evaluate these outcomes. This application to be the Data Coordinating Center (DCC) for the pelvic floor disorders network brings together experienced investigators from biostatistics, urogynecology, urology, quality of life and health services research to prospectively assess the outcomes from various surgical interventions for female pelvic floor disorders. The specific aims of the DCC are to: 1. Assist in protocol development by providing expertise in the design, conduct and analysis of clinical trials conducted by the PFDN. 2. Provide expertise in measurement of quality of life and in the selection of the appropriate instruments to assess treatment outcomes and, when appropriate, to perform the interviews. 3. Coordinate the implementation of the study protocols approved by the Steering Committee, including design of the case report forms and interviewing protocols, development of a manual of operations, centralized database management with either centralized or remote data entry, submission of an IND to the FDA when necessary, and by organizing training and certification sessions, as needed. 4. Establish a database for each study conducted by the PFDN. 5. Implement either centralized or web-based data entry and verification. 6. Monitor the clinical sites with respect to data quality. 7. Provide infrastructure for monitoring adverse events and regulatory oversight for the network. 8. Provide logistical support for the Steering Committee, Advisory Board and DSMB, for both face-to-face meetings and teleconferences. 9. Maintain a website for the PFDN that includes web pages with content for the public, and a password- protected site with all study documentation and databases. 10. Manage and distribute protocol funds to the Clinical Centers. To illustrate the work of the DCC, a randomized clinical trial is proposed to compare surgical procedures for pelvic organ prolapse using a vaginal approach.