Creating Public Use Datasets for PFDN Surgical Trials

项目摘要 盆底疾病网络(PFDN)是由尤尼斯·肯尼迪·施莱弗国家研究所建立的 儿童健康和人类发展部(NICHD)于2001年开展合作研究并改进 盆腔器官脱垂、应激和尿急等盆腔功能障碍患者的临床护理 尿失禁(UI)和大便失禁(FI)。固定术和减少尿量(CARE)试验， 骨盆支持、骨盆症状和术后患者满意度的研究 阴道脱垂修补术和中段尿路吊带(OPUS)试验的结果包括三项研究 在人阵的头两个供资周期(2001年至2011年6月)期间完成的POP外科修复。 CARE和OPUS试验评估了POP修复时是否进行了抗尿失禁手术 能有效预防新的应激性尿失禁(SUI)。结肠裂解研究评估了临床和质量 剥离手术修复脱垂后的生活结果，一些研究参与者还 同时接受了SUI手术。这些研究的结果已经发表，但内容全面 网络以外的研究人员不能获得数据集和文件。与此同时，这些数据 对研究人员来说仍然非常有价值，特别是考虑到正在进行的关于相对安全性和 2008年食品和药物管理局(FDA)公众推动的网状装置手术的疗效 关于经阴道放置网片治疗POP和POP相关并发症的健康通知 隋国。这三项研究包括用于治疗POP和SUI的一系列外科手术的数据，以及 不使用网状装置，使用腹部和阴道途径。如果这些数据可以提供给 研究人员，他们将使分析能够帮助填补重要的知识空白，包括 关于使用较旧的网状装置进行手术的安全性和有效性 今天的市场。CARE、Colpocleisis和OPUS产生的数据代表了一种宝贵的资源；然而， 这些研究是在上一个人阵数据协调中心任职期间完成的 (DCC)，数据不公开，创建公共使用数据集不属于工作范围 对于当前的DCC。因此，自2011年7月以来，作为民阵的DCC，RTI International提议 利用可通过PAR-16-149归档和记录获得的资金实现以下具体目标 儿童健康和人类发展数据集(R03)：(1)创建公共用途数据集和文件 对于 护理、科普清理术和OPUS研究 、(2) 协调数据以便于分析利用 来自多项研究的数据，以及(3)通过NICHD共享公共使用数据集和文件 数据和样本中心(DASH)。

Project Summary The Pelvic Floor Disorders Network (PFDN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in 2001 to conduct collaborative research and improve clinical care for women with PFDs including pelvic organ prolapse (POP), stress and urgency urinary incontinence (UI), and fecal incontinence (FI). The Colpopexy and Urinary Reduction Effort (CARE) trial, the Pelvic Support, Pelvic Symptoms, and Patient Satisfaction after Colpocleisis (Colpocleisis) study, and the Outcomes following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) trial are three studies involving surgical POP repair that were completed during the first two funding cycles of the PFDN (2001-June 2011). The CARE and OPUS trials evaluated whether anti-incontinence surgeries performed at the time of POP repair were effective in preventing new-onset stress UI (SUI). The Colpocleisis study assessed clinical and quality of life outcomes following prolapse repair with a colpocleisis procedure, and some study participants also underwent concomitant SUI surgery. The results of these studies have been published, but comprehensive datasets and documentation are not available to researchers outside of the Network. Meanwhile, these data remain highly valuable to researchers, particularly in light of the ongoing debate about the relative safety and efficacy of surgeries involving mesh devices spurred by the 2008 Food and Drug Administration (FDA) Public Health Notificationregarding complications associated with transvaginal placement of mesh to treat POP and SUI. These three studies include data on a range of surgical procedures used to treat POP and SUI, with and without mesh devices, and using abdominal and vaginal approaches. If these data were available to researchers, they would enable analyses that could help fill important knowledge gaps, including those regarding the safety and efficacy of surgeries performed with older mesh devices compared to devices on the market today. The data resulting from CARE, Colpocleisis, and OPUS represent a valuable resource; however, for these studies which were completed during the tenure of the previous PFDN data coordinating center (DCC), data are not publicly available, and creating public use datasets does not fall within the scope of work for the current DCC. Therefore, as the DCC for the PFDN since July 2011, RTI International proposes to achieve the following specific aims using funding available through PAR-16-149 Archiving and Documenting Child Health and Human Development Data Sets (R03): (1) creating public use datasets and documentation for the CARE, Colpocleisis, and OPUS studies , (2) harmonizing the data to facilitate analyses that make use of data from multiple studies, and (3) sharing the public use datasets and documentation through the NICHD Data and Specimen Hub (DASH).