Creating Public Use Datasets for PFDN Surgical Trials

为 PFDN 手术试验创建公共使用数据集

• 批准号: 9370095
• 负责人: MARIE G GANTZ
• 金额: $ 8.87万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-05 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9370095
• 关键词: Abdomen; Access to Information; Archives; Child health care; Client satisfaction; Clinical; Communities; Data; Data Coordinating Center; Data Element; Data Files; Data Set; Devices; Documentation; Ensure; Fecal Incontinence; Funding; Future; Goals; Human Development; Incontinence; Infant Mortality; International; Knowledge; Label; Leadership; Light; Manuscripts; Minority; Multicenter Neonatal Research Network; Names; National Institute of Child Health and Human Development; Notification; Operative Surgical Procedures; Outcome; Participant; Pelvic Floor Disorders; Pelvis; Population; Principal Investigator; Procedures; Ptosis; Public Health; Public Health Administration; Publishing; Quality of life; Reporting; Research; Research Personnel; Resource Sharing; Resources; Safety; Specimen; Standardization; Stress; Stress Urinary Incontinence; Symptoms; Time; United States Food and Drug Administration; United States National Institutes of Health; Urethra; Urinary Incontinence; Vagina; Vaginal Prolapses; Woman; Work; clinical care; experience; improved; micturition urgency; pelvic organ prolapse; prevent; repaired; symposium; urinary

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).

项目摘要 骨盆底疾病网络（PFDN）是由尤尼斯肯尼迪施莱佛国家研究所建立的 儿童健康和人类发展（NICHD）在2001年进行合作研究， PFDs女性的临床护理，包括盆腔器官脱垂（POP）、压力和尿急 失禁（UI）和大便失禁（FI）。Colpopexy and Urinary Reduction Effort（CARE）试验 阴道闭合术（阴道闭合术）研究后的盆腔支持、盆腔症状和患者满意度，以及 阴道脱垂修复术和尿道中部吊带（OPUS）试验的结果是三项研究，涉及 PFDN前两个供资周期（2001年至2011年6月）完成的POP手术修复。 CARE和OPUS试验评价了在POP修复时是否进行了抗尿失禁手术 有效预防新发应激性UI（SUI）。阴道闭合术研究评估了 使用阴道闭合术进行脱垂修复后的生活结局，一些研究参与者还 同时接受SUI手术。这些研究的结果已经发表，但很全面 数据集和文件不提供给网络以外的研究人员。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的辩论， 2008年美国食品药品监督管理局（FDA）公开的涉及补片器械的手术的有效性 关于经阴道置入补片治疗POP相关并发症的健康通知， SUI。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， 不使用网状装置，并使用腹部和阴道途径。如果这些数据可以用于 研究人员，他们将能够进行分析，帮助填补重要的知识空白，包括那些 关于使用旧补片器械进行手术的安全性和有效性，与 市场今天CARE、阴道闭合术和OPUS产生的数据代表了宝贵的资源;然而， 对于在前任PFDN数据协调中心任职期间完成的这些研究 (DCC)，数据不公开，创建公共使用数据集不属于工作范围 目前的DCC。因此，自2011年7月以来，作为人民民主阵线的协调委员会，RTI国际提议， 利用PAR-16-149可获得的资金，实现以下具体目标 儿童健康和人类发展数据集（R 03）：（1）创建公共使用数据集和文档 为 CARE、阴道闭合术和OPUS研究 、（二） 协调数据，以促进利用 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档 数据和样本中心（DASH）。