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 Eunice Kennedy Shriver National Institute建立了骨盆地板障碍网络（PFDN） 2001年儿童健康与人类发展（NICHD）进行合作研究并改善 PFD女性在内的临床护理包括骨盆器官脱垂（POP），压力和紧急尿液 尿失禁（UI）和粪便失禁（FI）。 Colpopexy和减少尿量工作（护理）试验， 骨盆症状的骨盆支持，骨盆症状和患者满意度（Colpocleisis）研究，以及 阴道脱垂修复和中尿道吊索（Opus）试验后的结果是三项研究，涉及 在PFDN（2001- 6月2011年）的前两个资金周期中完成的手术POP修复。 护理和作品试验评估了在POP修复时进行的抗内分手术是否进行 有效防止新发压力UI（SUI）。 Colpocleisis研究评估了临床和质量 通过侧脊髓理程序进行脱垂后的生活结果，一些研究参与者也 接受了SUI手术。这些研究的结果已经发表，但全面 网络以外的研究人员无法使用数据集和文档。同时，这些数据 对于研究人员来说仍然很有价值，特别是鉴于关于相对安全和 2008年食品药品监督管理局（FDA）公众刺激的网格设备的手术功效 健康通知将与网格的经阴道放置相关的并发症治疗，以治疗POP和 Sui。这三项研究包括有关用于治疗POP和SUI的一系列手术程序的数据， 没有网格设备，并使用腹部和阴道方法。如果这些数据可用于 研究人员，他们将进行分析，以帮助填补重要的知识差距，包括 关于使用较旧网格设备进行的手术的安全性和功效，与该设备相比 今天的市场。由Care，Colpocleisis和Opus产生的数据代表了宝贵的资源；然而， 对于以前的PFDN数据协调中心任职期间完成的这些研究 （DCC），数据无法公开可用，创建公共用途数据集不在工作范围之内 对于当前的DCC。因此，作为自2011年7月以来PFDN的DCC，RTI International建议 使用PAR-16-149归档和记录的资金实现以下特定目标 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档 为了 Care，Colpocleisis和Opus研究 ，（2） 协调数据以促进使用的分析 来自多个研究的数据，以及（3）通过NICHD共享公共使用数据集和文档 数据和标本中心（仪表板）。