Pelvic floor Disorders Network-Data Coordinating Center

盆底疾病网络-数据协调中心

• 批准号: 7485583
• 负责人: Catherine A Spino
• 金额: $ 266.87万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7485583
• 关键词: Abdomen; Adverse event; Advisory Committees; Ancillary Study; Biometry; Case Report Form; Certification; Clinical; Clinical Data; Collaborations; Communication; Condition; Conduct Clinical Trials; Data; Data Coordinating Center; Data Quality; Databases; Diagnostic; Documentation; Electronic Mail; Evaluation; Fecal Incontinence; Female; Funding; Generic Drugs; Goals; Health Services Research; Incontinence; Internet; Interview; Laboratories; Living Costs; Manuals; Measurement; Michigan; Monitor; Morbidity - disease rate; Numbers; Online Systems; Operative Surgical Procedures; Organ; Outcome; Patient Recruitments; Patients; Pelvic Floor Disorders; Pelvis; Personal Satisfaction; Policies; Preparation; Procedures; Protocols documentation; Ptosis; Publications; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research Infrastructure; Research Personnel; Sampling; Scheme; Site; Standardization; Statistical Data Interpretation; Stress Urinary Incontinence; Structure; Teleconferences; Telephone Interviews; Therapy Evaluation; Training; Treatment outcome; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Urinary Incontinence; Urology; Vagina; Woman; Work; Writing; clinical research site; demographics; design; experience; instrument; protocol development

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.

描述（由申请人提供）：盆底疾病，例如尿失禁、盆腔器官脱垂和大便失禁，是美国女性常见且严重的健康相关问题。盆底疾病的手术和非手术干预的结果尚未得到充分评估。因此，无法获得充分告知患者和做出重要政策决策所需的数据。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、泌尿妇科、泌尿学、生活质量和健康服务研究领域经验丰富的研究人员，以前瞻性地评估针对女性盆底疾病的各种手术干预的结果。 DCC 的具体目标是： 1. 通过提供 PFDN 进行的临床试验的设计、实施和分析方面的专业知识来协助方案开发。 2. 提供衡量生活质量和选择适当工具来评估治疗结果以及在适当时进行访谈的专业知识。 3. 协调指导委员会批准的研究方案的实施，包括设计病例报告表和访谈方案、制定操作手册、通过集中或远程数据输入进行集中数据库管理、必要时向 FDA 提交 IND，并根据需要组织培训和认证课程。 4. 为 PFDN 进行的每项研究建立数据库。 5. 实施集中式或基于网络的数据输入和验证。 6. 监控临床中心的数据质量。 7. 提供监控不良事件和网络监管的基础设施。 8. 为指导委员会、顾问委员会和 DSMB 的面对面会议和电话会议提供后勤支持。 9. 维护 PFDN 的网站，其中包括包含公众内容的网页，以及包含所有研究文档和数据库的受密码保护的网站。 10. 管理并向临床中心分配协议资金。为了说明 DCC 的工作，建议进行一项随机临床试验，以比较使用阴道入路治疗盆腔器官脱垂的手术程序。