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）：骨盆底疾病，例如尿失禁，骨盆器官脱垂和粪便尿失禁，对于美国妇女来说是常见且与健康有关的问题。骨盆底疾病的手术和非手术干预后的结果尚未得到充分评估。结果，无法充分告知患者并做出重要的政策决策所需的数据。骨盆底疾病网络（PFDN）的长期目标是系统地评估这些结果。该应用程序是骨盆底部疾病网络的数据协调中心（DCC），从而使经验丰富的研究人员聚集了来自生物统计学，泌尿疗法，泌尿外科，泌尿外科，生活质量和卫生服务研究，以预期评估女性骨盆地板障碍的各种手术干预措施的结果。 DCC的具体目的是：1。通过在PFDN进行的临床试验的设计，行为和分析方面提供专业知识来协助协议开发。 2.提供衡量生活质量和选择适当工具的专业知识，以评估治疗结果，并在适当的情况下进行访谈。 3.协调指导委员会批准的研究方案的实施，包括案例报告的设计和访谈协议的设计，开发手册，集中的数据库管理以及集中式数据输入或远程数据输入，必要时在必要时向FDA提交IND，并根据需要组织培训和认证会议。 4。为PFDN进行的每项研究建立一个数据库。 5。实施集中式或基于Web的数据输入和验证。 6。根据数据质量监视临床部位。 7.提供基础架构，以监视不良事件和网络监管的监管。 8。为指导委员会，顾问委员会和DSMB提供后勤支持，以面对面的会议和电视会议。 9.维护PFDN的网站，其中包含包含公众内容的网站，以及一个由密码保护的网站，其中包含所有研究文档和数据库。 10。管理和分配方案资金到临床中心。为了说明DCC的工作，提出了一项随机临床试验，以比较使用阴道方法的骨盆器官脱垂的手术程序。