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当前临床研究理念:基于网络的、自动化的、关节镜手术前瞻性数据库注册。

Current concepts in clinical research: web-based, automated, arthroscopic surgery prospective database registry.

机构信息

Taos Orthopaedic Institute, Taos, New Mexico 87571, USA.

出版信息

Arthroscopy. 2012 Mar;28(3):425-8. doi: 10.1016/j.arthro.2011.08.297. Epub 2011 Nov 23.

Abstract

In 2011, postsurgical patient outcome data may be compiled in a research registry, allowing comparative-effectiveness research and cost-effectiveness analysis by use of Health Insurance Portability and Accountability Act-compliant, institutional review board-approved, Food and Drug Administration-approved, remote, Web-based data collection systems. Computerized automation minimizes cost and minimizes surgeon time demand. A research registry can be a powerful tool to observe and understand variations in treatment and outcomes, to examine factors that influence prognosis and quality of life, to describe care patterns, to assess effectiveness, to monitor safety, and to change provider practice through feedback of data. Registry of validated, prospective outcome data is required for arthroscopic and related researchers and the public to advocate with governments and health payers. The goal is to develop evidence-based data to determine the best methods for treating patients.

摘要

2011 年,术后患者的预后数据可在研究注册库中进行汇总,利用符合《健康保险携带和责任法案》(Health Insurance Portability and Accountability Act,HIPAA)规定、经机构审查委员会批准、获得美国食品药品监督管理局(Food and Drug Administration,FDA)批准、远程、基于网络的数据收集系统,进行比较疗效研究和成本效益分析。计算机自动化可最大程度地降低成本和减少外科医生的时间需求。研究注册库是一种强大的工具,可以观察和了解治疗方法和结果的差异,研究影响预后和生活质量的因素,描述护理模式,评估疗效,监测安全性,并通过数据反馈来改变医疗服务提供者的实践。关节镜和相关研究人员以及公众需要为政府和医疗付费方提供经过验证的前瞻性结局数据注册库,以进行倡导。目标是制定基于证据的数据,以确定治疗患者的最佳方法。

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