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实施患者报告的结果措施:对临床试验,实践和注册表中现有的指南进行范围审查

Randi Thisakya Jayasinghe¹, Susannah Ahern¹, Ashika D Maharaj¹

¹School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

|January 16, 2026

目的:

确定有关在临床试验、临床实践和临床登记系统中实施患者报告结局测量（PROMs）的现有指导文件，如指南、框架、清单和建议。

Study Design:

范围综述

方法:

对五个科学数据库从建库至2024年6月的文献进行了系统检索。同时检索了Google Scholar和灰色文献网站，以识别相关指导性文件。纳入了现有文档，包括在临床试验、临床实践和临床注册研究中实施患者报告结局（PROMs）的指南、框架、清单和建议。对所选出版物进行了叙述性综合分析。

结果:

共识别并评估了4905条记录，其中177篇文献进行了全文筛选，最终纳入本综述的指导文件共38份。在这38份文件中，18份（47%）为临床试验中使用患者报告结局（PROMs）的指导文件，12份（32%）为临床实践中的指导文件，8份（21%）为临床注册登记研究中的指导文件。大多数指南和建议集中于患者报告结局在临床试验和临床实践中的实施，而针对临床注册登记研究发布的建议较少。

结论:

本文综述主要识别了在临床试验和临床实践中实施患者报告结局（PROMs）的指导文件。关于在临床注册研究中实施PROMs的指南，现有文献尚存空白。鉴于临床注册研究与PROMs数据在医疗质量改进和以患者为中心的照护中日益受到重视，制定一项基于证据的标准化指南，以高效实施临床注册研究中的PROMs，将具有重要意义。

关键词:

临床注册表临床注册表临床注册表准则和建议准则和建议与健康相关的生活质量.患者报告的结果衡量结果.患者报告的结果

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