Queen's University, Kingston, ON, Canada.
Qual Life Res. 2013 Aug;22(6):1161-75. doi: 10.1007/s11136-012-0252-1. Epub 2012 Sep 18.
To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.
A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.
Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.
ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.
就 RCT 中健康相关生活质量（HRQL）结局的报告标准制定专家共识。
国际生活质量研究学会（ISOQOL）的一个工作组对文献进行了系统回顾，以确定 RCT 中 HRQL 报告的候选标准。随后，进行了一项基于网络的 ISOQOL 成员调查。调查对象根据报告将 HRQL 作为主要或次要研究结局的研究时的感知价值，对候选标准进行 4 分李克特量表评分。结果被综合成报告指南草案，进一步由成员审查，为最终指导提供信息。
综合了 46 项现有的 RCT 中报告 HRQL 结果的候选标准，产生了一个包含 40 个项目的调查，由 161 名受访者通过电子方式完成。当 HRQL 是主要 RCT 结局时，大多数受访者将所有 40 个项目的评分均评为“必要”或“理想”。当 HRQL 是次要研究结局时，评分会发生变化。对调查结果的反馈导致工作组将指导方针推广到包括患者报告结局（PRO）。最终的指导方针建议了一般报告 PRO 的标准，更具体地说，还建议了作为主要研究结局的 PRO 的标准，该指导方针得到了 ISOQOL 董事会的批准。
ISOQOL 已经制定了一套用于报告 RCT 中 PRO 结果的推荐标准。改善 PRO 的报告将使证据能够更准确地解释，以告知患者选择、帮助临床决策并为卫生政策提供信息。
