Research Innovation Office, University of York, York, UK,
Qual Life Res. 2014 Apr;23(3):971-6. doi: 10.1007/s11136-013-0534-2. Epub 2013 Oct 5.
The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs.
A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist.
Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust.
The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.
在肿瘤学随机对照试验（RCT）中，纳入患者报告的结局（PRO）工具来记录患者健康相关生活质量（HRQOL）数据已几乎成为常规。尽管如此，最近人们关注的焦点集中在 HRQOL 的报告质量上。本研究的主要目的是评估两种常见肿瘤学 RCT 中 PRO 工具所报告的 HRQOL 数据的报告质量。
对报告使用 PRO 工具收集的 HRQOL 数据的肿瘤学 RCT 的系统评价进行了荟萃回顾。纳入了发表于 2000 年至 2012 年间的英语文章，并根据方法检查表进行了评估。
共确定了 435 篇潜在文章。纳入了 6 项系统评价进行分析。共有 70403 名患者完成了 PRO。欧洲癌症研究与治疗组织 EORTC QLQ-C30 和癌症治疗功能评估-一般问卷（FACT-G）占 RCT 的 55%。80%的 RCT 使用了心理测量学上有效的工具；70%报告了文化上有效的工具，几乎所有工具都报告了评估时间（96%）。30%的 RCT 报告了临床意义和缺失数据。在方法设计方面，只有 25%的 RCT 可以归类为可能是稳健的。
根据监管和方法指南评估，大多数肿瘤学 RCT 在报告 HRQOL 数据方面存在缺陷。如果要成功地将 HRQOL 数据用于支持肿瘤学中的临床决策、治疗选择和标签主张，这些局限性需要得到解决。
