Investigating Trends in the Quality of Reporting of Patient-Reported Outcomes in Oncology Over Time: Analysis of 631 Randomized Controlled Trials Published Between 2004 and 2019
Investigating Trends in the Quality of Reporting of Patient-Reported Outcomes in Oncology Over Time: Analysis of 631 Randomized Controlled Trials Published Between 2004 and 2019
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DOI：
10.1016/j.jval.2021.06.003
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发表时间：
2021-11-24
期刊：
影响因子：
4.5
通讯作者：
Aaronson, Neil K.
中科院分区：
文献类型：
--
作者：
Efficace, Fabio;Giesinger, Johannes M.;Aaronson, Neil K.
目的：肿瘤学随机对照试验（RCT）中患者报告结局（PRO）关键信息的不完整报告已被反复强调为临床实践中使用研究结果的主要障碍。我们调查了癌症RCT中PRO数据的报告质量在过去15年中是否有所改善。研究方法：我们确定了2004年至2019年期间在全球最常见的实体瘤类型中进行的所有癌症RCT（PRO终点）。使用国际生活质量研究学会推荐的标准评估PRO报告的质量，其中包括与评估方法、统计分析和数据解释相关的重要方面。结果如下：我们共评估了631项癌症RCT，包括乳腺癌（n =187）、肺癌（n =131）、前列腺癌（n = 120）、结直肠癌（n = 107）和妇科癌（n = 86）。我们观察到，在最近发表的研究中，对国际生活质量研究学会报告标准的依从性更高。在多变量线性回归分析中，我们观察到PRO报告质量随时间推移有统计学显著性改善（P <0.001），并且这种关系与其他测量的混杂因素无关，例如样本量和研究赞助商。总体而言，在试验报告统一标准-PRO扩展版发表后发表的研究的PRO报告质量更高。结论：过去15年发表的癌症RCT中PRO报告的质量显著提高。我们的发现是令人鼓舞的，因为更好地报告PRO结果可能会转化为研究结果对真实的世界实践的更大影响。
Objectives: Incomplete reporting of key information on patient-reported outcomes (PROs) in randomized controlled trials (RCTs) in oncology has been highlighted repeatedly as a major barrier to the use of study findings in clinical practice. We investigated whether the quality of reporting of PRO data in cancer RCTs has improved over the last 15 years. Methods: We identified all cancer RCTs with PRO endpoints conducted across the most prevalent solid tumor types worldwide published between 2004 and 2019. The quality of PRO reporting was assessed using the International Society for Quality of Life Research recommended standards, which include important aspects related to assessment methodology, statistical analyses, and interpretation of data. Results: We assessed a total of 631 cancer RCTs in breast (n =187), lung (n =131), prostate (n = 120), colorectal (n = 107), and gynecological (n = 86) cancer. We observed a higher adherence to the International Society for Quality of Life Research reporting criteria in the more recently published studies. In a multivariable linear regression analysis, we observed a statistically significant improvement in the quality of PRO reporting over time (P,.001), and this relationship was independent of other measured confounding factors, such as sample size and study sponsorship. Overall, the quality of PRO reporting was higher for studies published after the publication of the Consolidated Standards of Reporting Trials-PRO Extension. Conclusions: The quality of PRO reporting in cancer RCTs published in the last 15 years has improved significantly. Our findings are encouraging because better reporting of PRO results may translate into a greater impact of study findings on real world practice.