癌症试验中临床医生报告的有症状不良事件：它们与患者报告的结果一致吗？
Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?
作者信息
Sparano Francesco, Aaronson Neil K, Cottone Francesco, Piciocchi Alfonso, La Sala Edoardo, Anota Amelie, Deliu Nina, Kieffer Jacobien M, Efficace Fabio
机构信息
Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health Outcomes Research Unit, Rome, Italy.
Department of Psychosocial Research, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, The Netherlands.
出版信息
J Comp Eff Res. 2019 Apr;8(5):279-288. doi: 10.2217/cer-2018-0092. Epub 2019 Mar 6.
AIM
We investigate the concordance, in terms of favoring the same treatment arm, between clinician-reported symptomatic adverse events (AEs) and information obtained via patient-reported outcomes (PRO) measures in cancer randomized controlled trials (RCTs).
METHODS
We conducted a systematic literature search to identify all RCTs conducted in breast, colorectal, lung and prostate cancer, published between 2004 and 2017.
RESULTS
We identified 207 RCTs. In the majority of RCTs (n=133, 64.2%) a discordance between PROs and AEs was found. In 104 studies (50.2%), PRO data favored the experimental arm when AEs did not, while the opposite situation was found in 29 trials (14.0%).
CONCLUSION
Frequently, information obtained via PRO measures and clinician-reported AEs do not favor the same treatment arm in RCT settings.
目的
我们研究在癌症随机对照试验（RCT）中，临床医生报告的症状性不良事件（AE）与通过患者报告结局（PRO）测量获得的信息在支持同一治疗组方面的一致性。
方法
我们进行了系统的文献检索，以识别2004年至2017年间发表的所有关于乳腺癌、结直肠癌、肺癌和前列腺癌的RCT。
结果
我们识别出207项RCT。在大多数RCT中（n = 133，64.2%），发现PRO与AE之间存在不一致。在104项研究（50.2%）中，当AE不支持试验组时，PRO数据支持试验组，而在29项试验（14.0%）中发现了相反的情况。
结论
在RCT环境中，通过PRO测量获得的信息和临床医生报告的AE通常不支持同一治疗组。
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