Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?

被引：6
|
作者：
Sparano, Francesco [1 ,2 ]
Aaronson, Neil K. [3 ]
Cottone, Francesco [1 ,2 ]
Piciocchi, Alfonso [1 ,2 ]
La Sala, Edoardo [1 ,2 ]
Anota, Amelie [4 ]
Deliu, Nina [1 ,2 ]
Kieffer, Jacobien M. [3 ]
Efficace, Fabio [1 ,2 ]
机构：
[1] Italian Grp Adult Hematol Dis GIMEMA, Ctr Data, Rome, Italy
[2] Hlth Outcomes Res Unit, Rome, Italy
[3] Netherlands Canc Inst, Dept Psychosocial Res, Div Psychosocial Res & Epidemiol, Amsterdam, Netherlands
[4] Univ Hosp Besancon, Qual Life Oncol French Natl Platform, Methodol & Qual Life Oncol Unit, INSERM,UMR 1098, Besancon, France
来源：
JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH | 2019年 / 8卷 / 05期
关键词：
adverse events; cancer; patient-reported outcomes; randomized controlled trials; symptoms; RANDOMIZED CONTROLLED-TRIALS; COMMON TERMINOLOGY CRITERIA; QUALITY; AGREEMENT;
D O I：
10.2217/cer-2018-0092
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
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.
引用
收藏
页码：279 / 288
页数：10
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