Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?-Reference-Cited by-同舟云学术

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

Published:2019-04 Issue:5 Volume:8 Page:279-288
ISSN:2042-6305
Container-title:Journal of Comparative Effectiveness Research
language:en
Short-container-title:Journal of Comparative Effectiveness Research

Author:

Sparano Francesco¹,Aaronson Neil K²,Cottone Francesco¹,Piciocchi Alfonso¹,La Sala Edoardo¹,Anota Amelie³,Deliu Nina¹,Kieffer Jacobien M²,Efficace Fabio¹

Affiliation:

1. Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health Outcomes Research Unit, Rome, Italy

2. Department of Psychosocial Research, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, The Netherlands

3. Quality of Life in Oncology French National Platform, Methodological & Quality of Life in Oncology Unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France

Abstract

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.

Publisher

Future Medicine Ltd

Subject

Health Policy

Link

https://www.futuremedicine.com/doi/pdf/10.2217/cer-2018-0092

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