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

Abstract

METHODS

We conducted a systematic literature search to identify all RCTs conducted in breast, colorectal, lung and prostate cancer, published between 2004 and 2017.

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).

CONCLUSION

Frequently, information obtained via PRO measures and clinician-reported AEs do not favor the same treatment arm in RCT settings.

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%).