Patient-Reported Outcomes in Randomized Clinical Trials Including Bladder Cancer Patients - Expert Commentary

Several randomized clinical trials (RCTs) have incorporated patient-reported outcomes (PRO) to evaluate the effectiveness of new treatment modalities. Adhering to systematic and consistent reporting methods is critical for defining the impact of cancer treatments on clinical trial participants.

A recent study published by Van Hemelrijck et al. in BMC Urology examined PRO reporting in bladder cancer to assess reporting quality. Using PubMed/Medline, the investigators searched for bladder cancer RCTs evaluating PRO as a primary or secondary outcome. They collected the demographics of trial subjects, clinical and PRO characteristics, and elements of PRO reporting based on the recommendations of the International Society of Quality of Life Research.

The investigators found that between April 2014 and June 2018, only eight bladder cancer RCTs included PROs. The quality of PRO reporting among all of the studies published between 2004 and 2018 was found to be inadequate. The investigators found the quality of PRO reporting improved between 2014-2018 compared to 2004-2014 in two areas. Two statistically significant improvements in the reporting of missing data and the identification of PROs in trial protocols were observed. However, the study also noted consistently poor documentation of several key data points, including the reporting of statistical approaches for dealing with missing data, stating a clear PRO hypothesis statement and the generalizability of the PRO results. The authors recommend adopting the available recommendations and standards for PRO use in bladder cancer RCTs to assess the impact of novel treatments on patients fully.

Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

Reference:

1. Van Hemelrijck, Mieke, Francesco Sparano, Debra Josephs, Mirjam Sprangers, Francesco Cottone, and Fabio Efficace. "Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review." BMC urology 19, no. 1 (2019): 86.

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