Patient-reported outcomes in randomized clinical trials of bladder cancer: An updated systematic review
BMC Urology Sep 22, 2019
Van Hemelrijck M, et al. - Via conducting a systematic literature search, researchers sought to update the 2014 review in order to integrate current evidence-based knowledge of patient-reported outcomes (PROs) from randomized clinical trials (RCTs) in bladder cancer (BC). In addition, they investigated whether improvement in the quality of PRO reporting has occurred over time and provided evidence-based recommendations for future studies in this area. They identified undertaking of only eight new RCTs for bladder cancer that also included a PRO component since April 2014; in all these studies PROs were considered as secondary outcomes. Also, the quality of PRO reporting improved a little during this time period. Indeed, when comparing the new studies identified in this update with previously published RCTs between January 2004 and March 2014, the mean standardized International Society of Quality of Life Research (ISOQOL) checklist scores did not indicate significant improvement, possibly due to the small number of studies considered. When comparing each individual item of the ISOQOL checklist over time, only two statistically significant improvements were observed that were related to the reporting of missing data and the identification of PROs in trial protocols. Poor documentation of some of the key recommended issues (eg reporting of statistical approaches for dealing with missing data, PRO hypothesis statement and generalizability issues regarding the PRO results) remained.
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