Quality of Patient-Reported Outcomes in Oncology Trials Improves

Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.

The quality of patient-reported outcomes in oncology clinical trials have improved over the last 15 years, according to a recent analysis published by Value in Health, a publication of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Investigators indicated that incomplete reporting of key information on patient-reported outcomes (PROs) in randomized controlled trials in oncology has been seen as a major barrier to the use of study findings in clinical practice.

Investigators in this analysis aimed to study cancer trials conducted across the five most prevalent cancer types worldwide — breast, colorectal, gynecological, non–small cell lung, and prostate cancer — that included a patient reported outcome end point between January 2004 and February 2019. They used the PROMOTION (Patient-Reported Outcome Measurements Over Time In ONcology) registry.

The quality of PRO reporting was assessed using the International Society for Quality of Life (ISQOL) standards. Investigators assessed a total of 631 cancer randomized clinical trials: 187 in breast cancer, 131 in lung cancer, 120 in prostate cancer, 107 in colorectal cancer, and 86 in gynecological cancer. They observed a statistically significant improvement in the quality of PRO reporting over time, and this relationship was independent of other measured factors, such as sample size and study sponsorship.

“A higher quality of PRO reporting was found in RCTs with PROs as a primary endpoint and with larger sample sizes. At the same time, date of publication (more recent vs older) remained an independent predictor of the quality of reporting of PRO information,” investigators wrote.

They suggest this is the result of the publication of clear standards for the reporting of PRO results, including the 2013 publication of both the Task Force of The International Society of Quality of Life Research (ISOQOL) standard and the CONSORT-PRO Extension.

The investigators said, however, that one limitation of their analysis was focused on PRO reporting quality and not on the quality of the PRO elements of trial protocols themselves. “It is challenging to obtain study protocols of older RCTs because it is only in recent years that it has become common practice to publish protocols in conjunction with reports of RCT study results,” they said.