Quality of patient-reported outcomes in oncology clinical trials using immune checkpoint inhibitors: A systematic review.

ABSTRACT:

Background

There are limited data regarding the quality of patient-reported outcome (PRO) data in immune checkpoint inhibitor (ICI) clinical trial publications.

Methods

A systematic search of citations from various databases was conducted to identify prospective clinical trials involving ICI in advanced tumors from 2003 to 2020. A 30-point score was adapted from the CONSORT PRO extension statement to assess adherence to CONSORT PRO reporting. Linear regression was used to identify factors associated with quality reporting.

Results

After the review of 8058 articles, 33 trials were included with ICIs as either monotherapy (91%) or part of a combination regimen (9%). The median score was 23.5 points (range 15-29). In the majority of cases (82%), PROs were reported in a s

SUBMITTER: Malone E 

PROVIDER: S-EPMC8335827 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature