(151) PRO Reporting and Methodological Rigor in NSCLC RCTs, a Cause for Concern

Publication Number: 812

Background: Patient-reported outcome (PRO) endpoints are increasingly considered for inclusion in randomized controlled trials (RCTs) involving patients with NSCLC. Despite the existing guidance on PRO reporting, most of the reviews on NSCLC used incomplete/modified checklists resulting in misinterpretation and poor reporting practices.

Objectives: This systematic review aims to investigate the methodological quality and PRO reporting of the NSCLC clinical trials using the CONSORT-PRO Extension and ISOQOL checklists.

Methods: Embase, Cochrane Library, and PubMed were searched for articles published between 2018-2022. Eligible articles were RCTs of adult advanced NSCLC patients with first-line therapy with PROs in primary or subsequent publications, with a comparison of PROs among treatment groups.

Results: A total of 1248 studies were assessed, and 20 RCTs, enrolling 6358 patients, were included in the review. Most RCTs (n=15 [75%]) had PRO measures as a secondary or exploratory endpoint. A PRO hypothesis and relevant PRO domains were specified in 4 (20%) RCTs. Statistical approaches for missing data were documented in 4 (20%) RCTs. The most applied PRO tools were the EORTC-QLQ-C30 (11, 55%) and EORTC-QLQ-LC13 (8, 40%). Only 3 (15%) RCTs performed subgroup analyses on mutation type and brain metastasis. Independent Predictor factors significantly associated with higher reporting included having PROs as a primary endpoint (p=0·009) and the presence of a subsequent publication on PROs (p < 0·0001).

Conclusions: International guidelines for designing, reporting, and analyzing PRO data are available to improve overall study quality, but PRO reporting in clinical trials still needs to be more consistent. Tailored efforts to measure QoL for different subsets of the NSCLC patient are required. The findings can help investigators to focus on critical aspects most in need of attention when reporting PROs in NSCLC trials—further assisting in understanding lung cancer patients' real-life experiences in the era of personalized medicine.