PRO reporting and methodological rigor in NSCLC RCTs, a cause for concern

Patient-reported outcome (PRO) endpoints have been used for at least the last two decades in randomized controlled trials (RCTs) involving patients with NSCLC. Despite the existing guidance on PRO reporting, which the FDA issued in 2009, most PRO studies on NSCLC used incomplete/modified checklists resulting in misinterpretation and poor reporting practices. 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.