Reporting quality of randomized, controlled trials evaluating immunotherapy in lung cancer

BACKGROUND With the improvement of therapeutic strategies from cytotoxic chemotherapy to immunotherapy, the possibility of achieving timely intervention for lung cancer has dramatically increased. This study aimed to systematically evaluate the reporting quality of randomized controlled trials (RCT) on immunotherapy in lung cancer. METHODS The RCTs evaluating the efficacy of immunotherapy in lung cancer published up to 2021 were searched and collected from PUBMED and EMBASE by two investigators. The 2010 Consolidated Standards for Test Reports (CONSORT) statement-based 28-point overall quality score (OQS) and the 2001 CONSORT statement-based 19-point OQS was utilized for assessing the overall quality of each report. RESULTS One hundred and fifty-two related RCTs were retrieved in this study, including 81,931 patients. The average OQS in 2010 was 17.89 (range, 7.5-24.5). Overall, studies have sufficiently reported the eligibility criteria (143/152; 94.07%), described the scientific background (150/152; 98.7%) and discussed interventions (147/152; 96.7%). However, the RCTs did not consistently report the changes to trial after commencement (48/152; 31.6%), allocation, enrollment and assignment personnel (34/152; 22.4%), blinding (48/152; 31.6%), or randomization method (58/152; 38.2%). CONCLUSIONS The overall reporting quality of RCTs on immunotherapy in lung cancer was found to be unsatisfactory despite the fact that the CONSORT statement was issued more than a decade ago. Furthermore, there was virtual selectivity and heterogeneity in reporting some key issues in these trials. This is the first study to enlighten lung cancer researchers especially focusing on immunotherapy, and also to remind editors and peer reviewers to strengthen their due diligence.