OBJECTIVES: To evaluate the adherence of reporting Patient Reported Outcomes (PROs) to the 2013 CONSORT PRO extension, CONSORT-Outcomes 2022 extension and ISOQOL standards in Randomized Control Trials (RCTs) among Aggressive Large B Cell Lymphoma (LBCL) patients.

METHODS: Literature search was performed on PubMed, Embase, Cochrane library between 2013 and 2022 to identify RCTs in Aggressive LBCL patients with a PRO endpoint for assessing the adherence to the CONSORT PRO extension, CONSORT-2022 Outcomes extension and ISOQOL standards. Trial frequencies and percentage were reported for data items. According to Mercieca-Bebber et al, individual item compliance was rated "good", "moderate", "poor" when ≥80%, 50–79% and ≤49% of RCTs respectively addressed the CONSORT 2013 and 2022 items checklist.

RESULTS: In all the ten included studies, PROs were secondary endpoints. Five studies pertained to single-arm trials in patients experiencing relapse/refractory to two or more systemic treatment regimens and seven studies reported PROs in secondary publications. Across all RCTs, the most consistently reported items with good overall compliance to CONSORT-PRO and CONSORT-outcomes extension were P6ai-evidence of PRO instrument (10/10), 13ai-participants reporting PRO data at baseline (9/10; 90%) and at subsequent time-points (13aii; 10/10), P20-PRO-specific limitations (8/10; 80%) and 6a.5-state the time-points used for analysis (10/10). Items P2bi-PRO hypothesis present (1/10; 10%), P2bii-PRO domains specified in the hypothesis (1/10; 10%) and P6aiii-mode of administration specified (3/10; 30%) were least often reported with poor compliance to CONSORT-PRO extension. Items specific to missing data such as P12a-statistical approach for dealing with missing data specified (3/10; 30%) in CONSORT-PRO, 12a.3-describe the methods used to handle missing outcome items or entire assessments (2/10; 20%) in CONSORT- 2022 Outcomes extension and statistical approaches for dealing with missing data (3/10; 30%) in ISOQOL, were poorly reported across all RCTs.

CONCLUSIONS: Our research indicated incomplete adherence to the established standards of reporting PROs among RCTs in aggressive LBCL.