Reporting of patient-reported outcomes amongst randomized clinical trials in plastic surgery: a systematic review using CONSORT-PRO

Background

Patient-reported outcomes (PROs) are key to investigating patient perspectives in randomized controlled trials (RCTs). Standardization of PRO reporting is critical for trial generalizability and the application of findings to clinical practice. This systematic review aimed to evaluate the reporting quality of RCTs published in the top plastic surgery journals according to the consolidated standards of reporting trials (CONSORT)-PRO extension.

Methods

We completed a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. All RCTs with a validated PRO endpoint published in the top 10 plastic surgery journals (based on the 2021 Web of Science Impact Factor) from 2014 to 2023 were included. Two reviewers independently extracted data and scored the included studies using the CONSORT-PRO checklist. Univariate regression was applied to assess factors associated with reporting adherence. Studies were assessed for their risk of bias using the Cochrane Risk of Bias 2.0 tool.

Results

A total of 88 RCTs were included. PROs were the primary endpoint in 50 (57%) and the secondary endpoint of 38 (43%) studies. Mean overall reporting adherence was poor (39% (±12) and 36% (±13) in studies with PRO as primary and secondary endpoints, respectively). The presence of industry support was significantly associated with greater adherence.

Conclusions

There is low adherence to the CONSORT-PRO extension among plastic surgery RCTs published in the top 10 plastic surgery journals. We encourage journals and authors to endorse and apply the CONSORT-PRO extension. This may optimize the dissemination of clinical findings from RCTs and assist patient-centered care.