Evaluation of the completeness of interventions reported in published randomized controlled trials in plastic surgery: A cross-sectional review protocol

Highlights • Randomized Controlled Trials in plastic surgery are uncommon and complicated. • Plastic surgery articles have been shown to have poor compliance to CONSORT, with intervention reporting being the poorest. • The TIDieR checklist, when applied, improves intervention reporting and reproducibility.
Background Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist. Methods A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication. Dissemination We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.