Title : CONSORT compliance of randomised controlled trials in elective hand surgery: A systematic review
Abstract:
Purpose: The Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) guidelines were developed to improve the reporting quality of Randomised Controlled Trials (RCTs). Compliance of RCTs with these checklist criteria ensures transparency, reproducibility, bias minimisation and better application of results into clinical practice. Poor reporting of methodological details in RCTs hinders the reproducibility of study results and compromises the reliability of clinical recommendations. This systematic review evaluates the adherence of RCTs in the field of Elective Hand Surgery (EHS) to the latest updated CONSORT-NPT guidelines.
Methods: Following registration of this systematic review with PROSPERO (CRD42025630289), in January 2025, Cochrane, EMBASE, PubMed and WebOfScience were searched by two independent authors for RCTs in EHS, published since 2017. Relevant studies were identified and scored against each of the 42 CONSORT-NPT sub-criteria. Overall compliance to each sub-criterion and overall compliance of each RCT were calculated.
Results: A total of 58 RCTs met the inclusion criteria, with an overall mean CONSORT-NPT compliance of 66.1%. The highest-reported sub-criteria were “scientific background and rationale” and “participant allocation details” (100% each), whereas the lowest were “attempts to limit bias without blinding” (13.2%) and “modifications to trial outcomes post-commencement” (17.2%). The "Methods" section had the lowest compliance (55.7%). A weak but statistically significant correlation was found between the number of authors and reporting compliance (p = 0.0123, R² = 0.103), while no significant relationship was observed between compliance and journal impact factor (p = 0.26, R² = 0.01) or between compliance and number of citations per year (p = 0.1105, r = 0.2112).
Conclusions: Reporting quality of RCTs in elective hand surgery remains moderate, with critical gaps in methodological transparency. Stronger collaboration among researchers, journals, funding agencies, and guideline developers is necessary to enhance adherence and ensure high-quality evidence in clinical practice.
