Abstract
PURPOSE: The purpose of this study was to comprehensively evaluate clinical outcome reporting in hand surgery randomized controlled trials (RCTs), using wide-awake local anesthesia no tourniquet (WALANT) studies as a model. METHODS: This International Prospective Register of Systematic Reviews-registered systematic review (CRD42023461653) adheres to preferred reporting items for systematic reviews and meta-analysis guidelines, focusing on RCTs evaluating WALANT in hand and upper limb surgery. A systematic search across five databases was conducted to include all eligible articles from inception until search date (April 1, 2023). Inclusion criteria encompassed WALANT RCTs in upper limb surgery, with exclusion criteria addressing non-RCTs and non-English studies. Data extraction covered study characteristics, patient demographics, procedures performed, and outcomes reported. The revised Cochrane risk-of-bias tool for randomized trials was employed for quality assessment. RESULTS: The search identified 304 articles-after screening, 11 were included for analysis, encompassing 889 patients in WALANT RCTs. Technical outcomes were most reported (73%), whereas functional was least commonly reported (36%). The analysis encompassed a heterogeneous patient cohort, with an average follow-up period of 41.3 days. Challenges in standardizing functional outcomes and patient-reported outcomes were identified. The Cochrane risk-of-bias tool for randomized trials indicated an overall low risk, affirming the methodological rigor of the included studies. CONCLUSIONS: A significant diversity in outcome reporting and assessment tools was identified, emphasizing the challenges in standardization and outcome reporting across RCTs. Although technical outcomes were prevalent, patient-reported and functional outcomes were often lacking. The study underscores the need for further research standardization to optimize patient care and advance evidence-based decision making, as variability in outcomes reporting hinders the ability to draw consistent conclusions and comparisons across studies. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapy/Prevention, Etiology/Harm IA.