Lawand Jad, Hantouly Ashraf, Bouri Fadi, Muneer Mohammad, Hagert Elisabet
University of Texas Medical Branch, Galveston, TX.
Department of Orthopedic Surgery, Hamad Medical Cooperation, Doha, Qatar.
J Hand Surg Glob Online. 2024 Sep 19;6(6):875-881. doi: 10.1016/j.jhsg.2024.08.007. eCollection 2024 Nov.
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.
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.
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.
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.
本研究旨在以清醒局部麻醉无止血带（WALANT）研究为模型，全面评估手外科随机对照试验（RCT）中的临床结果报告情况。
这项在国际系统评价前瞻性注册库注册的系统评价（CRD42023461653）遵循系统评价和Meta分析的首选报告项目指南，重点关注评估WALANT在手和上肢手术中的RCT。对五个数据库进行了系统检索，以纳入从开始到检索日期（2023年4月1日）的所有符合条件的文章。纳入标准包括上肢手术中的WALANT RCT，排除标准涉及非RCT和非英文研究。数据提取涵盖研究特征、患者人口统计学、所进行的手术以及报告的结果。采用修订后的Cochrane随机试验偏倚风险工具进行质量评估。
检索到304篇文章，筛选后纳入11篇进行分析，涵盖WALANT RCT中的889例患者。技术结果报告最多（73%），而功能结果报告最少（36%）。分析涵盖了异质性患者队列，平均随访期为41.3天。确定了标准化功能结果和患者报告结果方面的挑战。Cochrane随机试验偏倚风险工具表明总体风险较低，证实了纳入研究的方法学严谨性。
结果报告和评估工具存在显著差异，强调了RCT标准化和结果报告方面的挑战。尽管技术结果普遍存在，但患者报告和功能结果往往缺失。该研究强调需要进一步进行研究标准化，以优化患者护理并推进基于证据的决策，因为结果报告的变异性阻碍了在不同研究中得出一致结论和进行比较的能力。
研究类型/证据水平：治疗/预防、病因学/危害IA。
