报告手外科随机对照试验的临床结果：以宽醒局部麻醉无止血带研究为模型的系统性综述

Q3 Medicine

Journal of Hand Surgery Global Online Pub Date : 2024-11-01 DOI:10.1016/j.jhsg.2024.08.007

Jad Lawand MS , Ashraf Hantouly MS, MD , Fadi Bouri MD , Mohammad Muneer MD , Elisabet Hagert MD, PhD

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引用次数: 0

摘要

本研究的目的是以宽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）的临床结果报告。方法本国际前瞻性系统综述注册系统综述（CRD42023461653）遵循系统综述和荟萃分析指南的首选报告项目，重点关注手部和上肢手术中评估WALANT的RCT。该研究在五个数据库中进行了系统检索，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，排除标准为非 RCT 和非英语研究。数据提取涵盖研究特点、患者人口统计学特征、所实施的手术以及所报告的结果。结果检索发现了 304 篇文章，经过筛选，纳入了 11 篇文章进行分析，涵盖了 WALANT RCT 中的 889 名患者。技术性结果的报道最多（73%），而功能性结果的报道最少（36%）。分析涵盖了不同类型的患者群，平均随访时间为 41.3 天。研究发现了功能性结果和患者报告结果标准化方面的挑战。科克伦随机试验偏倚风险工具显示总体风险较低，这肯定了纳入研究在方法上的严谨性。虽然技术性结果很普遍，但往往缺乏患者报告的功能性结果。这项研究强调了进一步实现研究标准化的必要性，以优化患者护理和推进循证决策，因为结果报告的差异阻碍了得出一致结论和对不同研究进行比较的能力。

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Reporting Clinical Outcomes in Hand Surgery Randomized Controlled Trials: A Systematic Review Using Wide-Awake Local Anesthesia No Tourniquet Studies as a Model

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.