Siegel Niels, Rotärmel André, Polychronidis Georgios, Salg Gabriel, Klotz Rosa, Probst Pascal, Pausch Thomas
Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, Heidelberg, 69120, Germany, 49 6221-56-6110.
University Center for Orthopedics, Trauma and Plastic Surgery, Carl Gustav Carus Hospital, Dresden, Germany.
J Med Internet Res. 2025 Jul 28;27:e72703. doi: 10.2196/72703.
Recently, surgical data recorders that are comparable to flight data recorders, also known as black boxes in the aviation industry, have been developed to improve patient safety and performance in surgery. These devices allow for unique insights in the operating room by providing new data capture capabilities. No systematic review has been carried out to evaluate the areas of application of surgical data recorders to date.
This systematic review and single-arm meta-analysis aims to assess the aspects of the operating theater environment for which surgical data recorders are used and to make a preliminary assessment of the quantifiable data that can be collected, compared to traditional collection methods.
This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Medline, Embase, and Web of Science databases were lastly systematically searched for papers that focused on a clinical use case for surgical data recorders on February 10, 2025. In particular, not relevant papers focusing on implementation of surgical data recorders were excluded. Title, abstract, and full-text screening were completed to identify relevant articles. The included studies were analyzed descriptively using data extraction forms. Where possible, quantifiable data was also analyzed. Risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies of Exposure (ROBINS-E) tool.
In total, 70 studies were screened, and a total of 17 studies were included. A total of 10 of the 17 studies had a low overall risk of bias; however, confounding, selection bias, small sample sizes, short study periods, and potential Hawthorne effects were the notable limitations. Only 2 studies were assessed to have publication bias. Use cases could be grouped into 4 categories: economic, safety, behavior in the operating room, and technical skill assessment. A single-arm meta-analysis focusing on adverse events and distractions in the operating theater could be conducted, demonstrating accurate reporting of distractions in line with the existing literature.
Surgical data recorders provide an unobstructed view of various aspects of the operating theatre. Most published papers present preliminary studies on surgical data recorders, indicating the potential for further, larger-scale studies with enhanced methodological quality.
最近，已开发出与飞行数据记录器类似的手术数据记录器（在航空业中也称为黑匣子），以提高手术中的患者安全性和手术表现。这些设备通过提供新的数据捕获功能，使人们能够对手术室有独特的见解。迄今为止，尚未进行系统评价来评估手术数据记录器的应用领域。
本系统评价和单臂荟萃分析旨在评估使用手术数据记录器的手术室环境方面，并与传统收集方法相比，对可收集的可量化数据进行初步评估。
本系统评价遵循PRISMA（系统评价和荟萃分析的首选报告项目）指南。2025年2月10日，最后系统检索了Medline、Embase和Web of Science数据库，以查找关注手术数据记录器临床用例的论文。特别排除了关注手术数据记录器实施情况的无关论文。完成标题、摘要和全文筛选以识别相关文章。使用数据提取表对纳入的研究进行描述性分析。在可能的情况下，还对可量化数据进行了分析。使用非随机暴露研究中的偏倚风险（ROBINS-E）工具评估偏倚风险。
共筛选了70项研究，共纳入17项研究。17项研究中有10项总体偏倚风险较低；然而，混杂、选择偏倚、样本量小、研究周期短和潜在的霍桑效应是显著的局限性。只有2项研究被评估存在发表偏倚。用例可分为4类：经济、安全、手术室行为和技术技能评估。可以进行一项关注手术室不良事件和干扰因素的单臂荟萃分析，结果表明干扰因素的报告与现有文献一致。
手术数据记录器提供了对手术室各个方面的清晰视角。大多数已发表的论文展示了关于手术数据记录器的初步研究，表明有潜力开展方法学质量更高的进一步大规模研究。
