Dartmouth-Hitchcock Medical Center, Lebanon, NH, US.
Independent Consultant, Plainfield, NH, US.
Undersea Hyperb Med. 2022 Third Quarter;49(3):275-287.
The International Multicenter Registry for Hyperbaric Oxygen Therapy (International Report Registered Identifier DERR1-10.2196/18857) was established in 2011 to capture outcomes and complications data for both Undersea and Hyperbaric Medical Society (UHMS) approved and selected unapproved hyperbaric oxygen (HBO2) therapy indications.
A Research Electronic Data Capture (REDCap) template was designed and distributed to all participating centers for prospective data collection. Centers contributed de-identified demographic, treatment, complications, and outcome data. This report provides summary data on sites and enrollment, as well as pre- and post-treatment data on quality of life (EQ-5D-5L questionnaire), head and neck radiationoutcomes, non-healing wounds (Strauss score), and idiopathic sudden sensorineural hearing loss. Data were analyzed mainly using the Wilcoxon signed-rank test.
Twenty-two centers contributed data for 2,880 patients. The most common UHMS-approved indication was delayed radiation injury, followed by enhancement of wound healing, and carbon monoxide poisoning. One hundred and twenty-five patients were treated for non-UHMS approved indications. Quality of life, head and neck radiation symptoms, Strauss wound scores, and hearing were significantly improved after HBO2. Complication rates were low and comparable to previous reports. The registry also offered the ability to analyze factors that affect outcomes, such as smoking and severity of hearing loss.
The registry accrues prospective data on defined outcomes from multiple centers and allows for analysis of factors affecting outcomes. This registry does not have a control group, which is a limitation. Nevertheless, the registry provides a unique, comprehensive dataset on HBO2 outcomes from multiple centers internationally.
国际高压氧治疗多中心注册研究(国际报告注册标识符 DERR1-10.2196/18857)成立于 2011 年,旨在收集深海和高压医学协会(UHMS)批准和选定未经批准的高压氧(HBO2)治疗适应症的结果和并发症数据。
设计并向所有参与中心分发了研究电子数据捕获(REDCap)模板,用于前瞻性数据收集。中心提供了匿名的人口统计学、治疗、并发症和结果数据。本报告提供了关于站点和入组的汇总数据,以及生活质量(EQ-5D-5L 问卷)、头颈部放疗结果、未愈合伤口(Strauss 评分)和特发性突发性感觉神经性听力损失的治疗前后数据。数据主要使用 Wilcoxon 符号秩检验进行分析。
22 个中心为 2880 名患者提供了数据。最常见的 UHMS 批准适应症是延迟性放射性损伤,其次是促进伤口愈合和一氧化碳中毒。125 名患者接受了非 UHMS 批准的适应症治疗。HBO2 治疗后,生活质量、头颈部放疗症状、Strauss 伤口评分和听力显著改善。并发症发生率低且与既往报告相当。该注册还提供了分析影响结果的因素的能力,例如吸烟和听力损失的严重程度。
该注册从多个中心前瞻性地收集了关于特定结果的定义数据,并允许分析影响结果的因素。该注册没有对照组,这是一个限制。尽管如此,该注册提供了一个独特的、全面的来自多个国际中心的 HBO2 结果数据集。