International Multicenter Registry for Hyperbaric Oxygen Therapy: Results through June 2021.

IF 0.7
Nicole P Harlan, Judy A Ptak, Judy R Rees, Devin R Cowan, Abigail M Fellows, Rachel A Moses, Judith A Kertis, Pamela M Hannigan, Saeed A Juggan, Janet Peacock, Michael Bennett, Jay C Buckey
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Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Discussion: 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.

高压氧治疗国际多中心注册:截至2021年6月的结果。
国际多中心高压氧治疗注册(国际报告注册标识符DERR1-10.2196/18857)成立于2011年,旨在获取海底和高压氧医学学会(UHMS)批准和选择未批准的高压氧(HBO2)治疗适应症的结果和并发症数据。方法:设计研究电子数据采集(REDCap)模板并分发到各参与中心进行前瞻性数据收集。各中心提供了去识别的人口统计、治疗、并发症和结果数据。该报告提供了地点和入组的汇总数据,以及治疗前后的生活质量数据(EQ-5D-5L问卷)、头颈部辐射结果、未愈合伤口(Strauss评分)和特发性突发性感音神经性听力损失。数据分析主要采用Wilcoxon符号秩检验。结果:22个中心提供了2880例患者的数据。ums批准的最常见适应症是延迟辐射损伤,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术后患者的生活质量、头颈部放射症状、Strauss伤口评分及听力均有显著改善。并发症发生率低,与以前的报道相当。该登记处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。讨论:该注册表收集了来自多个中心的已定义结果的前瞻性数据,并允许分析影响结果的因素。这个注册中心没有控制组,这是一个限制。尽管如此,该注册表提供了来自国际多个中心的HBO2结果的独特、全面的数据集。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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