Devaney Bridget, Wackett Jonathan Pc, Ma Nicola, Nguyen Amanda, Yogaraj Vikash, Hedetoft Morten, Hyldegaard Ole, Burrell Aidan, Mitra Biswadev
Department of Intensive Care and Hyperbaric Medicine, Alfred Health, Melbourne, Australia.
Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.
Diving Hyperb Med. 2025 Jun 30;55(2):91-103. doi: 10.28920/dhm55.2.91-103.
Necrotising soft tissue infections (NSTI) are serious infections associated with considerable morbidity and mortality. Heterogeneity of outcome reporting in the NSTI literature precludes the synthesis of high-quality evidence. There is substantial interest in studying the efficacy of hyperbaric oxygen treatment as an adjunctive treatment in NSTI. The aim of this study was to develop a set of core outcome measures for future trials evaluating interventions for NSTI.
A modified Delphi consensus method was used to conduct a three-round survey of a diverse panel of clinicians and researchers with expertise in NSTI, and patients with lived experience of NSTI. Participants rated the preliminary list of outcomes using a 9-point scale from 1 (least important) to 9 (most critical). The a priori definition of consensus required outcomes to be rated critical (score ≥ 7) by ≥ 70% of participants, and not important (score ≤ 3) by ≤ 15% of participants. After meeting consensus, outcomes were removed from subsequent rounds. Outcomes that did not meet consensus were included in subsequent rounds.
Ninety-eight participants from 14 countries registered and 86%, 69% and 57% responded for each round, respectively. Outcome measures quantifying five core areas achieved consensus: Death, surgical procedures of debridements and amputations, functional outcome among survivors, measures of sepsis, including septic shock and organ dysfunction and resource use measured through length of hospital and intensive care unit stay.
This initial core set of outcome measures will be evaluated and optimised and can harmonise outcome measurements for investigations among patients with NSTI.
坏死性软组织感染（NSTI）是严重感染，与相当高的发病率和死亡率相关。NSTI文献中结局报告的异质性妨碍了高质量证据的综合。研究高压氧治疗作为NSTI辅助治疗的疗效具有很大的兴趣。本研究的目的是为未来评估NSTI干预措施的试验制定一套核心结局指标。
采用改良的德尔菲共识方法，对一组由具有NSTI专业知识的临床医生、研究人员以及有NSTI实际经历的患者组成的多元化小组进行三轮调查。参与者使用从1（最不重要）到9（最关键）的9分制对初步结局列表进行评分。共识的先验定义要求≥70%的参与者将结局评为关键（评分≥7），且≤15%的参与者将结局评为不重要（评分≤3）。达成共识后，结局将从后续轮次中删除。未达成共识 的结局将纳入后续轮次。
来自14个国家的98名参与者注册，三轮的回复率分别为86%、69%和57%。量化五个核心领域的结局指标达成了共识：死亡、清创和截肢的外科手术、幸存者的功能结局、脓毒症指标（包括感染性休克和器官功能障碍）以及通过住院时间和重症监护病房住院时间衡量的资源使用情况。
这组初步的核心结局指标将得到评估和优化，并可统一NSTI患者调查的结局测量。
