Wackett Jonathan, Devaney Bridget, Chau Raymond, Ho Joshua, King Nicholas, Grewal Jasleen, Armstrong Joshua, Mitra Biswadev
Department of Medicine, Alfred Health, Melbourne, Australia.
Emergency and Trauma Centre, Alfred Health, Melbourne, Australia.
Diving Hyperb Med. 2024 Mar 31;54(1):47-56. doi: 10.28920/dhm54.1.47-56.
There are inconsistencies in outcome reporting for patients with necrotising soft tissue infections (NSTI). The aim of this study was to evaluate reported outcome measures in NSTI literature that could inform a core outcome set (COS) such as could be used in a study of hyperbaric oxygen in this indication.
A systematic review of all NSTI literature identified from Cochrane, Ovid MEDLINE and Scopus databases as well as grey literature sources OpenGrey and the New York Academy of Medicine databases which met inclusion criteria and were published between 2010 and 2020 was performed. Studies were included if they reported on > 5 cases and presented clinical endpoints, patient related outcomes, or resource utilisation in NSTI patients. Studies did not have to include intervention. Two independent researchers then extracted reported outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. An attempt was made to identify trends in outcome measures over time and by study design.
Three hundred and seventy-five studies were identified and included a total of 311 outcome measures. Forty eight percent (150/311) of outcome measures were reported by two or more studies. The four most frequently reported outcome measures were mortality without time specified, length of hospital stay, amputation performed, and number of debridements, reported in 298 (79.5%), 260 (69.3%), 156 (41.6%) and 151 (40.3%) studies respectively. Mortality outcomes were reported in 23 different ways. Randomised controlled trials (RCTs) were more likely to report 28-day mortality or 90-day mortality. The second most frequent amputation related outcome was level of amputation, reported in 7.5% (28/375) of studies. The most commonly reported patient-centred outcome was the SF-36 which was reported in 1.6% (6/375) of all studies and in 2/10 RCTs.
There was wide variance in outcome measures in NSTI studies, further highlighting the need for a COS.
坏死性软组织感染（NSTI）患者的结局报告存在不一致性。本研究的目的是评估NSTI文献中报告的结局指标，这些指标可为核心结局集（COS）提供信息，例如可用于该适应症高压氧治疗研究的结局指标。
对从Cochrane、Ovid MEDLINE和Scopus数据库以及灰色文献来源OpenGrey和纽约医学院数据库中识别出的所有符合纳入标准且在2010年至2020年期间发表的NSTI文献进行系统综述。如果研究报告了超过5例病例，并呈现了NSTI患者的临床终点、患者相关结局或资源利用情况，则纳入研究。研究不必包括干预措施。然后由两名独立研究人员提取报告的结局指标。将相似的结局进行分组并分类到不同领域，以生成一份结构化清单。尝试确定结局指标随时间和研究设计的趋势。
共识别出375项研究，总共包括311个结局指标。48%（150/311）的结局指标由两项或更多研究报告。报告频率最高的四个结局指标分别是未指定时间的死亡率、住院时间、截肢情况和清创次数，分别在298项（79.5%）、260项（69.3%）、156项（41.6%）和151项（40.3%）研究中报告。死亡率结局以23种不同方式报告。随机对照试验（RCT）更有可能报告28天死亡率或90天死亡率。第二常见的截肢相关结局是截肢水平，在7.5%（28/375）的研究中报告。最常报告的以患者为中心的结局是SF-36，在所有研究的1.6%（6/375）以及10项RCT中的2项中报告。
NSTI研究中的结局指标存在很大差异，进一步凸显了核心结局集的必要性。
