如果按 "治疗 "进行分析，OXYGEN 试验的结果是否会发生变化？对 OXYGEN 试验的二次分析。

IF 2.2 3区医学 Q3 CRITICAL CARE MEDICINE

Injury-International Journal of the Care of the Injured Pub Date : 2024-10-13 DOI:10.1016/j.injury.2024.111953

Augustine M. Saiz , Anthony R. Carlini , Renan C. Castillo , Manjari Joshi , Yanjie Huang , Clinton K. Murray , Michael J. Bosse , Arman Dagal , Joshua L. Gary , Madhav A. Karunakar , Michael J. Weaver , William Obremskey , Todd O. McKinley , Gregory T. Altman , Jean-Claude G. D'Alleyrand , Reza Firoozabadi , Susan C. Collins , Julie Agel , Tara J. Taylor , Alec C. Stall , Stephen J. Warner

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引用次数: 0

摘要

目的：确定 OXYGEN 试验的结果是否会因采用 "治疗 "方法而非最初的 "意向治疗 "方法而发生变化。多中心随机对照 OXYGEN 试验旨在确定高 FiO2 在降低高风险胫骨平台、胫骨皮隆和方骨骨折感染率方面的有效性：对在美国 29 家创伤中心进行的多中心随机对照试验进行了二次分析。共有 1231 名年龄在 18-80 岁之间、患有胫骨平台、胫骨皮隆或方骨骨折、被认为感染风险较高的患者入选。患者被随机分配接受FiO2浓度为80%的吸氧（治疗）或FiO2浓度为30%的吸氧（对照）。坚持治疗的标准有两种。标准 1 要求对照组至少 80% 的手术时间内 FiO2 浓度低于 40%，或治疗组至少 80% 的手术时间内 FiO2 浓度≥70%。标准 2 要求至少 80% 的手术时间在 20-40% FiO2（对照组）或 70-90% FiO2（治疗组）范围内。主要结果是骨折固定后 182 天内的手术部位感染（SSI）。次要结果是明确固定后 90 天、182 天和 365 天内的深层和浅层手术部位感染：根据标准 1，治疗组和对照组分别有 7%（38/523）和 10%（49/471）的患者出现主要结果（P = 0.10）。治疗组和对照组分别有 30% （6%）和 30% （6%）的患者发生深部感染（P = 0.75）。治疗组和对照组分别有 9 人（2%）和 20 人（4%）发生表皮感染（RR，0.41；P = 0.03）。根据标准 2，7%（36/498）的治疗患者和 10%（48/468）的对照组患者出现了主要结果（p = 0.12）。深部感染发生在 28 例（6%）治疗患者和 29 例（6%）对照组患者中（P = 0.81）。9例（2%）治疗患者和20例（4.3%）对照组患者发生了表皮感染（RR = 0.43; p = 0.03）：根据哪些患者实际接受了高水平或控制水平的围手术期氧分重新进行分析，结果与最初的 "意向治疗 "分析基本一致。具体来说，围手术期高氧降低了浅表 SSI 的风险，但对深部感染没有影响。

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Do the results of the OXYGEN trial change if analyzed as “as-treated?”: A secondary analysis of the OXYGEN trial

Objective

To determine if the results of the OXYGEN trial changed using an “as-treated” approach instead of the original “intention-to-treat” approach. The multi-center randomized controlled OXYGEN trial aimed to determine the effectiveness of high FiO2 in decreasing infection rates for high-risk tibial plateau, tibial pilon, and calcaneus fractures.

Methods

A secondary analysis of a multi-center randomized controlled trial conducted at 29 US trauma centers was performed. A total of 1231 patients aged 18–80 years with tibial plateau, tibial pilon, or calcaneus fractures thought to be at elevated risk of infection were enrolled. Patients were randomly assigned to receive inspired oxygen at a concentration of 80 % FiO2 (treatment) or 30 % FiO2 (control). Adherence was defined using two different criteria. Criterion 1 required at least 80 % of the surgery time ≤40 % FiO2 for the control group or ≥70 % FiO2 for the treatment group. Criterion 2 required at least 80 % of surgery time within 20–40 % (control) or 70–90 % FiO2 (treatment). The primary outcome was surgical site infection (SSI) within 182 days of definitive fracture fixation. Secondary outcomes were deep and superficial surgical site infections within 90, 182, and 365 days of definitive fixation.

Results

Under Criterion 1, the primary outcome occurred in 7 % (38/523) and 10 % (49/471) of patients in the treatment and control groups, respectively (p = 0.10). Deep infection occurred in 30 (6 %) treatment and 30 (6 %) control patients (p = 0.75). Superficial infection occurred in 9 (2 %) treatment and 20 (4 %) control patients (RR, 0.41; p = 0.03). Using Criterion 2, the primary outcome occurred in 7 % (36/498) of treatment and 10 % (48/468) of control patients (p = 0.12). Deep infection occurred in 28 (6 %) treatment and 29 (6 %) control patients (p = 0.81). Superficial infection occurred in 9 (2 %) treatment and 20 (4.3 %) control patients (RR = 0.43; p = 0.03).

Conclusions

When re-analyzing based on which patients actually received high or control levels of perioperative oxygen fraction, the results are somewhat consistent with the original “intent-to-treat” analysis. Specifically, high perioperative oxygen lowered the risk of superficial SSI but did not affect deep infections.

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来源期刊

Injury-International Journal of the Care of the Injured 医学-急救医学

CiteScore

4.00

自引率

8.00%

发文量

699

审稿时长

96 days

期刊介绍： Injury was founded in 1969 and is an international journal dealing with all aspects of trauma care and accident surgery. Our primary aim is to facilitate the exchange of ideas, techniques and information among all members of the trauma team.