1 Population Health and Optimal Health Practices Research Unit, Trauma-Emergency-Critical Care Medicine, Centre de recherche du CHU de Québec-Université Laval, Québec, QC, Canada.
2 Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Université Laval, Québec, QC, Canada.
Clin Trials. 2018 Aug;15(4):398-412. doi: 10.1177/1740774518771233. Epub 2018 Jun 4.
Background Most deaths following severe traumatic brain injury follow decisions to withdraw life-sustaining therapies. However, the incidence of the withdrawal of life-sustaining therapies and its potential impact on research data interpretation have been poorly characterized. The aim of this systematic review was to assess the reporting and the impact of withdrawal of life-sustaining therapies in randomized clinical trials of patients with severe traumatic brain injury. Methods We searched Medline, Embase, Cochrane Central, BIOSIS, and CINAHL databases and references of included trials. All randomized controlled trials published between January 2002 and August 2015 in the six highest impact journals in general medicine, critical care medicine, and neurocritical care (total of 18 journals) were considered for eligibility. Randomized controlled trials were included if they enrolled adult patients with severe traumatic brain injury (Glasgow Coma Scale ≤ 8) and reported data on mortality. Our primary objective was to assess the proportion of trials reporting the withdrawal of life-sustaining therapies in a publication. Our secondary objectives were to describe the overall mortality rate, the proportion of deaths following the withdrawal of life-sustaining therapies, and to assess the impact of the withdrawal of life-sustaining therapies on trial results. Results From 5987 citations retrieved, we included 41 randomized trials (n = 16,364, ranging from 11 to 10,008 patients). Overall mortality was 23% (range = 3%-57%). Withdrawal of life-sustaining therapies was reported in 20% of trials (8/41, 932 patients in trials) and the crude number of deaths due to the withdrawal of life-sustaining therapies was reported in 17% of trials (7/41, 884 patients in trials). In these trials, 63% of deaths were associated with the withdrawal of life-sustaining therapies (105/168). An analysis carried out by imputing a 4% differential rate in instances of withdrawal of life-sustaining therapies between study groups yielded different results and conclusions in one third of the trials. Conclusion Data on the withdrawal of life-sustaining therapies are incompletely reported in randomized controlled trials of patients with severe traumatic brain injury. Given the high proportion of deaths due to the withdrawal of life-sustaining therapies in severe traumatic brain injury patients, and the potential of this medical decision to influence the results of clinical trials, instances of withdrawal of life-sustaining therapies should be systematically reported in clinical trials in this group of patients.
大多数严重创伤性脑损伤后死亡是由于决定停止维持生命的治疗。然而，维持生命治疗的停止率及其对研究数据解释的潜在影响尚未得到充分描述。本系统评价的目的是评估严重创伤性脑损伤患者随机临床试验中维持生命治疗停止的报告和影响。
我们检索了 Medline、Embase、Cochrane 中心、BIOSIS 和 CINAHL 数据库以及纳入试验的参考文献。所有在一般医学、重症监护医学和神经重症监护学六个最高影响期刊上发表的 2002 年 1 月至 2015 年 8 月之间的随机对照试验（共 18 种期刊）均被认为符合入选条件。如果试验纳入了格拉斯哥昏迷量表评分≤8 的成年严重创伤性脑损伤患者，并报告了死亡率数据，则纳入随机对照试验。我们的主要目的是评估出版物中报告维持生命治疗停止的试验比例。我们的次要目标是描述总体死亡率、维持生命治疗停止后的死亡率比例，并评估维持生命治疗停止对试验结果的影响。
从 5987 篇引文检索中，我们纳入了 41 项随机试验（n=16364 例，范围为 11 至 10008 例）。总体死亡率为 23%（范围为 3%至 57%）。20%的试验（8/41，932 例患者）报告了维持生命治疗的停止，17%的试验（7/41，884 例患者）报告了因维持生命治疗停止而导致的死亡人数。在这些试验中，63%的死亡与维持生命治疗的停止有关（168 例中有 105 例）。对研究组之间维持生命治疗停止率的差异率进行 4%的差值推断分析，导致三分之一的试验得出不同的结果和结论。
严重创伤性脑损伤患者的随机对照试验中，维持生命治疗停止的数据报告不完整。鉴于严重创伤性脑损伤患者因维持生命治疗停止而导致的死亡比例较高，以及这一医疗决策对临床试验结果的潜在影响，应系统地报告此类患者临床试验中维持生命治疗停止的情况。
