Tasker Robert C, Vonberg Frederick W, Ulano Elizabeth D, Akhondi-Asl Alireza
1Division of Critical Care Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA. 2Department of Neurology, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Pediatr Crit Care Med. 2017 Apr;18(4):355-362. doi: 10.1097/PCC.0000000000001098.
To evaluate clinical trials of hypothermia management on outcome in pediatric patients with severe traumatic brain injury using conventional and Bayesian meta-analyses.
Screening of PubMed and other databases to identify randomized controlled trials of hypothermia for pediatric severe traumatic brain injury published before September 2016.
Four investigators assessed and reviewed randomized controlled trial data.
Details of trial design, patient number, Glasgow Coma Scale score, hypothermia and control normothermia therapy, and outcome of mortality were collated.
In conventional meta-analysis, random-effects models were expressed as odds ratio (odds ratio with 95% credible-interval). Bayesian outcome probabilities were calculated as probability of odds ratio greater than or equal to 1. In seven randomized controlled trials (n = 472, patients 0-17 yr old), there was no difference in mortality (hypothermia vs normothermia) with pooled estimate 1.42 (credible-interval, 0.77-2.61; p = 0.26). Duration of hypothermia (24, 48, or 72 hr) did not show difference in mortality. (Similar results were found using poor outcome.) Bayesian analyses of randomized controlled trials ordered by time of study completed recruitment showed, after the seventh trial, chance of relative risk reduction of death by greater than 20% is 1-in-3. An optimistic belief (0.90 probability that relative risk reduction of death > 20% hypothermia vs normothermia) gives a chance of relative risk reduction of death by greater than 20% of 1-in-2.
Conventional meta-analysis shows the null hypothesis-no difference between hypothermia versus normothermia on mortality and poor outcome-cannot be rejected. However, Bayesian meta-analysis shows chance of relative risk reduction of death greater than 20% with hypothermia versus normothermia is 1-in-3, which may be further altered by one's optimistic or skeptical belief about a patient.
采用传统和贝叶斯荟萃分析评估低温治疗对小儿重型颅脑损伤患者预后的临床试验。
筛选PubMed及其他数据库，以识别2016年9月之前发表的关于小儿重型颅脑损伤低温治疗的随机对照试验。
四名研究人员评估并审查了随机对照试验数据。
整理试验设计细节、患者数量、格拉斯哥昏迷量表评分、低温及对照正常体温治疗情况以及死亡率结局。
在传统荟萃分析中，随机效应模型表示为比值比（比值比及95%可信区间）。贝叶斯结局概率计算为比值比大于或等于1的概率。在七项随机对照试验（n = 472，患者年龄0至17岁）中，低温治疗与正常体温治疗的死亡率无差异，合并估计值为1.42（可信区间，0.77 - 2.61；p = 0.26）。低温治疗持续时间（24、48或72小时）在死亡率方面未显示出差异。（使用不良结局时发现了类似结果。）按研究完成招募时间排序的随机对照试验的贝叶斯分析显示，在第七项试验之后，死亡相对风险降低超过20%的机会为三分之一。一种乐观信念（低温治疗与正常体温治疗相比死亡相对风险降低> 20%的概率为0.90）给出死亡相对风险降低超过20%的机会为二分之一。
传统荟萃分析表明，零假设——低温治疗与正常体温治疗在死亡率和不良结局方面无差异——不能被拒绝。然而，贝叶斯荟萃分析显示，低温治疗与正常体温治疗相比死亡相对风险降低超过20%的机会为三分之一，这可能会因个人对患者的乐观或怀疑信念而进一步改变。
