Large Between-Center Differences in Outcome After Moderate and Severe Traumatic Brain Injury in the International Mission on Prognosis and Clinical Trial Design in Traumatic Brain Injury (IMPACT) Study
Large Between-Center Differences in Outcome After Moderate and Severe Traumatic Brain Injury in the International Mission on Prognosis and Clinical Trial Design in Traumatic Brain Injury (IMPACT) Study
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DOI：
10.1227/neu.0b013e318209333b
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发表时间：
2011-03-01
期刊：
影响因子：
4.8
通讯作者：
Steyerberg, Ewout W.
中科院分区：
文献类型：
--
作者：
Lingsma, Hester F.;Roozenbeek, Bob;Steyerberg, Ewout W.
背景：各中心之间创伤性脑损伤后患者结局的差异对于多中心研究很重要，但很少进行研究。目的：量化随机临床试验 (RCT) 和调查中招募患者的中心之间的差异。方法：我们分析了 10 项随机临床试验和 3 项观察性研究中纳入的 9578 名中度和重度创伤性脑损伤患者的个体患者数据。我们使用随机效应逻辑回归模型来估计 6 个月时不利结果（死亡、植物人状态或用格拉斯哥结果量表测量的严重残疾）的中心间差异，并根据患者特征的差异进行调整。我们计算了结果分布高端中心与低端中心之间出现不利结果的几率差异。我们分别分析了整个数据库、欧洲和美国以及 4 个较大的随机对照试验。 结果：265 个中心的 9578 名患者入组，其中 4629 名患者（48%）出现不良结果。调整患者特征后，结果分布较低端（第 2.5 个百分位）的中心与结果分布较高端（第 97.5 个百分位；P < .001）的中心之间出现不良结果的几率存在 3.3 倍差异。在 4 个较大的随机对照试验中，各中心之间的差异相似。然而，美国中心之间的差异（2.4 倍）比欧洲中心之间的差异（3.8 倍）要小。结论：创伤性脑损伤后的结果在中心之间存在显着差异，特别是在欧洲。需要进一步研究来解释这些差异，以提出可以在哪些方面改进护理质量的建议。
BACKGROUND: Differences between centers in patient outcome after traumatic brain injury are of importance for multicenter studies and have seldom been studied.OBJECTIVE: To quantify the differences in centers enrolling patients in randomized clinical trials (RCTs) and surveys.METHODS: We analyzed individual patient data from 9578 patients with moderate and severe traumatic brain injury enrolled in 10 RCTs and 3 observational studies. We used random-effects logistic regression models to estimate the between-center differences in unfavorable outcome (dead, vegetative state, or severe disability measured with the Glasgow Outcome Scale) at 6 months adjusted for differences in patient characteristics. We calculated the difference in odds of unfavorable outcome between the centers at the higher end vs those at the lower end of the outcome distribution. We analyzed the total database, Europe and the United States separately, and 4 larger RCTs.RESULTS: The 9578 patients were enrolled at 265 centers, and 4629 (48%) had an unfavorable outcome. After adjustment for patient characteristics, there was a 3.3-fold difference in the odds of unfavorable outcome between the centers at the lower end of the outcome distribution (2.5th percentile) vs those at the higher end of the outcome distribution (97.5th percentile; P < .001). In the 4 larger RCTs, the differences between centers were similar. However, differences were smaller between centers in the United States (2.4-fold) than between centers in Europe (3.8-fold).CONCLUSION: Outcome after traumatic brain injury differs substantially between centers, particularly in Europe. Further research is needed to study explanations for these differences to suggest where quality of care might be improved.