Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury:: A systematic review
Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury:: A systematic review
复制标题
DOI：
10.1227/01.neu.0000186039.57548.96
复制
发表时间：
2005-12-01
期刊：
影响因子：
4.8
通讯作者：
Maas, AIR
中科院分区：
文献类型：
--
作者：
Hernández, AV;Steyerberg, EW;Maas, AIR
目的：在创伤性脑损伤（TBI）领域，很少有随机临床试验（rct）显示出显著的治疗效果。我们批判性地回顾了两种类型的二次分析的使用，协变量调整和亚组分析，这在TBI试验中很常见。方法：我们对治疗性III期随机对照试验进行了系统的回顾，包括急性、中度至重度TBI的成年患者。格拉斯哥结局量表（GOS）， >= 3个月为结局，>=每组50例患者。我们比较了协变量调整和亚组分析的实际报告与合并标准报告试验（CONSORT）建议。同样，我们回顾了六个大型多中心随机对照试验方案，并比较了计划和报告的亚组。结果：共纳入18项rct （n = 6439）。16项试验在6个月时使用GOS作为结果。5个随机对照试验报告了协变量调整。协变量的数量有限(
OBJECTIVE: Few randomized clinical trials (RCTs) in the field of traumatic brain injury (TBI) have shown a significant treatment benefit. We critically reviewed the use of two types of secondary analyses, covariate adjustment and subgroup analysis, which are common in TBI trials.METHODS: We performed a systematic, review of therapeutic phase III RCTs, including adult patients with acute, moderate-to-severe TBI. Glasgow Outcome Scale (GOS) at >= 3 months as outcome, and >= 50 patients per arm were required. We compared the actual reporting of covariate adjustment and subgroup analyses with the Consolidated Standards of Reporting Trials (CONSORT) recommendations. Likewise, we reviewed six protocols of large multicenter RCTs and compared planned and reported subgroups.RESULTS: We identified 18 RCTs (n = 6439). Sixteen trials used GOS at 6 months as outcome. Five RCTs reported covariate adjustment. The number of covariates was limited (