亚组分析和临床试验中基线数据的其他 (错误) 使用
S F Assmann1, S J Pocock, L E Enos
1New England Research Institutes, Watertown, MA, USA.
Lancet (London, England)
|April 1, 2000
概括
临床试验的基线数据对于患者描述和组可比性至关重要. 然而,报告实践,特别是对子组分析和共变量调整的报告实践,往往缺乏统计学严谨性,需要改进标准.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医疗研究报告报告 医学研究报告
背景情况:
- 控制临床试验的基线数据有多种用途,包括人口描述,治疗组可比性评估和预后因素调整.
- 有效利用基线数据对于稳健的临床试验设计和解释至关重要.
- 之前对主要临床试验报告中基线数据实践的评估是有限的.
研究的目的:
- 在主要临床试验报告中评估基线数据利用的程度和质量.
- 确定报告基线数据分析中的常见做法和缺陷.
- 为改善临床试验中的统计报告标准提供建议.
主要方法:
- 1997年7月至9月间在四个主要医学期刊上发表的连续50份临床试验报告的系统审查.
- 使用标准化表格提取数据,以表格化基线数据的使用.
- 分析重点是报告基线可比性,随机化方法,共变量调整和子组分析.
主要成果:
- 大多数试验呈现出基线可比性表,通常过大,在约一半的试验中不适当使用显著性测试.
- 随机化方法,包括分层,经常被描述得很差,并且对共变量调整的标准不清楚.
- 亚组发现很常见 (报告的三分之二),但往往缺乏适当的统计测试来测试相互作用和足够的统计能力.
结论:
- 临床试验需要预先定义的统计分析计划来利用基线数据,特别是对共变量调整和子组分析.
- 研究人员和期刊需要改进统计报告标准.
- 在解释子组发现时建议谨慎,因为它们在报告和统计能力上的常见限制.
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