干预忠实度对复杂干预临床试验中治疗效果估计的影响:一项超流行病学研究
Arsenio Páez1, David Nunan2, Peter McCulloch3
1Nuffield Department for Primary Care Health Sciences, University of Oxford, Oxford, UK; Bouvé College of Health Sciences, Northeastern University, Boston, MA, USA; Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK; Nuffield Department for Surgical Sciences, University of Oxford, Oxford, UK.
Journal of clinical epidemiology
|November 11, 2024
概括
随机临床试验 (RCT) 中干预忠实度较差可能会高估治疗效果. 监测忠诚度对于准确的康复研究和医疗保健决策至关重要.
科学领域:
- 临床试验 临床试验
- 康复医学 康复医学 康复医学
- 超流行病学 超流行病学
背景情况:
- 随机临床试验 (RCT) 对于评估治疗有效性至关重要.
- 复杂的干预,就像康复的干预一样,容易导致分娩的变化.
- 干预准确度较差可能会导致RCT中的治疗效果估计偏差.
研究的目的:
- 评估干预忠实度差是否会在康复RCT的元分析中偏见治疗效果估计.
- 调查干预忠实度对治疗效果大小的影响.
- 检查忠实性监测对治疗效果估计精度的影响.
主要方法:
- 一个对19个元分析和204个RCT (2010-2020) 的元流行病学研究.
- 使用和不使用监测干预精度的RCT之间干预效应的比较.
- 随机效应元回归用于分析忠实度,偏差风险,样本大小和治疗效应之间的关联.
主要成果:
- 忠实度和治疗效果大小之间存在线性关系,独立于偏差或样本大小.
- 更高的准确度与更小,更精确的效果估计相关 (d = -0.23).
- 较低或不存在的准确性导致较大,不那么精确的估计,可能会对元分析产生偏见.
结论:
- 在RCT中缺乏或干预忠实度较差,可能导致对治疗效果的高估.
- 这种过度估计可能会扭曲个别研究和聚合元分析中的结果.
- 在解释缺乏忠实性监测或报告的复杂干预RCT时,建议谨慎.
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