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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (7): 690-699.doi: 标准CONSORT的描述:受试者如何分配至干预组(如“随机分配”、“随机”或“随机分组”)。

• Biomedical Publication • Previous Articles     Next Articles

Isabelle Boutrona,David Moherb,Douglas G. Altmanc,Kenneth F. Schulzd,Philippe Ravauda   

  1. a INSERM U738,AP-HP,Hopital Bichat-Claude Bernard, Universite Paris 7 Denis Diderot, Paris, France
    b Chalmers Research Group, Children^ Hospital of Eastern Ontario Research Institute, University of Ottawa, Ottawa, Ontario, Canada
    c University of Oxford,Oxford,United Kingdom
    d Quantitative Sciences, Family Health International, Research Triangle Park, North Carolina, USA
  • Online:2009-07-20 Published:2009-07-15

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在大多数RCT中使用的统计分析都是基于这样的假设:对由相同的医生或者在同一治疗中心治疗的不同患者而言,所观察到的结局是独立的。在大多数双盲的药物RCT中,这种假设是切合实际的。然而,在评价非药物治疗时,这一假设的有效性就值得怀疑了,因为治疗成功的原因可能部分是基于医疗保健人员的技能或专业知识以及治疗中心的医疗环境。此外,在这类试验中,盲法常常不可行,而缺少盲法导致治疗提供者可能会对其所施行的治疗产生影响[88]。因此,在非药物临床试验中,对于接受相同治疗者服务或者在同一治疗中心接受治疗的患者的观察研究可能相互关联或者进行过聚类(clustering)。在试验中,聚类的存在会减少统计效力[89, 90]。这种减少依赖于从群组内相关系数(任何两个接受相同治疗者服务或者在同一治疗中心接受治疗的患者的相关性)和接受相同治疗者服务或者在同一治疗中心接受治疗的患者数目[88, 91-93]。在样本量计算和统计分析时应该将这种聚类考虑在内(见条目7和12)。
在评价非药物治疗效果的单个RCT中,对患者聚类十分重要。一篇对42项此类研究的综述显示,其中38篇有某种形式的聚类,6篇提到聚类是一种潜在因素,只有4篇报告在试验结果分析中允许某种形式的聚类[90]。一篇对心理治疗研究RCT的综述发现2/3的试验忽略了聚类[94]
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