Boutron I, Ravaud P, Nizard R
Université Paris VII Denis Diderot, Paris, France.
J Bone Joint Surg Br. 2007 Jul;89(7):858-63. doi: 10.1302/0301-620X.89B7.19440.
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
随机对照试验是评估治疗效果的金标准。之所以需要进行这类试验，是因为治疗效果之间的差异已被最小化，且观察性研究可能会对结果给出有偏差的估计。然而，开展此类试验具有挑战性。为了降低偏倚风险，必须解决几个方法学问题，包括患者或外科医生的偏好、盲法、手术标准化以及外部效度。已经开发了特定工具，以考虑非药物干预文献评估的特殊性。更好地了解方法学问题将使骨科医生能够开展更合适的研究，并更好地评估其干预措施的局限性。
