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Journal of Bone and Joint Surgery - British Volume, Vol 89-B, Issue 7,
858-863.
doi: 10.1302/0301-620X.89B7.19440 Copyright © 2007 by British Editorial Society of Bone and Joint Surgery The design and assessment of prospective randomised, controlled trials in orthopaedic surgeryI. Boutron, MD, PhD, Research Fellow1; P. Ravaud, MD, PhD, Professor of Clinical Epidemiology1; and R. Nizard, MD, PhD, Professor of Orthopaedic Surgery2
1 Départment dEpidémiologie, Biostatistique et Rechercher Clinique, Hôpital Bichat, rue Henri, Huchard, Paris, France. Correspondence should be sent to Professor R. Nizard; e-mail: remy.nizard{at}noos.fr 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.
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