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Báo cáo y học: "Ethics of randomised controlled trials – not yet time to give up on equipoise Richard E Ashcroft"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Ethics of randomised controlled trials – not yet time to give up on equipoise Richard E Ashcroft. | Available online http arthritis-research.eom content 6 6 237 Commentary Ethics of randomised controlled trials - not yet time to give up on equipoise Richard E Ashcroft Medical Ethics Unit Imperial College London London UK Corresponding author Richard E Ashcroft r.ashcroft@imperial.ac.uk Published 14 September 2004 Arthritis Res Ther 2004 6 237-239 DOI 10.1186 ar1442 2004 BioMed Central Ltd Abstract In this commentary on Fries and Krishnan s argument that design bias undermines the status of equipoise as the ethical justification for randomised controlled trials it is argued that their argument is analogous to Bayesian arguments for the use of informative priors in trial design but that this does not undermine the importance of equipoise. In particular mismatches between the outcomes of interest to industrial sponsors of research and outcomes of interest to patients and clinicians ensure that in many cases industry-sponsored trials can fail to reflect the reasonable equipoise of working clinicians. Keywords design bias ethical principles expected outcomes randomised controlled trials Introduction James Fries and Eswar Krishnan have recently presented an interesting argument for the proposition that equipoise is a false and diverting principle and propose an alternative test of the ethics of a randomised controlled trial the positive expected value test 1 . The concept of equipoise has been introduced into the medical literature on many occasions 2-7 . Both concepts are intended to give ethical justification to entering patients into randomised controlled trials. The problem that critics of such trials pose is that entering a patient into a trial seems to involve knowingly failing to offer the patient the treatment the doctor believes to be best for the patient in the interests of scientific research and future patients. However if there is genuine uncertainty as to which of the treatments being compared is superior then randomised assignment can be justified 8 . .