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      Assessing the Gold Standard--Lessons from the History of RCTs.

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          Most cited references28

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          A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

          Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee. A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial. At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference. In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
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            The ethics of clinical research in the Third World.

            M Angell (1997)
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              Uneasy alliance--clinical investigators and the pharmaceutical industry.

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                Author and article information

                Journal
                N. Engl. J. Med.
                The New England journal of medicine
                New England Journal of Medicine (NEJM/MMS)
                1533-4406
                0028-4793
                Jun 02 2016
                : 374
                : 22
                Affiliations
                [1 ] From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (L.E.B.), and the Department of Global Health and Social Medicine, Harvard Medical School (S.H.P., D.S.J.), Boston, and the Department of the History of Science, Harvard University, Cambridge (D.S.J.) - both in Massachusetts; and the Division of General Internal Medicine and the Department of the History of Medicine, Johns Hopkins University School of Medicine, Baltimore (J.A.G.).
                Article
                10.1056/NEJMms1604593
                27248626
                3c4bfa05-4a20-4bf6-b22e-8654849caa31
                History

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