title: Discrepancy between published report and actual conduct of randomized clinical trials.
abstract: Randomized clinical trial (RCT) publications with inappropriate random-sequence generation, lack of allocation concealment, or imperfect blinding yield inflated estimates of effect compared to those in which adequate methods are described. RCTs that do not state methods used yield similar effect estimates, suggesting that inadequate methods were used. We compared RCT publications with investigator reports of actual practice for 40 rheumatology RCTs published in 1997/1998. In RCTs in which these methods were not described in the trial reports and would thus have been characterized as "inadequate," investigators reported using methods of random-sequence generation and allocation concealment that would be considered adequate in 77.4 and 78.1% of RCTs, respectively. This suggests that, in contrast to previous reports, inadequate random-sequence generation and allocation concealment, per se, may not be a major problem in RCTs. Characterizing RCTs as "good" or "poor" quality based on the published report is likely to be inappropriate.
authors.affiliation: Clinical Epidemiology Research and Training Unit, Department of Medicine, Boston Medical Center, MA, USA.
authors.forename: Catherine L
authors.initials: CL
authors.lastname: Hill
authors.forename: Michael P
authors.initials: MP
authors.lastname: LaValley
authors.forename: David T
authors.initials: DT
authors.lastname: Felson
mesh_terms: D015982:Bias; D006801:Humans; D015201:Meta-Analysis as Topic; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012216:Rheumatic Diseases / Q000628:therapy; D012219:Rheumatology; D011795:Surveys and Questionnaires; D014481:United States