title: Evaluating the evidence for evidence-based medicine: are randomized clinical trials less flawed than other forms of peer-reviewed medical research?
abstract: Evidence-based medicine considers randomized clinical trials (RCTs) to be the strongest form of evidence for clinical decision making. To test the hypothesis that RCTs have fewer methodological flaws than non-RCTs, limitations of 17,591 RCTs and 39,029 non-RCTs were characterized. Panels of experts assembled to write meta-analyses evaluated this literature to determine which articles should be included in 316 meta-analytic reviews. Overall, 38.7% of RCTs evaluated were excluded from review for an identified flaw. Commonly identified flaws in RCTs were as follows: insufficient data provided to evaluate the study (9.6% of 17,591 RCTs); inadequate randomization (9.0%); inadequate blinding (4.9%); and duplicative publication (4.4%). Overall, 20.2% of all published medical research has an identified methodological flaw, with RCTs having as many limitations as non-RCTs.
authors.affiliation: MediCC! Medical Communications Consultants, LLC, 103 Van Doren Place, Chapel Hill, NC 27517, USA. g_steen_medicc@yahoo.com
authors.forename: R Grant
authors.initials: RG
authors.lastname: Steen
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Dager
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D019317:Evidence-Based Medicine / Q000379:methods*; D017712:Peer Review, Research / Q000379:methods*; D016032:Randomized Controlled Trials as Topic
keywords: meta-analysis; meta-analytic review; prospective study; retrospective study; study design