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Quality of Reporting of Randomized Clinical Trials in Abstracts of the 2005 Annual Meeting of the American College of Rheumatology
CATHERINE L. HILL, RACHELLE BUCHBINDER, and RICHARD OSBORNE
ABSTRACT. Methods. All 2005 abstracts including late-breaking abstracts were assessed. An abstract was deemed to be reporting an RCT if it indicated that participants were randomized in the title or body of the abstract. RCT were excluded if they included only pharmacokinetic data. The CONSORT checklist was applied and relevant data extracted. We defined manufacturer support as acknowledgment of industry support or industry employee as co-author. Results. Of 2146 abstracts, 143 (6.7%) reported RCT. Of these, 78.3% were drug trials, and 63.6% indicated manufacturer support. Only 30.8% of abstracts used "randomized" in the title, 44.1% did not explicitly state whether blinding was undertaken, and only 7.0% clearly stated who was blinded. Thirty percent of studies did not give an explicit definition of eligibility criteria of participants. While 84.6% explicitly described the experimental intervention, only 37.1% explicitly described the comparator intervention. Only 21% explicitly stated that an intention to treat analysis was performed. Baseline demographic and clinical characteristics were reported in 48.3%. While most abstracts reported summary results for each treatment group, only 35.7% reported effect size with its precision. Conclusion. The quality of reporting is suboptimal in many RCT abstracts. Abstracts reporting RCT would benefit from a structured approach that ensures more detailed reporting of eligibility criteria, active and comparator interventions, flow of participants, and adequate summary and precision of results. (First Release Nov 1 2007; J Rheumatol 2007;34:2476-80) Key Indexing Terms:
RANDOMIZED CLINICAL TRIALS
From The Queen Elizabeth Hospital, Woodville, South Australia; Monash Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine, Monash University; and University of Melbourne, Victoria, Australia. C.L. Hill, MBBS, MSc, FRACP, The Queen Elizabeth Hospital; R. Buchbinder, MBBS (Hons), MSc, PhD, FRACP, Monash Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine, Monash University; R. Osborne, BSc, PhD, University of Melbourne. Address reprint requests to Dr. C. Hill, Rheumatology Unit, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville, South Australia 5011. E-mail: Catherine.Hill@nwahs.sa.gov.au Accepted for publication August 9, 2007. |
