IngentaConnect Determining the reporting quality of RCTs in clinical pharmacolog...

Abstract:

Background

The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). Objective

To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. Design and setting

Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. Main outcome measures

Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. Results

Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. Conclusion

The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

Keywords: randomized controlled trials; reporting quality; clinical pharmacology; methodology

Document Type: Research article

DOI: 10.1111/j.1365-2125.2004.2092.x

Affiliations: 1: University of Oxford, Oxford and 2: London School of Hygiene and Tropical Medicine, London, UK, 3: Department of Medicine, University of Toronto, Toronto, 4: Thomas Chalmers Centre for Systematic Reviews, University of Ottawa, Ottawa and 5: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

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Determining the reporting quality of RCTs in clinical pharmacology