Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2004 Jul;58(1):61-5.
doi: 10.1111/j.1365-2125.2004.2092.x.

Determining the reporting quality of RCTs in clinical pharmacology

Edward Mills  1 , Yoon K Loke, Ping Wu, Victor M Montori, Daniel Perri, David Moher, Gordon Guyatt
Affiliations

Determining the reporting quality of RCTs in clinical pharmacology

Edward Mills et al. Br J Clin Pharmacol. 2004 Jul.

Erratum in

  • Br J Clin Pharmacol. 2004 Jul;58(1):102

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart of studies considered for inclusion
See this image and copyright information in PMC

Comment in

  • What is a clinical trial?
    Aronson JK. Aronson JK. Br J Clin Pharmacol. 2004 Jul;58(1):1-3. doi: 10.1111/j.1365-2125.2004.02184.x. Br J Clin Pharmacol. 2004. PMID: 15206985 Free PMC article. No abstract available.

References

    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–4. - PubMed
    1. Egger M, Juni P, Bartlett C. Value of flow diagrams in reports of randomized controlled trials. JAMA. 2001;285:1996–9. - PubMed
    1. Huwiler-Muntener K, Juni P, Junker C, Egger M. Quality of reporting of randomized trials as a measure of methodologic quality. JAMA. 2002;287:2801–4. - PubMed
    1. Nuovo J, Melnikow J, Chang D. Reporting number needed to treat and absolute risk reduction in randomized controlled trials. JAMA. 2002;287:2813–4. - PubMed
    1. Bhandari M, Guyatt GH, Lochner H, Sprague S, Tornetta P3rd. Application of the Consolidated Standards of Reporting Trials (CONSORT) in the Fracture Care Literature. J Bone Joint Surg Am. 2002;84-A:485–9. - PubMed