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
Comparative Study
. 2009 Mar;30(2):116-22.
doi: 10.1016/j.cct.2008.11.004. Epub 2008 Nov 30.

The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry

Changsu Han  1 , Kyung-phil Kwak, David M Marks, Chi-Un Pae, Li-Tzy Wu, Kamal S Bhatia, Prakash S Masand, Ashwin A Patkar
Affiliations
Comparative Study

The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry

Changsu Han et al. Contemp Clin Trials. 2009 Mar.

Abstract

To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Disposition of selected studies
See this image and copyright information in PMC

References

    1. Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 3. St. Louis: Mosby; 1998.
    1. Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988;9:365–74. - PubMed
    1. Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol. 1995;48:23–40. - PubMed
    1. Dunn G. Estimating the causal effects of treatment. Epidemiol Psichiatr Soc. 2002;11:206–15. - PubMed
    1. Slavin RE. Best evidence synthesis: an intelligent alternative to meta-analysis. J Clin Epidemiol. 1995;48:9–18. - PubMed

Publication types