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

Publication ,  Journal Article
Han, C; Kwak, K-P; Marks, DM; Pae, C-U; Wu, L-T; Bhatia, KS; Masand, PS; Patkar, AA
Published in: Contemp Clin Trials
March 2009

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.

Duke Scholars

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

March 2009

Volume

30

Issue

2

Start / End Page

116 / 122

Location

United States

Related Subject Headings

  • United States
  • Research Design
  • Republic of Korea
  • Randomized Controlled Trials as Topic
  • Public Health
  • Psychiatry
  • Informed Consent
  • Humans
  • General Clinical Medicine
  • Ethics Committees, Research
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Han, C., Kwak, K.-P., Marks, D. M., Pae, C.-U., Wu, L.-T., Bhatia, K. S., … Patkar, A. A. (2009). The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. Contemp Clin Trials, 30(2), 116–122. https://doi.org/10.1016/j.cct.2008.11.004
Han, Changsu, Kyung-phil Kwak, David M. Marks, Chi-Un Pae, Li-Tzy Wu, Kamal S. Bhatia, Prakash S. Masand, and Ashwin A. Patkar. “The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.Contemp Clin Trials 30, no. 2 (March 2009): 116–22. https://doi.org/10.1016/j.cct.2008.11.004.
Han C, Kwak K-P, Marks DM, Pae C-U, Wu L-T, Bhatia KS, et al. The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. Contemp Clin Trials. 2009 Mar;30(2):116–22.
Han, Changsu, et al. “The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.Contemp Clin Trials, vol. 30, no. 2, Mar. 2009, pp. 116–22. Pubmed, doi:10.1016/j.cct.2008.11.004.
Han C, Kwak K-P, Marks DM, Pae C-U, Wu L-T, Bhatia KS, Masand PS, Patkar AA. The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry. Contemp Clin Trials. 2009 Mar;30(2):116–122.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

March 2009

Volume

30

Issue

2

Start / End Page

116 / 122

Location

United States

Related Subject Headings

  • United States
  • Research Design
  • Republic of Korea
  • Randomized Controlled Trials as Topic
  • Public Health
  • Psychiatry
  • Informed Consent
  • Humans
  • General Clinical Medicine
  • Ethics Committees, Research