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

Changsu Han, Kyung phil Kwak, David M. Marks, Chi Un Pae, Li Tzy Wu, Kamal S. Bhatia, Prakash S. Masand, Ashwin A. Patkar

Research output: Contribution to journalArticlepeer-review

59 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)116-122
Number of pages7
JournalContemporary Clinical Trials
Issue number2
Publication statusPublished - 2009 Mar
Externally publishedYes

Bibliographical note

Funding Information:
Dr. Patkar is a consultant for Bristol-Myers Squibb, GlaxoSmithKline. Dr. Masand is a consultant for Bristol-Myers Squibb Company, Eli Lilly and Company, Janssen Pharmaceutica, Organon, Pfizer, Inc., and is on the speaker's bureau of Bristol Myers Squibb Company, Janssen Pharmaceutica, Pfizer Inc., and Wyeth Pharmaceuticals. Dr. Pae has received research support from GlaxoSmithKline. Dr. Marks receives research support from Johnson & Johnson, Merck, and the National Institutes of Health, and is on the speakers' bureau of Eli Lilly and Company and Pfizer. Dr. Wu has received research support from the National Institutes of Health (HSN271200522071C, DA019623, and DA019901).


  • CONSORT statement
  • Psychiatry
  • Randomized clinical trial

ASJC Scopus subject areas

  • Pharmacology (medical)


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