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

Authors
Han, ChangsuKwak, Kyung-philMarks, David M.Pae, Chi-UnWu, Li-TzyBhatia, Karnal S.Masand, Prakash S.Patkar, Ashwin A.
Issue Date
3월-2009
Publisher
ELSEVIER SCIENCE INC
Keywords
CONSORT statement; Randomized clinical trial; Psychiatry
Citation
CONTEMPORARY CLINICAL TRIALS, v.30, no.2, pp.116 - 122
Indexed
SCIE
SCOPUS
Journal Title
CONTEMPORARY CLINICAL TRIALS
Volume
30
Number
2
Start Page
116
End Page
122
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/120504
DOI
10.1016/j.cct.2008.11.004
ISSN
1551-7144
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. (C) 2008 Elsevier Inc. All rights reserved.
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