The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.
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.
Han
Changsu
C
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA. mindconsult@gmail.com
Kwak
Kyung-phil
KP
Marks
David M
DM
Pae
Chi-Un
CU
Wu
Li-Tzy
LT
Bhatia
Kamal S
KS
Masand
Prakash S
PS
Patkar
Ashwin A
AA
D000704:Analysis of Variance; D019992:Databases as Topic; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D011570:Psychiatry; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D056910:Republic of Korea; D012107:Research Design / Q000592:standards*; D014481:United States