Impact of the Consolidated Standards of Reporting Trials (CONSORT) checklist on reporting of randomized clinical trials in traditional Chinese medicine.

Abstract

To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs. RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63-item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P < 0.05 was considered statistically significant. SPSS was used for all analyses. A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). Significant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post-CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT-promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively). Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.