Article type
Year
Abstract
Background:
There is a paucity of data regarding whether the Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reports of randomized controlled trials (RCTs) on traditional Chinese medicine (TCM). Issues on the quality of reporting have not received as much attention as concerns with methodological quality.
Objectives:
To examine the reporting characteristics and key methodological factors of RCTs in the field of TCM and assess whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.
Methods:
RCTs published in two major TCM journals were retrieved and systematically reviewed. One of these journals 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 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 value < 0.05 was considered statistically significant. SPSS was used for all analyses.
Results:
A total of 76 RCTs were included in the analysis (38 from JCIM and 38 from CJIM). Significant improvements in both the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) were observed over time in the adopter journal (JCIM) (P value 0.001) (Table 1). Overall CONSORT score of studies published from 2010–2011 (post-CONSORT) increased 15.30 averagely with 95%CI: 8.34 to 22.26 (P value 0.001), of those, items addressing reporting of methodological quality were significantly different too, JCIM had more 1.30 items addressed than CJIM in average (95% CI: 0.52 to 2.08, P value 0.003) (Table 2). In multivariate analysis regression, the page length and CONSORT-promoting status had statistical significance (P values 0.001, and 0.040 respectively) (Table 3).
Conclusion:
Although a large area of reporting of RCTs in TCM needs to be improved, the impact for improvement of reporting of RCTs on TCM has been proven to some extent.
There is a paucity of data regarding whether the Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reports of randomized controlled trials (RCTs) on traditional Chinese medicine (TCM). Issues on the quality of reporting have not received as much attention as concerns with methodological quality.
Objectives:
To examine the reporting characteristics and key methodological factors of RCTs in the field of TCM and assess whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.
Methods:
RCTs published in two major TCM journals were retrieved and systematically reviewed. One of these journals 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 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 value < 0.05 was considered statistically significant. SPSS was used for all analyses.
Results:
A total of 76 RCTs were included in the analysis (38 from JCIM and 38 from CJIM). Significant improvements in both the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) were observed over time in the adopter journal (JCIM) (P value 0.001) (Table 1). Overall CONSORT score of studies published from 2010–2011 (post-CONSORT) increased 15.30 averagely with 95%CI: 8.34 to 22.26 (P value 0.001), of those, items addressing reporting of methodological quality were significantly different too, JCIM had more 1.30 items addressed than CJIM in average (95% CI: 0.52 to 2.08, P value 0.003) (Table 2). In multivariate analysis regression, the page length and CONSORT-promoting status had statistical significance (P values 0.001, and 0.040 respectively) (Table 3).
Conclusion:
Although a large area of reporting of RCTs in TCM needs to be improved, the impact for improvement of reporting of RCTs on TCM has been proven to some extent.