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We identified a significantly higher rate of reporting of key methodological items in CONSORT endorsing journals (fig 3).
The responses of the experts to reporting items and methodological items in all rounds are presented in Additional File 1.
22 When assessing the reporting of key methodological items in CONSORT endorsing as opposed to non-endorsing journals, we identified significantly better reporting in CONSORT endorsing journals.
Much of our study's method and protocol design models another study that also looked at the association between a PICOT structured research question and quality of reporting and reporting of key methodological items in RCTs, separately [ 24].
Differences of the reporting quality of key methodological items in proportions in 1998 versus 2008 were tested using Chi-square analysis, and expressed as risk ratio (RR) with 95%CI.
Our analysis, although not exhaustive, suggests a significant improvement between 1998 and 2008 in the reporting quality of key methodological items in the major gastroenterology and hepatology journals, which is most likely the result of compliance with the CONSORT Statement.
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Our analysis focused on the reporting of methodological items (items in method and results' sections).
All of these studies showed there is poor quality of reporting, with the 3 key methodological items assessed in this study (appropriate allocation concealment mechanism, blinding and numbers analysed by ITT) being highlighted as poorly reported [ 17, 21, 23- 27, 35, 44].
Also, the overall quality of reporting does not necessarily correspond with the proper reporting of the 3 key methodological items assessed for in this study; 3 items which are deemed important in preventing bias [ 9, 35].
An inter-rater agreement was calculated for each of the three included methodological items as done in a previous study [ 3].
In this study, reporting quality of key methodological items of RCTs published in five major gastroenterology and hepatology journals in 2008 or 1998 were systematically assessed and compared.
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