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For each methodological item, we defined adequate reporting based on the Cochrane Collaboration Risk of Bias tool [1], the Consolidated Standards of Reporting Trials (CONSORT) [11], the WHO Trial Registration Data Set (http://www.who.int/ictrp/network/trds/en/index.html) and the instructions for registrants provided by registries (Table 1).
Sometimes, a methodological item could be scored as 'not applicable'.
This score was termed Key Methodological Item Score (KMIS).
Most reports, 15 of 23 (65.2%) did not give any information about this key methodological item.
The number of studies that reported each key methodological item is provided in Table 3.
However, this methodological item was seldom assessed in previous articles evaluating the methodological reporting of RCTs about digestive disease.
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This checklist includes a description of methodological items and instructions on how to use them to transparently report observational studies.
To evaluate the reporting quality of key methodological items of randomized control trials (RCTs) in 55 of the highest ranked journals.
Methodological items retained for vignette generation were income level of the population, types of treatments compared, randomization unit, blinding, treatment-administration site, diagnosis method and criteria, and primary outcome measure.
The methodological choices of the studies were analysed using an analytical grid which contains the main methodological items of COI studies.
Examples of adequate and unclear reporting are shown in Table 3. Concerning other methodological items, weighted overall proportions of trial records with adequately reported items were variable (Table S2).
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