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The inter-rater agreement for the quality of key methodological items was 1 for all items, thus there was perfect agreement.
Also very noteworthy was that the reporting of the key methodological items was poor with less than 50% of the articles reporting any of the 3 key methodological items (Table 3).
Each of the three above mentioned methodological items was scored 1 point if the method was appropriately reported and performed and 0 points if it was inappropriate or ambiguous.
At the beginning of round 1 the Delphi consisted of two domains as determined by the internal working group: quality (internal validity) and generalizability (external validity) After round 1 a clear distinction between reporting items and methodological items was made, as suggested by one of the external experts.
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3) The tool is suitable for rating study quality, that is, a list of methodological items is given that have to be answered or assessed.
Each of the three mentioned methodological items were given a score of 1 if the method was appropriate and 0 if it was inappropriate or vaguely reported.
These three methodological items are: 1) appropriate concealment of allocation, 2) blinding, and 3) numbers analysed (or known as the intention-to-treat principle).
The methodological items are also underreported in studies with a high overall reporting quality score hence emphasizing the need to assess them separately [ 34, 35].
Methodological items were use of the term "randomised" in the study title and specification of the primary outcome, sample size calculation, method of random sequence generation and allocation concealment, who was blinded, and how blinding was achieved.
Compared with those studies [ 15- 18], we have done a more comprehensive evaluation of the methodological reporting, while some of the methodological items were seldom assessed in previous studies, especially the items related to incomplete outcome, ITT analysis and free of selective reporting, which are also important for readers to assess the internal validity of the RCTs.
However, this methodological item was seldom assessed in previous articles evaluating the methodological reporting of RCTs about digestive disease.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com