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. 2016 Aug 23;2016(8):CD008011. doi: 10.1002/14651858.CD008011.pub3

1. Criteria list for the assessment of risk of bias of included studies.

Item ID Description Implementation
Selection bias
a Was the allocation sequence adequately generated? Adequate when a random (and therefore unpredictable) sequence was used to allocate the intervention to the participants
b Was allocation adequately concealed? Adequate when the upcoming allocations of participants were masked from those involved in enrolment into the trial
Performance bias
c Was knowledge of the allocated intervention by participants adequately prevented during the study? Adequate when the participants were unaware of the intervention they received
d Was knowledge of the allocated intervention by personnel adequately prevented during the study? Adequate when the personnel involved in the care of the participants were unaware of the intervention a participant received
Detection bias (for each outcome separately)
e Was knowledge of the allocated intervention by the outcome assessor adequately prevented during the study? Adequate when the outcome assessor was unaware of the intervention a participant received
Attrition bias (for each outcome separately)
f Was the follow‐up of the outcome complete? Complete when the outcome was assessed in at least 80% of the study cohort
g Was an intention‐to‐treat‐analysis performed? Adequate when all participants were analysed in the treatment group to which they were randomised, regardless of whether or not they received the allocated intervention
Reporting bias
h Are reports of the study free of the suggestion of selective outcome reporting? Adequate when a study protocol was available that prespecified study outcomes and analyses, which were all reported in the final study report
Other sources of bias
i Was the study apparently free of other problems that could put it at a high risk of bias? Adequate when there were no other important personal concerns about bias not addressed in the other domains in the tool

All items were scored yes, no, or unclear.