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.