Study
Rater
Domain	Criteria	Review authors’ judgment
Sequence generation	Investigators describe a random component in the sequence generation such as: Referring to a random number table Using a computer random number generator Coin tossing Shuffling cards or envelopes Throwing dice Drawing of lots minimization	Was the allocation sequence adequately generated? YES / NO / UNCLEAR
Allocation concealment	Participants and investigators enrolling participants could not foresee assignment because one of the following or an equivalent method was used to conceal allocation: Central allocation (including telephone, web‐based and pharmacy‐controlled allocation) Sequential numbered drug containers of identical appearance Sequentially numbered, opaque, sealed envelopes.	Was allocation adequately concealed? YES / NO / UNCLEAR
Blinding of participants, personnel and outcome assessors Outcome:	Was knowledge of the interventions adequately prevented during the study: No blinding, but the review author’s judge that the outcome and outcome measurement are not likely to be influenced by lack of blinding. Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. Either the participants or some key study personnel were not blinded, but outcome assessment was blinded and the non‐blinding of others unlikely to introduce bias.	Was knowledge of the allocated intervention adequately prevented during the study? YES / NO / UNCLEAR
Incomplete outcome data Outcome:	Were incomplete data adequately addressed: No missing outcome data Reasons for missing outcome data unlikely to be related to true outcome. Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate. For continuous outcome data, plausible effect size among missing outcomes not enough to have a clinically relevant impact on observed effect size. Missing data have been imputed using appropriate methods.	Were incomplete outcome data adequately addressed? YES / NO / UNCLEAR
Selective outcome reporting	Are reports of the study free of suggestion of selective outcome reporting? The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way. The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon).	Are reports of the study free of suggestion of selective outcome reporting? YES / NO / UNCLEAR
Other sources of bias	Was the study apparently free of other problems that could put it at risk of bias? (this is a wastebasket category for anything that we may identify that is unique to this group of studies that could potentially introduce bias). NOTE: Cochrane notes that it is likely that the majority of studies will fall in the unclear category for this quality item.	Was the study apparently free of other problems that could put it at a high risk of bias? YES / NO / UNCLEAR
Industry sponsorship		YES / NO / UNCLEAR