Criteria for a judgement of 'Low risk' of bias. |
Any one of the following.
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 (difference in means or standardized difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size.
Missing data have been imputed using appropriate methods.
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Criteria for the judgement of 'High risk' of bias. |
Any one of the following.
Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.
For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate.
For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size.
'As‐treated' analysis done with substantial departure of the intervention received from that assigned at randomization.
Potentially inappropriate application of simple imputation.
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Criteria for the judgement of 'Unclear risk' of bias. |
Any one of the following.
Insufficient reporting of attrition/exclusions to permit judgement of 'Low risk' or 'High risk' (e.g. number randomized not stated, no reasons for missing data provided).
The study did not address this outcome.
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