Allocation sequence generation
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High risk
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Non-randomised method used
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Allocation concealment
|
High risk
|
Controlled before and after study
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Similarity in baseline outcome measurements
|
High risk
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Although all sites had low recruitment prior to the intervention, this was imbalanced across the sites
|
Similarity in baseline characteristics
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Low risk
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Similar recruitment processes across sites
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Incomplete outcome data addressed
|
Low risk
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No missing data
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Knowledge of the allocated intervention
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Low risk
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Objective outcomes, not affected by knowledge of the intervention
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Protection against contamination
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Low risk
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Allocation was by study site
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Free from selective reporting
|
Low risk
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All pre-specified outcomes are reported
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Free from other risks of bias
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Unclear risk
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Possible risk from confounders
|