Bias domain	Issues addressed*
Bias arising from the randomisation process	Whether: the allocation sequence was random; the allocation sequence was adequately concealed; baseline differences between intervention groups suggest a problem with the randomisation process.
Bias due to deviations from intended interventions	Whether: participants were aware of their assigned intervention during the trial; carers and people delivering the interventions were aware of participants’ assigned intervention during the trial. When the review authors’ interest is in the effect of assignment to intervention (see Section 8.2.2): (if applicable) deviations from the intended intervention arose because of the experimental context (i.e. do not reflect usual practice); and, if so, whether they were unbalanced between groups and likely to have affected the outcome; an appropriate analysis was used to estimate the effect of assignment to intervention; and, if not, whether there was potential for a substantial impact on the result. When the review authors’ interest is in the effect of adhering to intervention (see Section 8.2.2): (if applicable) important non‐protocol interventions were balanced across intervention groups; (if applicable) failures in implementing the intervention could have affected the outcome; (if applicable) study participants adhered to the assigned intervention regimen; (if applicable) an appropriate analysis was used to estimate the effect of adhering to the intervention.
Bias due to missing outcome data	Whether: data for this outcome were available for all, or nearly all, participants randomized; (if applicable) there was evidence that the result was not biased by missing outcome data; (if applicable) missingness in the outcome was likely to depend on its true value (e.g. the proportions of missing outcome data, or reasons for missing outcome data, differ between intervention groups).
Bias in measurement of the outcome	Whether: the method of measuring the outcome was inappropriate; measurement or ascertainment of the outcome could have differed between intervention groups; outcome assessors were aware of the intervention received by study participants; (if applicable) assessment of the outcome was likely to have been influenced by knowledge of intervention received.
Bias in selection of the reported result	Whether: the trial was analysed in accordance with a pre‐specified plan that was finalised before unblinded outcome data were available for analysis; the numerical result being assessed is likely to have been selected, on the basis of the results, from multiple outcome measurements within the outcome domain; the numerical result being assessed is likely to have been selected, on the basis of the results, from multiple analyses of the data.