Bias domain	Issues addressed
Risk of bias arising from the randomisation process	Was the allocation sequence random? Was the allocation sequence concealed until participants were enrolled and assigned to interventions? Did baseline differences between intervention groups suggest a problem with the randomisation process?
Risk of bias due to deviation from the intended intervention (effect of assignment to intervention)	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 interest is in the effect of assignment to intervention: (if applicable) deviations from the intended intervention arose because of the experimental context, 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.
Bias due to missing outcome data	Whether: data for this outcome were available for all, or nearly all, randomised participants; (if applicable) there was evidence that the result was not biased by missing outcome data; (if applicable) missingness in the outcome was likely dependent on its true value (e.g. proportion 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; assessment of the outcome was likely to have been influenced by knowledge of intervention received.
Bias in selection of the reported results	Whether: trial was analysed in accordance with a prespecified 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 (e.g. scales, definitions, time points) 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.