Chatterjee 2011 |
Low risk of bias |
A random allocation sequence was used. Allocation was concealed until after participant enrolment. There were no substantial differences between arms at baseline. |
Low risk of bias |
We assumed that an ethical consent to a psychosocial intervention would require participants to be aware of which are they were assigned to. We also assumed it would require intervention practitioners to be aware of allocation. We did not mark risk of bias based on these factors. No deviation from the intervention was noted. The study does not report fidelity to model. Analysis was conducted on an intent‐to‐treat basis. |
Low risk of bias |
Follow up data were available from nearly all participants randomised; 167/187 intervention arm, 86/95 control arm (overall 90%). We have assumed this is the same for all outcomes. |
Low risk of bias |
Count of hospital admissions has been used as one of four indications of severe adverse events. We consider this to be an appropriate measure. Researchers were masked as to allocation. |
Low risk of bias |
Results were produced in line with a pre‐specified analysis plan in the form of a protocol paper. The extent to which this was published before unblinded outcome data was available is unknown and likely limited by the nature of psychosocial interventions. We did not deem this to increase risk of bias. Results were not considered to have been selected from multiple eligible analyses of the data. |
Low risk of bias |
There was a random allocation sequence, which was concealed from participants. Data were available for nearly all partipants randomised. An appropriate measure was used. Results were produced in line with protocol paper. |