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. 2024 May 7;2024(5):CD009531. doi: 10.1002/14651858.CD009531.pub3

Risk of bias for analysis 1.2 Mental state: clinically important change (binary) ‐ 12 months.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
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 arm 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 intervention. Analysis was on an intent‐to‐treat basis. Low risk of bias Data were available for nearly all participants randomised: 167/187 intervention arm, 86/95 control arm (overall 90%). Low risk of bias The Positive and Negative Syndrome Scale (PANSS) is used to measure schizophrenia symptoms. This is an appropriate measure for this concept. It is unlikely measurement could vary between arms. This is a clinician rated outcome, therefore we deemed it important in determining risk of bias whether outcome assessors were blinded as to allocation. Outcome assessors 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 to which participants and researchers were masked. There was little missing outcome data. An appropriate measure was used and there was masking of assessors. There was a preplaned analysis plan.