Methods |
Cluster‐randomized trial of decision aid vs usual care |
Participants |
54 + 59 patients with schizophraenia considering treatment options (cluster‐RCT with 12 wards paired and randomized) in Germany |
Interventions |
DA: 16‐page booklet on options' outcomes, outcome probabilities, explicit values clarification, coaching/guidance
Comparator: usual care |
Outcomes |
Knowledge, participation in decision making (COMRADE ‐ doctor gave me a chance to decided which treatment I thought was best for me), uptake of psycho‐education, rehospitalization, adherence, satisfaction with care, severity of illness (baseline only), attitudes about drug use, decision making preference |
Notes |
Primary outcome was not specified |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
"[O]ne member of each pair being randomly assigned to the control or to the interventional condition" (p 266). Sequence generation method was not stated |
Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No information provided |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No information provided |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for attrition mentioned |
Selective reporting (reporting bias) |
Unclear risk |
No information provided |
Other bias |
High risk |
Clustering was not accounted for in the analysis |