Table 1. Suggestions for trial design.
Methods | Participants | Interventions | Outcomes | Notes |
---|---|---|---|---|
Allocation: randomised, with sequence generation and concealment of allocation clearly described. Blindness: single. Duration: 12 months at least. Raters: independent. |
Diagnosis: SMI with a clear definition of SMI from the outset. N=300.* History: in need of psychiatric admission. Sex: both. Age: any. |
1. Standard Hospital care: focus on outpatient appointments and only occasional emergency domicillary visits. A 9 till 5 service with little team working with or without care management. N=150. 2. CMHT: community and multidisciplinary team focus. A 9 till 5 service and not primarily emergency assessments. N=150 |
Death. Serious harm to self and others. Service outcomes: hospital admission, readmissions. Leaving the study early. Global and mental state (CGI, binary outcome). ** Use scales as used by Merson a 92 and Tyrer 98. Satisfaction: family burden, patient satisfaction, relative satisfaction, staff burden (binary data) Economic data. |
* Size of study with sufficient power to highlight ~10% difference between groups for primary outcome. ** Primary outcome. |