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. Author manuscript; available in PMC: 2014 Sep 23.
Published in final edited form as: Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000270. doi: 10.1002/14651858.CD000270.pub2

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.