Table 1. Suggested design of study.
Type of study | Patients | Interventions | Outcomes | Notes |
---|---|---|---|---|
Allocation: the randomisation process should be clearly described. Double-blind evaluation of the outcomes of a lifestyle intervention is extremely difficult, and probably impossible. Trialists should, take every precaution to minimise the effect of biases by using blind or independent raters. Intention-to-treat analysis is preferable. Trialists should describe from which groups with-drawals came, why they occurred and what was their outcome. Duration: Two year follow-up at minimum. Setting: in a situation where hospitalisation of people from schizophrenia tends to extend well beyond 28 days - perhaps in a low-middle income country setting |
Diagnosis: people with schizophrenia or schizophrenia-like illnesses. Age: all ages. Sex: men & women. N=300.* History: people needing admission. |
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Service outcomes: read-mission, use of day hospital. Loss to follow up. Functioning: including employment. Serious events: any, list. Satisfaction. Quality of life. Economic outcomes. |
* Size of study with sufficient power to highlight ~10% difference between groups for primary outcome |