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. 2016 Nov 27;2016(11):CD009830. doi: 10.1002/14651858.CD009830.pub2

2. Suggested design for a randomised trial.

Methods Allocation: randomised, clearly described.
Blinding: double, described and tested.
Duration: 52 weeks.
Participants Diagnosis: have psychoses.
N=300*.
Age: any.
Sex: both.
History: persistently aggressive.
Interventions 1. Haloperidol: dose flexible within recommended limits. N=150.
2. Other antipsychotic drug: dose flexible within recommended limits. N=150.
Outcomes Outcomes grouped into short term (3 months or less), medium term (> 3 and up to 6 months or less) and long‐term (> 6 months).
Aggression: events.
Adverse effects.
Specific behaviours ‐ self harm including suicide, injury to others, aggression.
Global outcomes ‐ overall improvement, use of additional medication, use of restraints/seclusion.
Service outcomes ‐ duration of hospital stay, re‐admission.
Mental state ‐ no clinically important change in general mental state.
Leaving the study early ‐ why.
Satisfaction with and acceptance of treatment.
Quality of life ‐ no clinically important change in quality of life.
Economic outcomes.
Notes * Powered to be able to identify a difference of ˜ 20% between groups for primary outcomes with adequate degree of certainty.

N: number of participants.