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Study flow diagram.
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Study flow diagram.

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Table 2. Outline design for a randomised trial of de‐escalation technique

Methods

Allocation: cluster‐randomised, clearly described, with researched and recorded intra‐class correlation coefficient (ICC) reported.

Blinding: none.

Duration: 2 weeks.

Setting: any psychiatric ward with high rate of aggression.

Participants

Diagnosis: any.

History: people admitted or, or getting admitted to psychiatric ward.

N =*.

Age: adult.

Sex: men or women.

Exclude: those already randomised.

Interventions

1. De‐escalation technique training.

2. Waiting list for training.

The de‐escalation technique training could involve refining of: a. Verbal communication techniques; b. Use of body language; c. Prevention and recognition strategies (risk assessment tools); d. Staff attitudes, knowledge and skills; e. Setting of limits for patients to follow; f. Environmental controls (such as minimising light, noise, conversations and so on) used for the management of aggression ‐ or any combination of these.

Outcomes

Primarily routinely‐recorded binary outcomes.

1. Clinically important changes in global state (short‐term outcomes)

2. Aggression

2.1 Improved to an important extent
2.2 Deterioration: incidence of violence to self or others (harm)
2.3 Changes in aggression as recorded by any other outcomes

2.4 Recurrance of aggression

3. Adverse effects

3.1 Physical adverse effects
3.2 Death, suicide or natural causes
3.3 Psycological adverse effects

4. Service outcomes

4.1 Time in hospital

5. Acceptability

5.1 To staff

5.2 To patients

6. Cost

Notes

* We are unclear of power calculations at this point. It is likely that the sample of people will have to total at least 300 to gain sufficient power to find clear outcomes that are likely to effect clinical practice, but this figure would have to be modified depending on a well‐researched (not imputed) ICC.

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Table 2. Outline design for a randomised trial of de‐escalation technique
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Summary of findings for the main comparison. De‐escalation for aggression thought to be due to psychosis versus standard care

Patient or population: people who are aggressive secondary to serious mental illness
Settings: anywhere
Intervention: de‐escalation versus standard care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Standard care control

De‐escalation technique

Clinically important changes in global state

We identified no relevant studies.

Aggression ‐ Improved to an important extent

Aggression ‐ deterioration: incidence of violence to self or others

Aggression ‐ changes in aggression as recorded by any other outcomes

Adverse effects ‐

physical adverse effects

Adverse effects ‐ death, suicide or natural causes

Adverse effects ‐ psychological adverse effects

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

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Summary of findings for the main comparison. De‐escalation for aggression thought to be due to psychosis versus standard care
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Table 1. Other relevant Cochrane reviews

Focus of review

Reference

Completed and maintained reviews

'As required' medication regimens for seriously mentally ill people in hospital

Douglas‐Hall 2015

Benzodiazepines for psychosis‐induced aggression or agitation

Gillies 2013

Chlorpromazine for psychosis‐induced aggression or agitation

Ahmed 2010

Clotiapine for acute psychotic illnesses

Berk 2004

Containment strategies for people with serious mental illness

Muralidharan 2006

Droperidol for acute psychosis

Khokhar 2016

Haloperidol for psychosis‐induced aggression or agitation (rapid tranquillisation)

Powney 2012

Haloperidol plus promethazine for psychosis‐induced aggression

Huf 2016

Olanzapine IM or velotab for acutely disturbed/agitated people with suspected serious mental illnesses

Belgamwar 2005

Seclusion and restraint for serious mental illnesses

Sailas 2000

Zuclopenthixol acetate for acute schizophrenia and similar serious mental illnesses

Jayakody 2012

Reviews in the process of being completed

Clozapine for people with schizophrenia and recurrent physical aggression

Toal 2012

De‐escalation techniques for managing aggression

Spencer 2016

Haloperidol for long‐term aggression in psychosis

Khushu 2016

Loxapine inhaler for psychosis‐induced aggression

Vangala 2012

Quetiapine for psychosis‐induced aggression or agitation

Wilkie 2012

Risperidone for psychosis‐induced aggression or agitation

Ahmed 2011

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Table 1. Other relevant Cochrane reviews
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