Cochrane Database of Systematic Reviews

De-escalation techniques for psychosis-induced aggression or

agitation (Review)

Du M, Wang X, Yin S, Shu W, Hao R, Zhao S, Rao H, Yeung WL, Jayaram MB, Xia J

Du M, Wang X, Yin S, Shu W, Hao R, Zhao S, Rao H, Yeung WL, Jayaram MB, Xia J.
De-escalation techniques for psychosis-induced aggression or agitation.
Cochrane Database of Systematic Reviews 2017, Issue 4. Art. No.: CD009922.
DOI: 10.1002/14651858.CD009922.pub2.

www.cochranelibrary.com

De-escalation techniques for psychosis-induced aggression or agitation (Review)

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . 3
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . 24

De-escalation techniques for psychosis-induced aggression or agitation (Review) i

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

De-escalation techniques for psychosis-induced aggression or

agitation

Maolin Du1 , Xuemei Wang1 , Shaohua Yin1 , Wei Shu1 , Ruiqi Hao1 , Sai Zhao2 , Harish Rao3 , Wan-Ley Yeung4 , Mahesh B Jayaram5 ,
Jun Xia2
1 Schoolof Public Health, Inner Mongolia Medical University, Hohhot, China. 2 Systematic Review Solutions Ltd, The Ingenuity
Centre, The University of Nottingham, Nottingham, UK. 3 Psychiatry, Borough Road and Nunthorpe Medical Group, Middlesbrough,
UK. 4 Bridge House Community Mealth Health Team, Leeds, UK. 5 Department of Psychiatry, Melbourne Neuropsychiatry Centre,
Melbourne, Australia

Contact address: Xuemei Wang, School of Public Health, Inner Mongolia Medical University, Jinshan Development District„ Hohhot,
Inner Mongolia, 010110, China. wangxm_zsu@163.com.

Editorial group: Cochrane Schizophrenia Group.

Publication status and date: Edited (no change to conclusions), published in Issue 4, 2017.

Citation: Du M, Wang X, Yin S, Shu W, Hao R, Zhao S, Rao H, Yeung WL, Jayaram MB, Xia J. De-escalation techniques
for psychosis-induced aggression or agitation. Cochrane Database of Systematic Reviews 2017, Issue 4. Art. No.: CD009922. DOI:
10.1002/14651858.CD009922.pub2.

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
Aggression is a disposition, a willingness to inflict harm, regardless of whether this is behaviourally or verbally expressed and regardless
of whether physical harm is sustained.
De-escalation is a psychosocial intervention for managing people with disturbed or aggressive behaviour. Secondary management
strategies such as rapid tranquillisation, physical intervention and seclusion should only be considered once de-escalation and other
strategies have failed to calm the service user.
Objectives
To investigate the effects of de-escalation techniques in the short-term management of aggression or agitation thought or likely to be
due to psychosis.
Search methods
We searched Cochrane Schizophrenia Group’s Study-Based Register of Trials (latest search 7 April, 2016).
Selection criteria
Randomised controlled trials using de-escalation techniques for the short-term management of aggressive or agitated behaviour. We
planned to include trials involving adults (at least 18 years) with a potential for aggressive behaviour due to psychosis, from those in a
psychiatric setting to those possibly under the influence of alcohol or drugs and/or as part of an acute setting as well. We planned to
include trials meeting our inclusion criteria that provided useful data.
Data collection and analysis
We used the standard methodological procedures expected by Cochrane. Two review authors inspected all abstracts of studies identified
by the search process. As we were unable to include any studies, we could not perform data extraction and analysis.
De-escalation techniques for psychosis-induced aggression or agitation (Review) 1
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Of the 345 citations that were identified using the search strategies, we found only one reference to be potentially suitable for further
inspection. However, after viewing the full text, it was excluded as it was not a randomised controlled trial.
Authors’ conclusions
Using de-escalation techniques for people with psychosis induced aggression or agitation appears to be accepted as good clinical practice
but is not supported by evidence from randomised trials. It is unclear why it has remained such an under-researched area. Conducting
trials in this area could be influenced by funding flow, ethical concerns - justified or not - anticipated pace of recruitment as well
the difficulty in accurately quantifying the effects of de-escalation itself. With supportive funders and ethics committees, imaginative
trialists, clinicians and service-user groups and wide collaboration this dearth of randomised research could be addressed.

PLAIN LANGUAGE SUMMARY

De-escalation techniques for psychosis-induced aggression or agitation
Review question:
Are de-escalation techniques effective for managing psychosis-induced aggression or agitation?
Background
Aggression is a willingness to inflict harm, regardless of whether this is behaviourally or verbally expressed and regardless of whether
physical harm is sustained.
De-escalation is a psychosocial intervention for management of aggressive or agitated behaviour. It uses techniques that help someone
with aggression or agitation to self-monitor their emotions and self-manage their behaviour to try and stop aggressive behaviour
escalating.
Searches
We ran electronic searches (last searched April 2016) for trials that randomised people with psychosis who were displaying aggressive or
agitated behaviour to receive de-escalation techniques, standard care or other intervention to manage aggression. Three-hundred and
forty-five records were found and checked by the review authors.
Results
No trials met the review requirements. There is no trial-based evidence currently available assessing the effectiveness of de-escalation
techniques for managing aggression or agitation.
Conclusions
It is unclear why there are no randomised trials. Several issues such as cost, ethical considerations, difficulty recruiting people into trials,
as well the ability to accurately quantify the effects of de-escalation itself could all be contributing factors. Meanwhile, de-escalation
techniques are currently used without any trial-based evidence that they are effective.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 2

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
De-escalation techniques for psychosis-induced aggression or agitation (Review) S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

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

Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evidence Comments
(95% CI) (studies) (GRADE)

Assumed risk Corresponding risk

Standard care control De- escalation tech-

nique

Clinically im portant We identif ied no relevant studies.

changes in global state

Aggression - Im proved
to an im portant extent

Aggression - deteriora-
tion: incidence of vio-
lence to self or others

Aggression - changes in
aggression as recorded
by any other outcom es

Adverse ef f ects -
physical adverse ef -
f ects

Adverse ef f ects - death,

suicide or natural
causes
3
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
De-escalation techniques for psychosis-induced aggression or agitation (Review)

Adverse ef f ects - psy-

chological adverse ef -
f ects

* The basis f or the assumed risk (e.g. the m edian control group risk across studies) is provided in f ootnotes. The corresponding risk (and its 95% conf idence interval) is
based on the assum ed risk in the com parison group and the relative effect of the intervention (and its 95% CI).
CI: Conf idence interval;

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our conf idence in the estim ate of ef f ect.
M oderate quality: Further research is likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and m ay change the estim ate.
Low quality: Further research is very likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and is likely to change the estim ate.
Very low quality: We are very uncertain about the estim ate.
4
BACKGROUND the patient’s perspective, being asleep is also less traumatic than
being physically restrained (Andrade 2007).

Description of the condition How the intervention might work

Aggression is a range of behaviours or actions to inflict harm, There are competing theoretical approaches to de-escalation, in-
hurt or injury to anther person regardless of whether this is be- cluding verbal de-escalation. Some approaches make use of com-
haviourally or verbally expressed and regardless of whether physical munication theory (Paterson 1997), others of situational analy-
harm is sustained or intention is clear (NICE 2015). Aggression sis (Rix 2001). All approaches emphasise the need to observe for
can present in a variety of settings including emergency rooms, signs and symptoms of anger and agitation, approaching the per-
inpatient unit, community and primary care settings and some son in a calm controlled manner, giving choices and maintaining
times in police cells. Untreated, this can quickly escalate risks to the service user’s dignity. Some approaches suggest mirroring the
the patient, healthcare professionals and family members who are patient’s mood.
often victims of violence (Bourget 2002; Maguire 2007). De-escalation methods help by establishing a positive therapeutic
The incidence of aggression is more frequent in emergency depart- alliance with the patient, and the active collaboration of the pa-
ments (25%) and inpatient psychiatric hospitals (32.4%) (Bowers tient in the treatment process with behavioural expectations and
2011; NHS Protect 2013). The relationship between psychosis prescribed treatments it makes it easier to manage patient-staff
and violence is uncertain. There is some evidence to suggest that conflicts and de-escalate aggressive episodes (Levenson 2004).
individuals with a mental disorder/severe mental disorder are more
likely to be violent than the general population (Fazel 2006; van
Dorn 2012); however others have argued that it is substance mis-
Why it is important to do this review
use, instead of a mental health problem itself that increases the
risk for violence (Elbogen 2009). A recently published guideline Guidelines recommend de-escalation as an intervention in their
indicated that a mental disorder is probably only a predictive fac- algorithms for managing patients with acute aggression (NICE
tor of violence, and that substance misuse is more likely related to 2015). A recent report notes that, despite the emphasis that is often
the incidence of violence (NICE 2015). Swift containment of the placed on the importance of de-escalation, little research has been
situation is essential and preventive de-escalation techniques, such carried out into the effectiveness of any given approach, leaving
as restraint, should be utilised prior to interventional measures for nurses to contend with conflicting advice and theories. Also, a sur-
the management of aggression (NICE 2015). vey of guidelines suggests that recommendations based on NICE
were of (grade D) and there were no trials or systematic reviews in
this area. There is also lack of evidence regarding effectiveness of
rapid tranquillisation, physical intervention and seclusion (Yeung
Description of the intervention 2009).
De-escalation is an intervention using emotional regulation or self- There is no standard approach to de-escalation (Paterson 1997).
management techniques to avert aggressive or violent behaviour There has been little research conducted into the effectiveness of
(NICE 2015). ’The assault cycle’ typically includes a trigger phase, different approaches to de-escalation, or, for that matter, into the
escalation phase, crisis phase, recovery phase and depression phase effectiveness of training in any given approach. There is thus an
(Kaplan 1983). De-escalation is a complex range of skills designed urgent need to systematically review the available evidence evalu-
to abort the assault cycle during the escalation phase, and this ating the effectiveness of de-escalation in managing patients with
includes both verbal and non-verbal communication skills (CRAG acute aggression.
1996). This is one of a series of related Cochrane reviews (Table 1).
De-escalation is part of the process of managing aggression and is
usually recommended as either a preventative measure or an early
step to prevent deterioration in the patient’s condition. Secondary
management strategies such as rapid tranquillisation, physical in- OBJECTIVES
tervention and seclusion should only be considered once de-es-
calation and other strategies have failed to calm the service user To investigate the effects of de-escalation techniques in the short-
(NICE 2015). Regrettably, these recommendations are impracti- term management of aggression or agitation thought or likely to
cal in most emergency medical settings in developing countries, be due to psychosis.
where resources are strained by heavy patient loads and under-
staffing, and where a sleeping patient is better than one who needs
constant observation to assess the need for tranquillisation. From METHODS

De-escalation techniques for psychosis-induced aggression or agitation (Review) 5

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Criteria for considering studies for this review Types of outcome measures
The effects of de-escalation techniques for managing aggression
would usually be immediate (15 minutes) to short term (one to
Types of studies two hours).
We planned to select all relevant randomised controlled trials us-
ing de-escalation techniques for the management of aggressive be-
haviour. If a trial was described as ’double blind’ but implied ran- Primary outcomes
domisation, we would have included such trials in a sensitivity
analysis (see Sensitivity analysis). We planned to exclude quasi-ran-
domised studies, such as those allocating by alternate days of the 1. Clinically important change in global state: as defined by
week. For trials where people were given additional treatments, we studies
would have included the data if the adjunct treatment was evenly
distributed between groups and it was only the de-escalation that
was randomised. 2. Aggression
2.1 Improved to an important extent
Types of participants 2.2 Deterioration: incidence of violence to self or others (harm)
2.3 Changes in aggression as recorded by any other outcomes
We would have included adults (at least 18 years) with a potential
for aggressive behaviour due to psychosis, from those in a psychi-
atric setting to those possibly under the influence of alcohol or 3. Adverse effects
drugs and/or as part of an acute setting as well.
3.1 Physical adverse effects
Types of aggressive behaviours can include the following.
3.2 Death, suicide or natural causes
1. Verbal abuse
3.3 Psycological adverse effects
2. Non-verbal abuse
3. Physical violence to self/others
4. Threatening behaviours
Secondary outcomes
5. Assault

Types of interventions 1. Global state

1.1 Relapse: as defined by individual studies
1.2 Any change in global state
1. De-escalation:

NICE 2015 defines de escalation as the use of techniques (in- 2. Mental state
cluding verbal and non-verbal communication skills) aimed at de-
2.1 Changes to mental state deemed clinically significant by study
fusing anger and averting aggression. Prescibed ’as required’ (’pro
2.2 Continuous measures of mental state
re nata’ or p.r.n.) medication can be used as part of a de-escalation
2.3 Psychiatric symptoms
strategy but, used alone is not de-escalation.
There are various techniques that can be used to defuse an aggres-
sive situation.
3. Leaving the study early
1. Verbal communication techniques
2. Use of body language
3. Prevention and recognition strategies (risk assessment tools)
4. Staff attitudes, knowledge and skills 4. Service use
5. Setting of limits for patients to follow 4.1 Hospital admission
6. Environmental controls (such as minimising light, noise, 4.2 Length of stay in hospital
conversations and so on) used for the management of aggression 4.3 Changes to hospital status
De-escalation does not involve restraint, medication used alone or
seclusion.
We planned to include trials that used the above techniques specif- 5. Social functioning
ically during, or prior to, aggressive or agitated behaviour. 5.1 Continuous measures in social functioning

De-escalation techniques for psychosis-induced aggression or agitation (Review) 6

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
6 Satisfaction Electronic searches
6.1 Patient satisfaction Cochrane Schizophrenia Group’s Study-based Register of Tri-
6.2 Carer satisfaction als
6.3 Changes to quality of life defined as significant by individual On 7 April, 2016, the Information Specialist searched the register
studies using the following search strategy which has been developed based
on literature review and consulting with the authors of the review:
((*Aggress* OR *Agitat* OR *Violen*) in Title OR Abstract of
7. Economic outcomes REFERENCE OR Intervention of STUDY) AND ((*De-Escalat*
OR *Deescalat* OR *De-Stimulat* OR *Destimulat* OR *De-
Fus* OR *Defus* OR *One-To-One* OR *One To One* OR
*Diffuse* OR *Calming* OR *Non Aversive* OR *Non-Aversive*
8. Aggression/behaviour OR *Non Confrontat* OR *Non-Confrontat* OR *Psycho So-
8.1 Changes in verbal aggression cial* OR *Psycho-Social* OR *Verbal* OR *Talk* OR *Nurse*
8.2 Changes in violence towards objects Role*) in Title OR Abstract of REFERENCES)
8.3 Other changes in behaviour In such a study-based register, searching the major concept re-
trieves all the synonyms and relevant studies because all the stud-
ies have already been organised based on their interventions and
’Summary of findings’ table linked to the relevant topics.
This register is compiled by systematic searches of major resources
We intended to use the GRADE approach to interpret find-
(including MEDLINE, Embase, AMED, BIOSIS, CINAHL,
ings (Schünemann 2008) and to use the GRADE profiler (
PsycINFO, PubMed, and registries of clinical trials), and their
GRADEPRO) to import data from RevMan 5 (Review Manager)
monthly updates, handsearches, grey literature, and conference
to create ’Summary of findings’ tables. These tables provide out-
proceedings (see Group’s Module). There is no language, date,
come-specific information concerning the overall quality of evi-
document type, or publication status limitations for inclusion of
dence from each included study in the comparison, the magnitude
records into the register.
of effect of the interventions examined, and the sum of available
For previous searches, please see Appendix 1.
data on all outcomes we rate as important to patient-care and deci-
sion making. We intended to select the following main outcomes
for inclusion in the ’Summary of findings’ table. Searching other resources

1. Reference searching
1. Clinically important changes in global state (short-term
outcomes) We would have inspected the references of all included studies for
further relevant studies.

2. Aggression 2. Personal contact

We would have contacted the first author of each included study
2.1 Improved to an important extent
for information regarding unpublished trials.
2.2 Deterioration: incidence of violence to self or others (harm)
2.3 Changes in aggression as recorded by any other outcomes

Data collection and analysis

3. Adverse effects
3.1 Physical adverse effects Selection of studies
3.2 Death, suicide or natural causes Review authors WY and HR inspected all abstracts of studies iden-
3.3 Psycological adverse effects tified as above for potentially relevant reports. In addition, to en-
sure reliability, review author MBJ inspected a random sample of
these abstracts, comprising 20% of the total. Where disagreement
occurred, this was resolved by discussion, or where there was still
Search methods for identification of studies doubt, we obtained the full article for further inspection. We ac-
No language or publication status restriction was applied within quired the full article of the relevant report for reassessment and
the limitations of the search tools. carefully inspected for a final decision on inclusion(see Criteria

De-escalation techniques for psychosis-induced aggression or agitation (Review) 7

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
for considering studies for this review). Once the full article was 2.3 Endpoint versus change data
obtained, in turn MD and WS inspected the full report and in- There are advantages of both endpoint and change data. Change
dependently decided whether it met inclusion criteria. MD and data can remove a component of between-person variability from
WS were not blinded to the names of the authors, institutions or the analysis. On the other hand, calculation of change needs two as-
journal of publication. sessments (baseline and endpoint) which can be difficult in unsta-
ble and difficult to measure conditions such as schizophrenia. We
decided primarily to use endpoint data, and only use change data if
Data extraction and management
the former were not available. We would have combined endpoint
and change data in the analysis as we would have preferred to use
mean differences (MD) rather than standardised mean differences
1. Extraction
(SMD) throughout (Higgins 2011).
Review author MD and SY would have extracted data from all in-
cluded studies. In addition, to ensure reliability, if trials had been
found, XW would have independently extracted data from a ran- 2.4 Skewed data
dom sample of these studies, comprising 20% of the total. Again, Continuous data on clinical and social outcomes are often not
we would have discussed any disagreement, documented decisions normally distributed. To avoid the pitfall of applying parametric
and, if necessary, contacted authors of studies for clarification. tests to non-parametric data, we planned to apply the following
With remaining problems, XW would have helped clarify issues standards to all data before inclusion:
and we would have documented these final decisions. We would
have extracted data presented only in graphs and figures whenever a) standard deviations (SDs) and means are reported in the paper
possible, but included the data only if two review authors indepen- or obtainable from the authors;
dently had the same result. We would have attempted to contact b) when a scale starts from the finite number zero, the SD, when
authors through an open-ended request in order to obtain miss- multiplied by two, is less than the mean (as otherwise the mean is
ing information or for clarification whenever necessary. If studies unlikely to be an appropriate measure of the centre of the distri-
were multi-centre, where possible, we would have extracted data bution, (Altman 1996);
relevant to each component centre separately. c) if a scale started from a positive value (such as the Positive and
Negative Syndrome Scale (PANSS, Kay 1986), which can have
values from 30 to 210), we planned to modify the calculation
2. Management described above to take the scale starting point into account. In
these cases skew is present if 2 SD > (S-S min), where S is the
mean score and S min is the minimum score.
2.1 Forms Endpoint scores on scales often have a finite start and end point and
We planned to extract data onto standard, simple forms. these rules can be applied. We would have presented skewed end-
point data from studies of less than 200 participants as other data
within the data analyses section rather than in analyses. Skewed
2.2 Scale-derived data data pose less of a problem when looking at means if the sample
We would have included continuous data from rating scales only size is large (> 200) and we would have entered these into the
if: syntheses.
a. the psychometric properties of the measuring instrument had When continuous data are presented on a scale that include a
been described in a peer-reviewed journal (Marshall 2000); and possibility of negative values (such as change data), it is difficult
b. the measuring instrument had not been written or modified by to tell whether data are skewed or not. We would have entered
one of the trialists for that particular trial. change data, regardless of sample size, into the analyses.
Ideally, the measuring instrument should either be i. a self-report
or ii. completed by an independent rater or relative (not the ther-
2.5 Common measure
apist). We realise that this is not often reported clearly, and we
would have noted in the ’Description of studies’ if this was the To facilitate comparison between trials, we intended to convert
case or not. variables that can be reported in different metrics, such as days in
c) the instrument should be a global assessment of an area of func- hospital (mean days per year, per week or per month) to a common
tioning and not sub-scores which are not, in themselves, validated metric (e.g. mean days per month).
or shown to be reliable. However there are exceptions, and we
would have included sub-scores from mental state scales measur-
2.6 Conversion of continuous to binary
ing positive and negative symptoms of schizophrenia.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 8

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Where possible, we would have made efforts to convert outcome 2. Continuous data
measures to dichotomous data. This can be done by identifying For continuous outcomes, we would have estimated the MD be-
cut-off points on rating scales and dividing participants accord- tween groups. We prefer not to calculate effect size measures
ingly into ’clinically improved’ or ’not clinically improved’. It is (SMD). However, if scales of very considerable similarity had been
generally assumed that if there is a 50% reduction in a scale- used, we would have presumed there was a small difference in
derived score such as the Brief Psychiatric Rating Scale (BPRS, measurement, and we would have calculated effect size and trans-
Overall 1962) or the PANSS (Kay 1986), this could be considered formed the effect back to the units of one or more of the specific
as a clinically significant response (Leucht 2005; Leucht 2005a). If instruments.
data based on these thresholds were not available, we would have
used the primary cut-off presented by the original authors.
Unit of analysis issues

2.7 Direction of graphs

Where possible, we would have entered data in such a way that the 1. Cluster trials
area to the left of the line of no effect indicates a favourable out- Studies increasingly employ ’cluster-randomisation’ (such as ran-
come for de-escalation. Where keeping to this would have made it domisation by clinician or practice), but analysis and pooling of
impossible to avoid outcome titles with clumsy double-negatives clustered data poses problems. Firstly, authors often fail to account
(e.g. ’Not improved’), we would have reported data where the left for intra-class correlation in clustered studies, leading to a ’unit
of the line indicates an unfavourable outcome. This would have of analysis’ error (Divine 1992) whereby P values are spuriously
been noted in the relevant graphs. low, confidence intervals unduly narrow and statistical significance
overestimated. This causes type I errors (Bland 1997; Gulliford
1999).
Assessment of risk of bias in included studies
Where clustering was not accounted for in primary studies, we
Again, review authors MD and WS would have worked indepen- would have presented data in a table, with a (*) symbol to indicate
dently to assess risk of bias using criteria described in the Cochrane the presence of a probable unit of analysis error. We would have
Handbook for Systematic Reviews of Interventions (Higgins 2011) sought to contact first authors of such studies to obtain intra-class
to assess trial quality. This set of criteria is based on evidence of correlation coefficients (ICCs) for their clustered data and adjusted
associations between overestimate of effect and high risk of bias of for this by using accepted methods (Gulliford 1999). Where clus-
the article such as sequence generation, allocation concealment, tering had been incorporated into the analysis of primary studies,
blinding, incomplete outcome data and selective reporting. we would have presented these data as if from a non-cluster ran-
If the raters disagreed, the final rating would have been made by domised study, but adjusted for the clustering effect.
consensus, with the involvement of another member (SZ) of the We were advised that we needed to reduce the size of each trial to
review group. If inadequate details of randomisation and other its ’effective sample size’ (Rao 1992). The effective sample size of a
characteristics of trials had been provided, we would have con- single intervention group in a cluster-randomised trial is its origi-
tacted the authors of the studies in order to obtain further in- nal sample size divided by a quantity called the ’design effect’. This
formation. We would have reported non-concurrence in quality is calculated using the mean number of participants per cluster
assessment, but if disputes had arisen as to which category a trial (m) and the ICC [Design effect = 1+(m-1)*ICC] (Donner 2002).
was to be allocated, again, resolution would have been made by If the ICC was not reported, we would have assumed it to be 0.1
discussion. (Ukomunne 1999). A common design effect is usually assumed
We would have noted the level of risk of bias in both the text of across intervention groups. For dichotomous data, both the num-
the review and in the ’Summary of findings’ table. ber of participants and the number experiencing the event are di-
vided by the same design effect. Since the resulting data must be
rounded to whole numbers for entry into RevMan, this approach
Measures of treatment effect may be unsuitable for small trials. For continuous data, only the
sample size needs to be reduced; means and SDs should remain
unchanged.
1. Binary data
For binary outcomes, we would have calculated a standard estima-
tion of the risk ratio (RR) and its 95% confidence interval (CI). 2. Cross-over trials
It has been shown that RR is more intuitive (Boissel 1999) than A major concern of cross-over trials is the carry-over effect. It oc-
odds ratios and that odds ratios tend to be interpreted as RR by curs if an effect (e.g. pharmacological, physiological or psycholog-
clinicians (Deeks 2000). ical) of the treatment in the first phase is carried over to the second

De-escalation techniques for psychosis-induced aggression or agitation (Review) 9

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
phase. As a consequence, on entry to the second phase, the par- 3.2 Standard deviations (SDs)
ticipants can differ systematically from their initial state despite a If SDs were not reported, we would have first tried to obtain the
wash-out phase. For the same reason cross-over trials are not ap- missing values from the authors. If not available, where there were
propriate if the condition of interest is unstable (Elbourne 2002). missing measures of variance for continuous data, but an exact
As both effects are very likely in severe mental illness, we would standard error (SE) and confidence intervals available for group
have only used data from the first phase of cross-over studies. means, and either ’P’ value or ’t’ value available for differences in
mean, we would have calculated them according to the rules de-
3. Studies with multiple treatment groups scribed in the Cochrane Handbook for Systematic Reviews of Inter-
Where a study involved more than two treatment arms, if relevant, ventions (Higgins 2011). When only the SE is reported, SDs can
we would have presented the additional treatment arms in com- be calculated by the formula SD = SE * square root (n). Chap-
parisons. If data were binary, we simply would have added and ters 7.7.3 and 16.1.3 (Higgins 2011) present detailed formulae
combined them within the two-by-two table. If data were con- for estimating SDs from P values, t or F values, confidence inter-
tinuous, we would have combined data following the formula in vals, ranges or other statistics. If these formulae did not apply, we
section 7.7.3.8 (Combining groups) of the Cochrane Handbook would have calculated the SDs according to a validated imputation
for Systematic Reviews of Interventions . Where the additional treat- method, based on the SDs of other included studies (Furukawa
ment arms were not relevant, we would not present these data. 2006). Although some of these imputation strategies can intro-
duce error, the alternative would be to exclude a given study’s out-
come and thus to lose information. We nevertheless would have
Dealing with missing data examined the validity of the imputations in a sensitivity analysis
excluding imputed values.
1. Overall loss of credibility
At some degree of loss of follow-up, data must lose credibility (Xia 3.3 Last observation carried forward
2009). We chose that, for any particular outcome, should more
We anticipated that in some studies the method of last observa-
than 50% of data be unaccounted for, we would not present these
tion carried forward (LOCF) would have been employed within
data or use them within analyses. If, however, more than 50% of
the study report. As with all methods of imputation to deal with
those in one arm of a study were lost, but the total loss was less
missing data, LOCF introduces uncertainty about the reliability of
than 50%, we would have marked such data with (*) to indicate
the results (Leucht 2007). Therefore, where LOCF data had been
that such a result may well be prone to bias.
used in the trial, if less than 50% of the data had been assumed,
we would have reproduced these data and indicated that they were
2. Binary the product of LOCF assumptions.
In the case where attrition for a binary outcome was between 0%
and 50% and where these data were not clearly described, we
would have presented data on a ’once-randomised-always-analyse’ Assessment of heterogeneity
basis (an intention-to-treat analysis). Those leaving the study early
would all be assumed to have the same rates of negative outcome
as those who completed, with the exception of the outcomes of 1. Clinical heterogeneity
death and adverse effects. For these outcomes, the rate of those We planned to consider all included studies initially, without see-
who stayed in the study - in that particular arm of the trial - ing comparison data, to judge clinical heterogeneity. We would
would be used for those who did not. We would have undertaken have simply inspected all studies for clearly outlying people or sit-
a sensitivity analysis to test how prone the primary outcomes were uations which we had not predicted would arise. If such situations
to change when data only from people who completed the study or participant groups had been noted, these would have been fully
to that point were compared with the intention-to-treat analysis discussed.
using the above assumptions.

2. Methodological heterogeneity
3. Continuous
We would have considered all included studies initially, without
seeing comparison data, to judge methodological heterogeneity.
3.1 Attrition We would have simply inspected all studies for clearly outlying
In the case where attrition for a continuous outcome was between methods which we had not predicted would arise. If such method-
0% and 50% and data only from people who completed the study ological outliers had been noted, these would have been fully dis-
to that point were reported, we would have reproduced these. cussed.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 10

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3. Statistical heterogeneity 2. Investigation of heterogeneity
If inconsistency was high, we would have reported this. First, we
3.1 Visual inspection would have investigated whether data had been entered correctly.
Second, if data had been entered correctly, we would have visually
We would have visually inspected graphs to investigate the possi-
inspected the graph and successively removed outlying studies to
bility of statistical heterogeneity.
see if homogeneity was restored. For this review, we had decided
that should this occur with data contributing to the summary
3.2 Employing the I2 statistic finding of no more than around 10% of the total weighting, we
We intended to investigate heterogeneity between studies by con- would present the data. If not, we would not pool data but discuss
sidering the I2 method alongside the Chi2 ’P’ value. The I2 pro- the issues. We know of no supporting research for this 10% cut-off
vides an estimate of the percentage of inconsistency thought to be but considered investigating the use of prediction intervals as an
due to chance (Higgins 2003). The importance of the observed alternative to this unsatisfactory state. If unanticipated clinical or
value of I2 depends on i. magnitude and direction of effects and methodological heterogeneity were obvious, we would have simply
ii. strength of evidence for heterogeneity (e.g. ’P’ value from Chi stated hypotheses regarding these for future reviews or versions of
2
test, or a confidence interval for I2 ). An I2 estimate greater than this review. We would not have anticipated undertaking analyses
or equal to around 50% accompanied by a statistically significant relating to these.
Chi2 statistic, is interpreted as evidence of substantial levels of het-
erogeneity (Section 9.5.2 - Higgins 2011). If substantial levels of
heterogeneity had been found in the primary outcome, we would Sensitivity analysis
have explored reasons for heterogeneity (Subgroup analysis and
investigation of heterogeneity).
1. Implication of randomisation
Assessment of reporting biases We aimed to include trials in a sensitivity analysis if they were de-
Reporting biases arise when the dissemination of research findings scribed in some way to imply randomisation. For the primary out-
is influenced by the nature and direction of results (Egger 1997). comes, we aimed to include these studies and if their inclusion did
These are described in Section 10 of the Cochrane Handbook for not result in a substantive difference, they would have remained
Systematic Reviews of Interventions (Higgins 2011). We are aware in the analyses. If their inclusion resulted in important clinically
that funnel plots may be useful in investigating reporting biases significant, but not necessarily statistically significant differences,
but are of limited power to detect small-study effects. We would we would not have added the data from these lower quality studies
not have used funnel plots for outcomes where there were 10 or to the results of the better trials, but presented such data within a
fewer studies, or where all studies were of similar sizes. In other subcategory.
cases, where funnel plots were possible, we would have sought
statistical advice in their interpretation.
2. Assumptions for lost binary data

Data synthesis Where assumptions had to be made regarding people lost to follow-
up (see Dealing with missing data), we planned to compare the
We understand that there is no closed argument for preference for
findings of the primary outcomes when we used our assumption/s
use of fixed-effect or random-effects models. The random-effects
and when we used data only from people who completed the study
method incorporates an assumption that the different studies are
to that point. If there was a substantial difference, we planned to
estimating different, yet related, intervention effects. This often
report results and to discuss them, but would have continued to
seems to be true to us and the random-effects model takes into
employ our assumption.
account differences between studies even if there is no statistically
Where assumptions had to be made regarding missing SDs data
significant heterogeneity.
(see Dealing with missing data), we would have compared the
findings of the primary outcomes when we used our assumption/
Subgroup analysis and investigation of heterogeneity s and when we used data only from people who completed the
study to that point. A sensitivity analysis would have been under-
taken to test how prone results were to change when completer-
1. Subgroup analyses only data only were compared with the imputed data using the
We anticipated one subgroup analysis to test the hypothesis that above assumption. If there was a substantial difference, we would
de-escalation is most effective for those with acute aggression. We report results and discuss them but would continue to employ our
hoped to present data for this subgroup for the primary outcomes. assumption.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 11

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
RESULTS

Description of studies

Results of the search

Over 300 records were identified using the search criteria. No
record met the inclusion criteria (please refer to Figure 1 for study
screening flow diagram).

De-escalation techniques for psychosis-induced aggression or agitation (Review) 12

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 1. Study flow diagram.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 13

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Of the 345 studies identified from the search, none were found
Included studies
suitable to include in the review. In summary, no trial-based evi-
We were unable to include any study in this review. dence is available for any of the key outcomes of clinical relevance
(Summary of findings for the main comparison).

Excluded studies
We assessed Nijman 1997, but we excluded this trial as it was not
Overall completeness and applicability of
randomised. We identified no registered clinical ongoing studies.
evidence
No studies are awaiting assessment.
There were no randomised controlled trials relevant to the review
Risk of bias in included studies and hence, we are unable to make any inferences about applica-
bility. Because of the broad scope of what could be considered ’de-
escalation’, it is possible that very wide-ranging and less precise
searching may find occasional trials of some relevance to this area.
Allocation
However, we think it unlikely that we have missed large relevant
There were no included studies to assess risk of bias. studies.

Blinding
Quality of the evidence
There were no included studies to assess risk of bias.
There were no randomised controlled trials identified relevant to
this review
Incomplete outcome data
There were no included studies to assess risk of bias.
Potential biases in the review process
Selective reporting We searched for published and unpublished trials and two review
There were no included studies to assess risk of bias. authors screened the potential studies. It is possible that our En-
glish language searching failed to identify trials, but important
studies such as would be expected for this review are probably
Other potential sources of bias likely to be published in journals indexed by the major databases
There were no included studies to assess risk of bias. we had searched.

Effects of interventions Agreements and disagreements with other

studies or reviews
See: Summary of findings for the main comparison De-
escalation for aggression thought to be due to psychosis versus Hockenhull 2012 revealed extensive literature that does exist in
standard care this field. Unfortunately the studies included in this review were
There were no randomised controlled trials identified comparing low quality. Much of the research is opportunistic by practitioners
the effect of interventions with de-escalation techniques in man- on the basis of what is possible within their own clinical setting.
aging psychosis-induced aggression. Although this is laudable as a contribution to the principle of evi-
dence-based practice, without adequate resources to improve study
design, the cumulative evidence base may never allow conclusions
to be made that are strong enough to direct policy. We know of no
robust quantification of the effects of de-escalation techniques.
DISCUSSION

Summary of main results

AUTHORS’ CONCLUSIONS

De-escalation techniques for psychosis-induced aggression or agitation (Review) 14

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Implications for practice 3. For policymakers
Current research in this area has not produced evidence of any
effects. Should training in such techniques be encouraged, this
1. For people with schizophrenia encouragement should be based on more than well-meaning sen-
timent. Objective meaningful outcomes are possible to investi-
gate from well-designed, conducted and reported randomised tri-
The incidents where de-escalation could be employed is often a
als (please see Implications for research).
traumatic time for the service user and staff involved and some de-
escalation techniques are recommended as part of various policy Implications for research
documents (NICE 2015). Unfortunately, this recommendation
appears to be based on what is acceptable as good clinical practice
rather than being supported by more objective evidence. Recog- 1. Reviews
nising that deploying a de-escalation technique would tend to oc-
cur when a person with serious mental illness was felt to be out Perhaps with broadening of the search, trials could be found but it
of control, people with schizophrenia or other psychotic illnesses seems unlikely that we have missed any large studies. It would seem
may feel powerless to change the dearth of evidence. This is not important to regularly maintain this review as wide dissemination
so. Advanced directives could advise clinicians to take heed and of the first trials in this area should aid clinical impact. As use of ’as
use only de-escalation elements that are acceptable to the patient, required’ medication can be part of de-escalation (Douglas-Hall
and service-user groups could lobby for, and help create, useful 2015), it would also seem important that this review is regularly
trials in this area. maintained.

2. Trials
2. For clinicians Other researchers have investigated de-escalation in acute aggres-
In the mental health setting, dealing with aggressive patients can sion for people with Alziehiemer’s disease with randomised tri-
be an everyday occurrence for healthcare professionals. Patient als for “Snoezelen” (Andreeva 2011), relaxing and music therapy
death or injury resulting from the use of restraint and seclusion (Casby 1994), simulated family presence (Garland 2007), ther-
is an increasing concern. In a report from the USA, there were apeutic and simulated therapeutic touch (Hawranik 2008) and
142 restraint-related deaths over a decade, 40% of which were lavender aromatherapy (Lee 2005)). It is not impossible to un-
attributed to unintentional asphyxiation during restraint (Weiss dertake trials in this very difficult area. Previous study designs
1998). Restraint not only poses a risk of harm for the patient, but for adults with general psychotic problems and aggression have
is also physically and emotionally traumatising for staff involved included single-group pre- and post-, quasi-experimental tech-
in the process. It has also been pointed out that “high restraint niques. There is clearly a need to conduct randomised control tri-
rates are now understood as evidence of treatment failure” (Stefan als in this area. We do realise that such a design takes much careful
2002). consideration and negotiation, but we have given this area some
In Leeds and York Partnerships NHS Foundation Trust, between thought and suggest an outline for a design of future trials (Table
January 2012 and December 2012, data from the Trust’s critical 2).
incident reports showed that there were a total of 5153 incidents,
of which nearly 20% (908) involved restraint. Of these, 67% (680)
incidents involved more than two members of staff. Five-hundred
and sixty three (83.5%) of these incidents involved at least four ACKNOWLEDGEMENTS
staff members in each incident. Nearly 2200 person-hours have
The Cochrane Schizophrenia Group Editorial Base in Notting-
been used up in managing aggression at mental health units in
ham produces and maintains standard text for use in the Methods
Leeds (LYPFT 2013). A survey of staff knowledge of de-escalation
section of their reviews. We have used this text as the basis of what
practices in Leeds and York Partnerships NHS Trust (Rao 2013)
appears here and adapted it as required.
showed that most staff agreed that it was a positive thing to have
training in de-escalation along with breakaway techniques and The search terms for the protocol were developed, in collabora-
restraint. Nearly half of the staff were able to identify the varied tion with the review authors, by the Information Specialist of the
situations where aggression could be de-escalated. Only 50% of Cochrane Schizophrenia Group, Samantha Roberts. We would
the staff stated, however, that they would ensure their own safety like to thank Mohamed Gomaa and Seyed Mazloomi for peer re-
when faced with an aggressive patient with whom they had to deal. viewing this version of the review.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 15

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 REFERENCES

References to studies excluded from this review comparison des indices et utilisation. Groupe d’etude des
indices d’efficacite]. Therapie 1999;54(4):405–11.
Nijman 1997 {published data only}
Bourget 2002
Nijman HL, Merckelbach HL, Allertz WF, a Campo JM.
Bourget D, El-Guebaly N, Atkinson M. Assessing and
Prevention of aggressive incidents on a closed psychiatric
managing violent patients. CPA Bulletin de l’APC 2002:
ward. Psychiatric Services 1997;48(5):694–8. MEDLINE:
25–7.
9144826
Bowers 2011
Additional references Bowers L, Stewart D, Papadopoulos C, Dack C, Ross J,
Khanom D. Inpatient violence and aggression: A literature
Ahmed 2010 review. Report from the Conflict and Containment
Ahmed U, Jones H, Adams CE. Chlorpromazine for Reduction Research Programme. http://www.kcl.ac.uk/
psychosis-induced aggression or agitation. Cochrane ioppn/depts/hspr/research/ciemh/mhn/projects/litreview/
Database of Systematic Reviews 2010, Issue 4. [DOI: LitRevAgg.pdf 2011 [Accessed 06/02/2017].
10.1002/14651858.CD007445.pub2; PUBMED:
20393959] Casby 1994
Casby JA, Holm MB. The effect of music on repetitive
Ahmed 2011
disruptive vocalizations of persons with dementia. American
Ahmed U, Rehman F, Jones H, Adams CE. Risperidone
Journal of Occupational therapy 1994;48(10):883–9.
for psychosis-induced aggression or agitation. Cochrane
Database of Systematic Reviews 2011, Issue 11. [DOI: CRAG 1996
10.1002/14651858.CD009412] Clinical Research and Audit Guidelines (CRAG) Working
Group on Mental Illness. The prevention and management
Altman 1996
of aggression - a good practice statement. Scottish
Altman DG, Bland JM. Detecting skewness from summary
Office, National Health Service in Scotland 1996. [ISBN
information. BMJ 1996;313(7066):1200.
0748031448, 9780748031443]
Andrade 2007
Deeks 2000
Andrade C. Rapid Tranquillsation in emergency psychiatric
Deeks J. Issues in the selection for meta-analyses of binary
settings. BMJ 2007;335:835.
data. Proceedings of the 8th International Cochrane
Andreeva 2011 Colloquium; 2000 Oct 25-28; Cape Town. Cape Town:
Andreeva V, Dartinet-Chalmey V, Kloul A, Fromage B, The Cochrane Collaboration, 2000.
Kadri N. “Snoezelen”: Multisensorial stimulation effects
Divine 1992
on behavioural problems in elderly demented patients
Divine GW, Brown JT, Frazier LM. The unit of analysis
[“Snoezelen” ou les effets de la stimulation multisensorielle
error in studies about physicians’ patient care behaviour.
sur les troubles du comportement chez les personnes âgées
Journal of General Internal Medicine 1992;7(6):623–9.
démentes à un stade avancé]. NPG Neurologie - Psychiatrie -
Geriatrie 2011;11(61):24–9. Donner 2002
Donner A, Klar N. Issues in the meta-analysis of cluster
Belgamwar 2005
randomised trials. Statistics in Medicine 2002;21:2971–80.
Belgamwar RB, Fenton M. Olanzapine IM or
velotab for acutely disturbed/agitated people with Douglas-Hall 2015
suspected serious mental illnesses. Cochrane Database Douglas-Hall P, Whicher EV. ’As required’ medication
of Systematic Reviews 2005, Issue 2. [DOI: 10.1002/ regimens for seriously mentally ill people in hospital.
14651858.CD003729.pub2] Cochrane Database of Systematic Reviews 2015, Issue 12.
[DOI: 10.1002/14651858.CD003441.pub3; CD003441]
Berk 2004
Berk M, Rathbone J, Mandriota-Carpenter SL. Clotiapine Egger 1997
for acute psychotic illnesses. Cochrane Database of Egger M, Davey Smith G, Schneider M, Minder C. Bias
Systematic Reviews 2004, Issue 4. [DOI: 10.1002/ in meta-analysis detected by a simple, graphical test. BMJ
14651858.CD002304.pub2] 1997;315:629–34.
Bland 1997 Elbogen 2009
Bland JM. Trials randomised in clusters. BMJ 1997;315: Elbogen EB, Johnson SC. The intricate link between
600. violence and mental disorder:results from the National
Epidemiologic Survey on Alcohol and Related Conditions.
Boissel 1999
Archives of General Psychiatry 2009;66:152–61.
Boissel JP, Cucherat M, Li W, Chatellier G, Gueyffier F,
Buyse M, et al. The problem of therapeutic efficacy indices. Elbourne 2002
3 Comparison of the indices and their use [Apercu sur Elbourne D, Altman DG, Higgins JPT, Curtina F,
la problematiquedes indices d’efficacite therapeutique 3: Worthingtond HV, Vaile A. Metah-analyses involving cross-
De-escalation techniques for psychosis-induced aggression or agitation (Review) 16
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 over trials: methodological issues. International Journal of Jayakody 2012
Epidemiology 2002;31(1):140–9. Jayakody K, Gibson RC, Kumar A, Gunadasa S.
Zuclopenthixol acetate for acute schizophrenia and
Fazel 2006
similar serious mental illnesses. Cochrane Database
Fazel S, Grann M. The population impact of severe mental
of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/
illness on violent crime. American Journal of Psychiatry
14651858.CD000525.pub3]
2006;163:1397–403.
Kaplan 1983
Furukawa 2006 Kaplan S, Wheeler E. Survival skills for working with
Furukawa TA, Barbui C, Cipriani A, Brambilla P, Watanabe potentially violent clients. Social Casework 1983;64(6):
N. Imputing missing standard deviations in meta analyses 339–46.
can provide accurate results. Journal of Clinical Epidemiology Kay 1986
2006;59(7):7–10. Kay SR, Opler LA, Fiszbein A. Positive and Negative
Garland 2007 Syndrome Scale (PANSS) Manual. North Tonawanda, NY:
Garland K, Beer E, Eppingstall B, O’Connor DW. A Multi-Health Systems, 1986.
comparison of two treatments of agitated behaviour in Khokhar 2016
nursing home residents with dementia: Simulated family Khokhar MA, Rathbone J. Droperidol for psychosis-
presence and preferred music. American Journal of Geriatric induced aggression or agitation. Cochrane Database of
Psychiatry 2007;15(6):514–21. Systematic Reviews 2016, Issue 12. [DOI: 10.1002/
14651858.CD002830.pub3]
Gillies 2013
Gillies D, Sampson S, Beck A, Rathbone J. Benzodiazepines Khushu 2016
for psychosis-induced aggression or agitation. Cochrane Khushu A, Powney MJ. Haloperidol for long-
Database of Systematic Reviews 2013, Issue 4. [DOI: term aggression in psychosis. Cochrane Database of
10.1002/14651858.CD003079.pub3] Systematic Reviews 2016, Issue 11. [DOI: 10.1002/
14651858.CD009830.pub2]
Gulliford 1999
Lee 2005
Gulliford MC. Components of variance and intraclass
Lee SY. The effect of lavender aromatherapy on cognitive
correlations for the design of community-based surveys
function, emotion, and aggressive behaviour of elderly with
and intervention studies: data from the Health Survey for
dementia. Taehan Kanho Hakhoe Chi 2005;35(2):303–12.
England 1994. American Journal of Psychiatry 1978;135(3):
Leucht 2005
325–8.
Leucht S, Kane JM, Kissling W, Hamann J, Etschel E,
Hawranik 2008 Engel RR. What does the PANSS mean?. Schizophrenia
Hawranik P, Johnson P, Deatrich J. Therapeutic touch and Research 2005;79(2-3):231–8. [PUBMED: 15982856]
agitation in individuals with Alzheimer’s disease. Western Leucht 2005a
Journal of Nursing Research 2008;30:417–34. Leucht S, Kane JM, Kissling W, Hamann J, Etschel E,
Higgins 2003 Engel R. Clinical implications of brief psychiatric rating
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. scale scores. British Journal of Psychiatry 2005;187:366–71.
Measuring inconsistency in meta-analyses. BMJ 2003;327: Leucht 2007
557–60. Leucht S, Engel RR, Bauml J, Davis JM. Is the superior
Higgins 2011 efficacy of new generation antipsychotics an artefact of
Higgins JPT, Green S (editors). Cochrane Handbook LOCF?. Schizophrenia Bulletin 2007;33(1):183–91.
for Systematic Reviews of Interventions Version 5.1.0 Levenson 2004
[updated March 2011]. The Cochrane Collaboration, Levenson JL. American Psychiatric Publishing Book of
2011. Available from www.cochrane-handbook.org. Psychosomatic Medicine. American Psychiatric Association,
2004.
Hockenhull 2012
LYPFT 2013
Hockenhull JC, Whittington R, Leitner M, Barr W,
Leeds and York Partnerships NHS Trust. Innovation
McGuire J, Cherry MG, et al. A systematic review of
Research and Development Newsletter 2013; Vol. March,
prevention and intervention strategies for populations at
issue 13:1–19.
high risk of engaging in violent behaviour:update 2002-8.
Maguire 2007
Health Technology Assessment 2012;16(3):1–152.
Maguire J, Ryan D. Aggression and violence in mental
Huf 2016 health services: categorizing the experiences of Irish nurses.
Huf G, Alexander J, Gandhi P, Allen M. Haloperidol Journal of Psychiatric and Mental Health Nursing 2007;14:
plus promethazine for psychosis-induced aggression. 120–7.
Cochrane Database of Systematic Reviews. John Marshall 2000
Wiley & Sons, Ltd, 2016, issue 11. [DOI: 10.1002/ Marshall M, Lockwood A, Bradley C, Joy C, Fenton M.
14651858.CD005146.pub3; CD005146] Unpublished rating scales - a major source of bias in
De-escalation techniques for psychosis-induced aggression or agitation (Review) 17
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 randomised controlled trials of treatments for schizophrenia. Spencer 2016
British Journal of Psychiatry 2000;176:249–52. Spencer S, Johnson P. De-escalation techniques for
managing aggression. Cochrane Database of Systematic
Muralidharan 2006
Reviews. John Wiley & Sons, Ltd, 2016, issue 1. [DOI:
Muralidharan S, Fenton M. Containment strategies for
10.1002/14651858.CD012034; CD012034]
people with serious mental illness. Cochrane Database
of Systematic Reviews 2006, Issue 3. [DOI: 10.1002/ Stefan 2002
14651858.CD002084.pub2] Stefan S. Legal and regulatory aspects of seclusion and
restraint in mental health settings. Special edition: Violence
NHS Protect 2013 and Coercion in Mental Health Settings: Eliminating the
NHS Protect. Reported physical assaults on NHS Use of Seclusion and Restraint. NTAC Networks. 2002;
staff figures (2012-2013). Available from: http: Summmer/Fall; Vol. 3.
//www.nhscounterfraud.nhs.uk/2012-13%20Re-
Toal 2012
ported%20physical%20assaults%20on%20NHS%20staff%20NO%20PCT%20&
Toal F, Roberts K. Clozapine for people with schizophrenia
%20SHA%20v2%20PCC.pdf. London: NHS Security
and recurrent physical aggression. Cochrane Database of
Management Services 2013.
Systematic Reviews.
NICE 2015 Ukomunne 1999
Violence and aggression: short-term management in mental Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA,
health, health and community settings. NICE guidelines Burney PG. Methods for evaluating area-wide and
[NG10] May 2015. organisation-based interventions in health and health care:
Overall 1962 a systematic review [Methods for evaluating area–wide and
Overall JE, Gorham DR. The brief psychiatric rating scale. organisation–based interventions in health and health care:
Psychological Reports 1962;10:799–812. a systematic review]. Health Technology Assessment 1999;3:5.
Paterson 1997 van Dorn 2012
Paterson B, Leadbetter D. McComish A. De escalation in van Dorn R, Volavka J, Johnson N. Mental disorder and
the short term management of violence - A process based violence: is there arelationship beyond substance use?
approach. Nursing Times 1997;93(36):58–61. . Social Psychiatry and Psychiatric Epidemiology 2012;47:
487–503.
Powney 2012
Vangala 2012
Powney MJ, Adams CE, Jones H. Haloperidol for psychosis-
Vangala R, Ahmed U, Ahmed R. Loxapine inhaler for
induced aggression or agitation (rapid tranquillisation).
psychosis-induced aggression or agitation. Cochrane
Cochrane Database of Systematic Reviews 2012, Issue 11.
Database of Systematic Reviews 2012, Issue 11. [DOI:
[DOI: 10.1002/14651858.CD009377.pub2; PUBMED:
10.1002/14651858.CD010190]
23152276]
Weiss 1998
Rao 1992 Weiss EM. Deadly restraint: a Hartford Courant
Rao JNK, Scott AJ. A simple method for the analysis of investigative report. Hartford Courant. October 1998;
clustered binary data.. Biometrics 1992;48:577–85. Section A.1:11–5.
Rao 2013 Wilkie 2012
Rao H. Survey of management techniques among staff Wilkie F, Fenton M. Quetiapine for psychosis-
in acute inpatient mental health units in LYPFT. MSc induced aggression or agitation. Cochrane Database
Psychiatry Dissertation 2013. of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/
Rix 2001 14651858.CD009801]
Rix R. De-escalation techniques. In: Beer MD, Pereira Xia 2009
SM, Paton C editor(s). Psychiatric Intensive Care. Xia J, Adams CE, Bhagat N, Bhagat V, Bhoopathi P, El-
GreenwichMedical Media Limited, 2001. Sayeh H, et al. Loss to outcomes stakeholder survey: the
LOSS study. Psychiatric Bulletin 2009;33(7):254–7.
Sailas 2000
Sailas E, Fenton M. Seclusion and restraint for people Yeung 2009
with serious mental illnesses. Cochrane Database of Yeung W-L, Jayaram M, Kotha S, Adams CE. Is NICE
Systematic Reviews 2000, Issue 2. [DOI: 10.1002/ nice?. RCGP Annual National Primary Care Conference,
14651858.CD001163] Excellence in Practice: winning ways for primary care; 2009
Nov 5-7; Glasgow. 2009.
Schünemann 2008
Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks References to other published versions of this review
JJ, Glasziou P, et al. Chapter 12: Interpreting results and
drawing conclusions. In: Higgins JPT, Green S editor(s). Rao 2012
Cochrane Handbook for Systematic Reviews of Interventions. Rao H, Yeung WL, Jayaram MB. De-escalation techniques
The Cochrane Collaboration, 2008:359–83. for psychosis-induced aggression or agitation. Cochrane

De-escalation techniques for psychosis-induced aggression or agitation (Review) 18

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Database of Systematic Reviews 2012, Issue 7. [DOI:
10.1002/14651858.CD009922]
∗
Indicates the major publication for the study

De-escalation techniques for psychosis-induced aggression or agitation (Review) 19

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CHARACTERISTICS OF STUDIES

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Nijman 1997 Allocation: not randomised.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 20

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES
This review has no analyses.

ADDITIONAL TABLES
Table 1. Other relevant Cochrane reviews

Focus of review Reference

Completed and maintained reviews Completed and

’As required’ medication regimens for seriously mentally ill people Douglas-Hall 2015
in hospital

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 Powney 2012

tranquillisation)

Haloperidol plus promethazine for psychosis-induced aggression Huf 2016

Olanzapine IM or velotab for acutely disturbed/agitated people Belgamwar 2005

with suspected serious mental illnesses

Seclusion and restraint for serious mental illnesses Sailas 2000

Zuclopenthixol acetate for acute schizophrenia and similar serious Jayakody 2012
mental illnesses

Reviews in the process of being completed Reviews in the p

Clozapine for people with schizophrenia and recurrent physical Toal 2012
aggression

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

De-escalation techniques for psychosis-induced aggression or agitation (Review) 21

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. Other relevant Cochrane reviews (Continued)

Risperidone for psychosis-induced aggression or agitation Ahmed 2011

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

De-escalation techniques for psychosis-induced aggression or agitation (Review) 22

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
APPENDICES

Appendix 1. Previous searches

1.1 Search in 2009, 2012 and 2014

1.1.1 Electronic searches

1.1.1.1 Cochrane Schizophrenia Group’s Study-Based Register of Trials

We searched this register (June 16, 2009; March 22, 2012; July 25, 2012; May 13, 2014) using the following search strategy:
[(*aggress* or *agitat* or *violen*) and (*de-escalat* or *deescalat* or *de-stimulat* or *destimulat* or *de-fus* or *defus* or *one-
to-one* or *one to one* or or *diffuse* or *calming* or *non aversive* or *non-aversive* or *non confrontat* or *non-confrontat*
or *psycho social* or *psycho-social* or *verbal* or *non verbal* or *non-verbal* or *talk* (*talk* and *down*) *nurses role*) in title
abstract and index terms of REFERENCE]
This register is compiled by systematic searches of major databases, handsearches and conference proceedings (see Group’s Module).

1.1.2 Searching other resources

1.1.2.1 Reference searching

We inspected the references of all identified studies for further relevant studies.

1.1.2.2 Personal contact

We contacted the first author of each included study for information regarding unpublished trials.

WHAT’S NEW
Last assessed as up-to-date: 7 April 2016.

Date Event Description

10 April 2017 Amended Review author, Harish Rao, affiliation updated. Reference LYPFT 2013 updated. Text in Authors’
conclusions amended.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 23

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
HR and MJ devised the protocol for the study.
HR and WY reviewed the abstracts of the studies obtained from the search.
MJ reviewed the abstracts of a random sample of the search studies.
MD, SY, WS and HR completed the first draft of this review manuscript.
MD and SZ revised the review manuscript.
XM and JX reviewed and final proofed the manuscript.

DECLARATIONS OF INTEREST
All review authors have no known conflicts of interest.
Review authors JX and SZ work for Systematic Review Solutions which is an independent health care research company.

SOURCES OF SUPPORT

Internal sources
• Leeds PFT, UK.

External sources
• Inner Mongolia Medical University, Inner Mongolia, China.
One million projects of Science and Technology. Project code: YKD2013KJBW006

DIFFERENCES BETWEEN PROTOCOL AND REVIEW

We have amended the objective of the review and description of participants to reflect our title more accurately, that is, to investigate
effects of de-escalation techniques in the management of aggression due to psychosis. We have stated the age of participants more
clearly.
We have also updated Types of interventions to clarify the description of de-escalation techniques.
For Types of outcome measures, we added adverse events as a primary outcome and an outcome of interest for the ’Summary of findings’
table.
A new team of authors joined the original review authors of the protocol and helped to complete the review.

De-escalation techniques for psychosis-induced aggression or agitation (Review) 24

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.