Post‐incident debriefing for people with schizophrenia after coercive measures

Abstract

Background

Schizophrenia and schizophrenia‐type psychosis, severe mental illnesses globally impacting millions, present a dual challenge with their characteristic positive and negative symptoms, economic burdens, and heightened susceptibility to coercive measures. These measures, including seclusion and restraint, raise ethical concerns despite their intent to ensure safety, particularly during acute stages marked by violent behaviour. Addressing this backdrop, the significance of post‐incident debriefing as an intervention to curtail the use and duration of coercive measures and alleviate the negative psychological effects of using these methods in managing individuals with schizophrenia is underscored. The employment of coercive measures, such as physical restraint and seclusion, to manage aggressive behaviour in psychiatric settings necessitates a thorough examination of their ethical implications and potential psychological harm. Although post‐incident debriefing is recommended, the limited evidence supporting its efficacy and concerns about its impact on psychological well‐being prompt a comprehensive analysis of existing literature.

Objectives

To investigate the effects of post‐incident debriefing after coercive measures for people with schizophrenia or schizophrenia‐type psychosis.

Search methods

The Information Specialist conducted searches of the Cochrane Schizophrenia Specialised Register (compiled from searches of CENTRAL, MEDLINE, Embase, PubMed, CINAHL, PsycINFO, ClinicalTrials.gov, WHO ICTRP, ISRCTN, ProQuest Dissertations and Theses A&I) on 28 February 2023. We also inspected the references of all identified studies.

Selection criteria

We included all randomised controlled trials (RCTs) of post‐incident debriefing after coercive measures in adult psychiatric care with participants diagnosed with schizophrenia or schizophrenia‐type psychosis, encompassing various clinical states and stages. We considered studies if the post‐incident debriefing was the only intervention randomised.

Data collection and analysis

At least two authors inspected the citations, selected studies, extracted data and conducted quality appraisal. We calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous outcomes. We assessed study risk of bias and used the GRADE approach to create a summary of findings table.

Main results

We included one study; the total number of participants randomised was 422, of which 109 participated. Participants were between 18 and 65 years old with psychotic disorder, at the acute stage of their illness, and had experienced at least one coercive measure during their hospital stay. The study included a standardised post‐coercion review that was conducted until the discharge of the participant.

For the primary outcome, we found that there may be an increased risk of being secluded again for those receiving post‐incident debriefing compared to treatment as usual, but the evidence is very uncertain (RR 1.32, 95% CI 0.74 to 2.33; 1 study, 109 participants; very low‐certainty evidence).

No evidence was found that post‐incident debriefing had an effect in reducing peritraumatic distress (MD ‐1.62, 95% CI ‐7.47 to 4.23; 1 study, 82 participants; very low‐certainty evidence) or increasing satisfaction with care (perceived coercion: MD ‐0.37, 95% CI ‐1.59 to 0.85; 1 study, 109 participants; coercion experience: MD ‐1.61, 95% CI ‐13.36 to 10.14; 1 study, 109 participants; very low‐certainty evidence) compared to treatment as usual. The evidence is very uncertain about the effect of post‐incident debriefing on these outcomes.

No usable data were available for change in patient behaviour or adverse effects.

Authors' conclusions

Considering the available evidence, it is not possible to arrive at definitive conclusions that post‐incident debriefing after coercive measures is effective for people with schizophrenia or schizophrenia‐type psychosis. Further high‐quality studies are warranted to evaluate the effects of post‐incident debriefing in psychiatric inpatient care.

Plain language summary

Is post‐incident debriefing after coercive measures for people with schizophrenia effective?

Key messages

• Due to a lack of evidence, the benefits of post‐incident debriefing after coercive measures (seclusion: locking someone in a separate room, or restraint: preventing them from moving) for people with schizophrenia or schizophrenia‐type psychosis are unclear.

• Future research is needed into the effects of post‐incident debriefing after coercive measures to find out whether it has benefits for people with schizophrenia and whether it has unwanted effects and costs.

What is schizophrenia, and what are seclusion and restraint?

Schizophrenia is a severe mental health condition that affects how people think, feel and behave. Schizophrenia and related psychotic disorders significantly impact millions of people globally, and pose challenges due to their diverse symptoms, economic burden and the risk of a person being locked in a secure room (seclusion) or prevented from moving (restraint), particularly if their behaviour is violent. Post‐incident debriefing is suggested as a way to reduce the use and duration of these measures, and aims to ensure safety while acknowledging the ethical concerns and potential psychological harm that such measures may cause.

Seclusion is a coercive measure, which means locking a person into a separate room in a psychiatric ward. Restraint means preventing a person from moving, manually by staff members, or with different equipment, such as belts. These measures should be used as a last resort to prevent a person from hurting themselves or others. Post‐incident debriefing can be used after these coercive measures and is a form of talking therapy. It aims to allow staff and people who have experienced coercion to learn from the event and so prevent future episodes of coercion.

What did we want to find out?

We wanted to find out the benefits and harms of post‐incident debriefing after coercive measures for people with schizophrenia or schizophrenia‐type psychosis.

What did we do?

We carried out a comprehensive search in specialised databases to identify studies in which people with schizophrenia were randomly assigned to two or more treatment groups to assess post‐incident debriefing in adult psychiatric care.

What did we find?

We found one relevant study with data for 109 people. This study involved standardised post‐incident debriefing until the person left hospital. People who received post‐incident debriefing after coercive measures may be more likely to be secluded again compared to those receiving standard treatment, but this is very uncertain. The evidence supporting this result is based on one study, and we have very limited confidence in this finding. There was no evidence to suggest that people are less distressed during or immediately after the event or that they are more satisfied with their care compared to standard treatment. Again, we have very limited confidence in this finding. There was not enough information to determine changes in patient behaviour or unwanted or harmful effects.

What are the limitations of the evidence?

We have very little confidence in these findings because we only found one small study, and there were problems with how it was designed and reported. Although post‐incident debriefing is common practice in clinical settings, the evidence is currently not available to support it in current forms. The findings of this review therefore suggest caution in its use. The review highlights the need for further high‐quality studies to thoroughly assess the effects of post‐incident debriefing in psychiatric inpatient care. Any post‐incidence debriefing measures should be clearly defined and described so that people know how and why to use them in daily practice.

How up to date is this evidence?

This evidence is current to February 2023.

Summary of findings

Summary of findings 1. Post‐incident debriefing compared with treatment as usual after coercive measures for people with schizophrenia.

Post‐incident debriefing compared with treatment as usual after coercive measures for people with schizophrenia
Patients or population: people with schizophrenia or schizophrenia‐type psychosis Settings: all treatment settings Intervention: post‐incident debriefing after coercive measures Comparison: treatment as usual after coercive measures
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)
	Risk with treatment as usual	Risk with post‐incident debriefing
Further seclusion and restraint ‐ further use of seclusion room (number of times seclusion used during the index hospital stay)	263 per 1000	982 per 1000 (553 to 1000)	RR 1.32 (0.74 to 2.33)	109 (1 RCT)	⨁⊝⊝⊝ Very lowa,b
Mental state (specific symptoms) ‐ average endpoint score on specific symptom scale (PDI, scores ranging from 13 to 65, measured immediately after coercion)	The mean mental state (specific symptoms) ‐ average endpoint score on specific symptom scale (PDI) was 22.03	MD 1.62 lower (7.47 lower to 4.23 higher)	‐	82 (1 RCT)	⨁⊝⊝⊝ Very lowa,b
Satisfaction with care ‐ recipient ‐ coercion experience (CES, scores ranging from 29 to 145, measured shortly before discharge)	The mean satisfaction with care ‐ recipient ‐ coercion experience (CES) was 97.22	MD 1.61 lower (13.36 lower to 10.14 higher)	‐	109 (1 RCT)	⨁⊝⊝⊝ Very lowa,b
Any change in specific aspects of behaviour	The outcome was not reported by the included study.
At least one adverse effect	The outcome was not reported by the included study.

*The risk in the intervention group (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).

CES: Coercion Experience Scale; CI: confidence interval; MD: mean difference; PDI: Peritraumatic Distress Inventory; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Explanations

^aDowngraded by one level for study limitations. This outcome is from a single study assessed to have a high risk of bias.
^bDowngraded by two levels for imprecision as the outcome includes only one study with small sample size and wide CI.

Background

Schizophrenia

Schizophrenia and schizophrenia‐type psychosis are severe mental illnesses (WHO 2022). They are classified in the International Classification of Diseases (ICD)‐11 as F20 to F29, schizophrenia, schizotypal, delusional and other non‐mood psychotic disorders (WHO 2019), and in the Diagnostic and Statistical Manual of Mental Disorders (DSM)‐5 as schizophrenia and other psychotic disorders (APA 2022). Schizophrenia alone affects almost 21 million people globally (Charlson 2018). About 71% of cases (14.8 million) occur in people between 25 and 54 years of age (Charlson 2018). It has been estimated that the incidence of schizophrenia per year is 15.2 cases per 100,000 population, while the lifetime prevalence is 7.2 cases per 1000 (McGrath 2008). The disorder usually has an onset in late adolescence or early adulthood (Gogtay 2011).

Schizophrenia is characterised by positive and negative symptoms (Tandon 2013). Positive symptoms may include hallucinations, delusions, disorganised speech, and catatonic or grossly disorganised behaviour, while negative symptoms include diminished emotional expression and avolition (Tandon 2013). For a person to be diagnosed with schizophrenia, symptoms must be present for at least one month within the last six months, and be accompanied by social or occupational dysfunction (APA 2022; Tandon 2013). The illness may also cause cognitive impairments (Keefe 2008).

Schizophrenia has a high economic burden (Chong 2016), and also has a significant negative impact on those who suffer from the illness. Schizophrenia accounts for 13.4 million years lived with disease (YLDs) globally, equivalent to 1.7% of total YLDs in 2016 (Charlson 2018). People suffering from schizophrenia also have a higher risk of developing certain somatic illnesses, such as type 2 diabetes (Vancampfort 2015), and metabolic syndrome (Ward 2015). High mortality rates have been found in all age groups, and the life expectancy of people with schizophrenia is approximately 20 years lower than that of the general population (Laursen 2014). The illness may also negatively impact the person's quality of life (Savilla 2008).

Coercive measures

In its acute stage, especially when positive symptoms are present (Rund 2018), violent behaviour may occur in people with schizophrenia (Iozzino 2015). The prevalence of aggressive behaviour on psychiatric wards varies between 8% to 76% (Weltens 2021). In psychiatric hospitals, coercive measures may be used to manage violent or aggressive behaviour, to ensure the safety of people with schizophrenia and others (Thibaut 2019). However, the use of coercive measures is a controversial issue, as it may violate a person's human rights and freedom of movement (Montaguti 2019). According to the National Institute for Health and Care Excellence (NICE), coercive measures include: 1) close observation, during which a staff member observes and maintains contact with the person; 2) use of a seclusion room, which is a specific, locked room in which a person is put for supervised confinement; 3) manual restraint, which is a hands‐on method of physical restraint used by staff; 4) mechanical restraint, which is a physical intervention, during which staff uses authorised equipment to restrain the individual (e.g. handcuffs or restraining belts); and 5) rapid tranquillisation, which is the use of parenteral medication for urgent sedation, if oral medication is not possible (NICE 2015).

The use of coercive measures varies across countries. A nationwide cohort study, following 112,233 people in Denmark between 1999 and 2014, found that 22% of people treated in inpatient psychiatric services were exposed to different types of coercion (Thomsen 2017). In Finland between 1995 and 2014 (N = 226,948 participants), the overall prevalence of coercive treatment for inpatients was 9.8% (Välimäki 2019). A study in Norway found that among the 19,283 people admitted to hospitals between 2004 and 2011, 324 were exposed to restraint, which included a total of 1458 cases (mean 4.5 cases per exposed person); 9% were mechanical restraints and 41% were pharmacological restraints (Reitan 2018). In 2011, in the Netherlands, 11% of all people admitted to psychiatric hospitals (N = 42,960) experienced seclusion (Noorthoorn 2015). Further, a meta‐analysis of 77 studies showed that the pooled prevalences of physical restraint, seclusion and chemical restraint were 14.4%, 15.8% and 25.7%, respectively (Belayneh 2024).

Researchers have found a number of characteristics associated with the use of coercive measures. Personal characteristics associated with higher odds of experiencing coercive measures are: being male (Reitan 2018; Thomsen 2017), being younger than 50 years old, having a history of substance abuse and having a diagnosis of schizophrenia spectrum disorder or mood disorder (Reitan 2018). Researchers also found that lower socioeconomic class, unemployment and being an immigrant from a low‐ or middle‐income country increased the odds of experiencing coercion. However, having social relations, such as being a parent or being married, seems to protect people from being coerced (Thomsen 2017). Other factors related to being coerced include the treatment culture on the ward and organisational characteristics, such as the staff‐patient ratio and the characteristics of the direct‐care staff (Doedens 2020).

Coercive measures have an impact on people and their well‐being. The psychological impact may include significant distress (Frueh 2005), humiliation (Robins 2005), or a depressed or powerless state of mind (Fugger 2016). Re‐traumatisation (Strout 2010), and post‐traumatic stress disorder have also been reported as outcomes of coercive methods (Fugger 2016). Chieze 2019 conducted a systematic review and found that subjective perceptions towards seclusion and restraint have high interindividual variability; for example, post‐traumatic stress disorder incidence after coercion has varied from 25% to 47%. Physical impacts may include injuries and even death (Kersting 2019). Associations between coercion and treatment outcomes, such as longer inpatient stays and a person's disapproval of treatment, have also been found (McLaughlin 2016). Overall, a person's experiences of being subjected to coercion are negative (Askew 2019). Still, some contrary results have been found. For example, Soininen and colleagues reported that neither seclusion nor restraints were significantly associated with a person's quality of life (Soininen 2013).

Description of the intervention

Post‐incident debriefing is an intervention that could support efforts to reduce the use (Huckshorn 2014; Whitecross 2013), and duration (Goulet 2018), of coercive measures, aggressive incidents (NICE 2015), and post‐traumatic symptoms following the use of coercive measures (Abdelghaffar 2018). 'Incident' refers here to both the use of the coercive measure itself and the situation (e.g. violent behaviour) that led to the use of coercive measures.

Originating in the field of psychology, debriefing can be defined as a set of procedures, including counselling, that give information to prevent psychological morbidity and aid in recovery after a traumatic event (Kenardy 2000). According to the literature, post‐incident debriefing related to the use of coercive measures is defined in numerous ways, and may include a number of different elements. It has later been used as a reflective practice in nursing and called a “post‐seclusion and/or restraint review” (Goulet 2016).

Post‐incident debriefing can be defined as an intervention, conducted immediately after coercive measures, when those involved have recovered their composure, and when the risk of harm related to the event has been contained (NICE 2015). Debriefing has also been described as a form of talking therapy, during which the involved parties recount the incident (Needham 2010). The Restraint Reduction Network (RRN) defines this intervention as a post‐incident review, which has two main components: post‐incident support, i.e. attention to the physical and emotional well‐being of the individuals involved, and a post‐incident reflection and learning review (RRN 2019). The Six Core Strategies for reducing and preventing the use of seclusion and restraint include the use of rigorous debriefing techniques, which are defined as systematically analysing seclusion and restraint incidents, and the use of acquired knowledge to inform policy, procedures and practices to avoid future incidents (Huckshorn 2014).

One of the main goals of debriefings is to improve clinical outcomes in psychiatric settings by learning through discussion and reflection of events and transferring that learning into clinical practice (Cant 2011). Typically, debriefing takes place within the first few days after a traumatic event and may last one to three hours (Kenardy 2000). According to NICE, a debrief should take place as soon as possible after the person has recovered their composure (NICE 2015). It may include a discussion about the factors that contributed to the incident that led to the use of coercive measures and typically acknowledges the emotional responses to the incident, assesses the need for emotional support or possible trauma experienced, supports feelings of safety and relaxation, and encourages a return to normal activities (NICE 2015). It offers the person the opportunity to make sense of the experience (Needham 2010), and share the emotional experience (Zech 2005). It also allows participants to share their perspectives of the event and understand what happened (NICE 2017). It may include counselling, ventilation, support and reassurance, physical intervention and psychoeducation (Needham 2010; Whitecross 2013). The intervention may be led by a nurse (Needham 2010; Whitecross 2013), psychologist, social educator or doctor (Hammervold 2020), who was not involved in the incident.

For the purpose of this review, we define post‐incident debriefing as a structured or unstructured discussion related to the use of a coercive measure, involving staff and the person with schizophrenia, with or without their families (Scanlan 2010).

How the intervention might work

There are no standardised procedures or techniques for post‐incident debriefing after coercive measures. Essential components of the debriefing intervention are inconsistently described in related literature (Mangaoil 2018). Thus, interventions used to describe debriefing vary from study to study (Hammervold 2019). Kaplan has argued that debriefing could assist in preventing permanent emotional injury, by allowing time for emotional processing, cognitive appraisal and normalisation of reactions to a traumatic experience (Kaplan 2001). The mechanism behind a debriefing intervention is learning together about why the event that led to the use of coercion by staff occurred, and any other useful information about that specific event (Petti 2001). Therefore, in a debriefing session, it is possible to identify risk factors that can be addressed to reduce the likelihood of a future event, and amend the risk and care plans accordingly (Hirsch 2019; NICE 2015). It has also been assumed that analysing past incidents can reduce the future use of seclusion and restraint (Huckshorn 2014).

Why it is important to do this review

Post‐incident debriefing is recommended as an intervention to be used after coercive measures. It helps the organisation to identify and address any physical harm to service users or staff, ongoing risks and the emotional impact on service users and staff. However, the incident should only be discussed with service users, witnesses and staff involved after they have recovered their composure (NICE 2015).

Several benefits have been reported, including the reduction of the emotional impact of coercive measures (Aguilera‐Serrano 2018), helping to restore the therapeutic relationship between the person with schizophrenia and staff (Goulet 2018; Wullschleger 2019), allowing participants to find individual alternatives for coercion (Huckshorn 2014), assisting in changing the culture of psychiatric settings (Petti 2001), increasing ethical awareness for staff (Hammervold 2020), and leading to better care for people with schizophrenia and schizophrenia‐type psychosis.

Post‐incident debriefing is in place in several countries such as the UK, Canada, the USA, Norway, Sweden, Finland and Germany (Hammervold 2019; Hammervold 2020; Putkonen 2013; Steinert 2020; Wullschleger 2019). However, the evidence behind the recommendations in the NICE guideline for the use of post‐incident debriefing intervention is based on qualitative studies, which lack information about the actual effectiveness of the intervention (NICE 2019). There has been debate over whether debriefing should be used in inpatient care, due to its possible harmful psychological effects on people (NICE 2019). The effectiveness of debriefing has also been questioned, especially in preventing post‐traumatic stress disorder after traumatic events (Rose 2002). To address these controversies, there is a need to conduct a systematic review of all available evidence evaluating the effectiveness of post‐incident debriefing after the use of coercive measures.

Objectives

To investigate the effects of post‐incident debriefing after coercive measures for people with schizophrenia or schizophrenia‐type psychosis.

Methods

Criteria for considering studies for this review

Types of studies

We considered all relevant randomised controlled trials (RCTs). We would have considered trials that were described as double‐blind, in which randomisation was implied. We also considered cluster‐randomised trials and the first‐phase data of cross‐over trials.

We excluded quasi‐randomised studies, such as those that allocate intervention by alternate days of the week. When people were given treatments additional to post‐incident debriefing, we would have included data if the adjunct treatment was evenly distributed between groups, and it was only the post‐incident debriefing that was randomised.

Types of participants

We included adult participants who had been diagnosed with a wide spectrum of schizophrenia or schizophrenia‐type psychosis (F20 to F29, schizophrenia, schizotypal, delusional and other non‐mood psychotic disorders (ICD‐11) (WHO 2019); Schizophrenia and Other Psychotic Disorders, DSM‐5 (APA 2022)).

We included trials in which the majority (> 50%) of the participants had a severe mental illness, which is likely to be schizophrenia or schizophrenia‐type psychosis, including those with multiple diagnoses, and those who had already been subjected to coercive measures. Adult participants were not excluded due to age, nationality, gender, duration of illness or treatment setting.

We wanted to make sure that information was as relevant as possible to the current care of people with schizophrenia or schizophrenia‐type psychosis, so we highlighted the current clinical state (acute, early post‐acute, partial remission, remission), the stage (prodromal, first episode, early illness, persistent) and whether the studies primarily focused on people with particular problems (for example, negative symptoms, treatment‐resistant illnesses).

Types of interventions

1. Post‐incident debriefing plus standard professional care

For the purpose of this review, we defined post‐incident debriefing as either a structured or unstructured discussion about the use of a coercive measure, involving staff and the person with schizophrenia, with or without their families (Scanlan 2010). This definition was chosen due to its broad nature, which allowed it to include a variety of interventions and also included family members as potential participants of the intervention. We also considered interventions labelled as post‐incident review as a synonym for post‐incident debriefing. For our main comparison, we considered only post‐incident debriefing as an intervention.

2. Standard professional care

The control intervention was standard professional care of people with schizophrenia for whom no post‐incident debriefing was used after coercive measures. This 'treatment as usual' may or may not have included some form of discussion about coercion experiences, but it needed to be clearly stated that it was a control condition.

Types of outcome measures

We planned to divide all outcomes into immediate (less than one day), short‐term (one to seven days), medium‐term (up to two months) and long‐term (longer than two months), but due to lack of data we did not categorise the outcomes.

We planned to report binary outcomes that recorded clear and clinically meaningful degrees of change first (e.g. global impression of much improved, or more than 50% improvement on a rating scale, as defined within the trials). Thereafter, we would have listed other binary outcomes, and then continuous outcomes. Again, due to lack of data, we could not report binary outcomes in this way.

1. Further seclusion and restraint

1.1 Further use of a seclusion room (placing the person in a locked room from which free exit is denied; involves isolation with or without the reduction of sensory stimuli)

1.2 Further use of mechanical/physical restriction (devices are used to restrict a person's free movement, such as belts/physical holding)

1. Mental state (specific symptoms)

1.1 Clinically important change in specific symptoms, as defined by each of the studies (positive, negative, affective, cognitive symptoms of schizophrenia or schizophrenia‐type psychosis)

1.2 Any change in specific symptoms, as defined by each of the studies (positive, negative, affective, cognitive symptoms of schizophrenia or schizophrenia‐type psychosis)

1.3 Average endpoint or change score on specific symptom scale (e.g. post‐traumatic stress disorder (PTSD), measured by Clinician‐Administered PTSD Scale (CAPS (Weathers 2013))

1.4 Mental state (general symptoms, e.g. overall symptoms of schizophrenia, measured by Positive and Negative Syndrome Scale (PANSS) total (Kay 1986))

2. Satisfaction with care (recipients of care or carers, including subjective well‐being and family burden)

2.1 Recipient

2.1.1 Clinically important change in satisfaction, as defined by each of the studies

2.1.2 Recipient of care satisfied/not satisfied with treatment

2.1.3 Recipient of care average endpoint or change score on satisfaction scale (e.g. patient satisfaction measured by a scale, such as Mental Health Care Thermometer for Appreciation of Clients (GGZ (Kok 2003))

2.2 Carers (including health professionals)

2.2.1 Clinically important change in satisfaction, as defined by each of the studies

2.2.2 Carer satisfied/not satisfied with treatment (general impression of carer/other)

2.2.3 Carer average endpoint or change score on satisfaction scale (e.g. caregiver satisfaction measured by a published scale, such as Client Satisfaction Questionnaire (CSQ (Attkisson 2012))

3. Behaviour

3.1 General

3.1.1 Clinically important change in general behaviour, as defined by each of the studies

3.1.2 Any change in general behaviour, as defined by each of the studies

3.1.3 Average endpoint or change score on general behaviour scale (e.g. patient behaviour measured by Brief Psychiatric Rating Scale (BPRS (Overall 1962))

3.2 Specific

3.2.1 Clinically important change in specific aspects of behaviour, as defined by each of the studies, e.g. aggression, violence

3.2.2 Any change in specific aspects of behaviour, as defined by each of the studies, e.g. aggression, violence

3.2.3 Average endpoint or change on specific aspects of behaviour scale (e.g. patient aggression measured by a published scale, such as Staff Observation Aggression Scale – Revised (SOAS‐R (Nijman 1999))

4. Additional medication

4.1 Use of rapid tranquillisation/increased medication (medication administered by parenteral route, if oral medication is not possible or appropriate, and urgent sedation with medication is needed)

4.2 Use of rapid tranquillisation/increased medication (oral medication for rapid tranquillisation)

5. Use of compulsion

5.1 Other treatment or detainment against a person's will, besides seclusion or restraints

6. Quality of life (recipient of care)

6.1 Overall

6.1.1 Clinically important change in quality of life, as defined by each of the studies

6.1.2 Any change in quality of life, as defined by each of the studies

6.1.3 Average endpoint or change score on quality of life scale (e.g. quality of life measured by a rating scale, such as World Health Organization Quality of Life (WHOQOL (WHO 2012))

6.2 Specific

6.2.1 Clinically important change in specific aspects of quality of life, as defined by each of the studies

6.2.2 Any change in specific aspects of quality of life, as defined by each of the studies

6.2.3 Average endpoint or change score on specific aspects of quality of life scale (e.g. health‐related quality of life measured by Health‐Related Quality of Life scale (HRQOL‐14 (Moriarty 2003))

7. Adverse events and safety

7.1 Suicide attempts

7.2 Death (all causes)

7.3 Injuries

7.4 Occupational injuries

8. Adverse effects

8.1 General adverse effects

8.1.1 At least one adverse effect

8.1.2 Clinically important adverse effects

8.1.3 Average endpoint or change scores on adverse‐effect scales (e.g. unwanted events, measured by a scale, such as Unwanted Event to Adverse Treatment Reaction (UE–ATR) checklist (Linden 2013))

8.2 Specific adverse effects

8.2 Clinically important, as defined by each of the studies

9. Acceptability of intervention

Number of participants leaving the study early

9.1 For any reason

9.2 Due to inefficacy

9.3 Due to adverse effect

10. Economic outcomes

10.1 Costs due to treatment, as defined by each study

10.2 Total direct and indirect costs

10.3 Average change in total cost of medical and mental health care

Search methods for identification of studies

Electronic searches

The Information Specialist searched the Cochrane Schizophrenia Specialised Register using the following search strategy: [(*seclusion*) AND (*post*)] OR [(*incident*) AND (*post*)] [(*restraint*) AND (*review*)] in abstract terms of REFERENCE)]

The Cochrane Schizophrenia Specialised Register is a study‐based register, which allows the Information Specialist to search for the major concept and retrieve all the synonyms and relevant studies. This is because the studies have already been organised, based on their interventions, and linked to the relevant topics (Shokraneh 2017). This allows rapid and accurate searches that reduce waste in the next steps of systematic reviewing (Shokraneh 2019). Following Cochrane methods, the Information Specialist compiles this register from systematic searches of major resources and their monthly updates (unless otherwise specified (Lefebvre 2022)).

• CENTRAL (Cochrane Central Register of Controlled Trials)

• MEDLINE

• Embase

• PubMed

• CINAHL (Cumulative Index to Nursing and Allied Health Literature)

• PsycINFO

• US National Institute of Health Ongoing Trials Register (ClinicalTrials.gov)

• World Health Organization International Clinical Trials Registry Platform (ICTRP; www.who.int/ictrp)

• ISRCTN registry

• ProQuest Dissertations and Theses A&I and its quarterly update

The Specialised Register also includes the results of handsearches and conference proceedings (see schizophrenia.cochrane.org/resources). It does not place any limitations on language, date, document type or publication status (Appendix 1).

1. Reference searching

We inspected the references of all included studies for further relevant studies. However, none were located.

2. Personal contact

We contacted the corresponding author of the included study for information regarding unpublished trials. We would have noted the outcome of this contact in the included studies or studies awaiting classification tables. No unpublished trials were, however, identified as a result of this contact.

Data collection and analysis

Selection of studies

Review authors TL and JV independently inspected citations from the searches and identified relevant abstracts. TL and JV then obtained and inspected full reports of the abstracts or reports meeting the review criteria. Due to the low number of full reports, MV re‐inspected all of these, in order to ensure the reliability of the selection. Any disagreements would have been solved by the third author by discussing two others; however, none arose.

1. Extraction

Review authors TL and JV independently extracted data from the only included study. We discussed any disagreement and documented our decisions. We would have attempted to extract data only presented in graphs and figures whenever possible, but no such data existed. We would have attempted to contact trial authors with an open‐ended request if there had been a need to obtain missing information, or for clarification.

2. Management

2.1 Forms

We extracted data onto standard, predesigned, simple forms.

2.2 Scale‐derived data

We included continuous data from rating scales only if:

1. the psychometric properties of the measuring instrument have been described in a peer‐reviewed journal (Marshall 2000);

2. the measuring instrument has not been written or modified by one of the trialists for that particular trial; and

3. the instrument is a global assessment of an area of functioning and not sub‐scores, which are not, in themselves, validated or shown to be reliable. However, there are exceptions. We would have included sub‐scores from mental state scales measuring positive and negative symptoms of schizophrenia or schizophrenia‐type psychosis. Ideally, the measuring instrument should be either a self‐report or completed by an independent rater or relative (not the therapist). We realise that this is not often reported clearly; in the description of studies table, we have noted if this was the case.

2.3 Endpoint versus change data

There are advantages to both endpoint and change data: change data can remove a component of between‐person variability from the analysis; however, calculation of change needs two assessments (baseline and endpoint), which can be difficult to obtain in unstable and difficult‐to‐measure conditions, such as schizophrenia. We decided to primarily use endpoint data, and only use change data if the former were not available. If it had been necessary, we would have combined endpoint and change data in the analysis, as we preferred to use mean differences (MDs) rather than standardised mean differences (SMDs) throughout (Deeks 2022).

2.4 Skewed data

Continuous data on clinical and social outcomes are often not normally distributed. To avoid the pitfall of applying parametric tests to non‐parametric data, we applied the following standards to relevant continuous data before inclusion.

For endpoint data from studies including fewer than 200 participants, we calculated the observed mean minus the lowest possible value of the scale, and divided this by the standard deviation (Deeks 2022).

For example, for a scale that has a possible lowest value higher than 0, such as the PANSS, which can have values from 30 to 210 (Kay 1986), we have subtracted the minimum score (in this case, 30) from the observed mean, and then divided by the standard deviation. For a scale that has 0 as the minimum possible score, we have divided the observed mean by the standard deviation. For this calculation, we have checked the original publication of the scales referenced in the studies, in order to understand if they have a lowest possible score different from 0, and whether the described adjustment was needed. If the ratio obtained was lower than one, it strongly suggests that the data were skewed. If the ratio was greater than one but less than two, this suggested that the data were skewed; if the ratio was greater than two, we planned to include the data, as it was less likely they were skewed (Altman 1996). When there was a suggestion of skewness (ratio < 2), we planned to exclude the relevant studies in a sensitivity analysis to assess their impact on the results (see Sensitivity analysis for further details). These skewed results were planned to be presented in other data tables.

In this review we had only one study to include, with fewer than 200 participants. We conducted the aforementioned calculations. The ratio was more than 2 on one scale (3.1, CES), close to 2 on one scale (1.9, PDI) and below 2 on one (1.5, CI). We were not able to conduct a sensitivity analysis as we had only one included study. We decided to still include the study, but have mentioned suggestions of data skewness in the results.

2.5 Common measurement

To facilitate comparison between trials, we would have converted variables that can be reported in different metrics, such as days in hospital (mean days per year, per week, or per month) to a common metric (e.g. mean days per month).

2.6 Conversion of continuous to binary

We made all efforts to convert outcome measures to dichotomous data. This could have been done by identifying cutoff points on rating scales, and dividing participants accordingly into clinically improved or not clinically improved. It is generally assumed that if there is a 50% reduction in a scale‐derived score, such as the BPRS (Overall 1962), or the PANSS (Kay 1986), this could be considered a clinically significant response (Leucht 2005a; Leucht 2005b). If data based on these thresholds were not available, we have used the primary cutoff presented by the trial authors.

2.7 Direction of graphs

Where possible, we have entered data so that the area to the left of the line of no effect indicates a favourable outcome for post‐incident debriefing. When keeping to this would have made it impossible to avoid outcome titles with clumsy double‐negatives (e.g. not unimproved), we would have reported data for which the left of the line indicates an unfavourable outcome, and noted this in the relevant graphs.

Assessment of risk of bias in included studies

Review authors TL and MV independently assessed the risk of bias by using the RoB 1 criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2017). This set of criteria is based on evidence of associations between potential overestimation of effect and the level of risk of bias in the report that may be due to aspects of sequence generation, allocation concealment, blinding of personnel, participants and outcome assessment, incomplete outcome data and selective reporting, or the way in which these domains are reported.

If the raters disagreed, we would have made the final rating by consensus. Where inadequate details of randomisation and other characteristics of trials were provided, we would have attempted to contact trial authors to obtain further information.

We noted the level of risk of bias (high, low, unclear) in both the text of the review, a summary of the risk of bias graph, and the summary of findings table.

1. Binary data

For binary outcomes, we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI), as it has been shown that RR is more intuitive than odds ratios (Boissel 1999); and that clinicians tend to interpret odds ratios as RR (Deeks 2000). Although the number needed to treat for an additional beneficial outcome (NNTB) and the number needed to treat for an additional harmful outcome (NNTH), with their CIs, are intuitively attractive to clinicians, they are problematic to calculate and interpret in meta‐analyses (Hutton 2009). For binary data presented in the summary of findings table, we calculated illustrative comparative risks.

2. Continuous data

For continuous outcomes, we estimated the mean difference (MD) between groups.

Unit of analysis issues

1. Cluster trials

Studies increasingly use cluster‐randomisation (such as randomisation by clinician or practice), but analysis and pooling of clustered data pose problems. Trial authors often fail to account for intra‐class correlation in clustered studies, leading to a unit of analysis error, whereby P values are spuriously low, CIs unduly narrow and statistical significance overestimated (Divine 1992). This causes type I errors (Bland 1997; Gulliford 1999).

Where clustering would have been incorporated into the analysis of primary studies, we would have presented these data as if from a non‐cluster randomised study, but adjusted for the clustering effect.

Where clustering was not accounted for in primary studies, we would have presented data in a table, with a (*) symbol to indicate the presence of a probable unit of analysis error. We would have tried to contact trial authors to obtain intra‐class correlation coefficients for their clustered data, and to adjust for this by using accepted methods (Gulliford 1999).

We sought statistical advice, and have been advised that the binary data from cluster trials presented in a report should be divided by a design effect. This is calculated using the mean number of participants per cluster (m) and the intra‐class correlation coefficient (ICC): thus, the design effect = 1 + (m − 1) * ICC (Donner 2002). If the ICC had not been reported, we would have assumed it to be 0.1 (Ukoumunne 1999).

If cluster studies had been appropriately analysed, and intra‐class correlation coefficients and relevant data documented in the report had been taken into account, synthesis with other studies would have been possible, using the generic inverse variance technique.

2. Cross‐over trials

A major concern of cross‐over trials is the carry‐over effect. This occurs if an effect (e.g. pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a consequence, participants can differ significantly from their initial state at entry to the second phase, despite a wash‐out phase. For the same reason, cross‐over trials are not appropriate if the condition of interest is unstable (Elbourne 2002). As both carry‐over and unstable conditions are very likely in severe mental illness, we would have used data from the first phase of cross‐over studies.

3. Studies with multiple treatment groups

When a study involved more than two treatment arms, we would have presented the additional treatment arms in comparisons, if relevant. If data were binary, we would have simply added these and combined them within the two‐by‐two table. If data were continuous, we would have combined data following the formula in the Cochrane Handbook for Systematic Reviews of Interventions (McKenzie 2022). When additional treatment arms were not relevant, we would not have reproduced these data.

1. Overall loss of credibility

Although at some degree of loss of follow‐up, data lose credibility, we have not excluded studies based on this (Xia 2009).

However, if more than 50% of the data were unaccounted for (lost to follow‐up), we would have excluded these studies in a Sensitivity analysis. If more than 50% were lost in one arm of a study, but the total loss was less than 50%, we would have addressed this in the summary of findings table by downgrading the certainty of the evidence, but not excluding the study in the sensitivity analysis. Finally, we would have also downgraded the certainty of the evidence in the summary of findings table should the loss have been between 25% and 50% in total.

2. Binary

We analysed participant data in an intention‐to‐treat (ITT) analysis, in the groups to which they were randomised. If studies presented data only on completers, we would have used these studies, but we would have undertaken a sensitivity analysis excluding studies using completer analyses.

3. Continuous

3.1 Standard deviations

If standard deviations (SDs) had not been reported, we would have tried to obtain the missing values from the trial authors. If they had not been available, and there were missing measures of variance for continuous data, but a standard error (SE) and CI available for group means, and either a P value or t value available for differences in mean, we could have calculated the SD, according to the rules described in the Cochrane Handbook for Systematic Reviews of Interventions (McKenzie 2022). When only the SE had been reported, the SD would have been calculated by the formula SD = SE * √(n). The Cochrane Handbook for Systematic Reviews of Interventions presents detailed formulae for estimating the SD from P, t, or F values, CI, ranges, or other statistics (McKenzie 2022). If these formulae did not apply, we would have calculated the SD according to a validated imputation method, which is based on the SD of the other included studies (Furukawa 2006). Although some of these imputation strategies can introduce error, the alternative would have been to exclude a given study’s outcome, and thus lose information. Nevertheless, we would have examined the validity of the imputations in a sensitivity analysis that excludes imputed values.

3.2 Assumptions about participants who left the trials early or were lost to follow‐up

Various methods are available to account for participants who left the trials early, or were lost to follow‐up. Some trials just present the results of study completers; others use the method of last observation carried forward (LOCF). More recently, methods such as multiple imputation or mixed‐effects models for repeated measurements (MMRM) have become more of a standard. While the latter methods seem to be somewhat better than LOCF (Leon 2006), we feel that the high percentage of participants leaving the studies early, and differences between groups in their reasons for doing so, are often the core problems in randomised schizophrenia trials. Therefore, we would not have excluded studies based on the statistical approach used. However, by preference, we would have used the more sophisticated approaches, i.e. MMRM or multiple‐imputation rather than LOCF, and we would have only presented completer analyses if ITT data were not available at all. Moreover, we would have addressed this issue when assessing incomplete outcome data in RoB 1.

1. Clinical heterogeneity

We would have considered all included studies initially, without seeing comparison data, to judge clinical heterogeneity. We would have inspected all studies for participants who were clearly outliers, or situations that we had not predicted would arise and, when found, would have discussed such situations or participant groups.

2. Methodological heterogeneity

We would have considered all included studies initially, without seeing comparison data, to judge methodological heterogeneity. We would have inspected all studies for clearly outlying methods that we had not predicted would arise, and discussed any such methodological outliers.

3. Statistical heterogeneity

3.1 Visual inspection

We would have inspected forest plots visually to investigate the possibility of statistical heterogeneity.

3.2 Using the I² statistic

We would have investigated heterogeneity between studies by considering the I² statistic and the Chi² P value. The I² statistic provides an estimate of the percentage of inconsistency thought to be due to chance (Higgins 2003). The importance of the observed value of I² depends on the magnitude and direction of effects, and the strength of evidence for heterogeneity (e.g. P value from Chi² test, or a confidence interval for I²). We would have interpreted an I² estimate of 50% or higher, accompanied by a statistically significant Chi² statistic, as evidence of substantial heterogeneity (Chapter 10 in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2022)). If substantial levels of heterogeneity (I² = 50% to 90%) were found for the primary outcome, we would have explored reasons for heterogeneity with Subgroup analysis and investigation of heterogeneity.

Assessment of reporting biases

Reporting biases arise when the dissemination of research findings is influenced by the nature and direction of results (Egger 1997). These are described in section 10.1 of the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2022).

1. Protocol versus full study

We located a protocol for the included randomised trial. We compared outcomes in the protocol and the published report. If the protocol had not been available, we would have compared outcomes listed in the methods section of the trial report with the actual reported results.

2. Funnel plot

We are aware that funnel plots may be useful in investigating reporting biases but are of limited power to detect small‐study effects. We did not plan to use funnel plots for outcomes when there were 10 or fewer studies, or when all studies were of similar size. In other cases, if funnel plots were possible, we would have sought statistical advice for their interpretation.

Data synthesis

We understand that there is no closed argument for the preferred use of fixed‐effect or random‐effects models. The random‐effects method incorporates the assumption that the different studies are estimating different, yet related, intervention effects. The random‐effects model takes into account differences between studies, even if there is no statistically significant heterogeneity. However, there is a disadvantage to the random‐effects model: it puts added weight onto small studies, which are often the most biased ones. Depending on the direction of effect, these studies can either inflate or deflate the effect size. Therefore, we have used a fixed‐effect model for all analyses.

Subgroup analysis and investigation of heterogeneity

We did not anticipate subgroup analyses due to the known low number of relevant trials in this research area.

Sensitivity analysis

We would have performed sensitivity analyses for the primary outcomes, when possible, to explore the influence of the following factors on effect size. If there were substantial differences in the direction or precision of effect estimates in any of the sensitivity analyses listed below, we would have discussed them in the discussion section.

1. Implication of randomisation

We would have excluded trials that were described as double‐blind, but where randomisation was not explicitly mentioned.

2. Assumptions for missing data

We would have excluded studies using completer analyses only (see Dealing with missing data).

3. Loss to follow‐up

We would have excluded studies in which the overall loss of data was greater than 50%.

4. Risk of bias

We planned to exclude trials that were at high risk of bias across one or more of the domains (see Assessment of risk of bias in included studies). However, we decided not to exclude the study with a high risk of bias, as it is currently the only trial fulfilling the inclusion criteria.

5. Imputed values

We would have excluded trials in which we used imputed values for ICC to calculate the design effect in cluster‐randomised trials, or in which we imputed SDs.

6. Fixed‐effect and random‐effects model

We resynthesised data for the primary outcome using a random‐effects model, to evaluate whether this altered the significance of the results. However, no differences in results were found.

7. Skewed data

We planned to exclude studies for which there was a suggestion of skewness (mean/SD ratio lower than 2; see Data extraction and management). For one scale, the ratio was lower than one. We decided not to exclude this study, but to note this in the results, due to the low number of studies.

Summary of findings and assessment of the certainty of the evidence

We used the GRADE approach to interpret our findings (Schünemann 2022), and GRADEpro GDT software to export data from our review and create a summary of findings table. This table provides outcome‐specific information concerning the overall certainty of evidence from the included studies in the comparison, the magnitude of the effect of the interventions examined and the sum of available data on all outcomes we rated as important to the person receiving care and clinical decision‐making. We selected the following main outcomes in the summary of findings table.

1. Further use of a seclusion room

2. Any change in specific symptoms, as defined by study authors

3. Recipient of care satisfied/not satisfied with treatment

4. Any change in specific aspects of behaviour, as defined by study authors, e.g. aggression, violence

5. At least one adverse effect

Results

Description of studies

Results of the search

In total, 136 hits were identified through the search. After duplicates were removed, a total of 113 references were left for screening. After initial appraisal, we selected two studies (three references) for further inspection of the full papers. One study with two references met our inclusion criteria (Wullschleger 2021), and we excluded one study. We did not identify any further relevant studies from the reference list. There were no ongoing studies identified, and none are awaiting assessment. See Figure.

1.

Flow chart of the systematic literature search

Included studies

See Characteristics of included studies.

Design and duration

Wullschleger 2021 used individual randomisation.

Participants

Participants were 18 to 65 years old and diagnosed with psychotic disorder (ICD‐10: F1x.5, F2x, F30.2 and F31.2). Most of them had a diagnosis of F2x (no further details). Their current clinical state, as well as state of illness, was acute. They had all experienced at least one coercive measure (mechanical restraint, seclusion and coerced medication on court order) during their hospital stay (Wullschleger 2021).

Size

The study included six public psychiatric clinics. In total, 422 participants were randomised and 109 consented to participate (Wullschleger 2021).

Setting

The study was conducted in Germany. It included six public psychiatric clinics with general psychiatric wards (Wullschleger 2021).

Funding

The included study reported non‐industrial funding (Wullschleger 2021).

Interventions

1. Post‐incident debriefing plus standard professional care

In Wullschleger 2021, the intervention was targeted towards patients. It consisted of a standardised post‐coercion review session conducted by trained staff members of the ward according to a published guideline. The session was repeatedly offered until discharge; the preferred moment to participate in the intervention varied between participants, so they were able to freely determine the best possible time for the intervention. One session lasted approximately 30 to 40 minutes. Patients were encouraged to invite any person of trust or another member of staff or peer workers to participate in this session.

2. Standard professional care

Wullschleger 2021 described their control intervention as standard professional care; this may have included conversations about experienced coercive measures, but these conversations were unstructured.

Outcomes

The following outcomes were reported by the included study: further seclusion and restraint, mental state (specific symptoms), satisfaction with care – recipient, additional medication and acceptability of intervention.

This study did not report five of the outcomes that were specified in our review protocol. The included study did not attempt to quantify behaviour, quality of life, adverse events and safety, adverse effects, or economic outcomes.

Outcome scales providing useable data

The following scales provided continuous data for the analysis.

1. Mental state (specific symptoms)

i. Peritraumatic Distress Inventory (PDI) (Brunet 2001)

A self‐reported questionnaire was used to measure an individual's experienced level of distress during and after a traumatic event. Study participants responded to the questionnaire during the assessment. PDI is a self‐reported questionnaire comprising 13 items on a five‐point Likert (0 to 4) scale measuring the diagnostic criterion A2 (fear, helplessness or horror) of DSM‐IV Posttraumatic Stress Disorder (Brunet 2001). The cutoff score for PDI is 14 for PTSD (sensitivity 84%, specificity 47%) (Guardia 2013).

2. Satisfaction with care – recipient

i. Coercion Experience Scale (CES) (Bergk 2010).

A self‐reported instrument was used to assess the psychological impact of coercive measures. Study participants responded to the questionnaire after coercive measures. CES is a 31‐item scale comprising six factors (humiliation, physical adverse effects, separation, negative environment, fear, coercion). The instrument comprises two items which are rated on a 0 to 100 visual analogue scale, and 29 items on a five‐point Likert (not/a little, moderate, severe, very severe, extreme) scale. Higher scores indicate more negative experiences (Bergk 2010).

ii. Coercion Ladder (Høyer 2002)

A self‐reported instrument was used to assess the perceived coercion during the whole hospital stay. The Coercion Ladder consists of one visual analogue scale depicted as a ladder with 10 steps (1 to 10). Higher values indicate higher levels of perceived coercion. Respondents assess their perceived coercion on the visual analogue scale after reading instructions to think about their admittance to the hospital (Høyer 2002). In Wullschleger 2021, the instructions were modified to address perceived coercion during the whole hospital stay.

Excluded studies

We excluded one study (Fleischman 1985). We inspected the study in full‐text to make the final decision. The reason for exclusion was the design being quasi‐randomised.

Risk of bias in included studies

Allocation

Wullschleger 2021 used individual randomisation. Potential participants meeting the inclusion criteria were randomised after the first coercive measure to either the intervention or the control group. A block randomisation with periods of eight on each ward was used, and allocation status was concealed using sealed envelopes. Randomisation blocks were generated using an online randomisation tool. However, participants’ willingness to join the study and inclusion criteria were screened after allocation, resulting in an unbalanced group size (52 intervention group, 57 control group). The risk of bias for allocation was unclear.

Blinding

Staff members, research workers, participants and researchers were not blinded in Wullschleger 2021. The outcome assessment was based on participants' self‐reporting and medical records. Blinding had a high risk of bias.

Incomplete outcome data

We identified incomplete outcome data in the included study, and it had a high risk of bias (Wullschleger 2021). The attrition rate was 83% in the intervention group and 78% in the standard treatment group.

Selective reporting

Wullschleger 2021 was retrospectively registered. Inclusion criteria such as persisting cognitive deficits, language barrier or adjustment of their main diagnosis were not defined in the original registration. The study did not report the following outcome measure identified in the study register: quality of the therapeutic relationship (Working Alliance Inventory – Short Revised, WAI‐SR). Thus, there was a high risk of bias for selective reporting.

Other potential sources of bias

We did not detect any other potential sources of bias.

Effects of interventions

See: Summary of findings 1 Post‐incident debriefing compared with treatment as usual after coercive measures for people with schizophrenia

Comparison 1: Post‐incident debriefing versus treatment as usual

Studies relevant to this review fall into a single comparison. In total, there is one included study (Wullschleger 2021), therefore no sensitivity or subgroup analyses were conducted. See Table.

1.1 Further use of seclusion and restraint

For further use of seclusion, we found an increased risk of the post‐incident debriefing group being secluded again compared to the treatment as usual group, but the evidence is very uncertain (RR 1.32, 95% CI 0.74 to 2.33; 1 study, 109 participants; very low‐certainty evidence; Analysis 1.1; Figure).

1.1. Analysis.

Comparison 1: Post‐incident debriefing versus treatment as usual, Outcome 1: Further seclusion and restraint

2.

Forest plot of the primary outcome

For the further use of restraint, there was no clear difference between the post‐incident debriefing group and the treatment as usual group (RR 0.92, 95% CI 0.68 to 1.23; 1 study, 109 participants; Analysis 1.1).

1.2 Mental state (specific symptoms)

For mental state (specific symptoms) (PDI), we found that post‐incident debriefing had little to no effect on the outcome, but the evidence is very uncertain (MD ‐1.62, 95% CI ‐7.47 to 4.23; 1 study, 82 participants; very low‐certainty evidence; Analysis 1.2). There is a possibility that the data are skewed.

1.2. Analysis.

Comparison 1: Post‐incident debriefing versus treatment as usual, Outcome 2: Mental state (specific symptoms)

1.3 Satisfaction with care ‐ recipient

This outcome included two different measures: perceived coercion and coercion experience. We did not find evidence that post‐incident debriefing increased participants' satisfaction with care compared to treatment as usual for either of these measures, but the evidence is very uncertain (perceived coercion MD ‐0.37, 95% CI ‐1.59 to 0.85; 1 study, 109 participants; coercion experience MD ‐1.61, 95% CI ‐13.36 to 10.14; 1 study, 109 participants; very low‐certainty evidence; Analysis 1.3). For coercion experience, the data are likely to be skewed.

1.3. Analysis.

Comparison 1: Post‐incident debriefing versus treatment as usual, Outcome 3: Satisfaction with care ‐ recipient

1.4 Additional medication

For additional medication, we found evidence of a difference in effects between post‐incident debriefing and treatment as usual, favouring post‐incident debriefing (RR 0.66, 95% CI 0.17 to 2.62; 1 study, 109 participants; Analysis 1.4). However, the CI is wide and includes both an increase and decrease in medication with the intervention.

1.4. Analysis.

Comparison 1: Post‐incident debriefing versus treatment as usual, Outcome 4: Additional medication

1.5 Acceptability of intervention

For this outcome, we did not find evidence that post‐incident debriefing was clearly different in its effects in terms of participants leaving the study early for any reason, compared with treatment as usual (RR 1.03, 95% CI 0.92 to 1.16; 1 study, 422 participants; Analysis 1.5).

1.5. Analysis.

Comparison 1: Post‐incident debriefing versus treatment as usual, Outcome 5: Acceptability of intervention

Discussion

Summary of main results

The present review includes only one study (two references) with 109 participants (Wullschleger 2021). We found very limited evidence on the effects of post‐incident debriefing after coercive measures for people with schizophrenia or schizophrenia‐type psychosis. We assessed the evidence for the primary outcome, further seclusion, to be of very low certainty. Given the lack of studies, the very low‐certainty evidence limits our ability to draw substantive conclusions. It is not possible to arrive at definite conclusions that post‐incident debriefing after coercive measures is effective for people with schizophrenia or schizophrenia‐type psychosis. The main results are presented in Table.

Overall completeness and applicability of evidence

We compared the effects of post‐incident debriefing plus standard professional care after coercive measures with standard professional care. We included all randomised controlled trials (RCTs) in adult psychiatric care with participants diagnosed with schizophrenia or schizophrenia‐type psychosis, encompassing various clinical states and stages. Overall, the completeness of evidence was poor and the total number of participants in the included study was low.

We expected studies assessing a wide variety of outcomes on the effects of post‐incident debriefing in terms of treatment‐related outcomes, patient‐related outcomes and the impact on society. Five out of 10 prespecified outcomes were reported: further seclusion and restraint, mental state (specific symptoms), satisfaction with care ‐ recipient, additional medication and acceptability of intervention, with very low‐certainty evidence (Wullschleger 2021). On the other hand, the included study did not report behaviour, quality of life, adverse events and safety, adverse effects or economic outcomes.

We were able to include only one study with two publications (Wullschleger 2021). The study was conducted in six public psychiatric clinics in Germany. It included people with psychotic disorder who had all experienced any type of coercive measure during their hospital stay (mechanical restraint, seclusion and coerced medication on court order). We aimed to ensure that information was relevant to the specific patient groups. We therefore aimed to highlight participants’ current clinical state, the stage, and people with particular problems (for example, negative symptoms, treatment‐resistant illnesses). However, the participants were able to decide the specific time of the intervention, which limits our awareness of the participant’s current stage and clinical problem at the time of the intervention; this further limits the generalisation of the results. The duration of an intervention session was 30 to 40 minutes, which included a structured discussion, moderated by a trained staff member. The intervention also included an open‐ended discussion with expressions of their subjective experience, reflection on past events and consideration of different perspectives. The intervention could be repeated in other settings. However, its content depends on each participant's initiatives. Further, the limited geographical representativeness of this single study, the disease severity of the included participants and differences in the specific content of the intervention decrease the generalisability of the evidence in current practice. This indicates that many more studies need to be conducted before specific conclusions can be drawn.

The study included in our review was published in 2021 (Wullschleger 2021). The results may change in the future if more studies are published related to our outcomes. The included study provides very low‐certainty data. This review reports the results based on the currently available, very limited data. There are no post‐incident debriefing studies awaiting classification, and we did not find any relevant ongoing studies. Therefore, in the coming years, we do not expect big changes in the research results regarding the study topic. In conclusion, we cannot say that the review evidence is complete or applicable and, therefore, our results are still inconclusive.

Certainty of the evidence

Overall, we assessed the certainty of the evidence in this review to be very low. The major issue having an impact on the certainty was that we were able to include only one RCT in our review, and thus all the outcomes included data from a single study only. We assessed the included study to have a high risk of bias. First, staff members, research workers, participants and researchers were not blinded in the study. Outcomes were based on participants' self‐assessments to a large extent. Second, there were incomplete outcome data in the included study. Third, we detected selective reporting in this study. The study was retrospectively registered, and there were deviations between registration and the published report in terms of inclusion criteria and outcomes reported. We considered these identified issues to result in a high risk of possible bias.

We further evaluated three individual outcomes using the GRADE approach. We evaluated all three outcomes (further use of seclusion, mental state (specific symptoms) and satisfaction with care ‐ recipient) to have a very low certainty of evidence.

Potential biases in the review process

There is a possibility that our search strategy may have missed some studies due to publications not using common keywords, or studies being labelled with subject headings that we did not capture. The search for studies was conducted by Cochrane Schizophrenia. The search strategies were systematic, and supplemented with handsearches from trial registers and reference lists from the papers included in this review.

The term 'post‐incidence debriefing' is defined in the literature in numerous ways, and may include a number of different elements. For example, Hammervold 2019 analysed 'post‐incidence review' (PIR) and found that out of 12 studies, PIR was used as a separate intervention after restraint use in five studies, while in the other studies, PIRs were described as one of several components in restraint reduction programs. A lack of a clear definition of 'post‐incidence debriefing' may have left room for subjectivity in the research team in deciding whether an intervention could be considered a post‐debriefing, especially when debriefing has been embedded into complex packages of care. Nevertheless, we do not consider that this would have introduced major bias in the review, as we only included studies where post‐incident debriefing was the intervention randomised (although it remains a possibility).

Finally, we followed the review protocol in the process of study selection, data extraction and analysis (Välimäki 2023). We only employed published reports. However, we could not entirely avoid the potential for publishing bias for negative results and small studies. We did not remove or add any main outcomes. There are no known conflicts of interest among the authors as none of the authors received any direct funding for the completion of this review or have completed studies about post‐incident review.

Agreements and disagreements with other studies or reviews

Previous studies have reported that post‐incident debriefing could support efforts to reduce the use (Huckshorn 2014; Whitecross 2013) and duration of coercive measures (Goulet 2018). NICE 2015 has also proposed that post‐incidence debriefing could be useful in decreasing aggressive incidents among patients. However, we found in the post‐incident debriefing group that there may be an increased risk of being secluded again compared to treatment as usual, although the certainty of the evidence was very low. On the other hand, for the further use of restraint, a clear difference between post‐incident debriefing compared to treatment as usual was lacking. Our results are supported by Billings 2023, who conducted a systematic review to assess the issue of whether 'post‐incident psychosocial interventions' have any impact after traumatic incidents in the workplace. The review was based on 80 research studies and 11 clinical practice guidelines and did not conclusively demonstrate the benefits of post‐incident psychosocial interventions. On the contrary, generic debriefing was associated with some negative outcomes. As opposed to single studies by Abdelghaffar 2018 and Huckshorn 2014, we did not find any evidence that post‐incident debriefing intervention was different in its effects in terms of reducing peritraumatic distress compared to standard professional care. However, as found by Billings 2023, no harms were demonstrated after post‐incident psychosocial intervention based on the analysis.

We did find evidence that post‐incident debriefing was different in its effects on additional medication compared with treatment as usual, favouring post‐incident debriefing. However, the result was based on one study only and the CI is wide and includes both an increase and decrease in medication with the intervention. Scarcity in this research area has also been noted by other reviews, perhaps indicating a lack of systematic use of post‐incident debriefing in clinical practice (Kodua 2023).

Authors' conclusions

Implications for practice.

Post‐incident debriefing is a well‐known practice in mental health settings, especially across the UK. Post‐incidence debriefing is a central part of treatment approaches in the Department of Health’s Positive and Proactive Care: reducing the need for restrictive interventions guidance (Department of Health 2014), restraint reduction initiatives and trauma‐informed approaches, such as in the Six Core Strategies (Huckshorn 2014), REsTRAIN yourself (Duxbury 2019), and Safewards (Safewards 2024). In addition, current guidelines support the use of post‐incident debriefing in psychiatric care. For example, NICE 2015 has recommended post‐incidence debriefing as one of the quality statements in their guideline for violent and aggressive behaviours in people with mental health problems. Based on the findings of this review, however, patients, their family members, care teams and managers should continue to ask questions about the rationale behind specific post‐incidence briefing interventions used after any traumatic events. This could encourage mental health professionals to think of reasons for using any specific approach in patient care.

Implications for research.

Post‐incidence debriefing interventions and their components should be clearly defined and described to increase the rationale for and understanding of how the intervention works in daily practice. Different experiences and study results should be made publicly available for researchers to increase the transparency of the interventions and allow researchers to carry out further analyses. If feasible, the impact of post‐incidence debriefing interventions should be assessed using robust assessment methods including randomised trials. We realise that the effects of post‐incidence briefing interventions alone are seldom assessed with a pragmatic approach. A lack of randomised clinical trials, for example, limits opportunities to develop feasible guidelines for patients, their family members and clinical use. More high‐quality studies would allow researchers to include them in reviews and further treatment guidelines regarding post‐incidence debriefing interventions for psychiatric patient populations.

History

Protocol first published: Issue 4, 2023

Appendices

Appendix 1. Electronic searches

The Information Specialist (IS) searched the Schizophrenia Group's Specialised Register using the following search strategy: [(*seclusion*) AND (*post*)] OR [(*incident*) AND (*post*)] [(*restraint*) AND (*review*)] in abstract terms of REFERENCE)]

The Schizophrenia Group's Specialised Register is a study‐based register, which allows the Information Specialist to search the major concept and retrieve all the synonyms and relevant studies. This is because the studies have already been organised, based on their interventions, and linked to the relevant topics (Shokraneh 2017). This allows rapid and accurate searches that reduce waste in the next steps of systematic reviewing (Shokraneh 2019). Following Cochrane methods, the Information Specialist compiles this register from systematic searches of major resources and their monthly updates (unless otherwise specified (Lefebvre 2022)).

• CENTRAL (Cochrane Central Register of Controlled Trials)

• MEDLINE

• Embase

• PubMed

• CINAHL (Cumulative Index to Nursing and Allied Health Literature)

• PsycINFO

• US National Institute of Health Ongoing Trials Register (ClinicalTrials.gov)

• World Health Organization International Clinical Trials Registry Platform (ICTRP; www.who.int/ictrp)

• ISRCTN registry

• ProQuest Dissertations and Theses A&I and its quarterly update

The Specialised Register also includes the results of handsearches and conference proceedings (see schizophrenia.cochrane.org/resources). It does not place any limitations on language, date, document type, or publication status.

Data and analyses

Comparison 1. Post‐incident debriefing versus treatment as usual.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Further seclusion and restraint	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.1.1 Further use of seclusion room (number of use of seclusion during the index hospital stay)	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.74, 2.33]
1.1.2 Further use of mechanical/physical restriction (number of use of restraint during the index hospital stay)	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.68, 1.23]
1.2 Mental state (specific symptoms)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.2.1 Average endpoint score on specific symptom scale ‐ Peritraumatic Distress Inventory (PDI)	1	82	Mean Difference (IV, Fixed, 95% CI)	‐1.62 [‐7.47, 4.23]
1.3 Satisfaction with care ‐ recipient	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.3.1 Perceived coercion (CL)	1	109	Mean Difference (IV, Fixed, 95% CI)	‐0.37 [‐1.59, 0.85]
1.3.2 Coercion experience (CES)	1	109	Mean Difference (IV, Fixed, 95% CI)	‐1.61 [‐13.36, 10.14]
1.4 Additional medication	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.4.1 Use of rapid tranquillisation/increased medication ‐ no information about administration route	1	109	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.17, 2.62]
1.5 Acceptability of intervention	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.5.1 Number of participants leaving the study early: for any reason	1	422	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.92, 1.16]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Wullschleger 2021.

Study characteristics
Methods	Allocation: potential participants meeting inclusion criteria were randomised after the first coercive measure to either the intervention or the control group. A block randomisation with periods of 8 on each ward was used; allocation status was concealed using sealed envelopes. Randomisation blocks were generated using an online randomisation tool. Blinding: unmasked to staff members, research workers, participants, and researchers Duration: single session Design: 2‐armed randomised controlled trial Setting: 6 public psychiatric clinics Country: Germany
Participants	Diagnosis: psychotic disorders (ICD‐10) N = 109 Age: intervention: 38.54 (SD 14.27), control: 39.11 (SD 11.36) Sex: n = 54 females, n = 55 males Coercion: at least one coercive intervention during their current hospitalisation Clinical state: acute Stage: acute. Symptom severity (absent‐severe): severe mental illness Exclusion: discharged within 24 hours after admission, comorbid severe organic brain disorders, severe cognitive deficits, insufficient German language
Interventions	1. Post‐coercion refecting review session: a standardised, post‐coercion refecting review session with interview, sharing between participants and staff, alternatives and future options 2. Standard care: unstructured encompassed conversations about experienced coercion
Outcomes	Objective use of coercion: seclusion, restraint, forced medication Perceived coercion: (adapted MacArthur admission experience scale (AES, only sub‐scales) and the coercion ladder (CL)) Coercion experience: coercion experience scale (CES) Peritraumatic reaction: Peritraumatic Distress Inventory (PDI) Symptoms of PTSD: Impact of Events Scale‐Revised (IES‐R, only sub‐scales) Leaving the study early
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Potential participants meeting inclusion criteria were randomised after the first coercive measure to either the intervention or the control group. A block randomisation with periods of 8 on each ward was used, and allocation status was concealed using sealed envelopes. Randomisation blocks were generated using an online randomisation tool. However, participants’ willingness to join the study and inclusion criteria were screened after allocation, resulting in unbalanced group size (52 intervention group, 57 control group).
Allocation concealment (selection bias)	Unclear risk	Randomisation was generated by the main research investigator immediately after they experienced the first coercive intervention. The randomisation result was communicated to the contact person on each ward. Random permuted blocks were not used, which may lead to concealment of the future randomisation results.
Blinding of participants and personnel (performance bias) All outcomes	High risk	The randomisation result was communicated to the contact person on each ward and, thus, unmasked to staff members, research workers and participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The outcome assessment was based on participants' self‐reporting and medical records. Awareness of the outcome of enrolment by personnel could affect the outcomes measured and the perceived effectiveness of intervention.
Incomplete outcome data (attrition bias) All outcomes	High risk	Participants (N = 422) were allocated to either the intervention or the control group immediately after they experienced the first coercive intervention during their hospital stay. However, in each group, 98 participants were discharged unexpectedly. Further, 35 participants in the intervention group and 40 in the control arm refused to participate, and 26 and 16 participants in the intervention and control group were excluded because of persisting cognitive defects, language barriers or adjustment of their main diagnosis. Finally, 109 participants consented to participate: 52 participants in the intervention group and 57 in the control group. A total of 82 participants answered both instruments. Thus, the attrition rate (out of the original 422 randomised) is 83% in the intervention group and 78% in the standard treatment group.
Selective reporting (reporting bias)	High risk	The trial was retrospectively registered. Inclusion criteria such as persisting cognitive deficits, language barrier or adjustment of their main diagnosis, are not defined in the original registration. The study does not report the following outcome measure identified in the study register: quality of the therapeutic relationship (WAI‐SR).
Other bias	Low risk	No other sources of bias identified.

ICD: International Classification of Diseases; SD: standard deviation

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Fleischman 1985	Quasi‐randomised study

Differences between protocol and review

We planned to exclude trials that are at high risk of bias across one or more of the domains (see Assessment of risk of bias in included studies). However, we decided not to exclude the study with a high risk of bias, as it is currently the only trial fulfilling the inclusion criteria. We also did not exclude the study based on possible skewness of the data for one outcome.

Contributions of authors

MV: development and writing the review

JV: writing the review

TL: development and writing the review

Sources of support

Internal sources

• University of Turku, Finland

  Internal fund 26003424 (Maritta Välimäki); Department of Nursing Science (Maritta Välimäki); and the Doctoral Programme in Nursing Science (Jaakko Varpula)

• National Institute for Health and Care Research (NIHR), UK

  Provided funding for Cochrane Schizophrenia

External sources

• Academy of Finland, Finland

  Grants 294298 and 307367 (Maritta Välimäki); and 316206 (Tella Lantta)

Declarations of interest

MV: research interest is related to patient aggression

JV: none known

TL: none known

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