Methods

Allocation: randomised (1:1 ratio).

Blinding: not blinded: randomisation involved allocation to 2 different types of legal status. Therefore, it was impossible and unlawful to mask research assistants, treating clinicians or participants.

Duration: 12 and 36 months

Participants

Diagnosis: people with psychosis discharged from hospital; 84% had schizophrenia, diagnostic criteria not stated.

n = 336. However, on the 1st day, 1 participant assigned to a CTO withdrew and 2 on Section 17 were excluded (1 was already on a CTO and the other had been on a Section 17 too long). This left 333 for an ITT analysis.

Age: 18 to 65 years.

Sex: 225 M, 111 F.

History: involuntarily admitted to hospital with psychosis and deemed suitable for supervised outpatient care by the treating clinicians.

Exclusion criteria: none.

Interventions

1. CCT.

2. Supervised discharge (Section 17 leave): participants allowed to leave hospital for some hours or days, or even exceptionally weeks, while still subject to recall.

Outcomes

Service use: readmission to hospital, number of days in psychiatric hospital, number of readmissions, time to admission.

Mental state: BPRS.

Global state: GAF.

Unable to use: loss to care, adherence to prescribed medication, satisfaction with services, engagement with clinical services.

Notes

ITT analysis for 12‐month follow‐up. All but 3 people were followed up at 36 months (n = 330) although not all completed all the secondary and tertiary outcome measures.

Both intervention and control groups were subject to some form of CCT for at least part of the study.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Consenting participants were randomly assigned (ratio 1:1) by an independent statistician to be discharged from hospital either on CTO or Section 17 leave. Randomisation used random permuted blocks with lengths of 2, 4 and 6, and stratified for sex (male or female), schizophrenic diagnosis (yes or no) and duration of illness (< 2 years or ≥ 2 years). Assignments were enclosed in sequentially numbered, opaque, sealed envelopes and stored by a researcher independent to the trial team.

Allocation concealment (selection bias)

Unclear risk

The details of the sequence remained unknown to all members of the trial team until recruitment, data collection and analyses were completed.

Randomisation took place after consent was obtained and the baseline interview was done. The envelope was opened on the day of the interview by the independent researcher after recording the participant's trial identification number on the envelope. She then communicated the randomised allocation to the recruiting researcher by telephone.

Blinding (performance bias and detection bias)
All outcomes

High risk

See above; randomisation involved allocation to 2 different types of legal status. Therefore, it was impossible and unlawful to mask research assistants, treating clinicians or participants.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There was no attrition for the primary outcome measure, or health service use; outcome data on psychiatric symptoms and the GAF were only available on 70% of the sample.

Selective reporting (reporting bias)

Low risk

Not apparent

Other bias

High risk

Other potential sources of bias in the study included allowing clinicians to make decisions independent of initial randomisation, whereby 40 participants (25%) allocated to Section 17 were subsequently placed on a CTO during the study and 35 participants randomised to CTOs (22%) did not actually receive the intervention. A sensitivity analysis to remove these protocol violations may, in turn, have left the study underpowered and not removed the possibility that Section 17 participants swapped to a CTO might have been more severely ill than participants remaining on Section 17 as per the protocol. Uncertainty concerning control condition.

Although length of initial compulsory outpatient treatment differed widely between the 2 groups (medians of 183 days with CCT versus 8 days with supervised discharge), Section 17 participants averaged 4 months on some form of compulsory treatment over the 12 months consisting of the mean of 8 days on Section 17 plus periods of compulsory care during follow‐up (outcome).

Another potential source of bias was that clinicians could keep participants on Section 17 for a variable period of time. It is possible that participants who were most likely to default on treatment were maintained on Section 17 and that for these participants it acted more like a CTO thus reducing the chance of the study finding an effect of CTOs. A final issue was generalisability. Around 20% of the sample were ineligible or refused to take part. These participants may have been the most unwell or lacking in insight, and therefore the ones most likely to benefit from CTOs.

Methods

Allocation: randomised, described.

Blinding: unclear*.

Duration: 11 months.

Participants

Diagnosis: majority had psychosis; diagnostic criteria not stated.

n = 152.*

Age: > 18 years.

Sex: 94 M, 48 F.

History: poor compliance with services when discharged.

Exclusion criteria: history of violence.

Interventions

1. CCT: enhanced service package + intensive, court‐ordered compulsory OPC, including involuntary medication for people thought by court to lack capacity to give informed consent. n = 78.

2. Standard care: enhanced service package with inpatient assessment and comprehensive discharge treatment plan in which participants participated, case management and oversight by OPC co‐ordinating plan. n = 64.**

Outcomes

Service use: number of admissions, compliance with medication.

Social functioning: number of arrests, homelessness.

Satisfaction with care: perceived coercion (MAES).

We were unable to use:

Service use: hospitalisation; length of stay (no SD), remaining in contact (leaving the study early) (data unusable).

Mental state: PANSS (no SD).

Global state: GAF (no SD).

Quality of life: LBQL (no SD).

Adverse effects: various adverse effects (no SD).

Notes

ITT analysis.

* Study did not specifically mention blinding but did use self‐report measures for at least some of the outcomes, which are effectively self‐blinding

* 142 participants completed baseline interview, 10 excluded from all reporting (7 from the CTO group and 3 from the controls).

** There was a suggestion that members of the control group and their case managers thought that they were actually on OPC.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The study used a random number list to identify assignment to either the intervention or control group. Random number list was generated by computer, which then split 200 numbers between groups.

Allocation concealment (selection bias)

Unclear risk

Unclear. The printed list was maintained in the research team's office in a locked file. When the treatment team had completed their treatment plan, they called the research team who checked the computer list to see whether the client was to be assigned to the experimental or comparison group.

Blinding (performance bias and detection bias)
All outcomes

High risk

No specific mention in the study. Although self‐report measures were used for at least some of the outcomes, it was unlikely participants, clinicians or assessors were blind to treatment status. There was also confusion that resulted in some control participants and their clinicians believing that they were in the intervention group.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Only 57% to 68% of the participants completed interviews at 1, 5 and 11 months after hospital discharge. Only some outcomes were assessed by ITT analysis.

Selective reporting (reporting bias)

Unclear risk

Unclear from paper.

Other bias

Unclear risk

Unclear, no conflict of interests reported. The New York Police did not bring people for assessment when they breached their treatment orders. Therefore, there was no consequence to the order as intended by the law.

Methods

Allocation: randomised.

Blinding: not blinded.

Duration: 12 months.

Participants

Diagnosis: schizophrenia, schizoaffective disorder or other major psychotic or affective disorder; diagnostic criteria not stated.

n = 264.*

Age: > 18 years.

Sex: 132 M, 132 F.

History: ill > 1 year, significant functional impairment (NCFAS score ≥ 90), intensive treatment in past 2 years, awaiting period of court‐ordered CCT, only included people discharged from hospital and not those already living in the community.

Exclusion criteria: personality disorder, psychoactive substance‐use disorder, organic brain syndrome in absence of primary psychotic or mood disorder, recent serious act of violence involving injury or use of a weapon.*

Interventions

1. CCT: intensive, court‐ordered compulsory OPC. n = 129.

2. Standard care: control group were released from OPC by notifying the court. n = 135.

Outcomes

Service use: number of admissions, compliance with medication.

Social functioning: number of arrests, threatening behaviour, homelessness.

Quality of life: victimisation; number of violent or non‐violent attacks.

Satisfaction with care: perceived coercion (MAES).

We were unable to use:

Hospitalisation: length of stay (data unusable).

Leaving the study early (data unusable).

Notes

* Data for this review based only on those randomised to treatment groups and only non‐violent participants were randomised.

The RCT was supplemented by a non‐random post hoc analysis of the intervention group based on duration of involuntary outpatient treatment. Renewals of CCT were not randomised for people who no longer met legal criteria.

ITT analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Stated to be randomised but did not describe process.

Allocation concealment (selection bias)

Unclear risk

Stated to be randomised but did not describe process.

Blinding (performance bias and detection bias)
All outcomes

High risk

No specific mention in the study. Although self‐report measures were used for at least some of the outcomes, it is unlikely participants, clinicians or assessors were blind to treatment status.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Of the identified eligible people, about 12% refused to participate. Subsequent attrition from the study was 18.2% (n = 48) but bias was minimised by ITT analysis.

Selective reporting (reporting bias)

Unclear risk

Unclear from paper.

Other bias

Unclear risk

Unclear, no conflicts of interest reported.