Burns 2013.
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 |
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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. |
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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. |
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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. |
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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. |
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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. |