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Community treatment orders: background and implications of the OCTET trial

  • Tom Burns (a1) and Andrew Molodynski (a1)
Summary

Community treatment orders (CTOs) were introduced into the UK despite unconvincing international evidence for their effectiveness. The Oxford Community Treatment Order Evaluation Trial (OCTET) is a multisite randomised controlled trial of 333 patients with psychosis conducted in the UK. It confirms an absence of any obvious benefit in reducing relapse despite significant curtailment of liberty. Community mental health teams need to seriously consider whether they should continue using CTOs or shift their clinical focus to strengthening the working alliance.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution (CC-BY) license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Footnotes
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See commentary, pp. 6–8, this issue.

Declaration of interest

None.

Footnotes
References
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1 Churchill, R, Owen, G, Singh, S, Hotopf, M. International Experiences of Using Community Treatment Orders. Institute of Psychiatry, 2007.
2 Dawson, J. Community Treatment Orders: International Comparisons. Otago University, 2005.
3 Royal College of Psychiatrists. Community Supervision Orders (Council Report CR18). Royal College of Psychiatrists, 1993.
4 Genevra, R. Balancing autonomy and risk: a failure of nerve in England and Wales? Int J Law Psychiatry 2007; 30: 7180.
5 Maughan, D, Molodynski, A, Rugkåsa, J, Burns, T. Community treatment orders: a systematic review of clinical outcomes. Soc Psychiatry Psychiatr Epidemiol 2013; 18 Oct, epub ahead of print.
6 Swartz, M, Swanson, JD, Wagner, H, Burns, B, Hiday, V, Borum, R. Can involuntary outpatient commitment reduce hospital recidivism? Findings from a randomized trial with severely mentally ill individuals. Am J Psychiatry 1999; 156: 1968–75.
7 Steadman, HJ, Gounis, K, Dennis, D, Hopper, K, Roche, B, Swartz, M, et al. Assessing the New York City Involuntary Outpatient Commitment Pilot Program. Psychiatr Serv 2001; 52: 330–6.
8 Burns, T, Rugkåsa, J, Molodynski, A, Dawson, J, Yeeles, K, Vazquez-Montes, M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013; 381: 1627–33.
9 Eastman, N. Mental health law: civil liberties and the principle of reciprocity. BMJ 1994; 308: 43–5.
10 Dawson, J, Burns, T, Rugkåsa, J. Lawfulness of a randomised trial of the new community treatment order regime for England and Wales. Med Law Rev 2011; 19: 126.
11 Department of Health. Code of Practice: Mental Health Act 1983. TSO (The Stationery Office), 2008.
12 Killaspy, H, Kingett, S, Bebbington, P, Blizard, R, Johnson, S, Nolan, F, et al. Randomised evaluation of assertive community treatment: 3-year outcomes. Br J Psychiatry 2009; 195: 81–2.
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BJPsych Bulletin
  • ISSN: 2053-4868
  • EISSN: 2053-4876
  • URL: /core/journals/bjpsych-bulletin
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Community treatment orders: background and implications of the OCTET trial

  • Tom Burns (a1) and Andrew Molodynski (a1)
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eLetters

Why we should abandon the OCTET, and not community treatment orders

Feras A. Mustafa, Psychiatrist
04 June 2014

The persistent claims that the OCTET (1) is a rigorous trial are unsustainable.

In 2011, during the OCTET trial, we were told that patients who were viewed as clear candidates for supervised community treatment orders (CTO)should be excluded from the study: "the protocol states patients should not be included in the study who are viewed as clear candidates for eitherleave or a CTO, or considered suitable, when leaving hospital, for immediate discharge to voluntary care" (2). Then it was further reiteratedthat: "there is exclusion of patients who are considered by their RCs to be clear candidates for a CTO (and not candidates for leave)" (2).

There was an obvious reluctance among clinicians to recruit patients with a higher risk profile, or with more severe conditions. This had, undoubtedly, introduced a selection bias towards patients who were less suitable for CTO, which inevitably resulted in an under-estimation of the impact of intervention.

However, we were told after the publication of the OCTET report that:"Dr Mustafa suggests that being a clear candidate for a community treatment order (CTO) was an exclusion criterion, limiting external validity. This is not correct. Rather, the criterion was that clinicians had to be willing for patients' treatment to be randomised, that is, they would need to be in equipoise to recruit to the trial" (3). This confusiononly casts further doubt over the methodological integrity of the OCTET, particularly undermining its external validity (generalisability to "real-world" CTO patients).

Nonetheless, the OCTET is no better when it comes to internal validity. Burns and Molodynski firmly reject the proposition that clinicians could, at least in some cases, directly observe benefits from CTO, even when its implementation is associated with a dramatic and significant improvement in treatment-adherence, which could not be plausibly explained by other factors. Yet, clinicians' expert judgment wasthe main tool that the OTCET relied on, to fully and independently deliverand modify the intervention, in order to arrive at the intended outcome, without any experimental restrictions. What has gone wrong here? The OCTET utilises what it considers a false premise, in order to reach what it claims to be a true conclusion.

Furthermore, as I have pointed out elsewhere (4), the OCTET suffered with a potentially marked "learning curve effect"; CTOs may have been useddifferently between patients recruited at different stages of the study, and even for individual patients during the 12-month trial period. The Framework for Development and Evaluation of RCTs for Complex Interventionsto Improve Health, published by the Medical Research Council in 2000 (www.mrc.ac.uk) states the following: "once the RCT has begun, the intervention must not evolve, as the RCT results will be unusable if laterparticipants experience a different intervention than earlier ones".

Howick et al. (5) elegantly demonstrate that mechanistic reasoning can be epistemically superior to poor quality randomised trials, which I argue applies to the case of CTOs and the OCTET.

References:

1.Burns T, Racks J, Molodynski A, Dawson J, Yeeles K, Vazquez- Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013; 381: 1627 - 33.

2.Dawson J, Burns T, Rugkasa J. Lawfulness of a randomised trial of the new community treatment order regime for England and Wales. Med Law Rev 2011; 19: 1-26.

3.Rugkasa J, Dawson J, Burns T. The OCTET RCT-a reply to Dr Mustafa.Med Sci Law 2014; 54: 118 - 9.

4.Mustafa F. On the OCTET and supervised community treatment orders.Med Sci Law 2014; 54: 116 - 7.

5.Howick J, Glasziou P, Aronson JK. Evidence-based mechanistic reasoning. J R Soc Med 2010; 103: 433-41.

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Conflict of interest: None declared

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Author reply: Evidence matters (hopefully)

Andrew Molodynski, Consultant Psychiatrist
30 May 2014

Dr Owen (like Dr Curtis (1) whom he cites) fails to distinguish between intervention and outcome in the OCTET trial. The intervention is the imposition of a Community Treatment Order (CTO). The time under initial compulsion (183 days versus 8 on Section 17) demonstrates a clear and unequivocal difference. Wherehis figure of only 50% of CTO patients experiencing compulsion comes from baffles us. The difference in the total time under compulsion during the twelve month follow up that he cites includes the difference between the two outcomes (which includes inpatient compulsion from readmissions in both groups). There is no evidence that recruitment and selection were biased in any way and again we fail to understand on what Drs Owen and Curtis base this criticism. We adhered to the highest research standards throughout and the study has been extensively and rigorously peer reviewed.

Dr Mustafa in his letter advances no scientific critique of our work but does articulate the common response of many clinicians 'I have seen it work'. We have sympathy with this - we both entered this study expecting to find improved outcomes from CTOs. However they do not deliver them and we were as disappointed as Dr Mustafa. Psychiatry has a long history of cliniciansclinging to ineffective treatments convinced that they work. This is not surprising given the variation in outcomes in psychiatry and the fluctuating natural history of psychoses. Naturalistic observational studies do not prove otherwise - they have produced contradictory results,some for, some against (2). That is why we need rigorous RCTs. OCTET is such a rigorous trial and its findings, however unpalatable to some, are robust. It is also worth remembering that the only two other trials foundthe same (3). A profession that aspires to evidence based practice should take these results seriously.

References:

1.Curtis D. OCTET does not demonstrate a lack of effectiveness for community treatment orders. Psychiatr Bull 2014; 38: 36-39. 2.Maughan D, Molodynski A, Rugkasa J, Burns T. Community Treatment Orders: a systematic review of clinical outcomes. Soc Psychiatry PsychiatrEpidemiol. 2014: 49, 651-6633.Rugkasa J, Dawson J. Community Treatment Orders: current evidence and the implications. Br J Psychiat, 2013, 406-408

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Conflict of interest: None declared

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OCTET Study: flawed by Type 2 error

Andy J Owen, Consultant Psychiatrist
02 March 2014

The OCTET study overcame many legal and ethical difficulties in setting up a randomised controlled trial (RCT) of community treatment orders (CTOs) (1). We welcome the acknowledgment of some of the limitations of the trial, but are surprised that claims are still being made that the study demonstrates that CTOs do not achieve their principle purpose of reducing relapse and readmission (2).

Imagine a hypothetical RCT comparing medication with placebo. The trial would be powered based on estimated effect size and its duration would bebased on expected time for response. If in this scenario, 25%of those in the placebo arm had inadvertently been given the active drug, and if the duration of the study had been only a third of that planned, it would be inconceivable that the investigators would claim a negative result proved the drug ineffective. Yet this is analogous to what has taken place with OCTET.

In OCTET, median length of compulsion in the community was 183 days in the CTO group versus 8 days in the Section 17 group. Although this seems to indicate that it was a trial of people who were largely either subject to long periods of community compulsion (CTO group) or only a few days of compulsion (Section 17 group), a more detailed examination brings this into question. Almost 25% of the Section 17 group were still subject to compulsion by the end of the study, and the mean length of compulsion in this group was 46 days. In the CTO group, only 50% were subject to compulsion by the end of the study, with a mean length under compulsion of170 days. This has two main implications:

Firstly, the difference in mean length of compulsion between the CTO group and the Section 17 group was only 125 days, or a little over 4 months. It is questionable whether this is sufficient time for any benefits of CTOs to become apparent, and presumably the initial intention had been to compare 12 months in each arm.

Secondly, in effect, a quarter of the control group were receiving the same type of intervention as the CTO group throughout the course of the study. Any possible benefit in the CTO group would have been offset bythe same effects in a large number of control subjects, leading to a largereduction in the power of the study and to Type 2 error. The sensitivity analysis does nothing to address this loss of power. We contend that given these problems, in conjunction with the broader issues of recruitment and selection (3) it is not possible to claim that OCTET demonstrates CTOs to be ineffective.

References:

1. Burns T, Racks J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet 2013; 381: 1627-33.

2. Burns T, Molodynski A. Community treatment orders: background and implications of the OCTET trial. Psychiatr Bull 2014; 38: 3-5.

3. Curtis D. OCTET does not demonstrate a lack of effectiveness for community treatment orders. Psychiatr Bull 2014; 38: 36-39.

... More

Conflict of interest: None declared

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The OCTET trial, community treatment orders, and evidence based practice

Feras A. Mustafa, Psychiatrist
02 March 2014

Based on the findings of the OCTET study (1), Burns and Molodynski reject observations of consultants who reported directly observable benefits from community treatment orders (CTOs). They argue that it is not possible to "see with one's own eyes" a probabilistic outcome which takes months to manifest itself.

This is a false analogy. In a subgroup of patients, CTOs result in a striking improvement in treatment adherence: if the CTO is lifted, patients discontinue treatment; re-implement the CTO (following relapse and re-hospitalisation) and treatment adherence is re-achieved. In such cases, clinicians are able to "see" the effect of CTOs on treatment adherence, and reasonably expect improved clinical outcomes in the longer term. With such a dramatic response (treatment adherence) to the intervention (CTO), it would be scientifically unnecessary (2) and ethically unacceptable to refer patients to an RCT.

A number of previous reports have highlighted the potentially detrimental flaws in the methodology of the OCTET (3,4), which could explain the apparent paradox between the naturalistic observational studies that have shown significant benefit from CTOs (5), and the negativefindings of the OCTET.

Take the scenario of a young man with chronic schizophrenia, who attends the psychiatric outpatient department escorted by his carer. He has a long history of non-adherence to treatment, as well as multiple formal admissions. The patient is known to discontinue treatment immediately after discharge from hospital, invariably leading to rapid relapse and hospitalisation. Since discharge from hospital on CTO three months prior, his mental stability has been maintained and he has been accepting his fortnightly antipsychotic depot injections. His positive psychotic symptoms are minimal. He has become more sociable and has applied for a part-time college course. The psychiatrist tells the patientand his carer that he is going to lift the CTO. To his dismay, the carer asks the psychiatrist "Have you not seen with your own eyes that the CTO works?". The psychiatrist replies "Yes I have, but an RCT says this could not have been possible". Would this be evidence based practice?

References:

1.Burns T, Molodynski A. Community treatment orders: background and implications of the OCTET trial. Psychiatr Bull 2014; 38: 3-5.

2.Glasziou P, Chalmers I, Rawlins M, McCulloch P. When are randomisedtrials unnecessary? Picking signal from noise. BMJ 2007; 334: 349-51.

3.Mustafa FA. On the OCTET and supervised community treatment orders.Med Sci Law 2013 Oct 23. [Epub ahead of print]

4.Segal SP. Community treatment orders do not reduce hospital readmission in people with psychosis. Evid Based Ment Health 2013; 16:116.

5.Rawala M, Gupta S. Use of community treatment orders in an inner-London assertive outreach service. Psychiatr Bull 2014; 38: 13-18.

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Conflict of interest: None declared

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