LAWFULNESS OF A RANDOMISED TRIAL OF THE NEW COMMUNITY TREATMENT ORDER REGIME FOR ENGLAND AND WALES

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1 Medical Law Review, 19, Winter 2011, pp doi: /medlaw/fwq030 LAWFULNESS OF A RANDOMISED TRIAL OF THE NEW COMMUNITY TREATMENT ORDER REGIME FOR ENGLAND AND WALES J. DAWSON Faculty of Law, University of Otago, Dunedin, New Zealand T. BURNS Social Psychiatry, University of Oxford J. RUGKÅSA Oxford Community Treatment Order Evaluation Trial, University of Oxford john.dawson@otago.ac.nz This article debates and defends the lawfulness of a randomised controlled trial of compulsory outpatient treatment under the mental health legislation for England and Wales. The trial is designed to compare the outcomes for patients of their treatment under the new Community Treatment Order (CTO) regime with their treatment under the older leave scheme the two main forms of compulsory care in the community now authorised by the revised Mental Health Act The methods for the trial involve the random allocation of some patients between the two schemes, when they are considered by their Responsible Clinicians to be eligible for some form of compulsory outpatient care. The main question we consider is the lawfulness of that aspect of the methods. Can a carefully selected group of patients be allocated at random between the two regimes to permit an evaluation to proceed? Or would that involve some departure from the decision-making criteria specified by law? We argue that a group of patients can be identified who meet simultaneously the tests for treatment under both the CTO and the leave schemes. Those patients could then be allocated lawfully to treatment under either scheme. This opens the door, we argue, to their random allocation between the two schemes for the purposes of the research. In reaching this conclusion, we explain the methods and aims of the trial and closely compare the respective features of the leave and CTO regimes. Academic Visitor in 2008 at the Centre for Socio-Legal Studies, University of Oxford. I wish to express my gratitude to Professor Dennis Galligan, the staff of the Centre for Socio-Legal Studies, and the staff of the Academic Department of Psychiatry, University of Oxford, for their support and kindness during this research. Medical Law Review # The Author [2011]. Published by Oxford University Press; all rights reserved. For Permissions, please journals.permissions@oup.com

2 2 MEDICAL LAW REVIEW [2011] I. INTRODUCTION The Mental Health Act 2007 introduced a new Community Treatment Order (CTO) regime for England and Wales. 1 It came into force in late This regime provides a new form of statutory authority for supervising the outpatient treatment of compulsory psychiatric patients, particularly their continuing medication. It operates alongside (and has not replaced) the older leave scheme that was commonly employed to supervise patients care in the community under the prior law. 3 As a consequence, responsible clinicians (RCs) administering the mental health legislation must now make a number of choices when contemplating a sectioned patient s discharge from hospital. Initially, they must decide whether to use the Act s powers to supervise the patient s treatment on an outpatient basis, rather than discharge that person directly to voluntary community care. Then, if they think statutory supervision is required, they must decide whether to use the leave or the CTO regime. A major difficulty facing the clinicians who make these choices, however, is the lack of evidence, derived from rigorous research, concerning the likely treatment outcomes of involuntary outpatient care. A recent review of the research on the efficacy of CTOs, which was based on the standards of evidence-based medicine and issued by the Institute of Psychiatry, reached the conclusion that: 4 [R]esearch in this area has been beset by conceptual, practical and methodological problems, and the general quality of the empirical evidence is poor... [T]here is currently no robust evidence about either the positive or negative effects of CTOs on key outcomes, including hospital readmission, length of hospital stay, improved medication compliance, or patients quality of life. 1 The 2007 Act heavily amended the parent legislation, the Mental Health Act 1983 ( the Act ). All references hereafter to the provisions of legislation are to the Mental Health Act 1983 unless otherwise indicated. 2 On the new CTO regime, see J Dawson, Community Treatment Orders, in L Gostin and others (eds), Principles of Mental Health Law and Policy (Ch 14 OUP, Oxford 2010); P Fennell, Mental Health: The New Law (Jordans, Bristol 2007); P Bowen, Blackstone s Guide to the Mental Health Act 2007 (OUP, Oxford 2007); K Gledhill, Community Treatment Orders [2007] Journal of Mental Health Law 149; M Kinton, Towards an Understanding of Supervised Community Treatment [2008] Journal of Mental Health Law 7; J Dawson, Community Treatment Orders: International Comparisons (Otago University Print, Dunedin 2005); available from, otago.ac.nz/law/otagocto/index.html.. 3 Under s R Churchill and others, International Experiences of Using Community Treatment Orders (Institute of Psychiatry, London 2007) 7.

3 Med. L. Rev. Lawfulness of a Randomised Trial 3 The same observation could be made even more strongly about research on leave. 5 The efficacy of both these involuntary outpatient treatment schemes is largely unknown. It has not been demonstrated clearly that they will reduce the time patients subsequently spend in hospital, mitigate the severity of their symptoms, promote their compliance with medication, or enhance their engagement with a community mental health team the kinds of outcome these schemes seem designed to achieve. Despite this lack of evidence, however, clinicians must now decide, routinely, whether to use these schemes when managing the care of patients in England and Wales under the revised Mental Health Act 1983 ( the Act ). The question we consider in this article, therefore, is whether an experimental study can be designed that would permit researchers to collect lawfully the kind of data on treatment outcomes that would be required to evaluate rigorously involuntary outpatient care. The best approach might be to conduct a randomised controlled trial (RCT) in which the treatment of patients on leave or a CTO was directly compared with voluntary outpatient care. The consent of several hundred patients might be obtained for inclusion in the trial who had recently been placed under involuntary outpatient care. Half would remain under the statutory scheme, while the other half would be discharged immediately to voluntary outpatient treatment, with the choice between the two randomly made. The two groups progress would be followed, and their treatment outcomes compared, using such measures as the time spent in hospital in the following year, or change in the severity of psychiatric symptoms. If patients under compulsion did better on average on such measures than those under voluntary outpatient treatment, compulsion would be judged, to that extent, a success. If they did worse, that would pose a serious question about the legitimacy of involuntary community care. The major advantage of a randomised trial of that kind is to permit the element of compulsion to be isolated as the central point of difference in the treatment of the two groups, so the consequences of compulsion can be independently assessed. The random allocation of patients between the treatment mechanisms also reduces the potential for bias in the results, by ensuring that the patients included are similarly situated at the outset, and there is no selection bias in their allocation to one or other treatment mechanism. Robust, quantitative outcome measures can be employed. Researchers, not involved in the treatment 5 Little is known about the operation of the leave regime. It does not seem to have been the subject of sustained research. One recent paper is: B Jones and M Kinton, A Snap-shot of long-term Section 17 Use in South-West England [2008] Journal of Mental Health Law 75.

4 4 MEDICAL LAW REVIEW [2011] process, can administer well-validated psychiatric rating scales to patients in both arms of the trial, at the outset and at specified intervals during the follow-up period, and can measure accurately from hospital records the number of days patients spent in hospital in the following year. The results of treatment can then be readily compared. From a methodological perspective, therefore, this would probably be the best way to evaluate compulsory outpatient treatment through a randomised trial directly comparing voluntary and involuntary outpatient care. There is one great problem with that approach, however, that seems to preclude its use. This is that it seems to be unlawful, because it would involve the random discharge of half of the patients in the trial from supervised treatment under the statutory scheme. 6 They would be discharged from the compulsory treatment regime, for which they had been considered suitable by their RC, in order to produce the comparison between treatment mechanisms that is the essence of the research design. But their discharge, in those circumstances for the purposes of the research would not be governed by the criteria governing the release from compulsory treatment set by the Act. It would therefore appear to involve an unlawful exercise of the statutory discharge power. The general question we are posing, therefore, is whether an alternative research design can be found that exploits the methodological rigour of the RCT but does not involve the unlawful discharge of patients from the Act. II. OUR PROPOSED RESEARCH DESIGN We believe a rigorous and lawful alternative method can be found to evaluate involuntary outpatient care. We are currently conducting a study based on the model we propose. This study is known as OCTET, or the Oxford Community Treatment Order Evaluation Trial. It has received ethical clearance and is now in the data collection phase. Our method does not set up a direct comparison between compulsory and voluntary outpatient care. Nor will it lead to the random discharge of compulsory patients from the Act. Instead, it compares the treatment outcomes for patients placed under the two parallel compulsory outpatient treatment schemes now authorised by the reformed legislation for England and Wales: that is, leave and CTOs. Our study aims to compare the duration and outcomes for patients of their treatment under these two similar forms of 6 See J Dawson, Randomised Controlled Trials of Mental Health Legislation (2002) 10 Med L Rev 308.

5 Med. L. Rev. Lawfulness of a Randomised Trial 5 compulsory outpatient care. To facilitate this comparison, we are recruiting into our study a cohort of psychiatric patients who meet the following conditions: they have the capacity to consent to participate in the research and have given their consent; they have been diagnosed with a psychosis ; they have been detained in hospital under Section 3 or 37 of the Mental Health Act; their RC is of the view that continuing supervision of their outpatient treatment is required, under statutory authority, following their discharge from hospital; but their RC is uncertain (given the absence of any convincing experimental evidence for the treatment efficacy of either regime) whether leave or a CTO should be used to authorise their continuing outpatient care. Patients are included, therefore, who are considered proper candidates for supervised outpatient treatment, but only when their RC is genuinely uncertain concerning the legal mechanism to employ. Then, in order to exploit the methodological rigour of the randomised experiment, these patients will be randomly assigned, on discharge from hospital, to leave or a CTO: the two arms of the trial. Thereafter, they will be treated under the authority of the Act in the usual way. No patient will be released from compulsion due to their inclusion in the research. The usual powers and procedures applicable to the treatment mechanism to which they have been assigned will continue to apply, without interference from researchers. So, they may be discharged from the Act by their RC or by the Tribunal as the law allows, be returned to hospital from leave or the CTO, or be switched from leave to a CTO, and so on, in the usual way. But their progress will be followed for a year and be measured at intervals by researchers, to determine particularly the length of time they spent on leave or a CTO, and to determine whether (and for how long) they are readmitted to hospital during the following year. Those results will then be compared. The primary outcome measure we will employ is re-hospitalisation of the patient within the following year. That can be determined, objectively, from hospital records. 7 7 Many secondary outcome measures are also employed, some of which involve the administration of psychiatric rating scales at baseline and then at intervals during the research. These measures include: time to readmission (a survival analysis), days spent in hospital, contacts with clinical services, adherence to prescribed medication, severity of psychiatric symptoms, global level of functioning, degree of insight, patient experience of coercion in care, patient

6 6 MEDICAL LAW REVIEW [2011] This is not a trial in which the only difference in the treatment of the patients in the two arms is the element of compulsion. Instead, it compares two very similar forms of involuntary outpatient care. Nevertheless, it may produce data that will permit us to evaluate the efficacy of compulsory outpatient care because it may transpire that the patients in the two arms of the trial are on average treated under these two very similar outpatient treatment schemes for different lengths of time. Then, if different outcomes are found, we might reasonably infer that those differences are caused by the duration of their compulsion. It might be established, for instance, that better outcomes are achieved by patients who receive, say, nine months rather than six months of compulsory outpatient care. If so, that would surely count in favour of an extended use of this form of care. The average length of time for which a person s involuntary outpatient treatment is likely to continue under the leave or the CTO regime is currently unknown, and could not be known when our study commenced, on the day of the introduction of the new CTO regime. Nor is any maximum period for the use of leave or a CTO currently specified by law, because both can be renewed repeatedly as long as the ruling legal criteria continue to apply. Patients could therefore be treated under either regime for lengthy periods of time. And both provide similar powers over outpatients. Nevertheless, patients may in fact stay longer, on average, under one regime than the other. If so, our methods may put us in a position to compare the treatment outcomes flowing from different periods of involuntary outpatient care. Our results may then provide some evidence upon which RCs could base their future decisions. In particular, our study is designed to address three related research questions: does use of CTOs prolong the duration of involuntary outpatient treatment after a patient s discharge from compulsory in-patient care, compared with the use of leave? does the length of compulsory outpatient care affect the treatment outcomes measured in terms of rates of rehospitalisation and patients progress on a range of clinical and social indicators? if CTOs and leave are used for similar periods of time, do they produce different treatment outcomes? The answers to these questions are currently unknown. Our challenge has been to design a study that could answer these questions through methods that are sufficiently rigorous to meet the demands of evidencebased mental health care, do not involve RCs who treat patients in our satisfaction with care, and family satisfaction with care. Patients will be paid modestly for the time it takes to complete the rating scales.

7 Med. L. Rev. Lawfulness of a Randomised Trial 7 trial in unethical conduct, and do not involve the suspension, or contravention, of any aspect of mental health law. This article describes and defends the legality of this research method. III. THE LAWFULNESS OF THIS RESEARCH METHOD Our focus is therefore on the lawfulness of our research design. How can it be lawful to randomly allocate sectioned patients between the two different outpatient regimes that are now authorised by the Act, in order to test experimentally the treatment outcomes? Our analysis will focus mainly on the decisions made by the RCs who exercise key functions under the Act concerning patients in our trial. The RCs must decide whether to place sectioned patients under compulsory outpatient care in the first place; to allocate them to leave or a CTO; to keep them in that position for a certain length of time; to recall them to hospital from community care; and so on. In making those decisions, RCs exercise specific statutory powers. Simultaneously, they are pursuing therapeutic aims, such as maintaining the stability of the patient s condition, and ensuring continuity of care. Now, in addition, we are asking the RCs to collaborate with us on an RCT that would compare the treatment outcomes of the two regimes. Would they act lawfully in doing so? The RCs are not the only decision-makers to exercise relevant powers over compulsory outpatients. The Tribunal can also order a patient s release from compulsion, for instance. So, the impact of the research process on all statutory decision-makers must be considered. But RCs undoubtedly exercise considerable powers, particularly the power to direct compulsory outpatient treatment in the first place and to direct the form that treatment will take. So, the exercise of RCs statutory powers during the research process is our primary concern. In particular, we have to consider whether following our research protocol could cause RCs to commit any legal error in the exercise of their statutory powers that might expose them to judicial review, and might lead a court to declare the research process unlawful or to halt its progress. To avoid that possibility, nothing in our methods should prevent the RCs applying the correct legal criteria to decisions about compulsory patients, or prevent them following the correct procedures, or induce them to make what could be viewed in law as an unreasonable or irrational decision. In short, the RCs should avoid all the usual grounds for judicial review when following the research protocol. Moreover, the RCs must act lawfully when exercising any residual element of statutory discretion concerning patients in our trial. They exercise considerable discretion because the Act often authorises but does not require certain decisions to be made. An RC may place a sectioned

8 8 MEDICAL LAW REVIEW [2011] patient on leave or a CTO, 8 may impose certain conditions on outpatients treatment, 9 and may recall them to hospital in certain circumstances, 10 for example. Permissive language is used in the empowering provisions conferring significant discretion. But the exercise of these powers has important implications for patients rights. So, the manner in which this discretion is exercised is governed by important legal principles, drawn from administrative and human rights law. RCs must exercise their discretion for proper purposes. They must take into account all relevant considerations. They should avoid pre-determination or bias. Their decisions should not have a disproportionate or overly restrictive impact on the rights of patients involved in the research. Nor should they expose patients in the trial, or any other person, to heightened risks of harm. So, we need to consider whether following our research protocol could cause RCs to breach any principle of that kind. Two legal issues need special scrutiny to determine whether it is lawful to allocate patients at random to leave or a CTO. First, we need to consider whether some overlap exists between the legal criteria that apply to these two different forms of outpatient care, to determine whether some patients are eligible simultaneously for treatment under both regimes. If so, it may be possible to allocate them to either regime for the purposes of the research. And, second, we need to consider whether placing a person under one or other regime would constitute a less restrictive form of intervention in that person s life. This is important because if clinicians were left in a state of initial uncertainty as to the correct regime to use, then they should use the less restrictive option if one could properly be described in those terms. 11 They should take that approach because it would respect the general principle of proportionality under human rights law, which requires those who exercise public powers affecting people s rights to use the least restrictive viable approach. 12 On that view, only if neither the leave nor the CTO regime could be correctly described as less restrictive than the other because they scored equally on that parameter could RCs lawfully allocate eligible patients at random to one or other regime when in doubt. Those two legal issues the degree of overlap between the legal criteria governing the use of CTOs and leave, and whether one regime is less restrictive than the other will therefore be central to our analysis. 8 Ss 17(1), 17A(1). 9 Ss 17(1), 17B(2). 10 Ss 17(4), 17E(1). 11 The Act specifically requires, for instance, that minimising restrictions on liberty be included as a principle of the Code of Practice: s 118(2B)(c). 12 See R Clayton and H Tomlinson, The Law of Human Rights (2nd edn, Vol 1, Ch 6D, OUP, Oxford 2009), The doctrine of proportionality.

9 Med. L. Rev. Lawfulness of a Randomised Trial 9 IV. THE CRITERIA GOVERNING USE OF LEAVE AND CTOS Both the leave and the CTO regimes provide a cluster of powers designed to permit continuing contact to be maintained between compulsory outpatients and the members of a community mental health team. Conditions may be imposed on the patient s community tenure, control may be exercised over their place of residence, their treatment and condition may be monitored on a regular basis, and they may be recalled rapidly to hospital, if required. Further provisions govern the likely duration, and extension, of a patient s treatment under the scheme, and stipulate the associated procedural requirements or entitlements, including the right of a patient to apply to the Tribunal for discharge from the scheme. The criteria governing eligibility for both forms of involuntary outpatient care focus on the patient s continuing need for supervised medical treatment; on the manner in which the shift to outpatient care may affect the interests of the patient and others; on whether the patient s treatment is likely to require a continuing element of hospital-based care; and on whether clinicians should have the power to recall the patient swiftly to hospital without going through the initial certification process. The rules concerning leave in particular are found partly in parent standards governing a sectioned patient s liability to detention under the Act, 13 partly in specific leave provisions, 14 and partly in the Code of Practice 15 ( the Code ) that is issued under the authority of the Act whose guidance must be very carefully considered by clinicians. 16 In total, these rules require that: the patient suffers from a mental disorder that is likely (despite the grant of leave) to require a continuing element of hospital-based care 17 ; the treatment proposed is in the interests of the patient s health or safety, or for the protection of others 18 ; appropriate treatment is available 19 ; and RCs should continue to have the power to recall the patient to hospital, to enforce the treatment programme. 20 The English courts have made 13 See s Notably ss 17 and Mental Health Act Code of Practice (Department of Health 2008); available at, PublicationsPolicyAndGuidance/DH_ Ch 21 governs Leave of Absence. 16 R v Mersey Care NHS Trust, ex p Munjaz [2006] AC See s 3(2)(a); ch 21, Code of Practice; R v Barking Havering and Brentwood Community Healthcare NHS Trust ex p B [1999] Lloyd s Rep Med 101, CA; R (DR) v Mersey Care NHS Trust [2002] EWHC 1810 (Admin); R (CS) v Mental Health Review Tribunal [2004] EWHC 2958 (Admin). 18 Ss 3(2)(c), 17(1), para 21.8, Code of Practice. 19 S 3(2)(d). 20 S 17; para 28.5, Code of Practice; Barking (above n 17).

10 10 MEDICAL LAW REVIEW [2011] it clear, however, that the continuing periodic element of hospitalbased treatment that must be envisaged (despite the grant of leave) need not amount to inpatient care, overnight admission, or physical detention of the patient at the hospital. 21 The extended legal definition of a hospital includes the outpatient departments and clinics of a hospital. 22 So, the attendance at a hospital-based service of that kind is the minimum requirement necessary to justify an extended use of leave, along with the need for clinicians to retain the power to recall the patient swiftly to such premises for treatment, if required. In DR it was held, for instance, that a patient s leave could be extended for a further term provided an element of hospital-based care was a significant component of the treatment plan, 23 and in CS it was decided that that component could be gossamer thin. 24 It was sufficient that the patient attended ward rounds monthly for discussion of her progress and medication, received supportive and motivational interviewing from hospital staff, and had regular sessions at the hospital with a psychologist. 25 In both the cases, it was held that there was no requirement for the treatment to include the overnight admission or actual physical detention at the hospital for the patient to be viewed as liable to be detained with the result that leave could be lawfully extended for another term. Very similar standards govern the use of CTOs. These are stated in section 17A(5): Section 17A(5): the relevant criteria for a CTO (a) the patient is suffering from mental disorder of a nature or degree which makes it appropriate for him to receive medical treatment; (b) it is necessary for his health or safety or for the protection of other persons that he should receive such treatment; (c) subject to his being liable to be recalled..., such treatment can be provided without his continuing to be detained in hospital; (d) it is necessary that the responsible clinician should be able to exercise the power...to recall the patient to hospital; (e) appropriate medical treatment is available for him. Again the focus is on: the need for the patient s mental disorder to receive medical treatment, the need to advance the interests of the patient or others, the continuing need for clinicians to possess the 21 See Barking, DR and CS (above n 17). 22 S 145 and National Health Service Act DR above n 17, para CS above n 17, para Above n 17, para 41.

11 Med. L. Rev. Lawfulness of a Randomised Trial 11 recall power, and the availability of appropriate treatment. The one significant departure from the leave criteria is that when using a CTO there is no need for any current aspect of the treatment programme to take place in a hospital setting. Not even the gossamer thin element of occasional visits to an outpatient department is required. Nevertheless, the clinicians must still be convinced that a patient on a CTO should remain liable to immediate recall to hospital, should that be required. As the Code puts it, the key factor in the decision to use a CTO is whether the patient can safely be treated for mental disorder in the community only if the responsible clinician can exercise the power to recall the patient to hospital for treatment if that becomes necessary. 26 So, the prospect that the patient will again require compulsory hospital care remains an important part of the equation. Further factors are then listed in the Act and the Code of Practice that clinicians should take into account when deciding to use one or other regime. Regarding leave, the Code requires clinicians to consider, for example: the benefits and risks for the patient and others of granting or refusing leave; the conditions that may be attached; child protection and welfare issues; the wishes of the patient, carers, and friends; and the levels of social support, and community mental health services that will be available. 27 With regard to CTOs, the Act 28 and the Code 29 require attention to: the risk of deterioration in the patient s health if not detained in hospital; their history of mental disorder, hospital admissions, and subsequent compliance with outpatient treatment; their current mental state, insight, and attitude to treatment; the circumstances into which they would be discharged; the community treatment services available; and the attitudes of the patient and carers to the prospect of community-based care. The legal indicators for the use of the two regimes, therefore, strongly overlap in their content and virtually nothing is listed as a relevant factor in the use of leave that would not be relevant to a CTO. The legal provisions do not, therefore, establish mutually exclusive zones for the operation of the two regimes. There are legal provisions that directly address the choice between the two schemes. First, there is the requirement, added to the law by the 2007 Act, that, before granting longer-term leave (which is leave for an indefinite period or longer than seven days), the RC must first consider whether to place the patient on a CTO instead. 30 Moreover, the Code purports to specify the principal 26 Para Para S 17A(5). 29 Chs 25, Ss 17(2A), 17(2B).

12 12 MEDICAL LAW REVIEW [2011] purposes of the two regimes. Leave, it is said, is primarily intended to allow a patient to be temporarily absent from hospital where further in-patient treatment as a detained patient is still thought to be necessary, 31 while CTOs are principally aimed at preventing the revolving door scenario and the prevention of harm which could arise from relapse...even if there is no reason to think that the patient will need further treatment as a detained in-patient for the time being. 32 In addition, the Code provides certain pointers or factors suggesting the right choice between the two regimes. The factors pointing to use of a CTO, for instance, are said to include: confidence that the patient is ready for discharge from hospital on an indefinite basis ; good reasons to expect that the patient will not need to be detained for the treatment they need to be given ; the patient appears prepared to consent or comply with the treatment they need ; and the risks of arrangements in the community breaking down, or of the patient needing to be recalled to hospital for treatment, is sufficiently serious to justify a CTO, but not to the extent that it is very likely to happen (which would point instead to use of leave). 33 Ultimately, these provisions give little strong guidance, however, as to when a CTO must be used in preference to long-term leave and no final guillotine is imposed by law on leave; that is, a time beyond which it could not be extended if the patient had not been readmitted in the interim to inpatient care. The requirement imposed on RCs to first consider using a CTO before putting a patient on longer term leave does not mean, says the Code, that the responsible clinician cannot use longer-term leave if that is the more suitable option, provided both options have been duly considered. 34 And the Code even states explicitly that leave may also be useful in the longer-term, where the clinical team wish to see how the patient manages outside hospital before making the decision to discharge. 35 Kinton concludes that this shows the Government lost its nerve in the law reform process, and he finds a whiff of absurdity in the contrast between the Government s tough rhetoric about the need for a new CTO regime and the nonprescriptive character of the considerations to which clinicians are actually directed concerning the decision to use CTOs in preference to the leave scheme Para Para Para Para Para Kinton above n 2, 15.

13 Med. L. Rev. Lawfulness of a Randomised Trial 13 A. Uncertainty Concerning the Choice Between Regimes How should we sum up the position, then, concerning the choice between these two regimes in light of the provisions of the Act and the Code? We find that very similar legal criteria govern their use, there is a strong degree of overlap in the factors to which clinicians are directed when making the choice, and very few mandatory indicators are provided as to the direction in which clinicians must turn when convinced that they should continue a sectioned patient s care in the community under statutory authority. Some continuing element of hospital-based treatment is required to extend a patient s leave, but that element of treatment could also be suitable for a patient on a CTO, particularly visits to an outpatient clinic. So, that requirement does not draw a sharp line between the proper uses of the two schemes. Moreover, the application of the relevant standards to the position of particular patients relies heavily on a series of predictions. Clinicians must try to predict: the patient s likely progress in the community; the efficacy of the conditions imposed; the patient s response to the community mental health services they will receive, and to the social circumstances in which they will live; the need for the patient to attend an outpatient clinic of the hospital for treatment; the likelihood and imminence of their need for readmission as an inpatient; the effect of the threat of swift recall to hospital on the patient s compliance with treatment; and so on. Often genuine uncertainty will surround these judgements, both when the initial choice is made between leave and a CTO, and when the clinicians must decide whether to extend that form of care, or to switch a patient from leave to a CTO. The clinicians therefore face overlapping content in the ruling legal standards, considerable uncertainty in applying those standards in individual cases, and a lack of rigorous evidence as to the treatment efficacy of either regime. As a consequence, it is highly likely that varying practices will emerge as to the choice between CTOs and leave between different clinicians, hospitals, and regions, just as Pinfold and colleagues found a great variation in the implementation of the prior supervised discharge scheme. 37 These variations may simply reflect legitimate professional differences over the proper application of the law. In these circumstances, we suggest, some patients could lawfully be allocated to either leave or a CTO. Either decision would be a legitimate exercise of the discretion left in clinicians hands by the uncertainties surrounding the use of the two schemes. It is our case that when 37 V Pinfold and others, Persuading the Persuadable: Evaluating Compulsory Treatment in England Using Supervised Discharge Orders (2001) 36 Social Psychiatry and Psychiatric Epidemiology 260.

14 14 MEDICAL LAW REVIEW [2011] clinicians find themselves within this legitimate zone of discretion, they may lawfully and ethically allocate patients at random to one or other regime, to permit rigorous research into the efficacy of involuntary outpatient care. Our research protocol therefore states that patients may be included in our trial only when their RCs consider they are proper candidates for involuntary outpatient care, and are uncertain whether to use leave or a CTO. In addition, the protocol states patients should not be included in the study who are viewed as clear candidates for either leave or a CTO, or considered suitable, when leaving hospital, for immediate discharge to voluntary care. To reach those conclusions, the RCs would have to consider the relevant legal criteria, in the Act and the Code of Practice, and still be ambivalent between the two options. In that limited situation, it would be lawful, in our view, for RCs to allocate patients at random to one or other regime. V. THE LEAST RESTRICTIVE ALTERNATIVE Nevertheless, despite these arguments about overlapping criteria, and the uncertainties clinicians face, we must still address the further argument that RCs, when in doubt, should always allocate patients to the least restrictive regime. It is precisely when the other legal criteria fail to resolve the choice that this principle has most bite. The argument would be that the powers associated with compulsory outpatient treatment can have a significant impact on patients human rights, such as the right to privacy and respect for family life, protected by the European Convention on Human Rights. 38 It is well established that such powers must be exercised in a proportionate manner, and compliance with that proportionality principle requires that the least restrictive (or least drastic) form of intervention that is viable should be employed. 39 Thus, if either the leave or the CTO regime could be properly described as less restrictive of patients rights, then that regime should be used, when the decision is not dictated by other legal criteria and clinicians are in doubt. Human rights principles often have this function of structuring the exercise of residual elements of statutory discretion. This argument would apply in the current context, however, only if either the leave or the CTO regime could properly be described as less restrictive of patients rights. Determining that matter requires a full inquiry into the means used to implement both regimes. We need to study and compare the powers provided over outpatients, the 38 European Convention on Human Rights and Fundamental Freedoms 1950, Art See Clayton and Tomlinson, above n 12.

15 Med. L. Rev. Lawfulness of a Randomised Trial 15 conditions that may be imposed on patients community tenure, and the potential consequences of certain downstream decisions, such as the decision to recall a patient to compulsory hospital care. This inquiry would focus on the nature and seriousness of the impact of each of those measures on specific rights, to indicate the downside for the patient of their placement under the relevant regime. In addition, we need to consider the full range of procedural protections surrounding the use of community treatment powers. What steps must be taken, and by whom, before the critical decisions can be taken? What information must be considered; who must be consulted; how frequently is the person entitled to independent review of their compulsory status; and so on. The strength of all these procedural requirements must be assessed and compared, on the premise that more rigorous requirements signify a less restrictive regime. Moreover, the potential duration of a patient s compulsory outpatient treatment must be considered, as shorter periods of compulsion would again be less restrictive of patients rights. Full study and comparison of the powers, procedures, and likely duration of the two regimes would therefore be required to determine whether one is less restrictive than the other. Nevertheless, even that comparison might not produce a clear result, as either regime might be considered more restrictive on certain parameters, yet less restrictive on others, and no clear method may be available for reaching a final conclusion as to which is the least restrictive overall. Different aspects of the two schemes may simply have different impacts on different kinds of rights, without there being any common measure in which to compare their total impact. In the next section, we therefore compare certain central features of the two regimes. But, ultimately, we reach an ambivalent conclusion of that kind: i.e. leave is less restrictive in some respects and CTOs in other respects, without there being any obvious way to reach a definitive judgment as to which is the least restrictive overall. As a result, we take the view that even this final human rights principle cannot resolve the impasse between the two schemes. B. The Restrictiveness of the Two Regimes To provide some foundation for this comparison, it may be useful to summarise the broad similarities and differences between the two schemes. Their general structure is very similar. The same kinds of conditions can be imposed on compulsory outpatients community tenure; similar powers may be exercised by clinicians over outpatients, and in neither case is the patient s consent required to their initial placement under the scheme. Both patients on leave and those on CTOs may be swiftly returned to compulsory hospital care; both have a regular right

16 16 MEDICAL LAW REVIEW [2011] of access to independent review of their compulsory status before the Tribunal 40 ; both must be discharged by their RC or the Tribunal if they cease to meet the relevant criteria 41 ; and both are entitled to a second opinion from an approved doctor concerning certain forms of involuntary treatment, notably, the sustained use of medication, and ECT. 42 Furthermore, in both the cases, their involuntary outpatient treatment may be extended repeatedly, if the proper process is followed. Nevertheless, there are significant differences between the two regimes. The provisions governing leave are more open-textured, so may confer more discretion on clinicians. They also place the authority for decisions more squarely on the shoulders of the RC, instead of requiring prior agreement to be reached between the RC and an Approved Mental Health Professional (AMHP), as is required for many decisions about patients on CTOs. There are differences in the timing of patients entitlements to have their position reviewed by the Tribunal and to have their treatment approved by a Second Opinion Approved Doctor (SOAD). The scope of the treatment powers in the community differs in the two cases, particularly regarding patients who retain their capacity to consent. And somewhat different legal consequences flow from recall to hospital of patients treated under the different regimes. C. The Conditions of Outpatient Treatment With regard to the conditions that may be imposed on a patient s outpatient treatment, and the consequences that may flow from breach of those conditions, the CTO provisions appear somewhat more restrictive than the leave scheme due to the mandatory character of some conditions that must be imposed on treatment under a CTO, and the immediate power conferred to recall patients to hospital for breach of those mandatory conditions. Regarding leave, the Act establishes only very broad parameters concerning the conditions that may be imposed on outpatient care. The responsibility for fixing those conditions is placed squarely on the RC, who may grant a sectioned patient leave on such conditions (if any) as that clinician considers necessary in the interests of the patient or for the protection of other persons. 43 There are no mandatory conditions that must be imposed on leave, only discretionary conditions fixed in this manner by the RC. Breach of these conditions does not automatically authorise a patient s recall to hospital. 40 S Ss 23, Part 4, Part 4A. On powers to treat patients on CTOs, see Dawson in Gostin and others (eds) above n 2, paras S 17(1).

17 Med. L. Rev. Lawfulness of a Randomised Trial 17 Recall may only proceed when it appears to the responsible clinician that it is necessary to do so in the interests of the patient s health or safety or for the protection of other persons, 44 and breach of leave conditions is only one indicator that those standards have been met. Moreover, recall should only proceed on the basis of an up-to-date medical opinion that the patient remains mentally disordered in the necessary sense, to meet the procedural requirements of detention for mental health purposes specified by the European Court of Human Rights, in Winterwerp v Netherlands. 45 Under the CTO regime, on the other hand, the Act requires certain mandatory conditions to be imposed on outpatient care. Patients on CTOs must make themselves available for medical examination at two key points in the process: when the order s extension for another term is contemplated, and when approval of treatment by the SOAD must occur. 46 Furthermore, breach of those mandatory conditions authorises the patient s immediate recall to hospital. 47 In addition, optional conditions may be imposed on a CTO that are necessary or appropriate to ensure the patient receives treatment for mental disorder, to prevent risks to the patient s health or safety, or to protect other people. 48 Agreement on those optional conditions must be reached in advance, however, between the RC and an AMHP a somewhat more rigorous process than is required to set the conditions of leave. The optional conditions of a CTO might concern the patient s place of residence, compliance with treatment, availability to the treatment team, and avoidance of known risk factors or high-risk situations relevant to the patient s mental disorder. 49 Nevertheless, the patient cannot be recalled to hospital solely for breach of these optional conditions. Unless mandatory conditions have been breached, recall from a CTO is only justified when (a) the patient requires medical treatment in hospital for his mental condition; and (b) there would be a risk of harm to the health or safety of the patient or to other persons if the patient were not recalled. 50 Even when the patient is refusing treatment, those standards must be met for recall to occur. Comparison of the two regimes on these parameters therefore yields very mixed results. A less rigorous process must be followed to set the conditions for leave, but no mandatory conditions are imposed, nor is any automatic power conferred to recall patients to hospital simply 44 S 17(4). 45 ( ) 2 EHRR 387; Kay v UK (1998) 40 BMLR S 17B(3). 47 S 17E(2). 48 S 17B(2). 49 Para 25.34, Code of Practice. 50 S 17E(1).

18 18 MEDICAL LAW REVIEW [2011] for breaching the conditions of their leave. Regarding CTOs, on the other hand, a more rigorous process must be followed to set the conditions, but some mandatory conditions are imposed and their breach automatically authorises the use of the recall power. We might therefore say that a CTO is less restrictive of patients rights in certain respects (because a more rigorous process must be followed to set the conditions for outpatient care), but more restrictive in other respects (in imposing mandatory conditions linked to an immediate recall power). Perhaps, this last point is decisive, so we might say that the CTO regime is more restrictive overall regarding the conditions that may be imposed on leave and the consequences of their breach. But the equation remains equivocal, and, in practice, we might find that very similar conditions for treatment are imposed on the two categories of patient, and that very similar considerations influence clinicians decisions to recall patients to hospital, whether from leave or a CTO. D. Powers to Treat Without Consent The key difference between the powers conferred to treat outpatients by the CTO and leave regimes concerns the distinction between patients who retain, and those who lack, the capacity to consent to treatment for their mental disorder. The CTO regime makes this important distinction and confers different powers to treat these different categories of outpatient. The leave regime makes no such distinction. It appears to confer a single set of powers to treat outpatients regardless of their capacity. Patients on leave remain liable to be detained. So, they are subject to compulsory treatment under Part 4 of the Act, particularly the provisions concerning long-term use of medication. These provisions appear to authorise the administration of medication to patients on leave without their consent, regardless of their capacity, as long as the approval of an SOAD is obtained, as required (e.g. three months after involuntary treatment begins). 51 But the Act confers no express power to administer medication through the use of physical force or restraint in a community setting to a patient on leave and it is doubtful whether that would be a safe health practice; so, medication might be lawfully administered to patients on leave who are not consenting and not resisting if no significant physical force is used. But (except perhaps in an emergency) where physical force is to be used, the patient should be recalled to hospital for treatment to proceed. The Code therefore specifies that where treatment without consent of a 51 See N Munro, Treatment in Hospital, ch 13 of Gostin and others (eds) above n 2.

19 Med. L. Rev. Lawfulness of a Randomised Trial 19 patient on leave is contemplated consideration should be given to whether it would be more appropriate to recall the patient to hospital. 52 Recall permits more extensive assessment of the patient s condition before and after treatment, though it may also impose additional restrictions on liberty. Treatment in the community of patients on CTOs, on the other hand, is governed by the new Part 4A of the Act, and a clear distinction is made there between patients with and without the capacity to consent. 53 The rule is applied that patients on CTOs who retain their capacity cannot be treated in the community without their consent, even in an emergency. 54 To be treated without consent, they must be recalled to hospital premises. 55 Community patients who lack capacity, on the other hand, can generally be treated without consent, even over their objection, provided no force is used and the treatment does not conflict with an applicable advance directive they have issued, when capable, at an earlier time and does not conflict with the decision of a substitute decision-maker authorised to consent on their behalf under the Mental Capacity Act Furthermore, in emergencies, patients who lack capacity may be treated even more readily, their advance directives may be trumped and the use of limited force is expressly authorised. 57 The distinction made in Part 4A between CTO patients with and without the capacity to consent is therefore critical to the exercise of its treatment powers. This distinction requires the capacity of CTO patients to be regularly assessed, as their capacity may fluctuate during the course of their care. Then, if their capacity returns, their treatment choices must be respected unless they are recalled to hospital, where treatment without consent may proceed. When CTO patients are recalled to hospital, however, they become liable to detention once more and this shifts the source of authority for their treatment from Part 4A to Part The powers under Part 4 then permit medication to be administered without consent to CTO patients on hospital premises, even if they have capacity at that time, and even before the CTO is formally revoked. 59 The outcome, 52 Para See Dawson in Gostin and others (eds) above n 2, paras Ibid. 55 Para 23.14, Code of Practice; s 62A. 56 S 64D. 57 S 64G. 58 S 62A(2). 59 S 62A. The general principle that mentally disordered people cannot be treated involuntarily unless they lack the capacity to consent has not been incorporated into European human rights jurisprudence so far: see Pretty v UK (2002) 35 EHRR 1; J Dawson and A Kampf, Incapacity Principles in Mental Health Laws in Europe (2006) 12 Psychology, Public Policy and