Appraisal Consultation Document: Electroconvulsive therapy in depression, schizophrenia, mania and catatonia
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Appraisal Consultation Document
Electroconvulsive therapy
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The Department of Health and the Welsh Assembly Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of electroconvulsive therapy in depression, schizophrenia, mania and catatonia, and provide guidance on its use to the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of electroconvulsive therapy. This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website). Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).
The key dates for this appraisal are: Closing date for comments: Wednesday 18th September 2002 |
| Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. |
| 1 | Appraisal Committee's preliminary recommendations |
| 1.1 |
It is recommended that electroconvulsive therapy (ECT) is used only to achieve rapid and short-term improvement of severe symptoms when an intensive trial of other treatment options has proved ineffective or when the condition is considered to be potentially life-threatening, in individuals with:
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| 1.2 | The decision to use ECT should be made on a patient-by-patient basis. It should be based on a documented assessment of the risks and potential benefits to the individual, including: the risks associated with the anaesthetic; current co-morbidities; anticipated adverse events, including cognitive impairment; and the risks of no treatment. Particular caution should be taken during pregnancy, in elderly patients with cognitive impairment, and in children and young people. |
| 1.3 | The decision to use ECT should be made jointly by the individual and the clinician responsible for treatment on the basis of an informed discussion enabled by the provision of full and appropriate information. Valid consent should be obtained whenever possible and with strict adherence to recognised guidelines. In situations where informed discussion is difficult the individual's advocate and/or carer should be consulted and advance directives taken into account. |
| 1.4 | Assessment of clinical status and cognitive functioning should be undertaken at the end of each treatment session. Treatment should be stopped when a clinical response has been achieved or when an individual has not responded after an adequate trial of ECT. |
| 1.5 | It is recommended that a repeat course of ECT should be considered only for individuals with a condition listed in Section 1.1 who have previously responded well to ECT. |
| 1.6 | ECT should be carried out only by professionals trained in its delivery and the anaesthetic techniques required, and who maintain an appropriate level of skill through the regular clinical practice of ECT and continuing professional development. |
| 2 | Clinical need and practice |
| 2.1 | This appraisal considers electroconvulsive therapy (ECT) in the treatment of four clinical conditions: depression, schizophrenia, catatonia and mania. |
| 2.2 | Depression is associated with discrete episodes which are characterised by feelings of sadness, despair, loss of interest in daily life and discouragement. The severity of depression is determined by the number, intensity and frequency or persistence of depressive symptoms and the presence of specific symptoms such as delusions, hallucinations and suicidal ideation. Severe depression can deteriorate into a 'depressive stupor' where a person is conscious but is non-responsive to any stimulation. Because of the advent of modern treatments this extreme manifestation of depression is increasingly rare. |
| 2.3 | Schizophrenia is characterised by a broad range of cognitive, emotional and behavioural problems. The symptoms of schizophrenia are classified into positive and negative symptoms, relating respectively to an exaggeration and loss of normal functions. Individuals with delusions or hallucinations may be described as psychotic. |
| 2.4 | Catatonia is a syndrome that is associated with both schizophrenia and affective (mood) disorders. It is characterised by marked changes in muscle tone or activity that may alternate between the extremes of a deficit of movement (catatonic stupor) and excessive movement (catatonic excitement). |
| 2.5 | Mania is characterised by elated, euphoric or irritable mood and increased energy. The term may refer to a mental disorder or to a mood state or symptom, and mania is associated with bipolar disorders. In severe manic episodes, which can occur with or without psychosis, patients require continual supervision to prevent physical harm to themselves or others. |
| 2.6 | In 2000, the Psychiatric Morbidity Survey conducted by the Office of Population Censuses and Surveys found the prevalence of a depressive episode in people aged 16-64 years to be 27 per 1000 in England and 43 per 1000 in Wales. The prevalence of schizophrenia is estimated at between 2 and 10 per 1000 in the general population, and the incidence of first-onset schizophrenia is approximately 1 per 10,000 population per year. Recent estimates have suggested that bipolar affective disorder has a point prevalence of up to 50 per 1000 of the general population, of whom 1% are admitted to hospital for mania each year. There are no recent epidemiological studies on the incidence of catatonia. |
| 2.7 | Depression, schizophrenia and mania are chronic, relapsing conditions and are associated with considerable suicide risk. Diagnosable depressive disorders are implicated in between 40% and 60% of suicide attempts; 10-15% of people with major depressive disorders eventually kill themselves. Studies suggest that about 20% of individuals with schizophrenia recover, about 70% have relapsing disease and about 10% are seriously disabled by the disease. |
| 2.8 | Severe mental heath disorders are associated with considerable personal suffering, occupational disadvantage and impairment in interpersonal and family relationships in the long term. They also have a high economic impact, with the indirect costs far exceeding the direct costs. |
| 2.9 | Depression is managed with antidepressants, counselling and psychotherapy, either alone or in combination. Management of schizophrenia centres on antipsychotic medication, although individuals also require substantial clinical, emotional and social support. Catatonia is treated with benzodiazepines or barbiturates, and the introduction of effective psychotropic agents has led to a marked reduction in its prevalence. Acute manic episodes are treated with lithium, antipsychotics or anticonvulsants. |
| 2.10 | ECT is used in current clinical practice as a treatment option for individuals with depression, schizophrenia, catatonia and mania. Guidelines for the use of ECT were developed by the Royal College of Psychiatrists in 1995 and are currently undergoing revision. |
| 3 | The technology |
| 3.1 | During ECT, an electric current is passed briefly through the brain, via electrodes attached to the scalp, to induce generalised seizure activity. The individual receiving treatment is placed under general anaesthetic and muscle relaxants are given to prevent body spasms. The ECT electrodes can be placed on both sides of the head (bilateral placement) or on one side of the head (unilateral placement). Unilateral placement is usually to the non-dominant side of the brain with the aim of reducing cognitive side effects. The amount of current required to induce a seizure (the seizure threshold) can vary up to 40 fold between individuals. |
| 3.2 | Although ECT has been used since the 1930s, there is still no generally accepted theory that explains its mechanism of action. The most prevalent hypothesis is that it causes an alteration in the post-synaptic response to central nervous system neurotransmitters. |
| 3.3 | In recent years, there have been moves to improve standards in the administration of ECT, with the introduction of practice guidelines published by the Royal College of Psychiatrists and the Royal College of Nursing and the monitoring of the implementation of these guidelines through ongoing audit. However, there is still unacceptable variation in the use and practice of ECT within England and Wales. |
| 3.4 | ECT administration affects the central nervous system and causes changes in cardiovascular dynamics that put susceptible individuals at increased risk of a cardiovascular event. There are also other immediate potential complications, such as status epilepticus, vertebral compression fractures, skin burns, laryngospasm and peripheral nerve palsy, which have an estimated incidence of 1 per 1300 to 1400 treatments. The mortality associated with ECT is not reported to be in excess of that associated with the administration of a general anaesthetic. |
| 3.5 | ECT may cause short- or long-term memory impairment for past events (retrograde amnesia) and current events (anterograde amnesia). It is sometimes difficult to differentiate these effects from those associated with the condition itself and there are differences between individuals in the extent of memory loss and their perception of the loss. However, some individuals find their memory loss extremely distressing. |
| 3.6 | The Mental Health Act (1983) states that ECT may not be given to informal patients without valid consent, if they are capable of giving or withholding consent. Consent must be given freely and based on an informed understanding. ECT may be given without consent to detained patients if the clinician responsible deems it to be in the patient's best interest (for example, to save life) and a second opinion has been obtained that confirms that ECT is appropriate for the particular individual. The draft Mental Health Bill (June 2002), which is undergoing consultation at the time of this appraisal, proposes changes to the existing law governing consent to ECT. |
| 3.7 | The number of sessions undertaken during a course of ECT usually ranges from 6 to 12. ECT is usually given twice a week; less commonly, it is given once a fortnight or once a month as continuation or maintenance therapy to prevent the relapse of symptoms. It can be given on either an inpatient or outpatient basis. In England during January to March 1999, there were 16,482 administrations of ECT to 2835 individuals, 41% of whom were aged 65 years or over. Seventy-five per cent of the individuals were not formally detained under the Mental Health Act 1983 and of the 709 patients formally detained, 59% did not or were not able to consent to treatment. |
| 3.8 | Six treatment sessions of ECT cost £2475. This does not include inpatient costs, estimated as £171 per day. |
| 4 | Evidence and interpretation |
| The Appraisal Committee considered evidence from a number of sources (see Appendix B). | |
| 4.1 | Clinical effectiveness |
| 4.1.1 | The evidence presented in the Assessment Report was primarily drawn from a recent Cochrane Review of ECT in schizophrenia and a systematic review commissioned by the Department of Health on the use of ECT in schizophrenia, depression and mania. Both reviews are of high quality and consider a total of 119 RCTs and a number of observational studies. Evidence submitted by patient and professional groups was also considered. |
| 4.1.2 | There were problems with the design of many of the RCTs. A large proportion were conducted before the introduction of modern techniques of administering ECT and therefore do not reflect current practice. There were large variations in the parameters of the ECT administered that included the machine used, the number of sessions, the dosage and wave form, electrode placement and dosage and type of concomitant therapy. A number of studies used fixed dosage rather than individual thresholds. There was little evidence to support the routine prescription of a set number of treatment sessions per course of ECT or of the value of continuation (maintenance) ECT. |
| 4.1.3 | The Assessment Report reviews data from 90 RCTs in individuals with severe depression who had been referred for ECT. Overall, these RCTs provide evidence that real ECT (that is, where an electric current was applied) is more effective than sham ECT (where no electric current was applied) in the short term. The data provide evidence that the stimulus parameters have an important influence on efficacy - and at the end of a course of treatment, bilateral ECT was reported to be more effective than unilateral ECT. Applying electrodes to the dominant hemisphere and raising the electrical stimulus above the individual's seizure threshold was found to increase the efficacy of unilateral ECT at the expense of increased cognitive impairment. In trials comparing ECT with pharmacotherapy, ECT had greater benefit than the use of certain antidepressants but the trials were of variable quality and inadequate doses and durations of drug therapy were used. Combination of ECT with pharmacotherapy was not shown to be superior to ECT alone, although the duration of the RCTs was insufficient to show whether pharmacotherapy was beneficial. Compared with placebo, continuation pharmacotherapy with tricyclic antidepressants and/or lithium reduced the rate of relapses in people who had responded to ECT. Preliminary studies indicate that ECT is more effective than repetitive transcranial magnetic stimulation. |
| 4.1.4 | Evidence from 25 RCTs suggests that ECT may be effective in acute episodes of certain types of schizophrenia and reduce the occurrence of relapses, although the results are not conclusive. The data on differing efficacy related to electrode placement and stimulus parameters are equivocal and firm conclusions could not be drawn. No RCTs investigated the use of ECT in comparison with atypical antipsychotics and the studies that included individuals with treatment-resistant schizophrenia did not consider the use of clozapine. The combined weight of evidence suggests that ECT is not more effective and may be less effective than antipsychotic medication. The combination of ECT and pharmacotherapy may be more effective than pharmacotherapy alone, but the evidence is not conclusive. |
| 4.1.5 | The four RCTs reviewed in the Assessment Report suggest that ECT may be of benefit in the rapid control of mania and catatonia and this suggestion is supported by evidence from a number of observational studies. However, the evidence is insufficient to draw any general conclusions about the effectiveness of ECT or to determine the most appropriate therapeutic strategy. |
| 4.1.6 | There is clear evidence that cognitive impairment occurs both immediately after administration of ECT and following a course of therapy. The impairment is greater in individuals who have had electrodes applied bilaterally than in those who have had them placed unilaterally, and unilateral placement to the dominant hemisphere causes more impairment than placement to the non-dominant hemisphere. A reduction in the risk of cognitive impairment is however mirrored by a reduction in efficacy. There is some limited evidence from RCTs to suggest that the effects on cognitive function may not last beyond 6 months, but this has been inadequately researched. There is evidence to suggest that the impairment of cognitive function associated with ECT differs between individuals. There is no evidence to suggest that the effect of ECT on cognitive function is diagnosis dependent. |
| 4.1.7 | A systematic review of evidence from non-randomised studies relating to users' views and experiences of ECT was also considered. This provided important information on patient perceptions of the effects of ECT on memory loss and the validity of neuropsychological instruments used in clinical trials. There was testimony that patients are not provided with sufficient information on which to base a decision regarding consent. Also, some patients are unaware of their rights to refuse treatment, or may feel unable to do so. |
| 4.1.8 | There was no evidence to suggest that the mortality associated with ECT is greater than that associated with other procedures involving general anaesthetics, and there were limited data on mortality extending beyond the trial periods. The six studies reviewed that used brain-scanning techniques did not provide any evidence that ECT causes brain damage. Whilst there is no evidence to suggest that benefits and safety are age-dependent, there are no studies on the impact of ECT on the developing brain. Furthermore, it is likely that co-morbidities are likely to increase the risk of harm. The use of ECT during pregnancy is known to cause complications, which may have a greater impact during the first trimester, but the risks associated with ECT need to be balanced against the risks of using alternative drug treatments. |
| 4.2 | Cost effectiveness |
| 4.2.1 | There are no published economic studies relating to ECT, and none of the submissions from consultees contained any economic analyses. The Assessment Group therefore constructed economic models of ECT for depression and schizophrenia based on a review of published evidence. They were not able to construct robust models for mania and catatonia because of the low volume of data in these areas. |
| 4.2.2 | The depression model had a 1-year time horizon and compared the cost effectiveness of inpatient ECT with other inpatient treatments for adults with severe depression. The key comparators were different classes of antidepressants, with the augmentation of lithium for third-line therapy. After three lines of therapy, non-responders were assumed to receive 8 weeks of psychotherapy and to make a moderate improvement. |
| 4.2.3 | The results of the model showed that for eight different scenarios, total costs range from £10,592 to £15,354 and total quality-adjusted life years (QALYs) range from 0.424 to 0.539. Given the small differences in total costs and QALYs between the different strategies and the uncertainty in the data available, ECT and pharmacotherapy are likely to be equally cost effective. |
| 4.2.4 | The schizophrenia model also had a 1-year time horizon and compared the cost effectiveness of ECT in combination with a typical antipsychotic with that of (a) clozapine and (b) chlorpromazine or haloperidol for adults hospitalised with treatment-resistant schizophrenia of moderate symptomatology. |
| 4.2.5 | The results of the model suggest that ECT is dominated by clozapine, resulting in fewer QALYs (0.842 vs 0.863) at a higher cost (£55,267 vs £34,787). For patients who do not respond to clozapine, ECT dominates chlorpromazine/haloperidol, resulting in more QALYs (0.842 vs 0.820) at a lower cost (£55,267 vs £58,265). However, these results do not take into account the degree of uncertainty in the estimates of both costs and effectiveness. |
| 4.2.6 | To summarise, there is no published evidence regarding the cost effectiveness of ECT. The modelling exercises undertaken by the Assessment Group suggest that for those with severe depression and treatment-resistant schizophrenia, ECT and pharmacological treatment may be equally cost effective, with no real differences in costs or outcomes. |
| 4.3 | Consideration of the evidence |
| 4.3.1 | The Committee reviewed the evidence on both the clinical effectiveness and the cost effectiveness of ECT, having considered evidence from people who have received or may be eligible for ECT, those who represent them, and clinical experts, on the nature of the conditions. It was also mindful of the need to ensure that its advice took account of the efficient use of NHS resources. |
| 4.3.2 | The evidence submitted to the Committee, both written and verbal, demonstrated that, on balance, current opinion is that ECT is an effective treatment for certain subgroups of individuals with mental disorders. However opinion varies from those who consider that its adverse effects are tolerable to those who consider that it is associated with significant side effects including brain damage, severe confusion and considerable cognitive impairment in both the short and longer terms. Whilst some patients consider ECT to be a beneficial and lifesaving treatment, others report feelings of terror, shame and distress, and find it positively harmful and an abusive invasion of personal autonomy. |
| 4.3.3 | In consideration of these extremes of opinion, the Committee concluded that the choice of the patient must be of paramount importance and that it is essential that, whenever possible, all attempts should be made to obtain valid and informed consent, following recognised guidelines. The Committee felt strongly that consent should never be obtained by coercion, either explicit or implicit, and mechanisms to monitor and prevent this from occurring should be developed and implemented. |
| 4.3.4 | Testimony was heard that the information currently given to individuals does not always adequately inform consent and the Committee discussed the need for nationally agreed evidence-based patient information leaflets. These should be accessible to a wide range of service users (See Section 7) and should emphasise the right of the individual to withhold consent or to withdraw it at any point. |
| 4.3.5 | Whilst the limitations of advance directives were appreciated, the Committee believed that, whenever possible, they should be developed and documented in individuals' care programmes and be taken into account when considering ECT. |
| 4.3.6 | The Committee considered that on the evidence put before it, the short-term effectiveness of ECT in patients with severe depression has been demonstrated. However, there is less robust evidence to suggest that it is effective in the acute treatment of catatonia and mania and in individuals with schizophrenia associated with depressive symptoms. There is no evidence to support the effectiveness of ECT beyond the short term and no evidence that it is more beneficial as a maintenance therapy than currently available pharmacological alternatives. |
| 4.3.7 | The Committee noted that the efficacy and adverse effects of ECT are clearly linked to the method of delivery, although the optimum technique and stimulus parameters have not been adequately researched; for example gains in efficacy as a result of modifications to electrode placement and stimulus parameters are achieved at the expense of an increased risk of cognitive side effects. The Committee therefore considered that the evidence was not sufficient to allow conclusions to be drawn. |
| 4.3.8 | The RCT evidence considered by the Committee also leaves unanswered a number of important questions, and these require further research (see Section 5). Consideration was given to the fact that the majority of the RCTs are not applicable to modern practice because of advances in pharmacological management and ECT administration techniques. There was insufficient information to allow appropriate risk-benefit assessment for individual groups of patients, for example during pregnancy, in elderly patients with cognitive impairment, and in children and young people. Of particular concern were the lack of research into the appropriate number of treatment sessions that should be given and the lack of long-term evidence regarding adverse effects on cognitive function and mortality. The value of continuation (maintenance) ECT in the context of appropriate pharmacological treatment could not be established. |
| 4.3.9 | The deficiencies in current practice were highlighted to the Committee and the Committee strongly believed that action is required to ensure that appropriate standards of care are enforced whenever ECT is undertaken and that outcomes are continuously monitored. The Committee considered that ECT should be administered only by professionals who have been trained in its delivery and in the anaesthetic techniques required for the administration of ECT. These professionals should maintain an appropriate level of skill, both through the regular clinical practice of ECT and through undertaking appropriate continuing professional development. |
| 4.3.10 | Despite the uncertainty in the estimates of clinical effectiveness and the small differences in costs and outcomes generated in the economic models, the Committee considered that ECT is likely to be cost effective in appropriate patient groups. |
| 4.3.11 | In summary, the Committee considered that the evidence appraised supported the effectiveness of ECT in certain groups of individuals. However, the Committee recognised there remained a number of uncertainties, including a lack of information on longer-term outcomes. The Committee was aware of the negative experiences of some individuals who have undergone ECT. Therefore the Committee considered that that ECT should be used with caution and only in the restricted circumstances recommended in the guidance in Section 1. It is anticipated that NICE guidelines currently under development (see Section 8) will further define the place of ECT in the care pathways for individuals with depression. |
| 5 | Proposed recommendations for further research |
| 5.1 | There are a number of ongoing research projects that include studies of clinical and cost effectiveness in specific groups and an examination of the effects of seizure parameters. |
| 5.2 | Further research using modern techniques is urgently required. This should include further evaluation of whether it is necessary to induce a full seizure for therapeutic effect and how the efficacy and cognitive effects are influenced by the amount by which the applied electrical dose exceeds the seizure threshold. |
| 5.3 | It is clear that the stimulus parameters impact on the safety and efficacy of the technique and more recent research needs to be augmented. In particular, the research should focus on the use of ECT in comparison with and in conjunction with the antipsychotic and antidepressant drugs used in current practice. |
| 5.4 | Further research is urgently required to examine the long-term efficacy of ECT and the effectiveness of maintenance ECT. Outcome measures should include user perspectives of the impact of ECT, the incidence and impact of important side effects such as cognitive functioning, and mortality. |
| 5.5 | More research is also needed to determine the cost effectiveness of ECT. In particular, better quality-of-life information is needed for people considered for, or who have received, ECT. |
| 6 | Preliminary views on the resource impact for the NHS |
| This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible. | |
| 6.1 | As this guidance recommends the use of ECT only in certain restricted circumstances, it is anticipated that the guidance will reduce the use of ECT in England and Wales below current levels. This guidance is not expected, therefore, to result in a net increase in NHS expenditure. |
| 7 | Proposals for implementation and audit |
| This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1. | |
| 7.1 | National information leaflets should be developed through consultation with appropriate professional and user organisations to facilitate discussions about the use of ECT and to enable individuals to make an informed decision about whether to give consent to the treatment. The leaflets should be evidence based, include information about significant risks and alternatives, and be produced in formats and languages that make them accessible to a wide range of service users. |
| 7.2 | Existing clinical governance mechanisms in NHS Trusts should be used to ensure adherence to national standards and guidelines for the administration of ECT and to the guidance in Section 1. |
| 7.3 | NHS Trusts currently offering ECT and all clinicians involved in the care of these patients should review policies and practices regarding the use of ECT to take account of the guidance set out in Section 1. |
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7.4
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Local guidelines or care pathways involving ECT should incorporate the guidance in Section 1. |
| 7.5 | To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix C. |
| 7.6.1 |
ECT is used only for an individual with any of the following:
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| 7.6.2 | ECT is used only to achieve rapid and short-term improvement of an individual's severe symptoms when an intensive trial of other treatments has proved ineffective or when the condition is considered to be potentially life-threatening. |
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7.6.3
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An assessment of the risks and potential benefits to the individual undergoing ECT is documented. |
| 7.6.4 | The individual undergoing ECT provides informed and valid consent whenever possible in strict adherence to recognised guidelines. In situations where informed discussion is difficult the individual's advocate and/or carer is consulted and advance directives are taken into account. |
| 7.6.5 | The individual's clinical status and cognitive functioning are assessed at the end of each ECT treatment session. |
| 7.6.6 | ECT treatment is stopped when a clinical response is achieved or when an individual has not responded after an adequate trial of ECT. |
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7.6.7
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A repeat course of ECT is considered in an individual with one of the conditions listed above in 7.6.1 only if the individual has previously responded well to ECT. |
| 7.6.8 | ECT is carried out only by a professional trained in its delivery and the anaesthetic techniques required and who maintains an appropriate level of skill through the regular clinical practice of ECT and continuing professional development. |
| 7.7 | Local clinical audits also could include reference to standards in the current handbook on ECT published by the Royal College of Psychiatrists and the Royal College of Nursing and the suggested indicators for audit of anaesthesia for ECT published by the Royal College of Anaesthetists. |
| 8 | Related guidance |
| 8.1 |
The Institute has issued guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia.
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| 8.2 | The Institute is preparing guidance on the use of CCBT for depression and anxiety and on the use of atypical antipsychotics and anticonvulsants for the treatment of acute mania in bipolar affective disorder (anticipated publication date July 2003). |
| 8.3 | The Institute is also preparing guidelines for the management of schizophrenia (anticipated launch date December 2002), depression (September 2003) and depression in children (launch date to be confirmed). |
| 9 | Proposed date for review of guidance |
| 9.1 | The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review. |
| 9.2 | It is proposed that the guidance on this technology is reviewed in August 2005. |
| Professor David Barnett |
| Chairman, Appraisal Committee |
| August 2002 |
| Appendix A. Appraisal Committee members |
|
NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chairman, vice-chairman and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches. |
| Committee members are asked to declare any interests in the technology to be appraised. If there is a conflict of interest, the member is excluded from participating further in that appraisal. |
| The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declaration of interests, are posted on the NICE website. |
| Dr Jane Adam |
| Radiologist, St. George's Hospital, London |
| Professor R L Akehurst |
| Dean, School of Health Related Research, Sheffield University |
| Dr Sunil Angris |
| General Practitioner, Waterhouses Medical Practice |
| Professor David Barnett (Chairman) |
| Professor of Clinical Pharmacology, University of Leicester |
| Dr Sheila Bird |
| MRC Biostatistics Unit, Cambridge |
| Professor Carol Black |
| Consultant Physician, Royal Free Hospital & UCL, London |
| Professor John Brazier |
| Health Economist, University of Sheffield |
| Professor Martin Buxton |
| Director of Health Economics Research Group, Brunel University |
| Professor Mike Campbell |
| Statistician, Institute of General Practice & Primary Care, Sheffield |
| Dr Karl Claxton |
| Health Economist, University of York |
| Professor Sarah Cowley |
| Professor of Community Practice Development, Kings College, London |
| Professor Jack Dowie |
| Health Economist, London School of Hygiene & Tropical Medicine, London |
| Mr Chris Evennett |
| Chief Executive, Mid-Hampshire Primary Care Group |
| Dr Paul Ewings |
| Statistician, Taunton & Somerset NHS Trust |
| Professor Terry Feest |
| Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit, and Chairman of the UK Renal Registry |
| Professor Gary A Ford |
| Professor of Pharmacology of Old Age / Consultant Physician, Wolfson Unit of Clinical Pharmacology, University of Newcastle |
| Mrs Sue Gallagher |
| Chief Executive, Merton, Sutton and Wandsworth Health Authority |
| Dr Trevor Gibbs |
| Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline |
| Sally Gooch |
| Director of Nursing, Mid-Essex Hospital Services Trust |
| Mr John Goulston |
| Director of Finance, The Royal Free Hampstead NHS Trust |
| Professor Trisha Greenhalgh |
| Professor of Primary Health Care, University College London |
| Miss Linda Hands |
| Consultant Vascular Surgeon, John Radcliffe Hospital, Oxford |
| Professor Philip Home |
| Professor of Diabetes Medicine, University of Newcastle |
| Dr Terry John |
| General Practitioner, The Firs, London |
| Dr Diane Ketley |
| Research into Practice Programme Leader, NHS Modernisation Agency |
| Dr Mayur Lakhani |
| General Practitioner, Highgate Surgery, Leicester, and Lecturer, University of Leicester |
| Ruth Lesirge |
| Patient Representative; Director, Mental Health Foundation |
| Dr George Levvy |
| Patient Representative; Chief Executive, Motor Neurone Disease Association |
| Dr Gill Morgan |
| CEO, North & East Devon Health Authority |
| Professor Miranda Mugford |
| Health Economist, University of East Anglia |
| Mr M Mughal |
| Consultant Surgeon, Chorley and South Ribble NHS Trust |
| Mr James Partridge |
| Chief Executive, Changing Faces |
| Siân Richards |
| General Manager, Cardiff Local Health Group |
| Professor Philip Routledge |
| Professor of Clinical Pharmacology, University of Wales |
| Dr Rhiannon Rowsell |
| Pharmaceutical Physician, AstraZeneca UK Ltd |
| Dr Stephen Saltissi |
| Consultant Cardiologist, Royal Liverpool University Hospital |
| Professor Andrew Stevens (Vice-Chairman) |
| Professor of Public Health, University of Birmingham |
| Professor Ray Tallis |
| Consultant Physician, Hope Hospital, Salford |
| Dr Cathryn Thomas |
| General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham |
| Professor Mary Watkins |
| Head of Institute of Health Studies, University of Plymouth |
| Dr Norman Waugh |
| Public Health Consultant, University of Southampton |
| Appendix B. Sources of evidence considered by the Committee | |
| The following documentation and opinion was made available to the Committee: | |
| A. | Assessment Report prepared by: School of Health and Related Research University of Sheffield and Nuffield Institute for Health, University of Leeds Electroconvulsive Therapy (ECT) for Depressive Illness, Schizophrenia, Catatonia and Mania, May 2002 |
| B. |
Professional/specialist group submissions from:
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| C. |
Patient/carer group submissions from:
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| D. |
Expert perspectives from:
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| Appendix C. Detail on criteria for audit of the use of electroconvulsive therapy | |||
| Possible objective for an audit | |||
| An audit on electroconvulsive therapy (ECT) could be carried out to ensure that ECT is used appropriately and that the individuals receiving ECT participate in making the decision to use the treatment whenever possible. | |||
| Possible patients to be included in an audit | |||
| All patients who have received ECT in a suitable time period for audit, for example, 1 year. Alternatively, the audit could be undertaken concurrently with the provision of ECT treatments. | |||
| Measure to be used as a basis for an audit | |||
| The measures that can be used in an audit on ECT are as follows. |
| Criterion | Standard | Exception | Definition of Terms |
| 1. The individual receiving ECT has one of the following. (a) Severe depression (b) Schizophrenia associated with major depressive symptoms (c) Catatoniad. (d) A prolonged or severe manic episode |
100% of patients receiving ECT | None | Local clinicians will have to agree on how and where the indications for ECT are documented for audit purposes |
| 2. ECT is used to achieve rapid and short-term improvement of severe symptoms when the individual has not responded to an intensive trial of other treatments or has a potentially life-threatening condition |
100% of patients receiving ECT | None | Local clinicians will have to agree on how severe symptoms and response to other treatments and potentially life threatening conditions are documented for audit purposes |
| 3. An assessment of the risks and potential benefits of ECT is documented for the individual |
100% of patients receiving ECT | None | The documented assessment before treatment should note: risks associated with the anaesthetic; current co-morbidities; anticipated adverse events, including cognitive impairment; and the risks of no treatment |
| 4. The patient provides consent for each course of ECT treatment | 100% of patients receiving ECT | The patient is not able to provide consent, in which case the patient's advocates or carers are consulted and advance directives are taken into account in accordance with recognised guidelines | Local clinicians should agree on how consent to ECT is documented for audit purposesThe consent should indicate that there has been an informed discussion with the patient and that full and appropriate information about the risks and potential benefits has been provided to the patient Course of ECT = usually 6 to 12 sessions given twice a week |
| 5. The individual's clinical status and cognitive functioning are assessed after each ECT session | 100% of patients receiving ECT | None | Local clinicians should agree on what constitutes an assessment of clinical status and cognitive functioning following an ECT session |
| 6. ECT is stopped when either of the following situations occurs: a. A clinical response is achieved b. The individual has not responded after an adequate trial of ECT |
100% of patients receiving ECT in which either of the conditions listed occurs | None | Local clinicians will have to agree on what constitutes a desired clinical response and an adequate trial for audit purposes |
| 7. A repeat course of ECT is provided | 0% of patients receiving an ECT treatment | The individual has one of the conditions listed in 1.1 and has had a previous good response to ECT | Local clinicians will have to agree on what constitutes a good response to ECT for audit purposes See 4 above for definition of course of treatment |
| 8. ECT is carried out only by a professional with appropriate training who maintains an appropriate level of skill through the regular clinical practice of ECT and continuing professional development | 100% of patients receiving ECT | None | Appropriate training includes the delivery of ECT and the anaesthetic techniques required. Local clinicians will have to agree on what constitutes appropriate training and level of skill for individuals carrying out ECT for audit purposes |
| Calculation of compliance with the measures | ||
| Compliance with the measure described in the table is calculated as follows: | ||
|
Number of patients whose care is consistent with the criterion plus the number of patients who meet any exception |
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X 100 | |
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Number of patients to whom the measure applies |
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| Clinicians should review the findings of measurement, identify if practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved. | ||
This page was last updated: 30 March 2010