• National Institute for Clinical Excellence (NICE). Guidance on the use of electroconvulsive therapy. London (UK): National Institute for Clinical Excellence (NICE); 2003 Apr. 36 p. (Technology appraisal; no. 59).

This is the current release of the guideline.

• Depressive illness
• Schizophrenia
• Catatonia
• Mania

Assessment of Therapeutic Effectiveness
Management
Treatment

Psychiatry

Advanced Practice Nurses
Physician Assistants
Physicians

To establish the clinical and cost effectiveness of electroconvulsive therapy (ECT) for depressive illness, schizophrenia, catatonia, and mania

Adults with depressive illness, schizophrenia, catatonia, or mania

Electroconvulsive therapy

• Clinical effectiveness
  • Symptom improvement
  • Quality of life
  • Adverse effects
• Cost effectiveness

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Searches of Unpublished Data

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by The University of Sheffield, School of Health and Related Research [ScHARR] and the Nuffield Institute for Health, University of Leeds. (See the "Companion Documents" field.)

Search Strategy: Clinical Effectiveness

Sources Searched

17 electronic bibliographic databases were searched, covering biomedical, health-related, science, social science, and grey literature. A list of databases is provided in Appendix 1 of the Assessment Report (see "Availability of Companion Documents" field). This includes the Cochrane Schizophrenia Group Trials Register, which was searched on behalf of the review team by the Group's Trials Search Co-ordinator.

In addition, the reference lists of relevant articles were checked and 40 health services research related resources were consulted via the Internet. These included Health Technology Assessment (HTA) organisations, guideline producing bodies, generic research and trials registers and specialist psychiatric sites. A list of these additional sources is given in Appendix 2 of the Assessment Report (see "Availability of Companion Documents" field). Finally, citation searches of key papers were undertaken using the Science Citation Index (SCI) citation facility and the reference lists of included studies were checked for additional studies.

Search Terms

A combination of free-text and thesaurus terms were used. "Population" terms (e.g., depression, schizophrenia, catatonia, bipolar disorder, mania, mood disorders, adjustment disorders, psychotic disorders, mental disorders, etc.) were combined with "intervention" terms (e.g., electroconvulsive therapy, electro convulsive therapy, electroshock therapy, electro shock therapy, etc.). Copies of the search strategies used in the major databases are included in Appendix 3 of the Assessment Report (see "Availability of Companion Documents" field).

Search Restrictions

No date or language restrictions were applied. Where necessary (e.g., in the larger databases, such as Medline), searches were restricted to the highest quality of evidence, i.e., practice guidelines, systematic reviews, and randomised controlled trials, using methodological filters (Appendix 4 of the Assessment Report [see "Companion Documents" field]). These were supplemented by strategies designed to pick up other outcomes, such as patient acceptability, side effects and staff training (Appendix 4 of the Assessment Report [see "Availability of Companion Documents" field]).

Search Strategy: Cost Effectiveness

In addition to the searches conducted above, searches were conducted in the National Health Service Economic Evaluations Database (NHS EED) and Office of Health Economics Health Economic Evaluations Database (OHE HEED) to specifically identify cost effectiveness literature (Appendix 3 of the Assessment Report [see "Availability of Companion Documents" field]).

Methodological search filters designed to retrieve economic evaluations and quality of life studies (Appendix 4 of the Assessment Report [see "Availability of Companion Documents" field]) were also applied to the Medline and Embase search strategies.

There were no company submissions.

Inclusion and Exclusion Criteria

Populations

Papers were included in the review if they included the following populations: depressive illness (both unipolar and bipolar), schizophrenia and schizo-affective disorder, catatonia and mania. The Assessment Group also aimed to explore the clinical effectiveness of electroconvulsive therapy (ECT) in particular subgroups including people who are treatment resistant to pharmacotherapy, older people (defined as aged 65 and over), younger people (defined as aged 18 or under) and disorders associated with pregnancy and the puerperium. Papers were excluded if they included populations with more than one diagnosis (for example depression and schizophrenia) and did not stratify randomisation by disease type or report results separately for each diagnosis.

Interventions

Papers were included in the review if they examined the effectiveness or cost effectiveness of electroconvulsive therapy either as a monotherapy or in conjunction with other appropriate pharmacological or psychological treatment, at all doses and frequency of administration, by any technique, in all settings, and administered by any health professional. The Assessment Group also included studies investigating the efficacy of adjunctive and continuation or maintenance ECT or pharmacotherapy and interventions that aimed to improve patient knowledge about ECT.

Comparators

Papers were included if they compared ECT to any pharmacological or non-pharmacological treatment including sham ECT, psychotherapy, or repetitive transcranial magnetic stimulation (rTMS). Studies that compared one or more types of pharmacotherapy post ECT were also included.

Outcomes

Studies were included if they assessed outcomes relating to the efficacy, safety and acceptability of ECT. The primary indicator of the efficacy of ECT were clinically meaningful benefits in symptoms and/or quality of life as measured by a validated rating scale or clinical opinion, secondary indicators were the speed of response to ECT, premature withdrawals by the decision of either the participant, the clinician in charge of their care or the researcher, discharges from hospital and relapses. The primary indicators of the safety of ECT were adverse events including both objective and subjective reports of memory loss (anterograde, retrograde and subjective reports of memory loss) and all cause and cause specific mortality (including suicide). All these outcomes were considered immediately after the course of ECT, at 6 months and 12 month or longer. The primary indicators of acceptability were patients' choice of treatment and their views and experiences of ECT either from questionnaires or interviews.

Study Methodology

Published papers were included in the review according to the accepted hierarchy of evidence. In the first instance papers were only included if they were systematic reviews, randomised controlled trials and economic evaluations. Where no randomised controlled trial evidence was available, non-randomised comparator studies (for example non-randomised trials, controlled cohort studies, and case control studies) were included in the review. Where no evidence from non-randomised comparator studies is available, non-randomised, non-comparator studies (for example case series, case reports, non-controlled cohort studies) were included in the review.

Language

Any studies not available in English were excluded as the time scale of the review precluded time for translation.

Two good quality systematic reviews of randomised evidence of the efficacy and safety of electroconvulsive therapy (ECT) in people with depression, schizophrenia, catatonia and mania were identified. Also identified were 4 systematic reviews on non randomised evidence, though only one of these could be described as good quality.

Expert Consensus

Not applicable

Systematic Review with Evidence Tables

Expert Consensus

Considerations

Technology appraisal recommendations are based on a review of clinical and economic evidence.

Technology Appraisal Process

The National Institute for Health and Clinical Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process. Consultee organisations include national groups representing patients and carers, the bodies representing health professionals, and the manufacturers of the technology under review. Consultees are invited to submit evidence during the appraisal and to comment on the appraisal documents.

Commentator organisations include manufacturers of the products with which the technology is being compared, the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area. They can comment on the evidence and other documents but are not asked to submit evidence themselves.

NICE then commissions an independent academic centre to review published evidence on the technology and prepare an 'assessment report'. Consultees and commentators are invited to comment on the report. The assessment report and the comments on it are then drawn together in a document called the evaluation report.

An independent Appraisal Committee then considers the evaluation report. It holds a meeting where it hears direct, spoken evidence from nominated clinical experts, patients and carers. The Committee uses all the evidence to make its first recommendations, in a document called the 'appraisal consultation document' (ACD). NICE sends all the consultees and commentators a copy of this document and posts it on the NICE website. Further comments are invited from everyone taking part.

When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD). This is submitted to NICE for approval.

Consultees have a chance to appeal against the final recommendations in the FAD. If there are no appeals, the final recommendations become the basis of the guidance that NICE issues.

Who is on the Appraisal Committee?

NICE technology appraisal recommendations are prepared by an independent committee. This includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers. Although the Appraisal Committee seeks the views of organisations representing health professionals, patients, carers, manufacturers and government, its advice is independent of any vested interests.

Not applicable

There are no published economic studies relating to electroconvulsive therapy (ECT), and none of the submissions from consultees contained any economic analyses. The Assessment Group therefore constructed economic models of ECT for depressive illness 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.

See Section 4.2 of the original guideline document for a detailed discussion of the cost-effectiveness analysis.

External Peer Review

Consultee organizations from the following groups were invited to comment on the draft scope, Assessment Report and the Appraisal Consultation Document (ACD) and were provided with the opportunity to appeal against the Final Appraisal Determination.

• Manufacturer/sponsors
• Professional/specialist and patient/carer groups
• Commentator organisations (without the right of appeal)

In addition, individuals selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups were also invited to comment on the ACD.

• It is recommended that electroconvulsive therapy (ECT) is used only to achieve rapid and short-term improvement of severe symptoms after an adequate trial of other treatment options has proven ineffective and/or when the condition is considered to be potentially life-threatening, in individuals with:
  • Severe depressive illness
  • Catatonia
  • A prolonged or severe manic episode
• The decision as to whether ECT is clinically indicated 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, particularly cognitive impairment; and the risks of not having treatment.
• The risks associated with ECT may be enhanced during pregnancy, in older people, and in children and young people, and therefore clinicians should exercise particular caution when considering ECT treatment in these groups.
• Valid consent should be obtained in all cases where the individual has the ability to grant or refuse consent. The decision to use ECT should be made jointly by the individual and the clinician(s) responsible for treatment, on the basis of an informed discussion. This discussion should be enabled by the provision of full and appropriate information about the general risks associated with ECT and about the risks and potential benefits specific to that individual. Consent should be obtained without pressure or coercion, which may occur as a result of the circumstances and clinical setting, and the individual should be reminded of their right to withdraw consent at any point. There should be strict adherence to recognised guidelines about consent and the involvement of patient advocates and/or carers to facilitate informed discussion is strongly encouraged.
• In all situations where informed discussion and consent is not possible advance directives should be taken fully into account and the individual's advocate and/or carer should be consulted.
• Clinical status should be assessed following each ECT session and treatment should be stopped when a response has been achieved, or sooner if there is evidence of adverse effects. Cognitive function should be monitored on an ongoing basis, and at a minimum at the end of each course of treatment.
• It is recommended that a repeat course of ECT should be considered under the circumstances indicated in the first point (see above) only for individuals who have severe depressive illness, catatonia or mania and who have previously responded well to ECT. In patients who are experiencing an acute episode but have not previously responded, a repeat trial of ECT should be undertaken only after all other options have been considered and following discussion of the risks and benefits with the individual and/or where appropriate their carer/advocate.
• As the longer-term benefits and risks of ECT have not been clearly established, it is not recommended as a maintenance therapy in depressive illness.
• The current state of the evidence does not allow the general use of ECT in the management of schizophrenia to be recommended.
• National information leaflets should be developed through consultation with appropriate professional and user organisations to enable individuals and their carers/advocates to make an informed decision regarding the appropriateness of ECT for their circumstances. The leaflets should be evidence based, include information about the risks of ECT and availability of alternative treatments, and be produced in formats and languages that make them accessible to a wide range of service users.

None provided

The type of evidence supporting the recommendations is not specifically stated.

Appropriate use of electroconvulsive therapy in adults with depressive illness, schizophrenia, catatonia or mania

Side effects of therapy

This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

Implementation and Audit

• National Health Service (NHS) Trusts should ensure that electroconvulsive therapy (ECT) is carried out in accordance with the recommendations (see the "Major Recommendations" field) and only by clinical staff trained in its application. Such staff should maintain an appropriate level of skill through routine practice and continuing professional development.
• NHS Trusts currently offering ECT, and all clinicians involved in the care of individuals receiving ECT, should review policies and practices regarding its use to take account of the guidance (see the "Major Recommendations" field).
• Local guidelines or care pathways involving ECT should incorporate the guidance (see the "Major Recommendations" field).
• To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix D of the original guideline document.
  • ECT is used only for an individual with any of the following:
    • Severe depressive illness
    • Catatonia
    • A prolonged or severe manic episode.
  • ECT is used only to achieve rapid and short-term improvement of an individual's severe symptoms after an adequate trial of other treatment options has proven ineffective and/or when the condition is considered to be potentially life threatening.
  • An assessment of the risks and potential benefits to the individual undergoing ECT is documented. If the individual is pregnant, an older person, or a child or young person, the clinician(s) involved should exercise particular caution and the individual or their advocate or carer should be made aware that the risks associated with ECT may be enhanced in these circumstances.
  • The individual undergoing ECT provides valid consent if he or she has the ability to grant or refuse consent. In situations where joint decision making, informed discussion and consent are not possible, advance directives are fully taken into account and the individual's advocate and/or carer is consulted.
  • The consent process provides that the clinician(s) responsible for treatment:
    • Involves the individual's advocate and/or carer where possible
    • Provides full and appropriate information in a suitable format and language to enable an informed discussion
    • Explains and discusses the general risks of ECT, risks specific to the individual and potential benefits to the individual
    • Does not pressure or coerce the individual into consent to the treatment
    • Reminds the individual that he or she has the right to withdraw consent at any point.
  • The individual's clinical status is assessed following each ECT session and the individual's cognitive function is monitored on an ongoing basis and at a minimum at the end of each course of treatment.
  • ECT treatment is stopped once a response is achieved, if there is evidence of adverse effects, or if the individual withdraws consent.
  • A repeat course of ECT is considered only for an individual:
    • Under the circumstances described in sections 7.4.1 and 7.4.2 of the original guideline document who has previously responded well to ECT
    • Who has not responded previously but is experiencing an acute episode and all other options have been considered, and following discussion with the individual and/or where appropriate the carer/advocate of the risks and benefits of such a course of action. ECT is not used as a maintenance therapy in depressive illness.
  • ECT is not used in the general management of schizophrenia.
• Local clinical audits should include input from service users on at least criteria in sections 7.4.4-7.4.9 of the original guideline document and 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.

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• National Institute for Clinical Excellence (NICE). Guidance on the use of electroconvulsive therapy. London (UK): National Institute for Clinical Excellence (NICE); 2003 Apr. 36 p. (Technology appraisal; no. 59).

Not applicable: The guideline was not adapted from another source.

2003 Apr

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Appraisal Committee

Committee Members: Professor R L Akehurst, Dean, School of Health Related Research, Sheffield University; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Professor Sir Colin Berry, Retired Professor of Morbid Anatomy & Histopathology, The Royal London Hospital; Dr Sheila Bird, MRC Biostatistics Unit, Cambridge; Professor Rosamund Bryar, Professor of Community & Primary Care Nursing, St Bartholomew's School of Nursing & Midwifery, London; Professor Martin Buxton, Director of Health Economics Research Group, Brunel University, Uxbridge; Dr Karl Claxton, Health Economist, University of York; Professor Sarah Cowley, Professor of Community Practice Development, Kings College, London; Mr Chris Evennett (resigned June 2002) Chief Executive, Mid-Hampshire Primary Care Trust, Winchester; Professor Terry Feest, Clinical Director & Consultant Nephrologist, Richard Bright Renal Unit, & Chair of UK Renal Registry, Bristol; Professor Gary A Ford, Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust; Mrs Sue Gallagher, Former Chief Executive, Merton, Sutton & Wandsworth Health Authority, London; Dr Trevor Gibbs, Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, Greenford; Mr John Goulston, Director of Finance, St Bartholoemew's Hospital & the London NHS Trust; Professor Philip Home, Professor of Diabetes Medicine, University of Newcastle upon Tyne; Dr Terry John, General Practitioner, The Firs, London; Dr Diane Ketley (term of office ended August 2002) Research into Practice Programme Leader, NHS Modernisation Agency, Leicester; Dr Mayur Lakhani (term of office ended August 2002) General Practitioner, Highgate Surgery, Leicester, & Lecturer, University of Leicester; Mr Muntzer Mughal, Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley; Mr James Partridge, Lay Representative, Chief Executive, Changing Faces, London; Professor Philip Routledge, Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff; Professor Andrew Stevens (Vice-Chair) Professor of Public Health, University of Birmingham; Dr Cathryn Thomas, General Practitioner, & Senior Lecturer, Department of Primary Care & General Practice, University of Birmingham; Dr David Winfield, Consultant Haematologist, Royal Hallamshire Hospital, Sheffield

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

This is the current release of the guideline.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.