Review of the Advanced Interventions Service National Services Division September 2011
- TABLE OF CONTENTS -
Table of contents TABLE OF CONTENTS ...... I TABLE OF TABLES ...... IV TABLE OF FIGURES ...... V NATIONAL SERVICES ADVISORY GROUP RESPONSE TO THE RECOMMENDATIONS OF THE REVIEW OF ADVANCED INTERVENTIONS SERVICE ...... VI EXECUTIVE SUMMARY ...... VI 1. INTRODUCTION ...... 3
1.1. BACKGROUND TO THE REVIEW ...... 3 1.2. REVIEW AIM AND OBJECTIVE...... 3 1.3. REVIEW METHODOLOGY ...... 3 1.3.1. Review approach ...... 3 1.3.2. Service user engagement approach ...... 4 1.3.3. High-level mapping of services for people with the conditions covered by the Advanced Interventions Service ...... 4 2. OVERVIEW OF CONDITIONS COVERED AND TREATMENTS OFFERED BY THE ADVANCED INTERVENTIONS SERVICE ...... 5
2.1. CONDITIONS COVERED BY THE SERVICE ...... 5 2.1.1. Treatment-refractory depression ...... 5 2.1.2. Obsessive Compulsive Disorder ...... 6 2.2. SURGICAL PROCEDURES PROVIDED BY THE SERVICE ...... 7 2.2.1. Anterior cingulotomy ...... 7 2.2.2. Vagus nerve stimulation ...... 8 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND ...... 9
3.1. BACKGROUND ...... 9 3.2. MENTAL HEALTH (CARE AND TREATMENT) (SCOTLAND) ACT 2003 REGULATORY FRAMEWORK ...... 10 3.2.1. Ablative neurosurgery ...... 10 3.2.2. Non-ablative procedures ...... 11 3.3. NATIONAL SERVICE DEFINITION ...... 11 3.3.1. Service objective ...... 11 3.3.2. Service specification ...... 11 3.4. SERVICE INCLUSION AND EXCLUSION CRITERIA FOR NEUROSURGICAL INTERVENTION ...... 12 3.5. SERVICE STAFFING PROFILE ...... 12 3.6. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND – CONCLUSIONS ...... 12 4. NATIONAL SERVICE ACTIVITY LEVELS ...... 14
4.1. ACTIVITY SINCE NATIONAL DESIGNATION ...... 14 4.2. AVERAGE ANNUAL ACTIVITY ...... 14 4.3. BREAKDOWN OF ANNUAL ACTIVITY SINCE NATIONAL DESIGNATION ...... 15 4.4. NHS BOARD OF REFERRAL ...... 16 4.5. CONVERSION RATE TO SURGERY ...... 17 4.6. ASSESSMENT PROCESS ...... 18 4.7. REFERRAL PATHWAYS BETWEEN NHS SCOTLAND AND THE REST OF THE UK ...... 19 4.8. NATIONAL SERVICE ACTIVITY LEVELS – CONCLUSIONS ...... 19 5. PATIENT ILLNESS CHARACTERISTICS ...... 20
5.1. DEPRESSION CHARACTERISTICS...... 20 5.1.1. Depression characteristics of service users proceeding to anterior cingulotomy ...... 20 5.1.2. Depression characteristics of service users proceeding to vagus nerve stimulation .... 21 5.2. ILLNESS CHARACTERISTICS OF PATIENTS WITH OCD ...... 22 5.3. PATIENT ILLNESS CHARACTERISTICS – CONCLUSIONS ...... 24
i - TABLE OF CONTENTS - 6. QUALITY OF THE NATIONAL SERVICE ...... 25
6.1. CLINICAL QUALITY - INTRODUCTION ...... 25 6.1.1. Rating scales adopted by the service...... 25 6.1.2. Depression ratings used for the purposes of the review ...... 25 6.1.3. OCD ratings used for the purposes of the review ...... 26 6.2. CLINICAL QUALITY – PATIENT OUTCOMES ...... 26 6.2.1. Anterior cingulotomy outcomes - Change in depressive symptoms/OCD symptoms at follow-up appointment after anterior cingulotomy procedure ...... 26 6.2.2. Vagus nerve stimulation outcomes ...... 29 6.2.3. Adverse effects of intervention ...... 30 6.2.4. Critical incidents ...... 31 6.3. NON-CLINICAL QUALITY ...... 31 6.3.1. Initiatives to support service development ...... 31 6.3.2. Patient feedback ...... 31 6.4. QUALITY OF THE NATIONAL SERVICE – CONCLUSIONS ...... 33 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE ...... 34
7.1. RESPONSE RATE AND DEMOGRAPHICS ...... 34 7.2. PERCEPTION OF NEUROSURGERY FOR MENTAL DISORDERS ...... 35 7.2.1. Diagnostic categories perceived to be appropriate for various neurosurgical treatments ...... 36 7.2.2. Respondent’s perception of number of patients in their clinical practice who might have been suitable for assessment for a neurosurgical intervention ...... 37 7.3. AWARENESS OF THE ADVANCED INTERVENTIONS SERVICE ...... 37 7.3.1. Perception of the Advanced Interventions Service ...... 37 7.3.2. Awareness of the Advanced Interventions Service ...... 38 7.3.3. Referrals into Advanced Interventions Service ...... 38 7.3.4. Reasons preventing referral into Advanced Interventions Service ...... 38 7.3.5. Referrals of patients with treatment-refractory depression/OCD to tertiary services . 39 7.3.6. Services expected from tertiary-level mood disorder and OCD services ...... 40 7.4. EXPERIENCE OF THE ADVANCED INTERVENTIONS SERVICE ...... 40 7.5. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE PSYCHIATRIC COMMUNITY, AND COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE – CONCLUSIONS ...... 41 8. HIGH-LEVEL MAPPING OF SERVICES FOR PEOPLE WITH THE CONDITIONS COVERED BY THE ADVANCED INTERVENTIONS SERVICE...... 42
8.1. INTRODUCTION ...... 42 8.2. FINDINGS AND CONCLUSIONS ...... 42 9. FINANCE ...... 43 10. CONCLUSIONS ...... 44
10.1. FIT AGAINST NATIONAL SERVICES ADVISORY GROUP CRITERIA ...... 44 10.2. PERFORMANCE OF THE SERVICE...... 44 A safe and effective service ...... 44 A person-centred service ...... 45 10.3. AREAS FOR FURTHER DEVELOPMENT ...... 45 10.3.1. Referral and conversion rates...... 45 10.3.2. Retention and development of existing links with referrers ...... 46 10.3.3. Benchmarking ...... 46 10.3.4. Non-surgical service activity ...... 46 10.3.5. Deep brain stimulation ...... 46 10.4. PROVISION OF TERTIARY LEVEL OCD SERVICES IN SCOTLAND ...... 46 10.5. PROVISION OF QUATERNARY PSYCHOPHARMACOLOGICAL AND PSYCHIATRIC OCD SERVICES ...... 47 11. RECOMMENDATIONS ...... 48
ii - TABLE OF CONTENTS -
11.1. CONTINUING FIT AGAINST NATIONAL SERVICES ADVISORY GROUP CRITERIA ...... 48 11.2. RECOMMENDATIONS FOR A PERSON-CENTRED SERVICE ...... 48 11.2.1. Assessment process ...... 48 11.2.2. Capturing service user feedback ...... 48 11.2.3. Access for patients from across UK ...... 48 11.3. RECOMMENDATIONS FOR A SAFE AND EFFECTIVE SERVICE ...... 48 11.3.1. Communication ...... 48 11.3.2. Benchmarking ...... 49 11.3.3. Non-surgical service activity ...... 49 11.3.4. Deep brain stimulation ...... 49 11.4. FUTURE ACTIVITY LEVELS AND FINANCE ...... 49 11.5. PROVISION OF TERTIARY LEVEL OCD SERVICES IN SCOTLAND ...... 50 11.6. PROVISION OF QUATERNARY PSYCHOPHARMACOLOGICAL AND PSYCHIATRIC SERVICES FOR OCD ...... 50 BIBLIOGRAPHY ...... 51 APPENDIX 1 – NATIONAL SERVICES ADVISORY GROUP CRITERIA ...... 54 APPENDIX 2 – REFERRAL CRITERIA FOR ABLATIVE NEUROSURGERY AND VAGUS NERVE STIMULATION ...... 55
CRITERIA FOR CONSIDERATION FOR ABLATIVE NEUROSURGERY ...... 55 Treatment-refractory depression ...... 55 Obsessive Compulsive Disorder ...... 56 CRITERIA FOR CONSIDERATION FOR VAGUS NERVE STIMULATION ...... 56 APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE ...... 58 APPENDIX 4 – DETAILED SERVICE OUTCOMES ...... 61
OUTCOMES AFTER ANTERIOR CINGULOTOMY ...... 61 Outcomes after first anterior cingulotomy ...... 61 Outcomes after second anterior cingulotomy ...... 62 OUTCOMES AFTER VAGUS NERVE STIMULATION ...... 62 APPENDIX 5 – HIGH-LEVEL MAPPING OF SCOTTISH SERVICES ...... 64
AGGREGATE DISCHARGES 2007/08-2009/10 ...... 64 MAIN TREATMENT UNITS OF DISCHARGE ...... 64 Aggregate discharge data ...... 64 Main discharge units for bipolar affective disorder, depressive episode, and recurrent depressive disorder ...... 65 Main discharge units for Obsessive-Compulsive Disorder ...... 66 DISCHARGES BY LENGTH OF STAY AND DIAGNOSIS ...... 66 APPENDIX 6 – REVIEW MEMBERSHIP ...... 68
REVIEW BOARD ...... 68 EXPERT ADVISORY GROUP ...... 68 REVIEW TEAM ...... 69
iii - TABLE OF TABLES -
Table of tables TABLE 1 SERVICE STAFFING PROFILE ...... 12 TABLE 2 SERVICE ACTIVITY SINCE NATIONAL DESIGNATION AGAINST COMMISSIONING ASSUMPTIONS ...... 14 TABLE 3 SERVICE ACTIVITY OVER 2007/08 – 2010/11 FINANCIAL YEARS AGAINST COMMISSIONING ASSUMPTIONS ...... 14 TABLE 4 NHS BOARD / NATION OF REFERRAL - APRIL 2006 - MARCH 2011 ...... 16 TABLE 5 NHS BOARDS WITHIN AND OUT WITH AVERAGE RATES OF REFERRAL INTO ADVANCED INTERVENTIONS SERVICE . 17 TABLE 6 CONVERSION RATE TO SURGERY BY NHS ORGANISATION OF RESIDENCE ...... 18 TABLE 7 ILLNESS CHARACTERISTICS OF PATIENTS WHO PROGRESSED TO ANTERIOR CINGULOTOMY ...... 20 TABLE 8 ADVANCED INTERVENTIONS SERVICE HRSD-17 AND MADRS SCORES AGAINST MÜLLER ET. AL (2003) DEFINITION OF ‘SEVERE’ DEPRESSION ...... 21 TABLE 9 ILLNESS CHARACTERISTICS OF PATIENTS WHO PROGRESSED TO VAGUS NERVE STIMULATION ...... 22 TABLE 10 ILLNESS CHARACTERISTICS AND ADEQUACY OF PREVIOUS TREATMENTS FOR PATIENTS WITH OCD ...... 22 TABLE 11 PALLANTI GRADES OF TREATMENT RESISTANCE OF ADVANCED INTERVENTIONS SERVICE PATIENTS ...... 23 TABLE 12 DESCRIPTORS USED FOR ANALYSIS OF RESULTS WITHIN REPORT ...... 25 TABLE 13 SERVICE PATIENT FEEDBACK SCORING METHOD ...... 31 TABLE 14 SPECIALITY OF SURVEY RESPONDENTS ...... 34 TABLE 15 NHS BOARD OF EMPLOYMENT OF RESPONDENTS ...... 35 TABLE 16 MEDICAL CAREER GRADE OF RESPONDENTS ...... 35 TABLE 17 RESPONDENTS' PERCEPTIONS OF NEUROSURGERY FOR MENTAL DISORDERS ...... 36 TABLE 18 GIVEN THE APPROPRIATE DEGREE OF CHRONICITY AND SEVERITY, WHICH OF THE FOLLOWING DIAGNOSTIC CATEGORIES DO YOU CONSIDER AN APPROPRIATE REFERRAL FOR THE FOLLOWING PROCEDURES - OTHER RESPONSES ...... 37 TABLE 19 ESTIMATED NUMBER OF PATIENTS IN RESPONDENT’S CLINICAL PRACTICE OVER PAST FIVE YEARS, WHO MIGHT HAVE BEEN SUITABLE FOR A NEUROSURGICAL INTERVENTION TO TREAT MENTAL DISORDER ...... 37 TABLE 20 RESPONDENT’S REFERRAL PRACTICE INTO ADVANCED INTERVENTIONS SERVICE ...... 38 TABLE 21 REASONS PREVENTING REFERRAL INTO ADVANCED INTERVENTIONS SERVICE ...... 38 TABLE 22 REASONS PREVENTING REFERRAL INTO ADVANCED INTERVENTIONS SERVICE FOR CONSULTANTS IN GENERAL ADULT PSYCHIATRY ...... 39 TABLE 23 REFERRAL PATHWAYS INTO TERTIARY SERVICES FOR TREATMENT-REFRACTORY DEPRESSION AND TREATMENT- REFRACTORY OCD ...... 39 TABLE 24 SERVICES EXPECTED FROM TERTIARY-LEVEL MOOD DISORDERS AND OCD SERVICES ...... 40 TABLE 25 ADVANCED INTERVENTIONS SERVICE BUDGET, INCOME AND EXPENDITURE ...... 43 TABLE 26 ANTERIOR CINGULOTOMY (ACING) OUTCOMES ...... 61 TABLE 27 SUMMARISED REPORTED OUTCOMES AT FOLLOW-UP AFTER FIRST ANTERIOR CINGULOTOMY PROCEDURE ...... 61 TABLE 28 SUMMARISED REPORTED OUTCOMES AT FOLLOW-UP AFTER SECOND ANTERIOR CINGULOTOMY PROCEDURE .... 62 TABLE 29 VAGUS NERVE STIMULATION OUTCOMES ...... 62 TABLE 30 SUMMARISED REPORTED OUTCOMES AT FOLLOW-UP AFTER IMPLANT OF VAGUS NERVE STIMULATOR ...... 63 TABLE 31 DISCHARGES OF BIPOLAR AFFECTIVE DISORDER, DEPRESSIVE EPISODE, AND RECURRENT DEPRESSIVE DISORDER COVERED BY ICD-10 ADVANCED INTERVENTIONS SERVICE INCLUSIONS, WITH OVER 100 DISCHARGES BETWEEN 2007/08-2009/10 ...... 66 TABLE 32 DISCHARGES OF OCD COVERED BY ICD-10 ADVANCED INTERVENTIONS SERVICE, WITH OVER 10 DISCHARGES BETWEEN 2007/08-2009/10 ...... 66 TABLE 33 BREAK DOWN OF DISCHARGES BY DIAGNOSIS OVER THE 2007-2010 FINANCIAL YEARS, BY DISORDER AND LENGTH OF STAY ...... 67
iv - TABLE OF FIGURES -
Table of figures FIGURE 1 'NORMALISED' T1 MRI SCAN SHOWING TARGETS FOR ANTERIOR CINGULOTOMY. THE BASE SCAN IS 'COLIN' FROM THE MONTREAL NEUROLOGICAL INSTITUTE (MNI) ...... 7 FIGURE 2 AVERAGE AND EXPECTED ANNUAL SERVICE ACTIVITY SINCE 2007/08 ...... 15 FIGURE 3 ANNUAL SERVICE ACTIVITY SINCE NATIONAL DESIGNATION ...... 15 FIGURE 4 NHS BOARD RATE OF REFERRAL INTO THE NATIONAL ADVANCED INTERVENTIONS SERVICE (PER 100,000) – APRIL 2006-MARCH 2011 ...... 17 FIGURE 5 REPORTED OUTCOMES AT FOLLOW-UP AFTER FIRST ANTERIOR CINGULOTOMY PROCEDURE ...... 26 FIGURE 6 FIRST ANTERIOR CINGULOTOMY: HRSD-17 AND MADRS REPORTED CHANGE AT 1, 2 AND 6 YEAR FOLLOW-UP (MINIMUM, MEAN AND MAXIMUM VALUES)...... 27 FIGURE 7 REPORTED OUTCOMES AT FOLLOW-UP AFTER SECOND ANTERIOR CINGULOTOMY PROCEDURE ...... 28 FIGURE 8 SECOND ANTERIOR CINGULOTOMY: HRSD-17 AND MADRS REPORTED CHANGE AT 1, 2 AND 5 YEAR FOLLOW- UP (MINIMUM, MEAN AND MAXIMUM VALUES) ...... 29 FIGURE 9 REPORTED OUTCOMES AT FOLLOW-UP AFTER VAGUS NERVE STIMULATION ...... 29 FIGURE 10 VAGUS NERVE STIMULATION: HRSD-17 AND MADRS REPORTED CHANGE AT 1, 2, 3, 5 AND 6 YEAR FOLLOW- UP (MINIMUM, MEAN AND MAXIMUM VALUES) ...... 30 FIGURE 11 CUMULATIVE RESULTS OF OUTPATIENT SATISFACTION QUESTIONNAIRE, 2008-2011 FINANCIAL YEARS (N=42) ...... 32 FIGURE 12 CUMULATIVE RESULTS OF INPATIENT SATISFACTION QUESTIONNAIRE, 2008-2011 FINANCIAL YEARS (N=17) . 33 FIGURE 13 RESPONDENT’S CHOICES AS APPROPRIATE CONDITIONS FOR REFERRAL FOR ANTERIOR CINGULOTOMY, VAGUS NERVE STIMULATION, DEEP BRAIN STIMULATION AND OTHER PROCEDURES...... 36 FIGURE 14 RESPONDENT’S EXPERIENCE OF ADVANCED INTERVENTIONS SERVICE ...... 40 FIGURE 15 NUMBER OF SCOTTISH DISCHARGES OVER 2007/08-2009/10 FINANCIAL YEARS FOR F31.4-.5, F32.2-.3, F33.1-.3, F42.0-.9...... 64 FIGURE 16 SCOTTISH UNITS DISCHARGING OVER 100 PATIENTS OVER 2007/08-2009/10 ...... 65
v - NATIONAL SERVICES ADVISORY GROUP’S RESPONSE TO THE RECOMMENDATIONS OF THE REVIEW ON ADVANCED INTERVENTIONS SERVICE - National Services Advisory Group’s Response to the Recommendations of the Review on Advanced Interventions Service
Area 062 National Services Division Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Telephone 0131 275 6575 Fax 0131 275 7614 www.nsd.scot.nhs.uk
The output from the Advanced Interventions Service (AIS) Review port was reported to the National Services Advisory Group (NSAG). This committee had oversight responsibility for all nationally designated services within NHS Scotland and commissioned by National Services Division. NSAG has since been replaced by the National Specialist Services Committee and National Patient, Public and Professional Reference Group, who oversee the designation and de-designation of national services in NHS Scotland.
The AIS Review recommendation were considered by NSAG at their meeting on 27 October 2011 and below is an extract from the Minutes summarising the outcome of their discussion, decision and recommendation.
[Extract commences: NSAG noted the clear professional support for continuing designation of this service and considered that designation should continue. A closer definition should be agreed with the service – specifically in relation to its role in assessment - and clear action should be taken to exclude secondary and tertiary consultations from the designated service. The service should work to develop a networked approach across Scotland with experts getting together, perhaps facilitated by the Royal College of Psychiatrists to ensure sharing of good practice and the strengthening of tertiary services across Scotland.
On VNS, NSAG considered that this was still an experimental procedure and that the clinical outcomes achieved did not justify its inclusion within the national service. The Group therefore agreed to recommend that the continuing designation should exclude VNS.
In relation to providing the expert inpatient service (for (OCD) patients) currently available only in London at Springfield Hospital, NSAG recommended that this should be incorporated within the designated service if there was the proven expertise to take this on within the current budget (understanding that residents from outside Scotland would be charged for this service). Extract concludes].
The NSAG decision to de-designate the VNS element from the nationally designated Advanced Interventions Service and establish an inpatient obsessive-compulsive disorder programme for Scottish residents (only available at Springfield Hospital) was ratified by NHS Scotland Board Chief Executives and Scottish Government Health and Social Care Directorate Policy Leads.
February 2013
National Services Division Gyle Square, 1 South Gyle Crescent, Edinburgh EH12 9EB Director Deirdre Evans
NHS National Services Scotland is the common name of the Common Services Agency for the Scottish Health Service.
vi
- EXECUTIVE SUMMARY -
Executive Summary In 1996, the Scottish Office Clinical Resource and Action Group (CRAG) Working Group on Mental Illness made a series of recommendations that laid the foundations for the development of the existing service providing neurosurgery for mental disorders in Ninewells Hospital. The group recognised the role of neurosurgery for some well defined types of mental disorder. Subsequently in 2000, a Royal College of Psychiatrists Neurosurgery for Mental Disorder report complimented a number of the CRAG findings, noting that “it would be unwise to allow neurosurgery for mental disorder to die out.” The foresight of the CRAG and Royal College reports has proved to have been invaluable, with the current review finding that the Advanced Interventions Service has provided a highly valuable service for people from across Scotland and the rest of the UK. The review recommends that the Advanced Interventions Service should continue to be nationally designated. The review recognises the high quality of the service provided and the clinically significant improvements in mental health experienced by people with highly chronic and severe depression following a neurosurgical intervention carried out by the service. This is against the context of having tried a significant number of other failed treatments for their chronic and severe depression and/or chronic and severe OCD. Patient feedback about the Advanced Interventions Service has been very positive, highlighting the positive person-focus of the service, the staff’s respectful approach to their patients, and the necessary mutual involvement in decision-making about their package of care. Clinical feedback on the Advanced Interventions Service has also been complimentary, with a high proportion of respondents to a review survey noting that their overall experience of the service was either ‘good’ or ‘very good.’ The review recommends that the service continues in its existing areas of good practice including its robust assessment process, in capturing patient feedback, in developing the evidence-base in partnership with the University of Dundee, and in undertaking vigorous audit. A number of recommendations were also made to bring about further improvement in the service. These recommendations will assist the service to improve communication with the clinical community to better manage and develop referrals from non-Scottish home nations, and to continue to benchmark across the UK. The review recognises that the majority of the service’s activity to date has been non- surgical, for instance; in providing comprehensive patient assessments, home visits, treatment recommendations, an educational programme, and clinical advice to other clinical teams. This activity is acknowledged as entirely appropriate, and the review recommends that the service should be better recognised for this work. It is recommended that the service specification is amended to take this into account, and that the service reports more fully on these processes in the future. Whilst out of scope of this review, the findings draw attention to a perceived inequity in provision of OCD services across NHS Scotland, which has an impact on the quality of referrals into the service, the ongoing management of the patient post-intervention, and a low conversion rate to surgery. It is recommended that in order to appropriately recognise and develop tertiary OCD services, a mapping of service-need and existing provision for people with OCD be undertaken by NHS Scotland or the Scottish Government. Furthermore, whilst Scottish residents with OCD who require access to quaternary level psychopharmalogical and psychiatric services currently have access to services in England, it
1 - EXECUTIVE SUMMARY - is apparent that there is the expertise to provide this level of service in NHS Scotland. The review therefore invites relevant services with appropriate expertise and capacity to apply to the National Services Advisory Group for national designation. If capacity can be developed to provide this level of specialised psychopharmacological, psychiatric and other treatments for OCD in Scotland, then NHS Scotland service providers should consider making an application to provide this level of service to the National Services Advisory Group. It is hoped that developing the Advanced Interventions Service in the areas recommended by the review, and addressing these structural issues, will support the continuing successful provision of a high-quality national service over the next five years.
2 - 1. INTRODUCTION -
1. Introduction
1.1. Background to the review National Services Division (NSD) is responsible for the commissioning and performance management of a number of national healthcare programmes which include specialist clinical services, screening programmes, and National Managed Clinical Networks on behalf of the Scottish Government and NHS Scotland. NSD undertakes routine reviews of all nationally commissioned programmes bi-annually in the form of mid-year and forward-planning meetings with the service clinical, managerial and finance staff. At these meetings, activity over the reporting period is discussed by NSD and the respective programme. Additionally, National Services Division conducts major reviews of all national programmes on a rolling basis. These major reviews facilitate a more thorough appraisal of any programme’s progress. As part of NSD’s commitment to review all national programmes in order to ensure that each programme is meeting its original designation objectives, ensuring clinical effectiveness and delivering value for money; it was agreed that the national Advanced Interventions Service should be reviewed between March and October 2011, to report to the National Services Advisory Group in October 2011. The Advanced Interventions Service (formerly Neurosurgery for Mental Disorders service) has been nationally designated since April 2006. The service is hosted by NHS Tayside and is provided by a specialist multidisciplinary team in Ninewells Hospital. The objective of the service is to provide a comprehensive service for severe and chronic treatment-refractory depression (TRD) and obsessive-compulsive disorder (OCD) to residents of Scotland. The national service provides: Ablative neurosurgery (most commonly, anterior cingulotomy) Vagus nerve stimulation (VNS) The Advanced Interventions Service also provides other specialised interventions out with the national service specification. This 2011 review is the first major policy review of the service since national designation.
1.2. Review aim and objective The review’s aim was to review the nationally-designated Advanced Interventions Service, and develop a review report with recommendations to ensure the future provision of a quality service1 to the National Services Advisory Group for their October 2011 meeting. The objective of this review was to review the service’s fit against the National Services Advisory Group designation criteria2.
1.3. Review methodology
1.3.1. Review approach The review was developed and produced by a part-time Review Manager with the support of a part time Review Support Officer. The Review Manager managed the review under the direction of the Review Executive.
1 In line with the Scottish Government’s ‘Healthcare Quality Strategy for NHS Scotland’ (2010) 2 The criteria for national designation are included in chapter 10.
3 - 1. INTRODUCTION - There were two phases to the review. In the first phase, a desktop review of the service was undertaken. This allowed for an examination of existing data and for the development of preliminary findings prior to the wider engagement with stakeholders in the second phase of the review. In the review’s second phase, a Review Board and Expert Advisory Group were established. The Review Board met three times in order to provide overall strategic direction to the review. The Expert Advisory Group met once to assess the evidence and inform the development of review recommendations. These recommendations were included within a report and distributed to both the Expert Advisory Group and the Review Board by email for further comment. The final review report was assured by the Senior Management Team within National Services Division prior to submission to the National Services Advisory Group, who consider the review recommendations in line with the criteria for national designation. This group provide advice to NHS Boards and the Scottish Government on the designation and configuration of national services.
1.3.2. Service user engagement approach Discussions were held separately with OCD Action, Action on Depression (formerly the Depression Alliance Scotland), the Review Board and the Advanced Interventions Service on the best approach to engage with current and former patients. Following a review of the existing feedback collected by the Advanced Interventions Service using outpatient and inpatient questionnaires, it was decided by the Review Board that the service provided extensive data which covered the areas that were likely to be explored by the review. It was agreed that voluntary sector representation would ensure that the interests of people with OCD and depression were represented throughout the review, with these organisations supporting the development of the review approach, and supporting the appraisal and development of the review report.
1.3.3. High-level mapping of services for people with the conditions covered by the Advanced Interventions Service In order to gain a better understanding of the numbers of patients with the conditions covered by the referral criteria (Appendix 2), and the provision of services for people with chronic depression and OCD, an information request was made to Information Services Division for SMR04 data (Mental Health and Day Case) on patients covered by the referral inclusions, and excluding referral inclusions. Data was broken down by NHS Board, treatment Unit and by duration of stay (i.e. under 1 year, 2 years, n years). This data includes data on patients with the following criteria: 1. Age > 20 years 2. The following ICD-10 criteria: a. F32.2 – F32.3 b. F33.1 – 33.3 c. F31.4 – F31.5 d. F42.0 – F42.9. The request excluded data on patients with the following ICD-10 criteria: F00 – F09, F10 – F19, F60 – F69, F84
4 - 2. OVERVIEW OF CONDITIONS COVERED AND TREATMENTS OFFERED BY THE ADVANCED INTERVENTIONS SERVICE -
2. Overview of conditions covered and treatments offered by the Advanced Interventions Service
2.1. Conditions covered by the service Further information on the chronicity, severity and treatment-resistance of the service’s cohort of patients is available in the illness characteristics chapter (Chapter 5).
2.1.1. Treatment-refractory depression Treatment-refractory depression, treatment-resistant depression and therapy-resistant depression are terms that have been used interchangeably to describe treatment-refractory depression. For the purposes of this review, the term treatment-refractory depression (TRD) will be used throughout. There is no single agreed definition of treatment-refractory depression. The World Psychiatric Association provided one of the earlier definitions of resistant depression in 1974, defining it as “an absence of clinical response to treatment with a tricyclic anti- depressant at a minimum dose of 150mg/ day of imipramine (or equivalent drug) for 4 to 6 weeks3.” This definition is not universally accepted and in a systematic review of randomised control trials on its somatic treatment, Berlim and Tureki noted that there were more than 10 disparate definitions found whilst searching the specialised literature. They noted that “these definitions range, for example, from a failure to respond to an adequate trial of a single antidepressant for a minimum of 4 weeks (Roose et al., 1986), to a failure of at least one trial of electroconvulsive therapy (ECT) (Fink, 1991).4” They noted that the majority (55.3%) of retrieved studies signified that “clinically significant treatment resistance is considered when an episode of major depression has not improved after at least two adequate trials of different classes of ADs [anti-depressants].” Berman et al. 5 note that “unlike other categorizations of depression, TRD [treatment- refractory depression] is made apparent by the treatment process itself, or, rather, the unsuccessfulness of that process.” They add that “it would be advisable to describe treatment refractory patients by the medications that did not yield remission and by the intensity of that treatment.” Stimpson et. al conducted a systematic review of 16 randomised controlled trials “that included adults 18-75 years with a diagnosis of unipolar depression that had not responded to a 4 week course of a recommended dose of an antidepressant.” In this review investigating pharmacological and psychological interventions for treatment refractory depression, they found that there is a lack of guidance on the management of treatment- refractory depression, and that this “lack of guidance is reflected by variation in the management of treatment refractory depression.6” The review concluded that as there is
3 World Psychiatric Association. Symposium on therapy resistant depression. Pharmacopsychiatry, 1974: 7:69-224 4 Berlim, M. T and Turecki, G. What is the meaning of treatment resistant/refractory major depression (TRD)? A systematic review of current randomized control trials. European Neuropsychopharmacology 2007 17:696-707 5 Berman R. M. et al. Treatment-refractory depression: definitions and characteristics. Depression and Anxiety 1997 5:154-164 6 Stimpson N. et. Al. Randomised controlled trials investigating pharmacological and psychological interventions for treatment refractory depression. Systematic review. British Journal of Psychiatry 2002:181 284-294
5 - 2. OVERVIEW OF CONDITIONS COVERED AND TREATMENTS OFFERED BY THE ADVANCED INTERVENTIONS SERVICE - little evidence to inform the management of patients using pharmacological or psychological interventions for treatment refractory depression. Berlim and Tureki’s systematic review also concludes that “many patients do not achieve a satisfactory improvement with adequate doses of ADs [anti-depressants] given for sufficient duration, and are eventually classified as presenting with TRD [treatment-refractory depression].7” The National Institute for Health and Clinical Excellence (NICE) no longer use the term ‘treatment-resistant depression’ and rather prefer “to approach the problem of inadequate response by considering sequenced treatment options rather than by a category of patient.8” NICE have indicated that “the term implies that there is a natural cut-off between people who respond to one or two antidepressants compared with those who do not, which is not supported by the evidence, and the term may be taken by both doctors and patients as a pejorative label.” The term does not take into account different degrees of improvement or stages of illness, psychotherapeutic treatment (and non-antidepressant augmenting agents are not easily incorporated), and whether psychosocial factors may be preventing recovery.
2.1.2. Obsessive Compulsive Disorder Leckman et al. 9 note that a diverse range of symptoms are used to define obsessive compulsive disorder, with symptoms which include: aggressive obsessions, contamination obsessions, sexual obsessions, hoarding obsessions, religious obsessions, obsessions of symmetry, somatic obsessions, cleaning compulsions, checking compulsions, repeating rituals, counting compulsions, ordering and arranging, and hoarding and collecting. As noted in appendix 3, the World Health Organization state that for obsessive compulsive disorder10: “The essential feature is recurrent obsessional thoughts or compulsive acts. Obsessional thoughts are ideas, images, or impulses that enter the patient's mind again and again in a stereotyped form. They are almost invariably distressing and the patient often tries, unsuccessfully, to resist them. They are, however, recognized as his or her own thoughts, even though they are involuntary and often repugnant. Compulsive acts or rituals are stereotyped behaviours that are repeated again and again. They are not inherently enjoyable, nor do they result in the completion of inherently useful tasks. Their function is to prevent some objectively unlikely event, often involving harm to or caused by the patient, which he or she fears might otherwise occur. Usually, this behaviour is recognized by the patient as pointless or ineffectual and repeated attempts are made to resist. Anxiety is almost invariably present. If compulsive acts are resisted the anxiety gets worse.”
7 Berlim, M. T and Turecki, G. What is the meaning of treatment resistant/refractory major depression (TRD)? A systematic review of current randomized control trials. European Neuropsychopharmacology 2007 17:696-707 8 National Collaborating Centre for Mental Health. Depression: The NICE guideline on the treatment and management of depression in adults (Updated Edition). The British Psychological Society and the Royal College of Psychiatrists on behalf of the National Institute for Health and Clinical Excellence 2010 9 Leckman, J. F. et al. Symptoms of Obsessive-Compulsive Disorder. American Journal of Psychiatry, 1997 154:7 10 World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th revision. Version for 2007. Available from: http://apps.who.int/classifications/apps/icd/icd10online/ [last accessed 26.04.2011]
6 - 2. OVERVIEW OF CONDITIONS COVERED AND TREATMENTS OFFERED BY THE ADVANCED INTERVENTIONS SERVICE - In 2001, Fireman et al. reported on a large study in Northern California on the prevalence of Obsessive Compulsive Disorder11. The study recognised that 75% of patients with Obsessive Compulsive Disorder in its study population had a psychiatric comorbidity. The most common psychiatric comorbidity was major depression, experienced by 56% of people with Obsessive Compulsive Disorder. Christmas et al. note12 that “The pathophysiology of obsessive–compulsive disorder is thought to involve dysfunction of frontostriatal–pallidal–thalamic circuits within the brain. Similar circuits are also implicated in the pathology of depression. Neuropsychological studies have demonstrated abnormalities of the orbitofrontal cortex and anterior cingulate regions, a hypothesis supported by neuroimaging studies.”
2.2. Surgical procedures provided by the service The surgical procedures provided by the service are listed below. The service also provides a non-surgical detailed assessment and review element to the service which is briefly summarised in section 3.2.
2.2.1. Anterior cingulotomy Anterior cingulotomy involves making bilateral thermal lesions of the anterior cingulate gyri under a general anaesthetic. A stereotactic frame ring is fixed to the skull before a volumetric CT and MRI scan is performed. This permits the accuracy of targeting for cingulotomy.
Figure 1 'Normalised' T1 MRI Scan showing targets for anterior cingulotomy. The base scan is 'Colin' from the Montreal Neurological Institute (MNI)13 Christmas et al. report14 that “the targets for cingulotomy are the supracallosal fibres of the cingulum bundle (part of the Papez circuit) as it travels through the anterior cingulate gyrus. The lesion procedure also results in damage to a localised area of anterior cingulate cortex.” The Advanced Interventions Service reports15 that “Two small incisions are made 2.5cm from the midline and just anterior to the coronal suture. A six-millimetre tip radiofrequency lesion
11 Fireman, B. et al. The Prevalence of Clinically Recognized Obsessive-Compulsive Disorder in a Large Health Maintenance Organization. American Journal of Psychiatry 2001 158: 1904-1910 12 Christmas, D. et al. Neurosurgery for mental disorder. Adv. Psychiatr. Treat. 2004 10: 189-199 13 Advanced Interventions Service. Dundee Advanced Interventions Service: Anterior Cingulotomy. NHS Tayside. Available from: http://www.advancedinterventions.org.uk/treatments_ACING.htm [last accessed 27.05.2011] 14 Christmas, D. et al. Neurosurgery for mental disorder. Adv. Psychiatr. Treat. 2004 10: 189-199 15 NHS Tayside. Dundee Advanced Interventions Service. Anterior Cingulotomy. Available from: http://www.advancedinterventions.org.uk/treatments_ACING.htm [last accessed 19/04/2011]
7 - 2. OVERVIEW OF CONDITIONS COVERED AND TREATMENTS OFFERED BY THE ADVANCED INTERVENTIONS SERVICE - generator probe is then inserted to the previously-located target and the lesion is created by heating the probe to 70° Celsius for 90 seconds. The targets are 7 mm lateral to midline, 20 mm posterior to anterior portion of frontal horn, and 1 mm above the roof of the lateral ventricles. The intended lesion has a diameter of 8- 9mm.” 2.2.2. Vagus nerve stimulation In 2005, the United States Food and Drug Administration approved the use of the ‘Vagus Nerve Stimulation Therapy System’ for the adjunctive long-term treatment to medications and ECT for chronic or recurrent depression in people aged 18 years and over residing in the United States of America16. Vagus nerve stimulation is an approved treatment for refractory epilepsy, which involves intermittent electrical stimulation of afferent fibres within the vagus nerve. A pulse generator is implanted into the left anterior chest wall under a general or local anaesthetic, and bipolar electrodes are implanted subcutaneously to extend from the generator to the left cervical vagus nerve in the neck. The vagus nerve is stimulated periodically, and the frequency and intensity of stimulation can be regulated by an external control. The National Institute for Health and Clinical Excellence (NICE) indicate that “The aim of VNS for treatment-resistant depression is to improve mood regulation and reduce depression by stimulating the vagus nerve.17” Unlike ablative neurosurgery including anterior cingulotomy, the patient can inhibit vagus nerve stimulation by switching it off, and the device can be removed. Vagus nerve stimulation has been provided as a treatment by the national service since 2008, with the clinical support of the former Royal College of Psychiatrist Scottish division (now Royal College of Psychiatrists in Scotland) and the Mental Welfare Commission. The Advanced Interventions Service was (and is) regarded as a centre of excellence with the required special arrangements for robust governance, and with strong links to research. It must be noted that in 2009, NICE encouraged further research into VNS for treatment- refractory depression, noting that “Current evidence on the safety and efficacy of vagus nerve stimulation (VNS) for treatment-resistant depression is inadequate in quantity and quality. Therefore this procedure should be used only with special arrangements for clinical governance, consent and audit or research.18” Including vagus nerve stimulation as part of the national service has supported the development of the evidence base for future appraisals of VNS in the future.
16 U.S. Food and Drug Administration. Recently Approved Devices > VNS Therapy System - P970003s050. Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances /Recently-ApprovedDevices/ucm078532.htm [last accessed 29.06.2011] 17 NHS National Institute for Health and Clinical Excellence. Interventional procedure guidance 330. Vagus nerve stimulation for treatment-resistant depression. Available from: http://www.nice.org.uk/nicemedia/live/12149/46667/46667.pdf [last accessed 19.04.2011] 18 ibid
8 - 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND -
3. Current national service for residents of Scotland
3.1. Background The Royal College of Psychiatrists define Neurosurgery for Mental Disorder as: “a surgical procedure for the destruction of brain tissue for the purposes of alleviating specific mental disorders carried out by a stereotactic or other method capable making an accurate placement of the lesion.19” The Neurosurgery for Mental Disorders service was established in 1992 and was provided in Ninewells Hospital and Dundee Royal Infirmary by NHS Tayside and the University of Dundee. In 1996, the Scottish Office Clinical Resource and Action Group (CRAG) Working Group on Mental Illness reported on a comprehensive review of neurosurgery for mental disorder20. The review examined the historical context, the safety and efficacy of neurosurgery for mental disorder, safeguards for patients and the configuration of services. The review concluded that “there is still a role for neurosurgery for some well defined types of mental disorder” and made a series of recommendations including that: “A national centre be identified and supported.” The report recommended that the Ninewells service be the national centre. “That clear operational protocols should govern the whole process.” The report also recommended that a Standing Advisory Committee be established to support the governance of the service. “That a change in the law should be effected so that informal patients are covered by the safeguards already provided by the Mental Health (Scotland) Act 1984 for formal patients” It was noted that these changes should support the collection of prospective audit data on the specificity and effectiveness of neurosurgery for mental disorder. Following the closure of services at the Brook Hospital, Birmingham and Leeds, it became apparent that there were sustainability issues for neurosurgery for mental disorder services. This left only the Dundee service, and services at Frenchay Hospital, Bristol and the University Hospital of Wales in Cardiff available within the UK. Consequently, the Royal College of Psychiatrists established a Neurosurgery Working Group on Neurosurgery for Mental Disorder21. In 2000, the group reported that given the evidence reviewed by the group “it would be unwise to allow neurosurgery for mental disorder to die out22”. The report made a suite of recommendations to ensure the sustainability of services, the development of UK-wide audit and research, and the development of a National (UK) Advisory Committee to oversee developments, audit and research in neurosurgery for mental disorder. A Scottish Office Standing Advisory Committee was established to provide an overview of the Dundee service in 2001. Following two applications for national (Scottish) designation,
19 Royal College of Psychiatrists. ‘Neurosurgery for Mental Disorder. Report from the Neurosurgery Working Group of the Royal College of Psychiatrists,’ (2000), p11. 20 Scottish Office. ‘Neurosurgery for Mental Disorder. A report by a good practice group of the CRAG Working Group on Mental Illness (1996). 21 Royal College of Psychiatrists. ‘Neurosurgery for Mental Disorder. Report from the Neurosurgery Working Group of the Royal College of Psychiatrists,’ (2000) 22 ibid, p5.
9 - 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND - the Neurosurgery for Mental Disorders service has been commissioned by National Services Division since the 1st April 2006. At the transition of commissioning from the Standing Advisory Committee to National Services Division, the Standing Advisory Committee was satisfied that National Services Division “has its own overview arrangements that mirror many aspects of the role of the SAC.23” National Services Division has continued to work to oversee the safety and effectiveness of the service, and to sustain its development. National designation has supported the sustainability of the service and the further expansion of the evidence base for neurosurgery for mental disorders. At designation in 2006, the national service provided assessments and anterior cingulotomy for chronic and severe treatment-refractory Obsessive Compulsive Disorder and depression. In 2008, the service designation extended to include vagus nerve stimulation as a non-ablative procedure. Since national designation, the service has worked to extensively capture data on patient illness characteristics and outcomes. The service has reported these transparently in its annual reports which are available on its website, and in a number of peer-reviewed journals.
3.2. Mental Health (Care and Treatment) (Scotland) Act 2003 regulatory framework All patients assessed and in receipt of ablative and non-ablative procedures are covered by the Mental Health (Care & Treatment) (Scotland) Act 200324.
3.2.1. Ablative neurosurgery Section 234 of the Act puts into place legal safeguards for ablative neurosurgery, noting that treatment may be given to a patient only in accordance with section 235 or 236 of this Act. Section 235 sets out two requirements for patients who are able to consent to treatment. The first is that “a designated medical practitioner who is not the patient’s responsible medical officer certifies in writing that: the patient is capable of consenting to the treatment; the patient consents in writing to the treatment; and having regard to the likelihood of its alleviating, or preventing a deterioration in, the patient’s condition, it is in the patient’s best interests that the treatment should be given to the patient. The second requirement is that “two other persons (not being medical practitioners) appointed by the Commission for the purposes of this subsection certify in writing that the patient is capable of consenting to the treatment; and the patient consents in writing to the treatment.” Should this Mental Welfare Commission for Scotland panel deem that the patient can consent and that neurosurgical treatment is appropriate, they issue a form T1 (Safeguards for treatment by certain surgical operations).
23 Standing Advisory Committee on Neurosurgery for Mental Disorder Services in Scotland. ‘Report of the visit to the Dundee Advanced Interventions (AI)/NMD service. Tuesday 20 June 2006.’ 2006. Available from http://www.advancedinterventions.org.uk/library_NMD_reports.htm [last accessed 12.04.2011] 24 Mental Health (Care and Treatment) (Scotland) Act 2003. Available from: http://www.legislation.gov.uk/asp/2003/13/pdfs/asp_20030013_en.pdf [last accessed 29.06.2011]
10 - 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND - Section 236 of the Act sets out the requirements for patients who incapable of consenting, however, the Advanced Interventions Service does not provide neurosurgery to people who either can not, or do not consent to the procedure.
3.2.2. Non-ablative procedures Section 237 of the Act considers other medical treatments including vagus nerve stimulation. In the instance of non-ablative procedures, there is no requirement for the involvement of the Mental Welfare Commission for Scotland.
3.3. National service definition The definition below is an abridged excerpt of the current service agreement between National Services Division and NHS Tayside outlining the definition of the national service.
3.3.1. Service objective To provide a comprehensive service for severe and chronic treatment-refractory depression (TRD) and obsessive-compulsive disorder (OCD) to residents of Scotland, including: Ablative neurosurgery (most commonly, anterior cingulotomy) Vagus nerve stimulation (VNS)
3.3.2. Service specification The entry point for this service is: acceptance into the programme for assessment The exit point is: discharge to local clinical teams after follow-up The service covers the assessment and treatment for severe and chronic treatment- refractory depression (TRD) and obsessive-compulsive disorder (OCD) including: comprehensive review of patient casenotes diagnostic psychiatric assessments psychological review advice to patients on future management strategies ongoing treatment recommendations to referring Consultant Psychiatrists vagus nerve stimulation ablative neurosurgery All patients proceeding to ablative neurosurgery will be authorised by the Mental Welfare Commission (MWC) for Scotland in order to safeguard the individual’s capacity to consent as detailed in the Mental Health (Care and Treatment) (Scotland) Act 2003. Links with GPs and/ or the referring clinical team will be maintained to monitor the patients' progress prior to surgery, and to collaborate in post-surgery clinical management. The service will ensure that effective discharge planning arrangements are in place for patients undergoing neurosurgery. Shared care agreements must be in place with referring clinicians and GPs for the long term care of the patient. Communication with GPs and referring clinicians must be continuous and contact maintained. All patients proceeding to an Advanced Intervention (NMD) will be subject to comprehensive clinical review at 12, 24 and 60 months post-surgery.
11 - 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND - 3.4. Service inclusion and exclusion criteria for neurosurgical intervention The service has developed robust referral criteria designed to ensure that neurosurgery for mental disorder is an option for the small number of patients with severe and chronic treatment-refractory depression and obsessive compulsive disorder. These referral criteria are included in Appendix 2. ICD-10 definitions of these codes are included in Appendix 3.
3.5. Service staffing profile The service is made up of an expert multi-disciplinary team. The service is funded by contributions from both National Services Division, and the University of Dundee. The service’s staffing profile is included in the table below.
Staff member Whole Time Equivalent / Sessional input Consultant Psychiatrist 1.0 Neuropsychologist 30 sessions Psychotherapist 0.1 Mental Health Nurse Consultant 1.0 Senior Mental Health Nurse 2.5 Administrator 1.0 Receptionist 0.5
TOTAL NHS FUNDED STAFF 6.1 Consultant Psychiatrist 1.2 Clinical Psychologist 0.4
TOTAL UNIVERSITY FUNDED STAFF 1.6
TOTAL STAFF 7.7 Table 1 Service staffing profile
3.6. Current national service for residents of Scotland – conclusions In 1996, it was recognised that a national centre providing neurosurgery for some well- defined mental disorders is identified and supported by the Scottish Office Clinical Resource and Action Group (CRAG) Working Group on Mental Illness. In 2000 the Royal College of Psychiatrists Neurosurgery Working Group on Neurosurgery for Mental Disorder recommended that services providing neurosurgery for mental disorder should be sustained within a clear governance framework. The Advanced Interventions Service offering neurosurgery for mental disorder works within the governance frameworks of NHS Tayside, National Services Division and the Mental Welfare Commission, which include legal safeguards for those proceeding to ablative neurosurgery. The Advanced Interventions Service reports transparently and comprehensively to these organisations and members of the public by their website. The service has robust inclusion and exclusion criteria for referral and maintains close links with clinicians referring into the service.
12 - 3. CURRENT NATIONAL SERVICE FOR RESIDENTS OF SCOTLAND - The service is staffed by a small multi-disciplinary team, and receives the input of staff from the University of Dundee. This supports research and development, which benefits the ongoing development of the national service.
13 - 4. NATIONAL SERVICE ACTIVITY LEVELS -
4. National service activity levels
4.1. Activity since national designation The table below details activity since national designation against the expected activity levels set out in the service agreement.
Description Total Variance Assessments 160 +40 Service agreement assessments 120 Vagus nerve stimulation 7 -28 Service agreement vagus nerve stimulation 35 Anterior cingulotomy 16 -9 Service agreement anterior cingulotomy 25 Follow-up 54 -6 Service agreement follow-up 60 Table 2 Service activity since national designation against commissioning assumptions Despite having been designated as a national service in April 2006, due to the initial constraints of employing staff, the service only had adequate capacity to meet demand from April 2007. Therefore, in order to allow for the assessment of future commissioning assumptions, the table below compares average annual activity between April 2007 and March 2011.
Description Total Variance Assessments 116 +20 Service agreement assessments 96 Vagus nerve stimulation 7 -21 Service agreement vagus nerve stimulation 28 Anterior cingulotomy 12 -8 Service agreement anterior cingulotomy 20 Follow-up 43 -5 Service agreement follow-up 48 Table 3 Service activity over 2007/08 – 2010/11 financial years against commissioning assumptions
4.2. Average annual activity The chart below demonstrates the service’s average annual activity against the levels in the service level agreement for the financial years 2007-10. The error bars are used to indicate the range of activity levels provided by the service.
14 - 4. NATIONAL SERVICE ACTIVITY LEVELS -
Average annual service activity against anticipated activity (2007/08 - 2010/11)
40
35
30 29.3
25 24.0
20
15
12.0 10.8 10
7.0 5 5.0 3.0 1.8 0 Assessments Vagus Nerve Stimulation Anterior Cingulotomy Follow-up Intervention
Average annual activity Service agreement annual activity Figure 2 Average and expected annual service activity since 2007/08 It is clear that the average number of actual assessments far exceeds the expected levels as set out in the service agreement. On the other hand, Vagus Nerve Simulation implant activity and anterior cingulotomy activity are on average both below the forecast agreed activity levels, at an average of 1.8 (min. 1, max. 4) and 3.0 (min. 1, max. 6) procedures per annum respectively.
4.3. Breakdown of annual activity since national designation The chart below details annual activity since national designation. It should be noted that the reason for second and third anterior cingulotomy procedures is non-response to the preceding intervention.
Service activity since national designation 50
45 43
40
35 35
30 29 27 26 25
20
15 11 11 11 11 10 10
5 4 4 2 2 2 2 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 2006-07 2007-08 2008-09 2009-10 2010-11 Financial year Assessments Vagus Nerve Stimulation - As first procedure Anterior Cingulotomy - As first procedure Anterior Cingulotomy - As second procedure Anterior Cingulotomy - As third procedure Follow-up Figure 3 Annual service activity since national designation
15 - 4. NATIONAL SERVICE ACTIVITY LEVELS - 4.4. NHS Board of referral The table below provides the aggregated referral data since national designation in April 2006 to March 2011. Due to the small numbers for some Boards this has been presented in Regions
NHS Board of referral Number of referrals North of Scotland 27 South East & Tayside 114 West of Scotland 28
Total NHS Scotland 169 England 19 Northern Ireland 4 Out with United Kingdom 1
Total 193 Table 4 NHS Board / nation of referral - April 2006 - March 2011 The following chart draws on the aggregate service data presented above for patients in 2006/07 – 2010/11 financial years. This chart has been constructed showing 95% upper and lower confidence intervals indicating the level of chance variation around the rates for each NHS Board. The rates were derived from June 2008 NHS board populations from the General Register Office for Scotland adult population (16 years and older) and assume a Poisson distribution for the numbers. If the NHS Board is contained within the upper and lower limits of the confidence intervals, then the NHS Board does not have a significantly higher or lower rate than the Scottish average. The ‘Scotland average’ over the four financial years (4.03 referrals per 100,000) is shown as a horizontal line. This ‘Scotland average’ is based upon the aggregate service activity data noted above. Per annum, the ‘Scotland average’ equates to 1.01 referrals per 100,000 of the adult population. It must be noted that the outlier NHS Boards with both significantly lower and higher than average rates of referral impact on this average rate of referral.
16 - 4. NATIONAL SERVICE ACTIVITY LEVELS -
Figure 4 NHS Board rate of referral into the national Advanced Interventions Service (per 100,000) – April 2006-March 2011 The table below groups NHS Boards according to whether they fall within or out with the average rate of referral. Significantly lower than average rates of referral Average rate of referral Significantly higher than average rates of referral NHS Ayrshire and Arran NHS Borders NHS Tayside (host Board of service) NHS Greater Glasgow and Clyde NHS Dumfries and Galloway NHS Fife NHS Lanarkshire NHS Forth Valley NHS Lothian NHS Grampian NHS Highland NHS Orkney NHS Shetland NHS Western Isles Table 5 NHS Boards within and out with average rates of referral into Advanced Interventions Service
4.5. Conversion rate to surgery The table below used aggregate data compiled since national designation to demonstrate the range in conversion rates to surgery from referral between NHS Boards / NHS Organisations of residence. Due to the small numbers for individual NHS Boards, the Scottish data has been aggregated into Regional data.
Referral NHS Board / NHS Organisation Total referrals conversion rate to Total procedures surgery Out with UK 1 100% 1
NHS England organisations 19 42% 8 Northern Ireland Health and Social 4 25% 1 Care
North of Scotland 27 15% 4
17 - 4. NATIONAL SERVICE ACTIVITY LEVELS -
Referral NHS Board / NHS Organisation Total referrals conversion rate to Total procedures surgery South East & Tayside 114 4% 5 West of Scotland 28 4% 1 UK average 10% 193 Scottish average 20 Total 6% Table 6 Conversion rate to surgery by NHS Organisation of residence It is clear that the relatively low number of referrals and procedures per NHS Board will have an effect on the conversion rate to surgery. Overall, the average conversion rate from referral to surgery is 10%. However, the Scottish average conversion rate from referral to surgery is low at 6%. The service will need to continue to work with referrers to facilitate appropriate referrals with a view to improving the conversion rate to surgery. Whilst it is noted in section 4.4 that NHS Fife has a higher than expected average referral rate into the service, the conversion rate from referral to surgery of NHS Fife is above the current Scottish average, and in line with NHS Greater Glasgow and Clyde and NHS Lothian, which are two Boards noted as having lower than expected rates of referral into the service. Of note is the low conversion rate to surgery from the NHS Board of the provider, NHS Tayside, when taking into account the relatively high number of referrals. It is likely that the service is reporting on some local referral activity within the national referral data, and whilst this activity is likely to be appropriate within a local or regional context, it should be accounted for separately and extracted from the national service referral rate.
4.6. Assessment process As indicated in the sections above, the majority of patients referred to the service do not proceed to neurosurgery. The vast majority of the activity within the service focuses on undertaking comprehensive assessments and developing detailed treatment recommendations for patients and referring clinical teams. This comprises of multidisciplinary reviews of relevant clinical casenotes detailing previous treatments, undertaking extensive diagnostic psychiatric assessments (if necessary, within the patient’s home), and reviewing the previous psychological therapies received by the patient. Following these assessments, the Advanced Interventions Service provides each patient and referrer with a detailed clinical report on diagnosis, and advice on future management strategies. This will usually include specialist advice on the provision of advice of evidence- based pharmacological and psychological therapies. For a small number of patients eligible for surgery, the treatment recommendations may include neurosurgical interventions. This is first fed back to patients verbally, and then to patients and referrers by detailed clinical report. Despite this essential element of the service comprising the majority of the service’s workload, the Commissioner’s reporting requirements have historically focussed on the surgical element of the service. In the future, National Services Division should work with the service to also ensure that the fuller patient pathway within the service is detailed within future service reports.
18 - 4. NATIONAL SERVICE ACTIVITY LEVELS - 4.7. Referral pathways between NHS Scotland and the rest of the UK National Services Division supports the referral of patients to other specialised services in England when advised by the Advanced Interventions Service, through a risk sharing arrangement which facilitates access to specialised services in England and Wales. The Advanced Interventions Service is one of very few specialised services across the UK for patients with treatment-refractory chronic and severe Obsessive Compulsive Disorder and depression. The service is accessible to residents of the non-Scottish home nations whose referring organisation is charged on a cost per case basis by NHS Tayside. If access to the service was promoted to UK residents, it would be expected that as these referrals from out with Scotland would come from specialist tertiary services, there would be a higher average conversion rate from referral to surgery than the current Scottish rates. At full demand, this could far outstrip the service’s capacity. Should it be agreed that the service should actively promote referrals from NHS England, this would need to be undertaken in a planned and stepped manner.
4.8. National service activity levels – conclusions The average annual service activity has not met with the planning assumptions set at national designation. The service on average, annually assesses five more patients, and undertakes less vagus nerve stimulation and anterior cingulotomy procedures than originally forecast. The host NHS Board, NHS Tayside, and NHS Fife have significantly higher rates of referral into the service than the Scottish average. NHS Ayrshire and Arran, NHS Greater Glasgow and Clyde, NHS Lanarkshire and NHS Lothian all have significantly lower rates of referral than the Scottish average. Data on the NHS Board of referral and the patient conversion rate to surgery indicates that there is a low conversion rate to surgery, with a Scottish 6% average conversion rate, and rates ranging from 0% to 24% for patients referred from Scottish NHS Boards. The service will need to work with referrers to support an increase in this conversion rate. Of note is the low conversion rate to surgery from the NHS Board of the provider, NHS Tayside, when taking into account the high number of referrals from this Board, relative to other Scottish NHS Boards. It is likely that the service is reporting on some local referral activity within the national referral data, and whilst this activity is likely to be appropriate within a local or regional context, it should be extracted from the national service referral rate. The majority of patients referred to the service appropriately do not proceed to neurosurgery, and the vast majority of the activity within the service focuses on undertaking comprehensive assessments and developing detailed treatment recommendations for patients and referring clinical teams. Despite this essential element of the service comprising the majority of the service’s workload, the Commissioner’s reporting requirements have historically focussed on the surgical element of the service. In the future, National Services Division should work with the service to also ensure that the fuller patient pathway within the service is detailed within future service reports. The Advanced Interventions Service is recognised as a UK centre of excellence. If access to the service were fully open and promoted to UK residents, it would be expected that there would be a higher average conversion rate from referral to surgery than the current Scottish rates. At full demand, this could far outstrip the service’s capacity. Should it be agreed that the service should actively promote referrals from NHS England and Wales, this would need to be undertaken in a planned and stepped manner.
19 - 5. PATIENT ILLNESS CHARACTERISTICS -
5. Patient illness characteristics
5.1. Depression characteristics Service outcomes need to be considered against the context of studies into treatment- refractory depression (TRD) within the literature. In a systematic review of medium to long- term outcome studies, Fekadu et al. note that25: “TRD is highly relapsing condition with a tendency for chronicity; TRD is associated with disability and mortality; Residual symptoms are important and lead to high relapse in the short term and persistence of symptoms and disability in the longer term.” The service notes that its patient cohort has, on the whole, amongst the highest-reported levels of chronicity, disability and treatment-resistance in the world. This may impact upon the efficacy of treatment and the evaluation of patient outcomes during follow-up. There are a number of possible explanations for these higher-reported levels of chronicity, disability and treatment-resistance, including that: The Advanced Interventions Service notes that research studies demonstrate that the UK consistently report on having patients with more severe depression and OCD than in most parts of the United States of America. In line with Scottish governance arrangements, the Advanced Interventions Service is comprehensive in its reporting, and is likely to record and report data more thoroughly than a number of comparative services internationally. There may be a lower threshold for access into alternative similar services in private healthcare systems.
5.1.1. Depression characteristics of service users proceeding to anterior cingulotomy The table below highlights the illness characteristics of people who progress to anterior cingulotomy. It is clear that the service users have high-levels of chronicity, with the mean duration of their current Major Depressive Episode having lasted being 14 years. Patients using the service have, on average, also had a large number of hospital admissions. On average, patients have spent two years in a hospital by the time of their neurosurgical intervention.
Parameter Mean ± SD Median Range Age of onset of current Major Depressive Episode 35.6 ± 8.4 35.6 22.5 – 48.7 (MDE) (years) Duration of current MDE (years) 14.0 ± 6.0 12.1 8.4 – 29.3 Number of episodes (including current one) 1.8 ± 1.2 1.0 1 – 6 Number of hospital admissions 5.9 ± 4.2 4.2 0 – 15 Total duration of hospital admissions (weeks) 106.0 ± 89.6 97.9 0 – 374.3 Table 7 Illness characteristics of patients who progressed to anterior cingulotomy
25 Fekadu, A et al. What happens to patients with treatment-resistant depression? A systematic review of medium to long term outcome studies. Journal of Affective Disorders 116 (2009) 4-11
20 - 5. PATIENT ILLNESS CHARACTERISTICS - The table below provides the AIS mean and standard deviation HRSD-17 and MADRS scores against the definition of severe depression noted by Müller et. al.26. It is clear that the patients assessed by the Advanced Interventions Service have severe depression.
Mean (±SD) baseline HRSD-17 MADRS AIS 28.3 ± 5.3 40.6 ± 6.9 Müller et al. ‘Severe’ definition 28.9 ± 5.8 37.7 ± 4.4 Table 8 Advanced Interventions Service HRSD-17 and MADRS scores against Müller et. al (2003) definition of ‘severe’ depression
5.1.2. Depression characteristics of service users proceeding to vagus nerve stimulation The table below highlights the illness characteristics of Advanced Interventions Service users who progress to vagus nerve stimulation against major US (D-0227,28,29) and European-based (D-0330,31,32) studies supported by the vagus nerve stimulator manufacturer.
Parameter D-02 (US-based D-03 (European- Advanced studies) (n=205) based studies) Interventions (n=74) Service (n=16) Age in years (mean ± SD) 46.3 ± 8.9 47.4 ± 11.7 46.0 ± 9.9 Gender (F:M) 1.8:1 2.0:1 1.7:1 Diagnosis Unipolar 90.20% 73% 100% Bipolar 9.80% 27% 0% Length of Current MDE (months) 49.9 ± 52.1 41.5 ± 75.0 146.2 ± 67.8 Participants Having Chronic 68% 52.70% 100% (≥ 2 years) current MDE No. of Failed Adequate Trials in current MDE 3.5 ± 1.3 3.5 ± 1.3 9.1 ± 3.8 as defined by the ATHF Received ECT, Lifetime 53% 50% 87.50% No. of Lifetime Episodes of 0–2 24% 23% 93.80% Depression 3–5 34% 27% 6.30% 6–10 27% 25.70% 0%
26 Müller et. al. Differentiating moderate and severe depression using the Montgomery–Åsberg depression rating scale (MADRS). Journal of Affective Disorders 77 (2003) 255–260 27 George et al. A One-Year Comparison of Vagus Nerve Stimulation with Treatment as Usual for Treatment-Resistant Depression. Biological Psychiatry 58 (2005) 364–373 28 Rush et al. Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial. Biological Psychiatry 58 (2005) 347–354 29 Rush et al. Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study. Biological Psychiatry 58 (2005) 355–363 30 Corcoran et al. Vagus nerve stimulation in chronic treatment-resistant depression Preliminary findings of an open-label study. British Journal of Psychiatry 189 (2006) 282-283 31 Schlaepfer et al. Vagus nerve stimulation for depression: efficacy and safety in a European study. Vagus nerve stimulation for depression: efficacy and safety in a European study. 38 (2008) 651-661 32 Bajbouj et al. Two-Year Outcome of Vagus Nerve Stimulation in Treatment-Resistant Depression. Journal of Clinical Psychopharmacology 30 (2010) 273-281
21 - 5. PATIENT ILLNESS CHARACTERISTICS -
Parameter D-02 (US-based D-03 (European- Advanced studies) (n=205) based studies) Interventions (n=74) Service (n=16) >10 9% 21.60% 0% Unknown 5% 3% 0% No. of Admissions For Mood Disorders in 2.7 ± 5.4 - 3.4 ± 1.9 Lifetime Table 9 Illness characteristics of patients who progressed to vagus nerve stimulation Of note is the fact that when illness characteristics are compared with the D-02 and D-03 US and European studies for patients proceeding to vagus nerve stimulation, the Advanced Interventions Service has had: Patients with a lower number of lifetime episodes of depression More patients with unipolar depression (all patients have unipolar depression) Higher levels of chronicity (around three times as long as those published in the US and European based studies) A significantly higher number of failed adequate trials of antidepressants as defined by the Antidepressant Treatment History Form (ATHF) Higher numbers of patients having received ECT
5.2. Illness characteristics of patients with OCD The service had Y-BOCS scores available for 23 patients with OCD between 2005-2010. 43.5% of these patients had Y-BOCS scores that classified their OCD as severe (scores of 24- 31), and 34.8% had Y-BOCS scores that classified their OCD as extreme. The mean Y-BOCS severity score (± Standard Deviation) was 28.5 (± 6.4).
Parameter Advanced Interventions Service Mean ± SD Y-BOCS severity score at initial assessment 28.5 ± 6.4 Gender (F:M) 1:2.1 Diagnosis F42.2 Obsessive compulsive disorder, mixed obsessional thoughts and acts 73.6% F42.0 Obsessive compulsive disorder, predominantly obsessional thoughts 18.7% or ruminations F42.1 Obsessive compulsive disorder, predominantly compulsive acts 7.7% Percentage of patients who had not had a significantly adequate and robust trial of ERP 80.6% Percentage of patients who had not had an adequate (in either dose or duration) of an 25.8% SSRI Percentage of patients who had not had an adequate and robust trial of Clomipramine 54.8% Percentage of patients who had not had an adequate trial of antipsychotic augmentation 61.3% of an SRI Table 10 Illness characteristics and adequacy of previous treatments for patients with OCD Of note is the high percentage of patients who had not received adequate drug or psychological treatments prior to referral to the Advanced Interventions Service. The Advanced Interventions Service note that the most common reasons for psychological treatment inadequacy were: Failure to deliver ERP
22 - 5. PATIENT ILLNESS CHARACTERISTICS - Exposure not properly targeted at core symptoms Insufficient duration of therapy, or sessions too short to achieve habituation Therapy not delivered in environment where symptoms are most common; for example, delivering exposure work in a clinic rather than at home Common reasons for drug treatment inadequacy were noted by the service to include: Insufficient dose, or apparent unwillingness to push the dose to maximum-tolerated Treatment trials terminated too early (i.e. before 12 weeks at maximum dose) Use of drugs without sufficient evidence base to support their use in OCD (for example, Mirtazapine) Where a patient has co morbid depressive illness, trials of antidepressants are targeted at depression without ensuring they are adequate for the OCD The table below provides further information on insufficient drug or psychological treatments, describing the evidence-based Pallanti staging method33, which can be applied by clinicians to identify the next step to their treatment approach of people with OCD, if there is no response to treatment. The table below also includes a sample of 31 patients assessed by the Advanced Interventions Service, and their Pallanti stage, indicating their level of non-response.
Level of non- Description Percentage and response number of (Pallanti patients stage) (denominator=31) Stage 1 SSRI or CBT 55% (n=17) Stage 2 SSRI plus CBT 13% (n=4) Stage 3 2 SSRIs tried plus CBT 10% (n=3) Stage 4 At least 3 SSRIs tried plus CBT 3% (n=1) Stage 5 At least 3 SRIs (including CMI) plus CBT 3% (n=1) Stage 6 At least 3 SRIs including clomipramine augmentation plus CBT 13% (n=4) Stage 7 At least 3 SRIs including CMI + CBT + psychoeducation and other classes of 3% (n=1) medication (benzodiazepine, mood stabiliser, neuroleptic, psychostimulant) Stage 8 At least 3 SRIs including intravenous CMI + CBT + psychoeducation 0% (n=0) Stage 9 At least 3 SRIs including CMI + CBT + psychoeducation and other classes of 0% (n=0) antidepressant agents (NSRI, MAOI) Stage 10 All above treatments, neurosurgery 0% (n=0) Table 11 Pallanti grades of treatment resistance of Advanced Interventions Service patients It is clear that the vast majority of patients within this sample have not undergone the recommended levels of appropriate treatments prior to referral into the Advanced Interventions Service. This could be indicative of a lack of appropriate tertiary services for people with OCD in Scotland. The Advanced Interventions Service note that “in all cases of [OCD] patients proceeding to ablative neurosurgery in recent years, the AIS has had to deliver an inpatient ERP programme (not funded by NSD) in order to confirm and
33 Pallanti and Quercioli. Treatment-refractory obsessive-compulsive disorder: Methodological issues, operational definitions and therapeutic lines. Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 400 – 412
23 - 5. PATIENT ILLNESS CHARACTERISTICS - demonstrate non-response to intensive, therapist-guided ERP. This significantly prolongs the time it takes from the point of assessment to the point of neurosurgical intervention.34”
5.3. Patient illness characteristics – conclusions The service’s patients have high-reported levels of chronicity, severity, disability and treatment-resistance relative to the levels reported in the literature. It is clear that the service is robust in the assessments and the associated treatments offered, ensuring that patients who have not fully satisfied their criteria are provided with a set of ongoing treatment recommendations for additional psychological and pharmacological management strategies. The service has identified that the majority of patients referred with OCD have not fulfilled all necessary treatments prior to referral into the service. The illness characteristics of patients being referred to the Advanced Interventions Service, and the proportion of patients identified as not having received all necessary treatments in full adequacy prior to referral, supports the view that there are structural issues regarding the provision of tertiary level OCD services in Scotland.
34 Christmas, D. Treatment characteristics and severity of patients attending the Advanced Interventions Service with Obsessive-Compulsive Disorder. Advanced Interventions Service, 2010
24 - 6. QUALITY OF THE NATIONAL SERVICE -
6. Quality of the national service
6.1. Clinical quality - introduction The service has worked to develop the evidence base since national designation and has produced a number of medical publications, reports and theses. The service has also presented at a number of conferences and postgraduate meetings.
6.1.1. Rating scales adopted by the service The service has reported on the following complementary scales to assess the severity of and change in depressive symptoms: HRSD-17 (Hamilton Rating Scale of Depression)35 MADRS (Montgomery-Åsberg Depression Rating Scale)36 The service has reported on the following scale to assess the severity of and change in Obsessive Compulsive Disorder symptoms: Y-BOCS (Yale-Brown Obsessive Compulsive Disorder Scale) The service has also previously also reported on: CGI-I (Clinical Global Impression Improvement) SF-36 (Short Form – 36 Health Survey) to ascertain quality of life EQ-5D (EuroQoL 5D37) to provide a measure of health for clinical and economic appraisal The service details all outcomes covered by the national service in its annual reports.
6.1.2. Depression ratings used for the purposes of the review The table below includes information on the descriptions of ‘remission’, ‘response’, ‘other improvement’, ‘neutral’ and ‘worsening condition’ used within this report. The levels for ‘remission’ and ‘response’ are internationally recognised. For the purposes of this report, the terms ‘other improvement,’ ‘neutral’ and ‘worsening condition’ have also been adopted to assist in the analysis of outcomes.
Descriptor HRSD-17 score/change MADRS score/change Remission 7 HRSD-17 score 10 MADRS score Response 50% improvement in the baseline score of 50% improvement on the baseline HRSD-17 score of MADRS
Other improvement 50% improvement in the baseline score of 50% improvement in the baseline HRSD-17 score of MADRS Neutral 5% improvement in the baseline score of 5% improvement in the baseline HRSD-17 score of MADRS Worsening condition 5% decline in the baseline score of HRSD-17 5% decline in the baseline score of MADRS Table 12 Descriptors used for analysis of results within report
35 Hamilton, M. Hamilton Rating Scale for Depression (HRSD). Journal of Clinical Psychiatry, Vol 41(12, Sec 2), Dec 1980, 21-24. 36 Montgomery SA, Asberg M (April 1979). "A new depression scale designed to be sensitive to change". British Journal of Psychiatry 134 (4): 382–89. 37 EuroQoL Available from: http://www.euroqol.org/
25 - 6. QUALITY OF THE NATIONAL SERVICE - 6.1.3. OCD ratings used for the purposes of the review For patients with OCD, the service classifies ‘response’ as 35% improvement in the baseline Y-BOCS. The service classifies ‘remission’ as being determined by a Y-BOCS score of 10. For the purposes of this report, an improvement of 35% in Y-BOCS score that is not classified as ‘response’ will be termed ‘Other Improvement.’
6.2. Clinical quality – patient outcomes
6.2.1. Anterior cingulotomy outcomes - Change in depressive symptoms/OCD symptoms at follow-up appointment after anterior cingulotomy procedure Appendix 4 table 26 includes provides detail on all reported anterior cingulotomy outcomes since national designation. Patient outcomes are routinely assessed in their one year, two year and five year follow-up appointments. The service has reported on the outcomes of 13 patients following their first or second anterior cingulotomy procedure (number of episodes=19). As noted above, the reason for a second anterior cingulotomy procedure is non-response to the first intervention.
Outcomes after first anterior cingulotomy procedure The figure below summarises reported outcomes after a first anterior cingulotomy procedure, captured at 1, 2, 5 and 6 year follow-up appointments. Seven people received a first anterior cingulotomy procedure. One patient from this group was noted as in a state of remission (and response) one year post-operatively. Two other patients were noted as having responded to the first anterior cingulotomy at one of their later follow-up appointments.
Outcomes after first Anterior Cingulotomy procedure 7
6
1
5
4
3 4
2
1 2
1 1 1
0 1 year post-op 2 years post-op 5 years post-op 6 years post-op Post-operative follow-up
Remission (inc. response) Response (exc. remission) Other improvement Worsening condition Neutral Figure 5 Reported outcomes at follow-up after first anterior cingulotomy procedure Figure 6 below demonstrate the range of HRSD-17 and MADRS values from each year of follow-up, after a first anterior cingulotomy procedure. The error bars are used to denote the range of recorded outcomes, from the minimum to maximum reported values at each year of follow-up.
26 - 6. QUALITY OF THE NATIONAL SERVICE -
First Anterior Cingulotomy: HRSD-17 and MADRS reported change at 1, 2 and 6 year follow-up 40.00%
20.00%
0.00% 1 year 1 year 2 year 2 year 6 year 6 year Overall Overall -11.10% -16.10% -14.66% -15.40% -20.00% -18.41%
-29.53% -33.30% -36.00%
-40.00% HRSD-17/MADRS change HRSD-17/MADRS
-60.00%
-80.00%
-100.00% Follow-up appointment
Mean change in HRSD-17 Mean change in MADRS Figure 6 First anterior cingulotomy: HRSD-17 and MADRS reported change at 1, 2 and 6 year follow- up (minimum, mean and maximum values) Figure 6 above demonstrates that the majority of patients reported an improvement in outcome, with one patient reporting on a neutral condition.
27 - 6. QUALITY OF THE NATIONAL SERVICE - Outcomes after second anterior cingulotomy procedure The figure below summarises reported outcomes after a second anterior cingulotomy procedure, captured at 1, 2 and 5 year follow-up appointments.
Outcomes after second Anterior Cingulotomy procedure 6
5
1
4
1
3 2
1
2
1 2 2
1
0 1 year post-op 2 years post-op 5 years post-op Post-operative follow-up
Remission (inc. response) Response (exc. remission) Other improvement Worsening condition Neutral Figure 7 Reported outcomes at follow-up after second anterior cingulotomy procedure Six people received a second anterior cingulotomy procedure. The response and remission rates were more significant for those who had received a second anterior cingulotomy procedure. Using data from the most recent follow-up appointment, three people were in remission (and response), and an additional four people (4/6) were responders to a second anterior cingulotomy procedure. The condition of one patient deteriorated at their second year of follow-up (by an increase in HRSD-17 of 6.60% and an increase of MADRS of 11.40%). The minimum, mean and maximum HRSD-17 and MADRS values reported at each year of follow-up after a second anterior cingulotomy procedure are summarised in the chart below.
Second Anterior Cingulotomy: HRSD-17 and MADRS reported change at 1, 2 and 5 year follow-up 40.00%
20.00%
0.00% 1 year 1 year 2 year 2 year 5 year 5 year Overall Overall
-20.00%
-40.00%
-47.18% HRSD-17/MADRS change HRSD-17/MADRS -53.46% -57.45% -60.00% -65.75% -67.98% -66.70%
-77.80% -80.00% -78.10%
-100.00% Follow-up appointment
Mean change in HRSD-17 Mean change in MADRS
28 - 6. QUALITY OF THE NATIONAL SERVICE - Figure 8 Second anterior cingulotomy: HRSD-17 and MADRS reported change at 1, 2 and 5 year follow-up (minimum, mean and maximum values) It is clear that patients receiving a second anterior cingulotomy have reported, on average, larger improvements in outcome than after a first anterior cingulotomy procedure. However, the range of reported outcomes after a second procedure is also larger than those reported after a first anterior cingulotomy procedure.
6.2.2. Vagus nerve stimulation outcomes Appendix 4 table 29 includes provides detail on all reported vagus nerve stimulation outcomes since national designation. The service has reported on the outcomes of 12 patients who have received vagus nerve stimulation. The figure below summarises reported outcomes after the implanting of a vagus nerve stimulator, captured at 1 to 6 year follow-up appointments.
Outcomes after Vagus Nerve Stimulation 6
5
1
4
3
3 2
1
2 2
1 1
1 2 2 2
1 1 1
0 1 year post-op 2 years post-op 3 years post-op 4 years post-op 5 years post-op 6 years post-op Post-operative follow-up
Remission (inc. response) Response (exc. remission) Other improvement Worsening condition Neutral Unknown Figure 9 Reported outcomes at follow-up after vagus nerve stimulation The figure above highlights that the majority of patients have reported improved outcomes. However, it must be noted that three patients reported on having a worsened condition following vagus nerve stimulation at their first-year follow-up appointment (ranging from HRSD-17 +4.30% to +19.00% and MADRS +9.00% to +36.00%), and one patient reporting a worsened condition at their six year follow-up appointment after the implanting of the vagus nerve stimulator (HRSD-17 +26.20%, MADRS +13.30%). The mean, minimum and maximum HRSD-17 and MADRS values reported at each year of follow-up after vagus nerve stimulation are summarised in the chart below. Of note is the significant range in overall reported outcomes of a 111.90% change in HRSD-17, and 131.10% change in MADRS.
29 - 6. QUALITY OF THE NATIONAL SERVICE -
Vagus Nerve Stimulation: HRSD-17 and MADRS reported change at 1, 2, 3, 5 and 6 year follow-up 40.00%
20.00%
10.45%
0.00% -0.60% 1 year 1 year 2 year 2 year 3 year 3 year 5 year 5 year 6 year 6 year Overall Overall -8.68% -13.88% -20.00% -25.28% -23.88% -27.10% -27.75% -31.00%
-40.00% -38.36%
-41.24% -43.03% HRSD-17/MADRS change HRSD-17/MADRS
-60.00%
-80.00%
-100.00% Follow-up appointment
Mean change in HRSD-17 Mean change in MADRS Figure 10 Vagus nerve stimulation: HRSD-17 and MADRS reported change at 1, 2, 3, 5 and 6 year follow-up (minimum, mean and maximum values) The Advanced Interventions Service participated in a European multi-centre study that commenced in 2004 of vagus nerve stimulation in Treatment-Resistant Depression38. Response criteria were set as a 50% reduction in the HRSD-28 scores from baseline, and remission criteria were set as HRSD-28 scores 10. It must be noted that the Advanced Interventions Service as standard, reports on the 17 item Hamilton Rating Scale for Depression (HRSD-17), rather than the 28 item scale used in the multi-centre study (HRSD- 28). The 2010 long-term follow-up of the study reported that at two-year follow-up, 53.1% of patients within the multi-centre study fulfilled the response criteria, and 38.9% fulfilled the remission criteria. Using data reported by the Advanced Interventions Service, at two-year follow-up within the national service, 40.0% fulfilled the response criteria, 40.0% fulfilled the remission criteria and 10.0% reported on a neutral condition (taking into account HRSD-17 rather than HRSD-28).
6.2.3. Adverse effects of intervention The service routinely captures information on the adverse effects of anterior cingulotomy and vagus nerve stimulation. Additionally the service undertakes clinical battery and computerised neuropsychological assessments to detect post-surgical impairments in cognitive function.
Anterior cingulotomy The main general risks of anterior cingulotomy are the development of epilepsy, transient confusional states and potential neurological injury caused by vascular injury as a consequence of frame-based stereotactic surgery39. The service has reported on a number
38 Bajbouj et al. Two-year outcome of Vagus Nerve Stimulation in Treatment-Resistant Depression. Journal of Clinical Psychopharmacology 2010;30 3:273-281 39 Matthews, K. and Eljamel, M. S. Status of neurosurgery for mental disorder in Scotland. Selective literature review and overview of current clinical activity. The British Journal of Psychiatry 2003;182: 404-411
30 - 6. QUALITY OF THE NATIONAL SERVICE - of expected temporary adverse outcomes for anterior cingulotomy that present and resolve in the first 2-4 weeks post-operatively. These are in line with the expected outcomes noted in the literature and include headache, tiredness, nausea, concentration problems, dizziness and incontinence experienced by a proportion of patients. Few adverse effects persist in the longer term. As indicated above, the MADRS and HRSD-17 scores of one patient who underwent a second anterior cingulotomy procedure was noted to have worsened at their two-year follow-up appointment.
Vagus nerve stimulation Temporary adverse effects for vagus nerve stimulation are also reported, and it is emphasised that these only present during the period of stimulation. These are in line with the expected effects noted in the literature which include voice alteration, mild and unimpairing swallowing difficulties, throat discomfort and rare instances of facial numbness. As indicated above, the MADRS and HRSD-17 scores of four patients who underwent vagus nerve stimulation were noted to have worsened following the intervention.
6.2.4. Critical incidents The service has reported that there have been no critical incidents or deaths since national designation. The service reports that there also have been no suicides of patients who have received a neurosurgical intervention from the service since it was originally created.
6.3. Non-clinical quality
6.3.1. Initiatives to support service development The service has undertaken extensive work to ensure that it reports fully to National Services Division and the public. The service has aligned its reporting to the Institute of Medicine’s Six Domains of Quality, to support continuous improvement in the service, and align to the NHS Scotland Healthcare Quality Ambitions. The service developed a communications strategy shortly after national designation, and has worked to develop a comprehensive website which includes information on the service for patients and clinicians. The website address is www.advancedinterventions.org.uk. The service has initiated links with voluntary sector organisations including Action on Depression (formerly the Depression Alliance Scotland) and OCD Action.
6.3.2. Patient feedback The service has conducted standardised patient questionnaires at a patient’s first outpatient assessment and after inpatient admission, and reported on the results of these questionnaires since 2008. The service uses feedback to inform the ongoing development of the service. Overall, the results reported by the service have been either positive or very positive. Responses are allocated a score as per the table below, and average scores are then reported on.
Description Score Strongly disagree Much worse 1 Disagree Worse 2 Neutral Neutral 3 Agree Better 4 Strongly agree Much better 5 Table 13 Service patient feedback scoring method
31 - 6. QUALITY OF THE NATIONAL SERVICE - Outpatients and inpatients have reported on high levels of satisfaction, with outpatients reporting overall higher levels of satisfaction than inpatients. The results of the outpatient satisfaction questionnaire are included in the figure below.
Results of outpatient satisfaction questionnaire, 2008-2011 financial years (n=42)
Staff seemed knowledgeable about my condition 4.7 Good to meet at end to discuss recommendations 4.7 I found it helpful to be seen by the service 4.6 Had confidence in doctors and nurses who assessed me 4.5 Felt staff were honest and open with me 4.5 Felt staff listened to what I had to say 4.5 Pleased that partner/relatives/friend were also seen 4.4 Staff seemed to respect my decisions about my treatment 4.4 Overall, I am satisfied about with care I received 4.4 Information given at feedback was helpful 4.4 Felt I could talk freely with those meeting me 4.3 Staff were interested in me and not just my illness 4.3 Explained to me what would happen during the day 4.3 I learned something new about my problems and available treatments 4.2 Helpful to be seen by two people 4.2 Helpful for partner/relatives/friend to come 4.2 Felt staff involved me in decision-making about my care 4.2 Compared to attendance at other outpatient assessments, my attendance at AIS was* 4.1 After attending I feel more optimistic about treatment 3.8 Easy to complete questionnaires 3.4
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 Mean score Figure 11 Cumulative results of outpatient satisfaction questionnaire, 2008-2011 financial years (n=42) It is clear that on average, outpatients rated their experience highly, agreeing or strongly agreeing with the vast majority of the positive statements posed by the service. ‘Staff seemed knowledgeable about my condition’, and ‘good to meet at end to discuss recommendations’ were the two statements that on average, rated most positively. ‘Easy to complete questionnaires’ and ‘after attending I feel more optimistic about treatment’ were on average, positively rated, but the least strongly scored statements. The results of the inpatient satisfaction questionnaire are included in the figure below.
Results of inpatient satisfaction questionnaire, 2008-2011 financial years (n=17)
Compared to inpatient admission in other units, my stay in Dundee was* 4.3 Ward staff and nurses from AIS were in close communication 4.0 I knew who to contact if problems following discharge 4.0 Written information was made available to me 4.0 Staff seemed to respect my decisions about my treatment 4.0 I was clear about the arrangement for discharge 4.0 I had confidence in doctors and nurses in ward 4.0 Ward staff were welcoming 4.0 Staff seemed knowledgeable about my condition 4.0 Ward staff knew purpose of admission 4.0 My accomodation (room, shower, bed) was of acceptable standard 4.0 Ward staff and nurses from AIS were in close communication with ward 3.9 I felt staff involved me in decision-making about my care 3.9 Approachable, courteous, trustworthy, friendly and responsive ward nursing staff 3.9 I felt I could talk freely with those looking after me 3.9 Staff could respond to my physical needs 3.9 I felt staff were honest and open with me 3.9 I felt staff listened to what I had to say 3.9 I had a named nurse 3.9 Staff were interested in me and not just my illness 3.9 My named nurse knew about the purpose of admission 3.8 I was orientated to the ward 3.8 Able to discuss problems with staff during daily one-to-one contact 3.8 Staff could respond to my emotional needs 3.7
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 Mean score
32 - 6. QUALITY OF THE NATIONAL SERVICE - Figure 12 Cumulative results of inpatient satisfaction questionnaire, 2008-2011 financial years (n=17) It is clear that average inpatient responses were on the whole positive for the statements posed by the service. A number of the results of the two questionnaires demonstrate that in line with the Healthcare Quality Strategy, the service works to ensure service users are engaged in mutually beneficial partnerships with the service which respects individual needs and values and demonstrates compassion, continuity, clear communication and shared decision-making. For instance, a high proportion of service users agreed or strongly agreed with the statements that they: ‘felt staff were open and honest with me,’ ‘felt staff listened to what I had to say,’ ‘staff seemed to respect my decisions about my treatment,’ ‘felt I could talk freely with those meeting me,’ ‘felt staff involved me in decision-making about my care,’ ‘felt I could talk freely with those meeting/looking after me,’ ‘staff were interested in me, and not just my illness,’ and; ‘approachable, courteous, trustworthy, friendly and responsive ward nursing staff.’ 6.4. Quality of the national service – conclusions The service has worked to develop the evidence base since national designation and has robustly reported on patient outcomes in medical publications, reports and theses, and in its annual reports to National Services Division and the public. When considering outcomes, it is important to note the low denominator for each procedure, with the service reporting on the outcomes of 7 people proceeding to a first anterior cingulotomy procedure, 6 proceeding to a second anterior cingulotomy procedure, and 12 people proceeding to vagus nerve stimulation. Despite the high tendency to chronicity, disability and treatment-resistance, patient outcomes after first and second anterior cingulotomy procedures have been, predominantly positive. On average, patients have also demonstrated improvements in MADRS and HRSD- 17 scores at follow-up after implantation of a vagus nerve stimulator device, however, a wider range of outcomes have been reported. The service has also reported fully on adverse patient outcomes, and has noted a low number of temporary adverse outcomes for patients who have proceeded to anterior cingulotomy and vagus nerve stimulation, which is in line with the expected levels for these procedures. The service has undertaken and reported on patient experience questionnaires since 2008, and has used these results to inform its developing approach. Patient feedback on the service has on the whole, been positive, and demonstrates that the service is person- centred.
33 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE - 7. Perception and attitudes toward neurosurgery for mental disorder amongst the Scottish psychiatric community, and the community’s experiences of the Advanced Interventions Service In order to gauge the perception and attitudes towards neurosurgery for mental disorder, and the Advanced Interventions Service, a survey was sent out to the entire membership of the Royal College of Psychiatrists in Scotland, regardless of the speciality. A number of survey questions were based upon questions asked in a 1995/1996 survey by the Clinical Resource and Action Group Working Group on Neurosurgery for Mental Disorder which informed the embryonic development of the Scottish Advanced Interventions Service. It must be noted that the majority of respondents were not experts in anxiety disorders, or neurosurgery for mental disorder. It is acknowledged that the sample size is low at 10%, however, this exercise was not intended to be used for academic purposes, and was undertaken purely to assess: the perceptions and attitudes toward neurosurgery for mental disorders, and clinical experiences of the Advanced Interventions Service.
7.1. Response rate and demographics The survey was sent out to the 1,213 of the Royal College of Psychiatrists in Scotland. There were a total of 138 responses (11.4% response rate), 9 of which were incompletely completed on paper, and 4 of which were incompletely completed on the electronic survey. This left 125 complete responses made on paper surveys and through the electronic online survey, representing 10.3% of the Royal College’s Scottish membership. The speciality noted by respondents is included in the table below.
Speciality Responses Child Psychiatry / Child and Adolescent Mental Health 11 General Adult Psychiatry 69 Forensic 4 Learning Disabilities 7 Liaison 1 Mental Health/Psychiatry 8 Old Age Psychiatry 13 Psychotherapy 6 Rehabilitiation 3 Substance misuse 3
Total 125 Table 14 Speciality of survey respondents
The respondents’ noted NHS Board of employment is included in the table below.
34 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE -
NHS Board Responses NHS Ayrshire and Arran 6 NHS Borders 6 NHS Dumfries and Galloway 5 NHS Fife 7 NHS Forth Valley 6 NHS Grampian 14 NHS Greater Glasgow and Clyde 28 NHS Highland 7 NHS Lanarkshire 11 NHS Lothian 20 NHS Orkney 0 NHS Shetland Isles 0 NHS Tayside 13 NHS Western Isles 0 The State Hospital 2
Total 125 Table 15 NHS Board of employment of respondents The Medical Career Grade of respondents is included in the table below:
Speciality Responses Specialty Trainee 1 – 3 8 Specialty Trainee 4 + 9 Specialty Doctor 5 Associate Specialist 6 Consultant 97
Total 125 Table 16 Medical Career Grade of respondents
7.2. Perception of Neurosurgery for Mental Disorders This section asked respondents to state whether they agreed, disagreed, or were neutral on certain statements. The table below summarises responses.
Statement Agree Disagree Neutral For certain psychiatric disorders which have proved to be intractable to 85.6% 3.2% 11.2% other forms of treatment, or which have responded only briefly to other treatment, neurosurgery for mental disorder is an acceptable procedure which should continue to be available. The role of neurosurgery for mental disorder has never been established but 28.8% 36.8% 34.4% it probably still has a place in the treatment if psychiatric disorder. The effectiveness of neurosurgery for mental disorder is supported by an 38.4% 12.8% 48.8%
35 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE -
Statement Agree Disagree Neutral adequate evidence-base. Neurosurgery for mental disorder may have had a useful role among the 8.0% 66.4% 25.6% treatments of psychiatric disorder at one time; however, due to improvements in other forms of therapy it is now becoming obsolete. Future advances in technology and research might justify the use of 4.8% 76.8% 18.4% neurosurgery for mental disorder but at the current state of knowledge neurosurgery for mental disorder should not be carried out. Neurosurgery for mental disorder is, and always was, an unjustifiable 2.4% 86.4% 11.2% procedure which should never have been countenanced. Table 17 Respondents' perceptions of Neurosurgery for Mental Disorders The perception of neurosurgery for mental disorder has improved amongst the psychiatric community since the original 1995/1996 CRAG survey. In the current review’s survey, 86% of those responding considered that in certain circumstances, neurosurgery for mental disorder was an acceptable procedure which should consider to be available. In the original CRAG survey, 74% of those responding considered that this was the case. The results indicate that the majority of respondents are in favour of the neurosurgery for mental disorder service and agree that neurosurgery for mental disorder is an acceptable procedure that still has a place in Scotland, and should continue to be available.
7.2.1. Diagnostic categories perceived to be appropriate for various neurosurgical treatments The figure below summarises responses to the question asking respondents to indicate which diagnostic categories were appropriate for referral for anterior cingulotomy, vagus nerve stimulation and deep brain stimulation:
Given the appropriate degree of chronicity and severity, which of the following diagnostic categories do you consider an appropriate referral for the following procedures
Schizophrenia
Eating disorders
Chronic and severe treatment-refractory OCD
Category Chronic and severe treatment-refractory depression
Bipolar affective disorder
Anxiety / phobic disorders
0 20 40 60 80 100 120 140 160 Number of responses
Anterior Cingulotomy Vagus nerve stimulation Deep Brain Stimulation Other Figure 13 Respondent’s choices as appropriate conditions for referral for anterior cingulotomy, vagus nerve stimulation, deep brain stimulation and other procedures. A total of 81.9% of responses noted the two conditions covered by the Advanced Interventions Service, chronic and severe treatment refractory depression and OCD.
36 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE - A total of 80.6% of responses selected the two treatments provided by the Advanced Interventions Service, anterior cingulotomy and vagus nerve stimulation. The small number of other responses are included in the table below.
Psychological Other responses Medication ECT CBT referral Anxiety/phobic disorders 1 Bipolar affective disorder 1 1 Chronic and severe treatment-refractory depression 1 Eating disorders 1 1 Schizophrenia 1 Table 18 Given the appropriate degree of chronicity and severity, which of the following diagnostic categories do you consider an appropriate referral for the following procedures - other responses
7.2.2. Respondent’s perception of number of patients in their clinical practice who might have been suitable for assessment for a neurosurgical intervention Respondents were asked to estimate the number of patients in their own clinical practice (not second opinions), over the past 5 years, or since appointment to their present post, who might have been suitable for assessment for a neurosurgical intervention to treat mental disorder. Responses are highlighted in the table below:
Diagnostic category Responses Chronic and severe treatment-refractory depression 89 Chronic and severe treatment-refractory OCD 42 Anxiety / phobic disorders 18-19 Schizophrenia 12 Bipolar affective disorder 10-11 Eating disorders 2
Total 173-175 Table 19 Estimated number of patients in respondent’s clinical practice over past five years, who might have been suitable for a neurosurgical intervention to treat mental disorder
7.3. Awareness of the Advanced Interventions Service
7.3.1. Perception of the Advanced Interventions Service 95 respondents (76.0% of total sample, 96.9% when excluding neutral responses) agreed that there should continue to be a Scottish centre staffed by psychiatrists, and with access to a neurosurgeon with acceptable experience in the management of neurosurgery for mental disorders. Only 3 respondents (2.4%) disagreed with this statement, with the remaining 27 (21.6%) stating that they did not know. Of the three people who disagreed that there should continue to be a Scottish centre, two stated that this was as ‘there are not enough numbers to justify,’ and one stated that there are ‘other priorities in Scotland’.
37 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE - The numbers in favour of a Scottish centre have increased from the original CRAG survey from 52.9% to 76.0% in favour of a Scottish centre, from 22.0% to 2.4% against a Scottish centre, and from 25.1% to 21.6% remaining neutral.
7.3.2. Awareness of the Advanced Interventions Service 108 respondents (86.4%) noted that they were aware that there is a Scottish centre providing neurosurgery for mental disorders, prior to participating in the survey. 78 of the 108 respondents (72.2%) noted that they were aware that this Scottish centre provides anterior cingulotomy and vagus nerve stimulation for chronic and severe treatment-refractory depression, and chronic and severe treatment-refractory OCD.
7.3.3. Referrals into Advanced Interventions Service As expected, when asked if respondents had referred to the Advanced Interventions Service, the majority of respondents noted that they had not.
Responses Percentage I have not referred patients for neurosurgery for mental disorder to the 83 66.4% Advanced Interventions service and have had no such patients under my care. I have not referred patients for neurosurgery for mental disorder to the 18 14.4% Advanced Interventions service, but I have had such patients under my care. I have referred patients for neurosurgery for mental disorder to the Advanced 24 19.2% Interventions service in NHS Tayside. Table 20 Respondent’s referral practice into Advanced Interventions Service
7.3.4. Reasons preventing referral into Advanced Interventions Service The table below highlights the reasons preventing referral into the Advanced Interventions Service by respondents.
For candidates eligible for referral into the Advanced Interventions Service, please Percentage select what you consider to be the main reasons preventing you from referring to the Responses response service. Not applicable as I would refer eligible patients 51 57.3% Not applicable as I would refer to a secondary/tertiary service first 11 12.4% Perception of potential for adverse effects 8 9.0% Perception of lack of confidence in evidence base 7 7.9% Perception that treatment is of minimal benefit relative to the risks 5 5.6% Fully able to manage the care of these patients within my service 2 2.2% Other- Scottish numbers insufficient for a Scottish centre 1 1.1% Other- Patient group not appropriate for referral 2 1.1% Other- Patients have not participated in intensive treatment (e.g. psychological/ERP) 2 1.1% prior to referral Table 21 Reasons preventing referral into Advanced Interventions Service The table below highlights the reasons noted by respondents deemed to be Consultants in General Adult Psychiatry (having responded to being both a Consultant and practicing either ‘General Adult Psychiatry’, ‘General Psychiatry’, ‘General Forensic Psychiatry’, ‘Psychiatry’ or ‘Mental Health’).
38 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE -
For candidates eligible for referral into the Advanced Interventions Service, please Percentage select what you consider to be the main reasons preventing you from referring to the Responses response service. Not applicable as I would refer eligible patients 34 58.6% Not applicable as I would refer to a secondary/tertiary service first 7 12.1% Perception of potential for adverse effects 4 6.9% Fully able to manage the care of these patients within my service 2 3.4% Perception that treatment is of minimal benefit relative to the risks 2 3.4% Perception of lack of confidence in evidence base 1 1.7% Other- Scottish numbers insufficient for a Scottish centre 1 1.7% Table 22 Reasons preventing referral into Advanced Interventions Service for Consultants in General Adult Psychiatry
7.3.5. Referrals of patients with treatment-refractory depression/OCD to tertiary services Respondents were asked whether they had referred to a tertiary service for patients with treatment-refractory depression and treatment-refractory OCD, and if so, to where. Results are included in the table below.
I have previously referred patients with chronic and severe treatment-refractory TRD OCD depression/OCD, to a tertiary service. Advanced Interventions Service 26 14 Brook General Hospital, Shooters Hill Unit, Woolwich (Some years ago) 2 1 Southern General Hospital, Department of Neurosurgery, TRD, Glasgow 2 1 Newcastle Affective Disorders Service 2 0 Glasgow Tertiary Service 1 0 University of Glasgow (TRD) All Glasgow Psych Hospitals - Visiting Service 1 0 Opinion of Professor Reid at Royal Cornhill, NHS Grampian 1 0 To tertiary affective disorder clinic for pharmacological review 1 0 Maudsley, London 0 3 London 0 1 Could not recall 0 2
Total 36 22 Table 23 Referral pathways into tertiary services for treatment-refractory depression and treatment-refractory OCD The three Scottish tertiary depression services that survey respondents had previously referred to were the Advanced Interventions Service, services in Glasgow, and the Royal Cornhill service in NHS Grampian. The two Scottish tertiary OCD services that survey respondents had previously referred to were the Advanced Interventions Service and the Southern General Hospital Department of Neurosurgery. Despite the small sample size, this data indicates that there is a lack of recognised tertiary services for treatment-refractory depression and/or treatment-refractory OCD.
39 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE - 7.3.6. Services expected from tertiary-level mood disorder and OCD services Respondents were asked what services they would expect from tertiary-level mood disorder and OCD services. Results are included in the table below.
What service would you expect from tertiary-level mood disorders and OCD Responses Percentage services? Advice and treatment recommendations 121 96.8% Confirmation or clarification of diagnosis 102 81.6% Help to deliver complex treatment programs to some patients 101 80.8% Training for members of your team to build capacity locally 81 64.8% Inpatient treatment for severe OCD 76 60.8% Outpatient treatment for severe OCD 61 48.8% Inpatient treatment for chronic patients with mood disorders 57 45.6% Experts to take over the care of very difficult (out)patients 46 36.8% Table 24 Services expected from tertiary-level mood disorders and OCD services The majority of respondents expect that tertiary-level mood disorder and OCD services should provide advice and treatment recommendations, confirmation or clarification of diagnosis, help to deliver complex treatment programs to some patients, training for members of their team to build capacity locally, and inpatient treatment for severe OCD.
7.4. Experience of the Advanced Interventions Service The subset of respondents who noted that they had used the Advanced Interventions Service rated their experience of the service highly. Of those respondents who had managed patients who had been referred to the service, 82.1% noted that their overall experience of the Advanced Interventions Service was either ‘good’ or ‘very good.’
Please rate your experience of the Advanced Interventions Service at different points during the patient pathway:
100%
90%
80%
70%
60%
50%
40% Percentage of responses Percentage 30%
20%
10%
0% Pre-referral (e.g. Referral Assessment During treatment Discharge Follow-up Overall experience of website, educational the Advanced meetings, Interventions Service publications Very poor Poor Acceptable Good Very good Figure 14 Respondent’s experience of Advanced Interventions Service
40 - 7. PERCEPTION AND ATTITUDES TOWARD NEUROSURGERY FOR MENTAL DISORDER AMONGST THE SCOTTISH PSYCHIATRIC COMMUNITY, AND THE COMMUNITY’S EXPERIENCES OF THE ADVANCED INTERVENTIONS SERVICE - 7.5. Perception and attitudes toward neurosurgery for mental disorder amongst the psychiatric community, and community’s experiences of the Advanced Interventions Service – conclusions This exercise was designed and undertaken purely to build on the 1995 CRAG survey by assessing perceptions and attitudes toward neurosurgery for mental disorders. The survey was also undertaken to gain feedback on clinical experiences of the Advanced Interventions Service from amongst the psychiatric community. Hence it must be noted that the majority of respondents were not experts in anxiety disorders, or neurosurgery for mental disorder. Despite the survey’s low adjusted response rate of 10.3%, the results indicate that the majority of respondents are in favour of the neurosurgery for mental disorder service and agree that neurosurgery for mental disorder is an acceptable procedure that still has a place, and should continue to be available in Scotland. 72.2% of respondents indicated that they were aware that there is a Scottish centre providing anterior cingulotomy and vagus nerve stimulation for chronic and severe treatment-refractory depression, and chronic and severe treatment-refractory OCD. The Scottish depression services identified as tertiary services which had previously managed their referrals were the Advanced Interventions Service, services in Glasgow, and the Royal Cornhill service in NHS Grampian. The Scottish OCD services identified as tertiary services which had previously managed their referrals were the Advanced Interventions Service and the Southern General Hospital Department of Neurosurgery. Despite the small sample size, data found from the exercise on previous referrals of patients with chronic and severe treatment-refractory depression/OCD to tertiary services indicates that there is a lack of recognised tertiary services for these conditions. The majority of respondents expect that tertiary-level mood disorder and OCD services should provide advice and treatment recommendations, confirmation or clarification of diagnosis, help to deliver complex treatment programs to some patients, training for members of their team to build capacity locally, and inpatient treatment for severe OCD. Of those who had interacted with the Advanced Interventions Service, responses about clinical experience of the national service were on the whole, rated highly.
41 - 8. HIGH-LEVEL MAPPING OF SERVICES FOR PEOPLE WITH THE CONDITIONS COVERED BY THE ADVANCED INTERVENTIONS SERVICE -
8. High-level mapping of services for people with the conditions covered by the Advanced Interventions Service.
8.1. Introduction In order to gain a better understanding of the numbers of patients with the conditions covered by the referral criteria (Appendix 2), and the provision of services for severe depression and OCD in Scotland, an information request was made to Information Services Division for patients covered by the referral inclusions, and excluding referral inclusions on SMR04 data (Mental Health and Day Case). Data was broken down by NHS Board, treatment Unit and by duration of stay (i.e. under 1 year, 2 years, n years). It must be noted that the majority of these patients will not be eligible for the service, as whilst they will have the conditions covered by the service, they will not have received the necessary stepped psychological and drug treatments required to determine eligibility for treatment within the Advanced Interventions Service, and consequently they will not be of sufficient chronicity, severity or treatment-resistance to meet the criteria of the service. Further detail on the mapping findings can be found in Appendix 5.
8.2. Findings and conclusions The mapping identified that people with a bipolar affective disorder, severe depressive disorder and/or obsessive-compulsive disorder ICD10 code covered by the service are being treated in a range of hospitals across Scotland, with multiple sites providing treatment for these diagnoses. There were 4,244 discharges in Scotland of patients with the conditions covered by the Advanced Interventions Service over three years, which equates to 1,415 discharges a year. Per annum, there were an average of 94 discharges of people with bipolar affective disorder, 1,242 discharges of people with severe depressive disorder, and 79 discharges of people with obsessive-compulsive disorder. Of note are the low numbers of people with OCD discharged from units across Scotland. The mapping found that a large number of units (38 units) across Scotland discharged low numbers of patients with classifications of Obsessive Compulsive Disorder with ICD10 codes covered by the Advanced Interventions Service. The units with the highest annual level of discharges on average discharged only 6 patients per year. The three units who were noted as discharging patients with OCD who had an inpatient length of stay of 3 years or over, all discharged on average, less than two patients a year with OCD, regardless of their length of stay. This indicates that these units are not formally recognised as tertiary inpatient OCD services. Whilst the review has highlighted the numbers of people discharged from these units with an ICD-10 code recorded, it would be difficult to assess the level of provision of OCD and depression services without undertaking a more in-depth mapping of services, which is out of scope of the review.
42 - 9. FINANCE - 9. Finance The table below details the budget and expenditure for the service since national designation.
Other income (from Total NHS Scotland Financial year Budget other home nations) Total expenditure expenditure 2006/07 £501,509 £68,216 £242,464 £174,248 2007/08 £501,509 £53,772 £372,532 £318,760 2008/09 £514,796 £67,392 £375,164 £307,772 2009/10 £528,449 £14,811 £428,672 £413,861 2010/11 £547,694 £94,394 £472,542 £378,148 Table 25 Advanced Interventions Service budget, income and expenditure Expenditure in 2006/07 was significantly lower than subsequent years due to the lag time in recruiting staff to the service. As this service is the largest of three units in the UK providing neurosurgery for mental disorder, patients from out with Scotland are charged and this funding has offset the spend on the service by NHS Scotland. The Advanced Interventions Service is accessible to residents of the non-Scottish home nations, whose referring organisations are charged on a cost per case basis by NHS Tayside. This income is offset against the service’s expenditure, reducing overall costs of the service to NHS Scotland.
43 - 10. CONCLUSIONS - 10. Conclusions The Expert Advisory Group and Review Board considered the evidence summarised within this report, as a basis for discussion and the development of recommendations. Following consideration of this evidence, the review commended the Advanced Interventions Service’s progress to date and recommended that the service continues to be nationally designated, and continues in its robust audit programme.
10.1. Fit against National Services Advisory Group criteria Every three to five years, National Services Division is required by the Scottish Government and NHS Boards to review whether each designated national specialist service continues to meet the criteria for national designation. This review considered the national Advanced Interventions Service against the criteria used by the National Services Advisory Group who recommend services for designation of national funding, or the de-designation of existing services. To be recommended for designation services will be: highly specialist; of proven effectiveness; incidence of the condition requiring diagnosis and/or treatment is rare and/or unpredictable; meet a recognised need for all residents of Scotland within a clearly defined clinical area (i.e. service is national); require a highly skilled multidisciplinary team and / or specialist equipment and facilities that can only be provided cost effectively in one, or very few, locations; require concentration of expertise to achieve clinical effectiveness; require close monitoring e.g. of a new clinical technique, and/ or designation to prevent inappropriate proliferation; require scare clinical skills; are at risk, and require stable, protected, funding to ensure sustainability. The Advanced Interventions Service is highly specialised and is recognised as a UK service, as one of three UK centres providing neurosurgery for mental disorder. It was deemed by the Expert Advisory Group that the Advanced Interventions Service clearly fits the criteria for national designation.
10.2. Performance of the service
A safe and effective service Safe service: “There will be no avoidable injury or harm to people from healthcare they receive, and an appropriate, clean and safe environment will be provided for the delivery of healthcare services at all times. 40” Effective service: “The most appropriate treatments, interventions, support and services will be provided at the right time to everyone who will benefit, and wasteful or harmful variation will be eradicated.40” Patients proceeding to anterior cingulotomy or vagus nerve stimulation have high-reported levels of chronicity, severity, disability and treatment-resistance relative to the levels reported in the literature. Despite these high levels of chronicity, disability and treatment- resistance, it is apparent that the service has worked well and has reported on good, predominantly (and on average) positive outcomes, with the majority of service users
40 Scottish Government. The Healthcare Quality Strategy for NHS Scotland. (2010)
44 - 10. CONCLUSIONS - experiencing improvements including response and remission. It was noted that in the small number of cases where depression scores were worse after treatment than they were prior to it, without the intervention, service users may have experienced a greater worsening in their condition. The Expert Advisory Group concluded that both ablative neurosurgery and vagus nerve stimulation should continue to be offered by the national service within the current governance framework. The positive feedback from the psychiatric community was also highlighted, with 82% of respondents who had used the service noting that their overall experience of the service was either ‘good’ or ‘very good.’ The Expert Advisory Group praised the holistic multidisciplinary approach of the service, and joint working with the University of Dundee which has supported the development of the evidence-base for treatments for chronic and severe treatment-refractory depression. Of note was the service’s continued commitment to robustly assess patients and ensure that their condition is significantly and sufficiently chronic, severe and treatment-resistant, prior to offering ablative neurosurgery or vagus nerve stimulation as a treatment option. The Advanced Interventions Service should be commended for its work in ensuring that both patients, who have not fully satisfied these robust criteria, and their referring clinicians, are provided with a set of ongoing treatment recommendations for additional psychological and pharmacological management strategies.
A person-centred service Person-centred service: “Mutually beneficial partnerships between patients, their families and those delivering healthcare services which respect individual needs and values and which demonstrate compassion, continuity, clear communication and shared decision-making.40” The service has demonstrated a person-centred approach through its assessments, treatment and follow-up levels. The review of existing casenotes in addition to undertaking psychiatric and psychological reviews assist the service to better understanding the person’s illness, and the impact that this illness has on their life. The service’s feedback sessions allow for further discussion between the service user and members of the service, and support the development of a mutual understanding of the person’s illness which informs a shared decision-making process for ongoing treatments. The service has worked well to capture feedback from outpatients and inpatients, and to use this data to continue to develop the service. This data provides evidence from service users that the service is person-centred. The high-quality of the service has also been acknowledged and is supported by patient and clinical-user feedback, in addition to feedback from the wider UK clinical community with expertise in areas of mood and affective disorders. The service has worked well to report robustly to patients, the public, the clinical community and National Services Division through its annual and mid-year reports that are published on its extensive website.
10.3. Areas for further development
10.3.1. Referral and conversion rates In appraising the data collected for the review, it is clear that a number of NHS Boards have lower than expected referral rates into the service. On the other hand, the service’s host Board, NHS Tayside and NHS Fife have higher than expected referral levels into the service. The conversion rate to surgery of NHS Tayside patients indicates that there is a need to ensure that patients who would be part of regional specialist activity are accounted for separately to those who are part of the national specialist activity within the service.
45 - 10. CONCLUSIONS - 10.3.2. Retention and development of existing links with referrers It is acknowledged that people with chronic and severe treatment-refractory depression and OCD have long and complex treatment pathways that can last many years. The anterior cingulotomy and vagus nerve stimulation provided by the Advanced Interventions Service should be seen to compliment and act as treatment augmentation to other treatments. Indeed, referring Consultant Psychiatrists retain clinical responsibility for the patient during the assessment process by the Advanced Interventions Service, and in implementing the service’s treatment recommendations. The efficacy of treatment by the national service will be affected by the psychological, psychiatric and pharmacological treatments administered by the team retaining responsibility for the ongoing care of the patient following discharge by the national service. As this is the case, there is a need to continue to ensure close liaison between the national service and the team retaining responsibility for the ongoing care of the patient to ensure that approved treatment recommendations are followed.
10.3.3. Benchmarking It is noted that the Advanced Interventions Service is one of a low number of specialised centres in the UK for mood and affective disorders. Indeed the services provided by the Advanced Interventions Service place it at the top end of stepped care, making it a provider of a quaternary level service. The review’s Expert Advisory Group noted the service’s existing commitment to report transparently, and highlighted that it is important to continue to share data and benchmark with other units across the UK and internationally. Links between commissioners in National Services Division and their counterparts in England should be developed to support benchmarking and patient pathways across the UK.
10.3.4. Non-surgical service activity The review has recognised that the vast majority of the activity within the service currently and legitimately focuses on undertaking comprehensive assessments and developing detailed treatment recommendations for patients and referring clinical teams. It is important that in the future, the service, National Services Division and referrers formally recognise this existing activity.
10.3.5. Deep brain stimulation The national service is currently participating in a multi-centre trial of deep brain stimulation (DBS) for chronic, treatment-refractory depression. It was noted that there is currently an insufficient evidence-base to support the inclusion of deep brain stimulation as a treatment for chronic and treatment-refractory obsessive-compulsive disorder or depression by the Advanced Intervention Service.
10.4. Provision of tertiary level OCD services in Scotland Both the Expert Advisory Group and the Advanced Interventions Service have highlighted the inequity in provision of OCD services across NHS Scotland which has an impact on the quality of referrals into the service, the ongoing management of the patient post- intervention, and a low conversion rate to surgery. Whilst some clinicians in Scotland provide a tertiary level OCD service, there are a lack of consistently supported centres of expertise in Scotland. The illness characteristics of patients being referred to the Advanced Interventions Service, and the proportion of patients identified as not having received all necessary treatments in full adequacy prior to referral, supports the view that there are structural issues regarding the provision of tertiary level OCD services in Scotland.
46 - 10. CONCLUSIONS - The high-level mapping of services for people with conditions covered by the AIS found that a large number of units (38 units) across Scotland discharged low numbers of patients with classifications of Obsessive Compulsive Disorder covered by the Advanced Interventions Service. The units with the highest annual level of discharges on average discharged only 6 patients per year. The three units who were noted as discharging patients with OCD who had an inpatient length of stay of 3 years or over, all discharged on average, less than two patients a year with OCD, regardless of their length of stay. This indicates that these units are not formally recognised as tertiary inpatient OCD services. When asked what tertiary services patients had been referred to for treatment-refractory OCD, members of the Royal College of Psychiatrists in Scotland predominantly responded the AIS, with one respondent noting the Southern General Hospital. The low volume of patients and high number of units support the view of the Expert Advisory Group and the Advanced Interventions Service that it is unlikely that whilst some clinicians provide specialist services for OCD, there are no formally recognised tertiary OCD units in Scotland providing tertiary OCD services.
10.5. Provision of quaternary psychopharmacological and psychiatric OCD services Scottish residents with OCD who currently require access to quaternary level psychopharmalogical and psychiatric services have access to NHS England services through a NHS Scotland risk-sharing agreement. However, it has become apparent that there is the expertise to provide this level of service in NHS Scotland. The level of psychological assessments and therapies currently provided at a quaternary level in Scotland needs to be explored further by services across Scotland. If capacity is available in NHS Scotland, there could potentially be a more enhanced role in providing quaternary specialised psychopharmacological, psychiatric and other treatments for OCD that are currently being provided in the English Springfield Unit. This would help to develop capacity of quaternary services in Scotland, reducing travel distances for patients, in addition to yielding significant savings to NHS Scotland.
47 - 11. RECOMMENDATIONS -
11. Recommendations In 2000, the Royal College of Psychiatrists Neurosurgery for Mental Disorder report noted that “it would be unwise to allow neurosurgery for mental disorder to die out21.” Eleven years later, this review has found that the Advanced Interventions Service has provided a valuable service for people with highly chronic and severe treatment-refractory depression and obsessive compulsive disorder from across Scotland and the rest of the UK.
11.1. Continuing fit against National Services Advisory Group criteria National designation has both helped to sustain this highly specialised service, and to nurture the service’s ongoing surgical and non-surgical development, bringing clear benefits to a number of people with chronic and severe mental health conditions. The Expert Advisory Group noted that the service clearly continues to meet the National Services Advisory Group criteria, and recommended that the Advanced Interventions Service continues to be nationally designated, in providing both anterior cingulotomy and vagus nerve stimulation. It was also recommended that the national service should receive more formal recognition for its existing non-surgical assessment and advice service, which are necessary to complement and support the surgical service provided.
11.2. Recommendations for a person-centred service Person-centred service: “Mutually beneficial partnerships between patients, their families and those delivering healthcare services which respect individual needs and values and which demonstrate compassion, continuity, clear communication and shared decision-making.40”
11.2.1. Assessment process It is recommended that the Advanced Interventions Service’s current assessment process continues in its positive focus on the service user. This will allow for the continued development of mutually beneficial partnerships and shared decision-making between service users and the service.
11.2.2. Capturing service user feedback It is recommended that the service continue to capture feedback from service users, and to actively use this feedback to improve the ongoing quality of the service.
11.2.3. Access for patients from across UK In acknowledging that the Advanced Interventions Service is available to patients from across the UK, continued dialogue should be facilitated by the Advanced Interventions Service and National Services Division with other services and Commissioners in NHS England and Wales. This will need to be undertaken in a planned and stepped manner to ensure that future demand does not outstrip capacity and that if necessary, the Advanced Interventions Service can develop capacity to meet future levels of demand.
11.3. Recommendations for a safe and effective service Safe service: “There will be no avoidable injury or harm to people from healthcare they receive, and an appropriate, clean and safe environment will be provided for the delivery of healthcare services at all times.40” Effective service: “The most appropriate treatments, interventions, support and services will be provided at the right time to everyone who will benefit, and wasteful or harmful variation will be eradicated.40”
11.3.1. Communication The national service needs to proactively communicate and engage with the clinical community in Scotland to ensure that it is appropriately meeting the true Scottish need for
48 - 11. RECOMMENDATIONS - the service. It has been suggested that distributing the service’s referral criteria on an annual basis to the wider psychiatric community would support an increase in the referral rate into the service. The service has indicated the desire to more proactively communicate with the UK Psychiatric Community by placing low-cost advertisements in the British Journal of Psychiatry and assessing its impact. It is believed that this approach will support an increase in awareness of the service, and an associated increase in referrals to the service. The service should ensure that they are proactively identifying low-referring services, and developing links with these services. This will support both the referral rate and the conversion rate to surgery. There is a need to continue to ensure close liaison between the national service and the team retaining responsibility for the ongoing care of the patient to ensure that approved treatment recommendations are followed. This will support the ongoing efficacy of treatments provided by the service.
11.3.2. Benchmarking Formal links should be nurtured to support the further benchmarking between the Advanced Interventions Service, the English OCD networks; and the two other services providing neurosurgery for mental disorder: the University Hospital of Wales, and Frenchay Hospital, Bristol. Where possible, National Services Division should work in partnership with the service to support this work. The Advanced Interventions Service should continue to report robustly, develop the evidence-base and use the literature to benchmark internationally.
11.3.3. Non-surgical service activity Recognising that the vast majority of the activity within the service focuses on undertaking comprehensive assessments and developing detailed treatment recommendations for patients and referring clinical teams, it is important to ensure that this activity and the fuller patient pathway within the service is recognised within future service reports, and that this element of the service is clearly added to the future service definition. This should encompass assessment, home visits, the development of treatment recommendations, the delivery of the educational programme, and advice provided to other clinical teams.
11.3.4. Deep brain stimulation If in the future, when the evidence-base is developed, it becomes apparent that deep brain stimulation is a safe and effective procedure for the conditions covered by the national service, then the service could consider applying in a separate bid for an extension to their existing national designation.
11.4. Future activity levels and finance It is hoped that the suite of recommendations included within this report will support the national service’s sustainability and promote the development of the service, by increasing referral levels into the service. It is hoped that improved communication and engagement with referrers will bring about an increase in referrals from across Scotland and the UK, resulting in an increased level of surgical and non-surgical activity within the service. As the service’s degree of success in promoting future referrals and developing activity levels remains unknown, it is recommended that activity levels are continuously reviewed by National Services Division; and that commissioning assumptions and the associated service budget are updated as appropriate once trends in future activity levels are available.
49 - 11. RECOMMENDATIONS - 11.5. Provision of tertiary level OCD services in Scotland The Specialised Services National Definition Set for England and Wales recognises that people with complex and refractory mood affective disorders (ICD-10 codes: F30.- to F39.-) and anxiety disorders (ICD-10 codes: F40.- to F43.-) “require specialised in-patient and out- patient services. Such patients pose major therapeutic challenges and centres of expertise concentrate skills and experience to treat the relatively low number of patients.41” It is recommended that in order to appropriately recognise and develop tertiary OCD services, a mapping of service-need and existing provision for people with OCD be undertaken by NHS Scotland or the Scottish Government. This will support the further development of a safe and effective referral pathway for Scottish residents.
11.6. Provision of quaternary psychopharmacological and psychiatric services for OCD If it is thought that there is the expertise to provide quaternary specialised psychopharmacological, psychiatric and other treatments for OCD in Scotland, then NHS Scotland service providers should consider making an application to provide this level of service to the National Services Advisory Group.
41 Specialised Services National Definition Set. SSNDS Definition No. 22. Specialised Mental Health Services (all ages) (3rd Edition)
50 - BIBLIOGRAPHY -
Bibliography BAJBOUJ ET AL. Two-Year Outcome of Vagus Nerve Stimulation in Treatment-Resistant Depression. Journal of Clinical Psychopharmacology 2010 30:273-281 BERLIM, M. T AND TURECKI, G. What is the meaning of treatment resistant/refractory major depression (TRD)? A systematic review of current randomized control trials. European Neuropsychopharmacology 2007 17:696-707 BERMAN R. M. ET AL. Treatment-refractory depression: definitions and characteristics. Depression and Anxiety 1997 5:154-164 THE BRITISH PSYCHOLOGICAL SOCIETY AND THE ROYAL COLLEGE OF PSYCHIATRISTS ON BEHALF OF THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. National Collaborating Centre for Mental Health. Depression: The NICE guideline on the treatment and management of depression in adults (Updated Edition). London, 2010 CHRISTMAS, D. ET AL. Neurosurgery for mental disorder. Adv. Psychiatr. Treat. 2004 10: 189-199 CHRISTMAS, D. Treatment characteristics and severity of patients attending the Advanced Interventions Service with Obsessive-Compulsive Disorder. Advanced Interventions Service, Dundee: 2010 CORCORAN ET AL. Vagus nerve stimulation in chronic treatment-resistant depression Preliminary findings of an open-label study. British Journal of Psychiatry 2006 189:282-283 DEPARTMENT OF HEALTH. Specialised Services National Definition Set. SSNDS Definition No. 22. Specialised Mental Health Services (all ages) (3rd Edition). London: 2002 EUROQOL GROUP. EuroQoL. Available from: http://www.euroqol.org/ FEKADU, A ET AL. What happens to patients with treatment-resistant depression? A systematic review of medium to long term outcome studies. Journal of Affective Disorders 2009 116:4-11 FIREMAN, B. ET AL. The Prevalence of Clinically Recognized Obsessive-Compulsive Disorder in a Large Health Maintenance Organization. American Journal of Psychiatry 2001 158: 1904-1910 GEORGE ET AL. A One-Year Comparison of Vagus Nerve Stimulation with Treatment as Usual for Treatment-Resistant Depression. Biological Psychiatry 2005 58:364–373 HAMILTON, M. Hamilton Rating Scale for Depression (HRSD). Journal of Clinical Psychiatry, 1980 41:21-24. HMSO. Mental Health (Care and Treatment) (Scotland) Act 2003. Available from: http://www.legislation.gov.uk/asp/2003/13/pdfs/asp_20030013_en.pdf [last accessed 29.06.2011] LECKMAN, J. F. ET AL. Symptoms of Obsessive-Compulsive Disorder. American Journal of Psychiatry, 1997 154:7 MATTHEWS, K. AND ELJAMEL, M. S. Status of neurosurgery for mental disorder in Scotland. Selective literature review and overview of current clinical activity. The British Journal of Psychiatry 2003 182:404-411 MONTGOMERY SA, ASBERG M (APRIL 1979). "A new depression scale designed to be sensitive to change". British Journal of Psychiatry 134 4: 382–89. MÜLLER ET. AL. Differentiating moderate and severe depression using the Montgomery– Åsberg depression rating scale (MADRS). Journal of Affective Disorders 2003 77:255–260
51 - BIBLIOGRAPHY - NHS NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Interventional procedure guidance 330. Vagus nerve stimulation for treatment-resistant depression. London: 2009 Available from: http://www.nice.org.uk/nicemedia/live/12149/46667/46667.pdf [last accessed 19.04.2011] NHS TAYSIDE. Advanced Interventions Service. Anterior Cingulotomy. Dundee. Available from: http://www.advancedinterventions.org.uk/treatments_ACING.htm [last accessed 19/04/2011] NHS TAYSIDE. Advanced Interventions Service. Criteria for Ablative Neurosurgery. Dundee. Available from: http://www.advancedinterventions.org.uk/referrals_criteria_NMD.htm [last accessed 22.06.2011] NHS TAYSIDE. Advanced Interventions Service. Criteria for Consideration for Vagus Nerve Stimulation (VNS). Dundee. Available from: http://www.advancedinterventions.org.uk/referrals_criteria_VNS.htm [last accessed 22.06.2011] NHS TAYSIDE. Advanced Interventions Service. Dundee Advanced Interventions Service: Anterior Cingulotomy. Dundee. Available from: http://www.advancedinterventions.org.uk/treatments_ACING.htm [last accessed 27.05.2011] NHS TAYSIDE. Advanced Interventions Service. Annual Report. Dundee: 2007, 2008, 2009, 2010, 2011. NHS TAYSIDE. Advanced Interventions Service. Mid-year report. Dundee: 2007, 2008, 2009, 2010, 2011. PALLANTI AND QUERCIOLI. Treatment-refractory obsessive-compulsive disorder: Methodological issues, operational definitions and therapeutic lines. Progress in Neuro- Psychopharmacology & Biological Psychiatry 2006 30:400-412 ROYAL COLLEGE OF PSYCHIATRISTS. ‘Neurosurgery for Mental Disorder. Report from the Neurosurgery Working Group of the Royal College of Psychiatrists,’ 2000:11. RUSH ET AL. Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study. Biological Psychiatry 2005 58:355–363 RUSH ET AL. Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial. Biological Psychiatry 2005 58:347–354 SCHLAEPFER ET AL. Vagus nerve stimulation for depression: efficacy and safety in a European study. Vagus nerve stimulation for depression: efficacy and safety in a European study. 2008 38:651-661 SCOTTISH GOVERNMENT. The Healthcare Quality Strategy for NHS Scotland. Edinburgh: 2010 SCOTTISH OFFICE. ‘Neurosurgery for Mental Disorder. A report by a good practice group of the CRAG Working Group on Mental Illness. Edinburgh: 1996. STANDING ADVISORY COMMITTEE ON NEUROSURGERY FOR MENTAL DISORDER SERVICES IN SCOTLAND. ‘Report of the visit to the Dundee Advanced Interventions (AI)/NMD service. Tuesday 20 June 2006.’ Edinburgh: 2006. Available from http://www.advancedinterventions.org.uk/library_NMD_reports.htm [last accessed 12.04.2011] STIMPSON N. ET. AL. Randomised controlled trials investigating pharmacological and psychological interventions for treatment refractory depression. Systematic review. British Journal of Psychiatry 2002 181:284-294
52 - BIBLIOGRAPHY - U.S. FOOD AND DRUG ADMINISTRATION. Recently Approved Devices > VNS Therapy System - P970003s050. Silverspring: 2005. Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandCl earances/Recently-ApprovedDevices/ucm078532.htm [last accessed 29.06.2011] WORLD HEALTH ORGANIZATION. International Statistical Classification of Diseases and Related Health Problems, 10th revision. Version for 2007. Genève: 2007. Available from: http://apps.who.int/classifications/apps/icd/icd10online/ [last accessed 26.04.2011] WORLD PSYCHIATRIC ASSOCIATION. Symposium on therapy resistant depression. Pharmacopsychiatry, 1974: 7:69-224
53 - APPENDIX 2 – REFERRAL CRITERIA FOR ABLATIVE NEUROSURGERY AND VAGUS NERVE STIMULATION -
Appendix 1 – National Services Advisory Group criteria Every three to five years, National Services Division is required by the Scottish Government and NHS Boards to review whether each designated national specialist service continues to meet the criteria for national designation. This review will consider the Advanced Interventions Service against the criteria used by the National Services Advisory Group who recommend services for designation of national funding, or the de-designation of existing services. To be recommended for national designation, services will be: highly specialist; of proven effectiveness; incidence of the condition requiring diagnosis and/or treatment is rare and/or unpredictable; meet a recognised need for all residents of Scotland within a clearly defined clinical area (i.e. service is national); require a highly skilled multidisciplinary team and / or specialist equipment and facilities that can only be provided cost effectively in one, or very few, locations; require concentration of expertise to achieve clinical effectiveness; require close monitoring e.g. of a new clinical technique, and/ or designation to prevent inappropriate proliferation; require scare clinical skills; are at risk, and require stable, protected, funding to ensure sustainability.
54 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE -
Appendix 2 – Referral criteria for ablative neurosurgery and vagus nerve stimulation The following criteria for consideration for ablative neurosurgery and vagus nerve stimulation have been obtained from the Advanced Interventions Service’s website42, 43.
Criteria for consideration for ablative neurosurgery
Treatment-refractory depression
Inclusion criteria Age > 20 years Legal status: both formal and informal patients can be considered Confirmation of diagnosis: the individual will fulfil ICD-10 criteria for one of the following: F32.2 Severe depressive episode without psychotic symptoms F32.3 Severe depressive episode with psychotic symptoms F33.1 - F33.3 Recurrent depressive disorder, current episode moderate to severe F31.4 - F31.5 Bipolar Affective Disorder, current episode severe depression, with or without psychotic symptoms Duration of illness: an absolute minimum of 3 years, with at least 2 years of unremitting symptoms despite treatment. Only in exceptional circumstances would a duration of illness less than 5 years be considered. Consent: the patient must be capable of providing sustained, informed consent.
Exclusion criteria Age < 20 years Failure to fulfil ICD-10 criteria for F32.2, F32.3, F33.1-F33.3, F31.4-F31.5 Incapacity to give sustained, informed consent A current diagnosis of substance misuse fulfilling criteria for ICD-10 F10-F19 'Mental and behavioural disorders due to psychoactive substance use' A diagnosis of organic brain syndrome fulfilling criteria for ICD-10 F00-F09, including Alzheimer's disease, vascular, and other dementias A diagnosis of disorder of adult personality fulfilling criteria for ICD-10 F60-F69 A diagnosis of pervasive developmental disorder fulfilling criteria for ICD-10 F84
42 Dundee Advanced Interventions Service. Criteria for Ablative Neurosurgery. Available from: http://www.advancedinterventions.org.uk/referrals_criteria_NMD.htm [last accessed 22.06.2011] 43 Dundee Advanced Interventions Service. Criteria for Consideration for Vagus Nerve Stimulation (VNS). Available from: http://www.advancedinterventions.org.uk/referrals_criteria_VNS.htm [last accessed 22.06.2011]
55 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE - Obsessive Compulsive Disorder
Inclusion criteria Age > 20 years. Legal status: both formal and informal patients can be considered. Confirmation of diagnosis: individuals will normally fulfil criteria for a primary diagnosis according to ICD-10 F42.0-F42.9. Individuals with treatment-refractory obsessional and/or compulsive symptoms in the presence of other co-morbid mental disorder (e.g. depression, schizophrenia) can be considered for surgery but additional criteria for adequacy of treatment will be applied. Duration of illness: an absolute minimum of 3 years, with at least 2 years of unremitting symptoms despite intensive psychopharmacological and psychological treatment. Only in exceptional circumstances would a duration of illness of <5 years be considered. Consent: the patient must be considered capable of providing sustained, informed consent.
Exclusion criteria Age <20 years. Failure to fulfil ICD-10 criteria for F42.0-F42.9. Incapacity to give informed consent. A current diagnosis of substance misuse fulfilling criteria for ICD-10 F10-F19,‘Mental and behavioural disorders due to psychoactive substance use’. A diagnosis of organic brain syndrome fulfilling criteria for ICD-10 F00-F09, including Alzheimer’s disease, vascular and other dementias. A diagnosis of disorder of adult personality fulfilling criteria for ICD-10 F60-F69. A diagnosis of pervasive developmental disorder fulfilling criteria for ICD-10 F84. Absence of an adequate therapeutic trial of psychological treatment methods. Absence of adequate therapeutic trials of psychopharmacological treatment methods.
Criteria for consideration for vagus nerve stimulation
Inclusion Criteria The patient has a primary diagnosis of depression of at least moderate severity according to ICD-10. The patient's current episode of depression is of at least two years duration, or, the patient has a history of recurrent depression (at least four lifetime episodes, including the current, treatment-refractory, episode). The patient has not experienced an acceptable clinical response despite treatment with at least four confirmed, 'adequate' antidepressant medications from different pharmacological groupings during the current episode of depression. The treatment categories include: tricyclic antidepressants (TCA’s); selective serotonin reuptake inhibitors (SSRIs); monoamine oxidase inhibitors (MAOIs); bupropion; venlafaxine; mirtazapine; trazodone; and reboxetine. ECT may also have been tried and failed. 'Adequate' treatment is defined as an ARR score of 3 or more on the Antidepressant Treatment History Form (ATHF) [1].
56 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE - The patient has a history of treatment by psychological treatment methods (preferably Cognitive Behavioural Therapy - CBT) that did not result in significant clinical improvement. The patient must be able to comply with all pre- and post-implantation assessment and clinical review requirements. This would normally mean frequent visits to Dundee in the weeks following device implantation, with further reviews in the 12-24 months after surgery. The patient has to be able to provide signed, informed consent. The suitability of the proposed treatment and capacity to provide informed consent are independently verified by a designated medical practitioner appointed by the Mental Welfare Commission for Scotland.
Exclusion Criteria A primary diagnosis other than depression. (N.B. - Axis II comorbidity (i.e. a personality disorder or personality difficulties) is not necessarily a contraindication, but it should not be the primary diagnosis, and if difficulties are extensive the individual is unlikely to be suitable for VNS). The patient has other (progressive) neurological disease (e.g. multiple sclerosis, Parkinson's disease, stroke, etc.), or has had a cervical fracture that makes implantation of the VNS stimulator difficult. Inability to tolerate a general anaesthetic – if a patient has a history of myocardial infarction, cardiac arhythmia, or has significant cardiovascular or respiratory disease (such as COPD). The patient has significant current problems with alcohol or substance misuse. Individuals with a history of substance misuse in the previous 12 months are unlikely to be suitable. The patient has a history of significant head injury, or neurovascular disease, or previous neurosurgery. The patient has had a previous unilateral or bilateral cervical vagotomy. The patient has active peptic ulceration. The patient has a cardiac pacemaker, implantable defibrillator, or some other kind of implantable stimulator. TENS machines are not usually a problem and are not a contraindication. Since patients with VNS are unable to undergo MRI scanning or diathermy, any individual who is likely to require these is unsuitable.
57 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE -
Appendix 3 – World Health Organization ICD-10 classifications used as inclusions into the national service The following ICD-10 (International Statistical Classification of Diseases and Related Health Problems, 10th revision. Version for 2007) classifications44 are defined by the service to be inclusions into the national service:
F32 Depressive episode In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Capacity for enjoyment, interest, and concentration is reduced, and marked tiredness after even minimum effort is common. Sleep is usually disturbed and appetite diminished. Self-esteem and self-confidence are almost always reduced and, even in the mild form, some ideas of guilt or worthlessness are often present. The lowered mood varies little from day to day, is unresponsive to circumstances and may be accompanied by so-called "somatic" symptoms, such as loss of interest and pleasurable feelings, waking in the morning several hours before the usual time, depression worst in the morning, marked psychomotor retardation, agitation, loss of appetite, weight loss, and loss of libido. Depending upon the number and severity of the symptoms, a depressive episode may be specified as mild, moderate or severe. Includes: single episodes of: · depressive reaction · psychogenic depression · reactive depression Excludes: adjustment disorder ( F43.2 ) recurrent depressive disorder ( F33.- ) when associated with conduct disorders in F91.- ( F92.0 )
F32.2 Severe depressive episode without psychotic symptoms An episode of depression in which several of the above symptoms are marked and distressing, typically loss of self-esteem and ideas of worthlessness or guilt. Suicidal thoughts and acts are common and a number of "somatic" symptoms are usually present. Agitated depression } Major depression } single episode without psychotic symptoms Vital depression }
F32.3 Severe depressive episode with psychotic symptoms An episode of depression as described in F32.2, but with the presence of hallucinations, delusions, psychomotor retardation, or stupor so severe that ordinary social activities are impossible; there may be danger to life from suicide, dehydration, or starvation. The hallucinations and delusions may or may not be mood-congruent. Single episodes of: · major depression with psychotic symptoms · psychogenic depressive psychosis · psychotic depression · reactive depressive psychosis
44 World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th revision. Version for 2007. Available from: http://apps.who.int/classifications/apps/icd/icd10online/ [last accessed 26.04.2011]
58 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE - F33 Recurrent depressive disorder A disorder characterized by repeated episodes of depression as described for depressive episode (F32.-), without any history of independent episodes of mood elevation and increased energy (mania). There may, however, be brief episodes of mild mood elevation and overactivity (hypomania) immediately after a depressive episode, sometimes precipitated by antidepressant treatment. The more severe forms of recurrent depressive disorder (F33.2 and F33.3) have much in common with earlier concepts such as manic- depressive depression, melancholia, vital depression and endogenous depression. The first episode may occur at any age from childhood to old age, the onset may be either acute or insidious, and the duration varies from a few weeks to many months. The risk that a patient with recurrent depressive disorder will have an episode of mania never disappears completely, however many depressive episodes have been experienced. If such an episode does occur, the diagnosis should be changed to bipolar affective disorder (F31.-). Includes: recurrent episodes of: · depressive reaction · psychogenic depression · reactive depression seasonal depressive disorder Excludes: recurrent brief depressive episodes ( F38.1 )
F33.1 Recurrent depressive disorder, current episode moderate A disorder characterized by repeated episodes of depression, the current episode being of moderate severity, as in F32.1, and without any history of mania.
F33.2 Recurrent depressive disorder, current episode severe without psychotic symptoms A disorder characterized by repeated episodes of depression, the current episode being severe without psychotic symptoms, as in F32.2, and without any history of mania. Endogenous depression without psychotic symptoms Major depression, recurrent without psychotic symptoms Manic-depressive psychosis, depressed type without psychotic symptoms Vital depression, recurrent without psychotic symptoms
F33.3 Recurrent depressive disorder, current episode severe with psychotic symptoms A disorder characterized by repeated episodes of depression, the current episode being severe with psychotic symptoms, as in F32.3, and with no previous episodes of mania. Endogenous depression with psychotic symptoms Manic-depressive psychosis, depressed type with psychotic symptoms Recurrent severe episodes of: · major depression with psychotic symptoms · psychogenic depressive psychosis · psychotic depression · reactive depressive psychosis
59 - APPENDIX 3 – WORLD HEALTH ORGANIZATION ICD-10 CLASSIFICATIONS USED AS INCLUSIONS INTO THE NATIONAL SERVICE -
F42 Obsessive-compulsive disorder The essential feature is recurrent obsessional thoughts or compulsive acts. Obsessional thoughts are ideas, images, or impulses that enter the patient's mind again and again in a stereotyped form. They are almost invariably distressing and the patient often tries, unsuccessfully, to resist them. They are, however, recognized as his or her own thoughts, even though they are involuntary and often repugnant. Compulsive acts or rituals are stereotyped behaviours that are repeated again and again. They are not inherently enjoyable, nor do they result in the completion of inherently useful tasks. Their function is to prevent some objectively unlikely event, often involving harm to or caused by the patient, which he or she fears might otherwise occur. Usually, this behaviour is recognized by the patient as pointless or ineffectual and repeated attempts are made to resist. Anxiety is almost invariably present. If compulsive acts are resisted the anxiety gets worse. Includes: · anankastic neurosis · obsessive-compulsive neurosis Excludes: · obsessive-compulsive personality (disorder) ( F60.5 )
F42.0 Predominantly obsessional thoughts or ruminations These may take the form of ideas, mental images, or impulses to act, which are nearly always distressing to the subject. Sometimes the ideas are an indecisive, endless consideration of alternatives, associated with an inability to make trivial but necessary decisions in day-to-day living. The relationship between obsessional ruminations and depression is particularly close and a diagnosis of obsessive-compulsive disorder should be preferred only if ruminations arise or persist in the absence of a depressive episode.
F42.1 Predominantly compulsive acts [obsessional rituals] The majority of compulsive acts are concerned with cleaning (particularly handwashing), repeated checking to ensure that a potentially dangerous situation has not been allowed to develop, or orderliness and tidiness. Underlying the overt behaviour is a fear, usually of danger either to or caused by the patient, and the ritual is an ineffectual or symbolic attempt to avert that danger.
F42.2 Mixed obsessional thoughts and acts
F42.8 Other obsessive-compulsive disorders
F42.9 Obsessive-compulsive disorder, unspecified
60 - APPENDIX 4 – DETAILED SERVICE OUTCOMES -
Appendix 4 – Detailed service outcomes
Outcomes after anterior cingulotomy
Change in Change in ID Procedure Post-operative follow-up HRSD-17 MADRS Response? Remission? 10 2nd ACING 1 year -100.00% -97.70% Response Remission 2 years +6.60% +11.40% No No 28 2nd ACING 5 years -77.80% -66.70% Response No 30 1st ACING 6 years -36.00% -33.30% Response No 45 1st ACING 5 years - - Response No 61’ 2nd ACING 1 year -37.70% -18.60% No No 2 years -62.00% -51.00% Response No 82 2nd ACING 1 year -76.70% -60.00% Response No 2 years -67.40% -53.30% Response Remission 171 1st ACING 1 year - - Response Remission 184 1st ACING 1 year 0.00% 0.00% No No 2nd ACING 1 year -98.00% -95.60% Response Remission 2 years -88.00% -93.00% Response Remission 202 1st ACING 1 year -38.50% -26.30% No No 2 years -32.70% -2.60% No No 249 1st ACING 1 year -24.00% -7.00% No No 291 2nd ACING 2 years -56.50% -50.00% Response No 348 1st ACING 1 year -9.00% -20.00% No No 2 years +1.90% -19.60% No No Table 26 Anterior cingulotomy (ACING) outcomes ‘ Patient 61 had also received a course of VNS as noted in table 24. Patient 171 had a 91.9% reduction in Y-BOCS.
Outcomes after first anterior cingulotomy The table below summarises the change in depressive symptoms following a first anterior cingulotomy procedure.
Change in depressive symptoms following first ACING Min. Max. Median Mean HRSD-17 change (n=10 episodes) +1.90% -38.50% -16.50% -18.41% MADRS change (n=10 episodes) 0.00% -33.30% -19.80% -29.53% HRSD-17 change at 1 year follow-up (n=6 episodes) 0.00% -38.50% -9.00% -16.10% MADRS change at 1 year follow-up (n=6 episodes) 0.00% -26.30% -20.00% -14.66% HRSD-17 change at 2 year follow-up (n=2 episodes) +1.90% -32.70% -15.40% -15.40% MADRS change at 2 year follow-up (n=2 episodes) -2.60% -19.60% -11.10% -11.10% HRSD-17 change at 5 year follow-up (n=1 episode) - - - - MADRS change at 5 year follow-up (n=1 episode) - - - - HRSD-17 change at 6 year follow-up (n=1 episode) -36.00% -36.00% -36.00% -36.00% MADRS change at 6 year follow-up (n=1 episode) -33.30% -33.30% -33.30% -33.30% Table 27 Summarised reported outcomes at follow-up after first anterior cingulotomy procedure
61 - APPENDIX 4 – DETAILED SERVICE OUTCOMES -
Outcomes after second anterior cingulotomy
Change in depressive symptoms following second Min. Max. Median Mean ACING HRSD-17 change (n=10 episodes) +6.60% -100.00% -72.50% -65.75% MADRS change (n=10 episodes) +11.40% -97.70% -56.65% -57.45% HRSD-17 change at 1 year follow-up (n=4 episodes) -37.70% -100.00% -87.35% -78.10% MADRS change at 1 year follow-up (n=4 episodes) -18.60% -97.70% -77.80% -67.98% HRSD-17 change at 2 year follow-up (n=5 episodes) +6.60% -88.00% -62.00% -53.46% MADRS change at 2 year follow-up (n=5 episodes) +11.40% -93.00% -51.00% -47.18% HRSD-17 change at 5 year follow-up (n=1 episode) -77.80% -77.80% -77.80% -77.80% MADRS change at 5 year follow-up (n=1 episode) -66.70% -66.70% -66.70% -66.70% Table 28 Summarised reported outcomes at follow-up after second anterior cingulotomy procedure
Outcomes after vagus nerve stimulation The table below details all reported vagus nerve stimulation outcomes since national designation. The service has reported on the outcomes of 12 patients.
Change in Change in ID Procedure Post-operative follow-up HRSD-17 MADRS Response? Remission? 61 VNS 5 years 0.00% 0.00% No No 62 VNS 6 years -5.30% -12.10% No No 78 VNS 6 years +26.20% +13.30% No No 79 VNS 1 year -85.70% -91.40% Response Remission 88 VNS 2 years -83.70% -95.10% Response Remission 3 years -65.30% -65.90% Response No 5 years -51.00% -48.80% Response No 89 VNS 2 years -82.60% -77.80% Response Remission 4 years - - - - 5 years -50.00% -44.40% Response No 90 VNS 2 years -6.70% 7.70% No No 3 years -46.70% -15.40% No No 5 years -10.00% -30.80% No No 99 VNS 4 years - - - - 126 VNS 1 year +19.00% +9.00% No No 141 VNS 3 years -17.10% 0.00% No No 189 VNS 1 year +4.30% +36.00% No No 263 VNS 1 year -15.00% -9.00% No No 2 years -12.80% -25.00% No No 276 VNS 1 year +8.00% +12.00% No No 295 VNS 2 years -6.00% -16.00% No No Table 29 Vagus nerve stimulation outcomes
Min. Max. Median Mean HRSD-17 change (n=21 episodes) +26.20% -85.70% -12.80% -25.28% MADRS change (n=21 episodes) +36.00% -95.10% -15.40% -23.88% HRSD-17 change at 1 year follow-up (n=5 episodes) +19.00% -85.70% +4.30% -13.88%
62 - APPENDIX 4 – DETAILED SERVICE OUTCOMES -
Min. Max. Median Mean MADRS change at 1 year follow-up (n=5 episodes) +36.00% -91.40% +9.00% -8.68% HRSD-17 change at 2 year follow-up (n=5 episodes) -6.00% -83.70% -12.80% -38.36% MADRS change at 2 year follow-up (n=5 episodes) +7.70% -95.10% -25.00% -41.24% HRSD-17 change at 3 year follow-up (n=3 episodes) -17.10% -65.30% -46.70% -43.03% MADRS change at 3 year follow-up (n=3 episodes) 0.00% -65.90% -15.40% -27.10% HRSD-17 change at 4 year follow-up (n=2 episodes) Unknown Unknown Unknown Unknown MADRS change at 4 year follow-up (n=2 episodes) Unknown Unknown Unknown Unknown HRSD-17 change at 5 year follow-up (n=4 episodes) 0.00% -51.00% -30.00% -27.75% MADRS change at 5 year follow-up (n=4 episodes) 0.00% -48.80% -37.60% -31.00% HRSD-17 change at 6 year follow-up (n=2 episodes) +26.20% -5.30% +10.45% +10.45% MADRS change at 6 year follow-up (n=2 episodes) +13.30% -12.10% +0.60% +0.60% Table 30 Summarised reported outcomes at follow-up after implant of vagus nerve stimulator
63 - APPENDIX 5 – HIGH-LEVEL MAPPING OF SCOTTISH SERVICES -
Appendix 5 – High-level mapping of Scottish services
Aggregate discharges 2007/08-2009/10 The figure below demonstrates the total number of discharges for patients over the 2007/08-2009/10 financial years. There were 4,244 discharges from units across Scotland recorded over the period.
Number of discharges in Scotland, 2007-2010
F32.3 - Severe Depressive Episode With Psychotic Symptoms 1119
F32.2 - Severe Depressive Episode Without Psychotic Symptoms 909
F33.1 - Recurrent Depressive Disorder, Current Episode Moderate 755
F33.2 - Recurrent Depressive Disorder, Current Episode Severe W/O Psychotic Symptoms 502
F33.3 - Recurrent Depressive Disorder, Current Episode Severe With Psychotic Symptoms 441
F42.9 - Obsessive-Compulsive Disorder, Unspecified 161
F31.4 - Bipolar Affective Disorder, Curr Episode Sev Depression W/O Psychotic 146
Symptoms ICD10 code and ICD10 title F31.5 - Bipolar Affect Disorder, Cur Episode Severe Depression With Psychotic Symptoms 136
F42.0 - Predominantly Obsessional Thoughts Or Ruminations 36
F42.2 - Mixed Obsessional Thoughts And Acts 24
F42.1 - Predominantly Compulsive Acts [Obsessional Rituals] 12
F42.8 - Other Obsessive-Compulsive Disorders 3
0 200 400 600 800 1000 1200 Number of discharges Figure 15 Number of Scottish discharges over 2007/08-2009/10 financial years for F31.4-.5, F32.2-.3, F33.1-.3, F42.0-.9.
Main treatment units of discharge
Aggregate discharge data Discharges were made from 61 units from both NHS and private providers. The following figure demonstrates the units which discharged over 100 patients with these conditions in total over the 2007/08-2009/10 financial years, by diagnostic category.
64 - APPENDIX 5 – HIGH-LEVEL MAPPING OF SCOTTISH SERVICES -
Number of discharges on patients with diagnostic categories covered by the Advanced Interventions Service from units with over 100 discharges, 2007-2010 600
500
400
300
200 Totalnumber discharges of
100
0
Stobhill, GGC Parkhead, GGC Leverndale, GGC Falkirk Royal, FV Ailsa Hospital, A&A Murray Royal, Perth Gartnavel Royal, GGC Royal Cornhill, Grampian St John's Hospital, Lothian CrosshouseCarseview Hospital, A&ACentre, Tayside Huntlyburn House, Borders Rosslynlee Hospital, Lothian Crichton Royal Hospital, D&G Inverclyde Royal Hospital, GGC Royal Edinburgh Hospital, Lothian Monklands Hospital, Lanarkshire Pluscarden Clinic, Dr Gray's, Grampian New Craigs Psychiatric Hospital, Highland Unit name
Bipolar affective disorder Depressive episode Recurrent depressive disorder Obsessive Compulsive Disorder Figure 16 Scottish units discharging over 100 patients over 2007/08-2009/10
Main discharge units for bipolar affective disorder, depressive episode, and recurrent depressive disorder 32 Scottish units discharged patients with diagnoses of Bipolar Affective Disorder, 55 discharged patients with diagnoses of Depressive Episode, and 44 discharged patients with recurrent depressive disorder. The table below includes units with over 100 discharges of people with Advanced Interventions Service ICD-10 inclusion classifications of bipolar affective disorder, depressive episode, and recurrent depressive disorder over the 2007/08-2009/10 financial years.
Unit name Number of Average annual number discharges of discharges Royal Edinburgh Hospital, Lothian 470 157 Leverndale, Greater Glasgow and Clyde 301 100 Huntlyburn House, Borders 268 89 Crichton Royal Hospital, Dumfries and 157 52 Galloway St John's Hospital, Lothian 153 51 Ailsa Hospital, Ayrshire and Arran 148 49 New Craigs Psychiatric Hospital, Highland 136 45 Pluscarden Clinic, Grampian 130 43 Falkirk Royal, Forth Valley 129 43 Murray Royal, Tayside 129 43 Carseview Centre, Tayside 125 42 Crosshouse Hospital, Ayrshire and Arran 124 41 Stobhill, Greater Glasgow and Clyde 117 39 Gartnavel Royal, Greater Glasgow and 117 39 Clyde
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Unit name Number of Average annual number discharges of discharges Royal Cornhill, Grampian 114 38 Inverclyde Royal Hospital, Greater 114 38 Glasgow and Clyde Rosslynlee Hospital, Lothian 108 36 Parkhead, Greater Glasgow and Clyde 105 35 Table 31 Discharges of bipolar affective disorder, depressive episode, and recurrent depressive disorder covered by ICD-10 Advanced Interventions Service inclusions, with over 100 discharges between 2007/08-2009/10
Main discharge units for Obsessive-Compulsive Disorder 38 Scottish units discharged patients with OCD over the 2007/08-2009/10 period. The table below includes units with over 10 discharges of people with Advanced Interventions Service ICD-10 inclusion classifications of OCD over the period. This indicates that a large number of units discharge a low volume of patients with OCD.
Unit name Number of Average annual number discharges of discharges Leverndale, Greater Glasgow and Clyde 19 6 Monklands Hospital, Lanarkshire 17 6 Queen Margaret Hospital, Fife 16 5 Royal Edinburgh Hospital, Lothian 14 5 Stobhill, Greater Glasgow and Clyde 12 4 Parkhead, Greater Glasgow and Clyde 12 4 Falkirk Royal, Forth Valley 11 4 Crosshouse Hospital, Ayrshire and Arran 11 4 Royal Cornhill, Grampian 11 4 St John's Hospital, Lothian 10 3 New Craigs Psychiatric Hospital, Highland 10 3 Table 32 Discharges of OCD covered by ICD-10 Advanced Interventions Service, with over 10 discharges between 2007/08-2009/10
Discharges by length of stay and diagnosis The table below provides a break down of discharges by diagnosis over the 2007/08- 2009/10 financial years, by length of stay.
Under 1 3 years and Total Diagnosis 1-2 years year over F31.4 - Bipolar Affective Disorder, Current Episode 144 2 146 Severe Depression Without Psychotic Symptoms F31.5 - Bipolar Affective Disorder, Current Episode 136 136 Severe Depression With Psychotic Symptoms
Total Bipolar Affective Disorder 280 2 0 282 F32.2 – Severe Depressive Episode Without Psychotic 895 9 5 909 Symptoms
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Under 1 3 years and Total Diagnosis 1-2 years year over F32.3 – Severe Depressive Episode With Psychotic 1099 17 3 1119 Symptoms F33.1 – Recurrent Depressive Disorder, Current Episode 750 3 2 755 Moderate F33.2 – Recurrent Depressive Disorder, Current Episode 500 2 502 Severe Without Psychotic Symptoms F33.3 – Recurrent Depressive Disorder, Current Episode 431 7 3 441 Severe With Psychotic Symptoms
Total Severe Depressive Disorder 3675 36 15 3726 F42.0 – Predominantly Obsessional Thoughts Or 33 3 36 Ruminations F42.1 – Predominantly Compulsive Acts [Obsessional 12 12 Rituals] F42.2 – Mixed Obsessional Thoughts And Acts 24 24 F42.8 – Other Obsessive-Compulsive Disorders 3 3 F42.9 – Obsessive-Compulsive Disorder, Unspecified 161 161
Total Obsessive-Compulsive Disorder 233 0 3 236
Total 4188 38 18 4244 Table 33 Break down of discharges by diagnosis over the 2007-2010 financial years, by disorder and length of stay From the patients with a length of stay of three years and over (over the three financial years); 8 patients with depressive episode were discharged from six Scottish units, 7 patients with recurrent depressive disorder were discharged from 5 units, and 3 patients with OCD were discharged from 3 units. Aggregate data on the number of overall OCD discharges for units discharging patients with OCD and a length of stay of three years or over demonstrate that these units all discharged low numbers of patients of OCD (under 2 a year), regardless of their length of stay. This indicates that these units are not formally recognised as tertiary inpatient OCD services.
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Appendix 6 – Review membership
Review Board
Name Role on Review Board Ms. Kathy Collins, Nursing and Quality Adviser, National Services Review Executive Division Ms. Lynn Smith, Clinical Services Manager, NHS Tayside Service Representative Dr. John Taylor, Associate Medical Director, NHS Ayrshire and Psychiatric Adviser Arran Mr. David Berry, Policy Manager, Scottish Government Policy Adviser Dr. Mike Winter, Medical Director, National Services Division Medical Director Mr. Chris Myers, Programme Manager, National Services Division Review Manager
Expert Advisory Group
Name Designation on Expert Advisory Group Mr. David Berry Policy Manager, Scottish Government Mr. Dave Bertin Action on Depression (formerly Depression Alliance Scotland) Dr. Tom Brown Liaison Psychiatrist, NHS Greater Glasgow and Clyde, interests in severe depression and OCD (Royal College of Psychiatrists in Scotland) Dr. Katherine Cheshire Consultant Psychologist, Head of Psychology Services, NHS Fife Ms. Katherine Collins Nursing and Quality Adviser, National Services Division; and Review Executive Dr. Moira Connelly Psychiatric Advisor, Scottish Government Mr. Peter Croan Head of Finance, National Services Division Mrs. Deirdre Evans Director, National Services Division; Review Sponsor; and Chair of Expert Advisory Group Prof. Naomi Fineberg Clinical Lead, National NHS Service for Treatment- Resistant Obsessive Compulsive Disorders, QEII Hospital, Welwyn Garden City Prof. Stephen Lawrie Head of Psychiatry Department, University of Edinburgh. Director of the Scottish Mental Health Research Network and Co-chair of the Lothian Joint Formulary (Royal College of Psychiatrists in Scotland) Miss Patricia Littlechild Consultant Neurosurgeon, NHS Greater Glasgow and Clyde (Member of Neurosurgery Managed Service Network)
68 - APPENDIX 6 – REVIEW MEMBERSHIP - Dr. Hamish McAllister-Williams Reader in Clinical Psychopharmacology with an interest in mood disorders and stress, Newcastle University (Royal College of Psychiatrists) Prof. Ian Reid Chair in Mental Health (Clin), University of Aberdeen. Interest in Treatment-Refractory Depression and ECT. Honorary Consultant and lead for ECT in NHS Grampian. Mr. Joel Rose Director, OCD Action Mr. Brian Simpson Consultant Neurosurgeon, University Hospital of Wales (Welsh Neurosurgery for Mental Disorders service) Mr. Colin Stewart National Services Division Public Reference Group Dr. Mary Stewart Consultant Psychiatrist, Mental Welfare Commission Dr. John Taylor Associate Medical Director, NHS Ayrshire and Arran and General Psychiatrist (Royal College of Psychiatrists in Scotland) Dr. Linda Watt Medical Director, NHS Greater Glasgow and Clyde Mental Health Partnership (Vice Chair, Royal College of
Psychiatrists in Scotland) Dr. Mike Winter Medical Director, National Services Division
Review Team
Name Role Ms. Kathy Collins, Nursing and Quality Adviser, National Services Review Executive Division Mr. Chris Myers, Programme Manager, National Services Division Review Manager Miss. Eve Brindley, Programme Support Officer, National Services Review Support Officer Division
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