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1 The Quality Unit Planning and Quality Division E: T: abcdefghijklmnopqrstu NHSScotland Board Chief Executives NHSScotland Board Medical Directors NHSScotland Public Health Directors abcdefgh 16 July 2012 Dear Colleague OBESITY TREATMENT: BEST PRACTICE GUIDE Purpose 1. The purpose of this letter is to highlight to NHS Boards and primary and secondary care clinicians, the Best Practice Guide which has been developed for obesity treatment. Background 2. The National Planning Forum (NPF), a joint forum of Scottish Government and NHS Boards, was requested by the Scottish Government s Preventing Overweight and Obesity - A Route Map Towards Healthy Weight (February 2010) to establish a subgroup to provide advice on treatments for obesity. It was also agreed that surgical options should be placed in the wider context of weight management. 3. An Obesity Treatment Subgroup (OTS) was established by the NPF to set out options for a common approach to planning the provision of weight management services and surgical intervention for the treatment of people with severe and complex obesity. 4. The Subgroup recommendations were considered and approved by the NPF and a summary of the report was presented to NHS Board Chief Executives who also agreed that the recommendations should be taken forward. 5. A short life working group was formed to take forward the national recommendations on the basis of the extensive evidence reviews, a health inequalities impact assessment and expert clinical reports. These reports and the short life working group scoping reports are available from the NPF secretariat. The short life working group s advice is: 5.1 Agreed national care pathways need to be put in place for: Those patients with Type 2 diabetes who are age years with a BMI kg/m 2 and recent (less than 5 years) onset of their diabetes (Priority 1) St Andrew s House, Regent Road, Edinburgh EH1 3DG abcde abc a

2 Other groups of patients who, local clinicians, feel may benefit from bariatric surgery 5.2 There needs to be agreement concerning: Patient pathways from specialist weight management services into assessment for bariatric surgery, consideration of surgical procedures and follow up after surgery Assessment of patients who do not fulfil the criteria agreed by NPF through the use of local Board review panels for individual cases Provision of clinical and cost effectiveness outcome data on all bariatric procedures. 6. There were also regional recommendations which are being taken forward in parallel with the national recommendations and will also be informed by them. These are detailed below: Boards should work within regional planning groups to review centres within regions and consider existing services against the new criteria for surgical centres Boards should work within regional obesity groups to agree phased increased capacity over the next few years Boards should work within regional planning groups to review the level of Tier 3 provision and explore opportunities for cross board collaboration Development of the Good Practice Guidance 7. The Best Practice Guidance has been developed by a short life working group chaired by Heather Knox and Dr Jennifer Armstrong, Senior Medical Officer with a multidisciplinary group of experts (see Appendix A). It is based on the best available evidence. 8. The Guidance covers: 1. Patient Pathway From Specialist Weight Management Services Into Assessment For Bariatric Surgery 2. Surgical Procedures 3. Assessment Of Patients Who Do Not Fulfil The Criteria 4. Clinical Outcomes 5. Follow Up Protocols Following Surgery Yours sincerely Ms Heather Knox Regional Planning Director National Planning Forum member Dr Sara Davies Consultant Public Health Medicine Scottish Government Health and Social Care

3 OBESITY TREATMENT Best Practice Guide Publication date: July 2012

4 The National Planning Forum (NPF) was requested by the Scottish Government s Preventing Overweight and Obesity - A Route Map Towards Healthy Weight (February 2010) to establish a subgroup to provide advice on treatments for obesity. It was also agreed that surgical options should be placed in the wider context of weight management. This Best Practice Guidance is the result of the work undertaken by the subgroup. INDEX 1. Patient Pathway From Specialist Weight Management Services Into Assessment For Bariatric Surgery 2. Surgical Procedures 3. Assessment Of Patients Who Do Not Fulfil The Criteria 4. Clinical Outcomes Collection Of Data 5. Follow Up Protocols Following Surgery Strategic Approach The evidence for obesity treatment is growing and currently suggests a tiered health service is the most effective for population planning. The tiers are usually described as 1 to 4 thus: Tier 4: Specialist surgical service Bariatric surgery, gastric bands. Specialist follow up. Tier 3: Specialist Weight Management Access to multi-disciplinary team e.g. dietetic led programme, psychological expertise, physiotherapy. Tier 2: Primary Care NHS Healthy Weight programmes, Lifestyle Adviser, Community Dietetic. Drug therapy if appropriate supported by local clinical guidance. Tier 1: Population-wide health improvement work Community interventions including active referral, walking groups, leisure club classes, cooking classes. Links to Obesity Route Map.

5 1. PATIENT PATHWAY FROM SPECIALIST WEIGHT MANAGEMENT SERVICES INTO ASSESSMENT FOR BARIATRIC SURGERY Background To provide agreed referral guidelines for patients from Tier 3 into Tier 4 services including national gateway criteria. Recommendations Patients referred to Tier 4 services should be seen for their first pre surgery assessment (see below) within the referral to treatment pathway i.e. 18 weeks from when they leave Tier 3 to first being seen in Tier 4. Once surgery is agreed, the patients must receive treatment within 12 weeks. Pathway for Referral to Tier 4 Bariatric Surgery Services Tier 2: Primary Care management of diabetes and/or obesity GP identifies patient in priority group(s)* Type 2 diabetes, Age 18-44, BMI 35-40kg/m 2, diabetes <5 yrs Patient declines Referral to Tier 3 / specialist weight management services Patient opts into Tier 3 services Discharged due to non-attendance (12 month lock out from re-referral) Successful completion of specialist weight management programme* Weight maintenance or loss Major eating disorders excluded Weight gain (5kg) Other exclusion Patient declines Tier 4 referral Referral onwards to Tier 4 service for assessment and management Maintenance within Tier 3 as per local protocol *see priority groups below

6 Below is the gateway criteria for consideration of access to Tier 4 services. Priority group 1 Individuals who are aged between with a BMI kg/m 2 and recent (less than 5 years) onset of Type 2 diabetes Completion of Tier 3 intervention of at least 6 months duration with local programme compliance and completion of required activities e.g. food diaries Weight maintenance with additional weight loss of 5kg where possible Glycaemic control HBA1c maintained at <9% on completion of Tier 3 and supportive behaviour change compliance including achievement of locally agreed behavioural goals No contraindication to surgery identified Priority group 2 Subject to all Priority 1 patients being offered treatment and local Board agreement, individuals who are aged between with a BMI of kg/m 2 and onset of Type 2 diabetes of < 5 years Completion of Tier 3 intervention of at least 6 months duration with local programme compliance and completion of required activities e.g. food diaries Weight maintenance with additional weight loss of 5kg where possible Glycaemic control HBA1c maintained at <9% on completion of Tier 3 and supportive behaviour change compliance including achievement of locally agreed behavioural goals No contraindication to surgery identified Individual reviews Assessment of patients who do not fulfil the criteria agreed by NPF through the use of local Board review panels for individual cases Completion of Tier 3 intervention of at least 6 months duration with local programme compliance and completion of required activities e.g. food diaries Weight maintenance with additional weight loss of 5kg where possible

7 2. SURGICAL PROCEDURES Background To determine what the relative clinical effectiveness, cost effectiveness and safety of different bariatric surgery techniques (gastric bypass, gastric banding and sleeve gastrectomy) among: - Individuals who are aged between with a BMI kg/m 2 and recent (less than 5 years) onset of Type 2 diabetes - Individuals who are aged between with a BMI of kg/m 2 and onset of Type 2 diabetes of between 8-10 years Recommendations In the absence of robust evidence the choice of procedure should continue to be decided by the individual patient and surgeon as it is for any other surgical procedure. All units providing bariatric surgery should provide a range of procedures including banding but also bypass or sleeve and consideration should be given regarding any special requirements for women who are of child bearing age. As at present there should be the relevant clinical safeguards and competencies within the unit providing these procedures. Key Points Considered As the patient groups of interest were very tightly defined, there is limited direct evidence available to answer the question. The available data suggests that weight loss is more pronounced with gastric bypass and sleeve gastrectomy, and less so with banding. While banding appears less effective than other bariatric procedures, it is associated with fewer serious adverse side effects. Evidence from systematic reviews (of mainly lower level studies) suggests that bariatric surgery can result in improvements or resolution of Type 2 diabetes in many moderately or severely obese people. The effects seem to be more pronounced with certain procedures (e.g. BPD/duodenal switch, gastric bypass), and in people with newly established Type 2 diabetes (<5 years). A cost-effectiveness study reported that bypass surgery (relative to usual diabetes care) had cost-effectiveness ratios of US$7,000/QALY and US$12,000/QALY for severely obese people (BMI kg/m 2 ) with newly diagnosed and established diabetes, respectively. Banding surgery had cost-effectiveness ratios of US$11,000/QALY and US$13,000/QALY for the respective groups.

8 3. ASSESSMENT OF PATIENTS WHO DO NOT FULFIL THE CRITERIA Background To provide a process for handling exceptional cases which do not fall within the new pathway into Tier 4. Recommendations There should be consistency of approach across Scotland and between Boards along with the use of a standard format/process for proposed referrals into surgery. There should however be some flexibility regarding the criteria applied to allow for the current differences in service between Boards. The criteria should be transparent and discussed at good practice meetings between Boards. The recommended process is as follows: The local Board individual review panel process, either generic or bariatric surgery specific should be set up to assess cases; It should be multidisciplinary and consideration should be given to including weight and surgical specialists, psychologists and managers. There should be a national review of good practice of the Board cases carried out on a yearly basis. This Group should be headed by a Medical Director or Director of Public Health. The above outlines the best practice advice. Where the current practice in Boards exceeds this approach these should be maintained and examples shared at the annual meetings.

9 4. CLINICAL OUTCOMES COLLECTION OF DATA Background To recommend what data should be collected following bariatric surgery and also how this data should be collected. Recommendations It was recommended that the following fields be collected by boards Surgeon Site Patient CHI Criteria for selection for surgery - Type 2 DM Yes/No Duration Diabetes Medication Diet Oral Insulin GLP-1 Details at time of first assessment in Tier 3 service Weight Height Co-morbidities (non-mandatory) Exceptional Criteria /Reason for surgery (free text) Operative Procedure description Date of Operation Weight at time of operation Weight 1 year post op Weight 2 years post op Diabetes Medication at 1 year Diabetes Medication at 2 years Operative OPCS 4 code 2 nd Operative Procedure Description Operative OPCS 4 Code Date of Operation Weight at time of operation Weight 1 year post op Weight 2 years post op Diabetes Medication at 1 year Diabetes Medication at 2 years 3 rd Operative procedure Description Operative OPCS 4 Code Date of Operation Weight at time of operation Weight 1 year post op Weight 2 years post op Diabetes Medication at 1 year Diabetes Medication at 2 years Date of Operation. Boards should consider the best way in which to collect this information. The cost effectiveness of procedures will be reviewed and will determine future needs.

10 5. FOLLOW UP PROTOCOLS FOLLOWING SURGERY Background To provide a follow up protocol which should be used for people following Bariatric Surgery. Recommendations Follow-up after bariatric surgery consists of several components. Follow-up will be more intensive in the short to medium term, with lifelong follow-up required to detect late complications. Short to medium term (up to 2 years) This will take place within the Tier 4 service. Surgical: band adjustments, post-operative complications monitoring including nutritional bloods Dietetic: dietary assessments and advice Psychology: psychological support Advice on following physical exercise guidance (30 minutes 5 x a week where possible) and avoiding sedentary behaviour (in keeping with brief interventions) The design of services may vary between areas. Efforts should be made to ensure efficiency and avoid duplication of effort between members of the team. Patient burden should be taken into account when designing services. Innovative solutions may be required for rural settings, although all practitioners should have the support of being part of a multi-disciplinary Tier 4 service (e.g. joint training, CPD, MDT meetings). Long-term (lifelong from 1 year post-op) The purpose of lifelong follow-up is the early detection of complications and referral back to Tier 4 services when appropriate. This can occur in primary care (Tier 2) from 2 years post-operatively with a shared care system from 1 year post-operatively. The shared care can be with Tier 3 or Tier 2 depending on local arrangements. Depending on local arrangements the follow-up may remain between Tier 3 and Tier 4. This will include: Advice on following physical exercise guidance (30 minutes 5 x a week where possible) and avoiding sedentary behaviour (in keeping with brief interventions)

11 Weight monitoring Nutritional blood monitoring Complications monitoring Clear guidance will be required on the monitoring protocol, frequency of blood tests and the limits and actions to be taken on blood and weight results. Bloods tests and frequency are outlined in SIGN 115. As bariatric surgery will affect the care of obesity-related co-morbidities, there should be close communication between health professionals for effective management of patients co-morbidities as weight loss occurs (SIGN 115). For example general practitioners, diabetes services and sleep services. The Adult Exceptional Aesthetic Referral Protocol should be followed for any queries on body contouring surgery. CEL 27 (2011) Updated Adult Exceptional Aesthetic Referral Protocol The Guidance on Arrangements for NHS patients receiving healthcare through private healthcare arrangements provides the principles to be followed when patients attend following private care Peer support groups Patient to patient support groups can be very useful and are already available in most board area. Internet-based support may be helpful in rural areas. The use and growth of these support groups should be encouraged.

12 Group Membership Member Ms Heather Knox Co Chair Dr Jennifer Armstrong Co Chair Dr Sara Davies Mr Ian Ross Dr Carol Craig Ms Jan McClean Stuart Oglesby Ms Roseanne Urquhart Mr Duff Bruce Dr I Bashford Dr Susan Myles Mr Andrew de Beaux Susan McFadyen Representing NPF Scottish Government Health and Social Care Directorates Scottish Government Health and Social Care Directorates West of Scotland Planning Group West of Scotland Planning Group South East & Tayside Planning Group South East & Tayside Planning Group North of Scotland Planning Group North of Scotland Planning Group Medical Director Healthcare Improvement Scotland Scottish Academy Greater Glasgow and Clyde Advisers Dr Jennifer Logue Dr Shareen Forbes