A REPORT PREPARED FOR THE UK NATIONAL SCREENING COMMITTEE

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2 A REPORT PREPARED FOR THE UK NATIONAL SCREENING COMMITTEE BY MELANIE DAVIES KAMLESH KHUNTI UMESH CHAUHAN BERNIE STRIBLING ELIZABETH GOYDER AZHAR FAROOQI JAYNE HILL STEVE HILES NICK TAUB MARIAN CAREY MICHAEL BONAR PROFESSOR OF DIABETES MEDICINE, DEPARTMENT OF CARDIOVASCULAR SCIENCES, UNIVERSITY OF LEICESTER PROFESSOR OF PRIMARY CARE DIABETES AND VASCULAR MEDICINE, UNIVERSITY OF LEICESTER TRAINING FELLOW, NATIONAL PRIMARY CARE RESEARCH & DEVELOPMENT CENTRE, UNIVERSITY OF MANCHESTER; GP ADVISOR TO THE UK NATIONAL SCREENING COMMITTEE PROJECT MANAGER (CKD): KIDNEY RESEARCH UK SENIOR CLINICAL LECTURER PUBLIC HEALTH, SCHOOL OF HEALTH & RELATED RESEARCH, UNIVERSITY OF SHEFFIELD GENERAL PRACTITIONER, EAST LEICESTER MEDICAL PRACTICE ADDITION STUDY CO-ORDINATOR DIABETES RESEARCH, UNIVERSITY HOSPITALS OF LEICESTER DIABETES RESEARCH ASSOCIATE, UNIVERSITY HOSPITALS OF LEICESTER RESEARCH FELLOW IN MEDICAL STATISTICS, UNIVERSITY OF LEICESTER NATIONAL DIRECTOR : THE DESMOND PROGRAMME PROGRAMME MANAGER : THE DESMOND PROGRAMME Copyrights and acknowledgements Except for as stated below all copyright belongs jointly to the University of Leicester and the UK National Screening Committee: University of Leicester and the UK National Screening Committee The figures on pages 45, 46 and 130 are reproduced with kind permission from the BMJ Publishing Group. All rights reserved. All images (including but not limited to images, figures, tables and algorithms, whether labelled as such or not) on pages 11, 34, 35, 59, 60, 61, 62, 63, 64, 67, 82, 83, 107, 108, 109, 110, 114, 115, 124, 131 and 133, are the sole copyright of the University of Leicester. University of Leicester 2008 All rights reserved. No part of this publication may be reproduced, or stored in a database or retrieval system, distributed, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of the University of Leicester and the UK National Screening Committee. 002

3 FOREWORD FOREWORD TO UK NATIONAL SCREENING COMMITTEE HANDBOOK ON VASCULAR RISK ASSESSMENT Cardiovascular disease, diabetes and chronic kidney disease between them cause a huge amount of ill health and premature death. Our understanding of the most effective approaches to prevention, risk assessment and management of these diseases has developed considerably in recent years. These diseases manifest themselves in very different ways, but they share the same set of risk factors: poor diet, obesity, lack of physical activity, high blood pressure and smoking. And the risk factors interrelate with each other somebody with diabetes is at much higher risk of developing heart disease than someone without it. This handbook brings together in one place information on our current state of knowledge about vascular risk assessment, risk reduction and risk management. It has been designed to be comprehensive, giving an overview of the latest state of knowledge. The handbook reviews the clinical context and the available evidence in relation to risk assessment for these diseases. It goes on to give an overview of interventions and management of specific risk factors. The final section includes standard operating procedures for running risk assessment programmes and has useful examples to help front-line staff. The handbook is intended above all to act as a practical guide and resource to those who provide and commission services for people with, or who have risk factors for, vascular disease. It draws together existing, guidelines and tools available for CVD, diabetes and chronic kidney disease. It also builds on the experience and evaluation of the Diabetes and Heart Disease Screening Pilots commissioned by the UK National Screening Committee, which reported in The handbook is the product of great deal of dedicated hard work by Professor Melanie Davies and her team of colleagues at the University of Leicester. We warmly congratulate her on its publication and we recommend it to the healthcare and public health community as an invaluable resource. CONTENTS Dr Anne Mackie Programme Director UK National Screening Committee Sir Muir Gray Formerly Programme Director UK National Screening Committee 003

4 CONTENTS PART 1_Section 1 Remit of the Handbook 007 Background 007 Overview of this Handbook 008 Overarching Aims of a Programme 008 Broad Scope of the Programme 008 A Strategic Framework for Delivery of Vascular Risk Assessment and Risk Reduction 010 Record Based Strategy 012 Population Based Strategies for Vascular Risk Assessment 012 Sporadic and Opportunistic Risk Assessment Activities 013 Impact of Health Inequalities 013 CVD Score and Social Deprivation 013 Understanding the Purpose and Concept of Vascular Risk Assessment and Reduction 014 Communication of Risk 014 Reference List 015 PART 1_Section 2 Clinical Context & Review of the Evidence Cardiovascular Disease; Coronary Heart Disease, Stroke, Transient Ischaemic Attacks and 019 Peripheral Arterial Disease. The Need for Vascular Risk Assessment in Those at High Risk 019 The Approach to Multi-factorial CVD Risk Assessment 020 Cardiovascular Risk Assessment Methods 020 Choice of CVD Risk Assessment Score 021 Limitations of Risk Factor Assessment Using CVD Risk Scores 022 CVD Risk factors not taken into account using conventional CVD Risk Prediction Charts 022 Evaluation of Scientific Evidence: Bias Towards RCTs of Single Pharmaceutical Therapies 023 Potential Shortcomings of Using a CVD Risk Assessment Approach in Isolation 024 Chronic Kidney Disease 024 Defining CKD 024 Identifying CKD Earlier 025 Diabetes Mellitus 025 Screening, Early Detection and Prevention of Diabetes 026 Lessons from Diabetes, Heart Disease and Stroke (DHDS) Pilot 026 Implications for Policy and Practice from the DHDS 028 Measure-up Campaign from Diabetes UK 028 The Continuous Relationship Between Blood Glucose Levels and Vascular Outcomes Below 029 the Threshold for Diagnosing Diabetes Preventing Progression to Diabetes 030 Use of Glucose Testing to Detect Undiagnosed Diabetes and Its Utility in Detecting IGR 031 Recent Data From Screening Studies in Leicester 032 Activities in Finland Regarding Vascular Risk Assessment and Prevention of Diabetes 032 The FINDRISC Diabetes Risk Score 032 Type 2 Diabetes Risk Assessment Form (FINDRISC Test) 033 Comparison of Different Strategies to Identify those with Impaired Glucose Regulation 034 Black and Minority Ethnic Issues (BME) 035 Reference List

5 PART 1_Section 3 Vascular Risk Management Overview of the Efficacy of Interventions 041 Management of Specific Risk Factors 041 Smoking 041 Diet 041 Management of Obesity 042 Drug Management of Obesity 042 Lifestyle Advice for Those at High Risk of DM 042 Other Dietary Factors 043 Omega 3 Fatty Acids 043 Dietary Salt Intake 043 Fruit and Vegetable Intake 043 Antioxidant Vitamin Supplementation 044 Stanol Esters and Plant Sterols 044 Alcohol 044 Promoting Physical Activity 044 Hypertension 045 Interventions for Blood Pressure (BP) 045 Cholesterol and Lipid Lowering 047 The Benefits of Lowering Cholesterol for Cardiovascular Risk 047 Statin Therapy in High Risk Individuals without Cardiovascular Disease 048 Statin Therapy in Individuals with Established CVD 048 Cholesterol Targets for Therapy in Patients with Established Cardiovascular Disease 049 (Secondary Prevention) Measuring Lipid Levels 050 Management of Cholesterol in Special Groups 050 Antiplatelet Therapies 050 Reference List 051 CONTENTS PART 1_Section 4 Implications and Public Health Perspective Issues for Primary Care Trusts and Directors of Public Health 055 Review of Current Cardiovascular Risk Reduction Activities 055 Identification of Resource Implications, Costs and Benefits 056 Assessing Costs/Resource Implications 056 Assessing Potential Benefits 056 Assessing Potential Harm 056 Reducing Inequalities 056 Establishing Mechanisms for Evaluation and Audit 057 Other Issues 057 Screening Personnel 057 Data Recording 057 Reference List 057 PART 2_Section 1 Implementation of Vascular Risk Assessment Programme; Broad Overview Record Based - Existing Disease Registers 059 What the Practice Needs to Have in Place 061 Record Based Procedure 2 At Risk Registers 062 Clinical Assessment of Vascular Risk 063 List of Additional SOPs for Procedure 2 with Examples of all in SOP Section 064 Population-based screening 065 Self Assessment 067 Sporadic Activities 068 Reference List

6 PART 2_Appendix Comparison of Software Available for a Population Based CVD Risk Assessment Strategy 071 Development of the Vascular Component of the Mid Life Check Ongoing work at the University of Leicester Prototype Life Check Cardiovascular Risk Self Assessment Tool 078 Screening for Diabetes - Recent Data from Screening Studies in Leicester 080 Development of the Leicester Diabetes and Pre-Diabetes Risk Score 083 Comparison of Strategies to Detect DM and (Pre-diabetes or Impaired Glucose Regulation) Using 085 FPG in all, or Pre-Screening with either FINDRISC or the Leicester Diabetes and PDM Risk Score Example of Prototype Leicester Diabetes and Pre-diabetes Risk Score 087 Intensity and Energy Expenditure for Common Types of Physical Activity 089 Comparison of Various Diabetes Risk Scores 090 Reference List 091 PART 2_Standard Operating Procedures 093 Tables Table 1 Prevalence of Total Cardiovascular Disease (CVD) (over 10 years) 021 Risk in Adults aged in England, by Age and Sex Table 2 K/DOQI Stages of CKD 025 Table 3 Diagnosis of Diabetes Mellitus (DM), Impaired Fasting Glucose (IFG) 029 and Impaired Glucose Tolerance (IGT) Table 4 Performance of Screening Strategies for detection of T2DM and 031 Impaired Glucose Metabolism Table 5 Dietary Advice for those at Risk of Vascular Disease 041 Table 6 Optimal and audit standard blood pressure BP targets 046 Table 7 Record Based Procedure 1 Worked Example 061 Table 8 Record Based Procedure 2 Worked Example 064 Table 9 Population Based Strategy Worked Example 066 Figures Figure 1. Implementing Risk Prevention 008 Figure 2. Clinical Overview for Everyone in the Population to have CVD Risk Managed Appropriately 010 Figure 3. Implementation Overview of a Programme Framework 011 Figure 4. Record Based Strategy 011 Figure 5. Population Based Strategy 012 Figure 6. Approaches to Identification of IGR in the General Population 034 Figure 7. An Example of an Algorithm for Identification, Assessment and Intervention for those 035 at Increased Risk of Developing T2DM Figure 8. Intervention Thresholds for Blood Pressure 045 Figure 9. ABCD Treatment Algorithm for Hypertension 046 Figure 10. Record Based Strategy (Existing Disease Register) for Vascular Risk Assessment 059 Figure 11. Record Based Strategy (at Risk Register) for Vascular Risk Assessment 062 Algorithms Algorithm 1. Record Based Strategy Procedure Algorithm 2. Record Based Strategy Procedure Algorithm 3. Population Based Strategy 066 Algorithm 4. Self Assessment Approach

7 PART 1_Section 1 Remit of the Handbook The handbook, commissioned by the UK National Screening Committee [UK NSC], u Describes the context, and outlines evidence for a co-ordinated vascular disease control programme to identify and reduce risks of cardiovascular disease in the population. u Suggests aims, objectives and a delivery strategy framework appropriate for a Cardiovascular Disease (CVD) risk management programme. u Reports key messages from the Diabetes, Heart Disease & Stroke (DHDS) pilot project. u Provides examples of tools, resources and standard operating procedures that can be used by health professionals, many of whom are already undertaking some CVD risk assessment in a variety of ways. Background u The World Health Organisation defines a disease control programme as the co-ordination of disease prevention, screening and early detection, as well as disease management 1 (Figure 1). u Several groups have highlighted the need for a co-ordinated vascular disease control programme that would integrate prevention, screening, early detection and disease management for coronary heart disease (CHD), stroke, transient ischaemic attacks (TIA), peripheral arterial disease (PAD), Type 2 diabetes (T2DM) and chronic kidney disease (CKD). These conditions overlap considerably and often have similar risk factors. u Throughout this report, the term CVD is used to include CHD, stroke, TIA, T2DM, PAD and CKD. u The SIGN guideline on Risk estimation and the prevention of cardiovascular disease 2 takes a similar approach, as does the Joint British Society Guidelines Group 3 in their most recent report on prevention of cardiovascular disease in clinical practice. PART 1_Section 1 u NICE produced a draft guidance for consultation in June 2007 on Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease 4. u The UK NSC advice, following the pilots of screening for T2DM, and a review of current research, is that screening certain subgroups of the population for Type 2 Diabetes is feasible and should be taken forward, but this should be part of a programme to detect and manage vascular risk factors. It is appropriate that such a programme: looks at overall vascular risk in individuals. recognises that everyone in the UK is at some degree of risk of CVD, so that information and support to reduce risk should be widely available to all, whilst a subset of the population at higher risk may require more intervention to change lifestyle factors and consideration of pharmacological therapy. is proactive in the aim of reducing inequalities in CVD risk identification and management. integrates disease prevention with other public health activities aimed at detecting and reducing CVD risk, as there is considerable overlap. promotes a unified and systematic approach to delivery of preventive strategies for this group of conditions that meets national standards, is cost effective and can be quality assured. u In England, the National Service Frameworks for CHD, Diabetes and Renal disease have clear standards for prevention and early detection of the conditions 5-7. This handbook supports local health services in addressing these standards. 007

8 Overview of this Handbook u Part 1 describes the remit, rationale and clinical evidence for a holistic approach to CVD risk assessment, which incorporates assessment of diabetes risk. It sets out a possible outline framework for a coherent programme. u Part 2 focuses on standard operating procedures (SOP s) for disease prevention, screening, early detection and CVD risk management in practice. u It is important to remember that the evidence base is evolving; u Figure 1. Implementing Risk Prevention 1 Overarching Aims of a Programme u To reduce premature death from related vascular conditions including CHD, CKD, DM, stroke, TIA and PAD. u To reduce the incidence of these related vascular conditions. u To narrow inequalities in premature death from these related vascular conditions. Broad Scope of a Programme u Primary reduction of single or multiple risk factors for CVD in the population as a whole u Identification of those at high risk of CHD, CKD, Stroke, TIA or DM so that interventions can be delivered to prevent disease*. This includes the opportunity to prevent two-thirds of cases of T2DM diabetes with lifestyle intervention 8-9. u Identification of those already with CHD, CKD, Stroke, TIA or DM so these can be managed appropriately. *High risk of DM will be identified at a younger age than high risk for CVD in many people, especially in Black and Minority Ethnic (BME) populations 008

9 Risk Surveillance u To reduce future risk of CHD, DM, stroke, TIA, PAD and CKD u To ensure that all communities have equal access to vascular risk assessment which is appropriate to their risk factor profile and is appropriately adjusted according to ethnicity and socio-economic status u To ensure that all potential interventions from single risk factor intervention, to identification of those at high vascular risk and management of those with existing disease, are described at the level of the individual across the organisational spectrum, that professional issues are accounted for and that all potential systems and levers are used Risk Communication u To offer all adults undergoing a risk assessment feedback of the results with care planning and an agreed action plan to help reduce their personal risk 10 Risk Assessment u To offer adults access, according to need, to an individual risk assessment through a number of different strategies u To promote healthy lifestyle with a focus on the determinants of health influence on the risk of DM, CHD, stroke, TIA, PAD and CKD u To detect undiagnosed diabetes while undertaking a vascular risk assessment in order to offer microvascular screening for eye, renal and foot complications and CVD intervention at a lower threshold PART 1_Section 1 Risk Management u To integrate activities of the programme with primary prevention activities in the general population u To ensure that all those already identified with CHD, stroke, TIA, PAD, CKD or DM are offered optimal secondary intervention in line with existing NHS standards updated to reflect the best evidence u To ensure that those identified as being of higher risk of DM are offered appropriate diagnostic testing delivered according to agreed SOPs u To ensure that the programme is properly quality assured and that there is ongoing surveillance of the programme and its performance u To ensure that there is clear guidance and SOPs for the implementation of vascular risk assessment u To ensure that the overall programme of work does not increase, and preferably reduces, inequalities in health u To ensure the optimal integration of these policies with existing systems and initiatives, for example Quality and Outcomes Framework (QOF) 11, to avoid duplication and unnecessary testing and assessment. u To identify those at high risk due to lifestyle factors but who do not reach the traditional CVD risk threshold for intervention, usually because of their younger age, and offer them intensive lifestyle interventions 009

10 A Strategic Framework for Delivery of Vascular Risk Assessment and Risk Reduction Programme A clinical plan to ensure wide and equitable opportunity for cardiovascular risk assessment and management is shown in Figure 2. u Figure 2. Clinical Overview for Everyone in the Population to have CVD Risk Managed Appropriately Four broad streams of activity make up a framework for delivering such a programme. u 1) Record Based u 2) Population Based u 3) Self Assessment u 4) Sporadic Activity or Opportunistic Testing To ensure wide and equitable coverage all strategies may be implemented in parallel although the priority and timeframe for implementation may vary (See Figure 3). 010

11 u Figure 3. Implementation Overview of a Programme Framework PART 1_Section 1 u Figure 4. Record Based Strategy 011

12 Record Based Strategy (Figure 4.) This will comprise two groups. 1. Those with existing vascular disease (CHD/LVD/Stroke/PAD/TIA) 2. Those who can be easily identified from routine practice data or existing registers (e.g. obesity or hypertension, CKD registers) as being of high vascular risk. An alternative records based approach is using available routine primary care data to estimate CVD risk and then prioritising risk management to identify those with a CVD risk score over the next ten years of 20% 14. Optimisation of outcomes for those with established vascular disease and screening for related conditions. u For those with established vascular disease including those already on the CHD, Stroke/TIA and Left Ventricular Dysfunction (LVD) registers, the need for detection of undiagnosed diabetes is justified by lower intervention targets and opportunity for microvascular screening (for example access to National Diabetic Retinopathy Screening Programme) that is offered once a diagnosis of diabetes is established. Record based screening of those likely to be at high vascular risk. u Interrogation of the existing registers of those who may be at higher risk of vascular disease. This would be focused around the existing Obesity, Hypertension and CKD Registers, with all adults offered a comprehensive vascular assessment. Population Based Strategies for Vascular Risk Assessment (Figure 5.) Refers to risk assessment being offered to those who have not been identified via the self-assessment or record based approach. This approach was included in the Diabetes, Heart Disease and Stroke prevention (DHDS) pilot project and has demonstrated that this is feasible in a primary care setting, including the most deprived inner-city general practices 15. Broadly, this approach would proactively target and invite subjects, either not identified via the Record Based strategy or for whom no record or clinical data is available to allow record based stratification of risk. This might commence from the age of 40 and be repeated every 5 years (see Figure 5). The interval between assessments, if 10 year CVD risk is low at first, is likely to be not less than 5 years but subject to clinical judgement for individuals. The use of formal CVD risk scoring in those over 75 years is not validated; individual clinical assessment is appropriate. u Figure 5. Population Based Strategy Example 012

13 A modified version of the FINDRISC diabetes self-assessment tool has been suggested as a potential tool for identifying people at risk of vascular disease 12,13,17. Developed and used in Finland, and validated in other European countries, the tool is easy to complete and calculates an overall risk score ranging from 0 to 24 based on data supplied by the individual. It does not assess information on BP lipids or blood glucose levels. Notably FINDRISC does not assess smoking status. However, it has not been validated in a UK setting or in a BME population in the UK. Sporadic and Opportunistic Risk Assessment Activities This refers to a number of activities occurring in pharmacy chains, supermarket chains, food companies, occupational health departments or small businesses. These initiatives could make a major contribution, but do need to; u Be quality assured u Ensure that information from such screening activities is integrated into patients general practice records. u Ensure that the SOP for referral, diagnosis, risk management and intervention are clearly defined and followed. An example of this is Diabetes Screening via pharmacies advocated by the Pharmaceutical Society ( 18. Impact of Health Inequalities In England the Public Health White Paper, Choosing Health- making healthier choices easier (2004) gave priority to tackling health inequalities so that all groups in society benefit from improvements in public health 19. The gap in life expectancy (at birth) for men between the richest 10% of areas and the poorest 10% is 6 years (77.4 versus 71.4 yrs). For women, the gap is 3 years (81.2 versus 78.0 yrs) 20. PART 1_Section 1 Although people are living longer overall, the long-term trends show that the gap in mortality between the professional (social class I) and unskilled manual men (social class V) has increased by two and a half times in the last 60 years 21. Unemployed men are four times as likely to classify themselves as being in bad health as those in the top social class 22 and the geographical variation in health inequalities can largely be explained by deprivation 23. An important target set for the Department of Health in England is to increase life expectancy at birth in England to 78.6 years for men and to 82.5 years for women by reducing mortality from heart disease and stroke and related diseases by at least 40% in people under 75, with at least a 40% reduction in the inequalities gap between the fifth of areas with the worst health and deprivation indicators and the population as a whole 24. The Local Authorities and Primary Care trusts which make up the fifth of areas with the worst health and deprivation indicators the so called Spearhead Group, have been identified and one of the five factors for inclusion was high CVD mortality rates in under 75 year olds 24. An additional target is to narrow the gap in life expectancy between these areas in England by 10% by 2010 compared to the baseline. Work to identify and treat those at risk of CVD is a key component in achieving these targets 24. CVD Risk Score and Social Deprivation Any programme must consider its impact on, and aim to minimise, health inequalities. An example of a potential impact on health inequalities is the choice of the use of the CVD Risk Assessment tool, as there is evidence that use of conventional CVD risk calculators based on the Framingham data tend to overestimate CVD risk in low prevalence populations and underestimate it in those at highest risk This is of particular relevance to the South- Asian (SA) population and other BME groups living in the UK and all those living in deprived areas. Those at highest baseline risk as defined by ethnicity or socio-economic circumstances are less likely to access or benefit from screening and early treatment, thus potentially leading to increasing inequalities 27. One approach is to develop a CVD risk score which takes account of social deprivation and uses FH as a proxy for the impact of ethnicity. 013

14 The ASSIGN score (Assessing cardiovascular risk using SIGN guidelines to ASSIGN preventative treatment) has been developed to include social deprivation as a risk factor. The inclusion of family history provides an indirect approach to ethnic susceptibility 2,28,29. ASSIGN uses similar classic risk factors to Framingham, entered as continuous variables rather than categories. It includes the SIMD (Scottish Index of Multiple Deprivation) score for residential postcode. It also includes family history of cardiovascular disease, defined as a coronary heart disease or stroke in parents or sibling below the age 60 years or in several close relatives. Like Framingham it does not include obesity as a risk factor; unlike Framingham it excludes left ventricular hypertrophy as a risk factor. ASSIGN tends to classify more people with a positive family history who are socially deprived as being at highest risk. When used in its own host population it abolished a large social gradient in future CVD victims not identified for preventive treatment by the Framingham cardiovascular score. It therefore improved social equity, although overall discrimination of future events was not greatly improved 28,29. A demonstration of the ASSIGN tool is available at Another approach has been to use QRISK 30. This used data from UK practices contributing to the QRESEARCH Database. A cardiovascular disease risk algorithm (QRISK) was developed in a derivation cohort (1.28 million subjects aged years old). This algorithm used age, gender, smoking status, systolic blood pressure, ratio of total cholesterol to HDL. In addition to conventional CVD risk scores it also used BMI, family history of CVD in first degree relative, Townsend deprivation score and current prescription of at least one anti-hypertensive agent. When applied to a validation cohort (0.61 million subjects), the QRISK was better calibrated to a UK population. Overall the Framingham algorithm over predicted the CVD at 10 years by 35%, ASSIGN by 36% and QRISK by 0.4% 30. QRISK has undergone external validation with ongoing pilot work to integrate it into GP systems 31. Understanding the Purpose and Concept of Vascular Risk Assessment and Reduction All patients should expect to be given targeted and individualised advice about what they can do to reduce their own individual risk rather than the all or nothing concept of a positive or negative result. The terminology needs to be clear. Rather than screening one should use risk assessment and risk reduction. There is also a need to manage patient expectation to avoid increasing dissatisfaction and the recognition that many patients expect blood tests as part of their assessment process. This is particularly pertinent to blood glucose testing where a negative test result for diabetes itself may not be helpful to exclude those at high future risk of DM and vascular disease. Communication of Risk The key factors are; u Communicating the continuum of risk u Patient centred decision support u Standardisation of measurement and recording of risk factors Risk assessment involves identifying and recording risk factors. Within primary care this may be carried out by a number of individuals and therefore standardising how these are measured and recorded is a priority. Patients may have their blood pressure, weight, height, family history, smoking and alcohol status recorded without any communication as to the reasons why this has been done and yet the act of doing so can be regarded by some patients as receiving good care. 014

15 Risk communication is defined as the open, two way exchange of information and opinion about risk, leading to better decisions about clinical management 32. Discussing risk with patients in the clinical consultation has become increasingly important. Patients who are better informed and involved in decisions about their own care are more knowledgeable and also more likely to adhere to their chosen treatment plan 32,33. Patients values and preferences vary widely, as do their attitudes to risk. A two-way exchange of information is therefore important to explore the patient s personal beliefs to facilitate treatment decisions. It is possible for the healthcare professional to record risk factors, calculate risk scores and prescribe appropriate treatment without involving the patient in the decision-making process. Our aim should be to create a system where decision support is patient centred and focused towards increasing patient understanding, and allow patients to use this to their best advantage. It is increasingly apparent that most risk factors have a continuous relationship to risk of CVD and therefore it is important to move away from using the all or nothing or positive or negative concept when talking to our patients, but talk in terms of risk and risk reduction. Although some research has looked at issues of risk communication in the areas of CHD and other areas of health, there is still much to be learned. Changes in attitude or behaviour mainly occur when the individual or group identify with the threat, and people s perception of risk may be inaccurate and influenced by dramatic or sensational causes, e.g. with media coverage. Risk perceptions are socially constructed, and individual behaviours are driven by perception, or beliefs about risks, and not with the technical risk estimates provided by healthcare professionals. Communication of risk is not straightforward. Clinicians need to support patients in making choices by turning raw data into information that can be used to aid discussion of risk. Decision aids are one way of facilitating this process. Decision aids are systematically developed tools to aid patients to understand and participate in medical decisions. Decision aids often include visual representations of risk information and relate this information to more familiar risks. They can be in the form of booklets, DVDs, interactive computer programmes, tapes or webbased products. There is, however, very little evidence of the effectiveness of these aids in communicating risk in patients at high cardiovascular risk 34. PART 1_Section 1 It is important to ensure that we develop systems to clearly communicate risks to our patients and to engage them in prioritising them and implementing the changes that they wish to make in order to reduce their own individual risk. Structured education programmes such as the DESMOND Programme (Diabetes Education Self- Management Ongoing and Newly Diagnosed) include a health profile in which patients assess their own risk and then develop action plans to address this This is important, as a strong predictor of a patient s readiness for medical treatment and preventative behaviour is their perceived vulnerability to disease. We will be asking patients to take medicines and change their lifestyle when a combination of risk factors such as smoking, blood pressure, cholesterol and age results in them breaching a certain threshold for CVD risk. PART 1_Section 1 Reference List 1. The World Health Report. Reducing Risks, Promoting Healthy Life Scottish Intercollegiate Guidelines Network. Risk estimation and the prevention of cardiovascular disease: A national clinical guideline JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v National Collaborating Centre for Primary Care. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease - full guideline DRAFT

16 5. Department of Health. National Service Framework for Coronary Heart Disease Department of Health. National Service Framework for Diabetes:Standards. London: DH, Department of Health. National Service Framework for Renal Services Part Two: Chronic kidney disease, acute renal failure and end of life care Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N.Engl.J.Med. 2001;344: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N.Engl.J.Med. 2002;346: Department of Health & Diabetes UK Care Planning Working Group. Care Planning in Diabetes: Joint report Department of Health. Quality and Outcomes Framework (updated) Lindstrom J,.Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26: Rathmann W, Martin S, Haastert B, Icks A, Holle R, Lowel H et al. Performance of screening questionnaires and risk scores for undiagnosed diabetes: the KORA Survey Arch.Intern.Med. 2005;165: Marshall T. The use of cardiovascular risk factor information in practice databases: making the best of patient data. Br.J.Gen.Pract. 2006;56: Goyder E, Carlisle J. National Evaluations of DHDS Diabetes Screening Pilot Programme: Interim Report to UK National Screening Committee, Sheffield: Public Health Section of ScHARR Department of Health. Our health, our care, our say: a new direction for community services Silventoinen K, Pankow J, Lindstrom J, Jousilahti P, Hu G, Tuomilehto J. The validity of the Finnish Diabetes Risk Score for the prediction of the incidence of coronary heart disease and stroke, and total mortality. Eur.J.Cardiovasc.Prev.Rehabil. 2005;12: The Royal Pharmaceutical Society of Great Britain. RPS e-pic References on: Diagnostic testing in community pharmacy Department of Health. Choosing Health: making healthy choices easier. Public Health white paper Bajekal M. Healthy life expectancy by area deprivation: magnitude and trends in England, Health Stat.Q. 2005; Office of National Statistics. Trends in ONS Longitudinal Study estimates of life expectancy by social class Drever F, Doran T, Whitehead M. Exploring the relation between class, gender, and self rated general health using the new socioeconomic classification. A study using data from the 2001 census. J.Epidemiol. Community Health 2004;58: Woods LM et al. Geographical variation in life expectancy at birth in England and Wales is largely explained by deprivation. J. Epidemiol. Community Health 2005; Department of Health. Tackling health inequalities: the Spearhead Group of Local Authorities and Primary Care Trusts Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation 1991;83: Brindle P, Beswick A, Fahey T, Ebrahim S. Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review. Heart 2006;92: Cappuccio FP, Oakeshott P, Strazzullo P, Kerry SM. Application of Framingham risk estimates to ethnic minorities in United Kingdom and implications for primary prevention of heart disease in general practice: cross sectional population based study. BMJ 2002;325: Woodward M, Brindle P, Tunstall-Pedoe H. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart 2006;93: Cardiovascular risk assessment score for men and women aged years Hippisley-Cox J Coupland C, Vinogradova Y, Robson J, May M, Brindel P. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ, doi: /bmj

17 31. Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Brindle P The performance of the QRISK cardiovascular risk prediction algorithm in an external UK sample of patients from general practice: a validation study Heart. Published Online First: 4 October doi: /hrt Edwards A, Elwyn G, Mulley A. Explaining risks: turning numerical data into meaningful pictures. BMJ 2002;324: Gigerenzer G,.Edwards A. Simple tools for understanding risks: from innumeracy to insight. BMJ 2003;327: O'Connor AM, Stacey D, Rovner D, Holmes-Rovner M, Tetroe J, Llewellyn-Thomas H et al. Decision aids for people facing health treatment or screening decisions. Cochrane.Database.Syst.Rev. 2003;CD Skinner TC, Carey ME, Cradock S, Daly H, Davies MJ, Doherty Y et al. Diabetes education and self-management for ongoing and newly diagnosed (DESMOND): Process modelling of pilot study. Patient.Educ.Couns. 2006;64 (1-3): Davies MJ, Heller S, Khunti K, Skinner TC. The DESMOND (Diabetes Education Self-Management Ongoing and Newly Diagnosed) programme: from pilot to randomised controlled trial in a study of structured group education for people newly diagnosed with type 2 diabetes mellitus. Diabetic Medicine, (Suppl.2) :108.P333 PART 1_Section 1 017

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19 PART 1_Section 2 Clinical Context & Review of the Evidence Cardiovascular Disease Cardiovascular disease particularly, coronary heart disease (CHD), stroke/tia, peripheral arterial disease (PAD) and diabetes mellitus (DM) are the main cause of death in the UK. Even considering only coronary heart disease (CHD) and stroke in England and Wales, in 2005 more than one in three people died with 124,000 deaths; 39,000 of those who died were aged under 75 years 1. The death rate varies with age, gender, socio-economic status, ethnicity and UK geographical locality. Death rates from CVD have been falling since 1970, and it has been estimated that 58% of the CVD mortality decline in the UK in the 1980s and 1990s is attributable to reductions in major risk factors, principally smoking. The risk of CVD is directly related to blood cholesterol level and it is estimated that over 50% of CVD in developed countries is due to a blood cholesterol in excess of 3.8 mmol/l. In the Health Survey for England 2003, the prevalence of CHD (angina and heart attack) was 7.4% in men and 4.5% in women. With stroke added, CVD prevalence was 9.1% and 6.3% in men and women respectively. From age 65 onwards, between one quarter and one-third of men reported having CHD or stroke, and the prevalence rises with age: 26% between 65 and 74 years, 34% in those aged >75 years in men, with 14% and 25% respectively in women. The prevalence of cerebrovascular disease is also increasing, between 1994 and 2003 it rose from 7.1% to 9.1% in men, and 5.2% to 6.3% in women 2. A number of surveys have shown that the majority do not achieve recommended lifestyle, blood pressure (BP) and lipid targets despite the increase in prescribing of anti-hypertensive and lipid lowering therapies 3. Of major concern is that in apparently healthy individuals there appears to be an increasing prevalence of a combination of risk factors that puts them at high risk of developing vascular diseases including CHD, cerebrovascular disease, CKD, T2DM and PAD. In the Health Service for England 2003, the prevalence of smoking in those with established CVD was 28% in men and 25% in women, 64% of men and 55% of women were overweight (BMI 25kg/m 2 ), 29% of men and 27% of women had hypertension as defined by a blood pressure of >140/90 mmhg and 68% of men and 67% of women had an elevated cholesterol (>5mmol/L). The overall prevalence of DM was 4.3% in men and 3.4% in women 2. PART 1_Section 2 T2DM is a growing public health concern worldwide. The prevalence is increasing and diabetes contributes significantly to overall health inequalities within countries. DM leads to significant morbidity and mortality which can be reduced by effective treatment and preventative measures. BME groups, particularly the SA and Afro Caribbean populations, generally have a higher prevalence of T2DM and are also at greater risk of DM associated mortality and complications compared to the White European population. 75% of deaths in people with diabetes are caused by CVD. The Need for Vascular Risk Assessment in Those at High Risk The rationale for estimating total CVD risk based on major risk factors is because: u Risk factors tend to cluster u Co-existent risk factors tend to have a multiplicative effect on risk The advantages of this approach are that interventions are considered in the context of overall CVD risk. A threshold for drug interventions is based on robust scientific evidence. Treatment is targeted on the threshold of total CVD risk so by definition it tends to be targeted at those at highest risk and therefore the absolute benefits of such treatment will be greatest. 019

20 The Approach to Multi-factorial CVD Risk Assessment The NSF for CHD sets out clear standards for prevention and treatment 4. This is focused on people with established CHD and other related conditions of high vascular risk but also on offering treatment to apparently healthy individuals at high multi-factorial risk of developing CHD. At that time, risk calculators used CHD risk and it was suggested that those whose total CHD risk was >15% (equivalent to the current CVD risk of 20%) over 10 years should be eligible for both lifestyle and appropriate therapeutic interventions. However, given the scale of the task in identifying and managing such high risk individuals, it was advocated that a staged approach be used and that the starting point was those with a CHD risk of >30%. However, it is now clear that this policy of targeting very high risk, particularly with lipid lowering therapy, falls short of the scientific evidence base that now exists. There are RCTs showing clinical benefit down to levels of CHD risk of 6% (CVD risk of 8%) 5. There has been a focus on lipid lowering therapy and the evidence base for this is now even stronger, such that recent NICE guidance recommended statin therapy for adults with clinical evidence of CVD and for primary prevention of total CVD risk in those who have a 20% or greater 10 year risk 6. Subsequently the SIGN guidelines advocate that asymptomatic individuals over the age of 40 years with 20% risk of CVD over the next 10 years should be considered at high risk and warrant intensive lifestyle change and drug intervention including statins. 7 This is consistent with the advice in the recent public consultation document on Lipid Modification from NICE 8. Cardiovascular Risk Assessment Methods The Joint British Society (JBS) CVD Risk Prediction Chart based on the Framingham data can be used to estimate total risk of developing CVD, i.e. CHD and stroke, over a period of 10 years based on 5 key risk factors: u Age u Sex u Smoking habit u Systolic blood pressure (BP) u Ratio of total cholesterol to HDL cholesterol. The estimate is a probability (i.e. percentage chance) of developing CVD over the next 10 years and is therefore referred to as the total CVD risk. Current definitions state that the total CVD risk of over 20% is defined as high risk, and all those at high risk will require lifestyle intervention and advice and drug therapy focused around antithrombotic, lipid lowering and BP lowering drugs 6-8. SIGN specifically commissioned work to incorporate risk coefficients accounting for both family history and social deprivation and advocate the use of a new CVD risk score ASSIGN 7,9. However the cut off used ( 20%) and the age group targeted (Adults over age of 40 years) is likely to be consistent with the emerging guidance from NICE 8. The consultation document on Lipid Modification currently suggests that all adults aged over 40 years should have a risk score calculated with 20% defined as high risk

21 Choice of CVD Risk Assessment Score In this handbook we acknowledge that this field is moving rapidly. The latest JBS guidance uses a modified Framingham method, but SIGN advocate using the ASSIGN Tool, and recent draft NICE guidance also suggested using a Framingham based risk score There are a number of other risk assessment methods available. These include the New Zealand risk calculator, the Heart Score, the Sheffield Risk Table, the ETHRISK and others The Heart Score is based on the SCORE project and has been adopted by the Joint European Society guidelines. 15 It has the advantage of being based on European epidemiological studies, and also predicts CVD risk and not CHD risk alone. However, it can only predict fatal CVD and therefore underestimates the true burden of total CVD risk. The latest JBS guidance continues to recommend the Framingham based algorithm 10. The principal reasons stated are: u That it has been widely adopted u Physicians in both hospitals and primary care are familiar with the CVD risk threshold of 20%, u That the new algorithms do not offer sufficient advantage. In order to try to reduce the bias in terms of age group, the charts are provided for 3 age groups: <50 years, years, and >60 years. However, the actual risk given for these 3 age bands are based on the actual ages of 49, 59 and 69 respectively. Therefore the charts will deliberately tend to overestimate risk within the younger age bands, and potentially underestimate risk for people aged 70 or over. The approach used may change with the publication of the new QRISK tool 16. This algorithm has used parameters included in the Framingham method but also measures of social deprivation and other factors such as BMI 16. Whichever tool is used, the vascular risk threshold defined for intensive lifestyle and appropriate drug therapies is 20% over 10 years 7,8,10,16. This threshold for drug treatment cannot be based directly on the evidence from clinical trials because most clinical trials are uni-factorial in their design. Therefore, extrapolating from clinical trial results in hypertension or dyslipidaemia to an intervention threshold based on multifactorial risk is not possible. Nevertheless, absolute CVD event rates of 20% were common in most of the uni-factorial intervention trials. However, it is important that a risk threshold for drug treatment is a matter for clinical judgment. The size of the populations potentially eligible for intervention based on 20% CVD risk alone has been estimated to be around 23% of men and 8% of women aged years, based on data from the Health Survey of England 2003 (Table 1) 2. However there is some suggestion that these figures will be reduced if the QRISK score is used 16. PART 1_Section 2 CVD Risk (%) Age (%) (%) (%) (%) Total (%) Men < < < < Women < < < < Source HSE 2003 u Table 1. Prevalence of Total Cardiovascular Disease (CVD) (over 10 years) Risk in Adults aged in England, by Age and Sex 2 021

22 Limitations of Risk Factor Assessment Using CVD Risk Scores u It is vital that clinical intervention and assessment for a vascular risk reduction programme is not based on CVD risk score alone. u Conventional risk scores tend to overestimate risk in low risk populations and underestimate in high risk groups 17 u It is important to consider other factors and to ensure that the assessment of vascular risk using a risk assessment tool does not increase inequalities u There is no strong evidence supporting the assumption that CVD risk assessment performed by clinicians improves health outcomes 17 Risk assessment tools for vascular disease do present somewhat of a dilemma. This is because: A review including 27 studies with data from over 71,000 participants, showed that the predicted to observed ratios ranged from an underestimate of 0.43 in a high risk population to an over-prediction of 2.87 in a lower risk population so risk scores tend to overestimate risk in low risk populations and underestimate in high risk groups 17. One approach may to be multiply the derived Framingham risk score by 1.4 in the SA population. Another approach would be use an ethnically-adjusted prediction model, which adjusts the background risk of different geographical regions and ethnic groups 9,16. In Scotland when they applied the Framingham risk score to an adult population (13,000 aged years from 25 districts in Scotland) they found that overall the Framingham risk score overestimated actual observed CHD risk in the whole cohort but seriously underestimated the large gradient in risk by socio-economic status 7. They concluded that application of the Framingham risk score for essentially what is preventative treatment would result in relative under treatment of the most socially deprived, potentially exacerbating social disparities in disease rates. They addressed this by using a risk score system (ASSIGN) adjusted for social deprivation 9. A similar approach which may be appropriate is the QRISK tool which also includes Townsend Score and other risk factors such as BMI 16. RCTs examining the effect on clinical outcomes of healthcare professionals performing a vascular risk score in people predominantly without known vascular disease; show a very poor uptake by doctors and health care professionals in terms of the clinical decision support systems. There is no strong evidence supporting the assumption that CVD risk assessment performed by clinicians improves health outcomes. It is therefore important to engage practice staff on the ground in the overall strategy and implementation of the policy in practice 17. CVD Risk factors not taken into account using conventional CVD Risk Prediction Charts The current dilemma is that a number of other risk factors not included in the traditional risk assessment tool should also be taken account of in assessing and managing a person s overall vascular risk. These include; u Ethnicity u Family history of premature CHD u Family history of DM (first degree relative) u Weight (as defined by Body Mass Index) u Abdominal obesity as assessed by waist circumference u Impaired glucose regulation (both IFT/IGT and HbA1c 6%) u CKD u Raised triglycerides u Socio Economic Status 022

23 Recent guidelines recognise the importance of these additional risk factors and the shortcomings of the conventional CVD risk prediction tool 7,8,10 ; for example: u In people originating from the Indian subcontinent it is reasonable to assume that CVD risk is approximately 1.4 times higher than predicted from the charts 10 u Abdominal obesity as assessed by waist circumference of >94 cms in men and >88 cms in women (in South Asians 90cms in men and 80 cms in women) increases the risk of both diabetes and CVD u Impaired glucose regulation as defined by a fasting plasma glucose of 6mmol/L (IFG) and IGT (2 hour glucose during an OGTT of between 7.8 and 11.1 mmol/l) indicates an increased risk of developing DM and CVD. (Evidence suggests an increase CVD outcome by 50%, so by a factor of 1.5) 20 u Raised fasting triglycerides of >1.7 increases the risk of CVD by a factor of u A family history of premature CVD and especially coronary heart disease in men <55 years and women <65 years in a first-degree relative increases the risk of CVD by 1.3 8,21,22 u A first-degree relative history of DM also increases risk of subsequent development of T2DM u Individuals with Chronic Kidney Disease (CKD) are at significantly increased risk of CVD events 23 u Presence of Albuminuria and an egfr < 60 mls/min/1.73m 2 are independent predictors of CVD events Evaluation of Scientific Evidence: Bias Towards RCTs of Single Pharmaceutical Therapies u If we were only to consider clinical trial evidence, drug treatment would always take precedence over other interventions, principally those related to lifestyle change PART 1_Section 2 u It is important that we value evidence from epidemiological studies that give information as to the benefit of lifestyle intervention in those at high vascular risk Evidence-based medicine involves the integration of individual clinical expertise with the best available clinical evidence from systematic research. It is a holistic procedure, from the definition of important clinical questions, to searching for the best evidence, critically appraising the evidence, and applying the evidence to individual patient care and evaluating the process. This hierarchy by definition places meta-analysis of clinical trials at the top. Therefore in this context there tends to be greater emphasis on RCTs of individual drug therapy rather than epidemiological studies of the adverse effects of lifestyle factors such as smoking, poor diet and physical inactivity, or beneficial effects of healthy diet and increased physical activity. Another important factor is that whilst clinical trials may be well suited to evaluating a single drug therapy against a single risk factor, there are inherent limitations in the methodology of clinical trials when evaluating complex lifestyle interventions in the free-living population. If we were only to consider clinical trial evidence, drug treatment would always take precedence over other interventions, principally those related to lifestyle change. It is important that we value evidence from epidemiological studies that give information as to the benefit of lifestyle intervention in those at high vascular risk. 023

24 Potential Shortcomings of Using a CVD Risk Assessment Approach in Isolation There are disadvantages of using a CVD risk assessment tool in isolation; u A number of risk factors are not included in the Framingham based Risk Score as outlined above u Treatments will tend to be concentrated in older people and especially in those >70 years unless the potential effect of lifetime risk factor exposure is taken into account u Evidence-based medicine that favours single intervention RCTs as opposed to complex lifestyle interventions that may be effectively offered to patients at a much younger age even though they may not reach high vascular risk thresholds u It may increase inequalities unless adjustments are made, for example, in socio-economically deprived and BME populations Chronic Kidney Disease CKD is a worldwide public health problem. Early CKD (mild to moderate) is very common, with an estimated 11% of the US adult population having CKD 24. Early CKD if not treated, can progress to more severe forms of the disease. In the UK, a recent study has found that 8.5% of the general population have moderate to severe CKD 25. Established renal failure is relatively rare, but treatment with dialysis or transplantation is very costly. In the UK, it is reported that the number of patients needing dialysis or transplantation is rising rapidly and is unlikely to reach a steady state for another 25 years 26. Therefore, it is important to treat CKD early to prevent the progression of the disease to renal failure. CKD patients have an increased risk of CVD that accounts for 40-50% of all deaths in CKD 27. Risk markers of CKD have been shown to be highly predictive of cardiovascular events 28. This is very important because individuals with CKD are more likely to die of CVD than to develop kidney failure and this has led to the recommendation that these patients should be considered in the highest risk group for preventative treatment of CVD 28. Multiple risk factor intervention taking a chronic disease management approach can halt decline of kidney function and there is evidence that the combination of declining kidney function and proteinuria identifies the highest vascular risk and progressive kidney disease risk group However there is a lack of evidence of the benefit of Statin therapy in those with CKD alone. Defining CKD CKD is an umbrella term for all types of kidney disease that slowly destroy the kidneys over months or years. In the UK, CKD is now classified according to the NKF-K/DOQI guidelines (see Table 2) 24. This classification system is based on estimated GFR (glomerular filtration rate) as an indicator of kidney function, irrespective of the cause of the kidney disease. It identifies the progression of CKD in five stages from mild to severe. Proteinuria refers to the presence of increased protein in the urine. Proteinuria is an important marker of kidney damage and a potent predictor of increased cardiovascular risk 33, and of risk of progression. From 2006, egfr has been included with creatinine testing in many laboratories. Studies of general practice computerised medical records show that it is feasible to identify people with CKD and that computer records are a valid source of data The compilation of a register of people with CKD will enable appropriate investigation, advice, treatment and support for the patient to preserve kidney function and to reduce the risk of CVD. Only a minority of people with stage one or two CKD go on to develop end stage kidney disease and symptoms do not usually appear until stage four. 024

25 u For the purpose of this handbook we refer to CKD stages 3-5. However despite the increased awareness of CKD it is still often considered in isolation 24 u Early identification of CKD is important as it allows appropriate measures to be taken to slow or prevent the progression to more serious CKD u CKD is an independent risk factor for CVD and a multiplier of other risk factors u Identification of CKD also allows us to combat the major risk of illness or death due to CVD Stage GFR* Description Treatment stage Normal kidney function but urine findings or structural abnormalities or genetic trait point to kidney disease Mildly reduced kidney function, and other findings (as for stage 1) point to kidney disease Observation, control of blood pressure. Observation, control of blood pressure and risk factors Moderately reduced kidney function Observation, control of blood pressure and risk factors Severely reduced kidney function Planning for endstage renal failure. 5 <15 Very severe, or endstage kidney failure (sometimes called established renal failure) Treatment choices. * All GFR values are normalised to an average surface area (size) of 1.73m 2 u Table 2. K/DOQI Stages of CKD 24 PART 1_Section 2 Identifying CKD A recent paper describes a screening strategy for patients with CKD 34. This is based on data from an 8 year follow-up of 65,000 subjects in Norway. 4.7% of the adult population aged >20 years had CKD as defined by an estimated GFR filtration rate of <60mls per minute/1.73 m 2. The most effective strategy was to restrict screening to those with HT, DM, or aged over 55 years 34. A high risk screening model targeting only those with DM or HT identifies less than half of those with CKD. However, a model that targets those aged >55 years identifies 93%, with only a few more people needed to screen than the high risk strategy (9 versus 6 per case). It was noted that the incidence of end-stage renal disease was lower among people with GFR of 30-60mls per minute/1.73 m 2 while CVD mortality was much higher (4.2 per 100 person years). Those with egfr of <30 mls per minute/1.73 m 2 had a high risk of both renal failure and CVD mortality (2.6 and 10.1 per 100 person years) 34. It is possible that the simple strategy targeting people with DM, HT or aged > 55 yrs has the highest detection rate for CKD, combined with the low number needed to screen. Most patients detected had a low risk of progression to end-stage renal disease. The cost effectiveness of screening needs further research and at present we suggest routine egfr in those with HT or DM until there is further research in this area. Diabetes Mellitus T2DM is a growing public health concern worldwide. The prevalence is increasing and diabetes contributes significantly to overall health inequalities within countries. DM leads to significant morbidity and mortality which can be reduced by effective treatment and preventative measures. BME groups, particularly the SA population, generally have a higher prevalence of T2DM and are also at greater risk of DM associated mortality and complications compared to the White European population. 75% of deaths in people with diabetes are caused by CVD. 025

26 u There is now clear evidence that the majority ( 2 / 3 ) of T2DM can be prevented by lifestyle and diet interventions u Patients with established T2DM are all at high CVD risk and the use of CVD risk charts is no longer advocated u A diagnosis of T2DM means patients are offered vascular interventions at a lower threshold (for example lower BP targets are used) u A diagnosis of T2DM means patients are placed on a disease register and in addition are offered screening for microvascular complications (In particular Retinopathy and Nephropathy) Screening, Early Detection and Prevention of Diabetes The increasing evidence base for effective primary and secondary prevention of CVD and T2DM has led to increasing interest in screening, early detection and risk reduction intervention. Despite the lack of randomised trial evidence and long-term outcomes for the effectiveness of screening for T2DM, screening in high risk populations has been recommended by Diabetes UK, the American Diabetes Association and the Australian Diabetes Association 37,38,39. Up to 750,000 people with Type 2 DM remained undiagnosed in the UK with evidence that people have the condition for between 9 and 12 years before diagnosis 40,41. The UKPDS showed that up to 50% of people already have complications such as CVD and microvascular complications including neuropathy, nephropathy and retinopathy at diagnosis 42. There is evidence that those diagnosed by screening are as likely to have complications as those diagnosed on the basis of symptoms 4. Risk of CVD is increased among patients with previously undiagnosed diabetes compared to people with normal glucose tolerance. Patients with established DM are all considered at high vascular risk and therefore the continued use of vascular risk assessment charts is no longer advocated 7,8,10. The importance of a diagnosis of T2DM means that patients are offered vascular interventions at a lower threshold 7,10. Furthermore, patients are placed on a disease register (the Diabetes Register) and are offered microvascular screening, including for nephropathy and retinopathy 44,45. There is a range of evidence that screening for diabetes in general practice may be feasible, and identifies previously undiagnosed cases 46. A number of different approaches have been advocated including the use of risk questionnaires and risk assessment tools which aim to identify those who would benefit from attending for a blood test. Lessons from Diabetes, Heart Disease and Stroke (DHDS) Pilot 46 The Diabetes, Heart Disease and Stroke Project (DHDS) looked at the implications of vascular risk assessment in a general practice setting and provided useful information on its impact and feasibility. Important lessons learnt from this were: Testing u 50% of practices already had some systematic screening for vascular risk and DM in place, but there was marked variation particularly with regard to diagnostic testing for DM. u If practices used OGTTs these were often carried in the hospital setting. Population Screened u Around 25% of the practice population were eligible on age criteria (between 40 and 74 years) once those with a known BMI of 25 and those who had had previous blood glucose testing within the past two years were excluded. u Retired people, women and the worried well were most likely to attend for screening; patients at low risk still attended, expecting reassurance. 026

27 Results u Around 60% of those invited for screening attended, and around one-third had a positive screen test of whom 1.4% had newly diagnosed diabetes. This equates to 2 per 1,000 registered population of the practice. u There was marked variation in the practice yield of new cases of DM. Practices that had the highest yield were in fact in a predominantly white population in a deprived area who used all three inclusion criteria including age, BMI and recent blood glucose to select patients and used OGTTs for diagnosis. Follow Up u Follow-up of those who undergo initial testing was crucial as one-third of patients with an initial random capillary blood glucose of 6mmol (positive, as defined in this project) did not have any results of diagnostic testing recorded on their screening records, even after updating records from practice information systems. It is important to have systems that accurately record the results of screening investigation and prepare patients for the need for further diagnostic testing. u Patients tended to believe that a negative result gave them the all-clear, and therefore communicating continuous risk with regard to results of glucose tests, BMI, etc. needs to be clearly and carefully delivered, i.e. everyone is at risk. Logistics u An updatable, searchable, clinical database is crucial for identifying eligible patients. u Data collection was crucial and half the practices used their own locally designed templates. u It is important to implement strategies so that the practice can plan and cope with the increased workload. u Opportunistic invitation was popular because of the perceived high success rate with patients already attending the practice for an unrelated reason. u Adapting the method of invitation to the type of patient population and ensuring it was appropriate to the practice, generated better attendance. PART 1_Section 2 Staff u 55% of screening was undertaken by the healthcare assistant, who had a crucial role in implementation of the programme (see Job Description in SOP Section on page 147). u A number of practice staff need to be involved in identifying, inviting and providing vascular risk assessment and discussion of the results. u Staff felt overall job satisfaction from providing preventative care, and healthcare assistants enjoyed their increased responsibility. Barriers u The procedure was relatively time consuming, taking around 2 hours per person invited, with around one-third of time spent on identification and two-thrids spent on screening time. u Staff viewed the criteria for screening as sometimes being too restrictive and unfair to patients, particularly those in BME communities and those with a positive family history. u Staff were also concerned about the equity of access for all patients. u Sending out letters was costly in terms of staff time, but letters sent in English appeared to have a better uptake than in those other languages. u Barriers to attendance for screening and diagnostic testing were a lack of availability during the evenings and weekends. u Communication with BME populations may be enabled through local organisations, rather than direct translations of written information. 027

28 Implications for Policy and Practice from the DHDS Any programme will need to have: u A clear and consistent method of data collection u A system for data audit and continuous quality improvement u Screening invitation letters should be as simple as possible, and the value of translated materials needs to be explored in each location u Integration of assessment in the other ongoing practice activities may increase uptake and represent a more cost effective strategy Measure-up Campaign from Diabetes UK Diabetes UK has long been calling for the early identification of people with T2DM, to reduce the impact on individuals and NHS resources. Diabetes UK suggest screening those with the following risk factors: u White Europeans aged over 40 years; u People from BME groups aged over 25 with one or more of the risk factors below; u A first-degree family history of diabetes; u Those with obesity, morbidly obese or those who are overweight with a sedentary lifestyle; u Waist circumference measurements include >94cms for white/black men and 90cms for SA men, and >80cms for all women. u People with a history of IHD, cerebrovascular disease, PAD or treated HT; u Those with a history of gestational diabetes; u Women with polycystic ovary syndrome; u Those with previous IGT or IFG; u Those with severe mental health problems; u Those who have hypertriglyceridaemia. However, the evidence would suggest that whilst family history and WC measurements are ideal to be used for patients in terms of their self-assessment of risk, they are not often recorded on routine clinical data sets. Furthermore, isolated risk factors such as gestational diabetes and PCO are often not recorded on information systems and may have limited utility as most patients have other more easily ascertained risk factors such as BMI and a history of HT. Whilst screening those with severe mental health problems may well have a good rationale, this strategy has not been evaluated and the utility of this approach and its added value above screening for other more easily identifiable risk factors is not known. 028

29 The Continuous Relationship Between Blood Glucose Levels and Vascular Outcomes Below the Threshold for Diagnosing Diabetes u Glycaemia, whether evaluated by fasting glucose, a 2 hour glucose level during an oral glucose tolerance test (OGTT) or by HbA1c, has a continuous relationship to the risk of CVD 47,48 u This continuous relationship is similar in those both with and without DM u As is the case for BP and cholesterol, the absolute risk of CVD associated with any level of glycaemia is also determined by the presence of other risk factors Although the relationship between glycaemia and CVD is a continuous one, the traditional assessment and categorisation of glycaemic status has been using either a fasting sample or OGTT that categorises individuals as either normal glucose tolerance, impaired fasting glycaemia (IFG), impaired glucose tolerance (IGT) and DM (Table 3) 49. Fasting Plasma Glucose (FPG) test (preferred)* Random Plasma Glucose test Oral Glucose Tolerance test (OGTT) Diabetes Impaired Glucose Regulation (IGT, IFG or both) FPG 7.0 mmol/l plus symptoms IFG 6.1 and <7.0 mmol/l Random Plasma Glucose 11.1 mmol/l plus symptoms 2-hour plasma glucose 11.1 mmol/l IGT + 2 h PG 7.8 and <11.1 mmol/l Normal FPG 6.0mmol/l 2 h PG <7.8mmol/l PART 1_Section 2 * The FPG is the preferred initial test for diagnosis, but any one of the three listed is acceptable. In the absence of unequivocal hyperglycaemia with acute metabolic decompensation, one of these three tests should be repeated on a different occasion to confirm diagnosis. Venous plasma samples are used. (symptoms are the classic ones of polyuria, polydipsia, and unexplained weight loss). Fasting is defined as no caloric intake for at least 8 hours. Water is allowed. Random = anytime of day without regard for time since last meal OGTT should be performed using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water u Table 3. Diagnosis of Diabetes Mellitus (DM), Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) 49 u Focusing CVD prevention solely on diagnosed cases of DM will have a limited impact, and the focus needs to be broadened to include those with Impaired glucose regulation (IGR), this includes both IFG and IGT. It is important to recognise that diagnosed diabetes only accounts for about 20% of all subsequent fatal CVD, with the majority of the events coming from apparently healthy individuals with a HbA1c of >6% but in the absence of DM 48. Of patients admitted to the Coronary Care Unit with a myocardial infarction, approximately 40% have abnormal glucose tolerance and 25% have undiagnosed T2DM 50. The total risk of CVD for any value of HbA1c is further determined by the presence of other risk factors such as smoking, elevated BP and dyslipidaemia. Therefore, focusing CVD prevention solely on diagnosed cases of DM will have a limited impact, and the focus needs to be broadened to include those with impaired glucose regulation (IGR), this includes both IFG and IGT. 029

30 Preventing Progression to Diabetes u The best evidence for prevention of T2DM is in those with IGR (particularly IGT) 35,36 u Diet and Lifestyle has been shown to be the most effective intervention 35,36,51 u Fasting or Random Glucose used alone are very poor discriminators of IGT and IFG and will miss the majority of cases The best evidence for prevention of progression to T2DM is in IGT and IFG using diet and lifestyle intervention 35,36,51,52. IGT and IFG are under-diagnosed in clinical practice. It is well established from a number of epidemiological studies in North America, Europe and Asia that approximately 1 in 7 of the population have either IFG or IGT 20,53,54. There have now been a number of studies published that showed that intensive and effective lifestyle interventions lead to a 60% reduction in subsequent progression to T2DM in these subjects 35,36. There is a need for effective, feasible and affordable interventions that can be offered to people, in particular those with IGR (IGT and IFG), as in these groups there is good evidence that lifestyle change can delay progression to diabetes 35,36. The dilemma is that the glucose cut-off for diagnosing undiagnosed T2DM should have reasonable sensitivity and specificity. However, fasting or random glucose are both very poor discriminators of patients with IGR 55. Their use may lead to false reassurance as patients may regard the fact that they have a negative test means they are normal. There is ongoing work looking at effective behavioural interventions for people identified as being at high risk of future diabetes and vascular disease. Such subjects are unlikely to be identified using conventional vascular risk scores, as these tend to be biased in terms of detecting older patients. Diabetes risk scores tend to identify people decades earlier on the basis of poor lifestyle choices, and offer the opportunity for targeted lifestyle intervention (See page in the Appendix). It is important that any blood glucose testing done as part of a vascular control programme is focused on those with other risk factors (based on obesity, family history, hypertension etc.), with clear procedures for those who may need confirmation with an OGTT. The Diabetes Heart Disease and Stroke (DHDS) Programme showed that practices that offered widespread testing based on random glucose based on age criteria alone had the lowest yield of new cases, whereas practices which targeted screening on those with risk factors and followed with OGTT, had the highest yield of new cases of T2DM 46. When undertaking any vascular risk assessment including screening for diabetes, it is important that the individual is aware of the issues regarding employment, insurance and driving should a diagnosis of either CHD/CKD or DM be established. Practitioners should have a low threshold in offering diagnostic testing for diabetes in anybody who presents with symptoms, i.e. polyuria, polydipsia and unexplained weight loss or visual blurring. Such individuals should be offered an immediate random plasma glucose which, if 11.1 mmol/l in the presence of symptoms indicates a new diagnosis of diabetes. 030

31 Use of Glucose Testing to Detect Undiagnosed Diabetes and Its Utility in Detecting IGR The Australian experience regarding screening sensitivity and cut-offs for fasting glucose has been assessed in a population-based sample of 10,508 Australians 55. This study suggested that screening for diabetes is undertaken in those with any one of the following risk factors: u Those aged over 55yrs u People aged over 45 with one of more of the following factors: obesity as defined by a BMI of 30kg/m 2, first degree relative with T2DM, hypertension or a history of taking anti-hypertensive medications, a blood pressure 140/90. u In minority ethnic groups (Aborigines and Torres Strait Islanders) aged over 35 years u People with IFG or IGT u All people with clinical CVD including myocardial infarction and TIA or stroke u Women with gestational DM u Women with polycystic ovary syndrome who are obese Fasting plasma glucose (FPG) is measured and further testing (OGTT) is offered according to the level of fasting glucose. This study shows the poor sensitivity of using FPG to detect IGT/IFG, as using a strategy based on a fasting glucose of 5.5 mmol/l had a sensitivity of 80%, specificity of 80% to detect diabetes, 20% of the population required an OGTT but the sensitivity to detect IGT and IFG was only 51.9%. In this population, using FPG of 6.1 mmol/l, sensitivity for diabetes drops to 63% with a specificity of 93.9%, sensitivity for IGT or IFG falls to 34.6%, but only 6.6% of the population required an OGTT. u So in general terms using a FPG of 5.5 mmol/l picks up 50% of IFG/IGT using a FPG of 6.0 mmol/l only picks up 33% PART 1_Section 2 The authors discussed the favourable outcomes of the Finnish and US Prevention Studies that have stimulated greater interest in the detection of people with IGT and IFG 35,36. Any risk assessment programme that includes testing for blood sugar may offer detection of people with lesser degrees of glucose intolerance (IGT and IFG). However, even using a lower glucose threshold of 5.5 mmol/l only has a sensitivity of just over 50% for these conditions. Furthermore, the current assessment of the performance of screening showed that age combined with obesity and hypertension and parental history of diabetes accounted for 87% of patients with previously undiagnosed DM and the inclusion of gestational diabetes had little additional effect. The Australian programme, when based on a fasting glucose of 5.5 mmol/l, required 32 to be screened to identify one new case of DM, with 4 out of 10 people requiring fasting plasma glucose and a further 1 in 5 requiring an OGTT (Table 4). Newly diagnosed diabetes Sensitivity (%) Specificity (%) IGT or IFG % Population requiring test u Table 4. Performance of Screening Strategies for detection of T2DM and Impaired Glucose Regulation PPV (%) Sensitivity (%) Specificity (%) PPV (%) Sensitivity (%) Specificity (%) RF & FPG 5.5 * RF & FPG RF & FPG 5.5 then HbA1c 5.3% RF & FPG 5.5 or HbA1c 5.3% RF & HbA1c 5.3% All data were weighted to the Australian adult population RF=Risk Factor *Current guideline according to the National Health and Medical Council in Australia 55 u The majority (90%) of people with IGT/IFG will have either a positive family history or be hypertensive u Use of FPG (or RPG) alone is a poor discriminator of IGT/IFG with 50% missed if a cut off of 5.5 mmol/l is used and 66% missed if 6.0mmol/l is used PPV (%) 031

32 Recent Data From Screening Studies in Leicester In Leicestershire in the past 5 years there have been two large population-based screening studies that will help inform a strategy for detection of undiagnosed T2DM and IGT. They are detailed in the Appendix pages but essentially the findings were that in terms of screening for T2DM in people with HT and with a BMI of 25kg/m 2 using a FPG of 5.5 mmol/l had a sensitivity of 87% in the South Asian population and in the White European population a sensitivity of 86% dropping to 79.5% if a FPG of 6mmol/l was used. Thus a 2 stage screening procedure using BMI (if 25kg/m 2 ) and presence of HT in both the South Asian and White European population is reasonably sensitive (in 80%-86%) and only 7-9% required an OGTT if a cut off 6mmol/l is used (See Appendix pages 75-77). u A two stage procedure using BMI ( 25kg/m 2 ) and presence of HT in both South Asian and White European populations has a sensitivity of between 80-86% with only 7-9% requiring an OGTT u FPG cut off should be 6 mmol/l to detect undiagnosed diabetes u This approach will not detect the majority of cases of impaired glucose regulation (IGR) (See page 31) Moving to IGR (IGT & IFG) even if HT and BMI are included, the use of FPG if 5.5mmol/l in detecting IGT/IFG is poor with a sensitivity in both South Asian and White European population of about 25-30%. Thus for detection of IGR a different approach will need to be adopted (See page 34). Activities in Finland Regarding Vascular Risk Assessment and Prevention of Diabetes There has been a lot of innovative work in Finland in the area of CVD prevention. At a Public Health level the Finnish have been successful in implementing behaviour change in the general population to try and reduce the risk of CVD 64. The unequivocal evidence of DM prevention by lifestyle intervention shown in the Finnish study as well as the North American Diabetes Prevention Programme is a strong argument for detecting subjects who have an increased risk for future T2DM, such as those with IGR 35,36. There are two approaches to detecting IGR. One is to measure blood glucose levels but, as has been said earlier, FPG is largely unhelpful and in order to measure the 2 hour glucose and determine the presence of IGT requires large numbers of OGTTs which are expensive, time consuming and unlikely to be implemented on a large scale in primary care. The Finns, therefore, have done work looking at risk assessment models for T2DM and have developed the FINDRISC 57,58,59. The FINDRISC is unique in that it focuses on predicting future DM with several factors that are simple and easy to measure, non-invasive, and are known to be associated with the risk of T2DM. These are easily comprehensible and direct the person s attention to the modifiable risk factors of DM. The FINDRISC Diabetes Risk Score The original FINDRISC included only 7 questions and did not include family history of DM. Using the 7 questions around age, BMI, waist circumference, BP, history of high blood glucose, physical activity and consumption of vegetables, fruits or berries showed that the score was reliable in predicting future DM over a 10 year period, in two cohorts, with an area under the curve > Using this original score with a value of 9 or above was associated with an increased risk of future DM with a sensitivity of 78% and a specificity of 77% in the 1987 cohort (sensitivity of 81%, specificity 76% in the 1992 cohort). Using this original score of a cutpoint of 9 identified the highest risk 25% of the population, which produced 78% of the incidence cases of DM 56. The final FINDRISC has been amended in two ways; the age categories have been changed, with the addition of an age category of >64 years with a score value of 4, and the addition of a question regarding family history. The final FINDRISC is available at and is shown on page

33 PART 1_Section 2 FINRISC Test designed by Professor Jaakko Tuomilehto, Dept Public Health, University of Helsinki, and Jaana Lindstrom, MFS, National Public Health Institute, Finland 033

34 Even though the FINDRISC was designed to predict future DM risk, it has proved to be a reasonably reliable method in identifying previously unrecognised DM. Using the risk cut-off of 11(for the original version) it has a sensitivity of 66% in men and 70% in women. Furthermore it has also been shown to be strongly associated with the presence of CVD risk factors, the metabolic syndrome, and also as a future predictor of CHD, stroke and total mortality 58. The FINDRISC has been tested in other populations. In a German study which compared the Dutch, Cambridge and American risk scores in comparison to the FINDRISC, the FINDRISC had the highest sensitivity (88%) 59. It is important that any risk score is validated in the population it will be used in. Whilst there are other risk scores available (See page 090 of the Appendix) the FINDRISC compares well and can be used as a self assessment tool Comparison of different strategies to identify those with impaired glucose regulation (IGR) Previous studies have shown that approaches that identify those with Diabetes Mellitus are not particularly helpful at picking up those with lesser but important degrees of glucose intolerance, such as impaired glucose tolerance (IGT) and Impaired Fasting Glucose (IFG) (see page 31). We have compared three approaches to identify those with IGR in a UK, multi-ethnic population (see page for full details). The results are summarised in Figure 6. Essentially use of FPG in all has the highest sensitivity. For FPG of >5mmol/L the sensitivity is approximately 90% but this requires 100% of patients to have an initial FPG and over 60% to have an OGTT. Clearly this is not feasible. Increasing the FPG cut off to 5.5 mmol/l has a good sensitivity of 70% and reduces the number of required OGTTs to 30% but all patients would be required to have an initial FPG. An alternative option is to use the FINDRISC (see example on page 33). Using a cut off of 12 points will identify the top 40% of the population, and if a cut off of FPG of 5.0mmol/L is used the sensitivity is 56% and about 30% require an OGTT. We are in the process of developing and piloting a Leicester Diabetes Risk Score and early results suggest we can improve the performance of the FINDRISC (see page 78-82) u Figure 6. Approaches to Identification of IGR in the General Population 034

35 An example of an algorithm for identification, assessment and management for those at increased risk of developing T2DM is shown in Figure 7. PART 1_Section 2 u Figure 7. An Example of an Algorithm for Identification, Assessment and Management for those at Increased Risk of Developing T2DM Black and Minority Ethnic Issues (BME) South-Asian (SA) people form an important minority ethnic population in many countries worldwide with SA people originating from India, Pakistan, Sri Lanka and Bangladesh forming the largest minority ethnic group in the UK, amounting to some 2.3 million 65. A consistent finding in these migrant populations is a higher incidence and prevalence of premature CHD than in the indigenous population. In the UK, mortality from CHD is currently 46% higher for men and 51% higher for women of SA origin than in the non-asian population 66. South-Asians are not a uniform group, but include ethnic subgroups with different cultures and practices and the prevalence of recognised risk factors for CVD may vary between these subgroups 67. However, even taking these differences into account, classical risk factors do not fully explain the increased risk of CHD in the SA population. Systematic reviews have shown that levels of physical activity are lower in all SA groups 68. SA people who are physically active have a more favourable metabolic syndrome risk factor profile. Scientific evidence suggests that SA populations have different associations between BMI, percentage of body fat and health risk than do European populations. It has been shown that SA people have a high risk of T2DM and CVD at a substantially lower BMI than the existing WHO cut-off for overweight as currently defined, 25 kg/m 2 and obesity, currently defined as 30 kg/m 2. Public health action points for SA populations for overweight and obesity have been defined at 23 and 27.5 kg/m 2 respectively 69,

36 Evaluation of the candidate definitions for Metabolic Syndrome in adult SAs suggests modification of the NCEP ATP III definition with ethnically sensitive waist circumference (WC) cut-offs and BMI cut-offs. For example, for a definition of the Metabolic Syndrome, a cut-off of 90cms of WC in men and 80cms in women, and a BMI cut-off of 23 kg/ m 271. Vascular risk assessment and screening for DM is therefore particularly important in the BME population, particularly the SA population, in the UK. However, there remain a number of difficulties: u Screening is based on BMI requiring ethnically appropriate adjustments and BMI as trigger points for intervention, i.e. BMI of 23 and 27.5 kg/m 2 are used rather than 25 kg/m2 and 30 kg/m 2 to define overweight and obesity respectively u If traditional risk factor assessment tools based on the Framingham equation are used, an adjustment is made based on ethnicity (suggest multiply by a factor of 1.4, i.e. if 15% then multiply by 1.4 = 21%) u Systems for recording ethnicity are improved in general practice to allow structured and systematic risk assessment via record based strategies u The current tool in GP systems does not well categorise ethnicity (An example is shown on page 113) u That implementation of a programme does not increase inequalities by using tools that underestimate true vascular risk in BME populations PART 1_Section 2 Reference List 1. Annual update 2005 mortality statistics cause. England and Wales. Health Statistics Quarterly 2007; Department of Health. Health survey for England Lifestyle and risk factor management and use of drug therapies in coronary patients from 15 countries; principal results from EUROASPIRE II Euro Heart Survey Programme. Eur.Heart J. 2001;22: Department of Health. National Service Framework for Coronary Heart Disease Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279: National Institute for Clinical Excellence. Cardiovascular disease - statins: Guidance (Technology Appraisal 94) Scottish Intercollegiate Guidelines Network. Risk estimation and the prevention of cardiovascular disease: A national clinical guideline National Collaborating Centre for Primary Care. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular diesease - full guideline DRAFT Cardiovascular risk assessment score for men and women aged years JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v Jackson, R. Updated New Zealand cardiovascular disease risk-benefit prediction guide BMJ 2000;320: Conroy RM, Pyorala K, Fitzgerald AP, Sans S, Menotti A, De Backer G et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur.Heart J. 2003;24: Ramsay LE, Haq IU, Jackson PR, Yeo WW. The Sheffield table for primary prevention of coronary heart disease: corrected. Lancet 1996;348:

37 14. Brindle P, May M, Gill P, Cappuccio F, D'Agostino R, Sr., Fischbacher C et al. Primary prevention of cardiovascular disease: a webbased risk score for seven British black and minority ethnic groups. Heart 2006;92: De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J et al. European guidelines on cardiovascular dis ease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur.Heart J. 2003;24: Hippisley-Cox J, Coupland C, Vinogradova Y, May M, Brindel P. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ, doi: /bmj Brindle P, Beswick A, Fahey T, Ebrahim S. Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review. Heart 2006;92: Hamm P, Shekelle RB, Stamler J. Large fluctuations in body weight during young adulthood and twenty-five-year risk of coronary death in men. Am.J.Epidemiol. 1989;129: Despres JP, Moorjani S, Lupien PJ, Tremblay A, Nadeau A, Bouchard C. Regional distribution of body fat, plasma lipoproteins, and cardiovascular disease. Arteriosclerosis 1990;10: The DECODE Study Group. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch.Intern.Med. 2001;161: Lloyd-Jones DM, Nam BH, D'Agostino RB, Sr., Levy D, Murabito JM, Wang TJ et al. Parental cardiovascular disease as a risk factor for cardiovascular disease in middle-aged adults: a prospective study of parents and offspring. JAMA 2004;291: Sesso HD, Lee IM, Gaziano JM, Rexrode KM, Glynn RJ, Buring JE. Maternal and paternal history of myocardial infarction and risk of cardiovascular disease in men and women. Circulation 2001;104: Weiner DE, Tighiouart H, Amin MG, Stark PC, MacLeod B, Griffith JL et al. Chronic kidney disease as a risk factor for cardiovascular disease and all-cause mortality: a pooled analysis of community-based studies. J.Am.Soc.Nephrol. 2004;15: National Kidney Foundation. K/DOQ1 clinical practice guidelines for chronic kidney disease: evaluation, classification and stratification. Am.J Kidney Dis. 2002;39:S PE Stevens, DJ O Donoghue, S de Lusignan, J Van Vlymen, B Klebe, R Middleton, N Hague, J New and CKT Farmer. Chronic kidney disease management in the United Kingdom: NEOERICA project results. Kidney International advance online publication, 18 April 2007; doi: /sj.ki PART 1_Section Roderick P, Davies R, Jones C, Feest T, Smith S, Farrington K. Simulation model of renal replacement therapy: predicting future demand in England. Nephrol.Dial.Transplant. 2004;19: Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL et al. Kidney disease as a risk factor for development of cardio vascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation 2003;108: Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N.Engl.J Med. 2004;351: Richards N, Harris K, Whitfield MD et al. The impact of population-based identification of chronic kidney disease using estimated glomerular filtration rate (egfr) reporting. Nephrol Dial Transplant : 1 6 doi: /ndt/gfm Richards N, Harris K, Whitfield MD et al. Primary care-based disease management of chronic kidney disease (CKD), based on estimated glomerular filtration rate (egfr) reporting, improves patient outcomes. Nephrol Dial Transplant : 1 7 doi: /ndt/gfm John R, Webb M, Young A, Stevens PE. Unreferred chronic kidney disease: a longitudinal study. Am J Kidney Dis. 2004;43: doi: /j.ajkd Jones C, Roderick P, Harris S and Rogerson M. Decline in kidney function before and after nephrology referral and the effect on survival in moderate to advanced chronic kidney disease. Nephrology Dialysis Transplantation (8): ; doi: /ndt/gfl Muntner P, He J, Astor BC, Folsom AR, Coresh J. Traditional and nontraditional risk factors predict coronary heart disease in chronic kidney disease: results from the atherosclerosis risk in communities study. J.Am.Soc.Nephrol. 2005;16: Hallan SI, Dahl K, Oien CM, Grootendorst DC, Aasberg A, Holmen J et al. Screening strategies for chronic kidney disease in the general population: follow-up of cross sectional health survey. BMJ 2006;333: Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N.Engl.J.Med. 2001;344: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N.Engl.J.Med. 2002;346:

38 37. Diabetes UK. Early identification of people with Type 2 diabetes (position statement) American Diabetes Association. Screening for Type 2 Diabetes (position statement). Diabetes Care 2003; Timothy Welborn. ADS: Screening for non-insulin dependent diabetes (position statement) Derived from Forouhi etal. Diabetes prevalence in England, estimates from an epidemiological model. Diabetic Medicine 2005, 23, [Reference states 667,000 for England alone, if this figure is extrapolated pro rata for the rest of the UK, then the undiagnosed will be closer to 750,000]. 41. Harris MI, Klein R, Welborn TA, Knuiman MW. Onset of NIDDM occurs at least 4-7 yrs before clinical diagnosis. Diabetes Care 1992;15: Manley SM, Meyer LC, Neil HAW, Ross IS, Turner RC, Holman RR. UK Prospective Diabetes Study 6. Complications in newly diagnosed type 2 diabetic patients and their association with different clinical and biochemical risk factors. Diabetes Res. 1990;13: Colagiuri S, Cull CA, Holman RR, UKPDS Group. Are lower fasting plasma glucose levels at diagnosis of type 2 diabetes associated with improved outcomes?: UKPDS 61. Diabetes Care 2002;25: Department of Health. Quality and Outcomes Framework (updated) National Institute for Clinical Excellence. Management of type 2 diabetes - retinopathy: Early management and screening Goyder E and Carlisle J. National Evaluations of DHDS Diabetes Screening Pilot Programme: Interim Report to UK National Screening Committee, Sheffield: Public Health Section of ScHARR Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A meta-regression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care 1999; Khaw KT, Wareham N, Luben R, Bingham S, Oakes S, Welch A et al. Glycated haemoglobin, diabetes, and mortality in men in Norfolk cohort of european prospective investigation of cancer and nutrition (EPIC-Norfolk). BMJ 2001;322: Alberti KG,.Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet.Med. 1998;15: Norhammar A, Tenerz A, Nilsson G, Hamsten A, Efendic S, Ryden L et al. Glucose metabolism in patients with acute myocardial infarction and no previous diagnosis of diabetes mellitus: a prospective study. Lancet ; Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT et al. Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ 2007;334: Davies MJ, Tringham JR, Troughton J, Khunti KK. Prevention of Type 2 diabetes mellitus. A review of the evidence and its application in a UK setting. Diabet.Med. 2004;21: Cardiovascular risk profile assessment in glucose-intolerant Asian individuals--an evaluation of the World Health Organization two-step strategy: the DECODA Study (Diabetes Epidemiology: Collaborative Analysis of Diagnostic Criteria in Asia). Diabet.Med. 2002;19: Nelson KM,.Boyko EJ. Predicting impaired glucose tolerance using common clinical information: data from the Third National Health and Nutrition Examination Survey. Diabetes Care 2003;26: Colagiuri S, Hussain Z, Zimmet P, Cameron A, Shaw J. Screening for type 2 diabetes and impaired glucose metabolism: the Australian experience. Diabetes Care 2004;27: Lindstrom J,.Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26: Rathmann W, Martin S, Haastert B, Icks A, Holle R, Lowel H et al. Performance of screening questionnaires and risk scores for undiagnosed diabetes: the KORA Survey Arch.Intern.Med. 2005;165: Silventoinen K, Pankow J, Lindstrom J, Jousilahti P, Hu G, Tuomilehto J. The validity of the Finnish Diabetes Risk Score for the prediction of the incidence of coronary heart disease and stroke, and total mortality. Eur.J.Cardiovasc.Prev.Rehabil. 2005;12: Franciosi M, De Berardis G, Rossi MC, Sacco M, Belfiglio M, Pellegrini F et al. Use of the diabetes risk score for opportunistic screening of undiagnosed diabetes and impaired glucose tolerance: the IGLOO (Impaired Glucose Tolerance and Long-Term Outcomes Observational) study. Diabetes Care 2005;28: Glumer C, Carstensen B, Sandbaek A, Lauritzen T, Jorgensen T, Borch-Johnsen K. A Danish diabetes risk score for targeted screening: the Inter99 study. Diabetes Care 2004;27:

39 61. Park PJ, Griffin SJ, Sargeant L, Wareham NJ. The performance of a risk score in predicting undiagnosed hyperglycemia. Diabetes Care 2002;25: Thomas C, Hypponen E, Power C. Type 2 Diabetes Mellitus in Midlife Estimated From the Cambridge Risk Score and Body Mass Index. Arch.Intern.Med. 2006;166: Mohan V, Sandeep S, Deepa M, Gokulakrishnan K, Datta M, Deepa R. A diabetes risk score helps identify metabolic syndrome and cardiovascular risk in Indians - the Chennai Urban Rural Epidemiology Study (CURES-38). Diabetes Obes.Metab 2007;9: Puska P, Salonen J, Nissinen A, Tuomilehto J. The North Karelia project. Prev.Med. 1983;12: Office of National Statistics. Census of England and Wales Balarajan R. Ethnicity and variations in mortality from coronary heart disease. Health Trends 1996; Bhopal R, Unwin N, White M, Yallop J, Walker L, Alberti KG et al. Heterogeneity of coronary heart disease risk factors in Indian, Pakistani, Bangladeshi, and European origin populations: cross sectional study. BMJ 1999;319: Fischbacher CM, Hunt S, Alexander L. How physically active are South Asians in the United Kingdom? A literature review. Journal of Public Health 2004; WHO expert consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004;363: Razak F, Anand SS, Shannon H, Vuksan V, Davis B, Jacobs R et al. Defining obesity cut points in a multiethnic population. Circulation 2007;115: Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet.Med. 2006;23: PART 1_Section 2 039

40 040

41 PART 1_Section 3 Vascular Risk Management Overview of the Efficacy of Interventions The Joint British Society Guidelines on the Prevention of Cardiovascular Disease in Clinical Practice was a joint collaboration between the British Cardiac Society, British Hypertension Society, Diabetes UK, Heart UK, the Primary Care Cardiovascular Society and the Stroke Association 1. The aim was to promote a consistent multidisciplinary approach to the management of people with both established atherosclerotic CVD (those with CHD and stroke) and also those at high risk of developing symptomatic atherosclerotic disease. An emphasis of this guideline was that CVD prevention in clinical practice should focus equally on people with established atherosclerotic CVD and people with DM, but also on apparently healthy individuals who were at high risk of developing symptomatic atherosclerotic disease, this being defined as being 20% risk over 10 years as defined by a risk score. 1 This has been followed by the SIGN guidance for Risk Estimation and the Prevention of CVD and most recently the consultation document for Lipid Modification from NICE 2-3. There is a clear recognition that lifestyle and risk factor intervention including appropriate drug therapies mainly to lower BP, modify lipids and reduce glycaemia are required. These documents all include clear targets for lifestyle BP, lipid and lifestyle management and also clear specific clinical indications for particular CVD protective drug therapies 1-3. Management of Specific Risk Factors Smoking Smoking increases the risk of vascular disease and the adverse effect is related to the amount of tobacco smoked and the duration of smoking. The impact is greater for patients with HT and DM. Stopping smoking is followed by a rapid decline in risk of vascular disease. All current smokers should receive advice from a healthcare professional to stop smoking completely, and this advice should be consistent, reiterated and reinforced by all healthcare professionals. The advice should include a description of the vascular risk of smoking, provide appropriate information on the approaches to stopping, assessing readiness to stop, and agreeing a specific action plan with a follow-up arrangement. NICE have published advice on smoking cessation in primary care 4. There is also separate guidance on use of pharmacotherapy 5. This advocates that Nicotine Replacement Therapy (NRT) or bupropion should normally be prescribed when the person has made a commitment to stop smoking and agreed a target stop date 5. Diet There are complex relationships between diet and vascular disease. Epidemiological data shows that total fat and saturated fat are positively associated with long-term CHD mortality 6. Consumption of saturated fat increases LDL cholesterol. A decrease in fat intake results in a decrease in both HDL and LDL cholesterol. A meta-analysis of RCTs of reducing saturated fat using monounsaturated or polyunsaturated fats as a replacement has shown a risk reduction in CVD events 7. PART 1_Section 3 People at high risk of CVD should be advised to eat a diet in which total fat intake is 30% or less of total energy intake, saturated fats are 10% or less of the total energy intake, intakes of dietary cholesterol is less than 300mg/day and saturated fats are replaced by increasing the intake of monounsaturated fats. This advice is summarised at 8. Dietary targets for those at risk of Vascular Disease are highlighted below. 1 Keep total dietary intake of fat to 30% of total energy intake 2 Keep the intake of saturated fats to 10% of total fat intake 3 Keep the intake of dietary cholesterol to < 300 mg/day 4 Replace saturated fats by an increased intake of monounsaturated fats 5 Increase the intake of fresh fruit and vegetables to at least five portions per day u Table 5. Dietary Advice for those at Risk of Vascular Disease 1,2,3,8 041

42 Management of Obesity As body weight (defined conventionally by Body Mass Index) rises so does the risk of vascular disease. 9 However, there appears to be an additional risk from central adiposity which is easily measured by waist circumference (cm) 10. Overweight and abdominal obesity are also associated with other risk factors, including small and dense atherogenic LDL cholesterol, low HDL cholesterol, raised triglycerides, elevated BP, insulin resistance and impaired glucose regulation (IGR). Clustering of these risk factors has now been defined by the Metabolic Syndrome, of which there are a number of definitions Studies have shown weight loss in the range of 5-10% results in improvements in BP, Lipid Profile and glucose tolerance and if it can be maintained it is possible to extrapolate the reduction of the cardiac events that would be predicted by risk analysis Weight reduction strategies may be appropriate for those who are; u Overweight (BMI >25 kg/m 2 lower thresholds for those of SA origin, > 23 kg/m 2 ) u Obese (BMI > 30 kg/m 2 ) (27.5 kg/m 2 for those of SA origin) u Increased abdominal fat as defined by a circumference of >94cms in men and 80cms in women (90 cms for SA men, 80cms in SA women) Broad guidelines are that: u Calorie intake can be reduced by reducing consumption of high energy dense foods, particularly saturated fats, refined carbohydrate and some alcoholic drinks, as well as calorie restriction. u Fat intake should be <30% of total energy intake. u Foods with high fat content should be replaced with vegetables, fruit and cereal products. u Increasing physical activity can make an important contribution and it is important that strategies for promoting physical activity are offered and integrated into other initiatives that are ongoing (i.e. exercise on prescription). u Successful weight reduction requires sustained personal and family motivation, and long-term professional support (see 8. Drug Management of Obesity Other interventions include anti-obesity medication, including inhibitors of intestinal fat absorption and those acting on the central nervous system to suppress appetite, to reduce food intake and increase thermogenesis Guidelines currently recommend drug therapy be considered for those in obese people with one or more obesity related disorders. However, most clinical trials have been of short duration and there is no assessment of these drugs on long-term mortality. Weight regain is common when drug therapies are stopped. Lifestyle Advice for Those at High Risk of DM For those with IGT there is strong evidence that intensive diet and lifestyle interventions reduce the risk of DM. In both the Finnish and the American studies, the intervention group were given individualised counselling to achieve their lifestyle goals. After a median of 4 years, the Finnish Study showed a 58% reduction in risk of progression to T2DM in subjects with IGT 21. Exactly the same result was seen in a multi-ethnic population in the USA 22. The Finnish Study has been followed for a further 3 years and there continued to be a 43% reduction in relative risk of progression to diabetes. The benefits of lifestyle change were achieved in the intervention group even after discontinuation of the intervention, with a 36% reduction in relative risk of developing diabetes over the subsequent 3 years

43 u This highlights the importance of structured and targeted lifestyle interventions to people at high risk of subsequent DM. The main goals of this effective intervention were: u Weight reduction of 5% or more u Less than 30% of daily energy intake from fat u Less than 10% of daily energy intake from saturated fat u Fibre intake 15 grams per 1,000 Kilocalories or more u Moderately intense physical activity of 30 minutes per day or more Other Dietary Factors Omega 3 Fatty Acids Regular fish consumers appear to be at a lower risk of fatal CHD and RCTs show increased fish consumption results in reductions in coronary and total mortality. There is some conflicting evidence on the benefits associated with increased consumption of omega 3 fats. Some studies had suggested that omega 3 fatty acids were beneficial in preventing and treating CHD 24. A meta-analysis of 48 RCTs and 26 cohort studies does not support this 25. In view of this uncertain effect and in order to avoid conflicting dietary advice, no change is recommended from the advice given in the current dietary guideline (two 140g portions of fish, one of which should be a oily fish, per week) 26. Fish consumption may help to reduce intake of (saturated) fat from meat. u All individuals are recommended to eat at least two portions of fish per week, one of which should be an oily fish 2 Dietary Salt Intake PART 1_Section 3 A meta-analysis of 28 trials on the effect of moderate salt reduction on blood pressure demonstrated that a modest reduction in salt intake for four or more weeks has a significant effect on blood pressure in both hypertensive and normotensive individuals. A reduction in salt intake of 6g per day (100 mmol or 2.3g of sodium per day) predicted a fall in blood pressure of 7.1/3.9 mmhg (p<0.001 for both systolic and diastolic) in hypertensive patients and 3.6/1.7 mmhg in normotensive individuals (systolic: p<0.001; diastolic: p<0.005) 27. The Food Standard Agency has recommended that adults should consume no more than 6g of salt per day (approximately equivalent to one teaspoonful) 28. u People with hypertension should be advised to reduce their salt intake as much as possible to lower blood pressure u All individuals should aim to consume less than 6g of salt per day Fruit and Vegetable Intake Diets rich in fruit and vegetables tend also to be low in fat. Two systematic reviews of cohort studies examined the benefits of fruit and vegetable consumption for the reduction of CHD risk. There is evidence from cohort studies to support reduced CHD event rates from increased vegetable (risk ratio 0.77) and fruit (risk ratio 0.86) intake in one review, and a 15% reduced relative risk of CHD in those consuming high levels of fruit and vegetables, in another 29,30. u Increased fruit and vegetable consumption is recommended to reduce cardiovascular risk for the entire population 043

44 Antioxidant Vitamin Supplementation Several systematic reviews of RCTs were identified that investigated the association between vitamin supplementation and prevention of CHD. One systematic review of 84 RCTs found that neither supplements of vitamin E alone nor given with other agents yielded a statistically significant beneficial or adverse pooled relative risk for all-cause mortality, cardiovascular mortality, fatal or non-fatal myocardial infarction in blood lipids 31. The US Preventive Services Task Force guideline investigated the evidence on the role of antioxidant supplementation in reducing the incidence of or progression to CHD. The guideline found little evidence that any single vitamin supplementation (vitamin A, vitamin C, vitamin E, β-carotene), combined antioxidants or multivitamins had benefit on primary or secondary prevention 32. Stanol Esters and Plant Sterols Stanol esters and plant sterols are present in small amounts in normal diets, and can be supplemented using dietary products such as margarines and yogurt drinks. Two systematic reviews provide evidence that they can reduce LDL cholesterol 33,34. In the larger review of 41 RCTs of the effect on serum lipids, 2g per day supplements of stanol esters and plant sterols led to a 10% reduction in LDL cholesterol 33. There was no benefit from further dosage increases. The cost to the individual of this supplement has been estimated at 70 per year. 34 As yet, there is no evidence on whether these reductions in cholesterol translate in the longer term into reduction in CVD, nor is there long term data (more than five years) on their safety. Alcohol Guidance should be the same as for the general population. Alcohol consumption ranging between 1-3 alcohol units per day (1 unit equates to 80mrs of wine, 250mrs of normal strength beer and 30-50mls of spirits) is associated with the lowest all-cause mortality. Optimum consumption is lower for women than for men (recommendations are 14 units for women and 21 for men per week) 1. Promoting Physical Activity A sedentary lifestyle is associated with increased vascular risk. In asymptomatic people, aerobic physical activity and cardio-respiratory fitness are associated in a dose-response fashion with a significant reduction in CVD and all-cause mortality. Increased physical activity, whether at work or taken in leisure time, is associated with a lower CHD risk in both men and women 35. The greatest reduction in risk is between those with sedentary and moderately active individuals. The benefits of physical activity on vascular outcomes is lost once physical activity is discontinued. Physical activity has an important contribution in both losing weight and preventing weight gain, and has beneficial effects on blood pressure, increasing HDL cholesterol and reducing the risk of developing T2DM 36. NICE has recently published guidelines on strategies to promote physical activity 37. In general guidance should be given in line with the Chief Medical Officers Report 2004 and the NICE Guidance and this is in line with the guidance for the general population This is summarised as: u 30 minutes of moderate intensity physical activity at least 5 days a week u Those with co-morbidity/or personal circumstances which mean they are unable to do this, should be encouraged to exercise at their maximum safe capacity. u Recommend types of activity which can be incorporated into everyday life i.e. brisk walking u Any advice should take account of the persons needs, preference and circumstance. A useful table of intensity and energy expenditure for common types of physical activity is found in the Appendix page

45 Hypertension As BP rises, so does the risk of stroke, CHD and heart failure and CKD. Elevated BP is also associated with an accelerated rate of decline of cognitive and renal function. The vascular risk associated with elevated blood pressure is determined by both the level of BP and the presence of other risk factors. Data from many RCTs provide compelling data and evidence of the effectiveness of anti-hypertensive therapy at reducing risk. Reduction in BP by an average of 12/6 mmhg can be expected to reduce stroke by 40% and CHD by 20% 39. The absolute risk reduction is greatest in those at highest risk. In patients with diabetes and CKD lower targets for blood pressure management are required. In CKD evidence has shown that lowering target BP may slow the decline in kidney function in people that have moderate to high levels of proteinuria 40. In people who have a high rate of proteinuria (>1g in 24 hours) this effect was beneficial at a BP target of 125/75 mmhg. This was confirmed by a further meta-analysis 41. However in CKD with lower levels or no proteinuria the evidence for lower targets to preserve renal function is less clear 42. In DM a lower BP target is required because, the greater the blood pressure level, the greater the benefit in terms of CVD events and there appears to be no threshold effect. Strict control of blood pressure is the most important factor in preventing development of diabetes nephropathy and advanced renal failure Interventions for Blood Pressure (BP) All people with persistently high BP 140/90, high/normal BP ( /85-89) or a family history of HT should receive lifestyle advice to help reduce blood pressure and CVD risk. Lifestyle advice should continue, even when drug therapy is initiated (Figure 8). Lower thresholds are recommended for subjects following a MI, stroke or TIA, with established CKD and those with DM, where the intervention threshold is a systolic of >130 mmhg and/or a diastolic of >80 mmhg Those who reach 80 years should remain on therapy if there is evidence of CVD, target organ damage or other vascular disease such as DM. Optimal and audit standards for blood pressure target are outlined in Table 6. PART 1_Section 3 Those with persistent BP 160/100 mmhg should be offered treatment regardless of other risk factors. An audit standard of <150/90 should be considered as a minimum for all patients treated with hypertension and should be <140/80 for those at highest risk. This is suggested by JBS-2 Guidance 1. u Figure 8. Intervention Thresholds for Blood Pressure 045

46 Elevated BP 140/90 with a CVD risk 20% over 10 years and /or target organ damage Elevated BP with diabetes or CKD or established atherosclerotic disease Optimal 1,2 (mmhg) Audit Standard used by JBS-2 (mmhg) 1 <140/85 <150/90 <130/80 <140/80 u Table 6. Optimal and audit standard blood pressure targets In terms of selection of particular drug therapy, many RCTs have been consistent in showing that BP lowering based on various classes of drugs are effective at reducing complications and vascular morbidity and mortality. There is long-standing evidence with diuretics and β-blockers, and recent studies have also confirmed the safety and efficacy of ACE inhibitors, ARBs and calcium channel blockers Most clinical trials have shown that patients require 2 or 3 blood pressure lowering drugs in order to achieve recommended BP targets. However, current practice in the UK suggests that almost two-thirds of treated patients receive mono-therapy and less than 10% receive more than 2 drugs. This is reflected by the fact that less than half of patients with treated hypertension have their blood pressure optimally controlled 51. The British Hypertension Society in its most recent guidelines has suggested the ABCD treatment algorithm to advise and assist practitioners on logical sequencing and combinations of drug therapy in the treatment of hypertension (Figure 9). u Figure 9. ABCD Treatment Algorithm for Hypertension 52 * Beta Blockers are not a preferred initial treatment for hypertension but can be an alternative to A in patients < 55 years in whom A is not tolerated or contraindication (includes women of child bearing potential) 046

47 Cholesterol and Lipid Lowering Epidemiological evidence has shown that populations with higher cholesterol levels experience more atherosclerosis and CHD than populations with lower levels and the higher the level of cholesterol, the greater the risk of coronary event 53. As the concentration of total cholesterol and in particular LDL cholesterol increases, so does the risk of vascular disease 53. The relationship is continuous, and determined by the concentration of LDL cholesterol and that of HDL cholesterol (inversely) and to a lesser extent by triglyceride concentration. The cholesterol/hdl ratio is incorporated into the risk assessment. However, the preferred target for lipid lowering treatment decisions is the level of LDL cholesterol. The focus on LDL cholesterol is because although HDL cholesterol is also inversely related to the risk of vascular disease, and the total cholesterol to HDL ratio is used for vascular risk assessment, there is no particular treatment target for HDL cholesterol because HDL cholesterol is only altered modestly and not independently of changes in other lipid parameters and there are, as yet, no drugs available which independently alter HDL cholesterol. Statins increase HDL cholesterol by about 3-10%. Fibrates increase HDL cholesterol and reduce triglycerides, but have only a moderate effect on LDL cholesterol. A systematic review and meta-analysis of 58 RCTs of cholesterol lowering concluded that for 1 mmol reduction in LDL cholesterol there was a reduction in coronary death and non-fatal MI of 11% in the first year, 24% in the second year and 33% in the third-fifth year, and 36% in subsequent years 54. Lipid assessment should be offered to all subjects from age 40 years 1-3. The primary action of statins is to lower LDL cholesterol with only small effects on HDL cholesterol or triglyceride levels. A meta-analysis of 164 short term RCTs of lipid lowering by different statins showed absolute LDL cholesterol reduction associated with different doses of different statins. The reductions in LDL cholesterol are dosedependant and log-linear, so that with each doubling of dose of statin, LDL levels fall by approximately 6% 55. This meta-analysis showed that a reduction in LDL cholesterol of 1.6 mmol/l halves the risk of CHD events after two years and that this reduction can be achieved with standard doses of some statins 55. PART 1_Section 3 The Benefits of Lowering Cholesterol for Cardiovascular Risk Statins are central to lipid lowering therapy in the prevention of vascular events. Statins inhibit cholesterol synthesis in the liver, activating hepatocyte LDL receptors and increasing hepatic uptake of LDL from the circulation. A meta analysis of lipid lowering in five randomised, placebo-controlled, double-blind trials included two trials in patients without evidence of cardiovascular disease (n = 13,200) and three trials carried out in symptomatic patients (n = 17,617). Active treatment with statins was associated with a 34% relative risk reduction (95% CI 23% to 43%; p <0.001) in major coronary events in the primary prevention trials and a 30% relative risk reduction (95% CI 24% to 35%; p <0.001) in the secondary prevention trials. The mean reduction (weighted by sample size) in TC, LDL cholesterol, and triglyceride levels was 20%, 28%, and 13%, respectively, and HDL cholesterol was increased by an average of 5% among the five trials

48 Statin Therapy in High Risk Individuals without Cardiovascular Disease 2 u All adults over the age of 40 years who are assessed as having a ten year risk of having a first cardiovascular event 20% should be considered for treatment with a statin (simvastatin 40 mg/day or a drug of comparable effectiveness or acquisition cost 2-3 ) following an informed discussion of risks and benefits between the individual and a responsible clinician u The level of CVD risk should be measured using a recommended CVD risk equation u In individuals without established CVD, lifestyle measures to reduce cholesterol levels should be encouraged, irrespective of the need for pharmacological treatment u Secondary causes of dyslipidaemia should be considered and excluded before commencing lipid drug therapy Evidence from WOSCOPS and AFCAPS/TexCAPS indicates that the risk of major coronary events may be significantly reduced by standard doses of statin therapy A systematic review of economic evidence reported that it is cost effective to give statins to individuals without evidence of CVD but with a ten-year 20% risk of CVD with statins compared to providing standard diet and lifestyle measures 2,59. The model made several simplifying assumptions to conclude that such individuals could be identified with complete accuracy. It used an annual cost for statins of about 320 per person (a weighted average of the drugs used in the pooled trials). The advent of lower priced generic drugs has reduced the annual cost to under Statin Therapy in Individuals with Established CVD 2 Individuals who are at high CVD risk, such as those with established CVD, will gain more benefit from aggressive lipid lowering than individuals at lower absolute levels of risk. One systematic review reported that it is cost-effective to treat with a statin all individuals with CVD, compared to providing standard diet and lifestyle measures 59. This was confirmed in a large trial of treatment with 40mg per day simvastatin in people with different levels of coronary vascular risk 60. u All patients with established symptomatic atherosclerotic cardiovascular disease should be considered for more intensive statin therapy following an informed discussion of risks and benefits between individual and responsible clinician u Patients should be advised to report unexplained muscle pains or other adverse effects promptly, especially if associated with fever or malaise u If such effects are mild, a different statin may be tried and/or the statin dose reduced after discussing the risks with the patient u If severe side effects are experienced statin therapy should be discontinued 048

49 Cholesterol Targets for Therapy in Patients with Established Cardiovascular Disease (Secondary Prevention) The JBS2 guideline states there are no clinical trials which have evaluated the relative and absolute benefits of cholesterol lowering to different total and LDL cholesterol targets in relation to clinical events. 1 Establishing a cholesterol target for therapy is therefore an extrapolation from the apparent benefits indicated by major trials of lipid lowering, while maintaining appropriate margins for safety, given that there are still no long term follow up studies of statin therapy 1. Several guidelines have recommended titration of lipid lowering therapy to achieve LDL cholesterol levels less than 2.5 mmol/l for patients at high cardiovascular risk 1,61. Current guidance from the Department of Health in England and Wales recommends that patients with established CHD should receive statins and dietary advice to lower serum cholesterol concentrations either to less than 5 mmol/l (LDL cholesterol to below 3 mmol/l) or by 25% (30% for LDL cholesterol), whichever is greater 62. A systematic review of RCTs, cohort studies, and case control studies that examined the independent relationship between LDL cholesterol and major cardiovascular outcomes in patients with LDL cholesterol levels less than 3.36 mmol/l found no clinical trial subgroup analysis, valid cohort or case control analyses suggesting that the degree to which LDL cholesterol responds to statin independently predicts the degree of cardiovascular risk reduction 63. Although the review indicated that there was compelling evidence for the risk effectiveness of statin therapy in lowering cholesterol in patients at high cardiovascular risk (regardless of their LDL cholesterol values) it concluded that current clinical evidence does not demonstrate that lipid therapy should be titrated to achieve proposed LDL cholesterol targets. 64 While patients with established symptomatic cardiovascular disease should be considered for intensive statin therapy, the long term safety and cost-effectiveness of such therapy has not been established 64. In the SIGN guideline, the current NHS Scotland target for individuals at high cardiovascular risk is a total cholesterol of <5 mmol/l. This level is consistent with the Quality and Outcomes Framework 65. PART 1_Section 3 Reducing this target to 4.5 or 4.0 mmol/l would have major resource implications for NHS Scotland. Pending further studies on mortality, safety and cost-effectiveness, the guideline development group suggests that current NHS Scotland targets are maintained, as the minimum standard of care, and the NICE Lipid Modification Consultation also advocates this approach 2-3. Measuring Lipid Levels It is important that the level of cholesterol incorporated into any risk assessment tool is that taken before drug treatment was started, and this should always be used to estimate risk, not the cholesterol value on treatment. LDL cholesterol can be calculated indirectly by measuring total cholesterol (TC), HDL cholesterol and triglycerides (TG) from a fasting venous blood sample and applying the Friedewald equation: LDL = TC-HDL- (TG/2.2) 66. This method is not suitable for individuals with TG levels > 5 mmol/l. For greater accuracy fasting samples are required as HDL cholesterol and TG levels vary between fasting and non-fasting states. HDL cholesterol is lower by 5% to 10% in the non-fasting state than in the fasting state and TG levels are 20-30% higher. Given the practical problems of routinely collecting fasting samples, non-fasting blood samples are generally collected for estimation of TC and HDL cholesterol 67. It may be practical to start with a non-fasting sample for total cholesterol and HDL cholesterol in terms of a comprehensive vascular assessment done in the context of population-based screening (Population Based Strategy). However If the person is at high CVD risk, then a fasting sample is recommended at the initial assessment (Record Based Strategy). Secondary causes of elevated lipids should be investigated. These include excessive alcohol intake, undiagnosed or untreated DM, renal disease, liver disease and inadequately treated or undetected hypothyroidism. 049

50 Management of Cholesterol in Special Groups Subjects with diabetes are all considered to be at high CVD risk and should be offered a statin if aged 40 years or more 1-2. In subjects with DM aged between 18 and 39 the presence of; u Retinopathy, u Nephropathy, u Poor glycaemic control, u Elevated blood pressure, u Raised total cholesterol of 6mmol/L u Features of the Metabolic Syndrome u Family history of premature CVD are also indications for statin therapy 1. Antiplatelet Therapies Aspirin or other platelet modifying drugs are recommended in all people with established atherosclerotic disease and in those with DM, a dose of 75mg is advocated 1-3. Aspirin is recommended for all those with T2DM who are 50 years of age, and those at a younger age if they have had diabetes for more than 10 years or if they are already receiving treatment for HT or have evidence of target organ damage, particularly retinopathy or nephropathy. All those at high vascular risk (CVD risk 20% over ten years) should be considered for treatment with aspirin 75, OD 1-2. In patients with CVD Clopidrogel should be considered in patients with hypersensitivity or intolerance in whom aspirin causes unacceptable side effects 2. PART 1_Section 3 Reference List 1. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v Scottish Intercollegiate Guidelines Network. Risk estimation and the prevention of cardiovascular disease: A national clinical guideline National Collaborating Centre for Primary Care. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease - full guideline DRAFT National Institute for Clinical Excellence. Smoking Cessation: Brief interventions and referral for smoking cessation in primary care and other settings. Public health intervention guidance National Institute for Clinical Excellence. TA039 Smoking cessation - bupropion and nicotine replacement therapy: Guidance NHS Health Scotland. Cardiovascular disease: a guide to primary prevention in Scotland. A report on behalf of the Heart Health National Learning Committee Hooper L, Summerbell CD, Higgins JP, Thompson RL, Clements G, Capps N et al. Reduced or modified dietary fat for prevention of cardiovascular disease. Cochrane.Database.Syst.Rev. 2004;CD Food Standards Agency. Advice on cardioprotective dietary changes Jousilahti P, Tuomilehto J, Vartiainen E, Pekkanen J, Puska P. Body weight, cardiovascular risk factors, and coronary mortality. 15-year follow-up of middle-aged men and women in eastern Finland. Circulation 1996;93: Despres JP. Health consequences of visceral obesity. Ann.Med. 2001;33: Report of a WHO Consultation. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet.Med. 1998;15:

51 12. Alexander CM, Landsman PB, Teutsch SM, Haffner SM. NCEP-defined metabolic syndrome, diabetes, and prevalence of coronary heart disease among NHANES III participants age 50 years and older. Diabetes 2003;52: Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet.Med. 2006;23: Mulrow CD, Chiquette E, Angel L, Cornell J, Summerbell C, Anagnostelis B et al. Dieting to reduce body weight for controlling hypertension in adults. Cochrane.Database.Syst.Rev. 1998;CD Neter JE, Stam BE, Kok FJ, Grobbee DE, Geleijnse JM. Influence of weight reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension 2003;42: Dattilo AM,.Kris-Etherton PM. Effects of weight reduction on blood lipids and lipoproteins: a meta-analysis. Am.J Clin.Nutr. 1992;56: Anderson JW,.Konz EC. Obesity and disease management: effects of weight loss on comorbid conditions. Obes.Res. 2001;9 Suppl 4:326S-34S. 18. O'Meara S, Glenny AM, Wilson C, Melville A, Sheldon TA. Effective management of obesity. Qual.Health Care 1997;6: National Institute for Clinical Excellence. Orlistat for the treatment of obesity in adults (TA22) National Institute for Clinical Excellence. The clinical effectiveness and cost effectiveness of sibutramine for obesity.(ta31) Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. New England.Journal of Medicine ; Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N.Engl.J Med. 2002;346: Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet 2006;368: Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am.J Med. 2002;112: PART 1_Section Hooper L, Thompson RL, Harrison RA, Summerbell CD, Moore H, Worthington HV et al. Omega 3 fatty acids for prevention and treatment of cardiovascular disease. Cochrane.Database.Syst.Rev. 2004;CD Food Standards Agency. Health diet:nutrition essentials: fish and shellfish He FJ,.MacGregor GA. Effect of modest salt reduction on blood pressure: a meta-analysis of randomized trials. Implications for public health. J Hum.Hypertens. 2002;16: Food Standards Agency. Science on salt Anderson JW, Hanna TJ, Peng X, Kryscio RJ. Whole grain foods and heart disease risk. J Am.Coll.Nutr. 2000;19:291S-9S. 30. Law MR,.Morris JK. By how much does fruit and vegetable consumption reduce the risk of ischaemic heart disease: response to commentary. Eur.J Clin.Nutr. 1999;53: Shekelle PG, Morton SC, Jungvig LK, Udani J, Spar M, Tu W et al. Effect of supplemental vitamin E for the prevention and treatment of cardiovascular disease. J Gen.Intern.Med. 2004;19: Morris CD,.Carson S. Routine vitamin supplementation to prevent cardiovascular disease: a summary of the evidence for the U.S. Preventive Services Task Force. Ann.Intern.Med. 2003;139: Katan MB, Grundy SM, Jones P, Law M, Miettinen T, Paoletti R. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clin.Proc. 2003;78: Law M. Plant sterol and stanol margarines and health. BMJ 2000;320: US Department of Health and Human Services. Physical Activity and Health:a report of the Surgeon General. Atlanta, Geoargia: US Department of Health and Human Services, Centres for Disease Control and Prevention, National Centre for Chronic Disease Prevention and Health Promotion Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA 2001;286: National Institute for Clinical Excellence. Four commonly used methods to increase physical activity: brief interventions in primary care, exercise referral schemes, pedometers and community-based exercise programmes for walking and cycling. Public health intervention guidance

52 38. Department of Health. On the state of the public health: Annual report of the Chief Medical Officer Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardio vascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003;362: Buckalew VM, Jr., Berg RL, Wang SR, Porush JG, Rauch S, Schulman G. Prevalence of hypertension in 1,795 subjects with chronic renal disease: the modification of diet in renal disease study baseline cohort. Modification of Diet in Renal Disease Study Group. Am.J Kidney Dis. 1996;28: Jafar TH, Stark PC, Schmid CH, Landa M, Maschio G, De Jong PE et al. Progression of chronic kidney disease: the role of blood pressure control, proteinuria, and angiotensin-converting enzyme inhibition: a patient-level meta-analysis. Ann.Intern.Med. 2003;139: Wright JT, Jr., Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J et al. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA 2002;288: Schrier RW, Estacio RO, Esler A, Mehler P. Effects of aggressive blood pressure control in normotensive type 2 diabetic patients on albuminuria, retinopathy and strokes. Kidney Int. 2002;61: Williams B. The unique vulnerability of diabetic subjects to hypertensive injury. J Hum.Hypertens. 1999;13 Suppl 2:S3-S Estacio RO, Jeffers BW, Gifford N, Schrier RW. Effect of blood pressure control on diabetic microvascular complications in patients with hypertension and type 2 diabetes. Diabetes Care 2000;23 Suppl 2:B54-B Brown MJ, Palmer CR, Castaigne A, de Leeuw PW, Mancia G, Rosenthal T et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000;356: Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH et al. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA 2003;289: Hansson L, Lindholm LH, Ekbom T, Dahlof B, Lanke J, Schersten B et al. Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study. Lancet 1999;354: Hansson L, Lindholm LH, Niskanen L, Lanke J, Hedner T, Niklason A et al. Effect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial. Lancet 1999;353: Hansson L, Hedner T, Lund-Johansen P, Kjeldsen SE, Lindholm LH, Syvertsen JO et al. Randomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascular morbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study. Lancet 2000;356: Primatesta P, Brookes M, Poulter NR. Improved hypertension management and control: results from the health survey for England Hypertension 2001;38: National Institute for Clinical Excellence. Hypertension: management of hypertension in adults in primary care. Clinical Guidelines (CG34) Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA 1986;256: Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis.. BMJ 2003; 326: Hebert PR, Gaziano JM, Chan KS, Hennekens CH. Cholesterol lowering with statin drugs, risk of stroke, and total mortality. An overview of randomized trials. JAMA 1997;278: LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA 1999;282: Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279: Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, Macfarlane PW et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N.Engl.J Med. 1995;333: Ward S, Lloyd JM, Pandor A, Holmes M, Ara R, Ryan A et al. A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol.Assess. 2007;11:

53 60. Mihaylova B, Briggs A, Armitage J, Parish S, Gray A, Collins R. Cost-effectiveness of simvastatin in people at different levels of vascular disease risk: economic analysis of a randomised trial in 20,536 individuals. Lancet 2005;365: National Heart, Lung and Blood Institute. Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Final Report. National Institute of Health Department of Health. National Service Framework for Coronary Heart Disease Hayward RA, Hofer TP, Vijan S. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann.Intern.Med. 2006;145: Cannon CP, Steinberg BA, Murphy SA, Mega JL, Braunwald E. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am.Coll.Cardiol. 2006;48: NHS Scotland Information and Statistics Division. Quality and Outcomes Framework. Revisions to the QOF for 2006/7. Revision to the GMS Contract 2006/7. Delivering Investment in General Practice Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin.Chem. 1972;18: National Heart, Lung and Blood Institute. Recommendations on lipoprotein measurement. National Institute of Health PART 1_Section 3 053

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55 PART 1_Section 4 Implications and Public Health Perspective Issues for Primary Care Trusts and Directors of Public Health Cardiovascular disease is the commonest preventable cause of mortality in the developed world and there is a wide range of both population and individual interventions that could potentially reduce the burden of cardiovascular disease. An effective strategy to reduce population risk needs to both reduce overall population risk (by reducing smoking rates, changing diets and increasing physical activity) - shifting the curve - as well as identifying individuals at increased risk who could benefit from specific individual interventions. There is now a comprehensive set of guidance for assessment and management of overall cardiovascular disease and its risk factors in the general population 1-4. The evidence base for cardiovascular risk assessment and multiple risk factor intervention in general populations is less comprehensive and includes the findings of the OXCHECK trial, the British Family Heart and a subsequent systematic review and meta-analysis 5-7. Overall, the investment of major resources required for relatively small changes in risk factors in the general population led to an initial emphasis on secondary prevention and targeting largely individuals with major clinical risk factors (diabetes and hypertension) for risk reduction. It has been suggested that vascular risk assessment should be offered to adults aged from 40 years 1-3. As part of a comprehensive public health approach to cardiovascular risk reduction, there needs to be a review of current activity, as well as an assessment of both the potential resource implications and potential benefits of additional activity, including the potential impact on health inequalities. The additional benefit will depend on the extent to which these activities are already underway and this will vary between practices. Any risk reduction programme needs a robust and detailed strategy for evaluation and audit. PART 1_Section 4 Review of Current Cardiovascular Risk Reduction Activities This should include both population/community level activities and primary care activity and will identify gaps and variation in provision that can be addressed within any Vascular Risk Reduction Programme. Population activities, such as smoking, healthy eating and physical activity programmes should be reviewed with respect to both coverage and impact. Although many of these programmes involve wider partnership working, the NHS can set an example by introducing healthy eating policies on NHS premises and developing NHS transport plans to encourage walking and cycling. It should also include general practice level assessment of current activity, using QOF and/or local audit data where available, and including data on recording of and values recorded for: u ethnicity u smoking u BMI u blood pressure u cholesterol/lipid profile u blood glucose u appropriate prescription of aspirin, statins, anti-hypertensives (as indicated by risk factor information) u access to lifestyle interventions An audit can establish the extent to which individuals with risk factors have already been identified, had appropriate blood tests and been started on appropriate treatments. Comparison within and between practice populations will identify variations in risk and in risk assessment and risk management activity. 055

56 Identification of Resource Implications, Costs and Benefits Assessing Costs/Resource Implications The potential costs to the NHS of providing risk assessment to specific population groups should be considered before any additional activity is undertaken. The costs will depend on the number of people offered risk assessment and the number of people identified as needing follow up and further treatment. The costs will include u Costs of risk assessment including staff training, administrative costs of identifying eligible/high risk individuals and organising risk assessment u Costs of blood testing fasting lipid profiles and fasting glucose, glucose tolerance testing (which will not be routinely available in all practices) u Costs of behavioural interventions for those who need support to change lifestyle factors and of follow up and treatment of all those with treatable risk factors u Costs of audit One of the major costs of risk reduction will be the costs of follow up for all those identified at high risk or with abnormal test results and so these do need to be carefully considered alongside the costs of risk assessment. Assessing Potential Benefits The cost effectiveness of risk assessment is entirely dependent on whether as a result of risk assessment, costeffective interventions are introduced earlier than they would be otherwise. Evidence-based guidelines have already been produced by NICE and SIGN including for management of diabetes and hypertension and many of the pharmacological interventions available for managing cardiovascular risk factors, including smoking cessation, have been demonstrated to be cost effective 2,3,4,8-10. It is therefore possible to use audit data to estimate how many additional people might be treated with specific pharmacological interventions as a result of risk assessment. If overall appropriate prescribing increases as a result of any programme and risk factor levels fall in the practice population, the magnitude of change is an indicator of the potential benefit. Attempting to quantify the relative costs and relative benefits of different risk assessment strategies will be helpful in identifying which practices/communities and which population group to target initially. Assessing Potential Harm Risk assessment can have the well-recognised negative effects of disease-labelling in those identified with specific clinical risk factors (hypertension, diabetes, IGT or IFG) or false reassurance in those at lower cardiovascular risk who would still benefit from lifestyle change. This is difficult to quantify, but it is worth considering how a programme can maximise the proportion of those assessed who gain some evidence-based benefit from assessment, for example smoking cessation advice, to counter balance the potential to do more harm than good. Reducing Inequalities There is potential to use routine information sources and audit data to target resources in communities at higher risk in order to reduce inequalities as well as reduce the overall burden of cardiovascular disease. This requires PCTs to u Identify communities and population groups at increased risk of cardiovascular disease and diabetes u Raise local awareness of the potential to reduce risk through both population-wide initiatives (physical activity, healthy eating, smoking cessation) and individual risk assessment and clinical intervention (management of hypertension, lipids, diabetes) u Target support for general practices with the greatest unmet need for risk reduction u Use routine clinical management data to target treatment, for example look at QOF CHD scores verses CHD mortality rates to identify practices who appear to be providing below standard care. This may highlight practices with the most scope for improvement and allow targeted use of financial incentives provided by QOF 056

57 Establishing Mechanisms for Evaluation and Audit There needs to be development of a structure and process for audit of both current and future activity, which brings together information on both ad hoc and systematic screening, and to ensure that data is collected to avoid duplication of activity. This is in particular regard to lipid and glucose blood testing. If a new programme is to be introduced, an evaluation of population changes in risk factor levels, particularly if it is possible to compare practices introducing new activities with those who have not introduced those activities. This will allow an assessment of whether the programme is likely to produce the expected benefits in terms of measurable risk reduction. Introducing routine audit of risk assessment activity will assist practices in incrementally improving the recording of risk factors and in ensuring that where abnormal test results or significant overall risk is recorded that all the appropriate follow up and treatment has occurred. Other Issues Screening Personnel Healthcare assistants can be recruited and trained to offer a risk assessment and health promotion advice to people who attend for screening. Further work is needed to assess the effectiveness of health promotion and risk reduction intervention offered to individuals by healthcare assistants. An example Job Description with required competencies from the Skills and Knowledge framework is shown in the SOP Section pages Data Recording In the DHDS paper based systems were unpopular, and ultimately proved to be unsuitable. Practice systems are likely to be appropriate, but consistency in recording and coding information on risk factors, test results and diagnostic testing using locally developed system templates need to be better developed. An example of a template to record the outcome of a vascular assessment is shown in the SOP Section page 109. Routine risk assessment will become increasingly feasible as general practices continue to develop routine collection and recording with consistent coding of risk factors. In addition to age, this is required for body mass index, hypertension, ethnicity and smoking status. Other risk factors such as family history and waist circumference may be of value, particularly in terms of self-assessment of vascular risk. PART 1_Section 4 Reference List PART 1_Section 4 1. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v Scottish Intercollegiate Guidelines Network. Risk estimation and the prevention of cardiovascular disease: A national clinical guideline National Collaborating Centre for Primary Care. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease - full guideline DRAFT National Institute for Clinical Excellence. Hypertension: management of hypertension in adults in primary care. Clinical Guidelines (CG34) Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study. Imperial Cancer Research Fund OXCHECK Study Group. BMJ 1995;310: Family Heart Study Group. Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study. BMJ 1994;304: Ebrahim S,.Smith GD. Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease. BMJ 1997;314: National Institute for Clinical Excellence. Smoking Cessation: Brief interventions and referral for smoking cessation in primary care and other settings. Public health intervention guidance National Institute for Clinical Excellence. TA039 Smoking cessation - bupropion and nicotine replacement therapy: Guidance National Institute for Clinical Excellence. Four commonly used methods to increase physical activity: brief interventions in primary care, exercise referral schemes, pedometers and community-based exercise programmes for walking and cycling. Public health intervention guidance

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59 PART 2_Section 1 Implementation of Vascular Risk Assessment Programme; Broad Overview Record Based - Existing Disease Registers PART 2_Section 1 u Figure 10. Record Based Strategy (Existing Disease Register) for Vascular risk Assessment Procedure 1; Ensure current disease registers for LVD, Stroke/TIA CHD and DM registers are; u As complete as possible u That the optimal implementation of the current recommendations occurs u That all on these registers (except those on DM register already) should be offered annual screening for DM, as these subjects are at high risk for T2DM, but do not require CVS risk scoring as they already have established CVD u That all new patients diagnosed with DM as a result of the overall strategy are updated on to the Diabetes Register In this context, as patients often have planned visits, it is suggested that a fasting plasma glucose (FPG) is measured with a cut-off of 6 mmol/l. In both SA and White European populations, this will give a sensitivity of >80% and will result in less than 10% of subjects requiring an OGTT. As it is assumed that both patients on these disease registers will be offered optimal lifestyle advice, the need and justification for an addition of benefits of detecting patients with IGR is less of an issue. Patients could be given the choice of having a fasting glucose done along with their cholesterol and renal function, either before their assessment visit, or a fasting or random glucose could be sent on the day of the visit. u Use FPG to screen for T2DM (if Random Glucose used, use the same cut-off) u Offer OGTT to those with 6 mmol/l on FPG (See page 32) u < 10% will require OGTT if this strategy is used (based on FPG, more required if Random Glucose is used) 059

60 Subjects should be informed that there is a reasonable likelihood, i.e. 1 in 10, that they may require a confirmatory test, that the test is being done to look for undiagnosed diabetes, and if this is found then their targets for therapy for blood pressure may change, and that they may require additional screening of eyes, feet and kidney function. Procedure 1 is summarised in Algorithm 1 u Algorithm 1. Record Based Strategy Procedure 1 060

61 What the Practice Needs to Have in Place List of Required Standard Operating Procedures (SOP s) for procedure 1 with examples of all in the SOP Section u Search Strategy u Inclusion/Exclusion Criteria u Invitation Letter u DNA procedure u OGTT letter (if required) u What to expect from the visit u Procedure for OGTT what to expect (patient) u Procedure for OGTT (HCP) u Venepuncture p96 p98 p99 p105 p109 p107 p110 p117 p118 A worked example of this procedure with numbers involved in a typical practice is shown in Table 7. PART 2_Section 1 u Table 7. Record Based Procedure 1 Worked Example 061

62 Limiting assessment to those at high risk is only likely to be feasible if risk information can be obtained without patients being invited to attend the surgery and if the criteria are understood and accepted by the practice staff. It is important and practical to use age, BMI and hypertension which are already recommended to be recorded on registers as a starting point for such a record-based risk assessment programme. Record Based Procedure 2 At Risk Registers To offer all of those on existing vascular risk registers (to include those Hypertension Obesity and CKD Registers) a vascular assessment visit. Each individual register does not include a comprehensive assessment to allow CVD risk score, or a comprehensive assessment of lifestyle factors to allow targeted intensive lifestyle intervention and screening for undiagnosed T2DM and CKD. u Figure 11. Record Based Strategy (at Risk Register) for Vascular Risk Assessment It is suggested that the initial focus might be on the hypertension register which, from the QOF data, is the most complete. Vascular assessment could be offered to all adults on these registers. Patient already on a risk register (currently the Hypertension, Obesity Register, and CKD and those with a measured and recorded BMI of > 30 mg/kg 2, as not all will be recorded on the Obesity register) should be invited for a comprehensive vascular risk assessment. 062

63 Clinical Assessment of Vascular Risk This assessment should include a record of; u Age and gender u Ethnicity (for recording see SOP Section) p107 u Smoking habit (for recording see SOP Section) p107 u Record for Family history of CHD (to include history of premature cardiovascular disease, p108 i.e. angina, stroke or MI in men <55 years and women <65 years) u Record for FH of DM in a first degree relative p108 u Diabetes Risk Score (For example the Leicester Diabetes Risk Score) p82-83 See questionnaire template to collect this data before the visit p107 At the visit; u Measurement of weight (including calculation of BMI, weight in kg, height in metres, BMI calculated as kg/m 2 ) (see SOP Section pages ) u Waist circumference: indicate central obesity: >94cms in men and >80 in women in White Europeans, and 90cms and 80cms in SA populations (See SOP Section page 115) u BP (see SOP Section page 121) u Blood tests (fasting) sent to laboratory for lipid profile and glucose (egfr for those on HT register) Patients should be invited using an invitation letter that describes what to expect from their visit. Blood tests could be done prior to their vascular assessment so that results are available to the patient and healthcare professional, or could be done at the time of the vascular assessment with results communicated at a follow-up visit. The procedure is summarised in Algorithm 2 PART 2_Section 1 u Algorithm 2. Record Based Strategy Procedure 2 063

64 List of Additional SOPs for Procedure 2 with Examples of all in SOP Section u Measurement of Glucose p126 u Weight p117 u Measurement of Lipids p125 u Height p114 u Measurement of egfr (for those on HT/CKD Register) u BMI p118 u Collection of samples and transfer to the Laboratory p113 u Recording results on IT system u Pre-Visit Questionnaire p107 u Individual care plan p133 u Ethnicity Record p107 u Management plan p109 u Smoking History p107 u Equipment List p127 u Family History of CHD and DM p108 u BP p121 u WC p115 A worked example of this procedure with numbers involved in a typical practice is shown in Table 8 u Table 8. Record Based Procedure 2 Worked Example 064

65 Population-based screening This is suggested as the second phase of an overall vascular risk assessment strategy. All subjects on the practice register who are not on a disease register covered by the record based approach (CHD, DM, LVD, CKD HT Obesity), will be included. An example of population based screening in a structured and systematic way could start with patients offered this on their 50th birthday for the first year and then extended to those on their 40th birthday. Patients should receive an invitation letter which will clearly explain to them the reason that they are being invited and what to expect from the visit. Also the practice should encourage people to book for such an Assessment using posters in the surgery (see SOP Section p105 for example). Opportunistic screening should be encouraged and can be facilitated by computer prompts on records of eligible patients in their 40th and 50th year who may attend the surgery for other reasons. Patients should have the option of attending for a fasting blood test which will include assessment of lipid profile and glucose prior to their planned appointment, or be given the option of attending on the day and having the assessment done at the same time. For opportunistic testing a random blood test for lipids and glucose is acceptable but will need to be repeated in some patients (according to SOPs) Patients should be given clear feedback in terms of the results of the investigations, which should not be indicated as either positive or negative. The gradient of risk should be explained. It will be important to ensure that certain, already higher risk groups (for example those from BME groups or from deprived areas) respond to invitations for screening, otherwise this approach may inadvertently widen health inequalities. Practices need to guard against this by monitoring uptake and where uptake is low but risk/need is high they will need to use other approaches to improve uptake in these groups/geographical areas. This may require more innovative approaches with full use of the multi disciplinary team, social services and community facilities. Everybody, regardless of their fasting glucose level, may be at future risk of diabetes particularly in those who have a fasting or random glucose 5.0 mmol/l. This should be explained to the patients. Those with a FINDRISC score of 12 may have higher risk of DM and vascular disease, and would benefit from lifestyle intervention (intensive lifestyle intervention for those 15). This is based on data from North America and Finland where an intensive lifestyle intervention reduces the risk of diabetes by two-thirds. 1-2 The principal components of such a programme are well understood and include 5 key lifestyle targets as previously described. For summary of the procedure see Algorithm 3. (For further explanation of possible approaches to identify those with impaired glucose regulation see pages 34-35) PART 2_Section 1 A worked example of this procedure with numbers involved in a typical practice is shown in Table

66 u Algorithm 3. Population Based Strategy u Table 9. Population Based Strategy Worked Example 066

67 Self Assessment A self-assessment tool is being developed around the concept of the FINDRISC. The Leicester Diabetes questionnaire could be used to identify those who should be offered a blood test for diagnosis of impaired glucose regulation or an intensive lifestyle programme. Until further work is available, the FINDRISC offers some potential in assessment of those who need diagnostic testing ( 12) and those who should be offered intensive lifestyle intervention ( 15). The vascular assessment programme may require lifestyle and behavioural intervention not based on the level of blood glucose or CVD risk score but on the presence of risk factors such as increased BMI, waist circumference, positive family history and poor lifestyle and dietary habits such as is used in Finland with the FINDRISC. It can be used as a simple way to engage patients in assessing their own risk and also used to sign post subjects for further assessment 3 (see page 33). See algorithm 4 for an example of how this strategy could work. The whole area of self assessment and vascular risk needs further development, e.g. to include a question regarding smoking status. PART 2_Section 1 u Algorithm 4. Self Assessment Approach 067

68 Sporadic Activities When looking at any sporadic activity, it is important that the organisation liaise with the appropriate members of the local healthcare team, as well as the clinical biochemistry service. The Public Health Department within the local primary care organisation may be a useful first point of contact. There should be consultation regarding the choice of testing method, and clear referral pathways to primary care should be agreed. There is already a national advertised programme regarding screening for diabetes in Lloyds Pharmacy, using finger-prick blood tests. Whilst these are beyond the remit of the programme we have given general guidance regarding risk assessment and triggers for further assessment and intervention in the comprehensive list of Standard Operating Procedures (SOP s). It is important that any sporadic activity undertaken adheres to clinical governance principles. These include having clear lines of responsibility and accountability for the overall quality of clinical care, comprehensive programme of quality improvement activity, clear policies aimed at managing risk, procedures for all professional groups to identify and remedy poor performance. Regarding sporadic activities it is likely, for example, that pharmacies may have an important role in terms of being involved in sporadic activities involved with the risk reduction programme. For example, the Royal Pharmaceutical Society of Great Britain has issued clear guidance with regard to, for example, screening for undiagnosed diabetes. 5 There is clear guidance regarding the equipment, premises where this should be undertaken, and examples of quality assurance programme as well as outlining the code of ethics and clear Standard Operating Procedures for testing of body fluids 5. Regarding recommended training, in this case they suggest that pharmacists and pharmacy technicians who are involved in testing must be suitably trained in the procedure to be followed and in the advice to be given to patients. The training should be in the following areas: u Developing and working within Standard Operating Procedures u Testing (this includes the completion of any training programmes provided by the equipment suppliers to ensure competence in the use of equipment and interpretation of test results) u Quality assurance arrangements u Referral criteria and procedure u Feedback to patients (advice giving explanation of the probability of disease or risk in relation to the test results) u False negatives (why they can occur) u Safe handling of sharps u Record keeping u Giving consistent lifestyle advice u Reinforcing the person s desire to take care of themselves u Medicines management in issues related to vascular risk u Clinical governance and liability issues u Insurance It is important that any organisation involved in sporadic activities adheres to similar best practice. 068

69 PART 2_Section 1 Reference List 1. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N.Engl.J.Med. 2001;344: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N.Engl.J Med. 2002;346: Lindstrom J,.Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen.Intern.Med. 2001;16: The Royal Pharmaceutical Society of Great Britain. RPS e-pic References on: Diagnostic testing in community pharmacy PART 2_Section 1 069

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71 PART 2_Appendix Comparison of Software Available for a Population Based CVD Risk Assessment Strategy Oberoi Consulting Ltd u Features (see table on page 074) CHD risk tool based on the Framingham equation and a CVD risk tool based on BHS guidelines. Stand alone system, partially integrated. Practice populations based approach. Ranks all age-appropriate patients (32-74) in a practice by their Framingham risk score. Creates a list which can be exported to excel for further analysis. Excludes patients with pre-existing CVD (MI, stroke etc). Includes patients already on treatment for hypertension and basis management on latest recording of risk factors but provides worst case CVD risk score based on previous highest values of recorded risk factors (BP & cholesterol). Acknowledges any missing risk factors in the calculation. Allows easy comparison of change in CVD risk as a result of recent changes in risk factors. u Limitations Has not been peer reviewed Cost approx. 500 per practice Impossible to use opportunistically for individual patients as requires separate screen to be open for individual patient record to be accessed. It does not recognise patients who have already been risk assessed and have a risk score READ coded from a consultation say a week previously. Details obtained from Oberoi Consultancy Website 1. PART 2_Appendix EMIS u Features (see table on page 074) Integrated Framingham risk score currently CHD but evidently CVD risk score is being phased in. Can provide an estimated risk score for individual patients when information such as smoking status and cholesterol are missing by using population averages. u Limitations EMIS systems has a search function but it is not possible to follow one set of patients from start to finish comparing differences at two different time points as it brings different populations each time it is run. Search can identify those who have had risk assessment (READ coded) using integrated risk equation. At risk patient search limited to those with underlying risk factors only as cannot systematically risk score practice at population level. Smoking status is based on last recorded status (problem with actual risk if recently stopped). Uses last 2 BP readings and uses average not appropriate for treated hypertensive patients as pretreatment BP should be used 2,3. 071

72 E-nudge u Features (see table on page 074) Developed in collaboration with EMIS as part of an RCT. Integrated within clinical system Prompts clinician when individual patient may need risk assessment based on recorded risk factors and also identifies which risk factors need modification if at high risk. Assumes diabetes status as positive in those with no record of diabetes and no record of a normal glucose result in the last three years when estimating CVD risk score (prompt for screening for diabetes). If risk score is high then such a patient is categorised under the missing data group until glucose measurement is recorded. If still not on diabetes register, risk will then be calculated using negative diabetes status. Framingham risk score is never calculated on a patient known to have diabetes. Ex-smokers considered as smokers unless stopped for over a year when calculating CVD risk score. Allows for opportunistic and practice population screening strategy. As it is integrated regularly updated lists are available for practice population risk assessment. u Limitations May under-estimate risk in controlled hypertensive patients but these would not necessarily be a priority group initially. Structure of the algorithm used to create the software will be published in the medical literature and will allow any software company to duplicate it but is currently not available. u The e-nudge Trial baseline data collected June-September 2006 Aggregated data Total over 50 population Proportion in Group 1 (%) 8.92 Proportion in Group 2 (%) Proportion in Group 3 (%) 5.96 Proportion in Group 4 (%) 0.46 Proportion in Group 5 (%) 0.12 Proportion in Group 6 (%) 2.78 Group 1: Patients of all ages with existing CVD or diabetes, whose BP/cholesterol outside QOF targets Group 2: Patients not known to have CVD or diabetes and whose risk profile is incomplete but estimated CVD risk >20% using assumed values Group 3: Patients not known to have CVD or diabetes and <75yrs with CVD risk >20%. Group 4: Patients not known to have CVD or diabetes and >75yr old. Group 5: Patients with possible undiagnosed diabetes on the basis of at least one previous high blood glucose record Group 6: Patients with CVD but no diabetes, who have had no blood glucose measurement in the last three years For further information see 4,5 072

73 Sandwell u Features Interrogates clinical system and creates a list which can be exported to excel. Excluded patients on CHD register, or with CVD and those on BP treatment in the pilot project (but this can be modified). u Limitations Improvement in management seen where nurses are employed with the specific task to follow-up and manage patients. As yet, no evidence from comparative practices in that providing a list of at risk patients modifies professional behaviour. Intellectual property issues not resolved yet for integrated version (currently in discussion with isoft). For further information and Excel version allowing individual patient assessment, can be downloaded from the following site (but cannot be integrated into clinical system): 6,7 PART 2_Appendix 073

74 Comparison of Software Available for a Population Based CVD Risk Assessment Strategy GP clinical systems eg EMIS E-nudge (Warwickshire University) 4,5 Sandwell model 6,7 Oberoi Consulting Ltd 1 Equation used Framingham Framingham Framingham Framingham Risk factors included: Sex Age years Systolic BP (last two reading averages) * Cholesterol (Total & HDL)* Smoking status± Diabetes± ECG-LVH± Sex Age <75 years Systolic BP (average of last three readings) * Cholesterol (Total & HDL) * Smoking status Diabetes ECG-LVH± Sex Age years Systolic BP recorded in the last year* Cholesterol (total & HDL)* Smoking status± Diabetes status± ECG-LVH± Sex Age years Systolic BP Diastolic BP Cholesterol (total, LDL and HDL) Smoking status Diabetes status Calculated Risk Estimated and Actual 10 year CHD/ CVD risk score Estimated and actual 10 year CVD risk score 10 year CVD risk 5/10 CHD risk 5/10 CVD risk Population targeted Individual patients Population searches based on risk factors only Individual patients Can systemically risk score Practice population Can systemically risk score Practice population Can systemically risk score Practice population Integration with clinical system Fully integrated Fully integrated (EMIS only) Can interrogate clinical system (isoft) Can interrogate a number of clinical software systems (EMIS/iSOFT/). Strengths and Special features Risk assessment of individual patients Activity READ coded Prompts opportunistic screening (automatic screen alerts) Identifies those with abnormal blood glucose Highlights missing risk factors Activity READ coded Provides ʻworst caseʼ CVD risk score based on previous recorded risk factors. Limitations Can search for previous calculated risk scores but cannot systemically risk score practice population See text Not integrated Not integrated, stand alone system Cost Free See text See text 500 * Uses population averages when risk factors not present to create an estimated risk score Assumes diabetes status positive when no record or no blood glucose result record in last 3 years in those whose estimated CVD risk is particularly sensitive to this missing data. Ex-smokers considered as smokers unless stopped for over a year ± Assumes risk factor negative if no record 074

75 Screening for Diabetes - Recent Data from Screening Studies in Leicester The STAR (Screening Those At Risk) Study (Study 1) was designed to provide information regarding the logistics and best methods for screening for T2DM and IGT in a mixed ethnic population in the UK: It was a multimethod, multi-disciplinary approach regarding the utility of different strategies of screening. Inclusion criteria were White European subjects aged between 40 and 75 years, and South Asian subjects aged between 25 and 75 years. The Study involved 17 practices in Leicestershire of mixed urban and rural character, with some city practices having a high South Asian population. All subjects gave informed consent, and underwent 75 gram OGTT done in standardised conditions. There was standardised health assessment including anthropometric measures, questionnaires, full biochemical data and collection of data to allow calculations of both the Cambridge Diabetes Risk Score and the FINDRISC 8-9. We have full information on 3,418 subjects. ADDITION - Leicester (Study 2) 10 - which is currently being conducted in 24 practices across Leicestershire. These are different practices to those in the STAR Study, for the purpose of this report we have complete cleaned data on 2,813 subjects. For the purpose of this handbook we provide information regarding the sensitivity and specificity of a two-stage screening approach for diabetes based on looking at hypertension and obesity. The STAR Study is reported as part of a MD thesis by Dr Jenny Tringham 11. Study 1: n = 3418 Adults (33.3% SA) Study 2: n = 2813 (30% SA) 1) Results of two staged approach using HT/BMI then FPG Applying the Study 1 derived screen to the Study 2 study South Asians to detect T2D: Discrimination of score, with first stage derived from hypertension status and BMI for predicting T2DM, where second stage is: fasting blood glucose 5.5mmol/l PART 2_Appendix Cutpoint Sens Spec OGTT 95% CI 95% CI for BMI* (%) (%) (%) 95% CI NND All pass 1st stage Sens = Sensitivity, Spec = Specificity, OGTT = proportion of those screened continuing to OGTT, NND = Number needed to diagnose. * if HT absent; HT is equivalent to +6.4 units BMI) All text and tables University of Leicester 075

76 Applying the Study 1 derived screen to the Study 2 study South Asians to detect T2D: Discrimination of score, with first stage derived from hypertension status and BMI for predicting Type 2 diabetes, where second stage is: fasting blood glucose 6.0mmol/l Cutpoint Sens Spec OGTT 95% CI 95% CI for BMI* (%) (%) (%) 95% CI NND All pass 1st stage Sens = Sensitivity, Spec = Specificity, OGTT = proportion of those screened continuing to OGTT, NND = Number needed to diagnose. * if HT absent; HT is equivalent to +6.4 units BMI) 2) Results of two staged approach using HT/BMI then FPG Applying the Study 1 derived screen to the Study 2 study White Europeans to detect T2D: Discrimination of score, with first stage derived from hypertension status and BMI for predicting Type 2 diabetes, where second stage is: fasting blood glucose 5.5mmol/l Cutpoint Sens Spec OGTT 95% CI 95% CI for BMI* (%) (%) (%) 95% CI NND All pass 1st stage Sens = Sensitivity, Spec = Specificity, OGTT = proportion of those screened continuing to OGTT, NND = Number needed to diagnose. * if HT absent; HT is equivalent to +6.4 units BMI) All text and tables University of Leicester 076

77 Applying the Study 1 derived screen to the Study 2 study White Europeans to detect T2D: Discrimination of score, with first stage derived from hypertension status and BMI for predicting Type 2 diabetes, where second stage is: fasting blood glucose 6.0mmol/l Cutpoint Sens Spec OGTT 95% CI 95% CI for BMI* (%) (%) (%) 95% CI NND All pass 1st stage Sens = Sensitivity, Spec = Specificity, OGTT = proportion of those screened continuing to OGTT, NND = Number needed to diagnose. * if HT absent; HT is equivalent to +6.4 units BMI) PART 2_Appendix Using cut-off of plasma venous glucose of 6mmol/l reduces number of OGTTs required from ~20% to less than 10%. Sensitivity ~80% (87%~ in SA population) detecting T2DM if BMI cut off 25kg/m 2, sensitivity % for BMI 30kg/m 2 u A two stage procedure using BMI (>25kg/m 2 ) and the presence of hypertension in both South Asian and White European populations has a sensitivity of between 80-86% with only 7-9% requiring OGTT u FPG cut off should be >6mmol/l to detect undiagnosed diabetes u This approach will not detect the majority of cases of impaired glucose regulation (IGR) see page 31 All text and tables University of Leicester 077

78 Development of the Leicester Diabetes and Pre-diabetes Risk Score Screening for Type 2 diabetes and IGR (otherwise known as Pre-diabetes) in the population might consist of three stages. Stage 1 would consist of an initial screen using only information readily available to a general practice, or to a person assessing their own risk. People who scored above a specified cutpoint would progress to Stage 2 and attend to have their FPG measured. Those with sufficiently high values would be invited for an OGTT - to be followed, if necessary, with a second OGTT - after which a positive or negative diagnosis would be made. We compared the implications for sensitivity, specificity and resource use of three possible approaches to the first stage of screening as suggested above: u use of the FINDRISC test, the latest version to include information on family history of diabetes u use of a new prototype Leicester Diabetes and PDM risk score developed here for illustration only u having no separate Stage 1, and instead invite the entire population group to have their FPG tested The prototype Leicester Diabetes and Pre-diabetes risk score was derived from data from the STAR cross-sectional population-based study carried out in Leicester in which OGTT diagnoses were made on all participants, using logistic regression modelling. The characteristics initially considered for inclusion in the model were: age (ranging from 40 to 75 years), sex, ethnicity (either South Asian or white European), measures of obesity, frequency of physical exercise, frequency of fruit and vegetables in the diet, whether there was a 1st degree family history of diabetes and the IMD index of deprivation derived from the postcode. Obesity was assessed both as body mass index and as waist circumference - body mass index was assessed as quintiles calculated separately for each of the two ethnic groups, and waist circumference was assessed as quintiles calculated separately for each combination of ethnic group and sex. The variables in the model other than obesity were tested for an interaction to judge whether any relation they had to the presence of undiagnosed T2DM might differ between the ethnic groups, but these were not found to be statistically significant. The deprivation index was taken out of the model due to being non-significant, but as the score was developed in a relatively homogeneous cohort it may be included when we validate the tool in a larger more heterogeneous population. The resulting risk score is shown in the table below. variable level rounded score age SA Male Sa Female WE Male WE Female Gender and Ethnicity SA Male Sa Female WE Male WE Female WC (cm) 0 <88 <82 <90 < >103 >100 >108 >104 SA WE BMI (kg/m 2 ) 0 <23.8 < >30.6 >32.2 Previous HT Treatment no 0 yes 3 1 st degree FH of DM no 0 yes 4 All text and tables University of Leicester 078

79 The score could be made easier to use by replacing the use of quintiles for body mass index with a specific number of points assigned for each combination of ethnicity and BMI group (e.g kg/m 2, kg/m 2, etc ), and correspondingly for waist circumference, and this is illustrated in the example shown on pages Further work that will be needed in order to further develop a Diabetes and PDM risk score that can be provided for use in public health will include validation on other population datasets, possibly also using the same modelling approach of other datasets to examine the consistency of model coefficients, more complete examination for the more complex interaction effects and, if practical, the systematic examination of what information can be assumed from the fact that certain items of information are not recorded for that individual by the general practice (or are not answered by the user). An example of the current prototype is shown on pages We have used this with a cut off score of 19 to determine who should proceed to a fasting glucose test and compare using this approach to the FINDRISC and a strategy using FPG for all. PART 2_Appendix All text and tables University of Leicester 079

80 Comparison of Strategies to Detect DM and (Pre-diabetes or Impaired Glucose Regulation) Using FPG in all, or Pre-Screening with either FINDRISC or the Leicester Diabetes and PDM Risk Score Strategy with FPG for all FPG for all FPG for all FPG for all Overall prevalence of DM and PDM 361 / 1919 = 18.8% 361 / 1919 = 18.8% 361 / 1919 = 18.8% Stage 1 screen (none) (none) (none) People going on to have FPG 1919 = 100% 1919 = 100% 1919 = 100% Stage 2 screen FPG 5.0 mmol/l FPG 5.5 mmol/l FPG 6.0 mmol/l People going on to have OGTT Sensitivity: 327 / 361 = 90.6% Specificity: 690 / 1558 = 44.3% Overall sensitivity*: 327 / 361 = 90.6% Sensitivity: 269 / 361 = 74.5% Specificity: 1288 / 1558 = 82.7% Overall sensitivity*: 269 / 361 = 74.5% Sensitivity: 205 / 361 = 56.8% Specificity: 1542 / 1558 = 99.0% Overall sensitivity*: 205 / 361 = 56.8% 1195 / 1919 = 62.3% 539 / 1919 = 28.1% 221 / 1919 = 11.5% Results for screening for pre-diabetes (including diabetes), using various FPG cut-points, when there is no initial screen - based on STAR data, for South Asians and white Europeans, aged years (In 1919 subjects with complete FINDRISC Data). *Overall sensitivity of a staged approach to detect both DM and PDM. Strategy using Prototype Leicester Diabetes and Pre-diabetes Risk Score FPG if new score 19 FPG if new score 19 Overall prevalence 361 / 1919 = 18.8% 361 / 1919 = 18.8% Stage 1 screen Sensitivity = 247 cases / 361 = 68.4%, Specificity = 986 non-cases / 1558 = 63.3% Sensitivity = 247 cases / 361 = 68.4%, Specificity = 986 non-cases / 1558 = 63.3% People going on to have FPG 819 / 1919 = 42.7% 819 / 1919 = 42.7% Stage 2 screen FPG 5.0 mmol/l FPG 5.5 mmol/l Sensitivity: 226 / 247 = 91.5% Specificity: 223 / 572 = 39.0% Overall sensitivity*: 226 / 361 = 62.6% Sensitivity: 189 / 247 = 76.5% Specificity: 438 / 572 = 76.6% Overall sensitivity*: 189 / 361 = 52.4% People going on to have OGTT 575 / 819 = 70.2% of stage / 1919 = 30.0% overall 323 / 819 = 39.4% of stage / 1919 = 16.8% overall Results for screening for pre-diabetes (including diabetes), using various FPG cut-points, when the initial screen is new score 19 - based on STAR data, for South Asians and White Europeans, aged years (In 1919 subjects with complete FINDRISC Data) * Overall sensitivity of staged approach to detect both DM and PDM All text and tables University of Leicester 080

81 Strategy using FINDRISC FPG if FINDRISC 12 FPG if FINDRISC 12 Overall prevalence 361 / 1919 = 18.8% 361 / 1919 = 18.8% Stage 1 screen Sensitivity = 220 cases / 361 = 60.9, Specificity = 1006 non-cases / 1558 = 64.6%. Sensitivity = 220 cases / 361 = 60.9, Specificity = 1006 non-cases / 1558 = 64.6%. People going on to have FPG 772 / 1919 = 40.2% 772 / 1919 = 40.2% Stage 2 screen FPG 5.0 mmol/l FPG 5.5 mmol/l People going on to have OGTT Sensitivity: 204 / 220 = 92.7% Specificity: 221 / 552 = 40.0% Overall sensitivity*: 204 / 361 = 56.5% 535 / 772 = 69.3% of stage / 1919 = 27.9% overall Sensitivity: 168 / 220 = 76.4% Specificity: 438 / 552 = 79.3% Overall sensitivity*: 168 / 361 = 46.5% 282 / 772 = 36.5% of stage / 1919 = 14.7% overall Results for screening for pre-diabetes (including diabetes), using various FPG cut-points, when the initial screen is FINDRISC 12 - based on STAR data, for South Asians and white Europeans, aged years (In 1919 subjects with complete FINDRISC Data) * Overall sensitivity of staged approach to detect both DM and PDM PART 2_Appendix u For a summary of these strategies see page 080 All text and tables University of Leicester 081

82 Example of Prototype Leicester Diabetes and Pre-diabetes Risk Score* * This is a prototype and is not subject to external validation or pilot work. It is likely to change as a result of further developmental work and is shown as an example only Prototype University of Leicester 082

83 PART 2_Appendix Prototype University of Leicester 083

84 Intensity and Energy Expenditure for Common Types of Physical Activity Activity Intensity Intensity (METS) Energy Expenditure (Kcal equivalent, for a person of 60kg doing the activity for 30 minutes) Ironing light Cleaning and dusting light Walking - strolling, 2mph light Painting/decorating moderate Walking - 3mph moderate Hoovering moderate Golf - walking, pulling clubs moderate Badminton - social moderate Tennis - doubles moderate Walking - brisk, 4mph moderate Mowing lawn - walking, using power-mower moderate Cycling mph moderate Aerobic dancing vigorous Cycling mph vigorous Swimming - slow crawl, 50 yards per-minute vigorous Tennis - singles vigorous Running - 6mph (10 minutes/mile) Running - 7mph (8.5 minutes/mile) Running - 8mph (7.5 minutes/mile) vigorous vigorous vigorous

85 Comparison of Various Diabetes Risk Scores DIABETES RISK SCORES FINDRISC Danish Risk Cambridge Risk ARIC (clinical Questionnaire 15 Score 14,16,17 model) Sample Population based random sample of 4,435 subjects Population based random sample of 3,250 subjects Population based sample of 1,077 plus additional cases from 41 practices Cohort of 7,915 subjects Analysis Multivariate logistic regression Univariate & multivariate regression Logistic regression Multivariate analysis Performance Sensitivity 77% Specificity 66% PPV 7% AUC 80% Sensitivity 76% Specificity 72% PPV 11% AUC 80% Sensitivity 77% Specificity 72% PPV -11.3% NPV 98.6% AUC 80% Sensitivity 77% Specificity 55% - AUC 71% Internal Validation Temporal Validation on 4586 subjects 12 External& Cross -validation on 1,208 & 2,874 subjects External & cross validation Cross Validation External Validation of the risk score IGLOO study 13 (Franicosi et al. 2005) KORA Survey 14 Australian Study (Glumer, Borch- Johnsen et al. 2005) 15 (Park, Griffin et al. 2002) 16 KORA Survey 14 British Birth Cohort Study 17 N/A * AUC = Area under the curve PPV = Positive Predictive Value NPV = Negative Predictive Value PART 2_Appendix Symptom Risk Indian Score Questionnaire Population based sample of 1,112 subjects Population based cohort of 10,003 subjects Logistic regression Logistic regression Sensitivity 77% Specificity 55% PPV 8% AUC 80% Sensitivity 76.6% Specificity 59.9% PPV 9.4% NPV 97.9% AUC 73% Cross Validation & Temporal Validation External & Cross Validation KORA Survey (Rathman, Martin Mohan et al. (2007) 18 et al. 2005)

86 PART 2_Appendix Reference List 1. Oberoi Consultancy JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v National Institute for Clinical Excellence. Hypertension: management of hypertension in adults in primary care. Clinical Guidelines (CG34) E-Nudge Trial Holt TA, Thorogood M, Griffiths F, Munday S. Protocol for the 'e-nudge trial': a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN ]. Trials 2006;7: Marshall T. Estimating the value of information in strategies for identifying patients at high risk of cardiovascular disease.inform.prim.care 2006;14: Marshall T. The use of cardiovascular risk factor information in practice databases: making the best of patient data. Br.J Gen.Pract. 2006;56: Griffin SJ, Little PS, Hales CN, Kinmonth AL, Wareham NJ. Diabetes risk score: Towards earlier detection or type 2 diabetes in general practice. Diabetes/Metabolism Res.Rev. 2000;16: Lindstrom J,.Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26: Davies MJ, Khunti K, Griffin, S., Wareham, N., and Farooqi, A. ADDITION Leicester - part of the ADDITION Europe Study: A randomised trial of the cost effectiveness of screening and intensive multi-factorial intervention for Type 2 diabetes Tringham, J. R. Strategies for the early detection of type 2 diabetes in an at risk population MD University of Leicester Saaristo T, Peltonen M, Lindstrom J, Saarikoski L, Sundvall J, Eriksson JG et al. Cross-sectional evaluation of the Finnish Diabetes Risk Score: a tool to identify undetected type 2 diabetes, abnormal glucose tolerance and metabolic syndrome. Diab.Vasc.Dis.Res. 2005;2: Franciosi M, De Berardis G, Rossi MC, Sacco M, Belfiglio M, Pellegrini F et al. Use of the diabetes risk score for opportunistic screening of undiagnosed diabetes and impaired glucose tolerance: the IGLOO (Impaired Glucose Tolerance and Long-Term Outcomes Observational) study. Diabetes Care 2005;28: Rathmann W, Martin S, Haastert B, Icks A, Holle R, Lowel H et al. Performance of screening questionnaires and risk scores for undiagnosed diabetes: the KORA Survey Arch.Intern.Med. 2005;165: Glumer C, Borch-Johnsen K, Colagiuri S. Can a screening programme for diabetes be applied to another population? Diabet.Med. 2005;22: Park PJ, Griffin SJ, Sargeant L, Wareham NJ. The performance of a risk score in predicting undiagnosed hyperglycemia. Diabetes Care 2002;25: Thomas C, Hypponen E, Power C. Type 2 Diabetes Mellitus in Midlife Estimated From the Cambridge Risk Score and Body Mass Index. Arch.Intern.Med. 2006;166: Mohan V, Sandeep S, Deepa M, Gokulakrishnan K, Datta M, Deepa R. A diabetes risk score helps identify metabolic syndrome and cardiovascular risk in Indians - the Chennai Urban Rural Epidemiology Study (CURES-38). Diabetes Obes.Metab 2007;9:

87 PART 2_SOP Standard Operating Procedures u SECTION 1.1 Search & Invitation Strategy for Record Based Approach Search Used for New Vascular Risk Assessment Programme 089 Template for Identification and Search Record Based Procedure Template for identification and search Record Based Procedure Inclusion/Exclusion criteria - record based 092 Initial Invitation letter record based using existing disease register (procedure 1) 093 Initial Invitation letter - record based using at risk registers (procedure 2) 094 u SECTION 1.2 Search & Invitation Strategy for Population Based Approach Template for identification and search population-based strategy 095 Inclusion/Exclusion criteria - population based 096 Initial invitation letter to screening on 50th or 40th birthday 097 Initial invitation protocol - for population and starting with those aged 50 yrs or 40 yrs 098 Second invitation (reminder) protocol 099 Second invitation letter (reminder) 100 u SECTION 2 Information Sheets and Practice Posters Patient Information Leaflet - What to Expect at your Appointment 101 Patient Information Leaflet 2 - Why Should I Attend? 102 OGTT letter - Invitation for Patient 103 OGTT letter- What to Expect 104 Sample Poster for Population Based Strategy - Invitation 105 Sample Poster for Population Based Strategy - What to Expect 106 PART 2_SOP u SECTION 3 Collection of Clinical Data Pre-visit Questionnaire 107 Risk Assessment Patient Results Outcome Sheet 109 u SECTION 4 Clinical Protocols and Measurements OGTT procedure for Healthcare Professionals 111 Venepuncture 112 Collection of Samples and Transfer to the Laboratory 113 Height measurement 114 Waist circumference 115 Self Measurement of Waist Circumference 116 Weight 117 BMI 118 Patient Guide to BMI 119 Arm circumference 120 Blood pressure (JBS Guidance) 121 Blood pressure (using OMRON or similar electronic device) 122 What is meant by fasting 123 Measurement of blood glucose and diagnosis of Diabetes

88 u SECTION 4 Clinical Protocols and Measurements (cont) Measurement of lipids 125 Appropriate action for Ketones in urine 126 Equipment needed for clinic 127 u SECTION 5 Risk Assessment Calculating CVD Risk Score 128 CVD Risk Prediction Charts 129 CVD Risk Score Adjustment for Other Risk Factors 131 What is Your Risk; Risk Factors You Can Change. 132 Example of a Care Plan 133 u SECTION 6 Patient Information Sheets Cardiovascular Health Risk Assessment 134 Physical Activity for Health 137 Smoking - A Summary 138 Healthy Eating 139 Five Choices to Help You Stay Healthy 142 Cholesterol 143 u SECTION 7 Other Employing Health Care Assistants in General Practice 145 Health Care Assistant Job Description 147 Reference List

89 Search used for new vascular risk assessment programme Identification of Patients; An Example Example for Search performed on EMIS LV The administrator will identify, using the Practice EMIS Computer System (or whichever system is used), patients who are eligible for vascular risk assessment. These patients will fall within the following groups: 1) Build a Search on patients aged ST Search & statistics B Patient searches A Build and perform new search A On today s practice population Add a feature 1. Age Upper Limit = 74 enter Lower Limit = 40 enter A Shared Return Are features correct enter Y Give search a name: vascular assessment. - enter Save under One-Off Search File. The system will ask if you want to run the search enter Y for yes. PART 2_SOP Escape out of this section, until you get the screen which indicates the name of the Surgery in the top left-hand corner. 089

90 How to identify appropriate patients for assessment Template for identification and search: Record Based; Procedure 1 Search Strategy Template for identification Record-based strategy using the existing disease registers - (procedure 1) Search for all patients aged from 18 years up to 74 years (up to 74yrs, 11mths, 30 days) (lower age limit 18 years) From those in 1 above search for patients on the following registers; LVF Stroke/TIA CHD The criteria should be included Call this List A Exclude any patients on the Diabetes register Call this List B From List B exclude any patients with a blood glucose record of 6mmol or an HbA1c 6% in the past 15/12 Call this List C List C are those people who will need a FPG test done at the Vascular Assessment or earlier along with cholesterol & egfr 090

91 How to identify appropriate patients for assessment Template for identification and search: Record Based; Procedure 2 Search Strategy Template for identification Record-based strategy using at risk registers (obesity/hypertension/ckd) - procedure 2 u All adults aged 25 (up to 24yrs, 11mths, 30 days) to 74 (up to 74yrs, 11mths, 30 days) Call this List A u From List A exclude patients on any or all of the following registers; LVF Stroke/TIA CHD Diabetes Call this List B u From List B search for patients with the following criteria; Hypertension Obesity CKD PART 2_SOP Call this List C These are the people who will receive a Vascular Assessment invitation letter. 091

92 Inclusion/Exclusion criteria - record based Record-based using existing disease register (procedure 1): u Inclusion; Strategy for diabetes screening for patients on the LVD, stroke, TIA and CHD register: all Adults aged will be offered annual screening for diabetes in the form of a fasting plasma glucose, and screening for chronic kidney disease (egfr). u Exclusion: If there is already a record of a plasma glucose of < 6 mmol/l within the past 15 months (or an HbA1c 6%). At the clinician s discretion, for example, poor prognosis due to other co-morbidities which makes screening inappropriate. If the patient expresses a wish not to have the test done Record-based screening using at risk register (procedure 2): u Inclusion; All those on the CKD, Hypertension or Obesity register and all those with BMI > 30 kg/m2: Aged years u Exclusion: Those who have recorded that they have removed their consent to be contacted for vascular risk assessment. Those who, according to the clinician, have severe co-morbidities which means vascular assessment is inappropriate. 092

93 Initial Invitation letter record based using existing disease register (procedure 1): For those on LVD, stroke/tia and CHD registers: SAMPLE LETTER Anytown Surgery Dear Mr Bloggs: As you know the practice invites you for a regular check-up. As part of your check-up we will now be including a screening test for diabetes. This is because diabetes has been shown to be more common in people with established vascular disease, including a history of stroke and/or heart attack. Therefore we would like option 1: for you to attend fasting approximately 7-10 days before your planned visit to have your fasting blood test done, and when we send the blood test to check your cholesterol and kidney function we will also include a blood glucose or option 2: we would like you to attend fasting on the day of your visit so that we can send, in addition to your cholesterol level and kidney function, a blood test to screen for diabetes. 9 times out of 10 we will be able to tell on the initial fasting blood glucose whether you have diabetes or whether this is very unlikely. However, one in ten times we will need to do a second test to confirm this. If you need a second test this is nothing to worry about, but it does take a little longer. You will be informed of the need for a second test within two weeks of your visit. PART 2_SOP Please do not hesitate to get in touch should you have any queries, by calling The enclosed sheet tells you how to prepare for your visit. With kind regards, Yours sincerely, 093

94 Initial Invitation letter - record based using at risk register (procedure 2): SAMPLE LETTER Anytown Surgery Dear Mr Bloggs VASCULAR ASSESSMENT VISIT We would like to invite you to attend the surgery for a check-up. This is because as part of our practice s commitment to the health of patients people who we have identified who may be at higher risk of developing vascular diseases including diabetes, heart disease and kidney disease have been selected to have a general check up. I enclose an information sheet that explains exactly what will be involved in this check-up, and would encourage you to attend. If you cannot make this appointment please contact the surgery on to arrange another time. Yours sincerely, 94

95 How to identify appropriate patients for assessment Template for identification and search population based strategy Search Strategy; an example Template for identification population-based u Identify all those aged between 40 (up to 39yrs, 11mth, 30 days) and 74 (74 yrs, 11mths, 30 days) Call this Step 1 u From Step 1 exclude all those on the following registers; Hypertension CHD TIA/Stroke CKD Obesity Diabetes The criteria should be excluded as we want to exclude people already on any of the registers. Call this Step 2 Patients in Step 2 are invited, for example starting with people having their 50th birthday in that year and then as a second wave people from their 40th Birthday depending on the predicted workload. PART 2_SOP The interval between assessments, if CVD Risk is low at first, is likely to be not less than 5 years. 95

96 Inclusion/Exclusion criteria population based u Inclusion: All adults aged between 40 and 74 should be offered a risk assessment this may start from the year of their 40th birthday.* u Exclusion: Those who have recorded that they have removed their consent to be contacted for vascular risk assessment. Those who, according to the clinician, have severe co-morbidities which means vascular assessment is inappropriate. * 40 years old is the age currently suggested by recent guidelines 1-2. However local services will need to decide how long they will implement such a programme. For example start with patients that are aged 50 years old or over first. 96

97 Initial invitation letter to screening on 50th or 40th birthday SAMPLE LETTER Anytown Surgery Dear Mr Bloggs Congratulations on your recent birthday. The doctors and staff at Blooming Health Medical Centre would like to wish you a very Happy Birthday. Now that you have reached this milestone, we would like to invite you to X for a general check-up of your health. We note from our records that you have not had a health check including measurement of your blood pressure, cholesterol levels etc., and as part of our practice s commitment to the health of patients, we now see this as an important part of the preventative health care. I enclose a sheet that gives you information on what to expect at this appointment. If you have any further questions, please call , and someone will be able to help you. PART 2_SOP We look forward to hearing from you. Yours sincerely, 97

98 Initial invitation protocol for population and starting with those aged 50yrs or 40yrs Initial invitation u 1. At the beginning of each month perform a search to find anyone with a 50th (or 40th) birthday during the next month. i.e. First week in January search for patients with 50th birthday in February. u 2. Make a note on the calendar to send invitation birthday card 2-3 days before the due date. u 3. Ensure that PIL and What to expect at your clinic appointment are enclosed with invitation letter u 4. When patient calls for appointment make the blood test appointment first, entering reason Vascular Assessment - followed by the screening appointment 10 days later to ensure blood results are back. u 5. Enter reason for appointment Vascular Assessment OR enter on to a pre-booked clinic. 98

99 Second invitation (reminder) protocol No response to first and second invitations protocol u 1. At beginning of each month check on diary for preceding month for patients who had 1st reminder letter. If patient has not booked an appointment or DNA d for second time put entry on to patient record DID NOT ATTEND VASCULAR ASSESSMENT AT AGE 50 (OR AGE 40). Use the patient diary to enter the next due date for re-call. Second invitation u 2. At beginning of month check on diary to see who was due for appointment during preceding month. I.e then check the patient s diary to ensure they attended or have an appointment booked. u 3. If patient has not booked an appointment or DNA d; Ideally telephone to make another appointment. Confirm appointment by post enclosing PIS and What to expect leaflet Write to the patient using 2nd reminder letter also enclosing PIS and what to expect If patient contacts to decline invitation but would like to be invited in the future UPDATE RECORD If patient states they do not wish to be contacted UPDATE RECORD PART 2_SOP 99

100 Second invitation letter (reminder) SAMPLE LETTER No response to first and second invite Anytown Surgery Dear Mr Bloggs You may remember that I wrote to you on your recent birthday to invite you to come along to our (clinic title). I notice that we haven t heard from you. I would encourage you to come along as soon as possible for this important health check. This will give you peace of mind and if we do detect anything out of the ordinary we can start to deal with it before it becomes too serious. The appointment will only take (about 30 minutes) and with our flexible clinic times we can usually find a time that is convenient for you. Of course, if you wish to decline this time but would like to be invited in future please let us know. With kind regards 100

101 Patient Information Leaflet - What to Expect at Your Appointment What to expect at your (clinic name) appointment u Please allow 30 minutes for your appointment u Bring along any medication you are currently taking u Please bring along the enclosed questionnaire which should take no more than minutes to complete u If you have not had a fasting blood test prior to this appointment please attend fasting (fasting means nothing to eat or drink apart from water for at least 8 hours) u Wear comfortable, non-restrictive clothing PART 2_SOP u Your blood pressure will be taken 3 times throughout the appointment, so that we can get an ʻaverageʼ reading u We will measure your height and weight u We will measure your waist u We will discuss: Your blood test results Your lifestyle diet, exercise, smoking etc Family history of heart disease and/or diabetes In some patients (about 1 in 10) a follow-up visit is required for additional blood tests, e.g. to be certain whether someone does or does not have diabetes. You will be informed about this within 2 weeks of your visit We will test your urine with a test strip. If necessary we may ask you to do another urine sample to send off to the hospital for further tests (if we suspect infection for example) Anytown Surgery 101

102 Patient Information Leaflet 2 - Why Should I Attend? Why is it important that I attend this appointment? You have been invited to come along as you are now in the age range that maybe at an increased risk of high blood pressure, heart disease, stroke, kidney disease or diabetes. We would hope to delay the onset or minimise the risk of complications of these diseases by inviting you to attend this appointment. Initial appointment for a blood test When you contact the surgery to make your appointment for (insert clinic title) you will be asked to make an appointment for a fasting blood test. We will be checking for cholesterol, and kidney function and in some people, glucose. This test should be approximately 7 10 days before your screening appointment. At this initial appointment you will be given a urine bottle. Please use this to bring a sample to your screening appointment. What happens at my screening appointment? Your appointment will be with the Health Care Assistant or Practice Nurse and will take around minutes. He/she will measure your height and weight, take your blood pressure and test your urine. You will also have a discussion about your lifestyle (diet, exercise, smoking status etc.) and family history of heart disease and diabetes. Please feel free to ask any questions or raise concerns that you may have. The Nurse or Health Care Assistant will also discuss the results of your blood test. If necessary he/she may ask you to see the doctor. Don t worry, your results may be outside the desired range and the doctor may wish to do some further tests but this will be discussed fully with you. All the outcomes of the appointment will be discussed with you and recorded for you to take away. Will I have to come back again? In some patients (about 1 in 10) a follow-up visit is required for additional blood tests, e.g. to be certain whether someone does or does not have diabetes. You will be informed about this within 2 weeks of your visit. Provided all the tests are within the desired range we will not need to follow-up this appointment. If, however, something is a little out of the ordinary we will follow the National guidelines to give you the best care we can. You will be recalled for your next vascular review appointment after approximately 5 years but this will depend on the outcome of the initial visit. u Please bring a urine sample to your main screening appointment 102

103 OGTT Letter - Invitation to Patient SAMPLE LETTER Anytown Surgery Dear Mr Bloggs You recently attended the surgery for your vascular risk assessment. The sample that was sent for the measurement of blood sugar is above the normal range and therefore we need to perform a second test to confirm whether or not you have diabetes. This is nothing to worry about, and we enclose a patient information sheet to tell you how to prepare for this test. Option 1: Please find enclosed a date and time for the appointment for the test. If this is inconvenient, please ring on (insert number) PART 2_SOP Option 2: Please ring on (insert number) to arrange a convenient time and date for the test to be done, or if you have any queries. Yours sincerely, 103

104 OGTT Letter- What to Expect Patient Information Leaflet - Oral Glucose Tolerance Test Why should I have this test? Sometimes we check the level of glucose in blood by a ʻfinger-prick testʼ or on a single test sent to the laboratory. However, this is not an accurate way of detecting or diagnosing diabetes. If you have a test that is specifically designed to diagnose diabetes and have prepared properly for the test, following our guidelines, we can get a much more accurate diagnosis. How long does it take? We ask you to allow 2 1 / 2 hours from arrival to departure What should I do before having the test? The test will be carried out early in the morning, usually around a.m. Do not have any food or drink from midnight the night before. So, if your test is at 8.30a.m. on February 1st you should not eat or drink from 11.59p.m. (Midnight) January 31st. You may have water. Please do not smoke during this time. What about my medication? You should take your medication as normal unless it should be taken with food. If you need to eat something immediately before or after taking your medication please wait until after the test to take your tablets. Please check with your doctor if you are unsure about this. What will happen during the test? u You should arrive promptly for your appointment. The Practice Nurse or Health Care Assistant will check that you have had nothing to eat or drink since midnight and then she/he will take the first blood sample from your arm. u You will then be asked to drink your Lucozade. u After drinking the Lucozade you will be asked to sit in the waiting-room. Please feel free to bring a book or some other quiet activity as you will now have to wait for 2 hours. We ask that you do not leave the surgery as any form of exercise during these two hours may give a false reading when we take the final blood sample. Do not eat or drink anything else. u After 2 hours you will have another blood sample taken from your arm u You are now free to go or you may eat your snack and have a drink before you leave. After 7-10 days (option please telephone for the results of your test or your results will be sent to you). Please remember to bring along a snack for after the test if you want one. Anytown Surgery 104

105 Sample Poster for Population Based Strategy - Invitation Is it your 40th or 50th Birthday this year? If so, congratulations! PART 2_SOP Now you have reached this milestone we would like to invite you for a Vascular Risk check (includes blood pressure, cholesterol level and alot more) Please speak to your GP or Practice Nurse for details or make an appointment at reception Anytown Surgery 105

106 Sample Poster for Population Based Strategy - What to Expect Interested in Attending a Vascular Risk Assessment Visit? What to expect at your visit u u u u u u u u u Please allow 30 minutes for your appointment Bring along any medication you are currently taking Please bring along the enclosed questionnaire which should take no more than minutes to complete If you have not had a fasting blood test prior to this appointment please attend fasting (fasting means nothing to eat or drink apart from water for at least 8 hours) Wear comfortable, non-restrictive clothing Your blood pressure will be taken 3 times throughout the appointment, so that we can get an average reading We will measure your height and weight We will measure your waist We will discuss: Your blood test results Your lifestyle diet, exercise, smoking etc Family history of heart disease and/or diabetes In some patients (about 1 in 10) a follow-up visit is required for additional blood tests, e.g. to be certain whether someone does or does not have diabetes. You will be informed about this within 2 weeks of your visit We will test your urine with a test strip. If necessary we may ask you to do another urine sample to send off to the hospital for further tests (if we suspect infection for example) Anytown Surgery 106

107 Pre-Visit Questionnaire Pre-Visit Questionnaire for Vascular Risk Assessment (please complete this and bring along with you to your appointment) Name: Sex: Male Female Date of Birth: / / Health Questionnaire - Please tick ( ) the box that best describes your ethnic origin WHITE CHINESE White British Chinese White Irish Any other Any other white background MIXED BLACK OR BLACK BRITISH White and Black Caribbean Caribbean White and Black African African White and Asian Any other black background Any other mixed race ASIAN OR ASIAN BRITISH Indian Pakistani Bangladeshi Any other Asian background PART 2_SOP Smoking Status Non-smoker Yes Ex-smoker Yes Date stopped smoking How many used to smoke per day? Current smoker Yes How many per day? Do you currently take any medication? Yes No If ʻyesʼ, please enter details below: (or bring a list of your medicines) Name of Medication Reason for use University of Leicester 107

108 Family History Diabetes (type if known, for example type 1 or type 2) Which family member and at what age Number of 1st degree relatives with diabetes (mother, father, brother or sister) Parent or sibling with diabetes Yes Problem (Stroke or Peripheral Vascular Disease) Age Which family member Does anyone in your family have Heart Disease? (angina or heart attack) Yes If yes, please enter details below Problem Age Which family member No Do you have any 1st degree relatives with diabetes (mother, father, brother or sister) who had/has angina, stroke or a heart attack aged less than 55 years and male or 65 years and female: Yes No Do you usually have daily at least 30 minutes of physical activity at work and/or during leisure time (including normal daily activity)? Yes No How often do you eat vegetables or fruit? Every day Not every day Have you ever been found to have high blood glucose (eg in a health examination, during an illness, during pregnancy)? Yes No University of Leicester 108

109 Risk Assessment - Patient Results Outcomes Sheet Date Personal Details Name: Home Address: Sex: Male Female Date of Birth: / / Fasting: Yes No SCORE NOTES Weight Height BMI kg/m 2 if > 30 update of obesity register Waist Circumference Smoker Total Cholesterol Yes / No / Ex kg m cm mmol/l offer smoking cessation if current smoker PART 2_SOP Triglyceride Blood Pressure mmhg if > 150/90 place on HT register if < 60mls/1.73m egfr mls/m 2 2 place on CKD register CVD Risk Score % if > 20% offer place on CHD register (Specify which DM Risk Score score was used) FPG mmol/l OGTT Outcome (if relevant) mmol/l N/IGT/IFG/DM ENSURE RESULTS UPDATED IN PRACTICE TEMPLATE AND DATE RECORDED University of Leicester 109

110 Smoking Status Non-smoker Yes Ex-smoker Yes Date stopped smoking How many used to smoke per day? Current smoker Yes How many per day? Does your patient currently take any medication? (or update computer medical list) Yes No Medication Type Tick ( ) Name of Medication Reason for use ACE Inhibitor Alpha Blocker ARB Beta-blockers Calcium Channel Blockers Diuretics/Thiazides Aspirin Lipid Lowering Statin Lipid Lowering Fibrate Metformin Sulphonylurea Glitazone Prandial Glucose Regulator Steroids Please state whether Steroids are oral, injected or inhaled: Oral Injected Inhaled Thyroid/Anti-Thyroid Others Family History Diabetes (ask which type) Which family member and at what age Number of 1st degree relatives with diabetes (mother, father, brother or sister) Patient or sibling with diabetes Yes Patient and sibling with diabetes Yes Does the patient have a family history of Heart Disease? Yes If yes, please enter details below Problem Age Which family member No Other Measurements Height. m Waist Measurements cm Weight. kg University of Leicester 110

111 OGTT procedure for Health Care Professionals (HCPs) u 1. Prepare blood bottle and syringe following Health & Safety and Clinical Governance guidelines. For blood glucose measurement a yellow 2.7 fluoride bottle is required u 2. Perform venepuncture and label the blood bottle with time taken and patient details. Complete blood test request form according to local guidelines u 3. Ask patient to drink Lucozade (394ml of current preparation) within 5 minutes (or use an equivalent source of 75gms of anhydrous glucose). Note time subject starts the Lucozade. u 4. Patient should sit in the waiting-room for 2 hours. Advise the patient not to leave the surgery as any form of exercise can have a detrimental effect on the test u 5. After precisely 2 hours from subject starting to drink the Lucozade take the second blood test and again, label the bottle including timing of sample (i.e. second in series) and complete blood test request form according to local guidelines 111

112 Venepuncture Guidance on Venepuncture The subject attending for vascular assessment should expect venepuncture and be prepared (i.e. fasting) Venepuncture is not always straightforward and, since assessment sessions run smoothly only when adhering to tight time-lines, we must manage situations where there is difficulty. This plan aims to ensure that: u Subjects do not undergo multiple attempts at venepuncture u Venepuncture difficulties do not cause delay for other subjects u Ensure best practice, for example handwashing, is implemented The allocated Health Care Professional (HCP) including Health Care Assistant (HCA) (or screener ) may take up to two attempts at venepuncture with each subject at each timepoint. If blood samples are not collected after two attempts, the screener will request assistance from a suitably-qualified colleague, who may or may not be part of the Screening Team for that session i.e. the Practice Nurse or GP allocated to cover the assessment session. Provided the subject is agreeable, the colleague may take up to two attempts to collect blood samples. If samples are still not obtained, venepuncture will be abandoned and the subject will be invited to attend another assessment session. In addition to basic venepuncture training (see training manual for details of dates, venues etc.) further training or supervised practice is always available and anyone who feels they would benefit from these should discuss with their Line Manager. PART 2_SOP 112

113 Collection of Samples and Transfer to the Laboratory u Check whether the patient is fasting- if not- proceed but record non-fasting on form and on patient record (unless for OGTT in which case rebook appointment) u Check on clinical system or blood test request form what blood tests are needed u Prepare appropriate blood bottles u Invite patient into clinic room. Check details name address, D.O.B etc. u Take blood following practice guidelines u Label samples and send to lab for processing u Give patient a urine bottle for next appointment reminding them to bring it with them next time. u Glucose concentrations should not be determined on serum unless red cells are immediately removed, otherwise glycolysis will result in an unpredictable under-estimation of the true concentrations. It should be stressed that glucose preservatives do not totally prevent glycolysis. If whole blood is used, the sample should be kept at 0-4 C or centrifuged immediately, or assayed immediately WE RECOMMEND PLASMA SAMPLES FOR ASSESSMENT OF BLOOD GLUCOSE PART 2_SOP 113

114 Height measurement The height should be measured with the base plate on a firm and level surface, preferably with a perpendicular surface to ensure the measure is vertical. u Ask the subject to remove their shoes and stand on the base plate with their back to the measure. u If the subject has a ponytail or other hair dressing that may effect the result, ask them to remove it. u Tell them to stand as tall and straight as possible with feet together and arms held loosely at the side and shoulders relaxed (to avoid lordosis). u The head should be placed in the Frankfurt Plane, such that an imaginary line joining the upper margin of the external auditory meatus and the lower border of the eye is horizontal. (Ensure that subject is looking straight ahead with back of head against the back plate. i.e. head not tilted up or down) u Lower the head plate so that it gently rests on the highest part of the subjects head. Press down to flatten hair. u Read the height measurement from where the arrow points to on the measure to the nearest (cm). 114

115 Waist circumference u This should be measured over bare skin, or light clothing. u Ask the subject to stand with their arms by their sides and to relax, not to deliberately hold stomach in or out, looking straight ahead. u If possible, kneel or sit on a chair to the side of the subject. u Palpate the lower rib margin (coastal margin) and the iliac crest and mark half way between the two points. This is the level the measurement of waist circumference should be taken. u The measuring tape should be placed horizontally on the circumference and you should check that it is not kinked or twisted, this is best done by looking sideways on. As well as checking the front, peer round the subjects back to inspect their left side. The tape should rest on the skin, not indent it. Do not pull too tight. u Take the reading at the end of expiration. u Measure to the nearest (cm) u Add this data to the template Central obesity is present if the waist circumference is >102 cms (40.2 ) in men and 88cms (34.5 ) in women. For the Asian population, lower values of waist circumference are more appropriate: >90cms (35.4 ) in men and 80cms (31.4 ) in women. PART 2_SOP 115

116 Self-Measurement of Waist Circumference Waist Circumference Measurement Guide 3 Operating D-Loop tape measure: u 1) Pull out the tape measure end, with the cm side face up u 2) Pull the tape measure around your waist so the numbers are upside down u 3) When both ends of the tape measure meet, attach the open side to the notch and press the white button underneath to tighten the tape Measuring the waist circumference: u 1) Find your bottom rib u 2) Find the top of the hip bone u 3) Place the tape half way between your bottom rib and the top of your hip bone u 4) Read and note your waist circumference measurement Bottom Rib Waist Hip Bone Bottom Rib Hip Bone 116

117 Weight The participant should remove their shoes and coat and heavy outerwear for this test. u Ensure scales have been calibrated / serviced within the specified time range u Set scale to 0 u Ask patient to step on scales u Wait for weight to register properly u Record weight (usually in kg) in practice template and in patient record booklet PART 2_SOP 117

118 BMI - Body Mass Index kg/m 2 The body-mass index is used to assess if a person s weight lies within the healthy weight range for their particular height. The index is calculated by dividing body weight (kg) by the square of body height (m) for example, if height is 165cm and weight 70kg, body-mass index will be 70/(1.65 x 1.65), or Or use chart below to estimate BMI 118

119 Patient Guide to BMI - Body Mass Index A healthy weight range is based on a measurement known as the Body Mass Index (BMI). This can be determined if you know your weight in Kilograms and your height in Metres. Frame sizes vary, and it is difficult for any simple measurement to establish a person s frame. It is more accurate to recommend a weight range rather than a specific weight for a given height. You can calculate your BMI in 3 ways: u You can use an automatic calculator via the internet, where there are both imperial and metric versions available. u You can calculate your BMI manually yourself, by following these three steps: Work out your height in Metres, and multiply the number by itself, e.g. if your height is 1.6, then 1.6 X 1.6 = Measure your weight in Kilograms. Divide this by the answer to question 1. For example, you might be 1.6 Metres tall and weigh 65 Kilograms. The calculation would then be 1.6 X 1.6 = BMI would be = u If you know your height in metres (or in feet and inches) and your weight in kilograms (or in pounds), you can calculate your BMI by using the chart below. PART 2_SOP 119

120 Arm circumference u Ask the subject to stand with their arm hanging at the side. u The tip of the acromion (point of shoulder) is palpated and marked. u With the subject s arm flexed at 90 o, the olecranon (tip of elbow) is palpated. u Put the tape measure on the mark on the shoulder and drop it down to the tip of the elbow, by the side of the arm. u Read the exact distance as if you had drawn an imaginary horizontal line from the bottom part of the elbow to the tape. u Mark a point on the arm half way between the acromion and olecranon. This marks the level that the circumference should be taken. (See diagram) u Ask the subject to relax their arm u Apply the tape around the arm at the level marked. u Ensure the tape is horizontal all the way around. u The tape should rest on the skin but not indent it, do not pull it too tight. u Read the tape to the nearest 0.1cm. u Complete this information in the template. Acromion Olecranon Measure at midpoint between acromion and olecranon 120

121 Blood Pressure - taken from JBS Guidance 4 Blood pressure measurement by standard mercury sphygmomanometer or semi-automated device u Use a properly maintained, calibrated, and validated device u Measure sitting blood pressure routinely: standing blood pressure should be recorded in elderly and diabetic people u Remove tight clothing, support arm at heart level, ensure hand relaxed, and avoid talking during the measurement procedure u Use cuff of appropriate size u Lower mercury column slowly (2 mm/s) u Read blood pressure to the nearest 2 mm Hg u Measure diastolic as disappearance of sounds (phase V) u Take the mean of at least two readings; more recordings are needed if notable differences between initial measurements are found u Do not treat on the basis of an isolated reading Measurements should be made under standardised conditions using accurate validated and well-maintained monitors with an appropriate cuff-size. Further information at 5 It is important to note that ambulatory blood pressure monitoring or home blood pressure targets are usually lower than clinic readings and therefore thresholds and targets should be adjusted downward by 10/5mm of mercury. Therefore, for self-measurement of blood pressure, 135/85 should be considered to be in the hypertensive range. Seated blood pressure recordings are generally sufficient, but standing blood pressure should be measured in elderly or diabetic patients to exclude postural hypotension. PART 2_SOP The average of 2 readings, each of several visits, should be used to guide the decision to treat. 121

122 Blood pressure (using OMRON or similar electronic device) u Before taking blood pressure complete the template to say which arm was used (Left or Right). u In order to choose the right cuff size first of all measure the upper arm circumference. (See SOP: Arm circumference) u Choose the appropriate cuff size for the subject depending on the arm circumference. Normal size cuff = 22-32cms Large cuff = 32-42cms u Apply the cuff to the upper arm of the subject ensuring the tube is placed over the artery. u Secure the cuff using the Velcro. u Ensure the patient is not talking whilst the BP is being measured and make sure their legs are not crossed. u Press the on button u Press the start button u The cuff will inflate and deflate giving a reading that should be entered into the template. u The subject should be given 5 minutes rest between blood pressure readings. u The blood pressure should be repeated a further 2 times. u Insert all readings on to template, calculating the average using the last 2 readings.* *To calculate average of 130/90 and 125/85 1. Add = 155. Divide by 2 = (round up to nearest whole figure) = Add = 175. divide by 2 = 87.5 (round up to nearest whole figure) = 88 Average BP reading = 128/88 122

123 What is meant by fasting Fasting, which means that you should have nothing to eat or drink apart from water, from 10pm the night (preferably for least 10 hours) before the test. PART 2_SOP 123

124 Measurement of blood glucose and diagnosis of Diabetes * Blood glucose alone (with cut off of 5.0 mmol/l or above) is an unreliable means of diagnosis of IGR (IGT or IFG). Other measures of risk assessment are required (For example diabetes self-assessment score see pages 87-88) 124

125 Measurement of Lipids u Total cholesterol and HDL cholesterol can usually be measured in the non-fasting state. u However, in all of those in whom there is higher risk, i.e. those on hypertension or obesity registers, should have a fasting lipid profile. u Blood should be drawn after at least a 10 hour fast, and the lipid profile should include the total cholesterol, triglyceride, HDL cholesterol and, where available, a direct measurement of LDL cholesterol. u When the LDL cholesterol cannot be measured directly, it can be estimated. LDL cholesterol = total cholesterol minus HDL cholesterol minus (triglycerides/2.2). This formula should not be used in non-fasting individuals or if the plasma triglycerides are higher than 4 mmol/l and it is less reliable in patients with diabetes. u Monitoring lipids in the non-fasting state may underestimate the LDL cholesterol level. u Lipid analysis should be done in the laboratory participating in the National Quality Control scheme. u It is important to note that at the time of an acute event, particularly a MI, cholesterol and LDL cholesterol may fall. A lipid profile done within 24 hours of the onset of symptoms may give a reasonable indication of total cholesterol and HDL. However, this will still usually be an underestimate. It is important to repeat the fasting lipid profile 8-12 weeks after the event, even if a statin has been commenced, to determine whether a person has familial dyslipidaemia and to assess whether the person has achieved their total and LDL cholesterol targets. PART 2_SOP u Other laboratory baseline measures done at the time of initiation of treatment include muscle enzymes including creatinine phosphokinase (CK) and liver function tests including ALT or AST. If both CK and liver function tests are normal, repeat routine measurement of these tests is not usually indicated unless symptoms develop. 125

126 Appropriate action for Ketones in urine u Moderate or more ketones in the urine with any degree of glucose may indicate evolving type 1 diabetes. This needs to be reported ON THE DAY OF SCREENING. u After 40 secs, if see ++ GLUCOSE and ++KETONES together = contact doctor u It is the responsibility of the medical professional in charge to be aware of and act upon the urine dipstick results. u A capillary glucose estimation or an urgent laboratory glucose test should also be performed and reported with the abnormal urine result. 126

127 Equipment needed for clinic u 1. Urine test strips u 2. Blood pressure monitor (electronic Omron or similar, manual sphygmomanometer) duly calibrated and quality tested u 3. Scales electronic or manual, duly calibrated and quality tested u 4. Height measure u 5. Tape measure (for waist) u 6. Access to computer and patient clinical system (EMIS or similar) u 7. Record booklet / sheet for patient u 8. Relevant lifestyle/diet/stop smoking booklets PART 2_SOP 127

128 Calculating CVD Risk Score The following patients should not have a CVD risk calculated as they are of sufficiently high risk to justify intensive intervention without formal risk assessment. These include people with; u Established atherosclerotic vascular disease, including PAD, CHD and stroke or TIAs, u Persistently elevated blood pressure of >160/100 or when target organ damage is already present u Those with a total cholesterol of HDL ratio >6, u Those with either type 1 or type 2 DM u Those with established CKD u Those with familial hypercholesterolaemia. Risk score should not be used with patients 75 years old The information collected should be used to calculate the vascular risk score using the preferred CVD risk score as advocated by NICE or SIGN guidance. 1,2,4 Age Group: The risk should be estimated for the person s current age. In the younger age group, the risk will be overestimated because the chart is based on age at 49 and 59 years. Sex: It is important to consider the separate charts for men and women. Smoking habit: An assessment of lifetime tobacco exposure is required Blood pressure should be measured according to the British Hypertension Society Guidelines. 5 The risk score should be adjusted appropriately taking into account (see page 137 for adjustment of CVD score) u ethnicity multiply the score by a factor of 1.4 u triglyceride levels, raised triglyceride of >1.7 mmol/l multiply by a factor of 1.3 u for IGR (if known impaired glucose regulation (IGR) as defined by IGT or IFG but not DM multiply the score by factor of 1.5 u family history of premature CVD (multiply score by 1.3) For CVD vascular risk of >20% over 10 years, it is defined as high risk and justifies targeted lifestyle intervention and appropriate use of anti-thrombotic, antihypertensive and lipid lowering therapy. Other factors which should be assessed during the vascular assessment which are not included in the vascular risk prediction chart are obesity, low HDL, raised triglycerides and women with premature menopause. The physician and healthcare professional should always use clinical judgement by taking into account other risk factors before reaching a final decision about the person s overall CVD risk, and their need for intensive lifestyle and pharmacological intervention. 128

129 Cardiovascular Risk Prediction Charts (an example from JBS-2) 4 How to use the Cardiovascular Risk Prediction Charts for Primary Prevention These charts are for estimating cardiovascular disease (CVD) risk (non-fatal myocardial infarction and stroke, coronary and stroke death and new angina pectoris) for individuals who have not already developed coronary heart disease (CHD) or other major atherosclerotic disease. They are an aid to making clinical decisions about how intensively to intervene on lifestyle and whether to use antihypertensive, lipid lowering and anti-platelet medication, but should not replace clinical judgement. u The use of these charts is not appropriate for patients who have existing diseases which already put them at high risk such as: Coronary heart disease or other major atherosclerotic disease; Familial hypercholesterolaemia or other inherited dyslipidaemias; Renal dysfunction including diabetic nephropathy Type 1 and 2 diabetes mellitus u The charts should not be used to decide whether to introduce antihypertensive medication when blood pressure is persistently at or above 160/100mmHg or when target organ damage due to hypertension is present. In both cases antihypertensive medication is recommended regardless of CVD risk. Similarly the charts should not be used to decide whether to introduce lipid-lowering medication when the ratio of serum total to HDL cholesterol exceeds 6. Such medication is usually indicated regardless of estimated CVD risk. u To estimate an individual s absolute 10-year risk of developing CVD choose the chart for his or her gender, lifetime smoking status and age. Within this square identify the level of risk according to the point where the coordinates for systolic blood pressure and the ratio of total cholesterol to high density lipoprotein (HDL) cholesterol meet. If no HDL cholesterol result is available, then assume this is 1.0mmol/litre and the lipid scale can be used for total cholesterol alone. PART 2_SOP u Higher risk individuals (red areas) are defined as those whose 10-year CVD risk exceeds 20%, which is approximately equivalent to the coronary heart disease risk of > 15% over the same period. u The chart also assists in identifying individuals whose 10-year CVD risk is moderately increased in the range 10-20% (orange areas) and those in whom risk is lower than 10% over 10 years (green areas). u Smoking status should reflect lifetime exposure to tobacco and not simply tobacco use at the time of assessment. For example, those who have given up smoking within 5 years should be regarded as current smokers for the purposes of the charts. u The initial blood pressure and the first random (non-fasting) total cholesterol and HDL cholesterol can be used to estimate an individual s risk. However, the decision on using drug therapy should generally be based on repeat risk factor measurements over a period of time. u Men and women do not reach the level of risk predicted by the charts for the three age bands until they reach the ages 49, 59 and 69 respectively. The charts will overestimate current risk most in the under 40s. Clinical judgement must be exercised in deciding on treatment in younger patients. However, it should be recognised that blood pressure and cholesterol tend to rise most and HDL cholesterol decline most in younger people already with adverse levels. Left untreated, their risk at the age 49 years is likely to be higher than the projected risk shown on the age-under-50-years chart. From age 70 years CVD risk, especially for men, is usually > 20% over 10 years and the charts will underestimate true total CVD risk. 129

130 u These charts (and all other currently available methods of CVD risk prediction) are based on groups of people with untreated levels of blood pressure, total cholesterol and HDL cholesterol. In patients already receiving antihypertensive therapy in whom the decision is to be made about whether to introduce lipid-lowering medication, or vice versa, the charts can only act as a guide. Unless recent pre-treatment risk factor values are available it is generally safest to assume that CVD risk is higher than that predicted by current levels of blood pressure or lipids on treatment. u CVD risk is also higher than indicated in the charts for: Those with a family history or premature CVD or stroke (male first-degree relatives and <55 years and female first-degree relatives ages <65 years) Those with raised triglyceride levels (1.7mmol/l) Women with premature menopause; Those who are not yet diabetic, but have impaired fasting glycaemia ( mmol/l) or impaired glucose tolerance (2 hour glucose > 7.8 mmol/li but <11.1 mmol/l in an OGTT u The charts have not been validated in ethnic minorities and in some may underestimate CVD risk. For example, in people originating from the Indian subcontinent it is safest to assume that the CVD risk is higher than predicted from the charts. u An individual can be shown on the chart the direction in which his or her risk of CVD can be reduced by changing smoking status, blood pressure, or cholesterol, but it should be borne in mind that the estimate of risk is for a group of people with similar risk factors and that within that group there will be considerable variation in the risk. It should also be pointed out in younger people that the estimated risk will generally not be reached before the age of 50, if their current blood pressure and lipid levels remain unchanged. The charts are primarily to assist in directing intervention to those who typically stand to benefit most. Non Diabetic Men Non Diabetic Women Images University of Manchester 130

131 CVD Risk Score Adjusting for other factors Calculate CVD Risk Score According to SOP CVD Score % x = Adjusted No Score Yes Score Add 1 TOTAL South Asian Ethnicity 0.4 TG > 1.7 mmol/l 0.3 Family History of CHD (see definition) 0.3 IGR (IGT or IFG) 0.5 ADD TOTAL b Example CVD Risk Score = 12% No Yes Score Add 1 TOTAL South Asian Ethnicity - TG > 1.7 mmol/l - Family History of CHD (see definition) 0.3 IGR (IGT or IFG) 0.5 ADD TOTAL b PART 2_SOP CVD Score 12 % x 1.8 = 21.6% University of Leicester 131

132 What is Your Risk - Risk Factors you Can Change Male Waist Circumference (cm) Ideal Increased risk Greater risk Ideal Increased risk Greater risk Female Waist Circumference (cm) South Asian Male Waist Circumference (cm) Ideal Increased risk Greater risk BMI South Asian White European 25 30! BP Systolic ! BP Diastolic ! Total Cholesterol ! LDL < 2 3 > 4! Smoking NON SMOKER PASSIVE SMOKER SMOKER! CVD Risk Score Less than to to 30 More than 30! Diabetic Risk Score* 0 to or more! Glucose (FPG) < ! The DESMOND Collaborative * Using prototype Leicester Diabetes & Pre-diabetes Risk Score (see pages 82 and 83)

133 Example of a Care Plan Score Agreed Action My BMI is kg/m 2 My waist circumference is cm My smoking status is My total cholesterol level is mmol/l My blood pressure is mmhg My CVD risk score is % PART 2_SOP My diabetes risk score is My physical activity level is Changes that I may need to make to my diet University of Leicester 133

134 Cardiovascular Health Risk Assessment UK guidelines recommend that all people aged 40 or more should have a routine cardiovascular risk assessment. 1,2 A 'risk factor calculator' is commonly used by doctors and nurses to assess the risk of you developing a cardiovascular disease such as: heart attack, angina, stroke, and peripheral vascular disease. Treatment is recommended if you are at high risk. What is cardiovascular disease? Cardiovascular diseases are diseases of the heart or blood vessels that are caused by atheroma. Patches of atheroma are like small fatty lumps that develop within the inside lining of arteries (blood vessels). Atheroma is also known as 'hardening of the arteries'. A patch of atheroma makes an artery narrower, which can reduce the blood flow through the artery. Sometimes blood clots form over a patch of atheroma. Depending on the site of the atheroma the diseases that it causes include heart attack, angina, stroke, and peripheral vascular disease. Who should have their cardiovascular health risk assessed? u All adults aged 40 or more. u Adults of any age who have: A strong family history of early cardiovascular disease. This means if you have a father or brother who developed heart disease or a stroke before they were 55, or in a mother or sister before they were 65. A first degree relative (parent, brother, sister, child) with a serious hereditary lipid disorder. For example, familial hypercholesterolaemia or familial combined hyperlipidaemia. These diseases are uncommon. If you already have a cardiovascular disease or diabetes then you do not need to be screened. This is because you are already known to be in the high risk group. What does the screening involve? A doctor or nurse will ask if you have any current lifestyle risk factors that increase your risk of developing a cardiovascular disease. These include: smoking, obesity, a poor diet, lack of physical activity, and drinking a lot of alcohol. You will then have a blood test to check your blood cholesterol and glucose (sugar) level. Your blood pressure will be measured. A score is calculated based on several of these risk factors, your age and sex. An adjustment to the score is made for certain other risk factors such as strong family history and ethnic origin. What does the assessment score mean? You are given a score as a % chance. So, for example, if your score is 30% this means that you have a 30% chance of developing a cardiovascular disease within the next 10 years. This is the same as saying a 30 in 100 chance (or a 3 in 10 chance). In other words, in this example, 3 in 10 people with the same risk factors that you have will develop a cardiovascular disease within the next 10 years. Note: the score cannot say if you will be one of the three. It cannot predict what will happen to each individual person. It just gives you the odds. You are said to have a: u High risk - if your score is 20% or more. (That is, a 2 in 10 chance or more of developing a cardiovascular disease within the next 10 years.) u Moderate risk - if your score is 10-20% (between 1 in 10 and 2 in 10 chance). u Low risk - if your score is less than 10% (less than a 1 in 10 chance). 134

135 Who should be treated to reduce their cardiovascular health risk? Treatment to reduce the risk of developing a cardiovascular disease is usually offered to people with a high risk. That is: u People with a risk assessment score of 20% or more. That is, if you have a 2 in 10 chance or more of developing a cardiovascular disease within the next 10 years u People with an existing cardiovascular disease (to lower the chance of it getting worse, or of developing a further disease). u People with diabetes. If you have diabetes, the time that treatment is started to reduce cardiovascular risk depends on factors such as: your age, how long you have had diabetes, your blood pressure, and if you have any complications of diabetes. u People with certain kidney disorders. What treatments are available to reduce the risk? If you are at high risk If you are at high risk of developing a cardiovascular disease then drug treatment is usually advised along with advice to tackle any lifestyle issues. This usually means: u Drug treatment to lower your cholesterol level, usually with a statin drug. No matter what your current cholesterol level, drug treatment is advised. The aim is to reduce the level by 25% or to get the level under 5 mmol/l* - whichever is the biggest reduction. See leaflet called 'Cholesterol' for details. u Drug treatment to lower blood pressure if your blood pressure is high. This is even if your blood pressure is just mildly high. See leaflet called 'High Blood Pressure' for details. u A daily low dose of aspirin - depending on your age and other factors. Aspirin helps to prevent blood clots from forming on patches of atheroma. See leaflet called 'Aspirin to Prevent Blood Clots' for details. u Where relevant, to encourage you to tackle lifestyle risk factors. This means to: stop smoking if you smoke. eat a healthy diet. keep your weight and waist in check. take regular physical activity. cut back if you drink a lot of alcohol. You may be offered a referral to specialist services. For example, to a dietician to help you to lose weight and eat a healthy diet, to a specialist 'stop smoking clinic', or to a supervised exercise programme. PART 2_SOP What if I am at moderate or low risk? If you are not in the high risk category, it does not mean you have no risk - just a lesser risk. Drug treatment is not usually prescribed. However, you may be able to reduce whatever risk you do have even further by any relevant changes in lifestyle (as described in the above paragraph). Some people with a moderate risk buy a low dose statin drug from a pharmacy to lower their cholesterol level. (Statin drugs are available on prescription and funded by the NHS if your risk is high. However, you need to buy them if your risk is not in the high category.) EMIS and PIP 2006 Updated: July 2006 PRODIGY Validated 7 * Amended to be in line with recent National Guidance 1,2 135

136 Physical Activity for Health The benefits of doing regular physical activity include a reduced risk of: heart disease, stroke, bowel cancer, breast cancer, osteoporosis, and obesity. In addition, many people feel better in themselves. Regular physical activity helps you to control your weight, and is also thought to help ease stress, anxiety, and depression. How much physical activity should I take? To gain health benefits you should do at least 30 minutes of moderate physical activity, on most days (at least five days per week). u 30 minutes per day is probably the minimum to gain health benefits. However, you do not have to do this all at once. For example, cycling to work and back 15 minutes each way adds up to 30 minutes. Try to increase the amount to minutes per day if you can. For people who need to manage their weight and are at risk of putting on weight and becoming obese, it should be for minutes. For people who have been obese, or are still obese and have lost weight, it should be for minutes. For older people, the above recommendations still apply, depending on ability. Children should get at least one hour a day of moderate physical activity. u Moderate physical activity means that you get warm, mildly out of breath, and mildly sweaty. It does not have to be intense. However, some evidence suggests that the more vigorous the physical activity, the better for health - particularly for preventing heart disease. u On most days. You cannot 'store up' the benefits of physical activity. You need to do it regularly. What sort of physical activity? Anything that makes your heart rate increase, and makes you at least mildly out of breath. For example: brisk walking, jogging, swimming, cycling, dancing, badminton, tennis, etc. You can even use normal activities as part of your physical activity routine. For example, fairly heavy housework, DIY, or gardening can make you mildly out of breath and mildly sweaty. Consider a brisk walk to work or to the shops instead of using a car or bus, etc. What are the health benefits of physical activity? Heart disease and stroke On average, the risk of developing heart disease such as angina or a heart attack is reduced by about a third in people who are regularly physically active compared to those who are not. You are also less likely to have a stroke. Physical activity is good for the heart muscle, but it also reduces some 'risk factors' for heart disease and stroke. For example, on average, blood pressure, cholesterol, and body weight are lower in people who are regularly physically active compared with those who are not. If you already have heart disease, regular physical activity is usually advised as an important way to help prevent the heart disease from getting worse. Weight control Physical activity helps to burn off excess fat. Regular physical activity combined with a healthy diet is the best way of losing excess weight, and to maintain a healthy body weight. Osteoporosis Regular physical activity helps to prevent osteoporosis ('thinning of the bones'). The pulling and tugging on the bones by the muscles stimulates bone-making cells which strengthens the bones. (The benefits of doing regular physical activity include a reduced risk of: heart disease, stroke, bowel cancer, breast cancer, osteoporosis, and obesity. In addition, many people feel better in themselves. Regular physical activity helps you to control your weight, and is also thought to help ease stress, anxiety, and depression.) 136

137 Cancer Regular physical activity roughly halves the chance of developing cancer of the colon (bowel cancer). There is also evidence that breast cancer is less common in women who are regularly physically active. Mental health Physical activity is thought to help ease stress, and improve general well-being and self-esteem. Regular physical activity can also help to ease anxiety and depression. It can also help to make you sleep better. (But do the activity during the daytime or early evening, not near to bed time.) Older people If you are over 70, you are less likely to fall and be injured if you are regularly physically active. Are there any risks with physical activity? u Injury, sprains, and sometimes more serious injuries, are a risk if you do some types of activity such as competitive sports. You can cut down the risk of injury by always warming up before any vigorous activity, and by wearing the correct footwear. u Endurance sports such as marathon running can cause stress fractures, fatigue, and cause menstrual periods to stop in some women. u Sudden death sometimes occurs in people who are doing some physical activity. This is rare if you are used to moderate physical activity. It is more likely to occur if you do not usually do much physical activity, but then do a sudden bout of vigorous activity such as an intense game of squash. However, even in this situation, sudden death is uncommon. If you gradually build up to do regular moderate physical activity, the potential health gains greatly outweigh the small risks involved. Some other points about physical activity PART 2_SOP u If you have a condition that concerns you about physical activity, then see a doctor before starting a physical activity programme. However, there are few reasons why physical activity may be harmful. A common wrong belief is that physical activity may be "bad for the heart". On the contrary, physical activity is good for most people with heart disease. u If you are not used to physical activity, it is best to gradually build up the level of activity. u One of the biggest obstacles is the uphill battle to become fit. Many people feel that the first few attempts at physical activity are quite a struggle. Do not get disheartened. You are likely to find that each time it becomes easier and more enjoyable. u Try and keep physical activity high on your list of priorities. If one kind of activity becomes boring, try switching to other types to maintain the health benefits. u Some people set their goals too high. For example, aiming for a marathon run. This may take too much time, you may lose enthusiasm, and physical activity may become a drudge. Beware of this pitfall. u Physical activity is not just for young 'sporty' types. It is never too late to start to gain the benefits, no matter how old or unfit you are. The bottom line: realistically, walking is likely to be the activity chosen by many people. But, this is fine as brisk walking is an excellent moderate physical activity. One report about physical activity stated: "The bottom line - walking two miles a day can cut the risk of death by half". Note: The British Heart Foundation and the Countryside Agency are running a 'Walking The Way To Health' initiative to encourage people who do little physical activity to walk more in their own neighbourhoods. For more information: Tel: Website EMIS and PIP 2005 Updated: July 2006 PRODIGY Validated 8 See Page 089 in Appendix for Table of Physical Activity Intensity and Energy Expenditure 137

138 Smoking - A Summary Stopping smoking can make a big difference to your health. See your practice nurse if you want to give up, but are finding it difficult. This is a brief summary about smoking. If you prefer there are other more detailed leaflets about smoking. Why is smoking so bad? Smoking is the greatest cause of early death in the UK. If you smoke, it is not just that you are likely to die earlier. Smoking-related diseases such as lung cancer, heart disease, emphysema, and chronic bronchitis can cause distressing symptoms, often for several years before death. In addition, asthma, other lung diseases, Raynaud's phenomenon, and osteoporosis are often made worse by smoking. Male smokers have an increased chance of becoming impotent in middle age (due to the damaging effect of smoking on the blood vessels). Also, on average, children who live with smokers have more illnesses than children who live in a smoke-free home. Some tips which may help you to stop smoking u Set a date for stopping, and stop completely. (Some people prefer the idea of cutting down gradually. However, research has shown that if you smoke less cigarettes than usual, you are likely to smoke more of each cigarette, and nicotine levels remain nearly the same. Therefore, it is usually best to stop once and for all from a set date.) u Tell everyone that you are stopping. Friends and family often give support and help. u Get rid of ashtrays, lighters, and all cigarettes. u Be prepared for some withdrawal symptoms. When you stop smoking, you are likely to get symptoms such as: feeling sick, headaches, anxiety, being irritable, craving, and just feeling awful. These symptoms are caused by the lack of nicotine that your body has been used to. They tend to peak after hours, and then gradually ease over 2-4 weeks. u Be aware of situations in which you are most likely to want to smoke (for example, the pub). Try changing your routine for the first few weeks. u Take one day at a time. Mark off each successful day on a calendar. Look at it when you feel tempted to smoke, and tell yourself you don't want to start all over again. u Be positive. Tell people that you don't smoke. You will smell better. After a few weeks you should feel better, taste your food more, and cough less. You will have more money. u Food. Some people worry about gaining weight when they give up smoking as the appetite may improve. Be prepared for an increase in appetite, and try not to increase fatty or sugary foods as snacks. Try sugar-free gum and fruit instead. u Don't despair if you fail and have a cigarette. You don't have to start smoking again. Examine the reasons why you felt it was more difficult at that particular time, and try again. On average, people who eventually stop smoking have made 3 or 4 previous attempts. u Nicotine Replacement Therapy (NRT) can help if withdrawal symptoms are troublesome. You can get nicotine gum, sprays, patches, tablets, lozenges, and inhalers. Using one of these roughly doubles your chance of stopping smoking if you really want to stop. A pharmacist, GP, or practice nurse can advise. u A medicine called bupropion (trade name 'Zyban') is another option. It also roughly doubles your chance of stopping smoking if you really want to stop. It helps reduce the symptoms of nicotine withdrawal. It may be prescribed by your GP. Further help and information Quit - a charity to help people stop smoking. Quitline: Web: NHS smoking helpline: and website EMIS and PIP 2005 Updated: August 2005 PRODIGY Validated

139 Healthy Eating A healthy diet helps to prevent, or reduce the severity of, diseases such as heart disease, stroke and diabetes. A healthy diet may also help to reduce the risk of developing some cancers. Also, a main way of combating obesity and overweight is to eat a healthy diet. This leaflet gives the principles of a healthy diet. Eat plenty of starchy foods (complex carbohydrates) Starchy foods such as bread, cereals, potatoes, rice, and pasta, together with fruit and vegetables, should provide the bulk of most meals. Some people wrongly think that starchy foods are 'fattening'. In fact, they contain about half the calories than the same weight of fat. (However, it is easy to add fat to some starchy foods. For example, by adding butter to jacket potatoes or bread, or by adding oil to potatoes to make chips, etc.) Also, starchy foods often contain a lot of fibre (roughage). When you eat starchy foods, you get a feeling of fullness (satiety) which helps to control appetite. Tips to increase starchy foods include: u For most meals, include generous portions of rice, pasta, baked potatoes, or bread. u For more fibre, choose wholemeal bread. When baking, use at least 1/3 wholemeal flour. u If you have cereals for breakfast, choose porridge, high fibre cereals, or wholemeal cereals (without sugar coating). u Have tea breads, and plain or fruit scones, instead of sugary cakes and biscuits. Eat plenty of fruit and vegetables Is is recommended that we eat at least five portions, and ideally 7-9 portions, of a variety of fruit or vegetables each day. If you eat a lot of 'fruit and veg', then your chance of developing heart disease, a stroke, or bowel cancer are reduced. In addition, 'fruit and veg': PART 2_SOP u contain lots of fibre which help to keep your bowels healthy. Problems such as constipation are less likely to develop. u contain plenty of vitamins and minerals, which are needed to keep you healthy. u are naturally low in fat. u are filling but are low in calories. One portion of fruit or vegetables is roughly equivalent to one of the following. u One large fruit such as an apple, pear, banana, orange, or a large slice of melon or pineapple. u Two smaller fruits such as plums, kiwis, satsumas, clementines, etc. u One cup of small fruits such as grapes, strawberries, raspberries, cherries, etc. u Two large tablespoons of fruit salad, stewed or canned fruit in natural juices. u One tablespoon of dried fruit. u One glass of fresh fruit juice (150ml). u A normal portion of any vegetable (about two tablespoons). u One dessert bowl of salad. Some tips on how to increase fruit and vegetables in your diet include: u Try some different types which you have not tried before. The variety of tastes and textures may be surprising. Juices, frozen, canned, and dried varieties all count. u Try adding chopped bananas, apples, or other fruits to breakfast cereals. u Aim to include at least two different vegetables with most main meals. Do not over-boil vegetables. Steaming, stir-frying, or lightly boiling are best to retain the nutrients. u Always offer fruit or fruit juice to accompany meals. u Try new recipes which include fruit. For example, some curries or stews include fruit such as dried apricots. u Have fruit based puddings. Fruit with yoghurt is a common favourite. u How about cherry tomatoes, carrot sticks, dried apricots, or other fruits as part of packed lunches? A banana sandwich is another idea for lunch. u Fruit is great for snacks. Encourage children to snack with fruit rather than with sweets. 139

140 Eat plenty of fibre (roughage) Fibre is the part of food that is not digested. It is filling, but has few calories. It helps the bowels to move regularly, which reduces constipation and other bowel problems. Fibre may also help to lower your cholesterol level. Starchy foods, and fruit and vegetables contain the most fibre. So the tips above on starchy foods and fruit and vegetables will also increase fibre. Have plenty to drink when you eat a high fibre diet (at least 6-8 cups of fluid a day). Eat protein foods in moderation Meat, fish, nuts, pulses, chicken, and similar foods are high in protein. You need a certain amount of protein to keep healthy. However, most people eat more protein than is necessary. Beware, some meats are also high in fat. Choose poultry such as chicken, or lean meat. Also, many meat based recipes include creamy or fatty sauces which are high in calories. Fish. There is some evidence that eating oily fish helps to protect against heart disease. Oily fish include: herring, sardines, mackerel, salmon, fresh tuna (not tinned), kippers, pilchards, trout, whitebait, anchovies and swordfish. It is probably the 'omega-3 fatty acids' in the fish oil that helps to reduce the build up of atheroma (furring of the arteries) which causes angina and heart attacks. Aim to eat at least two portions of fish per week, one of which should be oily. Do not eat too much fat A low-fat diet helps to reduce the chance of developing diseases such as heart disease and stroke. It will also help you to reduce weight. The total amount of fat should be low. Also, the type of fat is important. You should not have much saturated fat such as butter, lard, dripping, and unspecified margarine. Unsaturated fats are better such as corn oil, sunflower oil, olive oil, and low fat spreads. Tips to reduce fat in your diet include the following. u Whenever possible, do not fry food. It is better to grill, bake, poach, barbecue, or boil food. If you do fry, use unsaturated oil. Drain the oil off the food before eating. u Choose lean cuts of meat, and cut off any excess fat. u Avoid adding unnecessary fat to food. For example, use low fat spreads, spread less butter or margarine on bread, measure out small portions of oil for cooking, etc. u Watch out for hidden fats that are in pastries, chocolate, cakes, and biscuits. u Have low-fat milk, cheeses, yoghurts, and other dairy foods rather than full-fat varieties. u Avoid cream. Use low fat salad cream, or low-fat yoghurt as a cream substitute. Do not have too many sugary foods and drinks Sugary foods and drinks are high in calories, and too much may cause weight gain. It isn't just the amount of sugar that may be bad. Eating small amounts of sugary foods (sweets etc) too often is bad for teeth. Tips include: u Try not to add sugar to tea, coffee, and breakfast cereals. Your taste for sweetness often changes with time. u Use artificial sweeteners only if necessary. u Reduce sugar in any kind of recipe. Use fruit as an alternative to add sweetness to recipes. u Try sugar-free drinks. Give children water as their main drink. u If you eat chocolate or sweets, try and keep the quantity down. Eating them as part of a meal, and then brushing your teeth, is better than between meals as snacks. 140

141 Do not eat too much salt Too much salt increases the risk of developing high blood pressure. Government guidelines recommend that we should have no more than 5-6 grams of salt per day. (Most people in the UK currently have more than this.) If you are used to a lot of salt, try to gradually reduce the amount that you have. Your taste for salt will eventually change. Tips on how to reduce salt include: u Use herbs and spices to flavour food rather than salt. u Limit the amount of salt used in cooking, and do not add salt to food at the table. u Choose foods labelled 'no added salt'. u As much as possible, avoid processed foods, salt-rich sauces, take-aways, and packet soups which are often high in salt. Keep alcohol within the recommended limits There is some evidence that drinking 1-2 units of alcohol per day may help to protect against heart disease. But, drinking above the recommended limits can lead to serious problems. For example, drinking heavily can damage the liver, brain, stomach, pancreas, and heart. It can also cause high blood pressure. Also, alcohol contains a lot of calories, and too much can cause weight gain. u Men should drink no more than 21 units of alcohol per week (and no more than four units in any one day). u Women should drink no more than 14 units of alcohol per week (and no more than three units in any one day). u Pregnant women - the amount that is safe is not known, so many women have little or no alcohol when they are pregnant. PART 2_SOP What is a unit of alcohol? One unit of alcohol is 10 ml (1 cl) by volume, or 8 g by weight, of pure alcohol. For example: u One unit of alcohol is about equal to: Half a pint of ordinary strength beer, lager, or cider (3 to 4% alcohol by volume), or A small pub measure (25 ml) of spirits (40% alcohol by volume), or A standard pub measure (50 ml) of fortified wine such as sherry or port (20% alcohol by volume). u There are one and a half units of alcohol in: A small glass (125 ml) of ordinary strength wine (12% alcohol by volume), or A standard pub measure (35 ml) of spirits (40% alcohol by volume). Further information British Nutrition Foundation EMIS and PIP 2005 Updated: July 2006 PRODIGY Validated

142 Five Choices to Help You Stay Healthy A healthy diet helps to prevent, or reduce the severity of, diseases such as heart disease, stroke and diabetes. A healthy diet may also help to reduce the risk of developing some cancers. Also, a main way of combating obesity and overweight is to eat a healthy diet. This leaflet gives the principles of a healthy diet. What can I do to help stay healthy? You should not smoke If you smoke, stopping smoking is often the single most effective thing that you can do to reduce your risk of future illness. The risk to health falls rapidly as soon as you stop smoking (but takes a few years before the increased risk reduces completely). If you find it hard to stop smoking, then see your practice nurse for help. Medication may be advised to help you to stop. Do some regular physical activity Anything that gets you mildly out of breath and a little sweaty is fine. For example: jogging, heavy gardening, swimming, cycling, etc. A brisk walk each day is what many people do - and that is fine. However, it is thought that the more vigorous the activity, the better. To gain most benefit you should do at least 30 minutes of physical activity on most days. Two shorter bursts is thought to be just as good. For example, two 15 minute bouts of activity at different times in a day. Eat a healthy diet Briefly, a healthy diet means: u AT LEAST five portions, and ideally 7-9 portions, of a variety of fruit and vegetables per day. u THE BULK OF MOST MEALS should be starch-based foods (such as cereals, wholegrain bread, potatoes, rice, pasta), plus fruit and vegetables. u NOT MUCH fatty food such as fatty meats, cheeses, full-cream milk, fried food, butter, etc. Use low fat, mono-, or poly-unsaturated spreads. u INCLUDE 2-3 portions of fish per week. At least one of which should be 'oily' (such as herring, mackerel, sardines, kippers, pilchards, salmon, or fresh tuna). u If you eat meat it is best to eat lean meat, or poultry such as chicken. u If you do fry, choose a vegetable oil such as sunflower, rapeseed or olive oil. u Try not to add salt to food, and limit foods which are salty. Try to lose weight if you are overweight or obese You don't need to get to a perfect weight. If you are overweight you can gain great health benefits by losing 5-10% of your weight. This is often about 5-10 kg. (10 kg is about one and a half stone.) Don't drink too much alcohol A small amount of alcohol is usually fine, but too much can be harmful. Men should drink no more than 21 units per week (and no more than 4 units in any one day). Women should drink no more than 14 units per week (and no more than 3 units in any one day). One unit is in about half a pint of normal strength beer, or two thirds of a small glass of wine, or one small pub measure of spirits. Do you want more detail? See you practice nurse if you want further advice or help on any of the above. Also, there is a more detailed leaflet for each of the topics listed above. There is also another leaflet called 'Preventing Cardiovascular Diseases' which is more detailed. EMIS and PIP 2006 Updated: July 2006 PRODIGY Validated

143 Cholesterol You will usually be advised to take a statin drug to lower your cholesterol level if you have a high risk of developing a cardiovascular disease such as heart disease or stroke. As a rule, no matter what your cholesterol level is, then lowering the level reduces your risk. UK guidelines recommend that all people aged 40 or more should have a cholesterol blood test as part of a routine cardiovascular risk assessment. 1-2 What is cholesterol? Cholesterol is a lipid (fat chemical) that is made in the liver from fatty foods that we eat. A certain amount of cholesterol is present in the bloodstream. You need some cholesterol to keep healthy. Cholesterol is carried in the blood as part of particles called lipoproteins. There are different types of lipoproteins, but the most relevant to cholesterol are: Low density lipoproteins carrying cholesterol - LDL cholesterol. This is often referred to as 'bad cholesterol' as it is the one mainly involved in forming atheroma. Atheroma is the main underlying cause of various cardiovascular diseases (see below). Usually, about 70% of cholesterol in the blood is LDL cholesterol, but the % can vary from person to person. High density lipoproteins carrying cholesterol - HDL cholesterol. This is often referred to as 'good cholesterol' as it may actually prevent atheroma formation. What are atheroma and cardiovascular diseases? Patches of atheroma are like small fatty lumps that develop within the inside lining of arteries (blood vessels). Atheroma is also known as 'atherosclerosis' and 'hardening of the arteries'. Patches of atheroma are often called 'plaques' of atheroma. PART 2_SOP Over months or years, patches of atheroma can become larger and thicker. So, in time, a patch of atheroma can make an artery narrower, which can reduce the blood flow through the artery. For example, narrowing of the coronary (heart) arteries with atheroma is the cause of angina. Sometimes a blood clot (thrombosis) forms over a patch of atheroma, and completely blocks the blood flow. Depending on the artery affected, this can cause a heart attack, a stroke, or other serious problems. Cardiovascular diseases are diseases of the heart (cardiac muscle) or blood vessels (vasculature). However, in practice, when doctors use the term 'cardiovascular disease' they usually mean diseases of the heart or blood vessels that are caused by atheroma. In summary, cardiovascular diseases that can be caused by atheroma include: angina, heart attack, stroke, transient ischaemic attack (TIA), and peripheral vascular disease. In the UK, cardiovascular diseases are a major cause of poor health and the biggest cause of death. What factors affect the level of blood cholesterol? In most people, your cholesterol level reflects the amount of fat that you eat. This is not the full story as different people who eat the same amount of fat can make different amounts of cholesterol. However, in general, if you eat less fat your cholesterol level is likely to go down. In some people a high cholesterol level is due to another condition. For example, an underactive thyroid gland, obesity, drinking a lot of alcohol, and some rare kidney and liver disorders can raise the cholesterol level. In some people a very high level of cholesterol runs in the family due to an inherited genetic problem with the way cholesterol is made. One example is called familial hypercholesterolaemia. 143

144 Risk factors Everybody has some risk of developing atheroma which then may cause one or more cardiovascular diseases. However, certain 'risk factors' increase the risk. Risk factors include: u Lifestyle risk factors that can be prevented or changed: Smoking. Lack of physical activity (a sedentary lifestyle). Obesity. An unhealthy diet. Excess alcohol. u Treatable or partly treatable risk factors: Hypertension (high blood pressure). High cholesterol blood level. High triglyceride (fat) blood level. Diabetes. Kidney diseases that affect kidney function. u Fixed risk factors - ones that you cannot alter: A strong family history. This means if you have a father or brother who developed heart disease or a stroke before they were 55, or in a mother or sister before they were 65. Being male. An early menopause in women. Age. The older you become, the more likely you are to develop atheroma. Ethnic group. For example, people who live in the UK with ancestry from India, Pakistan, Bangladesh, or Sri Lanka have an increased risk. However, if you have a fixed risk factor, you may want to make extra effort to tackle any lifestyle risk factors that can be changed. Note: Some risk factors are more 'risky' than others. For example, smoking and a high cholesterol level cause a greater risk to health than obesity. Also, risk factors interact. So, if you have two or more risk factors, your health risk is much more increased than if you just have one. For example, a middle aged male smoker who has high blood pressure and a high cholesterol level has a high risk of developing a cardiovascular disease such as a heart attack before the age of 60. What is a 'high' cholesterol level? The following levels are generally regarded as desirable u Total cholesterol (TC) mmol/l or less. However, about 2 in 3 adults in the UK have a total cholesterol level of 5.0 mmol/l or above. u Low-density lipoprotein (LDL) cholesterol after an overnight fast: 3.0 mmol/l or less. u High-density lipoprotein (HDL) cholesterol: 1.2 mmol/l or more. u TC/HDL ratio: 4.5 or less. That is, your total cholesterol divided by your HDL cholesterol. This reflects the fact that for any given total cholesterol level, the more HDL, the better. As a rule, the higher the cholesterol level, the greater the risk to health. However, your level of cholesterol has to be viewed as part of your overall cardiovascular health risk. The cardiovascular health risk from any given level of cholesterol can vary, depending on the level of your HDL cholesterol, and on other health risk factors that you may have. EMIS and PIP 2006 Updated: June 2006 PRODIGY Validated

145 Employing Health Care Assistants in General Practice There is a current drive to employ health care assistants (HCAs) within general practice; this is a new development for many practices. This paper aims to guide practice nurses and their colleagues through the principles of implementing good employment practice, an effective training framework and making appropriate use of HCAs. If effective processes and systems are in place the employment of HCAs in general practice should enhance patient care. HCAs are trained in a particular role, but do not have a professional registration. They undertake simple clinical procedures that have been taught and delegated, such as venepuncture, ECG recording, weighing, as well as a range of support functions such as re stocking clinical areas. They work at all times within defined protocols and procedures and should not be placed in a position where they are required to make clinical judgements. HCAs should always be directly accountable to a registered health care professional and should have regular supervision and assessment of competence. Careful consideration should be given to the education program for HCAs: in addition to clinical skills, their initial preparation should include: u Communication, including dealing with upset or aggressive patients u Confidentiality u Record keeping and IT systems The acquisition of a Vocational Qualification is not a permit to practice, but merely identifies the holder as competent to undertake a range of duties in a care environment. Decisions as to who should do what, remain with the manager (registered nurse or other professional). Storey (2002) PART 2_SOP When HCAs are appropriately trained, assessed, supervised as required, supported and updated their contribution to patient care as a member of the team should ensure that both patients and the practice benefit. There should be a formal arrangement for a health care professional to supervise the HCA on a regular basis. Supervision, including observation should include time built into the workload. Standards of care must not be compromised, and the patient must be made aware of the qualifications of the staff member who is delivering their care or treatment. HCAs must be an integral, valued member of the General Practice team and wider PCO organisations, which have a culture of life-long learning and good employment practice, meeting the recommendations of Improving Working Lives 15. It is recommended that all HCAs should undertake a nationally recognised qualification in care, such as National Vocational Qualifications/Scottish Vocational Qualifications or equivalent. Any role development e.g. from receptionist to HCA must be undertaken within an approved framework of training, assessment, supervision and update. Any person who trains, assesses and updates HCAs must be competent in the skill, and be an accredited trainer and assessor. Records must be kept of training undertaken, with dates and names/signatures of those concerned. All HCAs should be aware that they are accountable to the patient for any errors they may make, through civil law, and to their employer, through their contract. The RN, or other professional, is however accountable for the appropriate delegation of any task or duty. The HCA cannot be professionally accountable as they are currently unregulated, apart from in social care settings. 145

146 HCAS must not enter into consultations with patients unsupervised. They must be made aware of their limitations. Accountability and the registered nurse u You are personally accountable for ensuring that you promote the interests and dignity of each patient and client and respond to their need for care. u You remain accountable for the delegation of the work, for ensuring that the person who does the work is able to do it... u...such delegation must not compromise existing care but must be directed to meeting the needs and serving the interests of patients and clients. (NMC Code of Professional Conduct, 2004) GPs, practice managers and practice nurses planning to employ HCAs will need to either draw on the services of an already approved local S/NVQ assessment centre. This is most likely to be the local Primary Health Care organisation, or hospital. It is recommended that registered nurses within the practice undertake a VQ assessor qualification. Principles of Delegation The Registered Nurse must ensure that: u The primary motivation for delegation is to serve the interests of the patient u Delegation is appropriate u Always assess the needs of the patient their needs should define who does what. u The level of experience, competence, role of the person to whom the task is delegated is appropriate u The level of supervision is appropriate u They do not delegate to junior colleagues tasks and responsibilities beyond their level of skill and experience u Appropriate assessment, planning, implementation and evaluation of the delegated role u Communication related to the delegated role is in a manner understandable to the person to whom the role is being delegated u The level of supervision and feedback is appropriate to the task delegated u Rigorous protocols clearly define the HCA s role within a clinical activity. u These protocols should be updated regularly. u The registered practitioner should ensure their own competency in any delegated tasks u The competency of the HCA to deliver specific delegated clinical activities must be assessed prior to delegation and reviewed at regular intervals (6-12 monthly) References

147 Health Care Assistant Example Job Description Title: Health Care Assistant Base: Accountable to: The post holder will be employed by the partners of the Practice and as such will be account able to them via the Practice Manager Responsible to: Hours of Duty: Contract: Job Purpose: To provide an efficient auxiliary nursing service to the practice population, assisting the Nurses and GP s within the professional competencies of the post holder. DUTIES AND RESPONSIBILITIES: u 1. Correctly perform phlebotomy clinics and home tests when required. u 2. Correctly sterilise medical equipment to the required standard. u 3. Correctly send patient samples to the laboratory on a daily basis. PART 2_SOP u 4. Correctly monitor usage of sharps bins in all clinical rooms and replacing when required and preparing for collection by clinical waste contractor. u 5. Correctly restock all clinical rooms and ensure medical equipment inventory is maintained for each room. u 6. Monitoring of stock levels of vaccines in all fridges and relaying stock requirements to Admin. u 7. Correctly monitoring temperature of vaccine fridges and reporting readings beyond normal limits to Practice Nurse Co-ordinator and Practice Manager. u 8. Correctly carry out electro-cardio graphs (ECG s) according to Practice protocols as required. u 9. Correctly carry out blood pressure measurement according to Practice protocols as required. u 10. Correctly carry out spirometry tests according to Practice protocols as required. u 11. Take a positive and active role in audit, informing the Practice Nurse Co-ordinator of any problems. u 12. Training and education - Attend both in-house and external training courses whenever required, to develop skills. u 13. Ensure the Minor Ops Room is kept clean and tidy between visits from cleaning staff, with the aim of maximising efficiency at all times and minimising H&S incidents/accidents. u 14. Open up premises at the start of day, when required. u 15. Such other appropriate duties consistent with the nature and grading of the post which may be allocated, as the situation dictates, by the Practice Manager or the Partners. 147

148 Reference List 1. National Collaborating Centre for Primary Care. Cardiovascular risk assessment: the modification of blood lipids for the primary and secondary prevention of cardiovascular disease - full guideline DRAFT Scottish Intercollegiate Guidelines Network. Risk estimation and the prevention of cardiovascular disease: A national clinical guideline Despres JP, Lemieux I, Prud'homme D. Treatment of obesity: need to focus on high risk abdominally obese patients. BMJ. 2001;322: JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005;91 Suppl 5:v Williams B, Poulter NR, Brown MJ, Davis M, McInnes GT, Potter JF et al. British Hypertension Society guidelines for hypertension management 2004 (BHS-IV): summary. BMJ 2004;328: Lindstrom J,.Tuomilehto J. The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care 2003;26: Prodigy Guidance. Cardiovascular risk assessment Prodigy Guidance. Physical activity Prodigy Guidance. Smoking Cessation National Institute for Clinical Excellence. Smoking Cessation: Brief interventions and referral for smoking cessation in primary care and other settings. Public health intervention guidance National Institute for Clinical Excellence. TA039 Smoking cessation - bupropion and nicotine replacement therapy: Guidance British Nutrition Foundation. Healthy Eating for Cardiovascular disease Prodigy Guidance. 5 Choices Prodigy Guidance. Lipid Management Department of Health. Improving working lives Nursing & Midwifery Council. The NMC code of professional conduct: standards for conduct, performance and ethics Storey L. The 'Crackerjack' model of nursing and its relationship to accountability. ISSN Nurse Education in Practice 2007;2: Working in Partnership Program

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150 Further copies of this document can be downloaded at: Additional copies are available by contacting prolog on ref Vascular 03/2008