Health Authority Abu Dhabi. Issue Date: July 2009

Transcription

1 Health Authority Abu Dhabi هيئة الصحة - أبوظبي Title: HAAD Standards for diagnosis, management and data reporting for diabetes. Reference: PHP/PHPr/DC/02 Issue Date: July Purpose 1.1 The Health Authority Abu Dhabi is the authority responsible for regulating all aspects of health care service, including quality of care and patient safety. In order to achieve this, HAAD mandates regulations and develops standards. This may include developing and/or adopting international best-practice and standardised clinical care pathways. 1.2 This standard mandates the clinical service specifications and data reporting requirements (in Annex III) for patients with diabetes mellitus. 1.3 The clinical care pathways provided at Annex I and II in this Standard provide additional advisory guidance to healthcare professionals to support quality, evidence-based clinical services to diabetes patients. 2. Scope 2.1 This standard applies to all Healthcare Facilities and Professionals licensed by HAAD in the Emirate of Abu Dhabi. 2.2 This standard refers to type I and type II diabetes mellitus in adults (18 years and above). 2.3 This standard is intended to ensure that patients with diabetes mellitus receive quality and safe standard of treatment and supportive care; to do this it: Sets out the clinical care and service specifications for patients with diabetes mellitus. 2.4 Clinical services and patient care and data reporting must be delivered in accordance with the laws and regulations of the Emirate of Abu Dhabi and consistent with HAAD policies and standards. This Standard is related to, and has effect together with, the HAAD Reporting of Health Statistics Policy and the HAAD Data Standards and Procedures (found online at 3. Duties for Healthcare Facilities and Professionals All licensed healthcare facilities and professionals engaging in Diabetes care: 3.1 Must report and submit data to HAAD via e-claims and in accordance with the HAAD Reporting of Health Statistics Policy and as set out in the HAAD Data Standards and Procedures. 3.2 Must manage Diabetes patients as per internationally accepted best practice; HAAD Public Health Protocols (Annex I and II) are advisory in this regard. 4. Enforcement and Sanctions 4.1 HAAD may impose sanctions in relation to any breach of duties under this standard consistent with the HAAD Reporting of Health Statistics Policy and in accordance with the [HAAD Policy on Enforcement and Sanctions]. 5. Data reporting 5.1 HAAD requires all licensed healthcare facilities to submit data on healthcare delivery and health statistics. Reporting of data under this standard must comply with the HAAD Reporting of Page 1 of 11

2 Health Statistics Policy, the HAAD Data Standards and Procedures (found online at 6 Standards 6.1 All HAAD licensed healthcare providers in Abu Dhabi are authorized to diagnose and manage diabetes patients provided they meet this Standard. 6.2 The diagnosis and management of diabetes patients in Abu Dhabi: Must be a service that is supervised by a HAAD licensed physician; although the initial testing may be substantively provided by a HAAD licensed nurse, all cases confirmed to have diabetes must be assessed by a HAAD licensed physician, who will also be responsible for communicating a diagnosis of established risk factors (e.g. diabetes) and discussing the management options Should be in line with the HAAD care pathway for diabetes mellitus designed for diagnosis and initial management (Annex I) and consistent with International best practice for continuation of diabetes care (Annex II). The diagnosis and initial management care pathway in Annex I has been customized from International evidence-base so as to take into account local needs and care models. Annex II management care pathway is adopted from International best practice as it is available and has not undergone local customization as it fulfills the local management and care models. 6.3 The diagnosis of those suspected of being diabetic (including those identified through Weqaya screening) involves an initial visit (initial encounter) for screening for symptoms and blood testing as outlined in The initial encounter should be followed up for those individuals meeting the criteria for diabetes or pre-diabetes (in Annex I) by a consultation with a HAAD licensed physician, including examination, assessment for complications and risk factors and a personalised plan for diabetes care in line with International best practice (Annex II); it is recommended that this should be offered within 2 days of the initial consultation. 6.5 If a definitive diagnosis of diabetes is made, the patient must be referred for specialist care in the presence of: Gestational diabetes Diabetic complications Persistent poor control of glucose or glycosylated haemoglobin (HbA1c) 6.6 If the initial consultation for screening for symptoms and blood testing identifies pre-diabetes, as defined by the HAAD care pathway (Annex I), a consultation by a HAAD licensed physician and plan of care for pre-diabetes should take place as per the care pathway (Annex I). 7. Standard 1: Diagnosis of diabetes 7.1 Following a symptom check as per Annex I, data recording as specified in advisory care pathway to include laboratory results for HbA1c and oral glucose tolerance testing (fasting and 2-hour post glucose load). 8. Standard 2: Management of diabetes and data reporting 8.1 Clinical examination and assessment should be performed by a HAAD licensed physician on those who have diabetes mellitus confirmed by the tests specified in the care pathway (Annex I), using the tests outlined in Standard 1 above. Page 2 of 11

3 8.2 Further assessment of complications and cardiovascular risk (including reporting of observations) should be as indicated in Annex I and II. 8.3 Further continuation of management for diabetes should be in accordance with International best practice as outlined in Annex II. 8.4 The data set-out in 7.1 must be submitted via e-claims within 3 days of the visit for the clinical consultation, examination and assessment using the standard process. 9 Communication 9.1 All communication regarding the diabetes care must be in accordance with HAAD Policies and Standards, including general confidentiality and consent policies available at Page 3 of 11

4 Annex I: HAAD care pathway for diagnosis and initial management of diabetes mellitus Suspected Diabetes Mellitus Definitive Diagnostic Testing Presence of symptoms # & random blood glucose > 11.1 mmol/l Or -fasting plasma glucose > 7.0 mmol/l Or -2 Hour plasma glucose following oral glucose tolerance test > 11.1 mmol/l Other testing to be undertaken -HbA1c -fasting triglyceride level Diabetes Mellitus Confirmed Presence of alarming symptoms * (Suspected Diabetic Emergency) Yes Type 1 Consider in presence of: -young adults -ketonuria -marked weight loss -no other risk factors or features of metabolic syndrome -Follow diabetes mellitus treatment protocol -follow steps for prevention and early detection of complications $$ No Yes HbA1c > 6.1%? No Pre-Diabetes Present? Either: -fasting plasma glucose mmol/l (impaired fasting glucose) or; -oral glucose tolerance testing mmol/l (impaired glucose tolerance) Yes Offer help with lifestyle modification** -weight loss -dietary advice -exercise Formal assessment of cardiovascular risk ## (see algorithm for high cardiovascular risk if > 20%) Type 2 (adult onset) Consider in presence of: -older adults (although can also be seen in children) -milder symptoms -other features of metabolic syndrome $ No Yes Review as for normal population Review after 1 year Treat as a Hyperglycaemic emergency Referral to diabetes specialist in presence of: -pregnancy -any diabetic complications -persistent poor control of glucose or HbA1c Urgent (same-day) referral to diabetes specialist * Alarming Symptoms,Hyperglycaemic conditions: ketoacidosis (common in type 1 diabetes, rare in type 2 diabetes): O increased concentration of glucose in blood O ketone bodies accumulate in tissues and fluid O fluids become more acidic (increase in hydrogen ion concentration) O thirst or dry mouth O frequent urination O high ketone levels in urine O tiredness O dry, flushed skin O gastrointestinal symptoms O short, deep breaths O breath smells fruity O difficulty concentration or confusion O leads to coma and death non-ketotic hyperosmolar state (more common in type 2 diabetes): O increased concentration of glucose in blood O hyperosmolarity of extracellular fluid and dehydration of intracellular fluid O thirst or dry mouth O warm, dry skin that does not sweat O high fever (above 38.5 C) O confusion or drowsiness O vision loss O hallucinations O weakness on one side of body O leads to coma and death if untreated # Symptoms of Diabetes mellitus symptoms of hyperglycaemia (generally more severe in type 1 diabetes than in type 2 diabetes): O thirst O polyuria O blurred vision O weight loss O recurrent infections O tiredness symptoms of long-term complications: O type 2 diabetes may not be diagnosed until complications are present increased screening of patients at high risk of diabetes may lead to earlier diagnosis before onset of complications if symptoms are present, only one elevated glucose measurement is needed to confirm diagnosis Oral glucose tolerance testing: plasma glucose 2 hours following a glucose load of 75gms anhydrous glucose dissolved in water ** Lifestyle Modification : For those who meet the criteria for overweight (BMI Kg/m 2 and no other cardiovascular risk factors), encourage behavioural changes to achieve a healthy lifestyle, including: O modest weight loss - 5-7% of bodyweight in people who are overweight O regular physical activity - 30minutes/day on most days of the week or more if possible at around 50% intensity (this should make the individual breathless and sweat by the end of 30 mins). O follow-up counselling For those who are obese (BMI > 30 Kg/m 2 ), or with BMI Kg/m 2 and raised waist circumference (>88 in women, >102cm in men) and other two or more cardiovascular risk factors, the algorithm for weight management for obesity should be followed. ## Cardiovascular Risk Factor Score : Assess Cardiovascular Risk using the Framingham 10-year risk equations (Anderson et al 1991). Ten year CVD risk should be calculated as: CVD risk=10 year risk of coronary heart disease (CHD)+10 year risk of fatal and non-fatal stroke, including transient ischaemic attack $Features of metabolic syndrome: I.waist circumference >102cm in males, >88cm in females II. serum triglycerides 1.7mmol/l (150mg/dl) III. HDLcholesterol <1mmol/l (<40mg/dl) in males or <1.3mmol/l (<50mg/dl) in females IV. blood pressure 130/85mmHg. V.Fasting Plasma glucose > 6.1mmol/l (110mg/dl) $$ diabetic complications: O diabetic foot disease O renal disease O retinopathy O cardiovascular disease O other neuropathic complications Oregular monitoring and prompt treatment of problems reduces morbidity and mortality References: 1. National Institute for Health and Clinical Excellence (NICE). Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. Clinical Guideline 15. London: NICE; American Diabetes Association. Hyperglycemic crises in diabetes. Diabetes Care 2004; 27 (Suppl 1): S94-S Institute for Clinical Systems Improvement. Management of type 2 diabetes mellitus. Bloomington, MN: Institute for Clinical Systems Improvement; American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005; 28 (suppl 1): PRODIGY. Diabetes Type 2 - blood glucose management. Newcastle Upon Tyne: PRODIGY; Institute for Clinical Systems Improvement. Management of type 2 diabetes mellitus. Bloomington, MN: Institute for Clinical Systems Improvement; Moore H, Summerbell C, Hooper L et al. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev 2004; CD Norris SL, Zhang X, Avenell A et al. Long-term non-pharmacologic weight loss interventions for adults with type 2 diabetes. Cochrane Database Syst Rev 2005; CD Anderson KH, Odell PJ, Wilson PW et al. Cardiovascular disease risk profiles. American Heart Journal 1991; 121: Map of medicine healthguides: available at THE EXPERT COMMITTEE ON THE DIAGNOSIS AND CLASSIFICATION OF DIABETES MELLITUS. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. DIABETES CARE, VOLUME 26, SUPPLEMENT 1, JANUARY HAAD - Public Health Programmes Page 4 of 11

5 Annex II Areas of care that should be considered for continuation of the management of ALL diabetes patients include: 1. Patient education 2. Dietary advice 3. Assessment of blood glucose control 4. Blood glucose lowering treatment 5. Monitoring and management of blood lipids 6. Anti-thrombotic therapy 7. Monitoring and management of blood pressure Assessment of micro- and macro-vascular complications including: 8. Renal damage 9. Visual screening 10. Peripheral vascular screening 11. Peripheral neuropathy screening 12. Foot care 13. Other neuropathic complications These should be in line with International best practice. Widely used guidance including NICE guidance in the UK, the International Diabetes Federation and the American Diabetes Association all cover these areas. For the purpose of establishing best practice and for consistency with indicators highlighted in Annex III and Annex IV, the UK NICE guidance is recommended for this purpose. The summary of the NICE guidance (Type 2 diabetes, the management of type 2 diabetes: NICE clinical guideline 87). This should be used in combination with the full guidance document (National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical guideline for management in primary and secondary care (update). London: Royal College of Physicians, 2008). Page 5 of 11

6 Annex III Page 6 of 11

7 Measure Target Evidence base -for the requirement to report on this indicator Data reporting from initial diagnosis of diabetes ii. Oral Glucose Tolerance Test ( OGTT ) a. Fasting plasma glucose Oral glucose tolerance testing is the definitive test for diagnosis of diabetes. Taken alongside the fasting glucose it provides a complete picture of glucose handling from the fasting to post-prandial state. b. Plasma glucose (2 hours postglucose challenge, mmol/l) HbA1c (Glycosylated haemoglobin level) Whilst HbA1c is not recommended as a diagnostic test, this is mostly due to the lack of universal availability for comparison of rates globally. HbA1c provides information on longer term control and is not dependent on fasting status. It is also a better predictor of poor outcomes such as cardiovascular events than other measures of diabetes control. International consensus is increasing for its use as a diagnostic tool for diabetes. The threshold level of >6.1% equates to the WHO threshold for OGTT testing and has 68% sensitivity and 98% specificity. Data reporting on tests performed Data on diabetes patients to form a diabetes register Data submitted for all diabetes patients seen within the 12 month period for all ages, stating whether type 1 or type 2 diabetes and year of diagnosis The evidence for the benefit of a register, recall system and regular review has been demonstrated in Cochrane systematic reviews: UKPDS and DCCT demonstrated that diabetes is a progressive condition. Permits monitoring of changes in descriptive epidemiology Allows the option of targeting of payments according to disease stage and stage specific indicators for both process and outcome in the future. Allows assessment of education about diabetes for people who are recently diagnosed. Children should be included to better co-ordinate their diabetes care and improve epidemiological data on prevalence of diabetes. Page 7 of 11

8 Monitoring of Diabetes Indicators Glycosylated Haemoglobin (HbA1c) Blood lipid levels (mmol/l) - Fasting a. Fasting LDL Cholesterol b. Fasting HDL Cholesterol c. Fasting triglyceride Blood pressure level (mmhg) a. Systolic b. Diastolic Record of testing for albuminuria (unless has a history of proteinuria already) (mg/l) Serum creatinine testing or egfr Smoking status recorded (unless never smoked, when only first recording receives payment) Waist and Hip circumference Measured (once) in the last 12 months The HbA1c gives an indication of long term glucose handling typically over a 3 month period and is a better measure of glycaemic control than a point measure of glucose level. It should be monitored every 2-6 months depending of level of control. The evidence for the benefits of cholesterol lowering among people with diabetes, and in particular treatment with statins, is very strong. Although HDL and triglyceride are more associated with metabolic syndrome, the opportunity to influence LDL is greater through conventional lipid-lowering drugs. In diabetic patients, meta-analyses have shown a linear relationship between LDL levels and cardiovascular risk and that a 1mmol/l reduction in LDL results in a 12% reduction in all-cause mortality and a 21% reduction in the incidence of all vascular events (CTT collaborators metaanalysis). Intensive treatment of blood pressure had a greater impact on macrovascular disease in the UKPDS than intensive treatment of blood glucose. A Health Technology Assessment Review of urinary albumin testing for the detection of early diabetic complications (Newman et al. 2005) confirms the importance of urinary microalbuminuria as an independent risk factor for renal and cardiovascular complications of diabetes, and all cause mortality. Early detection of renal disease is important to enable optimal treatment to prevent progression. Estimated glomerular filtration rate, based on serum creatinine is reported as a better means to detect and monitor early renal disease than creatinine alone but is not routine practice for all laboratories. Smoking is strongly associated with increased risk of cardiovascular events. Even monitoring and brief advice on smoking cessation can be beneficial. Waist and hip circumference (and the derived waist-hip ratio) is a better independent predictor of cardiovascular risk than BMI. It is also a necessary indicator to determine metabolic syndrome. Page 8 of 11

9 BMI Record of peripheral vascular check Weight loss is an important predictor of health outcomes in type 2 diabetes and is associated with improvements in intermediate metabolic indicators The main role for these is the detection of foot problems that can affect anyone who has diabetes as a result of damage to the nerves, muscles, sweat glands and circulation in the feet and legs. Record of neuropathy testing Record of digital retinal screening Evaluation of skin, soft tissue, musculoskeletal, vascular, and neurological condition on an annual basis is important for the detection of feet at raised risk of ulceration. Both vibration perception threshold measurement and sensation threshold measurement accurately predict neuropathic patients at raised risk of ulceration. Diabetic retinopathy is the leading cause of blindness in working age adults and is preventable with effective screening and timely treatment. Data reporting on diabetes markers of control Control of Diabetes Indicators: scenario 1 HbA1c <7.5% DCCT showed that microvascular and metabolic complications of diabetes are prevented and macrovascular disease is reduced by obtaining HbA1c<7.5% in diabetic patients A 1% increase in HbA1c (across the full range of HbA1c) was associated with a relative risk of 1.18 (95% CI 1.10 to 1.26) for total cardiovascular events (combining 10 studies of coronary heart disease alone, stroke alone, and stroke and coronary heart disease combined) Blood Pressure < 145/85 Evidence for target setting for BP comes from the HOT study and favours lower targets for people with diabetes than others with hypertension. There was a 51% reduction in major cardiovascular events in people with diabetes assigned to the 80 mm Hg target compared with the 90 mm Hg target (p =0 005) Patients with Type 1 diabetes may benefit from a lower BP target of 135/85, unless the patient has abnormal albumen excretion or two or more features of the metabolic syndrome, in which case BP control of 130/80 is advocated Page 9 of 11

10 Cholesterol (total) < 5 mmol/l The annual measurement acts as a means of monitoring adherence as the effectiveness of statins among patients with type 2 diabetes appeared to be consistent regardless of the baseline level of total cholesterol. Smokers Control of Diabetes Indicators: scenario 2 HbA1c Smoking cessation advice administered or referral to smoking cessation specialist service >10.0% & evidence that patient is actively enrolled in a casemanagement programme There is strong evidence for smoking and cardiovascular events and for smoking cessation and the reduction in risk of cardiovascular events. Smoking is one of the most modifiable of risk factors for cardiovascular disease. Patients with HbA1c >10.0% are at the highest risk of complications and often have complex needs. At this level of poor glycaemic control, case management is recommended. Blood Pressure < 145/85 Evidence for target setting for BP comes from the HOT study and favours lower targets for people with diabetes than others with hypertension. There was a 51% reduction in major cardiovascular events in people with diabetes assigned to the 80 mm Hg target compared with the 90 mm Hg target (p =0 005) Patients with Type 1 diabetes may benefit from a lower BP target of 135/85, unless the patient has abnormal albumen excretion or two or more features of the metabolic syndrome, in which case BP control of 130/80 is advocated Cholesterol (total) < 5 mmol/l The annual measurement acts as a means of monitoring adherence as the effectiveness of statins among patients with type 2 diabetes appeared to be consistent regardless of the baseline level of total cholesterol. Smokers Smoking cessation advice There is strong evidence for smoking and cardiovascular events and for smoking cessation and the Page 10 of 11

11 administered or referral to smoking cessation specialist service reduction in risk of cardiovascular events. Smoking is one of the most modifiable of risk factors for cardiovascular disease. Data reporting of treatment for diabetes complications Diabetic patients with a diagnosis of proteinuria or micro-albuminuria Treated with ACE inhibitors (or A2 antagonists) Treatment with ACE inhibitors (or A2 antagonists if ACE inhibitors not tolerated) together with blood pressure control below 130/80 can prevent progression of renal disease. Diabetic patients known to have a 10 year CVD risk > 20% Treated with lipid-lowering drugs The prescription of lipid-lowering drugs should be part of a CVD risk analysis using documented risk score charts or computed CHD risk. The Framingham risk score is currently recommended. Diabetic patients known to have a 10 year CVD risk > 20% Treated with aspirin # There is unequivocal evidence for the treatment of those at high risk of CVD such as diabetics in preventing cardiovascular events and reducing all cause mortality. Data reporting on prevention of hospitalisation Diabetic patient Patient received follow up every 3 months and no inpatient admissions (for overnight stay or more) in last 12 months # Unless contra-indicated or not tolerated by the patient. If not tolerated, replace with clopidogrel. Page 11 of 11