Implementing CVD guidelines: physician and patient factors

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1 Implementing CVD guidelines: physician and patient factors Professor Richard Hobbs Head of Primary Care & General Practice Primary Care Clinical Sciences Building University of Birmingham, United Kingdom Disclosures Occasional consultant and speaker panels: AstraZeneca, Merck, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis Research funding from Pfizer, AstraZeneca, Roche

2 Leading causes of death and disability (disability adjusted life years) Rank Cause % Rank Cause % 1 Lower respiratory infections Ischaemic heart disease Diarrhoeal diseases Major depression Perinatal conditions Road traffic accidents Major depression Cerebrovascular disease Ischaemic heart disease COPD Cerebrovascular disease Lower respiratory infections Tuberculosis Tuberculosis Measles War Road traffic accidents Diarrhoeal diseases Congenital abnormalities HIV 2.6 Global Burden of Disease Project, 1996

3 Potentially Modifiable Risk Factors and MI : INTERHEART Study Cases Controls in 262 Centres in 52 Countries on 6 Continents 9 RFs associated with 90% of MI in men and 94% in women Odds Ratio PAR (%) Yusuf S. Lancet 2004

4 % % Relationship Between Proportional Reduction in Events and Mean LDL-C Reduction at 1 Year Major coronary events Major vascular events (19) 1.0 (38) 23% 1.5 (58) 2.0 (77) (19) 1.0 (38) 21% 1.5 (58) 2.0 (77) Reduction in LDL-C mmol/l (mg/dl) Reduction in LDL-C mmol/l (mg/dl) Lancet Published online September 27th

5 Effectiveness of guideline implementation: primary & secondary prevention?

6 Most physicians believe CHD guidelines are being properly implemented 17% 1%4% 18% 60% To what extent are guidelines being implemented? Major extent Moderate extent Minor extent Not at all Don t know The REACT survey was carried out in France, Germany, Italy, Sweden, and the United Kingdom. During the course of the survey 754 general practitioners were interviewed Hobbs FDR, Erhardt L. Family Practice. 2002;19: Hobbs FD et al. Fam Pract. 2002;19: Erhardt, Hobbs, REACT Study, IJCP, 2002.

7 Control of CV risk factors in specialist hospitals in Europe: EUROASPIRE III 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Raised BP Elevated TC Elevated LDL-C Diabetes Survey % 94.5% 96.4% 17.4% Survey % 76.7% 78.1% 20.1% Survey % 46.2% 47.5% 28.0% *SBP/DBP 140/90 mmhg for non-diabetics or 130/80 mmhg diabetics ** TC 4.5 mmol/l; *** LDL-C 2.5 mmol/l

8 Control of CV risk factors in primary care in Europe: EUROASPIRE III 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% **SBP/DBP 140/90 mmhg for non-diabetics or 130/80 mmhg for diabetes ****Self-reported and/or glucose 7.0 mmol/l; **** in patients with self reported diabetes BP>140/90mmHg** TC>4.5 mmol/l LDL-C>2.5 mmol/l Diabetes*** HbA1c<6.5% **** ALL 70.8% 78.9% 81% 43% 53% MEN 72.6% 72.5% 77% 39% 61% WOMEN 69.5% 83.6% 83% 39% 46%

9 NHANES : Lipid-lowering Drugs Were Not Prescribed and/or Taken Unaware of their dyslipidemia 7% 5% Aren t on prescription medication On medication but aren t controlled On medication and controlled 23% 65% Dyslipidemia=total cholesterol 200 mg/dl. Ford et al. Circulation. 2003;107:

10 UK Management of Hypertension: BP Control % Health Surveys for England: Control defined as >140/90 mmhg 40.0% 26.2% Diagnosed Treated Controlled 48.2% 32.9% 60.5% 44.7% % % 37.5% 57.7% 44.0% 63.9% 52.2% 0 9.4% 13.1% 21.5% 12.1% % % 2003 Primatesta & Poulter 2006

11 Why is clinical practice lagging behind guideline recommendations? Physician factors

12 RCT of national cholesterol guidelines in in Netherlands 20 practices & 32 PCPs Intervention (5/12) group education face to face instruction in the practice on guideline content and application desktop computerised decision support personal feedback on performance Study involved 3850 chart audits and 594 patient contacts Endpoint appropriate cholesterol testing of at-risk patients

13 Likelihood for a patient with positive risk profile to have cholesterol tested Baseline Follow up Intervention group 5.1 ( ) Control group 4.2 ( ) 4.9 ( ) 3.8 ( ) Van der Weijden et al, Int J Qual Health Care, 1999, 131-7

14 Why was this comprehensive guideline implementation unsuccessful? Cholesterol testing needs pro-active attitude and population approach Contrasts with day-to-day personal care in patient centred consultations PCPs had doubts on the evidence upon which the guidelines were based Guidelines and decision trees too complex Implementation of the guideline would mean significant increase in workload

15 Factors determining PC physician use of guidelines Observational adherence to 47 recommendations selected from 10 Dutch RCGP guidelines: 61 PCPs during clinical decisions ATTRIBUTES TO RECOMMENDATIONS Attribute present ADHERENCE (%) Attribute not present Based on scientific evidence 71% 51% Concretely defined 67% 39% Controversial 35% 68% Demands change in routines 44% 67% Consequences for management 50% 65% Grol et al, BMJ 1999;317:

16 What can we do? Simplify AND unify guidelines

17 Guidance over CVD risk prediction

18 Physicians Often Underestimate Their Patients CV Risk Comparison of actual versus perceived 10-year risk among 80 Swedish GPs asked to estimate the risk of a number of given patient profiles 60% 50% 40% 30% 33% 27% Framingham calculated risk Perceived risk 20% 10% 10% 10% 14% 5% 0% Man 61 years Smoker LDL cholesterol 6.3 mmol/l 244 mg/dl Total cholesterol 8.2 mmol/l 317 mg/dl Woman 66 years Diabetic LDL cholesterol 4.6 mmol/l 178 mg/dl Total cholesterol 6.9 mmol/l 267 mg/dl Woman 51 years Smoker LDL cholesterol 4.1 mmol/l 166 mg/dl Total cholesterol 6.5 mmol/l 255 mg/dl Backlund L et al. Prim Health Care Res Dev 2004;5(2):153 61

19 Systolic blood pressure Europe: 10-Year Risk of Fatal CVD in High-Risk Regions 2003 ESC Nonsmoker Women Smoker Age Men Smoker SCORE Cholesterol mmol Nonsmoker mg/dl 15% and over 10% - 14% 5% - 9% 3% - 4% 2% 1% < % 10-year risk of fatal CVD in populations at high CVD risk Chart should be used in all European countries excluding those considered low-risk (Belgium, France, Greece, Italy, Luxembourg, Spain, Switzerland, Portugal) De Backer G et al. Eur J Cardiovasc Prev Rehabil. 2003;10(suppl 1):S1-S78.

20 Step 1: Age Years Points Step 2: Total Cholesterol Assessing CHD risk: men ATP III Framingham Risk Scoring Step 4: Systolic Blood Pressure Systolic BP Points Points (mm Hg) if Untreated if Treated < TC Points at Points at Points at Points at Points at (mg/dl) Age Age Age Age Age < Step 3: HDL-Cholesterol HDL-C (mg/dl) Points > <40 2 Step 5: Smoking Status Step 7: CHD Risk Step 6: Adding Up the Points Age TC HDL-C Systolic BP Smoking status Point total Point Total 10-Year Risk Point Total 10-Year Risk <0 <1% 11 8% 0 1% 12 10% 1 1% 13 12% 2 1% 14 16% 3 1% 15 20% 4 1% 16 25% 5 2% 17 30% 6 2% 7 3% 8 4% 9 5% 10 6% Points at Points at Points at Points at Points at Age Age Age Age Age Nonsmoker Smoker Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285:

21 Risk Assessment Tools Several different algorithms exist Framingham UKPDS Risk Engine for patients with type 2-diabetes SCORE Heart-SCORE PROCAM BHS NZ Chart Pocock Risk Score Sheffield Tables Q-Risk

22 REACT Survey: Infrequent Use of Risk Charts Only 13% of physicians always use risk charts to assess a patient s risk of developing CHD 25% 18% 1% 13% 43% Always Sometimes Rarely Never Don t know Erhardt L, Hobbs FDR. Int J Clin Pract 2002;56(9):638 44

23 Specific guidance over CVD intervention targets

24 US LDL-C goals and cutpoints for therapeutic interventions: NCEP ATP III Risk Category LDL-C Goal (mg/dl) Non-HDL-C Goal* (mg/dl) LDL-C Level to Consider Drug Therapy (mg/dl) CHD or CHD Risk Equivalents (10-year risk >20%) <100 (2.5 mmol/l) Ideally <70 <130 (3.4 mmol/l) 130 ( : drug optional) In highest risk 2+ Risk Factors (10-year risk 20%) <130 (3.4 mmol/l) <160 (4.2 mmol/l) 10-year risk 10 20%: year risk <10%: Risk Factor <160 (4.2 mmol/l) <190 (5 mmol/l) 190 ( : LDL-C lowering drug optional) Diabetes mellitus or other established atherosclerotic disease *When triglycerides 200 mg/dl NCEP ATP III 2001

25 Non NCEP lipid treatment targets Guidelines and patient population Third Joint European Societies (2003) General treatment goals Established CVD or diabetes New Joint British Societies (2005) LDL-C mg/dl (mmol/l) < 115 (3.0) < 100 (2.6) Total cholesterol mg/dl (mmol/l) < 190 (5.0) < 175 (4.5) All CVD pts and those with >20% 10 year CVD risk <70 (2, audit 2.5) <160 (4, audit 4.5) ADA (2004) Established diabetes < 100 (2.6) Not included De Backer G et al. Eur Heart J. 2003;24: NCEP Expert Panel. JAMA. 2001;285: American Diabetes Association. Diabetes Care. 2004;27(suppl 1):S68-S71.

26 Reluctance to up-titrate statins - a major factor why patients do not get to target 2829 patients 1464 (52%) not at goal on starting dose 1365 (48%) at goal on starting dose 813 (55%) not titrated 651 (45%) titrated 448 (69%) not at goal 203 (31%) at goal Patients with an LDL-C goal of <100mg/dL (CHD and/or diabetes mellitus) with HDL-C 45 mg/dl Foley KA, Simpson RJ, Crouse JR et al. Am J Cardiol 2003;92:79-81

27 Why is clinical practice lagging behind guideline recommendations? Patient factors

28 % Persistence with LLD at One-Year Persistence with lipid-lowering drugs at one-year Literature Review Various methods to define discontinuation have been used Caspard Ellis Catalan Perreault Abraha Sturkenboom Mantel- Teeuwisse Yang Larsen USA CA ITA NL UK DK CAVE: Various methods to define discontinuation have been used. Caspard. Clin Ther. 2005; Perreault. Eur J Clin Pharmacol. 2005; Ellis. J Gen Intern Med. 2004; Abraha. Eur J Clin Pharmacol. 2003; Yang. Br J Clin Pharmacol. 2003; Larsen. Br J Clin Pharmacol. 2002; Catalan. Value Health. 2000; Mantel-Teeuwisse AK, et al. Heart

29 % Fully Adherent: >80% PDC Concordance with lipid lowering drugs USA Italy NL Months After Starting Treatment US data: Benner et al. JAMA. 2002;288: Other data from general practice databases in NL and Italy data on file Pfizer Inc, NY, USA.

30 Does public knowledge on CVD risk influence their uptake of guidance?

31 Public Unaware of Cholesterol as CHD Risk Factor Physicians believe their patients know cholesterol is associated with CVD Only half the public is aware (after prompting) that high cholesterol increases CHD risk 92% 7% Smoking High blood pressure Obesity/being overweight 70% 65% 62% Stress 58% Yes No High cholesterol Drinking alcohol 51% 40% Base: All GPs (N=754) Base: All 40- to 70-year-olds (N=5140) Erhardt, Hobbs, REACT Study, IJCP, 2002

32 Do patients with high cholesterol know the potential CVD risks they could face?

33 Patients (%) Patients with high cholesterol: knowledge that MI was a consequence of high cholesterol Overall, three-quarters of patients could not state heart attack as consequence of high cholesterol 19% could not identify any consequence of a high cholesterol Total Belgium Denmark Finland France Portugal UK Singapore South Korea Brazil Mexico Hobbs FDR, Erhardt L. From the Heart Survey. ISA Rome. June pts & 750 drs surveyed in 10 countries ( Belgium, Brazil, Denmark, Finland, France, Mexico, Portugal, Singapore, S Korea, UK)

34 Patients (%) Patients with high cholesterol: knowledge of cholesterol goals Given cholesterol goal Could not remember goal Total Belgium Denmark Finland France Portugal UK Singapore South Korea Brazil Mexico Hobbs FDR, Erhardt L. From the Heart Survey. ISA Rome. June pts & 750 drs surveyed in 10 countries ( Belgium, Brazil, Denmark, Finland, France, Mexico, Portugal, Singapore, S Korea, UK)

35 Patients (%) Patients with high cholesterol: opinion on cholesterol goal achievement Overall, 35% of patients believed that they had reached their cholesterol goal Total Belgium Denmark Finland France Portugal UK Singapore South Korea Brazil Mexico Hobbs FDR, Erhardt L. From the Heart Survey. ISA Rome. June pts & 750 drs surveyed in 10 countries ( Belgium, Brazil, Denmark, Finland, France, Mexico, Portugal, Singapore, S Korea, UK)

36 Patients (%) Patients attitudes towards their cholesterol treatment Satisfied Motivated Concerned Frustrated Disappointed Confused No strong feelings Hobbs FDR, Erhardt L. From the Heart Survey. ISA Rome. June pts & 750 drs surveyed in 10 countries ( Belgium, Brazil, Denmark, Finland, France, Mexico, Portugal, Singapore, S Korea, UK)

37 Patients (%) Hobbs FDR, Erhardt L. From the Heart Survey. ISA Rome. June pts & 750 drs surveyed in 10 countries ( Belgium, Brazil, Denmark, Finland, France, Mexico, Portugal, Singapore, S Korea, UK) Patients compliance with lipid-lowering therapy >0nce/week Once/week Once/fortnight <Once/month Unknown Forget to take medication Patients who agreed that they sometimes forgot to take their treatment (n=370)

38 So what guideline implementation strategies work?

39 Evidence for clinical implementation strategies in general Audit and feedback: 37 RCTs (Thomson et al, Cochrane Library) Limited evidence of effectiveness in some studies, but» Effect size small to moderate» Should not be relied upon on their own

40 Evidence for general clinical implementation strategies Educational interventions Lectures, conferences, CME, education outreach etc» SR of 99 RCTs of 160 educational interventions 1» SR of opinion leader interventions 2 Enhances knowledge rather than changes behaviour Limited evidence for changes in practice 1. Davis et al, J Am Med Assoc. 1995: 274: Lomas et al, J Am Med Assoc. 1991; 265:

41 Evidence for general clinical implementation strategies Decision support Conflicting trial evidence Modest effect size

42 Can incentives improve CVD risk management in primary care?

43 UK primary care incentive scheme: Quality and Outcomes Framework. Top ten QOF clinical point scores: RANK ORDER POINTS 70% hypertensives have bp recorded in past 9m 56 90% severe M H reviewed in past 15m 23 70% asthma reviewed past 15m 20 90% hypertensives bp <150/90 in past 9m 20 70% CHD pts have bp <150/90 in past 9m 19 70% diabetes pts have bp <145/85 in past 9m 17 60% CHD pts cholesterol <5 in past 15m 16 50% diabetes pts HbA1C <7.4 in past 15m 16 70% asthma pts 8+ have co nfirmed diagno sis 15 70% asthma pts 16+ immunised for flu in last 12m 12 Practices getting full marks in these 10 areas will gain 214 of the available 550 clinical points

44 Overall score (max 100) Quality of chronic disease care in the UK between 1998 and Angina Diabetes Asthma Campbell et al. Improvements in quality of clinical care in English GP BMJ 2005; 331: 11

45 Percentage of patients Quality of care improved between 1998 and 2003 (patients with coronary heart disease) Total cholesterol <5mmol/l BP <150/ Campbell et al. Improvements in quality of clinical care in English GP BMJ 2005; 331: 1121-

46 Quality of care between 2003 and 2005, following the introduction of QOF financial incentives Overall score Angina Diabetes Asthma Campbell et al. Improvements in clinical quality in English primary care before and after the introduc of a pay for performance scheme. NEJM; 2

47 Summary Traditional risk factors explain most observed CVD risk Large evidence base on treatments that reduce these risk factors Major clinical guidelines summarise all these data But barriers to CVD guideline implementation are multiple Significant limitations with CVD risk scores Those at risk under-identified Many physician and patient factors lead to under-treatment Guideline incentive and implementation strategies work Structured care, audit and feedback Explicit indicator targets with funding

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