Aldo P. Maggioni, Kees Van Gool, Nelly Biondi, Renato Urso, Niek Klazinga, Roberto Ferrari, Nikolaos Maniadakis and Luigi Tavazzi.

Transcription

1 Appropriateness of prescriptions of recommended treatments in OECD health systems: findings based on the Long-Term Registry of the ESC on Heart Failure Aldo P. Maggioni, Kees Van Gool, Nelly Biondi, Renato Urso, Niek Klazinga, Roberto Ferrari, Nikolaos Maniadakis and Luigi Tavazzi Disclosures: none

2 Background HF affects approximately 2% to 3% of the population, rising to around 10% in patients aged =>70 years HF is a common reason for hospital admissions: 14% of all CV hospital admissions in Organisation for Economic Cooperation and Development (OECD) countries Survival of patients with chronic HF improved over the last 2 decades due to the widespread adoption of treatment recommended by current clinical practice guidelines However, guidelines are often adopted too slowly or are applied partially and inconsistently The structure and organization of the health systems is likely to play an important role in explaining the insufficient application of guideline recommendations in drug prescriptions

3 Aim of the study To identify which patient clinical characteristics and which health system characteristics are associated with incomplete guideline incorporation and application in clinical practice

4 Methods (1) Patient characteristics are sourced from the ESC Heart Failure Long-Term Registry Country-level data are derived from the OECD s Health System Characteristics Survey, the OECD Health Statistics 2013 Database and Eurostats Statistics on Income and Living Conditions (EU-SILC) For the purpose of this analysis, only OECD countries, for which health system characteristics data is available, were considered Patients hospitalized for acute HF and chronic HF patients with an EF =>40% were excluded since current guidelines do not include EB recommendations for these patients Local audits were planned to check in a randomized sample of centres and patients the quality of the collected data and the consecutiveness of enrolment

5 Methods (2) Inappropriate prescription of pharmacological treatments recommended by ESC guidelines was defined as follows: q Patients not treated at all with at least one of the two recommended treatments (ACE-Inhibitors/ARBs and betablockers) or q Patients treated with both ACE-Inhibitors/ARBs and betablockers, but with a suboptimal dosage and q Absence of a documented contraindication or intolerance to the two recommended classes of drugs

6 Methods (3) Statistical analysis q q q First step: Each patient-level and country-level variables, either continuous or categorical was examined for its univariate association with inappropriate prescriptions Second step: Given the hierarchical nature of the data (patients nested within countries), a hierarchical model was tested in an empty model with the country identifier as random intercept All patient-level variables were then included in the multivariable model Thereafter, country group level covariates were added and examined one at a time The association between inappropriate prescription and each covariate was calculated using odds ratios (OR) with 95% confidence intervals (CI) The data were analysed using the SAS, version 9.3 for Windows statistical software (SAS institute, Cary, NC, USA)

7 Patient disposition n. 5,712 pts non-oecd countries n. 17,901 pts Total number n. 12,189 pts OECD countries 21 Countries 211 Cardiology centers From May 2011 to Dec 2013 n. 572 pts Sweden n. 11,617 pts Pts with available adherence data n. 3,357 pts Hospitalised HF pts n. 8,260 pts Chronic HF pts n. 1,303 pts Missing EF data n. 4,605 pts HF reduced EF n. 2,352 pts HF with EF 40% OECD: Organisation for Economic Co-operation and Development; HF: heart failure; EF: ejection fraction

8 Inappropriate prescriptions by OECD countries N. of centres N. of Pts Inappropriate drug prescription (%) Austria Czech Republic Denmark Estonia France Greece Hungary Israel Italy Poland Portugal Slovak Republic Slovenia Spain Turkey Total

9 Inappropriate prescriptions of participating centres, within and across country variation Proportion of patients not adherent AUT CZE DNK ESP EST FRA Panel A: All centres GRC HUN ISR ITA POL PRT SVK SVN TUR Proportion of patients not adherent AUT CZE Panel B: Centres with sample of 10 or more patients DNK ESP EST FRA GRC HUN ISR ITA POL PRT SVK SVN TUR

10 Patients characteristics and ORs for inappropriate prescriptions estimated by univariate models Age (years) < >75 Appropriate (n=3508) N (%) 1857 (52.9) 1008 (28.7) 643 (18.3) Inappropriate (n=1097) N (%) P-value 523 (47.7) 318 (29.0) 256 (23.3) Men 2752 (78.5) 844 (76.9) 0.31 Body mass index (kg/m 2 ) < > (9.3) 695 (19.9) 2475 (70.8) 91 (8.4) 228 (20.9) 770 (70.7) Ejection fraction <30% 2001 (57.0) 570 (52.0) 0.04 NYHA class III or IV 962 (27.4) 269 (24.5) 0.06 Heart rate >70 bpm 1577 (45.0) 486 (44.3) 0.73 Systolic Blood Pressure (mmhg) < > (35.0) 1399 (39.9) 881 (25.1) (33.3) 435 (39.6) 297 (27.1) 0.37

11 Patients characteristics and ORs for inappropriate prescriptions estimated by univariate models Appropriate (n=3508) N (%) Inappropriate (n=1097) N (%) P-value Creatinine >1.5 mg/dl 644 (19.6) 216 (21.2) 0.28 Sodium <136 meq/l 367 (11.6) 121 (12.5) 0.48 Ischemic etiology 1664 (47.4) 558 (50.9) 0.05 Atrial fibrillation 1186 (33.8) 378 (34.5) 0.72 Left bundle branch block 733 (23.0) 234 (24.9) 0.23 Mitral regurgitation 1032 (29.9) 368 (34.9) COPD 560 (16.0) 145 (12.9) 0.01 Peripheral arterial diseases 412 (11.8) 144 (13.2) 0.24 Chronic kidney diseases 638 (18.3) 221 (20.4) 0.14 Diabetes mellitus 1174 (33.5) 378 (34.5) 0.57 Prior stroke 322 (9.2) 107 (9.8) 0.60 Depression 266 (7.6) 69 (6.3) 0.17 COPD=chronic obstructive pulmonary disease

12 Country level variables and ORs for inappropriate prescriptions estimated by univariate models ACCESS Percentage of population skipping a doctor consultation Patient sample living in countries where health services are primarily free at the point of care Out of pocket expenditures on medical goods (per capita US$) Out of pocket expenditures on outpatient care (per capita US$) N. of annual doctor consultations (per capita) Appropriate (n=3508) Inappropriate (n=1097) P- value 6.3± ±3.2 < (55.0) 613 (56.8) ±37 210± ± ±104 < ± ±

13 Country level variables and ORs for inappropriate prescriptions estimated by univariate models RESOURCES Percentage of total health expenditure spend on ambulatory care Appropriate (n=3508) Inappropriate (n=1097) P- value 24.5± ±6.8 <.0001 Number of GPs (per 1000 population) 0.9± ±0.4 <.0001 Patients living in countries where GPs are mostly privately employed Patients living in countries where GPs are primarily paid fee-for-service Patient sample living in countries where there are obligation or incentives to register with a GP 975 (33.4) 261 (27.2) < (11.7) 60 (6.5) < (89.5) 928 (89.2) 0.81

14 Country level variables and ORs for inappropriate prescriptions estimated by univariate models QUALITY Patients living in countries with formal accreditation requirements for primary care practices to operate Patient sample living in countries with formal system of continuous medical education Patients living in countries with use of a patient registration system Patients living in countries with electronic exchange of information between providers Patients living in countries with incentives to comply with treatment guidelines Appropriate (n=3508) Inappropriate (n=1097) P- value 2357 (70.8) 688 (66.2) (87.1) 907 (87.2) (95.2) 964 (92.7) < (71.5) 694 (66.7) < (88.4) 847 (83.2) <.0001

15 Odds ratios by the multi-level logistic model Age (years) < >75 OR 95%CI P-value Ref Men Body mass index (kg/m 2 ) < > Ref Ejection fraction <30% NYHA class III or IV Heart rate >70 bpm Systolic Blood Pressure (mmhg) < > Ref Creatinine >1.5 mg/dl Sodium <136 meq/l

16 Odds ratios by the multi-level logistic model OR 95%CI P-value Ischemic etiology Atrial fibrillation Left bundle branch block Mitral regurgitation COPD Peripheral arterial diseases Chronic kidney diseases Diabetes mellitus Prior stroke Depression Incentives to comply with treatment guidelines COPD=chronic obstructive pulmonary disease

17 Limitations The analysis is limited by the small number of patients in some countries which restricts our ability to explore country-level data Consecutive enrolment cannot be fully proven. In the attempt to get the registry burden feasible and realistic, the enrolment was done on a one day per week basis. Local audits were performed to check quality of data and consecutiveness To maximize representativeness, the centres were selected in proportion to the size of the population of the countries and taking into account the technological levels of the cardiology centres The patients were enrolled by cardiologists and therefore the study population may not be representative the entire chronic HF population In a relevant rate of patients (16%) EF was not measured and these patients were excluded from the analysis. This can be considered an inappropriate way to manage HF patients, that probably merits future specific evaluations

18 Conclusions ESC-OECD analysis shows: q national borders can explain some variations in treatment patterns q the importance of within country variation Lack of appropriateness of prescriptions could impact patient outcomes and health care costs More efforts should be made towards understanding the role of health system characteristics in explaining application of guidelines both within and between countries Such an understanding could aid decision makers to design more effective policies to improve quality of health care and to potentially improve patients outcomes and reduce costs

19 Back up EURObservational Research Programme EORP Sponsor Meeting Brussels 16 April

20 Methods (2) Inappropriate prescription of pharmacological treatments recommended by ESC guidelines was defined as follows: q Patients not treated at all with at least one of the two recommended treatments (ACE-Inhibitors/ARBs and beta-blockers) or q and q Patients treated with both ACE-Inhibitors/ARBs and beta-blockers, but with a suboptimal dosage Absence of a documented contraindication or intolerance to the two recommended classes of drugs Clinical variables q Demographic characteristics (age and gender) q Vital signs and symptoms (SBP, HR, NYHA class) q Etiology of HF q Laboratory and instrumental results (LBBB at ECG, EF, sodium, creatinine) q Classical risk factors (BMI, diabetes mellitus, hypertension) q Comorbid condition and vascular history (history of stroke, AF, mitral EURObservational Research Programme regurgitation, depression, COPD, chronic kidney dysfunction, PAD) 20 EORP Sponsor Meeting Brussels 16 April 2014

21 Methods (3) OECD Health System Characteristics Survey q Patient access to health care q Financial and physical resources available for health care q Quality improvement initiatives within a health care system OECD Health and Eurostat Statistics q Health resources and activities q Health expenditures Eurostat s Statistics on Income and Living Conditions (EU-SILC) q Percentage of people who reported that they did not visit their doctor in the previous 12 months when they felt they needed health care

22 Methods (2) Inappropriate prescription of pharmacological treatments recommended by ESC guidelines was defined as follows: q Patients not treated at all with at least one of the two recommended treatments (ACE-Inhibitors/ARBs and beta-blockers) or q and q Patients treated with both ACE-Inhibitors/ARBs and beta-blockers, but with a suboptimal dosage Absence of a documented contraindication or intolerance to the two recommended classes of drugs Clinical variables q Demographic characteristics (age and gender) q Vital signs and symptoms (SBP, HR, NYHA class) q Etiology of HF q Laboratory and instrumental results (LBBB at ECG, EF, sodium, creatinine) q Classical risk factors (BMI, diabetes mellitus, hypertension) q Comorbid condition and vascular history (history of stroke, AF, mitral regurgitation, depression, COPD, chronic kidney dysfunction, PAD)