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
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 Co- operation 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
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
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
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 Patients treated with both ACE-Inhibitors/ARBs and beta- blockers, but with a suboptimal dosage and q Absence of a documented contraindication or intolerance to the two recommended classes of drugs
Methods (3) • Statistical analysis q First step: Each patient-level and country-level variables, either continuous or categorical § was examined for its univariate association with inappropriate prescriptions q 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 q 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)
Patient disposition 21 Countries n. 17,901 pts 211 Cardiology centers Total number From May 2011 to Dec 2013 n. 5,712 pts non-OECD countries n. 12,189 pts OECD countries n. 572 pts Sweden n. 11,617 pts Pts with available adherence data n. 8,260 pts n. 3,357 pts Hospitalised HF pts Chronic HF pts n. 1,303 pts Missing EF data n. 4,605 pts n. 2,352 pts HF reduced EF HF with EF ≥40% OECD: Organisation for Economic Co-operation and Development; HF: heart failure; EF: ejection fraction
Inappropriate prescriptions by OECD countries N. of N. of Pts Inappropriate drug centres prescription (%) Austria 4 126 17.5 Czech Republic 7 337 21.4 Denmark 21 160 38.1 Estonia 2 21 76.2 France 12 322 15.8 Greece 4 50 76.0 Hungary 5 239 15.9 Israel 2 286 18.2 Italy 17 754 28.8 Poland 17 236 32.2 Portugal 10 354 9.6 Slovak Republic 4 117 15.4 Slovenia 8 67 22.4 Spain 20 1440 25.3 Turkey 5 96 24.0 Total 138 4605 23.8
centres, within and across country variation Inappropriate prescriptions of participating Proportion of patients not adherent Proportion of patients not adherent 0 .2 .4 .6 .8 1 0 .2 .4 .6 .8 1 A A U U T T C C Z Z E E D D N N Panel B: Centres with sample of 10 or more patients K K E E S S P P E E S S T T F F R R A A Panel A: All centres G G R R C C H H U U N N I I S S R R I I T T A A P P O O L L P P R R T T S S V V K K S S V V N N T T U U R R
Patients’ characteristics and ORs for inappropriate prescriptions estimated by univariate models Appropriate Inappropriate P-value (n=3508) (n=1097) N (%) N (%) Age (years) <65 1857 (52.9) 523 (47.7) 65-75 1008 (28.7) 318 (29.0) >75 643 (18.3) 256 (23.3) 0.001 Men 2752 (78.5) 844 (76.9) 0.31 Body mass index (kg/m 2 ) <22 327 (9.3) 91 (8.4) 22-25 695 (19.9) 228 (20.9) 0.50 >25 2475 (70.8) 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) <110 1227 (35.0) 365 (33.3) 110-130 1399 (39.9) 435 (39.6) >130 881 (25.1) 297 (27.1) 0.37
Patients’ characteristics and ORs for inappropriate prescriptions estimated by univariate models Appropriate Inappropriate P-value (n=3508) (n=1097) N (%) N (%) 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) 0.003 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
Country level variables and ORs for inappropriate prescriptions estimated by univariate models Appropriate Inappropriate P- (n=3508) (n=1097) value ACCESS Percentage of population skipping a 6.3±3.2 6.9±3.2 <.0001 doctor consultation Patient sample living in countries where health services are primarily free at the 1874 (55.0) 613 (56.8) 0.29 point of care Out of pocket expenditures on medical 213±37 210±31 0.04 goods (per capita US$) Out of pocket expenditures on 215±100 230±104 <.0001 outpatient care (per capita US$) N. of annual doctor consultations (per 7.4±2.2 7.3±2.0 0.02 capita)
Country level variables and ORs for inappropriate prescriptions estimated by univariate models Appropriate Inappropriate P- (n=3508) (n=1097) value RESOURCES Percentage of total health expenditure 24.5±7.8 23.0±6.8 <.0001 spend on ambulatory care Number of GPs (per 1000 population) 0.9±0.5 0.8±0.4 <.0001 Patients living in countries where GPs 975 (33.4) 261 (27.2) <0.001 are mostly privately employed Patients living in countries where GPs 305 (11.7) 60 (6.5) <.0001 are primarily paid fee-for-service Patient sample living in countries where there are obligation or incentives to register 2981 (89.5) 928 (89.2) 0.81 with a GP
Country level variables and ORs for inappropriate prescriptions estimated by univariate models Appropriate Inappropriate P- (n=3508) (n=1097) value QUALITY Patients living in countries with formal accreditation requirements for primary 2357 (70.8) 688 (66.2) 0.01 care practices to operate Patient sample living in countries with formal system of continuous medical 2900 (87.1) 907 (87.2) 0.90 education Patients living in countries with use of a 3171 (95.2) 964 (92.7) <0.001 patient registration system Patients living in countries with electronic exchange of information 2381 (71.5) 694 (66.7) <0.001 between providers Patients living in countries with incentives to comply with treatment 2851 (88.4) 847 (83.2) <.0001 guidelines
Odds ratios by the multi-level logistic model OR 95%CI P-value Age (years) <65 Ref 65-75 1.0 0.8-1.3 0.87 >75 1.2 0.9-1.5 0.19 Men 0.9 0.7-1.2 0.57 Body mass index (kg/m 2 ) <22 0.9 0.6-1.2 0.37 22-25 Ref >25 0.9 0.7-1.1 0.21 Ejection fraction <30% 0.9 0.7-1.1 0.13 NYHA class III or IV 0.9 0.7-1.1 0.15 Heart rate >70 bpm 1.1 0.9-1.3 0.41 Systolic Blood Pressure (mmHg) <110 0.9 0.7-1.1 0.20 110-130 Ref >130 1.0 0.8-1.3 0.99 Creatinine >1.5 mg/dL 1.1 0.8-1.5 0.43 Sodium <136 mEq/L 1.2 0.9-1.6 0.26
Odds ratios by the multi-level logistic model OR 95%CI P-value Ischemic etiology 1.2 1.0-1.4 0.12 Atrial fibrillation 1.1 0.9-1.4 0.22 Left bundle branch block 1.2 1.0-1.6 0.07 Mitral regurgitation 1.4 1.1-1.7 0.01 COPD 0.7 0.5-0.9 0.01 Peripheral arterial diseases 1.1 0.8-1.5 0.44 Chronic kidney diseases 0.9 0.7-1.2 0.51 Diabetes mellitus 1.1 0.9-1.3 0.51 Prior stroke 1.2 0.9-1.7 0.20 Depression 0.9 0.6-1.2 0.36 Incentives to comply with 0.4 0.2-1.1 0.07 treatment guidelines COPD=chronic obstructive pulmonary disease
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