Cost-effectiveness of outpatient adherence to recommendations for monitoring of patients hospitalized for heart failure.

AIMS: A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out. METHODS AND RESULTS: Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014-2015 entered in the cohort and followed up until 2019. Adherence to evidence-based recommendations [i.e. renin-angiotensin-aldosterone system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and echocardiograms (ECCs)] experienced during the first year after index discharge was assessed. Composite clinical outcomes (cardiovascular hospital admissions and all-cause mortality) and healthcare costs (hospitalizations, drugs, and outpatient services) were assessed during the follow-up. The restricted mean survival time at 5 years (denoted as the number of months free from clinical outcomes), the hazard of clinical outcomes (according to the Cox model), and average annual healthcare cost (expressed in euros per person-year) were compared between adherent and non-adherent patients. A non-parametric bootstrap method based on 1000 resamples was used to account for uncertainty in cost-effectiveness estimates. A total of 41 406 patients were included in this study (46.3% males, mean age 76.9 ± 9.4 years). Adherence to RAS inhibitors, beta-blockers, MRAs, and ECCs were 64%, 57%, 62%, and 20% among the cohort members, respectively. Compared with non-adherent patients, those who adhered to ECCs, RAS inhibitors, beta-blockers, and MRAs experienced (i) a delay in the composite outcome of 1.6, 1.9, 1.6, and 0.6 months and reduced risks of 9% (95% confidence interval, 2-14%), 11% (7-14%), 8% (5-11%), and 4% (-1-8%), respectively; and (ii) lower (€262, €92, and €571 per year for RAS inhibitors, beta-blockers, and MRAs, respectively) and higher costs (€511 per year for ECC). Adherence to RAS inhibitors, beta-blockers, and MRAs showed a delay in the composite outcome and a saving of costs in 98%, 84%, and 93% of the 1000 bootstrap replications, respectively. CONCLUSIONS: Strict monitoring of patients with heart failure through regular clinical examinations and drug therapies should be considered the cornerstone of national guidelines and audits.

Developing and validating a novel multisource comorbidity score from administrative data: a large population-based cohort study from Italy.

OBJECTIVE: To develop and validate a novel comorbidity score (multisource comorbidity score (MCS)) predictive of mortality, hospital admissions and healthcare costs using multiple source information from the administrative Italian National Health System (NHS) databases. METHODS: An index of 34 variables (measured from inpatient diagnoses and outpatient drug prescriptions within 2 years before baseline) independently predicting 1-year mortality in a sample of 500 000 individuals aged 50 years or older randomly selected from the NHS beneficiaries of the Italian region of Lombardy (training set) was developed. The corresponding weights were assigned from the regression coefficients of a Weibull survival model. MCS performance was evaluated by using an internal (ie, another sample of 500 000 NHS beneficiaries from Lombardy) and three external (each consisting of 500 000 NHS beneficiaries from Emilia-Romagna, Lazio and Sicily) validation sets. Discriminant power and net reclassification improvement were used to compare MCS performance with that of other comorbidity scores. MCS ability to predict secondary health outcomes (ie, hospital admissions and costs) was also investigated. RESULTS: Primary and secondary outcomes progressively increased with increasing MCS value. MCS improved the net 1-year mortality reclassification from 27% (with respect to the Chronic Disease Score) to 69% (with respect to the Elixhauser Index). MCS discrimination performance was similar in the four regions of Italy we tested, the area under the receiver operating characteristic curves (95% CI) being 0.78 (0.77 to 0.79) in Lombardy, 0.78 (0.77 to 0.79) in Emilia-Romagna, 0.77 (0.76 to 0.78) in Lazio and 0.78 (0.77 to 0.79) in Sicily. CONCLUSION: MCS seems better than conventional scores for predicting health outcomes, at least in the general population from Italy. This may offer an improved tool for risk adjustment, policy planning and identifying patients in need of a focused treatment approach in the everyday medical practice.

Adherence to Long-Acting Bronchodilators After Discharge for COPD: How Much of the Geographic Variation is Attributable to the Hospital of Discharge and How Much to the Primary Care Providers?

In moderate-severe chronic obstructive pulmonary disease (COPD), long-acting bronchodilators (LBs) are recommended to improve the quality of life. The aims of this study were to measure adherence to LBs after discharge for COPD, identify determinants of adherence, and compare amounts of variation attributable to hospitals of discharge and primary care providers, i.e. local health districts (LHDs) and general practitioners (GPs). This cohort study was based on the Lazio region population, Italy. Patients discharged in 2007-2011 for COPD were followed up for 2 years. Adherence was defined as a medication possession ratio >80%. Cross-classified models were performed to analyse variation. Variances were expressed as median odds ratios (MORs). An MOR of 1.00 stands for no variation, a large MOR indicates considerable variation. We enrolled 13,178 patients. About 29% of patients were adherent to LBs. Adherence was higher for patients discharged from pneumology wards and for patients with GPs working in group practice. A relevant variation between LHDs (MOR = 1.21, p = 0.001) and GPs (MOR = 1.28, p = 0.035) was detected. When introducing the hospital of discharge in the model, the MOR related to LHDs decreased to 1.05 (p = 0.345), MOR related to GPs dropped to 1.22 (p = 0.086), whereas MOR associated with hospitals of discharge was 1.38 (p < 0.001). Treatments with proven benefit for COPD were underused. Moreover, a relevant geographic variation was observed. This heterogeneity raises equity concerns in access to optimal care. The reduction of variability among LHDs and GPs after entering the hospital level proved that differences we observe in primary care partially 'reflect' the clinical approach of hospitals of discharge.

Adherence to evidence-based drug therapies after myocardial infarction: is geographic variation related to hospital of discharge or primary care providers? A cross-classified multilevel design.

OBJECTIVES: To measure the adherence to polytherapy after myocardial infarction (MI), to compare the proportions of variation attributable to hospitals of discharge and to primary care providers, and to identify determinants of adherence to medications. SETTING: This is a population-based study. Data were obtained from the Information Systems of the Lazio Region, Italy (5 million inhabitants). PARTICIPANTS: Patients hospitalised with incident MI in 2007-2010. OUTCOME MEASURE: The outcome was chronic polytherapy after MI. Adherence was defined as a medication possession ratio ≥0.75 for at least three of the following drugs: antiplatelets, ß-blockers, ACEI angiotensin receptor blockers, statins. DESIGN AND ANALYSIS: A 2-year cohort study was performed. Cross-classified multilevel models were applied to analyse geographic variation and compare proportions of variability attributable to hospitals of discharge and primary care providers. The variance components were expressed as median ORs MORs. If the MOR is 1.00, there is no variation between clusters. If there is considerable between-cluster variation, the MOR will be large. RESULTS: A total of 9606 patients were enrolled. About 63% were adherent to chronic polytherapy. Adherence was higher for patients discharged from cardiology wards (OR=1.56 vs other wards, p<0.001) and for patients with general practitioners working in group practice (OR=1.14 vs single-handed, p=0.042). A relevant variation in adherence was detected between local health districts (MOR=1.24, p<0.001). When introducing the hospital of discharge as a cross-classified level, the variation between local health districts decreased (MOR=1.13, p=0.020) and the variability attributable to hospitals of discharge was significantly higher (MOR=1.37, p<0.001). CONCLUSIONS: Secondary prevention pharmacotherapy after MI is not consistent with clinical guidelines. The relevant geographic variation raises equity issues in access to optimal care. Adherence was influenced more by the hospital that discharged the patient than by the primary care providers. Cross-classified models proved to be a useful tool for defining priority areas for more targeted interventions.

P.Re.Val.E.: outcome research program for the evaluation of health care quality in Lazio, Italy.

BACKGROUND: P.Re.Val.E. is the most comprehensive comparative evaluation program of healthcare outcomes in Lazio, an Italian region, and the first Italian study to make health provider performance data available to the public. The aim of this study is to describe the P.Re.Val.E. and the impact of releasing performance data to the public. METHODS: P.Re.Val.E. included 54 outcome/process indicators encompassing many different clinical areas. Crude and adjusted rates were estimated for the 2006-2009 period. Multivariate regression models and direct standardization procedures were used to control for potential confounding due to individual characteristics. Variable life-adjusted display charts were developed, and 2008-2009 results were compared with those from 2006-2007. RESULTS: Results of 54 outcome indicators were published online at http://www.epidemiologia.lazio.it/prevale10/index.php. Public disclosure of the indicators' results caused mixed reactions but finally promoted discussion and refinement of some indicators. Based on the P.Re.Val.E. experience, the Italian National Agency for Regional Health Services has launched a National Outcome Program aimed at systematically comparing outcomes in hospitals and local health units in Italy. CONCLUSIONS: P.Re.Val.E. highlighted aspects of patient care that merit further investigation and monitoring to improve healthcare services and equity.