Epidemiologic Health Impact Assessment: Estimation of Attributable Cases and Application to Decision Making.

OBJECTIVES: The epidemiologic Health Impact Assessment (eHIA) process is receiving growing attention in Italy. In the context of such an approach, the present paper has three objectives: to review the computational aspects of eHIA for stressing strengths and weaknesses of methods and formulas; to discuss which rate at baseline could be used for the estimation of attributable cases; how to use the results of eHIA to make decisions regarding the realization of industrial projects. METHODS AND RESULTS: Using a linear formulation of the relationship between exposure and disease occurrence: a) formulas have been derived to compute attributable cases (AC) using both Relative Risk (RR) and Excess Risk (ER) approaches; b) a discussion is made of the use as baseline rate of the rate that is caused by all the risk factors for a particular disease and a suggestion is made to use the rate that is caused simply by the risk factors that are under evaluation; c) under assumptions and approximations that must be validated in any specific situation, formulas are derived to compute Incremental Lifetime Cumulative Risk (ILCR), an indicator that can be used to compare the results coming from the eHIA approach with the levels of action used by USEPA and others (10-6, 10-5, 10-4). -Conclusion: In this paper, the methodology and the formulas commonly used in eHIA have been enlarged to consider the case in which the baseline rate is equal to zero, suggesting to use Excess Risk (ER) estimates instead of Relative Risk (RR) estimates. Using different baseline rates produces very different estimates of AC, and work needs to be done on this topic. Lastly, due to assumptions, approximations, and uncertainty of eHIA computations, prudence and caution should be exercised in using eHIA results in decision making, particularly if hard decisions have to be made.

Cinacalcet adherence in dialysis patients with secondary hyperparathyroidism in Lombardy Region: clinical implications and costs.

BACKGROUND: Patients on dialysis often have secondary hyperparathyroidism (SHPT), a disorder associated with renal osteodystrophy, progressive vascular calcification, cardiovascular disease, and death. The objective of this retrospective observational study was to evaluate, in dialysis patients with SHPT, the impact of different levels of adherence to cinacalcet therapy on hospitalisations and direct healthcare costs charged to the Lombardy Regional Health Service (Italy). METHODS: Data recorded in the administrative databases on all citizens undergoing dialysis between 1 January 2011 and 31 December 2011 were selected. For the aim of this study, patients with SHPT already on dialysis in the first 6 months of 2009 who had been treated with cinacalcet for at least 365 days were selected and retrospectively analysed through to end of 2012. Healthcare resource utilisation, cinacalcet adherence, and costs for medication, hospitalisations, and diagnostic/therapeutic procedures were estimated. RESULTS: A total of 994 patients were identified (mean age 63.0 years, females 43.5%). The first patient tertile had an adherence to cinacalcet of <64.1%, whereas the third had an adherence of over 91.5%. Patients in the third adherence tertile experienced fewer all-causes hospitalisations than those in the first tertile (-19.2%; p=0.01423), fractures (-37.1%; p=0.59422), cardiovascular disease (-23.8%; p=0.04025), and sepsis (-32.3%; p=0.01386). The increase in costs for cinacalcet-adherent patients is almost completely offset by the reduction in costs for hospitalisations. CONCLUSIONS: The results of the analysis suggest that there may be some correlation between a high level of cinacalcet adherence and a decrease in hospitalisations.

Real-world data on healthcare resource consumption and costs before and after kidney transplantation.

End-stage renal disease (ESRD) is increasing worldwide as a consequence of population aging and increasing chronic illness. Treatment consists mostly of dialysis and kidney transplantation (KTx), and KTx offers advantages for life expectancy and long-term cost reductions compared with dialysis. This study uses the administrative database of the Lombardy Region to analyze the costs of a cohort of patients with ESRD receiving KTx, covering a time period of 24 months before transplant to 12 months after. During 2011, 276 patients underwent kidney transplantation (8.7% preemptive and 91.3% non-preemptive). In the period before transplantation, the main cost driver was dialysis (66.6% for the period from -24 to -12 months and 73.8% for the period from -12 to 0 months), while in the 12 months after KTx, the most relevant cost was surgery. The total cost -24 to -12 months pre-KTx was 35 049.2€; the cost -12 to 0 months was 36 745.9€; and the cost 12 months after KTx was 43 805.8€. Non-preemptive patients showed much higher costs both pre- and post-KTx than preemptive patients. This study highlights how KTx modifies the resource consumption and costs composition of patients with ESRD vs those undergoing dialysis treatment and how KTx may be economically beneficial, especially preemptive intervention.

Healthcare costs of the progression of chronic kidney disease and different dialysis techniques estimated through administrative database analysis.

BACKGROUND: Chronic kidney disease (CKD) progression is associated with significant comorbidities and costs. In Italy, limited evidence of healthcare resource consumption and costs is available. We therefore aimed to investigate the direct healthcare costs in charge to the Lombardy Regional Health Service (RHS) for the treatment of CKD patients in the first year after starting hemodialysis and in the 2 years prior to dialysis. METHODS: Citizens resident in the Lombardy Region (Italy) who initiated dialysis in the year 2011 (Jan 1 to Dec 31) were selected and data were extracted from Lombardy Regional databases on their direct healthcare costs in the first year after starting dialysis and in the 2 years prior to it was analyzed. Drugs, hospitalizations, diagnostic procedures and outpatient costs covered by RHS were estimated. Patients treated for acute kidney injury, or who died or stopped dialysis during the observational period were excluded. RESULTS: From the regional population (>9,700,000 inhabitants), 1067 patients (34.3 % females) initiating dialysis were identified, of whom 82 % underwent only hemodialysis (HD), 13 % only peritoneal dialysis (PD) and the remaining 5 % both treatments. Direct healthcare costs/patient were € 5239, € 12,303 and € 38,821 (€ 40,132 for HD vs. € 30,444 for PD patients) for the periods 24-12 months pre-dialysis, 12-0 months pre-dialysis, and in the first year of dialysis, respectively. CONCLUSIONS: This study highlights a significant economic burden related to CKD and an increase in direct healthcare costs associated with the start of dialysis, pointing to the importance of prevention programs and early diagnosis.

Antihypertensive drug use during pregnancy: a population based study.

PURPOSE: The study aimed at assessing if the European guideline on the use of antihypertensive drugs (AD) in pregnancy are followed in clinical practice. We also evaluated the association between the use of non-recommended drugs and individual characteristics. METHODS: This study analyzed a cohort of 86 171 singleton deliveries occurring between 2009-2010 in the Lombardy region, Italy. Women with first prescription of AD during pregnancy were considered as incident users. Methyldopa, labetalol and nifedipine were considered as "recommended drugs"; all other AD were considered as "non-recommended". Odds Ratio and 95% confidence intervals were estimated. RESULTS: Among the 1009 patients (1.2%) exposed to AD during pregnancy, 675 (66.9%) were incident users. Among the incident users, 31% received non-recommended drugs; this proportion decreased to 18% among women who started treatment in the third trimester. Women with at least four concomitant diseases had an elevated risk of receiving non-recommended drugs in pregnancy (OR 2.68; 95% CI 1.10-6.73). CONCLUSIONS: Exposure to recommended antihypertensives increased during pregnancy. Nevertheless, a fraction of users that continued or began treatment with non-recommended medications was still present.

Hospitalization rates and cost in severe or complicated obesity: an Italian cohort study.

BACKGROUND: The economic and social costs of obesity are estimated to be considerable, particularly for inpatient care. The aim of this study was to compare the hospitalization rates of individuals with severe (body mass index [BMI] ≥40 kg/m2) or complicated (BMI ≥30 kg/m2) obesity with those of the general population in two regions of Northwest Italy, and to describe absolute costs of hospitalization and their determinants. METHODS: Between 1996 and 2002, 6,516 patients who were admitted for the first time to a hospital offering a nutritional rehabilitation programme for obesity were enrolled and followed-up (mean follow-up time: 7.3 years). Standardized hospitalization rates (SHRs) were computed by sex for all-cause and cause-specific hospitalization. The general population of the two regions was used as the reference population. The annual cost of hospitalization was estimated for the study cohort only at the individual level, and its association with different determinants was assessed using a multivariable linear model for longitudinal data. RESULTS: SHRs of the study cohort versus the general population increased for all-cause hospitalization (males: 3.53, 95% CI 3.45-3.61; females: 3.22, 95% CI 3.18-3.26) as well as for most obesity-related conditions. The absolute median annual cost of hospitalization was 2,436 euros for males and 2,293 euros for females. Older age at cohort enrolment, BMI ≥40 kg/m2, waist circumference above the median (males: 1.26 metres; females: 1.13 metres), and the presence of co-morbidities, such as cardiovascular diseases, respiratory diseases, cancer, diseases of the musculoskeletal system and connective tissue, and mental disorders, significantly increased the absolute median annual costs of hospitalization. CONCLUSIONS: The economic consequences of high hospitalization rates in obese individuals are relevant. Reducing the occurrence of co-morbidities among obese persons may be one important goal, not only for clinical reasons, but also from a public health point of view.

Which community care for patients with schizophrenic disorders? Packages of care provided by Departments of Mental Health in Lombardy (Italy).

AIMS: The treatment of schizophrenic disorders is the most important challenge for community care. The analysis focuses on packages of care provided to 23.602 patients with a ICD-10 diagnosis of schizophrenic disorder and treated in 2001 by the Departments of Mental Health in Lombardy, Italy. METHODS: Packages of care refer to a mix of treatments provided to each patient during the year by different settings. Direct costs of the packages were calculated. Linear Discriminant Analysis has been used to link socio-demographic and diagnostic sub-groups of the patients to packages of care. RESULTS: People with schizophrenic disorders received relatively few care packages: only four packages involved more than 5%. Two thirds of the patients received only care provided by Community Mental Health Centres. In the other two packages with a percentage over 5%, the activity was provided by CMHCs, jointly with General Hospitals or Day Care Facilities. Complex care packages were rare (only 6%). As well as the intensity, also the variety of care provided by CMHCs increased with the complexity of care packages. In Lombardy more than half of the resources were spent for schizophrenia. The range of the costs per package was very wide. LDA failed to link characteristics of the patients to packages of care. CONCLUSIONS: Care packages are useful tools to understand better how mental health system works, how resources have been spent and to point out problems in the quality of care.

[ALEE-AO: epidemiologic and economic atlas of hospital activities in Lombardy]. / ALEE-AO: atlante Lombardo epidemiologico ed economico delle attività ospedaliere.

This paper describes the main characteristics of a data processing system that is available through the Internet and that is used to process epidemiological and economic data, predominantly from a geographical viewpoint, starting from the hospital discharge abstracts of the Lombardy Region. Technical aspects of the system are briefly reviewed, including epidemiological-statistical aspects (incidence, prevalence, variety of diagnoses, indicators, controlling for statistical variability, etc.) and aspects relating to information systems (hardware platform, software environment, Internet access and security problems, original database, etc). The system introduces several methodological innovations in the processing of hospital discharge abstracts (such as links between data files, evaluation of activity of each individual GP, and analysis of patient mobility), proposes three successive levels of case selection (time, geography, nosology) prior to statistical analysis which is performed starting from the information on each individual discharge abstract. Finally, several examples are given and critical aspects, as well as prospects of the system, are discussed.