[More equity in Lazio region health care: results from the Regional Outcome Evaluation Program (PReValE), 2012-2017]. / Accesso alle cure più equo nella regione Lazio: risultati del Programma regionale di valutazione degli esiti (PReValE) 2012-2017.

OBJECTIVES: to evaluate equity in the Lazio regional Health System, both in terms of unequal access to health care among individuals with different educational levels and of heterogeneity in hospital performance, between 2012 and 2017. DESIGN: retrospective cohort study. SETTING AND PARTICIPANTS: all patients living in Lazio region and discharged from a regional facility between 2012 and 2017 were enrolled. Three cohorts of hospitalizations were selected: acute myocardial infarctions with ST segment elevation (STEMI), hip fractures, and deliveries. MAIN OUTCOME MEASURES: the proportions of STEMIs with PCI within 90 minutes, of patients with a hip fracture who underwent surgery within 2 days, and of deliveries with primary caesarean section were evaluated, accounting for patient demographic characteristics and comorbidities that could affect the outcome under study. These proportions were calculated by education and by hospital of admission. The heterogeneity among facilities was assessed through the median odds ratio (MOR). RESULTS: in Lazio region, between 2012 and 2017, an improvement of the quality of care was observed: in 2017, 50.4% of STEMI patients underwent to a PCI within 90 minutes, 54.4% of patients with a hip fracture underwent surgery within 2 days, and 26.2% of women had a C-section. In 2012, when comparing the adjusted proportions of outcomes by educational level, the probability of being treated with a PCI within 90 minutes for STEMIs and with surgery within 2 days for hip fractures was higher for graduated patients than for those with the lowest education. In contrast, graduated women had the highest risk of having a C-section. In 2017, there was no difference anymore between classes of education in STEMIs and C-sections, while in patients with hip fracture the difference was decreased, but still present. For hip fractures, a reduction of heterogeneity of hospital performances was also detected. CONCLUSION: in Lazio region, a reduction in inequalities in access to health care was observed for different clinical areas. The "public disclosure" of the PReValE results and the management strategy applied in mid-2013 could have driven the overall improvement of the health system for the conditions under study, helping to achieve a fairer access to health.

Vaginal birth after caesarean birth in Italy: variations among areas of residence and hospitals.

BACKGROUND: The rates of caesarean section (CS) are increasing globally. CS rates are one of the most frequently used indicators of health care quality. Vaginal Birth After Caesarean (VBAC) could be considered a reasonable and safe option for most women with a previous CS. Despite this fact, in some European countries, many women who had a previous CS will have a routine CS subsequently and VBAC rates are extremely variable across countries. VBAC use is inversely related to caesarean use. The objective of the present study was to analyze VBAC rates with respect to caesarean rates and the variations among areas of residence, hospitals and hospital ownership types in Italy. METHODS: This study was based on information from the Hospital Information System (HIS). We collected data from all deliveries in Italy from January 1, 2010 to December 31, 2014 and we considered only deliveries with a previous caesarean section. Applying multivariate logistic regression analysis, the adjusted proportions of VBAC for each Local Health Units (LHU), each hospital and by hospital ownership types were calculated. Cross-classified logistic multilevel models were performed to analyze within geographic, hospitals and hospital ownership types variations. RESULTS: We studied a total of 77,850 deliveries with a previous caesarean section in Italy between January 1, 2010 and December 31, 2014. The proportion of VBAC in Italy slightly increased in the last few years, from 5.8% in 2010 to 7.5% in 2014. Proportions of VBAC ranged from 0.29 to 50.05% in Italian LHUs. The LHUs with lower proportions of VBAC deliveries were characterized by higher values for primary caesarean deliveries. Private hospitals showed the lowest mean of crude VBAC proportions but the highest variation among hospitals, ranging from 0 to 47.1%. CONCLUSIONS: Hospital rates of caesarean section for women with at least one previous caesarean section vary widely, and only some of the variation can be explained by case-mix and hospital-level factors, suggesting that additional factors influence practices. Identifying disparities in VBAC may have important implications for health services planning and targeted efforts to reduce overall rates of caesarean deliveries.

Regional Outcome Evaluation Program (P.Re.Val.E.): Reduction of inequality in access to effective health care in the Lazio region of Italy (2012-2015).

BACKGROUND: Inequalities in health among groups of various socio-economic status (as measured by education, occupation, and income) constitute one of the main challenges for public health. Since 2006, the Lazio Regional Outcome Evaluation Program (P.Re.Val.E.), presents a set of indicators of hospital performance based on quality standards driven by strong clinical recommendations, and measures the variation in the access to effective health care for different population groups and providers in the Lazio Region. One of the aims of the program was to compare population subgroups in order to promote equity in service provision. Since June 2013, a new management strategy has been put in place that assigned specific goals based on performance assessment to the chief executive officers of the hospitals. AIM: To evaluate whether, in recent years, there has been a reduction in the differential access to effective health care, among individuals with different educational levels. METHODS: We enrolled all patients discharged from both public and private hospitals of the Lazio region between 2012 and 2015, living in Lazio region. We analysed the proportion of patients with ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention within 90 minutes (primary PCI), the proportion of patients with hip fracture (HF) who underwent surgery within 2 days, and the proportion of women with primary C-section. We applied multivariate logistic regression models to assess the effect of educational level on health outcomes, adjusting for demographic characteristics and comorbidities that could affect the outcomes. For each year of the study period, we compared adjusted proportions of outcomes for the highest and the lowest level of education by using percentage differences. RESULTS: In the Lazio region, 44.6% of STEMI patients (N = 3,299) were treated with primary PCI, 54.4% of patients with hip fractures (N = 6,602) underwent surgery within 2 days, and 27.7% of women without a previous C-section (N = 34,718) delivered via C-section, in 2015. The corresponding proportions in 2012 were 27.8%, 31.3% and 31.5%, respectively. By comparing the adjusted proportions in patients with the highest education level (a university degree or higher) to those with the lowest level education level (None/Primary school), a decrease in the percentage difference was observed during the study period. In STEMI and delivery cohorts, the improvement of outcomes involved the least and the most educated patients, respectively, and the difference between the two educational levels was close to zero in 2015, whereas for hip patients, the improvement was more evident among the less educated patients. CONCLUSIONS: In the Lazio region, we observed a reduction in the differential access to effective heath care by educational level, in different clinical areas. Different factors might explain these results. On top of the public disclosure of outcome data, the management strategy applied in mid-2013 might have driven the overall improvement of the health system for the considered conditions, helping to achieve a fairer access to health.

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.

The Impact of EuroSCORE II Risk Factors on Prediction of Long-Term Mortality.

BACKGROUND: The European System for Cardiac Operation Risk Evaluation (EuroSCORE) II has not been tested yet for predicting long-term mortality. This study was undertaken to evaluate the relationship between EuroSCORE II and long-term mortality and to develop a new algorithm based on EuroSCORE II factors to predict long-term survival after cardiac surgery. METHODS: Complete data on 10,033 patients who underwent major cardiac surgery during a 7-year period were retrieved from three prospective institutional databases and linked with the Italian Tax Register Information System. Mortality at follow-up was analyzed with time-to-event analysis. RESULTS: The Kaplan-Meier estimates of survival at 1 and 5 were, respectively, 95.0% ± 0.2% and 84.7% ± 0.4%. Both discrimination and calibration of EuroSCORE II decreased in the prediction of 1-year and 5-year mortality. Nonetheless, EuroSCORE II was confirmed to be an independent predictor of long-term mortality with a nonlinear trend. Several EuroSCORE II variables were independent risk factors for long-term mortality in a regression model, most of all very low ejection fraction (less than 20%), salvage operation, and dialysis. In the final model, isolated mitral valve surgery and isolated coronary artery bypass graft surgery were associated with improved long-term survival. CONCLUSIONS: The EuroSCORE II cannot be considered a direct estimator of long-term risk of death, as its performance fades for mortality at follow-up longer than 30 days. Nonetheless, it is nonlinearly associated with long-term mortality, and most of its variables are risk factors for long-term mortality. Hence, they can be used in a different algorithm to stratify the risk of long-term mortality after surgery.

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.

The impact of time-window bias on the assessment of the long-term effect of medication adherence: the case of secondary prevention after myocardial infarction.

OBJECTIVES: Time-window bias was described in case-control studies and led to a biased estimate of drug effect. No studies have measured the impact of this bias on the assessment of the effect of medication adherence on health outcomes. Our goals were to estimate the association between adherence to drug therapies after myocardial infarction (MI) and the incidence of a new MI, and to quantify the error that would have been produced by a time-window bias. SETTING: This is a population-based study. Data were obtained from the Regional Health Information Systems of the Lazio Region in Central Italy (around 5 million inhabitants). PARTICIPANTS: Patients discharged after MI in 2006-2007 were enrolled in the cohort and followed through 2009. OUTCOME MEASURE: The study outcome was reinfarction: either mortality, or hospital admission for MI, whichever occurred first. DESIGN: A nested case-control study was performed. Controls were selected using both time-dependent and time-independent sampling. Adherence to antiplatelets, ß-blockers, ACE inhibitors/angiotensin receptor blockers (ACEI/ARBs) and statins was calculated using the proportion of days covered (PDC). RESULTS: A total of 6880 patients were enrolled in the cohort. Using time-dependent sampling, a protective effect was detected for all study drugs. Conversely, using time-independent sampling, the beneficial effect was attenuated, as in the case of antiplatelet agents and statins, or completely masked, as in the case of ACEI/ARBs and ß-blockers. For ACEI/ARBs, the time-dependent approach produced ORs of 0.83 (95% CI 0.57 to 1.21) and 0.72 (0.55 to 0.95), respectively, for '0.5 < PDC ≤ 0.75' and 'PDC>0.75' versus '0 ≤ PDC ≤ 0.5'. Using the time-independent approach, the ORs were 0.96 (0.65 to 1.43) and 1.00 (0.76 to 1.33), respectively. CONCLUSIONS: A time-independent definition of a time-dependent exposure introduces a bias when the length of follow-up varies with the outcome. The persistence of time-related biases in peer-reviewed papers strongly suggests the need for increased awareness of this methodological pitfall.

[Socioeconomic position and appropriate antiplatelet therapy after percutaneous coronary intervention: a population-based cohort study in Rome (Lazio Region, Central Italy)]. / Posizione socioeconomica e aderenza alla terapia antiaggregante post angioplastica coronarica: uno studio epidemiologico a Roma.

OBJECTIVES: to evaluate the association between socioeconomic position (SEP) and adherence to appropriate antiplatelet therapy (AAT) after percutaneous coronary intervention (PCI) in the year following the discharge. DESIGN: according to scientific guidelines, AAT for PCI patients consists of Clopidogrel for a minimum of 1 month and ideally up to 12 months after discharge, and with Acetylsalicylic Acid (ASA) indefinitely. For each patient, drug claims over a 1-year period after discharge were retrieved from Regional Drug Dispense Registry. Drug use was measured with Proportion of Days Covered (PDC). PDC was computed dividing the total number of dispensed Defined Daily Dose by each patient's follow-up time. Dual antiplatelet therapy with PDC ≥75% and single therapy based on Clopidogrel with PDC ≥75% were considered as AAT. We used a composite area-based index of socioeconomic position by census block of residence built using the 2001 census of Rome, assuming 5 levels (from 1 =High SEP to 5 =Low SEP). SETTING AND PARTICIPANTS: study population of 5,901 patients resident in Rome, who underwent their first PCI during 2006-2007 were selected from the Hospital Information System. MAIN OUTCOME MEASURES: proportions of patients treated with AAT by SEP was measured for the overall year and by semester. The association between SEP and adherence to AAT was estimated through logistic regression models adjusting for factors selected by a stepwise procedure (gender, age, comorbidities, discharged from cardiology or coronary care unit, new user of antiplatelet drugs). RESULTS: 76% of the study population were men, 96% were aged more than 44 years, and 63% belonged to medium-low SEP. In the 1-year follow-up, the proportion of patients adherent to appropriate antiplatelet therapy was 65%; SEP was associated with AAT (OR high vs. low SEP 1.26; 95%CI 1.05-1.51; p trend =0.002). CONCLUSIONS: during the year after discharge, adherence to AAT of PCI patients was unsatisfactory and it decreased overtime more in medium-low SEP patients than in high SEP patients. Strategies to improve adherence to AAT among patients who underwent PCI need to be identified taking into account the multifactorial nature of poor medication adherence, and in particular patients' socioeconomic position.

The impact of a pay-for-performance system on timing to hip fracture surgery: experience from the Lazio Region (Italy).

BACKGROUND: A tariff modulation mechanisms has been introduced in some Italian regions with the aim of reducing inappropriate admissions and improving quality of care. In response to a regional act, hospitals in Lazio adopted a clinical pathway for elderly patients with hip fracture and introduced a compensation system based on the quality of health care, as in a pay-for-performance model. The objective of the present study was to compare the proportion of surgery for hip fracture performed within 48 hours of admission among Lazio hospitals according to different payment systems, before and after the implementation of the regional act. METHODS: A retrospective cohort study of patients aged 65 years and over, residing in the Lazio region and admitted to an acute care hospital for hip fracture before (1 July 2008 - 30 June 2009) and after (1 July 2010 - 30 June 2011) the pay-for-performance act. The proportion of surgeries performed within 48 h of hospital arrival was calculated. An adjusted multivariate regression analysis was applied to assess the effect of hospital payment type on the likelihood of surgery within 48 h of hospital arrival. RESULTS: The share of patients with hip fracture that had surgery within 48 hours was 11.7% before the introduction of the pay-for-performance act and 22.2% after. The proportion of early hip fracture operations increased after the pay-for-performance act, regardless of hospital payment type. The largest increase of surgery within 48 h occurred in private hospitals (adjusted Relative Risk = 2.80, p < 0.001). CONCLUSIONS: The introduction of a compensation system based on health care quality is associated with improved quality of care for elderly patients with hip fracture, especially in hospitals that only use the Diagnosis Related Group system.

[Volume and health outcomes: evidence from systematic reviews and from evaluation of Italian hospital data]. / Volumi di attività ed esiti delle cure: prove scientifiche dalla letteratura e dalle valutazioni empiriche in Italia.

BACKGROUND: Improving quality and effectiveness of health care is one of the priorities of health policies. Hospital or physician volume represents a measurable variable with a relevant impact on effectiveness of health care. A recent Italian law, the "spending review", calls for the definition of "qualitative, structural, technological and quantitative standards of hospital care". There is a need for an accurate evaluation of the available scientific evidence in order to identify these standards, including the volume of care above or below which the public and private hospitals may be accredited (or not) to provide specific health care interventions. Since 2009, the National Outcomes Programme evaluates outcomes of care of the Italian hospitals; nowadays it represents an official tool to assess the National Health System (NHS). In addition to outcome indicators, the last edition of the Programme (2013) includes a set of volume indicators for the conditions with available evidence of an association between volume and outcome. The assessment of factors, such as volume, that may affect the outcomes of care is one of its objectives. OBJECTIVES: To identify clinical conditions or interventions for which an association between volume and outcome has been investigated. To identify clinical conditions or interventions for which an association between volume and outcome has been proved. To analyse the distribution of Italian health providers by volume of activity. To measure the association between volume of care and outcomes of the health providers of the Italian NHS. METHODS: Systematic review. An overview of systematic reviews and Health Technology Assessment (HTA) reports performed searching electronic databases (PubMed, EMBASE, Cochrane Library), websites of HTA Agencies, National Guideline Clearinghouse up to February 2012. Studies were evaluated for inclusion by two researchers independently; the quality assessment of included reviews was performed using the AMSTAR checklist. For each health condition and for each outcome considered, total number of studies, participants, high volume cut-off values (range, average and median) have been reported, where presented. Number of studies (and participants) with statistically significant positive association and metanalysis performed were also reported, if available. Analysis of the distribution of Italian hospitals by volume of activity and the association between volume of activity and outcomes. Outcomes National Programme 2011 The analyses were performed using the Hospital Information System and the National Tax Register pertaining the year 2011. For each condition, the number of hospitals by volume of activity was calculated. Hospitals with a volume of activity lower than 3-5 cases/year for the condition under study were excluded from the analysis. For conditions with more than 1,500 cases per year and frequency of outcome ≥ 3%, the association between volume of care and outcome was analysed. For these conditions, risk-adjusted outcomes were estimated according to the selection criteria and the statistical methodology of the National Outcome Programme. RESULTS: The systematic reviews identified were 107, of which 47, evaluating 38 clinical areas, were included. Many outcomes were assessed according to the clinical condition/procedure considered. The main outcome common to all clinical condition/procedures was intrahospital/30-day mortality. Health topics were classified in the following groups according to this outcome: Positive association: a statistically significant positive association was demonstrated in the majority of studies/participants and/or a pooled measure (metanalysis) with positive results was reported. Lack of association: no association was demonstrated in the majority of studies/participants and/or no metanalysis with positive results was reported. No sufficient evidence of association: both results of single studies and metanalysis do not allow to draw firm conclusions on the association between volume and outcome. Evidence of a positive association between volumes and intrahospital/ 30-day mortality was demonstrated for 26 clinical areas: AIDS, abdominal aortic aneurysm (ruptured and unruptured), coronary angioplasty, myocardial infarction, knee arthroplasty, coronary artery bypass, cancer surgery (breast, lung, colon, colon rectum, kidney, liver, stomach, bladder, oesophagus, pancreas, prostate); cholecystectomy, brain aneurysm, carotid endarterectomy, hip fracture, lower extremity bypass surgery, subarachnoid haemorrhage, neonatal intensive care, paediatric heart surgery. For 2 clinical conditions (hip arthroplasty and rectal cancer surgery) no association has been reported. Due to a lack of evidence, it was not possible to draw firm conclusion for 10 clinical areas (appendectomy, colectomy, aortofemoral bypass, testicle cancer surgery, cardiac catheterization, trauma, hysterectomy, inguinal hernia, paediatric oncology). The relationship between volume of clinician and outcomes has been assessed only through the literature review; to date, it is not possible to analyse this association for Italian health providers hospitals, since information on the clinician/surgeon on the hospital discharge chart is missing. The literature found a positive association for: AIDS, coronary angioplasty, unruptured abdominal aortic aneurysm, hip arthroplasty, coronary artery bypass, cancer surgery (colon, stomach, bladder, breast, oesophagus), lower extremity bypass surgery. The analysis of the distribution of Italian hospitals per volume of activity concerned the 26 conditions for which the systematic review has shown a positive association between volume of activity and intrahospital/30-day mortality. For the following conditions it was possible to conduct the analysis of the association between volume and outcome of treatment using national data: unruptured abdominal aortic aneurysm, coronary angioplasty, knee arthroplasty, coronary artery bypass, cancer surgery (colon, pancreas, lung, prostate, stomach, bladder), laparoscopic cholecystectomy, endarterectomy, hip fracture and acute myocardial infarction. For them, the association between volume and outcome of care has been observed. The shape of the relationship is variable among different conditions, with heterogeneous "slope" of the curves. DISCUSSION For many conditions, the systematic review of the literature has shown a strong evidence of association between higher volumes and better outcomes. Due to the difficulty to test such an association in randomized controlled studies, the studies included in the reviews were mainly observational studies: however, the quality of the available evidence can be considered good both for the consistency of the results between the studies and for the strength of the association. Where national data had sufficient statistical power, this association has been observed by the empirical analysis conducted on the health providers of the NHS in 2011. Analysing national data, potential confounders, including age and the presence of comorbidities in the admission under study and in the admissions of the two previous years, have been considered. The systematic review of the literature does not permit to identify predefined volume thresholds. The analysis of national data shows a strong improvement in outcomes in the first part of the curve (from very low volumes to higher volumes) for the majority of the studied conditions. In some cases the improvement in outcomes remains gradual or constant with the increasing volume of care, in other the analysis could allow the identification of threshold values beyond which the outcome does not improve further. However, a good knowledge of the relationship between effectiveness of treatments and their costs, the geographical distribution and the accessibility to health care services are necessary to choose the minimum volumes of care, under which specific health procedures in the NHS should not be provided. Some potential biases due to the use of information systems data should also be taken into account. In particular, it is necessary to consider possible selection bias due to the different way of coding among hospitals that could lead to a different selection of cases for some conditions (e.g. acute myocardial infarction), less likely to occur in the selection of cases for oncologic, orthopaedic, vascular, abdominal, and cardiac surgery. Regarding the definition of the exposure (volume of care), a possible bias could result from misclassification of health providers with high volume of activity. In fact, performing the intervention in different departments/units of the same hospital would result in an overestimation of the volume of care measured for hospital rather than for department/unit. A similar bias could occur if the main determinant of the outcome of treatment was the case load of each surgeon: the results of the analysis may be biased when the same procedure was carried out by different operators in the same hospital/unit. In any case, the observed association between volumes of care and outcome is very strong, and it is unlikely to be attributable to biases of the study design. However, the foreseen bias is likely to be non-differential, and, therefore, it would eventually lead to an underestimation of the true association between volume of care and outcome. Health systems operate, by definition, in a context of limited resources, especially when societies and governments choose to reduce the amount of resources to allocate to the health system. In such conditions, the rationalisation of the organization of health services based on the volume of care may make resources available to improve the effectiveness of interventions. The identification and certification of services and provider with high volume of activity can help to reduce differences in the access to noeffective procedures.

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.

Effects of socioeconomic position on 30-day mortality and wait for surgery after hip fracture.

OBJECTIVE: In countries where the National Health Service provides universal health coverage, socioeconomic position should not influence the quality of health care. We examined whether socioeconomic position plays a role in short-term mortality and waiting time for surgery after hip fracture. DESIGN: Retrospective cohort study. SETTING: and participants From the Hospital Information System database, we selected all patients, aged at least 65 years and admitted to acute care hospitals in Rome for a hip fracture between 1 January 2006 and 30 November 2007. The socioeconomic position of each individual was obtained using a city-specific index of socioeconomic variables based on the individual's census tract of residence. MAIN OUTCOME MEASURES: Three different outcomes were defined: waiting times for surgery, mortality within 30 days and intervention within 48 h of hospital arrival for hip fracture. We used a logistic regression to estimate 30-day mortality and a Cox proportional hazard model to calculate hazard ratios of intervention within 48 h. Median waiting times were estimated by adjusted Kaplan-Meyer curves. Analyses were adjusted for age, gender and coexisting medical conditions. RESULTS: Low socioeconomic level was significantly associated with higher risk of mortality [adjusted relative risk (RR) = 1.51; P < 0.05] and lower risk of early intervention (adjusted RR = 0.32; P < 0.001). Socioeconomic level had also an effect on waiting times within 30 days. CONCLUSIONS: Individuals living in disadvantaged census tracts had poorer prognoses and were less likely than more affluent people to be treated according to clinical guidelines despite universal healthcare coverage.

Risk adjustment for inter-hospital comparison of primary cesarean section rates: need, validity and parsimony.

BACKGROUND: Cesarean section rates is often used as an indicator of quality of care in maternity hospitals. The assumption is that lower rates reflect in developed countries more appropriate clinical practice and general better performances. Hospitals are thus often ranked on the basis of caesarean section rates. The aim of this study is to assess whether the adjustment for clinical and sociodemographic variables of the mother and the fetus is necessary for inter-hospital comparisons of cesarean section (c-section) rates and to assess whether a risk adjustment model based on a limited number of variables could be identified and used. METHODS: Discharge abstracts of labouring women without prior cesarean were linked with abstracts of newborns discharged from 29 hospitals of the Emilia-Romagna Region (Italy) from 2003 to 2004. Adjusted ORs of cesarean by hospital were estimated by using two logistic regression models: 1) a full model including the potential confounders selected by a backward procedure; 2) a parsimonious model including only actual confounders identified by the "change-in-estimate" procedure. Hospital rankings, based on ORs were examined. RESULTS: 24 risk factors for c-section were included in the full model and 7 (marital status, maternal age, infant weight, fetopelvic disproportion, eclampsia or pre-eclampsia, placenta previa/abruptio placentae, malposition/malpresentation) in the parsimonious model. Hospital ranking using the adjusted ORs from both models was different from that obtained using the crude ORs. The correlation between the rankings of the two models was 0.92. The crude ORs were smaller than ORs adjusted by both models, with the parsimonious ones producing more precise estimates. CONCLUSION: Risk adjustment is necessary to compare hospital c-section rates, it shows differences in rankings and highlights inappropriateness of some hospitals. By adjusting for only actual confounders valid and more precise estimates could be obtained.

Toward a new payment system for inpatient rehabilitation. Part II: Reimbursing providers.

BACKGROUND: The major fault with existing reimbursement systems lies in their failure to discriminate for the effectiveness of stay, both when paying per day and when paying per episode of treatment. OBJECTIVES: We sought to define an average length of effective stay and recovery trends by impairment category, to design a prospective payment system that takes into account costs and expected recovery trends, and to compare the calculated reimbursement with the predicted costs estimated in a previous study (Saitto C, Marino C, Fusco D, et al. A new prospective payment system for inpatient rehabilitation. Part I: predicting resource consumption. Med Care. 2005;43:844-855). RESEARCH DESIGN: We considered all rehabilitation admissions from 5 Italian inpatient facilities during a 12-month period for which total cost of care had already been estimated and daily cost predicted through regression model. We ascertained recovery trends by impairment category through repeated MDS-PAC schedules and factorial analysis of functional status. We defined effective stay and daily resource consumption by impairment category and used these parameters to calculate reimbursement for the admission. We compared our reimbursement with predicted cost through regression analysis and evaluated the goodness of fit through residual analysis. RESULTS: We calculated reimbursement for 2079 admissions. The r(2) values for the reimbursement to cost correlation ranged from 0.54 in the whole population to 0.56 for "multiple trauma" to 0.85 for "other medical disorders." The best fit was found in the central quintiles of the cost and severity distributions. CONCLUSION: For each impairment category, we determined the number of days of effective hospital stay and the trends of functional gain. We demonstrated, at least within the Italian health care system, the feasibility of a reimbursement system that matches costs with functional recovery. By linking reimbursement to effective stay adjusted for trends of functional gain, we suggest it is possible to avoid both needless cuts and extensions of hospital admissions.

Toward a new payment system for inpatient rehabilitation. Part I: Predicting resource consumption.

BACKGROUND: The measures of clinical status used to predict costs must pay the most attention possible to medical conditions and clinical complexity. Length of stay (LOS), which has been used as a proxy for resource consumption, is not a direct measure of costs. Classification and regression trees, which are used in defining iso-resource groups, can be affected by overfitting and are based on a priori choices of the splitting attributes. Finally, current approaches are mainly concerned in estimating average group costs and do not attempt to estimate individual case costs. OBJECTIVES: We sought to define comprehensive measures of clinical status and detailed measures of resource consumption. We also sought to predict individual inpatient rehabilitation costs through multiple regression models. RESEARCH DESIGN: A prospective analysis was conducted of all rehabilitation cases admitted to 5 Italian inpatient facilities during a period of 12 months. All admissions underwent repeated Minimum Data Set-Post Acute Care (MDS-PAC) schedules to collect information on clinical status and treatment provided. We used factorial analysis to yield continuous variables representing clinical characteristics, and we priced treatments to obtain cost of stay. We used linear regression models to predict cost of stay and validated the model-based cost predictions by data-splitting. RESULTS: We collected 9720 MDS-PAC schedules from 2702 hospital admissions. The multivariate regression models fitted costs reasonably well with r(2) values of at least 0.34. On cross-validation, the ability of the regression models to predict cost was confirmed. CONCLUSION: We were able to estimate actual rehabilitation costs and define reliable regression models to predict costs from individual patient characteristics. Our approach identifies the contribution of any single patient characteristic to rehabilitation cost and tests the assumptions of the analysis.

Differences in access to coronary care unit among patients with acute myocardial infarction in Rome: old, ill, and poor people hold the burden of inefficiency.

BACKGROUND: Direct admission to Coronary Care Unit (CCU) on hospital arrival can be considered as a good proxy for adequate management in patients with acute myocardial infarction (AMI), as it has been associated with better prognosis. We analyzed a cohort of patients with AMI hospitalized in Rome (Italy) in 1997-2000 to assess the proportion directly admitted to CCU and to investigate the effect of patient characteristics such as gender, age, illness severity on admission, and socio-economic status (SES) on CCU admission practices. METHODS: Using discharge data, we analyzed a cohort of 9127 AMI patients. Illness severity on admission was determined using the Deyo's adaptation of the Charlson's comorbidity index, and each patient was assigned to one to four SES groups (level I referring to the highest SES) defined by a socioeconomic index, derived by the characteristics of the census tract of residence. The effect of gender, age, illness severity and SES, on risk of non-admission to CCU was investigated using a logistic regression model (OR, CI 95%). RESULTS: Only 53.9% of patients were directly admitted to CCU, and access to optimal care was more frequently offered to younger patients (OR = 0.35; 95%CI = 0.25-0.48 when comparing 85+ to >=50 years), those with less severe illness (OR = 0.48; 95%CI = 0.37-0.61 when comparing Charlson index 3+ to 0) and the socially advantaged (OR = 0.81; 95%CI = 0.66-0.99 when comparing low to high SES). CONCLUSION: In Rome, Italy, standard optimal coronary care is underprovided. It seems to be granted preferentially to the better off, even after controversial clinical criteria, such as age and severity of illness, are taken into account.