Characteristics of ED crowding in the Lazio Region (Italy) and short-term health outcomes.

The effect of emergency department (ED) crowding on patient care has been studied for several years in the scientific literature. We evaluate the association between ED crowding and short-term mortality and hospitalization in the Lazio region (Italy) using two different measures. A cohort of visits in the Lazio region ED during 2012-2014 was enrolled. Only discharged patients were selected. ED crowding was estimated using two measures, length of stay (LOS), and Emergency Department volume (EDV). LOS was defined as the interval of time from entrance to discharge; EDV was defined at the time of each new entrance in ED. The outcomes under study were mortality and hospitalization within 7 days from ED discharge. A multivariate logistic model was performed (Odds Ratios, ORs, 95% CI). The cohort includes 2,344,572 visits. ED crowding is associated with an increased risk of short-term hospitalization using both LOS and EDV as exposures (LOS 1-2 h: OR = 1.71, 95% CI 1.66-1.76, LOS 2-5 h: OR = 1.38, 95% CI 1.34-1.43, LOS > 5 h OR = 1.45 95% CI 1.40-1.50 compared to patients with 1 h of LOS; EDV 75°-95° percentile: OR = 1.02, 95% CI 0.99-1.05 and EDV > 95° percentile: OR = 1.06, 95% CI 1.01-1.11 compared to patients with a EDV < 75° percentile upon arrival). Increased risk of short-term mortality is found with increasing level of LOS. High levels of EDV at the time of patients' arrival and longer LOS in ED are associated with greater risks of hospitalization for patients discharged 7 days before. LOS in ED is also associated with an increased risk of mortality.

The Tradeoff between Travel Time from Home to Hospital and Door to Balloon Time in Determining Mortality among STEMI Patients Undergoing PCI.

BACKGROUND: In ST-segment elevation myocardial infarction (STEMI), even in presence of short door to balloon time (DTBT), timely reperfusion with percutaneous coronary intervention (PCI) is hampered by pre-hospital delays. Travel time (TT) constitutes a relevant part of these delays and may contribute to worse outcomes. OBJECTIVE: To evaluate the relationship between TT from home to hospital and DTBT on 30-day mortality after PCI among patients with STEMI. METHODS: We enrolled a cohort of 3,608 STEMI patients with a DTBT within 120 minutes who underwent PCI between years 2009 and 2013 in Lazio Region (Italy). We calculated the minimum travel time from residential address to emergency department where the first medical contact occurred. We defined system delay as the sum of travel time and DTBT time. Logistic regression models, including clinical and demographic characteristics were used to estimate the effect of TT and DTBT on mortality. RESULTS: Among patients with 0-90 minutes of system delay, TT above the median value is positively associated with mortality (OR = 2.46; P = 0.009). Survival benefit associated with DTBT below the median results only among patients with TT below the median (OR for DTBT below the median = 0.39; P = 0.013), (OR for interaction between TT and DTBT = 2.36; p = 0.076). CONCLUSION: TT affects survival after PCI for STEMI, even in the presence of health care systems compliant with current guidelines. Results emphasize the importance of health system initiatives to reduce pre-hospital delay. Utilization of TT can contribute to a better estimate of patient mortality risk in the evaluation of quality of care.

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.

Role of Tiotropium in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease When Combined With Long-Acting ß2 -Agonists and Inhaled Corticosteroids: The OUTPUL Study.

Combined inhaled therapy in chronic obstructive pulmonary disease (COPD) is commonly used, but its benefits remain controversial. We assessed the effect of tiotropium in reducing COPD exacerbations when combined with long-acting ß2 agonists (LABA) and/or inhaled corticosteroids (ICS). This new-user cohort study is based on administrative data from 3 Italian regions. We identified adults hospitalized for COPD from 2006 to 2009 who were newly prescribed a fixed LABA/ICS combination (double therapy). We classified patients according to whether tiotropium was also prescribed (triple therapy), using both intention-to-treat and as-treated approaches, and followed them for 1 year. COPD exacerbations were measured as outcomes. Multivariate and propensity score-adjusted hazard ratios (HRs, 95%CI) were calculated with Cox regression models. We identified 5717 new users of LABA/ICS of which 31.9% initiated triple therapy. In the intention-to-treat analysis, the multivariate adjusted HR for moderate, severe, and any exacerbations were 1.02 (95%CI 0.89-1.16), 0.92 (95%CI 0.76-1.12), and 1.08 (95%CI 0.91-1.28), respectively. The propensity score adjustment produced similar results. In the subcohort of patients with previous exacerbations, triple therapy was significantly associated with reduced risk of moderate exacerbations, compared to double therapy (HR 0.68, 95%CI 0.48-0.98 in intention-to-treat approach). In conclusion, the addition of tiotropium to LABA/ICS did not reduce COPD exacerbations compared to LABA/ICS alone. A protective role for moderate exacerbations was found in patients at risk of frequent exacerbations. Given the impact of exacerbations on health status and prognosis, it is crucial to target COPD patients for optimal treatment.

Reliability of Modern Scores to Predict Long-Term Mortality After Isolated Aortic Valve Operations.

BACKGROUND: Contemporary scores for estimating perioperative death have been proposed to also predict also long-term death. The aim of the study was to evaluate the performance of the updated European System for Cardiac Operative Risk Evaluation II, The Society of Thoracic Surgeons Predicted Risk of Mortality score, and the Age, Creatinine, Left Ventricular Ejection Fraction score for predicting long-term mortality in a contemporary cohort of isolated aortic valve replacement (AVR). We also sought to develop for each score a simple algorithm based on predicted perioperative risk to predict long-term survival. METHODS: Complete data on 1,444 patients who underwent isolated AVR in a 7-year period were retrieved from three prospective institutional databases and linked with the Italian Tax Register Information System. Data were evaluated with performance analyses and time-to-event semiparametric regression. RESULTS: Survival was 83.0% ± 1.1% at 5 years and 67.8 ± 1.9% at 8 years. Discrimination and calibration of all three scores both worsened for prediction of death at 1 year and 5 years. Nonetheless, a significant relationship was found between long-term survival and quartiles of scores (p < 0.0001). The estimated perioperative risk by each model was used to develop an algorithm to predict long-term death. The hazard ratios for death were 1.1 (95% confidence interval, 1.07 to 1.12) for European System for Cardiac Operative Risk Evaluation II, 1.34 (95% CI, 1.28 to 1.40) for the Society of Thoracic Surgeons score, and 1.08 (95% CI, 1.06 to 1.10) for the Age, Creatinine, Left Ventricular Ejection Fraction score. CONCLUSIONS: The predicted risk generated by European System for Cardiac Operative Risk Evaluation II, The Society of Thoracic Surgeons score, and Age, Creatinine, Left Ventricular Ejection Fraction scores cannot also be considered a direct estimate of the long-term risk for death. Nonetheless, the three scores can be used to derive an estimate of long-term risk of death in patients who undergo isolated AVR with the use of a simple algorithm.

The effect of early surgery after hip fracture on 1-year mortality.

BACKGROUND: Hip fracture injuries are identified as one of the most serious healthcare problems affecting older people. Many studies have explored the associations among patient characteristics, treatment processes, time to surgery and various outcomes in patients hospitalized for hip fracture. The objective of the present study is to evaluate the difference in 1-year mortality after hip fracture between patients undergoing early surgery (within 2 days) and patients undergoing delayed surgery in Italy. METHODS: Observational, retrospective study based on the Hospital Information System (HIS). This cohort study included patients aged 65 years and older who were residing in Italy and were admitted to an acute care hospital for a hip fracture between 1 January 2007 and 31 December 2012. A multivariate Cox regression analysis was used to assess the effect of early surgery on the likelihood of 1-year mortality after hip fracture, adjusting for risk factors that could affect the outcome under study. The absolute number of deaths prevented by exposure to early surgery was calculated. RESULTS: We studied a total of 405,037 admissions for hip fracture. Patients who underwent surgery within 2 days had lower 1-year mortality compared to those who waited for surgery more than 2 days (Hazard Ratios -HR-: 0.83; 95 % CI: 0.82-0.85). The number of deaths prevented by the exposure to early surgery was 5691. CONCLUSIONS: This study is the first to evaluate the association between time to surgery and 1-year mortality for all Italian elderly patients hospitalized for hip fracture. The study confirmed the previous reports on the association between delayed surgery and increased mortality and complication rates in elderly patients admitted for hip fracture. Our data support the notion that deviating from surgical guidelines in hip fracture is costly, in terms of both human life and excess hospital stay.

Impact of off-pump coronary artery bypass grafting on long-term percutaneous coronary interventions.

OBJECTIVES: The debate regarding the advantages and limitations of off-pump versus on-pump coronary artery bypass grafting (CABG) has yet to be resolved. This study was designed to compare the impact of surgical technique on long-term mortality and subsequent revascularization. METHODS: The Predicting Long-Term Outcomes After Isolated Coronary Artery Bypass Surgery (PRIORITY) project was designed to evaluate the long-term outcomes of 2 large, prospective multicenter cohort studies on CABG conducted in Italy between 2002 and 2004 and in 2007 and 2008. Clinical data on isolated CABG were compiled from 2 administrative databases. RESULTS: The study population consisted of 11,021 patients who underwent isolated CABG (27.2% off-pump CABG). Surgical strategy did not affect in-hospital mortality. Multivariate logistic regression demonstrated that on-pump CABG was the only factor that protected from in-hospital percutaneous coronary intervention after surgery (odds ratio, 0.61). Although unadjusted long-term survival was significantly worse for off-pump CABG, adjustment did not confirm off-pump CABG as a risk factor for mortality (hazard ratio, 0.96; 95% confidence interval, 0.87-1.06). The on-pump CABG group had a significantly lower hospitalization for subsequent percutaneous coronary intervention, a finding confirmed even with adjustment for confounding factors (hazard ratio, 0.70; 95% confidence interval, 0.62-0.80; P < .001). Off-pump CABG thus carried a 42% higher risk for subsequent percutaneous coronary intervention than on-pump CABG. The incidence of repeat CABG was similar between groups. CONCLUSIONS: This study demonstrated that off-pump OPCAB did not affect short- and long-term mortality, but it was a significant risk factor for rehospitalization for percutaneous coronary intervention.

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.

Adherence to antiplatelet therapy after percutaneous coronary intervention: a population study in a region of Italy.

AIMS: We evaluated adherence to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for patients in the Lazio region of Italy and the impact of discharge ward type on therapy discontinuation. METHODS: From the Hospital Information System, we selected patients who underwent PCI from 2006 to 2007 and obtained Regional Drug Dispense Registry data for antiplatelet drugs prescribed for 12 months after discharge. Appropriate therapy was defined as DAPT with prescribed daily doses for each drug covering at least 75% of each individual follow-up period. The association between discharge ward type and antiplatelet therapy adherence at 12 months post discharge was estimated using multilevel logistic regression analysis. RESULTS: A total of 11 186 patients with PCI were included, and fewer than half (4984; 44.56%) were on adequate DAPT. Only 2930 of 5390 patients (54.36%) with DAPT in the first 6 months post discharge continued DAPT in the second 6 months. Patients discharged from cardiology units or intensive coronary care units were more likely (odds ratio = 1.26; P = 0.003) to receive appropriate antiplatelet therapy, and elderly patients were less likely (odds ratio = 0.65; P < 0.001) to do so. CONCLUSION: The proportion of PCI patients receiving appropriate DAPT after discharge is suboptimal in this region, and elderly patients are less likely to receive appropriate therapy. These findings could be important for improving patient management and ensuring adherence to clinical guidelines and indicate the need for a systematic evaluation of the appropriateness of postdischarge therapy.

Using clinical variables and drug prescription data to control for confounding in outcome comparisons between hospitals.

BACKGROUND: Hospital discharge records are an essential source of information when comparing health outcomes among hospitals; however, they contain limited information on acute clinical conditions. Doubts remain as to whether the addition of clinical and drug consumption information would improve the prediction of health outcomes and reduce confounding in inter-hospital comparisons. The objective of the study is to compare the performance of two multivariate risk adjustment models, with and without clinical data and drug prescription information, in terms of their capability to a) predict short-term outcome rates and b) compare hospitals' risk-adjusted outcome rates using two risk-adjustment procedures. METHODS: Observational, retrospective study based on hospital data collected at the regional level.Two cohorts of patients discharged in 2010 from hospitals located in the Lazio Region, Italy: acute myocardial infarction (AMI) and hip fracture (HF). Multivariate logistic regression models were implemented to predict 30-day mortality (AMI) or 48-hour surgery (HF), adjusting for demographic characteristics and comorbidities plus clinical data and drug prescription information. Risk-adjusted outcome rates were derived at the hospital level. RESULTS: The addition of clinical data and drug prescription information improved the capability of the models to predict the study outcomes for the two conditions investigated. The discriminatory power of the AMI model increases when the clinical data and drug prescription information are included (c-statistic increases from 0.761 to 0.797); for the HF model the increase was more slight (c-statistic increases from 0.555 to 0.574). Some differences were observed between the hospital-adjusted proportion estimated using the two different models. However, the estimated hospital outcome rates were weakly affected by the introduction of clinical data and drug prescription information. CONCLUSIONS: The results show that the available clinical variables and drug prescription information were important complements to the hospital discharge data for characterising the acute severity of the patients. However, when these variables were used for adjustment purposes their contribution was negligible. This conclusion might not apply at other locations, in other time periods and for other health conditions if there is heterogeneity in the clinical conditions between hospitals.

Differential misclassification of confounders in comparative evaluation of hospital care quality: caesarean sections in Italy.

BACKGROUND: Despite extensive studies on exposure and disease misclassification, few studies have investigated misclassification of confounders. This study aimed to identify differentially misclassified confounders in a comparative evaluation of hospital care quality and to quantify their impact on hospital-specific risk-adjusted estimates, focusing on the appropriateness of caesarean sections (CS). METHODS: We gathered data from the Hospital Information System in Italy for women admitted in 2005-2010. We estimated adjusted proportions of CS with logistic regression models. Among several confounders, we focused on high fetal head at term (HFH), which is seldom objectively documentable in medical records. RESULTS: A total of 540 maternity units were compared. The median HFH prevalence was 0.9%, ranging from 0 to 70%. In some units, HFH was coded so frequently that it was unlikely to reflect a natural heterogeneity. This "over-coding" was conditional on the outcome because it occurred more frequently for women that underwent CS. This suggested an opportunistic coding to justify the choice of a CS. HFH misclassification was not randomly distributed over Italy; it had an excess in the Campania region where, in some units, the proportion of HFHs gradually increased from 2005 to 2010 (e.g., from 0 to 26%), but the national average remained constant (2.5%). The inclusion of the misclassified diagnosis in the models favored those hospitals that codified in a less-than-fair manner. CONCLUSIONS: Our findings emphasized the importance of rigorously inspecting for differential misclassification of confounders. Their validity may be subject to substantial heterogeneity over hospitals, over time and geographical areas.

Does public reporting improve the quality of hospital care for acute myocardial infarction? Results from a regional outcome evaluation program in Italy.

OBJECTIVE: To evaluate whether public reporting of performance data was associated with a change over time in quality indicators for acute myocardial infarction (AMI) in Italian hospitals. DESIGN: Pre-post evaluation of AMI indicators in the Lazio region, before and after disclosure of the Regional Outcome Evaluation Program, and a comparative evaluation versus other Italian regions not participating in the program. SETTING/DATA SOURCES: Nationwide Hospital Information System and vital status records. PARTICIPANTS: 24 800 patients treated for AMI in Lazio and 39 350 in the other regions. INTERVENTION: Public reporting of the Regional Outcome Evaluation Program in the Lazio region. MAIN OUTCOME MEASURE: Risk-adjusted indicators for AMI. RESULTS: The proportion of ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary interventions (PCI) within 48 h in Lazio changed from 31.3 to 48.7%, before and after public reporting, respectively (relative increase 56%; P < 0.001). In the other regions, the proportion increased from 51.5 to 58.4% (relative increase 13%; P < 0.001). Overall 30-day mortality and 30-day mortality for patients treated with PCI did not improve during the study period. The 30-day mortality for STEMI patients not treated with PCI in Lazio was significantly higher in 2009 (29.0%) versus 2006/07 (24.0%) (P = .002). CONCLUSIONS: Public reporting may have contributed to increasing the proportion of STEMI patients treated with timely PCI. The mortality outcomes should be interpreted with caution. Changes in AMI diagnostic and coding systems should also be considered. Risk-adjusted quality indicators represent a fundamental instrument for monitoring and potentially enhancing quality of care.

Use patterns of long-acting bronchodilators in routine COPD care: the OUTPUL study.

BACKGROUND: COPD is the fourth leading cause of death in the world. In the case of exacerbations or persistent symptoms, regular treatment with long-acting bronchodilators is recommended to control the symptoms, reduce exacerbations and improve health status. Objectives. To describe patterns of drug utilization among patients diagnosed with COPD, to measure continuity with long-acting bronchodilators, to identify determinants of not receiving long-acting therapy continuously. METHODS: We identified a cohort of patients discharged from hospital with diagnosis of COPD between 2006 and 2008. Patients were observed for a two-year follow-up period, starting from the day of discharge. Follow-up was segmented in six-month periods, in order to dynamically evaluate prescription patterns of Long-Acting Beta-Agonists (LABA), tiotropium, and inhaled corticosteroids. Patients with prescriptions for LABA and/or tiotropium in each of the six-month periods were defined as "continuously treated with long-acting bronchodilators." The degree of drug treatment coverage was measured through the Medication Possession Ratio (MPR). Logistic regression was performed to identify determinants of not receiving long-acting bronchodilators continuously. RESULTS: A total of 11,452 patients diagnosed with COPD were enrolled. Only 34.8% received long-acting bronchodilators continuously. The MPR was greater than 75% in 19.6% of cases. Among the determinants of not receiving long-acting bronchodilators continuously, older age and co-morbidities played an important role. CONCLUSIONS: In clinical practice, the COPD pharmacotherapy is not consistent with clinical guidelines. Medical education is needed to disseminate evidence-based prescribing patterns for COPD, and to raise awareness among physicians and patients on the health benefits of an appropriate pharmacological treatment.

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.

Effect of evidence-based drug therapy on long-term outcomes in patients discharged after myocardial infarction: a nested case­control study in Italy.

PURPOSE: There are some methodological concerns regarding results from observational studies about the effectiveness of evidence-based (EB) drug therapy in secondary prevention after myocardial infarction. The present study used a nested case­control approach to address these major methodological limitations. METHODS: A cohort of 6880 patients discharged from hospital after acute myocardial infarction (AMI) in 2006­2007 was enrolled and followed-up throughout 2009. Exposure was defined as adherence to each drug in terms of the proportion of days covered (cutoff ≥ 75%). Composite treatment groups, that is, groups with no EB therapy or therapy with one, two, three, or four EB drugs), were analyzed. Outcomes were overall mortality and reinfarction. Nested case­control studies were performed for both outcomes, matching four controls to every case (841 deaths, 778 reinfarctions) by gender, age, and individual follow-up. The association between exposure to EB drug therapy and outcomes was analyzed using conditional logistic regression, adjusting for revascularization procedures, comorbidities, duration of index admission, and use of the study drugs prior to admission. RESULTS: Mortality and reinfarction risk decreased with the use of an increasing number of EB drugs. Combinations of two or more EB drugs were associated with a significant protective effect (p < 0.001) versus no EB drugs (mortality: 4 EB drugs: ORadj = 0.35; 95%CI: 0.21­0.59; reinfarction: 4 EB drugs: ORadj = 0.23; 95%CI: 0.15­0.37). CONCLUSIONS: These findings of the beneficial effects of EB polytherapy on mortality and morbidity in a population-based setting using a nested case­control approach strengthen existing evidence from observational studies.

Thirty-day complications after laparoscopic or open cholecystectomy: a population-based cohort study in Italy.

OBJECTIVE: The objective of the study is to evaluate short-term complications after laparoscopic (LC) or open cholecystectomy (OC) in patients with gallstones by using linked hospital discharge data. DESIGN: Population-based cohort study. SETTING: Data were obtained from the Regional Hospital Discharge Registry Lazio Region in Central Italy (around 5 million inhabitants) in 2007-2008. PARTICIPANTS: All patients admitted to hospitals of Lazio with symptomatic gallstones (International Classification of disease, 9th Revision, Clinical Modification (ICD-9-CM)=574) who underwent LC (ICD-9-CM 51.23) or OC (ICD-9-CM 51.22). OUTCOME MEASURES: (1)'30-day surgical-related complications' defined as any complication of the biliary tract (including postoperative infection, haemorrhage or haematoma or seroma complicating a procedure, persistent postoperative fistula, perforation of bile duct and disruption of wound). (2) '30-day systemic complications' defined as any complications of other organs (including sepsis, infections from other organs, major cardiovascular events and selected adverse events). RESULTS: 13 651 patients were included; 86.1% had LC, 13.9% OC. 2.0% experienced surgical-related complications (SRC), 2.1% systemic complications (SC). The OR of complications after LC versus OC was 0.60 (p<0.001) for SRC and 0.52 (p<0.001) for SC. In relation to SRC, the advantage of LC was consistent across age categories, severity of gallstones and previous upper abdominal surgery, whereas there was no advantage among people with emergency admission (OR=0.94, p=0.764). For SC, no significant advantage of LC was seen among very old people (OR=0.99, p=0.975) and among those with previous upper abdominal surgery (OR=0.86, p=0.905). CONCLUSIONS: This large observational study confirms that LC is more effective than OC with respect to 30-day complications. Population-based linkage of administrative datasets can enlarge evidence of treatment benefits in clinical practice.