EASY-NET Program: Effectiveness of an Audit and Feedback Intervention in the Emergency Care for Acute Conditions in the Lazio Region.

The EASY-NET network program (NET-2016-02364191)-effectiveness of audit and feedback (A&F) strategies to improve health practice and equity in various clinical and organizational settings), piloted a novel and more structured A&F strategy. This study compared the effectiveness of the novel strategy against the sole periodic dissemination of indicators in enhancing the appropriateness and timeliness of emergency health interventions for patients diagnosed with acute myocardial infarction (AMI) and ischemic stroke in the Lazio Region. The efficacy of the intervention was assessed through a prospective quasi-experimental design employing a pre- and post-intervention (2021-2022) comparison with a control group. Participating hospitals in the Lazio Region, where professional teams voluntarily engaged in the intervention, constituted the exposed group, while the control group exclusively engaged in routine reporting activities. Effectiveness analysis was conducted at the patient level, utilizing regional health information systems to compute process and outcome indicators. The effectiveness of the intervention was evaluated using difference-in-difference models, comparing pre- and post-intervention periods between exposed and control groups. Estimates were calculated in terms of the difference in percentage points (PP) between absolute risks. Sixteen facilities for the AMI pathway and thirteen for the stroke pathway participated in the intervention. The intervention yielded a reduction in the proportion of 30-day readmissions following hospitalization for ischemic stroke by 0.54 pp in the exposed patients demonstrating a significant difference of -3.80 pp (95% CI: -6.57; -1.03; 5453 patients, 63.7% cases) in the exposed group compared to controls. However, no statistically significant differences attributable to the implemented A&F intervention were observed in other indicators considered. These results represent the first evidence in Italy of the impact of A&F interventions in an emergency setting, utilizing aggregated data from hospitals involved in the Lazio Region's emergency network.

EASY-NET Program: Methods and Preliminary Results of an Audit and Feedback Intervention in the Emergency Care for Acute Myocardial Infarction in the Lazio Region, Italy.

Within the EASY-NET network program (NET-2016-02364191), Work Package 1 Lazio evaluates the effectiveness of a structured audit and feedback (A&F) intervention compared with the web-based regional periodic publication of indicators in improving the appropriateness and timeliness of emergency healthcare for acute myocardial infarction (AMI). This work describes the A&F methodology and presents the results of the first feedback delivered. The intervention involves sending periodic reports via e-mail to participating hospitals. The feedback reports include a set of volume and quality (process and outcome) indicators, calculated by facility through the health information system of the Lazio Region and compared with regional mean, target values and values calculated for hospitals with similar volumes of activity. Health managers and clinicians of each participating hospital represent the "feedback recipients". They are invited to organize clinical and organizational audit meetings to identify possible critical issues in the care pathway and define, where necessary, improvement actions. A total of 16 facilities are involved. Twelve facilities present high volumes in all volume indicators, while three facilities present low volumes for each indicator. Concerning the quality indicators, four facilities do not present critical indicators or had average results, three facilities do not present critical indicators but show average results in at least one of the indicators and six facilities present a critical value for at least one of the indicators. The first report highlighted some critical issues in some facilities on several indicators. During the audit meetings, each facility analyzes these issues, defining appropriate improvement actions. The outcome of these actions will be monitored through subsequent reporting to support the continuous care quality improvement process.

Pattern of care of brain tumor patients in the last months of life: analysis of a cohort of 3045 patients in the last 10 years.

BACKGROUND: End-of-life in patients with brain cancer presents special challenges, and palliative care approach is underutilized. Patients with brain cancer, in the last months of life, receive frequent hospital readmissions, highlighting bad end-of-life care quality. Early integration of palliative care improves quality of care in advanced stage of disease and patient's quality of death. PURPOSE: We retrospectively analyzed a consecutive series of patients with brain cancer discharged after diagnosis to evaluate pattern of treatment and rate of hospital readmission in the last months of life. DESIGN: Data were collected from the Lazio Region Healthcare database. SETTING: Adult patients discharged with diagnosis ICD-9 191.* between January 1, 2010, and December 31, 2019 were included. RESULTS: A total of 6672 patients were identified, and 3045 deaths were included. In the last 30 days 33% were readmitted to the hospital and 24.2% to the emergency room. 11.7% were treated with chemotherapy and 6% with radiotherapy. Most indicators of end-of-life care showed wide variability by hospital of discharge. CONCLUSIONS: Strategies to improve quality of care at the end of life and to decrease re-hospitalization and futile treatments are becoming increasingly important to improve quality of death and reduce healthcare costs. Variability observed by hospital of discharge indicates the lack of a standard approach to end-of-life care.

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The National Outcomes Evaluation Programme in Italy: The Impact of Publication of Health Indicators.

In Italy the National Outcomes Evaluation Programme, (P.N.E.) is the most comprehensive comparative evaluation of healthcare outcomes at the national level. The aim of this report is to describe the P.N.E. and some of the most relevant results achieved. The P.N.E. analysed 184 indicators on quality of care in 2015-2020 period. The data sources are the Italian Health Information Systems. The indicators reported were: proportion of surgery within 2 days after hip fracture in the elderly (HF), 30-day mortality after hospital admission for acute myocardial infarction (AMI), proportion of reoperations within 90 days of breast-conserving surgery and proportion of primary caesarean deliveries. Risk adjustment methods were used to take into account patients' characteristics. From 2010 to 2020 the proportion of interventions within 2 days after HF increased from 31.3% to 64.6%, the AMI 30-day mortality decreased from 10.4% to 8.3%, the proportion of reinterventions within 90 days of breast-conserving surgery decreased from 12.0% to 5.9% and the proportion of primary caesarean deliveries decreased from 28.4% to 22.7%. Results by area of residence showed heterogeneity of healthcare quality. We observed a general improvement in different clinical areas not always associated with a reduction of heterogeneity among areas of residence.

The impact of the SARS COV-2 pandemic on pediatric accesses in ED: A Healthcare Emergency Information System analysis.

BACKGROUND: The Emergency Department (ED) services play a fundamental role in managing the accesses of potential Sars-Cov-2 cases. The aim of this study is to evaluate the impact of the SARS COV-2 pandemic on pediatric accesses in Emergency Department of Lazio Region. METHODS: The population includes all pediatric accesses (0-17 years) in the ED of Lazio Region during 2019 and 2020. Accesses were characterized by age, week and calendar period. Four periods were defined: pre-lockdown, lockdown, post-lockdown and the second wave. The trend of ED accesses (total or for specific cause) in 2020 (by period and week) were compared to them occurred in 2019. ED visits have been described by absolute frequency and percentage variation. Percentage variation of adult was also reported to compare the trend in adult and young population. The Chi-square test was used to compare characteristics of admissions in 2019 and 2020. RESULTS: There is a large decrease of pediatric accesses in 2020 compared to 2019 (-47%), especially for younger age-classes (1-2 years: -52.5% and 3-5 years: -50.5%). Pediatric visits to ED in 2020 decreased following the same trend of adults, but more drastically (-47% vs -30%). ED accesses for suspected COVID-19 pneumonia trend show different characteristics between children and adults: in adults there is an increase in 2020, especially during the 2nd wave period (+321%), in children there is a decrease starting from the lockdown period to the achievement of the lowest level in December 2020 (-98%). CONCLUSIONS: This descriptive study has identified a decrease of total pediatric accesses in ED in 2020 compared to 2019 and a different trend of accesses by adult and young population especially by cause. The monitoring of paediatric accesses could be a useful tool to analyse the trend of COVID-19 pandemic in Italy and to reprogramming of the healthcare offer according to criteria of clinical and organizational appropriateness.

The Impact of the COVID-19 Pandemic on the Neck of the Femur and Hip Fracture Surgery Volumes in the Lazio Region.

This study compares surgery volumes for fractures of the neck of the femur (FNF) and hip replacements during the COVID-19 pandemic compared with previous years. Historical (2018-2019) and pandemic (2020-2021) surgery rates for FNF and hip replacement in Lazio, adjusted for age and gender, were calculated per period and compared with a Poisson regression model. For hip replacement surgery, a comparison of different types of hospitals was also made. Before COVID-19's spread, no difference was found in the volume of surgery of both interventions. From the lockdown to the end of 2021, a decrease in surgery volumes for FNF with stabilization between summer 2020 and summer 2021, as well as an additional decline beginning at the start of Omicron's spread, were found. Hip replacement surgeries showed a greater decline during the lockdown period and increased during summer 2020 and during the Delta wave period. The increment in hip replacements, mainly observed in 2021, is due to private and religious hospitals. These results highlight that the pandemic emergency, caused by SARS-CoV-2, has had an important indirect effect on the population's health assistance in the field of orthopedics.

Audit and Feedback in the Hospitals of the Emergency Networks in the Lazio Region, Italy: A Cross-Sectional Evaluation of the State of Implementation.

Audit and Feedback (A&F) is an effective multidimensional strategy for improving the quality of care. The optimal methods for its implementation remain unclear. This study aimed to map the state of art of A&F strategies in the hospitals involved in a time-dependent emergency network. For these purposes, a structured questionnaire was defined and discussed within the research group. This consists of 29 questions in three sections: (1) characteristics of the structure, (2) internal feedback systems, and (3) external feedback systems. All structures involved in the network were invited to participate in the e-survey by indicating a Health Management representative and a clinical representative for the Cardiovascular (CaV) and/or for the Cerebrovascular area (CeV). Of 20 structures invited, a total of 13 (65%) responded to the survey, 11 for the CaV area and 8 for the CeV area. A total of 10 of 11 (91%) facilities for the CaV area and 8/11 (75%) for the CeV area reported that they perform A&F activities. All facilities perform at least one of the activities defined as "assimilating A&F procedures." The most frequent is the presentation and discussion of clinical cases (82% CaV and 88% CeV) and the least is the identification of responsible for improvement actions (45% CaV and 38% CeV). In 4/10 (40%) facilities for the CaV area and 4/8 (50%) for the CEV area, corrective actions are suggested or planned when the feedback is returned. These results confirm the need to define, in a synergistic way with the relevant stakeholders, an effective and agreed A&F intervention to improve the level of implementation of A&F strategies.

Increase in Tuberculosis Diagnostic Delay during First Wave of the COVID-19 Pandemic: Data from an Italian Infectious Disease Referral Hospital.

BACKGROUND: The WHO advised that the impact of COVID-19 pandemic on TB services was estimated to be dramatic due to the disruption of TB services. METHODS: A retrospective data collection and evaluation was conducted to include all the patients hospitalized for TB at INMI from 9 March to 31 August 2020 (lockdown period and three months thereafter). For the purpose of the study, data from patients hospitalized in the same period of 2019 were also collected. RESULTS: In the period of March-August 2019, 201 patients were hospitalized with a diagnosis of TB, while in the same period of 2020, only 115 patients, with a case reduction of 43%. Patients with weight loss, acute respiratory failure, concurrent extrapulmonary TB, and higher Timika radiographic scores were significantly more frequently hospitalized during 2020 vs. 2019. The median patient delay was 75 days (IQR: 40-100) in 2020 compared to 30 days (IQR: 10-60) in 2019 (p < 0.01). Diagnostic delays in 2020 remain significant in the multiple logistic model (AOR = 6.93, 95%CI: 3.9-12.3). CONCLUSIONS: Our experience suggests that COVID-19 pandemic had an impact on TB patient care in terms of higher diagnostic delay, reduction in hospitalization, and a greater severity of clinical presentations.

Evaluation of the breast cancer care network within the Lazio Region (Central Italy).

BACKGROUND AND OBJECTIVES: A summary indicator for evaluating the breast cancer network has never been measured at the regional level. The aim is to design treemaps providing a summary description of hospitals (including breast units) and Local Health Units (LHUs) in terms of their levels of performance within the breast cancer network of the Lazio region (central Italy). The treemap structure has an intuitive design and displays information from both general and specific analyses. METHODS: Patients admitted to the regional hospitals for malignant breast cancer (MBC) surgery in 2010-2017 were selected in a population-based cohort study. These quality indicators were calculated based on the international guidelines (EUSOMA, ESMO) to assess the performance in terms of volume of activity, surgery procedure, post-surgery assistance and timeliness of medical therapy or radiotherapy beginning. The quality indicators were calculated using administrative health data systematically collected at the regional level and were included in the treemap to represent the surgery or the post-surgery areas of the breast cancer clinical pathway. In order to allow aggregation of scores for different indicators belonging to the same clinical area, up to five evaluation classes were defined using the "Jenks Natural Breaks" algorithm. A score and a colour were assigned to each clinical area based on the ranking of the indicators involved. The analyses were performed on an annual basis, by the LHU of residence and by the hospital which performed the surgical intervention. RESULTS: In 2017, 6218 surgical interventions for MBC were performed in the hospitals of Lazio. The results showed a continuous increase of the level of performance over the years. Hospitals showed higher variability in the levels of performance than the LHUs. 36% of the evaluated hospitals reached a high level of performance. An audit of the S. Filippo Neri breast unit revealed incorrect coding of the input data. For this reason, the score for the indicator for the volume of wards was re-calculated and re-evaluated, with a subsequent improvement of the level of performance. Most LHUs achieved at least an average overall level of performance, with 20% of the LHUs reaching a high level of performance. CONCLUSIONS: This is the first attempt to apply the treemap logic to a single clinical network, in order to obtain a summary indicator for the evaluation of the breast cancer care network. Our results supply decision makers with a transparent instrument of governance for heterogeneous users, directing efforts improving and promoting equity of care. The treemaps could be reproduced and adapted for other local contexts, in order to limit inappropriateness and ensure uniform levels of breast cancer care within local areas. The next step is the evaluation of audit and feedback interventions to improve the quality of care and to guarantee homogeneous levels of care throughout the region.

[Access to the Emergency Department in the time of COVID-19: an analysis of the first three months in the Lazio Region (Central Italy)]. / L'accesso al pronto soccorso ai tempi del COVID-19: un'analisi dei primi tre mesi nella regione Lazio.

OBJECTIVES: to evaluate the impact of the SARS-CoV-2 epidemic on the access to the emergency services of the Lazio Region (Central Italy) for time-dependent pathologies, for suspected SARS-CoV-2 symptoms, and for potentially inappropriate conditions. DESIGN: observational study. SETTING AND PARTICIPANTS: accesses to the emergency departments (EDs) of Lazio Region hospitals in the first three months of 2017, 2018, 2019, and 2020. MAIN OUTCOME MEASURES: total number of accesses to the emergency room and number of specific accesses for cardio and cerebrovascular diseases, for severe trauma, for symptoms, signs, and ill-defined conditions, and for symptoms related to pneumonia. RESULTS: in the first 3 months of 2019, there were 429,972 accesses to the EDs of Lazio Region; in the same period of 2020, accesses arise to 353,806, (reduction of 21.5%), with a 73% reduction in the last three weeks of march 2020 as compared with the corresponding period of 2019. Comparing the first 3 months of the 2017-2019 with 2020, the accesses for acute coronary syndrome and acute cerebrovascular disease decreased since the 10th week up to more than 57% and 50%, respectively. The accesses due to symptoms, signs, and ill-defined conditions, proxy of potentially inappropriate conditions, decreased since the 8th week, with a maximum reduction of 70%. Access to severe trauma decreased by up to 70% in the 11th week. The accesses for pneumonia increased up to a 70% increment in the 12th week. CONCLUSIONS: the evaluation of accesses to emergency services during the SARS-CoV-2 epidemic can provide useful elements for the promotion and improvement of the planning, for the management of critical situations, and for the reprogramming of the healthcare offer based on clinical and organizational appropriateness.

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.

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.

Neonatal outcomes following new reimbursement limitations on palivizumab in Italy.

OBJECTIVE: To evaluate the impact of new reimbursement decisions for palivizumab treatment on respiratory syncytial virus (RSV) hospitalisations and the concomitant number of palivizumab prescriptions for infants aged <2 years. DESIGN: We compared the RSV hospitalisation rates in infants before and after implementation of new limitations during three RSV seasons 2014-2017. SETTING: Population aged <2 years at the beginning of each RSV seasons extracted from regional health systems (Lazio region, 2016, 5 898 124 inhabitants and 47 595 births). PATIENTS: Out of 70 323 infants, 5895 (8.4%) premature babies (gestational age (GA) <37 weeks) were followed before-after Italian Medicines Agency (AIFA)-2016 limitations. INTERVENTION: In 2016, AIFA, following the American Academy of Pediatrics guidelines, decided to limit coverage of palivizumab prophylaxis (GA ≤29 weeks). MAIN OUTCOMES MEASURES: Trend of hospitalisations by months and rate of RSV before-after new restrictions were analysed. Palivizumab prescriptions and costs for National Health Service (NHS) were considered. RESULTS: In a population of 284 902 aged <2 years, the number of hospitalisations due to RSV infection was 1729. Following AIFA-2016 limitations, a reduction in the number of RSV infection-based hospitalisations from 6.3/1000 (95% CI 6.0 to 6.7) to 5.5/1000 (95% CI 5.0 to 5.9) was observed. Palivizumab showed a concomitant reduction of 48% in the number of prescriptions (saving €750 000 for the NHS). No differences of GA, age on admission or severity of RSV infection were observed. CONCLUSIONS: Implementation of the new palivizumab reimbursement criteria was not associated with an increase in the RSV hospitalisation rate for children aged <2 years despite a significant reduction in the number of palivizumab prescriptions.

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

BACKGROUND Improving quality and effectiveness of healthcare is one of the priorities of health policies. Hospital or physician volume represents a measurable variable with an impact on effectiveness of healthcare. An Italian law calls for the definition of «qualitative, structural, technological, and quantitative standards of hospital care¼. There is a need for an evaluation of the available scientific evidence in order to identify qualitative, structural, technological, and quantitative standards of hospital care, including the volume of care above or below which the public and private hospitals may be accredited (or not) to provide specific healthcare interventions. OBJECTIVES To identify conditions/interventions for which an association between volume and outcome has been investigated. To identify conditions/interventions for which an association between volume and outcome has been proved. To analyze 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 National Health Service (NHS). METHODS Systematic review An overview of systematic reviews was performed searching PubMed, EMBASE, and The Cochrane Library up to November 2016. Studies were evaluated by 2 researchers independently; quality assessment was performed using the AMSTAR checklist. For each health condition and outcome, if available, total number of studies, participants, high volume cut-off values, and metanalysis have been reported. According to the considered outcomes, health topics were classified into 3 groups: positive association: a positive association was demonstrated in the majority of studies/participants and/or a pooled measure (metanalysis) with positive results was reported; lack of association: both studies and/or metanalysis showed no association; 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. Analysis of the distribution of Italian hospitals by volume of activity and the association between volume of activity and outcomes: the Italian National Outcome evaluation Programme 2016 The analyses were performed using the Hospital Information System and the National Tax Register (year 2015). For each condition, the number of hospitals by volume of activity was calculated. Hospitals with a volume lower than 3-5 cases/year were excluded. For conditions with more than 1,500 cases/year and frequency of outcome ≥1%, the association between volume of care and outcome was analyzed estimating risk-adjusted outcomes. RESULTS Bibliographic searches identified 80 reviews, evaluating 48 different clinical areas. The main outcome considered was intrahospital/30-day mortality. The other outcomes vary depending on the type of condition or intervention in study. The relationship between hospital volume and outcomes was considered in 47 out of 48 conditions: 34 conditions showed evidence of a positive association; • 14 conditions consider cancer surgery for bladder, breast, colon, rectum, colon rectum, oesophagus, kidney, liver, lung, ovaries, pancreas, prostate, stomach, head and neck; • 11 conditions consider cardiocerebrovascular area: nonruptured and ruptured abdominal aortic aneurysm, acute myocardial infarction, brain aneurysm, carotid endarterectomy, coronary angioplasty, coronary artery bypass, paediatric heart surgery, revascularization of lower limbs, stroke, subarachnoid haemorrhage; • 2 conditions consider orthopaedic area: knee arthroplasty, hip fracture; • 7 conditions consider other areas: AIDS, bariatric surgery, cholecystectomy, intensive care unit, neonatal intensive care unit, sepsis, and traumas; for 3 conditions, no association was demonstrated: hip arthroplasty, dialysis, and thyroidectomy. for the remaining 10 conditions, the available evidence does not allow to draw firm conclusions about the association between hospital volume and considered outcomes: surgery for testicular cancer and intracranial tumours, paediatric oncology, aortofemoral bypass, cardiac catheterization, appendectomy, colectomy, inguinal hernia, respiratory failure, and hysterectomy. The relationship between volume of clinician/surgeon and outcomes was assessed only through the literature re view; to date, it is not possible to analyze this association for Italian health provider hospitals, since information on the clinician/surgeon on the hospital discharge chart is missing. The literature found a positive association for 21 conditions: 9 consider surgery for cancer: bladder, breast, colon, colon rectum, pancreas, prostate, rectum, stomach, and head and neck; 5 consider the cardiocerebrovascular area: ruptured and nonruptured abdominal aortic aneurysm, carotid endarterectomy, paediatric heart surgery, and revascularization of the lower limbs; 2 consider the orthopaedic area: knee and hip arthroplasty; 5 consider other areas: AIDS, bariatric surgery, hysterectomy, intensive care unit, and thyroidectomy. The analysis of the distribution of Italian hospitals concerned the 34 conditions for which the systematic review has shown a positive volume-outcome association. For the following, it was possible to conduct the analysis of the association using national data: unruptured abdominal aortic aneurysm, coronary angioplasty, hip arthroplasty, knee arthroplasty, coronary artery bypass, cancer surgery (colon, liver, breast, pancreas, lung, prostate, kidney, and stomach), laparoscopic cholecystectomy, hip fracture, stroke, acute myocardial infarction. For these conditions, the association between volume and outcome of care was observed. For laparoscopic cholecystectomy and surgery of the breast and stomach cancer, the association between the volume of the discharge (o dismissal) operating unit and the outcome was analyzed. The outcomes differ depending on the condition studied. The shape of the relationship is variable among different conditions, with heterogeneous slope of the curves. DISCUSSION For many conditions, the overview of systematic reviews has shown a strong evidence of association between higher volumes and better outcomes. The quality of the available reviews can be considered good for the consistency of the results between the studies and for the strength of the association; however, this does not mean that the included studies are of good quality. Analyzing national data, potential confounders, including age and comorbidities, 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 to higher volumes) for most 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 further improve. However, a good knowledge of the relationship between effectiveness of treatments and costs, the geographical distribution and the accessibility to healthcare services are necessary to choose the minimum volumes of care, under which specific health procedures could not been provided in the NHS. Some potential biases due to the use of information systems data should also be considered. The different way of coding among hospitals could lead to a different selection of cases for some conditions. Regarding the definition of the exposure (volume of care), a possible bias could result from misclassification of health providers with high volume of activity. 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. For the conditions with a further fragmentation within the same structure, the association between volumes of discharge department and outcomes has also been evaluated. In this case, the two curves were different. The limit is to attribute the outcome to the discharge unit, which in case of surgery may not be the intervention unit. A similar bias could occur if the main determinant of the outcome of treatment was the caseload of each surgeon. The results of the analysis may be biased when different operators in the same hospital/unit carried out the same procedure. In any case, the observed association between volumes and outcome is very strong, and it is unlikely to be attributable to biases of the study design. Another aspect on which there is still little evidence is the interaction between volume of the hospital and of the surgeon. A MEDICARE study suggests that in some conditions, especially for specialized surgery, the effect of the surgeon's volume of activity is different depending on the structure volume, whereas it would not differ for some less specialized surgery conditions. The data here presented still show extremely fragmented volumes of both clinical and surgical areas, with a predominance of very low volume structures. Health systems operate, by definition, in a context of limited resources, especially when the amount of resources to allocate to the health system is reduced. In such conditions, the rationalization 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 providers with high volume of activity can help to reduce differences in the access to non-effective procedures. To produce additional evidence to guide the reorganization of the national healthcare system, it will be necessary to design further primary studies to evaluate the effectiveness and safety of policies aimed at concentrating interventions in structures with high volumes of activity.

The Effect on Total Mortality of Adding Inhaled Corticosteroids to Long-Acting Bronchodilators for COPD: A Real Practice Analysis in Italy.

PURPOSE: Chronic therapy with long-acting bronchodilators (LB) is recommended to treat moderate-to-severe COPD. Although the benefits of adding inhaled corticosteroid (ICS) to LB are still unclear, patients who experience repeated exacerbations are suggested to add ICS to their LB treatment. The objective of this study is to analyze whether adding ICS to LB therapy reduces mortality. METHODS: We identified a cohort of patients discharged from hospital with COPD diagnosis between 2006 and 2009. The first prescription for LB or ICS following discharge was defined as the index prescription. Only new users were included (no use of any study drug in the 6 months before treatment). A 4-day time window was used to classify patients into "LB alone" or "LB plus ICS" initiators. We used propensity score to balance the study groups. Sensitivity analyses were performed in patients with recent out-of-hospital exacerbations. RESULTS: Among the 18615 adults enrolled, 12207 initiated "LB plus ICS" therapy and 6408 "LB alone." Crude mortality rates were 110 and 143 cases per 1000 person-years in the "LB plus ICS" and "LB alone" groups, respectively. The adjusted hazard ratio (HR) was 0.83 (95% CI: 0.72-0.97; p-value: 0.024). When analyzing patients with recent out-of-hospital exacerbations, the benefit of the combination therapy was more pronounced, HR = 0.63 (95% CI: 0.44-0.90; p-value: 0.012). DISCUSSION: Our findings showed a beneficial effect on mortality of adding inhaled corticosteroids to long-acting bronchodilators. The advantage was much more pronounced in patients with frequent exacerbations.

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.

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.