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

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

Understanding Patterns of Adherence to Antifibrotic Treatment in Idiopathic Pulmonary Fibrosis: Insights from an Italian Prospective Cohort Study.

Background: Pirfenidone and Nintedanib have significantly improved the prognosis of patients with idiopathic pulmonary fibrosis (IPF), reducing mortality risk and exacerbations. This study aimed to analyze antifibrotic treatment utilization and its association with clinical outcomes (i.e., acute exacerbation or death) during 2014-2021 in newly diagnosed IPF patients, using Healthcare Utilization Databases of the Marche Region, Italy. Methods: The first 12-month adherence to antifibrotic was estimated using the Proportion of Days Covered (PDC), defining adherence as PDC ≥ 75%. State Sequence Analysis over the initial 52 weeks of treatment was used to identify adherence patterns. The role of adherence patterns on acute exacerbations/death, adjusted by demographic, clinical features, and monthly adherence after the 52-week period (time-dependent variable), was assessed with Cox regression. Results: Among 667 new IPF cases, 296 received antifibrotic prescriptions, with 62.8% being adherent in the first year. Three antifibrotic utilization patterns emerged-high adherence (37.2%), medium adherence (42.5%), and low adherence (20.3%)-with median PDCs of 95.3%, 79.5%, and 18.6%, respectively. These patterns did not directly influence three-year mortality/exacerbation probability, but sustained adherence reduced risk over time. Conclusions: Good adherence was observed in in this population-based study, emphasizing the importance of continuous antifibrotics therapy over time to mitigate adverse outcomes.

Incidence of amyotrophic lateral sclerosis before and during the COVID-19 pandemic: evidence from an 8-year population-based study in Central Italy based on healthcare utilization databases.

BACKGROUND: Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder with a high multidimensional burden, with an obscure etiopathogenesis. METHODS: We designed a longitudinal, population-based study of people residing in Central Italy (Marche Region) who were beneficiaries of the National Health System. People with an unprecedented ALS hospitalization (335.20 ICD-9 CM) or tagged with an ALS exemption between 2014 and 2021 were considered incident cases. ALS cases residing in the region for <3 years or with an active ALS exemption or hospitalized for ALS before 2014 were excluded. We used secondary sources to identify new ALS diagnoses. The regional referral center for ALS's database was used to test the accuracy of secondary sources in detecting cases. ALS mean incidence was compared to that reported in similar studies conducted in Italy. The incidence rate trend adjusted by sex and age was evaluated using the Poisson regression model. RESULTS: We detected 425 new ALS cases (median age: 70y) in the 2014-2021 period, with a mean incidence of 3.5:100,000 py (95%CI: 3.2-3.8; M:F = 1.2), similar to that reported in similar studies conducted in Italy. No trend was observed during 2014-2019. After including 2020-2021 in the model, we observed a mean decrease in incidence of 5.8% (95% CI 2.0%; 9.5%, p = 0.003). CONCLUSION: We show a decrease in the incidence rate of ALS in Marche, during the 2014-2021 period, as a possible outcome of a delayed neurological assessment and diagnosis during the pandemic. An ad hoc developed identification algorithm, based on healthcare utilization databases, is a valuable tool to assess the health impact of global contingencies.

Role of viable but non culturable cells in patients with cystic fibrosis in the era of highly effective modulator therapy.

BACKGROUND: Lung infections antibiotic treatment in Cystic Fibrosis patients (pwCF) is often complicated by bacterial persisters, including the so-called Viable but Non Culturable (VBNC) forms, live cells undetected by the routine cultural microbiological methods. This study investigated the occurrence of VBNC cells of five CF bacterial pathogens in 94 pwCF over one year and the possible associations with the patients' clinical features. METHODS: Sputum samples, recovered at routine visits and during exacerbation episodes, were analyzed for the presence of the five pathogens by both routine culture-based assays and species-specific qPCR. VBNC cells were estimated as the difference between molecular and cultural counts and their presence was matched with the clinical data in particular the therapeutic regimens. RESULTS: All but ten pwCF showed the presence of VBNC cells at least once during the study. Pseudomonas aeruginosa and methicillin-susceptible Staphylococcus aureus were the species most frequently found in the VBNC state. Only the former showed a significant association between chronic infection and VBNC cells presence; VBNC-MSSA positive patients significantly increased overtime. The presence of non culturable bacteria was generally concurrent with poor lung functionality and more frequent pulmonary exacerbations. No significant association with modulator treatment was evidenced. CONCLUSIONS: The obtained data demonstrated the overwhelming occurrence of bacterial VBNC cells in CF lung infections, warranting a constant monitoring of pwCF and underlining the need of implementing the routine culture-based assays with culture-independent techniques. This is pivotal to understand the CF bacterial population dynamics and to efficiently contrast the lung infection progression and worsening.

Preoperative anxiety management in children. Benefits of humanoid robots: an experimental study.

Objective: The purpose of this study was to determine whether the use of a humanoid robot (Estrabot) could reduce preoperative anxiety levels in children. Methods: An experimental study was conducted at Azienda Ospedaliero Universitaria delle Marche Hospital, involving the Pediatric Surgery ward and the Operating Room (OR). Patients aged between 2 and 14 years who underwent minor surgery were included. The Instruments used were the Children's Emotional Manifestation Scale to evaluate anxiety levels, and Estrabot, a humanoid robot that interacts with people. Medical records between April and May 2023 were analyzed and the data was anonymous. The level of anxiety is extrapolated in Pediatric Surgery during the administration of oral pre-medication, and in the Operating Room, during the induction of anesthesia. Patients were divided into an intervention group treated with Estrabot, and a control group without a robot. Results: The population consists of 60 patients (86.7% male) with a median (IQR) age of 6 (4-8) years. The median (IQR) anxiety score during premedication was 7 (5-11), while the median (IQR) anxiety score during anesthesia was 6 (5-10). A significantly lower level of anxiety was reported in the Estrabot group. Patients in the Estrabot group had significantly lower anxiety levels in different age groups. Conclusion: A humanoid robot can reduce preoperative anxiety levels in children during premedication and the induction of anesthesia.

Assessing the quality of the care offer for people with personality disorders in Italy: the QUADIM project. A multicentre research based on the database of use of Mental Health services.

BACKGROUND: Italy can be viewed as a laboratory to assess the quality of mental healthcare delivered in a community-oriented system, especially for severe mental disorders, such as personality disorders. Although initiatives based on clinical indicators for assessing the quality of mental healthcare have been developed by transnational-organisations, there is still no widespread practice of measuring the quality of care pathways delivered to patients with severe mental disorders in a community-oriented system, especially using administrative healthcare databases. The aim of the study is to evaluate the quality of care delivered to patients with personality disorders taken-in-care by mental health services of four Italian regions (Lombardy, Emilia-Romagna, Lazio, Sicily). METHODS: A set of thirty-three clinical indicators, concerning accessibility, appropriateness, continuity, and safety of care, was implemented using regional healthcare utilization databases, containing data on mental health treatments and diagnosis, hospital admissions, outpatient interventions and exams and drug prescriptions. RESULTS: 31,688 prevalent patients with personality disorders treated in 2015 were identified, of whom 2,331 newly taken-in-care. One-in-10 patients received a standardized assessment, the treatment discontinuity affected half of the cases. 12.7% of prevalent patients received at least one hospitalization, 10.6% in the newly taken-in-care cohort. 6-out-of-10 patients had contact with community-services within 14 days from hospital discharge. Access to psychotherapy and psychoeducational treatments was low and delivered with a low intensity. The median of psychosocial interventions per person-year was 19.1 and 9.4, respectively, in prevalent and newly taken-in-care cases. Nearly 50% of patients received pharmacological treatments. CONCLUSIONS: Healthcare utilization databases were used to systematically evaluate and assess service delivery across regional mental health systems; suggesting that in Italy the public mental health services provide to individuals with personality disorders suboptimal treatment paths.

The quality of mental health care for people with bipolar disorders in the Italian mental health system: the QUADIM project.

BACKGROUND: The assessment of the quality of care pathways delivered to people with severe mental disorders in a community-based system remains uncommon, especially using healthcare utilization databases. The aim of the study was to evaluate the quality of care provided to people with bipolar disorders taken-in-care by mental health services of four Italian areas (Lombardy, Emilia-Romagna, Lazio, province of Palermo). METHODS: Thirty-six quality indicators were implemented to assess quality of mental health care for patients with bipolar disorders, according to three dimensions (accessibility and appropriateness, continuity, and safety). Data were retrieved from healthcare utilization (HCU) databases, which contain data on mental health treatments, hospital admissions, outpatient interventions, laboratory tests and drug prescriptions. RESULTS: 29,242 prevalent and 752 incident cases taken-in-care by regional mental health services with a diagnosis of bipolar disorder in 2015 were identified. Age-standardized treated prevalence rate was 16.2 (per 10,000 adult residents) and treated incidence rate 1.3. In the year of evaluation, 97% of prevalent cases had ≥ 1 outpatient/day-care contacts and 88% had ≥ 1 psychiatric visits. The median of outpatient/day-care contacts was 9.3 interventions per-year. Psychoeducation was provided to 3.5% of patients and psychotherapy to 11.5%, with low intensity. 63% prevalent cases were treated with antipsychotics, 71.5% with mood stabilizers, 46.6% with antidepressants. Appropriate laboratory tests were conducted in less than one-third of prevalent patients with a prescription of antipsychotics; three quarters of those with a prescription of lithium. Lower proportions were observed for incident patients. In prevalent patients, the Standardized Mortality Ratio was 1.35 (95% CI: 1.26-1.44): 1.18 (1.07-1.29) in females, 1.60 (1.45-1.77) in males. Heterogeneity across areas was considerable in both cohorts. CONCLUSIONS: We found a meaningful treatment gap in bipolar disorders in Italian mental health services, suggesting that the fact they are entirely community-based does not assure sufficient coverage by itself. Continuity of contacts was sufficient, but intensity of care was low, suggesting the risk of suboptimal treatment and low effectiveness. Care pathways were monitored and evaluated using administrative healthcare databases, adding evidence that such data may contribute to assess the quality of clinical pathways in mental health.

Assessment and Monitoring of the Quality of Clinical Pathways in Patients with Depressive Disorders: Results from a Multiregional Italian Investigation on Mental Health Care Quality (the QUADIM Project).

Ensuring adequate quality of care to patients with severe mental disorders remains a challenge. The implementation of clinical indicators aimed at assessing the quality of health care pathways delivered is crucial for the improvement of mental health services (MHS). This study aims to evaluate the quality of care delivered to patients who are taken-into-care with depressive disorders by MHS. Thirty-four clinical indicators concerning accessibility, appropriateness, continuity, and safety were estimated using health care utilization databases from four Italian regions (Lombardy, Emilia-Romagna, Lazio, Sicily). A total of 78,924 prevalent patients treated for depressive disorders in 2015 were identified, of whom 15,234 were newly engaged by MHS. During the year of follow-up, access to psychotherapeutic interventions was low, while the intensity was adequate; 5.1% of prevalent patients received at least one hospitalization in a psychiatric ward (GHPW), and 3.3% in the cohort of newly engaged in services. Five-out-of-10 patients had contact with community services within 14 days after GHPW discharge, but less than half of patients were persistent to antidepressant drug therapy. Furthermore, prevalent patients showed an excess of mortality compared to the general population (SMR = 1.35; IC 95%: 1.26-1.44). In conclusion, the quality of health care is not delivered in accordance with evidence-based mental health standards. Evaluation of health interventions are fundamental strategies for improving the quality and equity of health care.

Trends and cyclic variation in the incidence of childhood type 1 diabetes in two Italian regions over 33 years and during the COVID-19 pandemic.

AIM: There is conflicting evidence about the impact of the COVID-19 pandemic on the incidence of type 1 diabetes. Here, we analysed long-term trends in the incidence of type 1 diabetes in Italian children and adolescents from 1989 to 2019 and compared the incidence observed during the COVID-19 pandemic with that estimated from long-term data. MATERIALS AND METHODS: This was a population-based incidence study using longitudinal data from two diabetes registries in mainland Italy. Trends in the incidence of type 1 diabetes from 1 January 1989 to 31 December 2019 were estimated using Poisson and segmented regression models. RESULTS: There was a significant increasing trend in the incidence of type 1 diabetes of 3.6% per year [95% confidence interval (CI): 2.4-4.8] between 1989 and 2003, a breakpoint in 2003, and then a constant incidence until 2019 (0.5%, 95% CI: -1.3 to 2.4). There was a significant 4-year cycle in incidence over the entire study period. The rate observed in 2021 (26.7, 95% CI: 23.0-30.9) was significantly higher than expected (19.5, 95% CI: 17.6-21.4; p = .010). CONCLUSION: Long-term incidence analysis showed an unexpected increase in new cases of type 1 diabetes in 2021. The incidence of type 1 diabetes now needs continuous monitoring using population registries to understand better the impact of COVID-19 on new-onset type 1 diabetes in children.

Combining Bayesian Calibration and Copula Models for Age Estimation.

Accurately estimating and predicting chronological age from some anthropometric characteristics of an individual without an identity document can be crucial in the context of a growing number of forced migrants. In the related literature, the prediction of chronological age mostly relies upon the use of a single predictor, which is usually represented by a dental/skeletal maturity index, or multiple independent ordinal predictor (stage of maturation). This paper is the first attempt to combine a robust method to predict chronological age, such as Bayesian calibration, and the use of multiple continuous indices as predictors. The combination of these two aspects becomes possible due to the implementation of a complex statistical tool as the copula. Comparing the forecasts from our copula-based method with predictions from an independent model and two single predictor models, we showed that the accuracy increased.

Detecting early signals of COVID-19 outbreaks in 2020 in small areas by monitoring healthcare utilisation databases: first lessons learned from the Italian Alert_CoV project.

BackgroundDuring the COVID-19 pandemic, large-scale diagnostic testing and contact tracing have proven insufficient to promptly monitor the spread of infections.AimTo develop and retrospectively evaluate a system identifying aberrations in the use of selected healthcare services to timely detect COVID-19 outbreaks in small areas.MethodsData were retrieved from the healthcare utilisation (HCU) databases of the Lombardy Region, Italy. We identified eight services suggesting a respiratory infection (syndromic proxies). Count time series reporting the weekly occurrence of each proxy from 2015 to 2020 were generated considering small administrative areas (i.e. census units of Cremona and Mantua provinces). The ability to uncover aberrations during 2020 was tested for two algorithms: the improved Farrington algorithm and the generalised likelihood ratio-based procedure for negative binomial counts. To evaluate these algorithms' performance in detecting outbreaks earlier than the standard surveillance, confirmed outbreaks, defined according to the weekly number of confirmed COVID-19 cases, were used as reference. Performances were assessed separately for the first and second semester of the year. Proxies positively impacting performance were identified.ResultsWe estimated that 70% of outbreaks could be detected early using the proposed approach, with a corresponding false positive rate of ca 20%. Performance did not substantially differ either between algorithms or semesters. The best proxies included emergency calls for respiratory or infectious disease causes and emergency room visits.ConclusionImplementing HCU-based monitoring systems in small areas deserves further investigations as it could facilitate the containment of COVID-19 and other unknown infectious diseases in the future.

Surgical Epicondylar Axis of the Knee and Its Relationship to the Axial Tibia Alignment in Knee Osteoarthritis: The Concept of Proximal Twist Tibia.

The proximal tibia and distal femur are intimately linked with the biomechanics of the knee and they are to be considered in total knee arthroplasty (TKA). The aim of the present study was to evaluate the proximal tibial torsion (PTT) in relation to surgical epicondylar axis (SEA) in a healthy cohort and a pathological cohort affected by knee osteoarthritis (OA). We retrospectively analyzed computed tomography of OA knee of 59 patients before they underwent TKA and nonarthritic knee of 39 patients as control. Posterior condylar angle (PCAn), femoral tibial torsion (SEA-proximal tibial condyle [PTC] and SEA-PTT), PTT (PTC-PTT and posterior condylar axes [PCAx]-PTC), and distance between tibial tuberosity and the trochlear groove (TT-TG) were measured. No differences were found for gender, age, TT-TG, and PCAn angles. Statistically significant differences were found for all the other angles considered. Significant correlation was found between tibial torsion and SEA-PTT angles, between PCAx-PTC and SEA-PTC, between SEA-PTT and SEA-PTC, and between PCAx-PTC and SEA-PTT. All measures, except TT-TG and PCAn angles, showed high validity (area under the curve [AUC] > 75%) in associating with OA, with SEA-PTT displaying the highest validity with an AUC of 94.38%. This is the first study to find significant differences in terms of proximal tibia geometry and anatomy between nonarthritic and OA knees. From our results, we reported that OA group was characterized by a greater internal rotation of tibia with respect to SEAs compared with control group. Since the design of the study cannot evaluate a cause-effect relationship, further studies need to be performed to assess the potential implications of these anatomic differences for knee OA and arthroplasty surgeries.

Prognosis and Survival in Idiopathic Pulmonary Fibrosis in the Era of Antifibrotic Therapy in Italy: Evidence from a Longitudinal Population Study Based on Healthcare Utilization Databases.

The aim was to evaluate the determinants of acute exacerbation (AE) and death in new cases of idiopathic pulmonary fibrosis (IPF) using administrative databases in the Marche Region. Adults at their first prescription of antifibrotics or hospitalization with a diagnosis of IPF occurring in 2014-2019 were considered as new cases. Multiple Cox regression was used to estimate the risk of AE and of all-cause mortality adjusted by demographic and clinical characteristics, stratifying patients according to antifibrotic treatment. Overall, 676 new cases of IPF were identified and 276 deaths and 248 AE events occurred. In never-treated patients, the risk of AE was higher in patients with poor health conditions at diagnosis; the risk of death was higher in males, in patients aged ≥75 and in those with poor health conditions at baseline. The increasing number of AEs increased the risk of death in treated and never-treated patients. Within the limits of an observational study based on secondary data, the combined use of healthcare administrative databases allows the accurate analysis of progression and survival of IPF from the beginning of the antifibrotic therapy era, suggesting that timely and early diagnosis is critical to prescribing the most suitable treatment to increase survival and maintain a healthy life expectancy.

From contact coverage to effective coverage of community care for patients with severe mental disorders: A real-world investigation from Italy.

Objectives: To measure the gap between contact and effective coverage of mental healthcare (MHC). Materials and methods: 45,761 newly referred cases of depression, schizophrenia, bipolar disorder, and personality disorder from four Italian regions were included. A variant of the self-controlled case series method was adopted to estimate the incidence rate ratio (IRR) for the relationship between exposure (i.e., use of different types of MHC such as pharmacotherapy, generic contact with the outpatient services, psychosocial intervention, and psychotherapy) and relapse (emergency hospital admissions for mental illness). Results: 11,500 relapses occurred. Relapse risk was reduced during periods covered by (i) psychotherapy for patients with depression (IRR 0.67; 95% CI: 0.49 to 0.91) and bipolar disorder (0.64; 0.29 to 0.99); (ii) psychosocial interventions for those with depression (0.74; 0.56 to 0.98), schizophrenia (0.83; 0.68 to 0.99), and bipolar disorder (0.55; 0.36 to 0.84), (iii) pharmacotherapy for patients with schizophrenia (0.58; 0.49 to 0.69), and bipolar disorder (0.59; 0.44 to 0.78). Coverage with generic care, in absence of psychosocial/psychotherapeutic interventions, did not affect risk of relapse. Conclusion: This study ascertained the gap between contact and effective coverage of MHC and showed that administrative data can usefully contribute to assess the effectiveness of a mental health system.

Quantification of Carbonic Anhydrase Inhibitors and Metabolites in Urine and Hair of Patients and Their Relatives.

Carbonic anhydrase inhibitors (CAIs) are prescription drugs also used in doping to dilute urine samples and tamper with urinalyses. Dorzolamide, brinzolamide, and acetazolamide are prohibited by the World Anti-Doping Agency. Detecting CAIs and their metabolites in biological samples is crucial to documenting misuse in doping. We quantified dorzolamide, brinzolamide, acetazolamide, and their metabolites in the urine and hair of 88 patients under treatment for ocular hypertension or glaucoma. Samples of the patients' relatives were analyzed to assess potential for accidental exposure. After washing, 25 mg hair was incubated with an acidic buffer at 100 °C for 1 h. After cooling and centrifugation, the supernatant was analyzed by ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). Urine (100 µL) was diluted and centrifuged before UHPLC-MS/MS analysis. Run time was 8 min through a reverse-phase column with a mobile phase gradient. MS/MS analysis was performed in a multiple-reaction monitoring mode after positive electrospray ionization. Median urinary concentration was 245 ng/mL (IQR: 116.2-501 ng/mL) for dorzolamide, 81.1 ng/mL (IQR: 35.9-125.3 ng/mL) for N-deethyl-dorzolamide, 0.77 ng/mL (IQR: 0.64 ng/mL-0.84 ng/mL) for N-acetyl-dorzolamide, 38.9 ng/mL (IQR: 20.4-79.2 ng/mL) for brinzolamide, and 72.8 ng/mL (IQR: 20.7-437.3 ng/mL) for acetazolamide. Median hair concentration was 0.48 ng/mg (IQR: 0.1-0.98 ng/mg) for dorzolamide, 0.07 ng/mg (IQR: 0.06-0.08 ng/mg) for N-deethyl-dorzolamide, 0.40 ng/mL (IQR: 0.13-1.95 ng/mL) for brinzolamide. Acetazolamide was detected in only one hair sample. Dorzolamide and brinzolamide were detected in the urine of three and one relatives, respectively. Cutoff concentrations of urinary dorzolamide and brinzolamide are necessary to preclude false positives due to contamination or passive exposure. We reported the first concentrations of brinzolamide in hair.

Development and Validation of a Novel Pre-Pregnancy Score Predictive of Preterm Birth in Nulliparous Women Using Data from Italian Healthcare Utilization Databases.

Background: Preterm birth is a major worldwide public health concern, being the leading cause of infant mortality. Understanding of risk factors remains limited, and early identification of women at high risk of preterm birth is an open challenge. Objective: The aim of the study was to develop and validate a novel pre-pregnancy score for preterm delivery in nulliparous women using information from Italian healthcare utilization databases. Study Design: Twenty-six variables independently able to predict preterm delivery were selected, using a LASSO logistic regression, from a large number of features collected in the 4 years prior to conception, related to clinical history and socio-demographic characteristics of 126,839 nulliparous women from Lombardy region who gave birth between 2012 and 2017. A weight proportional to the coefficient estimated by the model was assigned to each of the selected variables, which contributed to the Preterm Birth Score. Discrimination and calibration of the Preterm Birth Score were assessed using an internal validation set (i.e., other 54,359 deliveries from Lombardy) and two external validation sets (i.e., 14,703 and 62,131 deliveries from Marche and Sicily, respectively). Results: The occurrence of preterm delivery increased with increasing the Preterm Birth Score value in all regions in the study. Almost ideal calibration plots were obtained for the internal validation set and Marche, while expected and observed probabilities differed slightly in Sicily for high Preterm Birth Score values. The area under the receiver operating characteristic curve was 60%, 61% and 56% for the internal validation set, Marche and Sicily, respectively. Conclusions: Despite the limited discriminatory power, the Preterm Birth Score is able to stratify women according to their risk of preterm birth, allowing the early identification of mothers who are more likely to have a preterm delivery.

Occurrence of Idiopathic Pulmonary Fibrosis in Italy: Latest Evidence from Real-World Data.

The aim of the study was to evaluate the trend in the incidence of idiopathic pulmonary fibrosis (IPF) in a real-world setting of the Marche region, a region of Central Italy, between 2014 and 2019. This observational prospective study was based on administrative databases of hospital discharges and drug prescriptions. All adult residents in the Marche Region with a first prescription of antifibrotic drugs, or a first hospitalization with a diagnosis of IPF during the study period, were identified as incident cases of IPF. A multiple Poisson regression analysis was used to estimate the IPF incidence trend, adjusted for age, sex, and health conditions. The mean incidence rate was 9.8 cases per 100,000 person-years. A significant increasing trend of 6% per year was observed. The incidence rates were significantly higher in males than females, older subjects, and those with poorer health conditions. To our knowledge, this is the first study evaluating incidences of IPF over a 6-year period in Italy, combining hospital discharge and drug prescription databases. The study highlights that the combined use of two secondary sources is a reliable strategy to accurately identify new cases of IPF when the appropriate disease registry is lacking.

The quality of mental health care delivered to patients with schizophrenia and related disorders in the Italian mental health system. The QUADIM project: a multi-regional Italian investigation based on healthcare utilisation databases.

AIMS: To evaluate the quality of mental health care delivered to patients with schizophrenia and related disorders taken-in-care by mental health services in four Italian regions (Lombardy, Emilia-Romagna, Lazio, Sicily). METHODS: Thirty-one clinical indicators concerning accessibility, appropriateness, continuity and safety were defined and estimated using healthcare utilisation (HCU) databases, containing data on mental health treatments, hospital admissions, outpatient interventions, lab tests and drug prescriptions. RESULTS: A total of 70 586 prevalent patients with schizophrenia and related disorders treated in 2015 were identified, of whom 1752 were newly taken-in-care by the facilities of regional mental health services. For most patients community care was accessible and moderately intensive. However, care pathways were not implemented based on a structured assessment and only half of the patients received psychosocial treatments. One patient out of ten had access to psychological interventions and psychoeducation. Activities specifically addressed to families involved a third of prevalent patients and less than half of new patients. One patient out of six was admitted to a community residential facility, and one out of ten to a General Hospital Psychiatric Ward (GHPW); higher values were identified in new cases. In general hospitals, few patients had a length of stay (LoS) of more than 30 days, while one-fifth of the admissions were followed by readmission within 30 days of discharge. For two-thirds of patients, continuity of community care was met, and six times out of ten a discharge from a GHPW was followed by an outpatient contact within 2 weeks. For cases newly taken-in-care, the continuity of community care was uncommon, while the readiness of outpatient contacts after discharge was slightly more frequent. Most of the patients received antipsychotic medication, but their adherence to long-term treatment was low. Antipsychotic polytherapy was frequent and the control of metabolic side effects was poor. The variability between regions was high and consistent in all the quality domains. CONCLUSIONS: The Italian mental health system could be improved by increasing the accessibility to psychosocial interventions, improving the quality of care for newly taken-in-care patients, focusing on somatic health and mortality, and reducing regional variability. Clinical indicators demonstrate the strengths and weaknesses of the mental health system in these regions, and, as HCU databases, they could be useful tools in the routine assessment of mental healthcare quality at regional and national levels.

Health data collection methods and procedures across EU member states: findings from the InfAct Joint Action on health information.

BACKGROUND: Health-related data are collected from a variety of sources for different purposes, including secondary use for population health monitoring (HM) and health system performance assessment (HSPA). Most of these data sources are not included in databases of international organizations (e.g., WHO, OECD, Eurostat), limiting their use for research activities and policy making. This study aims at identifying and describing collection methods, quality assessment procedures, availability and accessibility of health data across EU Member States (MS) for HM and HSPA. METHODS: A structured questionnaire was developed and administered through an online platform to partners of the InfAct consortium form EU MS to investigate data collections applied in HM and HSPA projects, as well as their methods and procedures. A descriptive analysis of the questionnaire results was performed. RESULTS: Information on 91 projects from 18 EU MS was collected. In these projects, data were mainly collected through administrative sources, population health interview or health examination surveys and from electronic medical records. Tools and methods used for data collection were mostly mandatory reports, self-administered questionnaires, or record linkage of various data sources. One-third of the projects shared data with EU research networks and less than one-third performed quality assessment of their data collection procedures using international standardized criteria. Macrodata were accessible via open access and reusable in 22 projects. Microdata were accessible upon specific request and reusable in 15 projects based on data usage licenses. Metadata was available for the majority of the projects, but followed reporting standards only in 29 projects. Overall, compliance to FAIR Data principles (Findable, Accessible, Interoperable, and Reusable) was not optimal across the EU projects. CONCLUSIONS: Data collection and exchange procedures differ across EU MS and research data are not always available, accessible, comparable or reusable for further research and evidence-based policy making. There is a need for an EU-level health information infrastructure and governance to promote and facilitate sharing and dissemination of standardized and comparable health data, following FAIR Data principles, across the EU.