Healthcare Utilization Databases Research Articles

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.

PS-P07-9: USE OF INITIAL AND SUBSEQUENT ANTIHYPERTENSIVE COMBINATION TREATMENT IN THE CLINICAL PRACTICE. EVIDENCE FROM A POPULATION-BASED INVESTIGATION IN ITALY

Objective: Hypertension guidelines issued in the last twenty years have consistently recommended use of a combination of two or more antihypertensive drugs to treat most hypertensive patients. Two-drug combinations have also been recommended as initial treatment. Aim of this study was to assess the use of antihypertensive combination treatment, both as the initial and as subsequent therapeutic step over a three-year treatment period, based on data from a large Italian population. Three temporal cohorts (2012, 2015, 2018) were identified to determine whether mono versus combination treatment strategies had changed over the years. Design and method: The residents of the Lombardy Region (Italy), aged > 40 years, who were newly treated with antihypertensive drugs during 2012, 2015 and 2018 were identified through the regional healthcare utilization database. The drug treatment strategy (monotherapy and combination of two, three and > 3 antihypertensive drugs) was assessed at treatment initiation, and after 6 months, 1, 2, and 3 years of treatment. Data were also analysed after stratification for demographic and clinical categories, i.e. sex, age, signs of cardiovascular disease, co-treatments, and clinical status. Results: About one-hundred thousand patients were identified for each cohort. About four out of ten patients were aged > 65 years, half of them were women, one in four patients was prescribed > 5 co-medications, and one in 6 patients had a poor clinical status. In the 2012 cohort, monotherapy was the most common initial treatment strategy (74%), followed by two-drug single-pill combination (17%), two-drug free combination (6%), and combination of > 3 drugs (3%). There were no significant differences between the 2012, 2015 and 2018 cohorts, and among strata of age, sex, clinical status, co-treatments, number of co-medications and evidence of cardiovascular disease. Use of two and three or more antihypertensive drugs increased during follow-up and reached about 32% (two drugs) and 11% (> 2 drugs) of the patients after 3 years from treatment initiation. Among patients prescribed a two-drug combination, the single-pill was the most common approach, whereas the use of the three-drug single-pill combination was extremely rare. There were no substantial differences in the use of combination treatment between the three cohorts and the results were similar in all demographic and clinical categories. Conclusions: In a real-life setting, use of antihypertensive drug combinations is low at treatment initiation and inferior to use of monotherapy during chronic treatment Contrary to guidelines recommendations, antihypertensive combination treatment did not show any noticeable increase over the years.

S-35-2: THE IMPACT OF RENAL DENERVATION PROCEDURE ON THE USE OF ANTIHYPERTENSIVE DRUGS. A REAL-LIFE INVESTIGATION FROM ITALY

Objective: Randomized controlled trials have shown that renal denervation lowers office and ambulatory blood pressure. However, the clinical environment of controlled trials is different from that characterizing medical practice, making real-life data appropriate to provide information on a number of issues, e.g. whether renal denervation is followed by a change in the intensity and type of antihypertensive drug use. The aim of the present study was to evaluate whether patients undergoing renal denervation procedure in a real-life setting have a reduction in antihypertensive drug prescription over the subsequent years. Design and method: Using the healthcare utilization database of the Lombardy Region (Italy), the 136 patients who, during the period 2011–2016, were prescribed four or more antihypertensive drugs and underwent renal denervation were included in the study cohort. The number and type of antihypertensive drugs were assessed over the year before and during the three-year period after renal denervation. Hospitalizations for cardiovascular diseases were also assessed during the three years before and during the three years after renal denervation. Results: The median age of the patients was 67 years and 68% of them were men. Based on a multisource comorbidity score, about 40% of patients showed a poor or very poor clinical status. Before renal denervation, about 80% of the patients were prescribed four or five antihypertensive drugs. The number of drugs decreased after the denervation: after three years, patients prescribed 4/5 drugs were 57% and patients prescribed six drugs decreased from 18% to 2%. Reduced prescription extended to all antihypertensive drugs throughout the post-denervation period. Compared to the year before the denervation, after three years prescription of diuretics was reduced by 15%, calcium channel blockers by 21%, angiotensin-converting enzyme inhibitors by 32%, angiotensin receptor blockers by 22%, beta-blockers by 20%, alfa-blockers by 30%, and mineralocorticoid receptor antagonists by 30%. Hospitalizations for cardiovascular diseases did not show appreciable differences between the two periods (before and after the renal denervation). Conclusions: In the real-life setting, patients who underwent renal denervation had a clearcut reduction in antihypertensive drug prescription over the following years.

PS-P07-8: TREATMENT STRATEGIES AND ADHERENCE TO THE TRIPLE COMBINATION OF AN ANGIOTENSIN-CONVERTING ENZYME INHIBITOR, A CALCIUM-CHANNEL BLOCKER, AND A DIURETIC

Objective: To compare adherence to antihypertensive treatment between patients prescribed the perindopril/amlodipine/indapamide single pill combination (SPC) vs the two pill combination of an angiotensin converting enzyme inhibitor (ACEI), a calcium channel blocker (CCB), and a diuretic (D). Design and method: Using the healthcare utilization database of the Lombardy Region (Italy), patients, aged 40 years or older, who received a prescription of perindopril/amlodipine/indapamide SPC during 2015 2018 were identified and the date of the first prescription was defined as the index date. For each patient prescribed the SPC, a subject who started ACEI/CCB/D treatment as a two drug SPC plus a third drug separately (i.e. 2 pills) at the index date was identified. Adherence to the triple combination was assessed over the year after the index date as the proportion of this year period in which prescription made the triple combination available, i.e. by the proportion of the follow up days covered (PDC) by prescription. The primary aim was to compare the odds of being highly adherent to the drug therapy (PDC> 75%) between groups. A secondary aim was to compare the odds of being poorly adherent (PDC < 25%). Log binomial regression models were fitted to estimate the risk ratio, and its 95% confidence interval, of treatment adherence in relation to the drug treatment strategy, using the two pill combination as reference. Adjustments were made for several demographic and clinical covariates. Results: 28,210 patients prescribed the perindopril/amlodipine/indapamide SPC were identified and matched to 28,210 patients prescribed ACEI/CCB/D in two pills. Compared with patients on the two pill combination, those treated with a SPC were slightly younger (68 vs 71 years) and more frequently men (54% vs 48%) with no between group difference in the clinical profile. About 59% and 25% of patients prescribed the three drug treatment as SPC and two pill combination showed high adherence, respectively. Compared with patients under two pill combination, those who were treated with the SPC had a higher propensity to be highly adherent to the triple combination (risk ratio: 2.38, 95% confidence interval 2.32 2.44). This was the case regardless of the sex, age, patient clinical status, and number of co treatments. The odds of being poorly adherent to treatment was much lower in the SPC than in the two pill combination group (risk ratio: 0.33, 0.31 0.34). Conclusions: In a real life setting, patients who were prescribed the perindopril/amlodipine/indapamide SPC exhibited more frequently a good adherence to antihypertensive treatment than those prescribed a two pill combination of ACEI/CCB/D.

Developing a comorbidity score in cancer patients using healthcare utilization databases during the COVID-19 pandemic: An experience from Italy.

A strong relationship has been observed between comorbidities and the risk of severe/fatal COVID-19 manifestations, but no score is available to evaluate their association in cancer patients. To make up for this lacuna, we aimed to develop a comorbidity score for cancer patients, based on the Lombardy Region healthcare databases. We used hospital discharge records to identify patients with a new diagnosis of solid cancer between February and December 2019; 61 comorbidities were retrieved within 2 years before cancer diagnosis. This cohort was split into training and validation sets. In the training set, we used a LASSO-logistic model to identify comorbidities associated with the risk of developing a severe/fatal form of COVID-19 during the first pandemic wave (March-May 2020). We used a logistic model to estimate comorbidity score weights and then we divided the score into five classes (<=-1, 0, 1, 2-4, >=5). In the validation set, we assessed score performance by areas under the receiver operating characteristic curve (AUC) and calibration plots. We repeated the process on second pandemic wave (October-December 2020) data. We identified 55,425 patients with an incident solid cancer. We selected 21 comorbidities as independent predictors. The first four score classes showed similar probability of experiencing the outcome (0.2% to 0.5%), while the last showed a probability equal to 5.8%. The score performed well in both the first and second pandemic waves: AUC 0.85 and 0.82, respectively. Our results were robust for major cancer sites too (i.e., colorectal, lung, female breast, and prostate). We developed a high performance comorbidity score for cancer patients and COVID-19. Being based on administrative databases, this score will be useful for adjusting for comorbidity confounding in epidemiological studies on COVID-19 and cancer impact.

Palliative medicine favourably influences end-of-life cancer care intensity: a large retrospective database study

ObjectivesHospice and home palliative care have been associated to a reduction of aggressive treatments in the end-of-life, but data in the Italian context are scanty. Therefore, we aim to investigate...

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.

Beta-blockers in post-acute myocardial infarction patients: Drug prescription patterns from 2018 to Italy's first wave of the COVID-19 pandemic.

Background: Major guidelines recommend the initiation of a beta-blocker therapy after an acute myocardial infarction (AMI). We aimed to map the treatment pathway of beta-blockers for AMI survivors during the first wave of COVID-19 pandemic in Italy and to investigate predictors for treatment non-initiation. Methods: Healthcare utilization databases of Lombardy Region were investigated. Subjects aged ≥18 years who were hospitalised with AMI in the period February-March-April of 2018, 2019, and 2020 were included, and followed for 30 days from the discharge date, to investigate whether they presented a first prescription of beta-blockers. A multivariate logistic model was performed to evaluate the effect of several covariates on the probability of not receiving a post-AMI beta-blocker therapy. Results: The cohorts comprised 2259, 2383, and 1932 individuals who were hospitalised with AMI in the 3-month period in 2018, 2019, and 2020, respectively. Overall in 2020, about 58-60% of individuals with AMI received a prescription of beta-blockers within 1month after the discharge. A continuous decreasing trend over time was observed. Men were 30% more likely to start the treatment than women, increasing age was associated with significant increasing probability of not receiving a post-infarction beta-blocker therapy, while having received an antihypertensive or lipid-lowering treatment, or having been hospitalized for heart failure prior to the AMI hospitalization reduced the likelihood of not being treated with beta-blockers. Conclusion: The initiation of beta-blocker treatment after AMI remains an under-prescribed practice, that does not seem to have been further affected by the first wave of the COVID-19 pandemic.

Validation of claims-based algorithms to identify non-live birth outcomes.

Perinatal epidemiology studies using healthcare utilization databases are often restricted to live births, largely due to the lack of established algorithms to identify non-live births. The study objective was to develop and validate claims-based algorithms for the ascertainment of non-live births. Using the Mass General Brigham Research Patient Data Registry 2000-2014, we assembled a cohort of women enrolled in Medicaid with a non-live birth. Based on ≥1 inpatient or ≥2 outpatient diagnosis/procedure codes, we identified and randomly sampled 100 potential stillbirth, spontaneous abortion, and termination cases each. For the secondary definitions, we excluded cases with codes for other pregnancy outcomes within ±5 days of the outcome of interest and relaxed the definitions for spontaneous abortion and termination by allowing cases with one outpatient diagnosis only. Cases were adjudicated based on medical chart review. We estimated the positive predictive value (PPV) for each outcome. The PPV was 71.0% (95% CI, 61.1-79.6) for stillbirth; 79.0% (69.7-86.5) for spontaneous abortion, and 93.0% (86.1-97.1) for termination. When excluding cases with adjacent codes for other pregnancy outcomes and further relaxing the definition, the PPV increased to 80.6% (69.5-88.9) for stillbirth, 86.6% (80.5-91.3) for spontaneous abortion and 94.9% (91.1-97.4) for termination. The PPV for the composite outcome using the relaxed definition was 94.4% (92.3-96.1). Our findings suggest non-live birth outcomes can be identified in a valid manner in epidemiological studies based on healthcare utilization databases.

A Population-Based Study on Survival of Higher Risks Myelofibrosis Patients Treated with Ruxolitinib in the Italian Lombardy Region

Introduction Myelofibrosis (MF) is a severe disease, and patients in the higher prognostic risk categories have a median overall survival (OS) between two and four years after diagnosis. Ruxolitinib (RUX) is the first approved drug for MF, with efficacy in terms of reduction of spleen and symptoms. An improvement of OS with RUX has been reported in different studies, such as a post-hoc analysis of the registration trials (Verstovsek et al, 2017) and in the real-world setting (Guglielmelli et al, 2022). In Italy, RUX is available since October 2014 for intermediate-2 (INT-2) and high risk (HR) and since January 2018 for intermediate-1 MF cases. High-cost drugs are delivered and monitored by each regional health authority. In this study, we analyzed the outcome of INT-2 and HR MF patients treated with RUX in Lombardy, a region of roughly 10 million individuals. Methods This is a population-based retrospective cohort study based on healthcare utilization databases of Lombardy region, including data on hospital admissions, drug prescriptions, outpatient's health services and demographics. The study cohort included all beneficiaries of the Regional Health Service who started RUX between October 2014 and December 2017 (to include only INT-2 and HR MF patients) and followed-up until 31st July 2021 (minimum observation period of the study: 3.5 years). The primary outcome of the study was OS, defined as the time between RUX start and death for any cause or censoring due to migration or to end of data availability. The secondary outcome was time-to-treatment failure (TTF), defined as the time between RUX start and interruption for any reason, including allogenic stem cells transplant (allo-SCT) or death, or censoring. OS and TTF were estimated by the Kaplan-Meier method and 95% confidence interval (95%CI) was calculated. The incidence of adverse events (AEs) and secondary malignancies (included blast phase, BP, or post MF-myelodysplastic syndromes, MDS) that required hospital admission and occurring during follow-up was assessed and expressed as incidence rate (IR) x100 person-years (p-y). Infections, bleedings, and major thrombotic events were considered if they occurred within 90 days from the last RUX prescription and before evolution into BP/MDS. Results During study period, 315 MF patients started RUX. Median age at first administration was 70 years (range, 24-92) and 57% were females. Within the three months preceding RUX start (from now on, referred to as "baseline"), 76 (24%) subjects received at least one red blood cells (RBC) transfusion unit and, among those, 18 (24%) could be classified as RBC transfusion-dependent (TD- Gale et al, 2011). RUX initial dose was <20 mg bid in 216 (69%) subjects and, within this subgroup, 93 (43%) started with only 5 mg bid. As for the 284 (90%) patients with at least six months of RUX exposure, modification of RBC transfusions needs compared to baseline is reported in Table 1. Median study follow-up was 40.5 months (range, 1-82). Overall, 173 (55%) deaths were observed. Median OS was 46.3 months (95%CI: 41.6-56.0), as reported in Figure 1. Treatment failure was observed in 144 (46%) patients, and the median TTF was 25.3 months (95%CI: 19.6-33.9). Among those subjects, median treatment duration was 12 months (range, 0.9-75.5). Allo-SCT was performed in 36 (11.4%) subjects at a median time of 8.7 months (range, 1.4-66.7) after RUX start. The most frequent AEs were infections (IR: 13.5 x100 p-y), bleeding events (4.2 x100 p-y) and thrombosis (1.8 x100 p-y). Secondary solid tumours had an IR of 4.5 x100 p-y, while the latter was 1.2 x100 p-y for lymphoproliferative disorders. Evolution into BP/MDS was reported in 58 (18%) of the cohort, with an IR of 5.8 x100 p-y. Conclusions This study provided a real-world description of RUX treatment outcomes in an unselected population-based cohort of patients with higher risks MF, reflecting the daily clinical practice in Lombardy, the most populated Italian region. In this cohort of 315 long observed INT-2 and HR MF patients, RUX demonstrated to have a robust effect on survival. Among patients without baseline transfusions needs, 21% started receiving RBC units during the first six months of exposure to RUX. In the same period, 77% of subjects that transfused at baseline continued receiving RBC units. MF progression rate into BP/MDS after RUX start was comparable to data of the pre-RUX era, confirming this still remains an unmet clinical need in the field. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Trends of hospital admissions and mortality of patients with dementia: descriptive study in Lombardy

Abstract Background In 2017 the amount of people globally affected by dementia was estimated about 50 million and is predicted to increase to 132 million by 2050. Coping with dementia is one of the most important challenges of governmental organizations’ agenda. The objective of this study is to analyse the hospital admissions trends and monitor the overall mortality in a population of older patients with dementia over the last two decades in northern Italy. Methods This study is based on the healthcare utilization database of the Lombardy region (Italy), considering on hospital discharge records and death registry flows. Primary or secondary diagnosis at admission of dementia was coded according to the ICD9-CM. We carried out descriptive analyses of hospital admissions’ data from 1 Jan 1999 to 31 Dec 2020 of older patients aged 65 or more. We then conducted a temporal analysis of mortality rate over the study period. Results A total of 15,683,024 hospital admissions occurred during the study period. Over the last two decades, the prevalence of dementia among patients admitted to acute care hospitals remained around 1.1-1.3%. Considering the total of 183,268 patients with dementia over the study period, the average age at admission increased from 80.2 in 1999 to 83.3 years old in 2020, whereas annual mortality rate increased from about 1,950 to 3,230 deaths per 10,000 person-years. The mortality rate ratio of patients with versus without dementia fluctuated between 1.28 and 1.70. Conclusions Our findings suggest that there is an ever-greater appropriateness of hospitalizations over the last two decades, supported by out-of-hospital care that led patients to hospitalization in increasingly late and serious phases of the disease. The present study has a great future potential as well as limitations, due to the dependence on a correct coding of cases by clinicians according to the ICD9-CM system. Key messages • We observed an increased mortality among older people with dementia admitted to hospital over the last two decades. • Our descriptive study, based on the Lombardy regional healthcare database, provides evidence of an increasing appropriateness of hospitalizations.

The changing impact of assisted reproductive techniques on preterm birth during the period 2007–2020 in Lombardy, Northern Italy

ObjectiveTo assess the impact of Assisted Reproductive Techniques (ART) on the risk of preterm birth (PTB). Study designThis retrospective population-based study used healthcare utilization databases of the Lombardy Region to select all the deliveries occurred between 2007 and 2020. Log-binomial regression models were fitted to estimate prevalence ratio (PR) and the corresponding 95% confidence interval (CI) of PTB among deliveries after ART. Estimates were adjusted for maternal sociodemographic features. Furthermore, the population attributable fraction was computed. All the analyses were performed for calendar period and were repeated excluding multiple births. ResultsIn our cohort, an increasing trend in the number of ART emerged, with an overall rate of 25.8 per 1,000 deliveries (N = 28,742). ART was positively related to PTB (aPR = 2.83, 95 % CI: 2.76–2.91) with a downward trend. Over the period study, multiple births after ART decreased (from 20.4 % to 8.4 %) and were constantly burdened by a higher number of PTB. Excluding multiple births, the association was substantially lower (aPR = 1.72, 95 % CI: 1.65–1.79) and did not describe any trend. Moreover, stratifying for type of pregnancy, the association was observed only among singletons. Finally, the proportion of PTB considered attributable to ART increased from about 2–3 % to 6 % till the 2016, then decreased. ConclusionThe investigation suggested that ART was related to PTB; this association may be partly justified by the high rate of multiple births among women who conceived non spontaneously. However, excluding multiple births, ART remained associated with PTB.

The Economic Burden of Pneumococcal Disease in Children: A Population-Based Investigation in the Veneto Region of Italy.

Despite widespread childhood immunization programs, pneumococcal disease (PD) continues to be associated with significant clinical and economic burden worldwide. This retrospective study assessed the PD-related economic burden in children from the Veneto region of Italy following the introduction of a 13-valent pneumococcal conjugate vaccine (PCV13) to the Italian immunization schedule in 2010. Between 2010 and 2017, the annual incidences of pneumonia, acute otitis media (AOM), and invasive pneumococcal disease (IPD), as well as syndromic-disease-related episodes, declined. In our analysis of data from regional expenditure and healthcare resource utilization (HCRU) databases related to children < 15 years of age, we found that regional expenditures decreased between 2010 and 2017 for pneumonia (EUR 8.88 to EUR 3.59 million), AOM (EUR 3.78 to EUR 2.76 million), and IPD (EUR 1.40 to EUR 1.00 million). Despite reductions in PD-related expenditure following the introduction of PCV13, there continues to be an economic burden associated with PD in Veneto, Italy.

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.

COVID-19 outbreak in Lombardy: Impact on reducing solid cancer diagnoses in 2020.

Our aim was to analyse, on a population level, the year‐long decline in cancer diagnoses in the region of Lombardy (Italy), and to characterise the tumours with the greatest reduction in diagnosis by patient age, sex and tumour stage at diagnosis. We used the health care utilisation databases of the Lombardy region to identify cancer patients' characteristics (eg, sex, age) and cancer‐related information (eg, cancer site, stage at diagnosis). The frequency of new cancer diagnoses in 2019 and 2020 were compared in terms of percentage differences in undiagnosed cases. We observed two peaks in the decline in cancer diagnoses: March to May 2020 (−37%) and October to December 2020 (−19%). The decline persisted over the course of 2020 and was higher in males and patients aged 74+. Diagnoses of all four common cancers analysed (female breast, lung, colorectal and prostate) remained below pre‐pandemic levels. For breast and colorectal cancers, the decline in diagnoses was high in the age groups targeted by population‐based screening programmes. We observed a reduction in localised stage cancer diagnoses for all four cancers. Our data confirm that timely monitoring of cancer diagnoses and interventions to prevent disruption of routine diagnostic services are needed to mitigate the impact of emergencies on cancer patients.

Propensity score methodology for confounding control in health care utilization databases

Propensity score (PS) methodology is a common approach to control for confounding in nonexperimental studies of treatment effects using health care utilization databases. This methodology offers researchers many advantages compared with conventional multivariate models: it directly focuses on the determinants of treatment choice, facilitating the understanding of the clinical decision-making process by the researcher; it allows for graphical comparisons of the distribution of propensity scores and truncation of subjects without overlapping PS indicating a lack of equipoise; it allows transparent assessment of the confounder balance achieved by the PS at baseline; and it offers a straightforward approach to reduce the dimensionality of sometimes large arrays of potential confounders in utilization databases, directly addressing the “curse of dimensionality” in the context of rare events. This article provides an overview of the use of propensity score methodology for pharmacoepidemiologic research with large health care utilization databases, covering recent discussions on covariate selection, the role of automated techniques for addressing unmeasurable confounding via proxies, strategies to maximize clinical equipoise at baseline, and the potential of machine-learning algorithms for optimized propensity score estimation. The appendix discusses the available software packages for PS methodology. Propensity scores are a frequently used and versatile tool for transparent and comprehensive adjustment of confounding in pharmacoepidemiology with large health care databases.

The CRACK programme: a scientific alliance for bridging healthcare research and public health policies in Italy

Healthcare utilisation databases, and other secondary data sources, have been used with growing frequency to assess health outcomes and healthcare interventions worldwide. Their increased popularity as a research tool is due to their timely availability, the large patient populations covered, low cost, and applicability for studying real-world clinical practice. Despite the need to measure Italian National Health Service performance both at regional and national levels, the wealth of good quality electronic data and the high standards of scientific research in this field, healthcare research and public health policies seem to progress along orthogonal dimensions in Italy. The main barriers to the development of evidence-based public health include the lack of understanding of evidence-based methodologies by policy makers, and of involvement of researchers in the policy process. The CRACK programme was launched by some academics from the Lombardy Region. By extensively using electronically stored data, epidemiologists, biostatisticians, pharmacologists and clinicians applied methods and evidence to several issues of healthcare research. The CRACK programme was based on their intention to remove barriers that thwart the process of bridging methods and findings from scientific journals to public health practice. This paper briefly describes aim, articulation and management of the CRACK programme, and discusses why it might find articulated application in Italy.

P-717 Trends in the incidence of major birth defects after Assisted Reproductive Technologies (ART) in Lombardy Region, Northern Italy

Abstract Study question Does the association between Assisted Reproductive Technologies (ART) and birth defects change over time? Summary answer The increased incidence of birth defects in ART pregnancies is not steady over time. A decline of this risk emerged in most recent years. What is known already The incidence of birth defects is increased in pregnancies after ART. The latest meta-analysis showed that infants born following IVF-ICSI have a 40% increased risk (Zhao et al., 2020). Even if infertile women are exposed to higher risk per se, some ART related factors may also contribute. To note, ART procedures are continuously evolving, and it cannot be excluded that the magnitude of the association of ART and birth defects may have changed in recent years. We failed to identify in the literature studies reporting on the trends of birth defects in IVF-ICSI pregnancies over time. Study design, size, duration This is a population-based study using the automated system of healthcare utilization databases from Lombardy, a region located in Northern Italy accounting for about 10 million inhabitants. We identified deliveries occurring between January 2014 and December 2020 from women beneficiaries of the public health system using the standard discharge form and the certificate of delivery assistance. We excluded cases with incomplete information and pregnancies obtained by intrauterine insemination or ovarian hyperstimulation alone. Participants/materials, setting, methods The rate of newborns affected by major defects was calculated among natural and IVF-ICSI pregnancies. A logistic regression model was used to adjust for maternal sociodemographic features (i.e., age, nationality, marital status, education, and employment). Data are presented as adjusted odd ratio (aOR) and corresponding 95% Confidence Interval (CI) of major defects among IVF-ICSI pregnancies compared to natural conceptions. Analyses were repeated for every calendar year. Main results and the role of chance A total of 508,421 live births were included, of whom 14,067 (2.8%) were achieved with IVF-ICSI. The proportion of non-spontaneous conceptions per year progressively increased over the years, being 2.1%, 2.3%, 2.6%, 2.8%, 3.2%, 3.4% and 3.2% in 2014, 2015, 2016, 2017, 2018, 2019, and 2020, respectively (p &amp;lt; 0.0001). Overall, 13,080 birth defects were recorded, of whom 412 occurred among ART newborns (3.1%). The risk of birth defects is increased in women undergoing ART (aOR 1.13; 95%CI:1.02-1.25), but a decreasing trend over time was highlighted. Indeed, the aOR dropped from 1.40 (95%CI: 1.04-1.91) in 2014 to 0.7 (95%CI: 0.73-1.28) in 2020 (p &amp;lt; 0.001). During the study period, a statistically significant reduction in multiple pregnancies (p-value for trend &amp;lt;0.0001) and in the ratio of ICSI to conventional IVF (p-value for trend &amp;lt;0.0001) was also observed, potentially explaining the positive trend observed for birth defects. Limitations, reasons for caution The diagnosis of malformation is based on information detected at the time of delivery, and not during the subsequent infant’s hospitalization, or later in lifetime. Further, we have no information on pregnancies terminated early. Finally, data was collected from registries and this modality may expose the findings to some inaccuracies. Wider implications of the findings The increased risk of birth defects in IVF-ICSI pregnancies is not steady over time. A decline of this risk emerged in our region. Policy changes in ART may explain this beneficial effect. Evidence obtained more than one decade ago may not be valid in the modern era of IVF. Trial registration number not applicable

Healthcare utilization database and real world evidence are we able to grasp an extraordinary challenge?

Healthcare utilization database and real world evidence are we able to grasp an extraordinary challenge?

Towards the rational use of Healthcare Utilization Databases for generating real-world evidence new challenges and proposals

Towards the rational use of Healthcare Utilization Databases for generating real-world evidence new challenges and proposals