Administrative Databases and Diagnostic Therapeutic and Assistance Paths -PDTA- in the Monitoring Treatment of Rheumatoid Arthritis: The Experience of ATS Pavia.

Background: The current flows of the SSN represent the set of interest whose interconnection alone justifies the current study. These flows can be interconnected with other sources, institutional or otherwise, in order to answer well-defined questions. Objective: The objective of the study is to verify, through the analysis of administrative databases, any differences in the consumption of health resources between biological off-patent originator drugs and biosimilars in real clinical practice, with particular reference to the rheumatology area. Methods: Through the use of assisted databases (BDA) of ATS Pavia we evaluated the differences in terms of consumption of health resources related to the different drugs under analysis. Annual and daily costs were calculated by total patient cost, stratified for different treatments, considering the sum of total costs for the prescriptions of drugs subject to the analysis. Another objective was to evaluate the adherence of the drugs of interest, by utilizing specific indicators (MPR). Results: A total of 145 patients were analyzed. Among enrolled patients, 26.9% of users were treated with a biosimilar drug, while 73.1% with a biologic originator. Adherence is higher if it is considered the population treated with biosimilar drugs (82.1%). Total cost (including drug prescriptions, hospitalizations, outpatient services, tests for any cause) during the observation period of 1 year is 14,274.08. 87.7% of the total is attributable to drugs. Non-hospitalized patients are the least expensive, whether they were treated with biologics or biosimilars. Conclusion: In our sample, biosimilar drugs tend to be underused: the treatment of a patient with a chronic autoimmune disease is a clinical process that involves many health professionals, and a criticality could also derive from the difficult communication between the various professional figures who get involved with the whole patient treatment.

Asthma, COPD, Respiratory, and Allergic Health Effects in an Adult Population Living near an Italian Refinery: A Cross-Sectional Study.

BACKGROUND AND AIM: Asthma and chronic obstructive pulmonary disease (COPD) are leading causes of morbidity and mortality worldwide. Globally, 545 million people suffer from chronic respiratory diseases with a wide geographical variability. Risk factors for asthma are both genetic and related to several environmental factors (internal and external pollutants); these also have an important role in the occurrence of COPD. The aim of this study was to describe the prevalence of asthma, COPD, and asthma/COPD overlap (ACO) in an adult population living in two municipalities located in the Po Valley. METHODS: A standardized questionnaire on respiratory symptoms and sociodemographic characteristics was self-administered to a random sample of the adult population aged 20-64 years, living near a refinery in Northern Italy during the period between 2016 and 2019. Logistic and multinomial regression were implemented to explore factors associated with asthma, COPD, and ACO. RESULTS: In total, 1108 subjects filled out the questionnaire, the mean age was 48.02 ± 12.34 years (range 21-68), and 53% of the respondents/participants were female. Half of the responders were non-smokers, but the frequency of current and former smokers was significantly greater in men than in women (p < 0.001). The likelihood of being a probable case of asthma decreased with increasing age and increased for smokers. Tobacco smoke was associated with the presence of COPD and ACO. CONCLUSION: Respiratory diseases such as asthma and COPD are common in the general population, with differences among countries worldwide. Our findings show, on the basis of the main confirmed risk factor, namely smoking, that it is useful to plan target programs and actions in order to reduce smoking, thus improving the quality of life in public health.

Impact of the COVID-19 Pandemic on Total and Cause-Specific Mortality in Pavia, Northern Italy.

The COVID-19 pandemic had an unfavorable impact on overall mortality in Italy, with the strongest consequences in northern Italy. Scant data are available on cause-specific mortality. This study aims at investigating the impact of the pandemic on the overall and cause-specific mortality in one province in northern Italy, Pavia. We linked individual-level administrative data (i.e., death certification and population data) from the Health Protection Agency (HPA) in Pavia province between 2015 and 2020. We computed age-standardized mortality rates (Italian population 2011) by cause, sex, and calendar year, and computed the rate ratio and the corresponding 95% confidence intervals to compare rates in 2020 versus 2015-2019. The 2020 excess total mortality in Pavia was 24% in men and 25% in women, reaching rates of 1272.6/100,000 and 1304.4/100,000, respectively. Significant excesses were found for infectious and parasitic diseases, excluding COVID-19 (about +30% in both sexes); respiratory system diseases (44% in men; 30% in women); and dementia and Alzheimer's disease among men (24%). Reductions were reported for neoplasms (-14% in men); cerebrovascular diseases (-25% in men); and ischemic diseases (-13% in women), but also for transport accidents in men. COVID-19 was the third cause of death in both sexes with rates of 274.9/100,000 men (859 total deaths) and 213.9/100,000 women (758 total deaths). Excess mortality in Pavia was higher than Italy but lower than Lombardy. Increases in mortality from causes related to infectious and respiratory diseases can likely be explained by underdiagnosed deaths from COVID-19.

Influence of initial glucocorticoid co-medication on mortality and hospitalization in early inflammatory arthritis: an investigation by record linkage of clinical and administrative databases.

BACKGROUND: While low-dose oral glucocorticoids (GCs) are recommended in the management of early arthritis, their impact on mortality is unclear. The aim of this study is to evaluate the effect of GCs on mortality in patients with early arthritis, by linking clinical and administrative databases. METHODS: The study included patients with new-onset rheumatoid arthritis (RA) or undifferentiated arthritis (2005-2010), who received DMARDs (MTX in RA or UA with poor prognosis, hydroxychloroquine in UA) and were alive at the second year of follow-up. Low-dose GCs could be prescribed. Clinical and administrative data were linked from Administrative Health Databases (AHD) of the corresponding province, which provided us with information on drug delivery, comorbidities, hospitalization, and mortality. The effect of GCs in the first year was defined using a dichotomous variable or a 3-level categorization (not delivered, ≤7.5 mg/day, or >7.5 mg/day of prednisone) on all-cause mortality, assessed with Cox regression, either crude or adjusted for age, gender, Charlson Comorbidity Index (CCI) or single comorbidities, ACPA, HAQ, and MTX in the first year. A secondary analysis of the effect of GCs on related hospitalizations (for cardiovascular events, diabetes, serious infections, osteoporotic fractures) was also carried. RESULTS: Four hundred forty-nine patients were enrolled (mean age 58.59, RA 65.03%) of which 51 (11.36%) died during the study. The median (IQR) follow-up was equal to 103.91 (88.03-126.71) months. Treatments with GCs were formally prescribed to 198 patients (44.10%) at ≤7.5 mg/day, although by the end of the study such treatments were received by 257 patients (57.24%); 88 patients (19.6%) were treated with GCs at >7.5 mg/day. In adjusted analyses, the GC delivery (HR, 95% CI 1.35 (0.74, 2.47)) did not significantly predict mortality - both at a low (HR, 95% CI 1.41 (0.73, 2.71)) and at a high (HR, 95% CI 1.23 (0.52, 2.92)) dosage. When "all-cause hospitalization" was used as an outcome, the analysis did not show a difference between patients receiving GC and patients not receiving GC. CONCLUSION: In patients with early inflammatory arthritis, the initial GC dose was higher than that prescribed by rheumatologists; however, on background treatment with DMARDs, GC treatments did not seem to increase mortality and hospitalizations.

[Epidemiological analysis on the hospitalization from neurological diseases in the Province of Pavia (Lombardy Region, Northern Italy)]. / Analisi epidemiologica dei ricoveri per patologie neurologiche in Provincia di Pavia.

OBJECTIVES: to evaluate time and spatial distribution of hospitalization due to neurological diseases in the province of Pavia (Lombardy Region, Northern Italy). DESIGN: ecological study. SETTING AND PARTICIPANTS: the study was performed on aggregate data of people residing in the province of Pavia in the period 2005-2014. MAIN OUTCOME MEASURES: hospital discharge records of neurological diseases and raw and standardized hospitalization rates. RESULTS: hospitalization due to neurological diseases in the Province of Pavia showed a slight decreasing trend in time. For the year 2014, the spatial analysis of hospitalizations highlights excesses of risk in the Lomellina district, both in males and in females. CONCLUSION: spatial analysis confirms previous results on specific neurological diseases and suggests more detailed analysis on hospitalization excesses in Lomellina area.

Under-recognized post-stroke acute kidney injury: risk factors and relevance for stroke outcome of a frequent comorbidity.

BACKGROUND: Acute kidney injury (AKI) is emerging as a predictor of poor stroke outcome, however, it is often not recognized. The aim of our study was to evaluate post-stroke AKI burden, AKI risk factors and their influence in post-stroke outcome. METHODS: From 2013 to 2016, 440 individuals with stroke diagnosis admitted in Stroke Unit, Foundation IRCCS Policlinico San Matteo (Pavia, Italy), were retrospectively enrolled. AKI cases identified by KDIGO criteria through the electronic database and hospital chart review were compared with the ones reported in discharge letters or in administrative hospital data base. Mortality data were provided by Agenzia Tutela della Salute of Pavia. RESULTS: We included 430 patients in the analysis. Median follow-up was 19.2 months. We identified 79 AKI cases (18% of the enrolled patients, 92% classified as AKI stage 1), a fivefold higher number of cases than the ones reported at discharge. 37 patients had AKI at the admission in the hospital, while 42 developed AKI during the hospitalization. Cardioembolic (p = 0.01) and hemorrhagic (p = 0.01) stroke types were associated with higher AKI risk. Admission National Institutes of Health Stroke Scale (NIHSS, p < 0.05) and Charlson Comorbidity Index (p < 0.01) were independently associated with overall AKI, while admission NIHSS (p < 0.05) and eGFR (p < 0.005) were independently associated with AKI developed during the hospitalization. AKI was associated to longer in-hospital stay (p = 0.01), worse Rankin Neurologic Disability Score at discharge (p < 0.0001) and discharge disposition other than home (p = 0.03). AKI was also independently associated to higher in-hospital mortality (OR 3.9 95% CI 1.2-12.9 p = 0.023) but not with long-term survival. CONCLUSIONS: Post-stroke AKI diagnosis needs to be improved by strictly monitoring individuals with cardioembolic or hemorrhagic stroke, reduced kidney function, higher Charlson Comorbidity Index and worse NIHSS at presentation.

A validation study of a new classification algorithm to identify rheumatoid arthritis using administrative health databases: case-control and cohort diagnostic accuracy studies. Results from the RECord linkage On Rheumatic Diseases study of the Italian Society for Rheumatology.

OBJECTIVES: To develop and validate a new algorithm to identify patients with rheumatoid arthritis (RA) and estimate disease prevalence using administrative health databases (AHDs) of the Italian Lombardy region. DESIGN: Case-control and cohort diagnostic accuracy study. METHODS: In a randomly selected sample of 827 patients drawn from a tertiary rheumatology centre (training set), clinically validated diagnoses were linked to administrative data including diagnostic codes and drug prescriptions. An algorithm in steps of decreasing specificity was developed and its accuracy assessed calculating sensitivity/specificity, positive predictive value (PPV)/negative predictive value, with corresponding CIs. The algorithm was applied to two validating sets: 106 patients from a secondary rheumatology centre and 6087 participants from the primary care. Alternative algorithms were developed to increase PPV at population level. Crude and adjusted prevalence estimates taking into account algorithm misclassification rates were obtained for the Lombardy region. RESULTS: The algorithms included: RA certification by a rheumatologist, certification for other autoimmune diseases by specialists, RA code in the hospital discharge form, prescription of disease-modifying antirheumatic drugs and oral glucocorticoids. In the training set, a four-step algorithm identified clinically diagnosed RA cases with a sensitivity of 96.3 (95% CI 93.6 to 98.2) and a specificity of 90.3 (87.4 to 92.7). Both external validations showed highly consistent results. More specific algorithms achieved >80% PPV at the population level. The crude RA prevalence in Lombardy was 0.52%, and estimates adjusted for misclassification ranged from 0.31% (95% CI 0.14% to 0.42%) to 0.37% (0.25% to 0.47%). CONCLUSIONS: AHDs are valuable tools for the identification of RA cases at the population level, and allow estimation of disease prevalence and to select retrospective cohorts.