75 results on '"Polo Friz H"'
Search Results
2. 9.5 Impact of Antihypertensive Treatment on Long-Term Risk of Diabetes Mellitus in a General Population Setting: Data from the PAMELA Study
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Bombelli, M., Rondinelli, M., Sanvito, R., Fodri, D., Toso, E., Polo Friz, H., Casati, A., Primitz, L., Ganz, F., Buzzi, S., Quarti-Trevano, F., Grassi, G., Sega, R., and Mancia, G.
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- 2008
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3. 2.3 New-Onset Diabetes Mellitus and Impaired Fasting Glucose in White Coat, Masked And Sustained Hypertension: the PAMELA Study
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Bombelli, M., Polo Friz, H., Ganz, F., Sanvito, R., Quarti-Trevano, F., Fodri, D., Toso, E., Primitz, L., Rondinelli, M., Facchetti, R., Grassi, G., Sega, R., and Mancia, G.
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- 2008
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4. 5.3 Left Ventricular Mass Independently Contributes to Long-Term Risk of Cardiovascular Morbidity and Mortality in a General Population: Data From the PAMELA Study
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Bombelli, M., Sanvito, R., Fodri, D., Toso, E., Polo Friz, H., Primitz, L., Casati, A., Ganz, F., Quarti-Trevano, F., Buzzi, S., Carugo, S., Facchetti, R., Grassi, G., Sega, R., and Mancia, G.
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- 2008
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5. 2.4 White Coat and Masked Hypertension Increase the Risk of New Onset Sustained Hypertension in the General Population
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Bombelli, M., Polo Friz, H., Ganz, F., Buzzi, S., Ronchi, I., Toso, E., Sanvito, R., Fodri, D., Beltrame, L., Primitz, L., Quarti-Trevano, F., Facchetti, R., Grassi, G., Sega, R., and Mancia, G.
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- 2008
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6. Disegni osservazionali in farmacoepidemiologia per la stima dell'associazione tra esposizioni transitorie ed eventi acuti. L'effetto degli antibiotici sul rischio di aritmia
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ZAMBON, ANTONELLA, QUATTO, PIERO, CORRAO, GIOVANNI, Polo Friz, H, Costiero, P, Zambon, A, Polo Friz, H, Quatto, P, Costiero, P, and Corrao, G
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Stima ,Associazione ,Farmacoepidemiologia - Published
- 2006
7. FRI0118 Carotid Ultrasonography and Ankle-Brachial Index in The Cardiovascular Risk Assessment of Patients with Rheumatoid Arthritis: Table 1.
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Ricioppo, A., primary, Menghini, A., additional, Polo Friz, H., additional, Marano, G., additional, Primitz, L., additional, Molteni, M., additional, Arpaia, G., additional, Boracchi, P., additional, and Cimminiello, C., additional
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- 2016
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8. The definition of valvular and non-valvular atrial fibrillation: results of a physicians' survey
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Molteni, M., primary, Polo Friz, H., additional, Primitz, L., additional, Marano, G., additional, Boracchi, P., additional, and Cimminiello, C., additional
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- 2014
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9. DEMOGRAPHIC, ANTHROPOMETRIC, HAEMODYNAMIC AND METABOLIC DETERMINANTS OF LEFT ATRIAL SIZE IN THE GENERAL POPULATION: DATA FROM THE PAMELA STUDY
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Bombelli, M., primary, Cuspidi, C., additional, Fodri, D., additional, Peronio, M., additional, Toso, E., additional, Polo Friz, H., additional, Primitz, L., additional, Zazzeron, C., additional, Facchetti, R., additional, Grassi, G., additional, Sega, R., additional, and Mancia, G., additional
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- 2011
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10. NEW ONSET LEFT ATRIAL ENLARGEMENT IN A GENERAL POPULATION. DATA FROM THE PAMELA STUDY
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Bombelli, M., primary, Cuspidi, C., additional, Fodri, D., additional, Peronio, M., additional, Toso, E., additional, Polo Friz, H., additional, Brambilla, G., additional, Primitz, L., additional, Ronchi, I., additional, Ganz, F., additional, Facchetti, R., additional, Grassi, G., additional, Sega, R., additional, and Mancia, G., additional
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- 2011
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11. IMPACT OF BODY MASS INDEX AND WAIST CIRCUMFERENCE ON THE RISK OF CARDIOVASCULAR EVENTS AND ALL-CAUSE DEATH IN A GENERAL POPULATION: PP.7.283
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Bombelli, M, primary, Toso, E, additional, Casati, A, additional, Fodri, D, additional, Polo Friz, H, additional, Facchetti, R, additional, Invernizzi, D, additional, Quarti Trevano, F, additional, Grassi, G, additional, Sega, R, additional, and Mancia, G, additional
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- 2010
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12. Effect of macrolide and fluoroquinolone antibacterials on the risk of ventricular arrhythmia and cardiac arrest: an observational study in Italy using case-control, case-crossover and case-time-control designs.
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Zambon A, Polo Friz H, Contiero P, Corrao G, Zambon, Antonella, Polo Friz, Hernan, Contiero, Paolo, and Corrao, Giovanni
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Objective: To compare the effect of macrolide and fluoroquinolone antibacterials on the onset of ventricular arrhythmia and cardiac arrest using three different observational designs.Methods: A population-based case-control study was performed by linking automated databases from the Varese Province of Italy. Cases were all subjects who experienced ventricular arrhythmia or cardiac arrest from July 1998 to December 2003. For each case, up to ten controls were randomly selected after matching for sex, age, practitioner and date of arrhythmia onset. The use of macrolides and fluoroquinolones during two time windows denoted as recent and referent intervals was ascertained. Odds ratios were estimated using case-control, case-crossover and case-time-control approaches.Results: 1275 cases and 9189 controls met the inclusion criteria. Adjusted odds ratios (and corresponding 95% CIs) associated with recent exposure to macrolides were 2.13 (1.34, 3.39), 1.70 (0.88, 3.26) and 1.62 (0.78, 3.34) by using case-control, case-crossover and case-time-control designs, respectively. The corresponding estimates for fluoroquinolones were 3.58 (2.51, 5.12), 1.98 (1.19, 3.29) and 1.59 (0.88, 2.87), respectively.Conclusions: Three observational study designs each using entirely different sets of controls consistently showed that recent use of macrolide and fluoroquinolone antibacterials may be associated with increased risk of ventricular arrhythmia and cardiac arrest. [ABSTRACT FROM AUTHOR]- Published
- 2009
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13. What hinders the uptake of computerized decision support systems in hospitals? A qualitative study and framework for implementation
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Liberati, Elisa, Ruggiero, F, Galuppo, L, Gorli, M, González-Lorenzo, M, Maraldi, M, Ruggieri, P, Polo Friz, H, Scaratti, G, Kwag, KH, Vespignani, R, and Moja, L
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healthcare professions ,evidence-based medicine ,qualitative research ,3. Good health ,clinical decision support systems ,health information technology - Abstract
Background: Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption. Methods: Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff and members of the boards of directors (n=30). We used a constant comparative approach to develop a framework for guiding implementation. Findings: We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as ‘positions’. The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians’ perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related with the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians’ reasoning and fostering organizational learning. Discussion: Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians’ attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships and an organizational ethos of transparency and accountability need to considered when exploring the readiness of a hospital to adopt CDSSs., This work is supported by the Italian Ministry of Health (GR-2009-1606736), Regione Lombardia (D.R.G. IX/4340 26/10/2012), and the Wellcome Trust (WT097899).
14. What hinders the uptake of computerized decision support systems in hospitals? A qualitative study and framework for implementation
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Liberati, EG, Ruggiero, F, Galuppo, L, Gorli, M, González-Lorenzo, M, Maraldi, M, Ruggieri, P, Polo Friz, H, Scaratti, G, Kwag, KH, Vespignani, R, and Moja, L
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healthcare professions ,evidence-based medicine ,qualitative research ,3. Good health ,clinical decision support systems ,health information technology - Abstract
Background: Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption. Methods: Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff and members of the boards of directors (n=30). We used a constant comparative approach to develop a framework for guiding implementation. Findings: We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as ‘positions’. The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians’ perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related with the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians’ reasoning and fostering organizational learning. Discussion: Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians’ attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships and an organizational ethos of transparency and accountability need to considered when exploring the readiness of a hospital to adopt CDSSs.
15. Short and long-term mortality in elderly patients with suspected not confirmed pulmonary embolism
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Valentina Pezzetti, Alessandro Caleffi, Annalisa Orenti, Luca Cavalieri d'Oro, Claudio Cimminiello, Giuseppe Vighi, Cristina Giannattasio, Patrizia Boracchi, Hernan Polo Friz, Mattia Brambilla, Polo Friz, H, Orenti, A, Brambilla, M, Caleffi, A, Pezzetti, V, Cavalieri d'Oro, L, Giannattasio, C, Vighi, G, Cimminiello, C, and Boracchi, P
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medicine.medical_specialty ,Prognosi ,Population ,030204 cardiovascular system & hematology ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Internal Medicine ,medicine ,Humans ,030212 general & internal medicine ,Mortality ,education ,Chronic cardiopulmonary disease ,Retrospective Studies ,Aged ,education.field_of_study ,business.industry ,Pulmonary embolism ,Retrospective cohort study ,Emergency department ,Prognosis ,medicine.disease ,Lower prevalence ,Population study ,Long term mortality ,business - Abstract
Introduction: Most patients evaluated for suspected pulmonary embolism(PE) conclude the Emergency Department(ED) work-up with a diagnosis of PE not confirmed(PE excluded;PE-E). We aimed to investigate the clinical features, short and long-term mortality, and prognostic factors for death in elderly with PE-E, and to compare these figures with those of patients with PE confirmed(PE-C). Methods: Consecutive patients ≥65 years old evaluated in the ED for clinically suspected hemodynamically stable acute PE were included in this retrospective cohort study. Results: Study population: 657 patients with suspected PE, PE-C:162(24.65%). When compared with PE-C, patients with PE-E presented a higher prevalence of chronic cardiopulmonary disease (17.37% vs 8.02%, p = 0.003), a lower prevalence of pulse rate >110 (13.13% vs 25.93%; p0 was associated with higher short and long-term mortality (30-day:HR:5.31,p = 0.029; 5 year:HR:2.18, p < 0.001), meanwhile comorbidity (Charlson Comorbidity Index>0) only with higher long-term mortality (30-day: HR:1.60, p = 0.342; 5 year: HR:1.41, p = 0.038). Conclusion: In real world haemodinamically stable elderly patients evaluated in the ED for suspected PE, short and long-term mortality was markedly high regardless whether PE was confirmed or excluded. At the time to set management and follow up strategies, elderly patients with PE excluded should not be considered a low-risk population.
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- 2020
16. Comorbidity burden conditions the prognostic performance of D-dimer in elderly patients with acute pulmonary embolism
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Melisa Polo Friz, Veronica Punzi, Luca Cavalieri d'Oro, Cristina Giannattasio, Valentina Pezzetti, Giuseppe Vighi, Alessandro Caleffi, Hernan Polo Friz, Annalisa Orenti, Chiara Crivellari, Daniela Teruzzi, Patrizia Boracchi, Francesco Petri, Claudio Cimminiello, Valeria Corno, POLO FRIZ, H, Pezzetti, V, Orenti, A, Caleffi, A, Corno, V, Crivellari, C, Petri, F, Polo Friz, M, Punzi, V, Teruzzi, D, D'Oro, L, Giannattasio, C, Vighi, G, Cimminiello, C, and Boracchi, P
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Male ,medicine.medical_specialty ,Prognosi ,Population ,Comorbidity ,Risk Assessment ,Severity of Illness Index ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,D-dimer ,medicine ,Humans ,Mortality ,education ,Proportional Hazards Models ,Retrospective Studies ,Aged ,Aged, 80 and over ,education.field_of_study ,business.industry ,Pulmonary embolism ,Area under the curve ,030208 emergency & critical care medicine ,Retrospective cohort study ,General Medicine ,Emergency department ,medicine.disease ,Emergency Medicine ,Population study ,Female ,Emergency Service, Hospital ,business - Abstract
Introduction The prognostic accuracy of D-dimer for risk assessment in acute Pulmonary Embolism (APE) patients may be hampered by comorbidities. We investigated the impact of comorbidity burden (CB) by using the Charlson Comorbidity Index (CCI), on the prognostic ability of D-dimer to predict 30 and 90-day mortality in hemodynamically stable elderly patients with APE. Methods All patients aged >65 years with normotensive APE, consecutively evaluated in the Emergency Department since 2010 through 2014 were included in this retrospective cohort study. Area under the curve (AUC) and ½ Net Reclassification Improvement (NRI) were calculated. Results Study population: 162 patients, median age: 79.2 years. The optimal cut-off value of CCI score for predicting mortality was ≤1 (Low CB) and >1 (High CB), AUC = 0.786. Higher levels of D-dimer were associated with an increased risk death at 30 (HR = 1.039, 95%CI:1.000–1.080, p = 0.049) and 90 days (HR = 1.039, 95%CI:1.009–1.070, p = 0.012). When added to simplified Pulmonary Embolism Severity Index (sPESI) score, D-dimer increased significantly the AUC for predicting 30-day mortality in Low CB (AUC = 0.778, 95%CI:0.620–0.937, ½NRI = 0.535, p = 0.015), but not in High CB patients (AUC = 0.634, 95%CI:0.460–0.807, ½ NRI = 0.248, p = 0.294). Similarly, for 90-day mortality D-dimer increased significantly the AUC in Low CB (AUC = 0.786, 95%CI:0.643–0.929, ½NRI = 0.424, p-value = 0.025), but not in High CB patients (AUC = 0.659, 95%CI:0.541–0.778, ½NRI = 0.354, p-value = 0.165). Conclusion In elderly patients with normotensive APE, comorbidities condition the prognostic performance of D-dimer, which was found to be a better predictor of death in subjects with low CB. These results support multimarker strategies for risk assessment in this population.
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- 2019
17. A survey on the views and attitudes of Italian physicians regarding the prophylaxis and treatment of venous thromboembolism
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Hernan Polo Friz, Walter Ageno, Claudio Cimminiello, Paolo Prandoni, Giovanni Di Minno, Giancarlo Agnelli, Davide Imberti, Francesco Scaglione, Ageno, W., Di Minno, G., Agnelli, G., Cimminiello, C., Imberti, D., Polo Friz, H., Prandoni, P., and Scaglione, F.
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medicine.medical_specialty ,Time Factors ,business.industry ,Attitude of Health Personnel ,MEDLINE ,Contraindications, Drug ,Anticoagulants ,General Medicine ,Venous Thromboembolism ,Heparin, Low-Molecular-Weight ,Health Care Surveys ,Physicians ,medicine ,Humans ,Enoxaparin ,Mobility Limitation ,Intensive care medicine ,business ,Venous thromboembolism - Published
- 2020
18. Predictors of medium- and long-term mortality in elderly patients with acute pulmonary embolism
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Giuseppe Vighi, Elia Gelfi, Cristina Giannattasio, Luca Cavalieri d'Oro, Laura Primitz, Annalisa Orenti, Claudio Cimminiello, Hernan Polo Friz, Elena Motto, Patrizia Boracchi, Polo Friz, H, Orenti, A, Gelfi, E, Motto, E, Primitz, L, Cavalieri d'Oro, L, Giannattasio, C, Vighi, G, Cimminiello, C, and Boracchi, P
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0301 basic medicine ,Prognostic factor ,medicine.medical_specialty ,Prognosi ,Cardiology ,Respiratory system ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,lcsh:Social sciences (General) ,Mortality ,lcsh:Science (General) ,Aged ,Public health ,Multidisciplinary ,business.industry ,Pulmonary embolism ,Retrospective cohort study ,Emergency department ,medicine.disease ,Prognosis ,Predictive value ,Cardiovascular system ,030104 developmental biology ,Charlson comorbidity index ,Hematological system ,Population study ,Long term mortality ,lcsh:H1-99 ,business ,030217 neurology & neurosurgery ,lcsh:Q1-390 ,Research Article ,Circulatory system - Abstract
Introduction Data on medium- and long-term prognostic factors for death in elderly patients with acute Pulmonary Embolism (APE) are lacking. The present study aimed to assess sPESI score and the Charlson Comorbidity Index (CCI) as medium- and long-term predictors of mortality in elderly patients with haemodinamically stable APE. Methods All consecutive patients aged≥65 years old, evaluated at the emergency department (ED) of our hospital from 2010 through 2014, with a final diagnosis of APE, were included in this retrospective cohort study. Results Study population:162 patients, female:36.5%, median age:79 years old, 74% presented a sPESI score>0, and 61% a CCI≥ 1. All causes mortality: 19.8%, 23.5%, 26.5%, 32.1% and 48.2% at 3, 6 months, 1, 2 and 5 years after APE. Univariate regression analysis: CCI≥1 was associated with a higher mortality at 3, 6 months, 1, 2 and 5 years. Multivariate Cox analysis: CCI≥1 associated with increased mortality at 3 months (HR:4.29; IC95%:1.46–12.59), 6 months (HR:5.33; IC95%:1.84–15.44), 1 year (HR:4.87; IC95%:1.87–12.70), 2 years (HR:3.78; IC95%:1.74–8.25), and 5 years (HR:2.30; IC95%:1.33–3.99). sPESI score≥1 was not found to be related to an increased medium-or long-term mortality. Negative predictive values (IC95%) of CCI≥1 were 93.65% (87.61–99.69), 93.65% (87.61–99.69), 92.06% (85.37–98.76), 87.3% (79.05–95.55) and 71.61% (60.13–83.1) for mortality at 3, 6 months, 1, 2 and 5 years. Conclusion In elderly patients with a confirmed normotensive APE, unlike sPESI score, CCI showed to be an independent prognostic factor for medium- and long-term mortality. In these patients, after the acute phase following a PE event, the assessment of the comorbidities burden represents the most appropriate approach for predicting medium- and long-term mortality., Public health; Cardiology; Cardiovascular system; Circulatory system; Hematological system; Respiratory system; Pulmonary embolism; Mortality; Prognosis; Aged
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- 2020
19. Comorbidity assessment as predictor of short and long-term mortality in elderly patients with hemodynamically stable acute pulmonary embolism
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Melisa Polo Friz, Patrizia Boracchi, Giuseppe Vighi, Veronica Punzi, Luca Cavalieri d'Oro, Cristina Giannattasio, Claudio Cimminiello, Valeria Corno, Chiara Buzzini, Francesco Petri, Daniela Teruzzi, Chiara Crivellari, Hernan Polo Friz, Annalisa Orenti, Polo Friz, H, Corno, V, Orenti, A, Buzzini, C, Crivellari, C, Petri, F, Polo Friz, M, Punzi, V, Teruzzi, D, Cavalieri d'Oro, L, Giannattasio, C, Vighi, G, Cimminiello, C, and Boracchi, P
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medicine.medical_specialty ,Prognosi ,Comorbidity ,030204 cardiovascular system & hematology ,Risk Assessment ,Severity of Illness Index ,03 medical and health sciences ,Hemodynamically stable ,0302 clinical medicine ,Internal medicine ,Severity of illness ,medicine ,Humans ,030212 general & internal medicine ,Mortality ,Retrospective Studies ,Aged ,Aged, 80 and over ,business.industry ,Pulmonary embolism ,Retrospective cohort study ,MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Hematology ,Emergency department ,Prognosis ,medicine.disease ,Surgery ,Cardiology ,Long term mortality ,Cardiology and Cardiovascular Medicine ,business ,Risk assessment - Abstract
Elderly patients presenting with acute pulmonary embolism (PE) frequently have significant underlying comorbidities which may condition the prognosis. The current study aimed to determine the ability of Charlson comorbidity index (CCI) score to predict short and long-term mortality in elderly patients with hemodynamically stable acute PE. All hemodynamically stable patients aged >65 years with acute PE, evaluated in the Emergency Department since 2010 through 2014, were included in this retrospective cohort study. CCI, simplified pulmonary embolism severity index (sPESI) scores and vital status were recorded. Were included 162 patients with confirmed PE, out of 657 suspected cases (24.7%). Median age: 79.2 years, 74.1% presented an sPESI > 1 and 61.1% a CCI > 1. The overall 30, 90-day and 2-year mortality was 11.7% (95%CI 6.6–16.6), 19.8% (95%CI 13.4–25.7) and 31.8% (95%CI 24.1–38.8). For 30-day mortality sPESI showed an AUC 0.642 (95%CI 0.511–0.772) and adding CCI as covariate did not increase its prognostic performance. For 90-day mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.282 (95%CI 1.151–1.429, p-value < 0.001), and sPESI a HR = NS(p-value = 0.267). For 2-year mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.295 (95%CI 1.180–1.421, p-value < 0.001) and sPESI a HR = NS(p-value = 0.353). In elderly patients with hemodynamically stable PE, the CCI score was found to be an independent predictor of mortality. CCI shows a significantly better ability to predict 90-day and 2-year mortality than sPESI. The assessment of comorbidity burden by using the CCI score may be proposed as an useful tool to predict mortality in these patients.
- Published
- 2017
20. Biosimilars of low-molecular-weight heparin products: Fostering competition or reducing 'biodiversity'?
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J. Harenberg, Paolo Prandoni, G. Di Minno, Giancarlo Agnelli, H. Polo Friz, Claudio Cimminiello, Francesco Scaglione, Harenberg, J., Cimminiello, C., Agnelli, G., DI MINNO, Giovanni, Polo Friz, H, Prandoni, P., and Scaglione, F.
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Male ,Drug ,medicine.medical_specialty ,Drug Industry ,medicine.drug_class ,media_common.quotation_subject ,Low molecular weight heparin ,030204 cardiovascular system & hematology ,Pharmacology ,Risk Assessment ,Drug Costs ,03 medical and health sciences ,Patient safety ,Biosimilar pharmaceuticals ,0302 clinical medicine ,Biosimilar Pharmaceuticals ,Risk Factors ,Drug Discovery ,Antithrombotic ,Biosimilar pharmaceutical ,Humans ,Medicine ,030212 general & internal medicine ,Low-molecular-weight heparin ,Intensive care medicine ,media_common ,Economic Competition ,business.industry ,Evidence-based practise ,Therapeutic equivalency ,Venous thromboembolism ,Hematology ,Anticoagulants ,Biosimilar ,Heparin, Low-Molecular-Weight ,Clinical trial ,Patient Safety ,business ,Risk assessment - Abstract
The term 'biosimilars' is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small-molecule drugs and this is especially true for low-molecular-weight heparins (LMWHs). Evidence on the antithrombotic management of acute coronary syndromes (ACS) showed that the introduction into the market of biosimilars approved on the basis of simple biological criteria, without robust data from comparative clinical trials, may be hazardous. Moreover, the mixtures of LMWH polysaccharide chains, some immunoallergic properties and potential contamination during the extraction process raise safety concerns. As was the case for the biosimilar erythropoietin, there is the risk that only copies of the most commercially successful LMWHs will be marketed, thus jeopardizing the 'biodiversity' now ensured by the presence of several LMWHs, each with unique features that support the use of an individual LMWH as first-choice therapy in certain categories of patients.
- Published
- 2016
21. Long-Term Risk of Sustained Hypertension in White-Coat or Masked Hypertension
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Hernan Polo Friz, Guido Grassi, Rita Facchetti, Roberto Sega, Fabiana Madotto, Fosca Quarti-Trevano, Michele Bombelli, Giuseppe Mancia, Mancia, G, Bombelli, M, Facchetti, R, Madotto, F, QUARTI TREVANO, F, Polo Friz, H, Grassi, G, and Sega, R
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,Ambulatory blood pressure ,Prognosi ,Office Visits ,White-coat hypertension ,White coat hypertension ,Risk Assessment ,Sensitivity and Specificity ,Severity of Illness Index ,Masked hypertension ,Body Mass Index ,Cohort Studies ,Sex Factors ,Reference Values ,Internal medicine ,Internal Medicine ,Humans ,Medicine ,Risk factor ,Probability ,Analysis of Variance ,Physician-Patient Relations ,business.industry ,Cholesterol, HDL ,Age Factors ,Case-control study ,Blood Pressure Determination ,Odds ratio ,Blood Pressure Monitoring, Ambulatory ,Middle Aged ,medicine.disease ,Survival Analysis ,Surgery ,Masked Hypertension ,Blood pressure ,Case-Control Studies ,Hypertension ,Ambulatory ,Cardiology ,Female ,Ambulatory blood pressure monitoring ,MED/09 - MEDICINA INTERNA ,business - Abstract
It is debated whether white-coat (WCHT) and masked hypertension (MHT) are at greater risk of developing a sustained hypertensive state (SHT). In 1412 subjects of the Pressioni Arteriose Monitorate e Loro Associazioni Study, we measured office blood pressure (BP), 24-hour ambulatory BP, and home BP. The condition of WCHT was identified as office BP >140/90 mm Hg and 24-hour BP mean P
- Published
- 2009
22. Simultaneous validation of the SunTech 247 diagnostic station blood pressure measurement device according to the British hypertension society protocol, the international protocol and the association for the advancement of medical instrumentation standards
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Valentina Galbiati, Laura Primitz, Hernan Polo Friz, Aristodemo Ricioppo, Luca Beltrame, Rita Facchetti, Roberto Sega, Michele Bombelli, Polo Friz, H, Facchetti, R, Primitz, L, Beltrame, L, Galbiati, V, Ricioppo, A, Bombelli, M, and Sega, R
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Male ,medicine.medical_specialty ,Systole ,SunTech medical ,Diastole ,Assessment and Diagnosis ,Automated blood pressure ,Device validation ,Oscillometric ,Medical instrumentation ,Oscillometry ,Internal Medicine ,Medicine ,Humans ,Blood pressure measurement ,Aged ,Advanced and Specialized Nursing ,Protocol (science) ,Aged, 80 and over ,Observer Variation ,business.industry ,Blood Pressure Determination ,General Medicine ,Middle Aged ,247 Diagnostic station ,International protocol ,Surgery ,Blood pressure ,Emergency medicine ,Hypertension ,Device validation protocols comparison ,Female ,Cardiology and Cardiovascular Medicine ,business ,Observer variation - Abstract
OBJECTIVE: SunTech 247 is an oscillometric blood pressure (BP) monitor manufactured by SunTech Medical Inc., Morrisville, North Carolina, USA. The aims of this study were (i) to determine its accuracy using the 1993 modified British Hypertension Society (BHS) protocol, the 2002 International Protocol (IP) and the 2002/2003 Association for the Advancement of Medical Instrumentation (AAMI) standards, (ii) to compare the performance of BHS protocol and IP. METHODS: Systolic BP (SBP) and diastolic BP (DBP) were recorded to the nearest 2 mmHg and measured with the arm supported at heart level. For each participant, nine sequential same arm measurements were taken by two trained observers, comparing the device to standard mercury sphygmomanometers. Procedures and data analysis were carried out following protocols guidelines. RESULTS: First, we recruited 33 participants required by the IP. Then, data collection continued to obtain 85 participants for the BHS protocol/AAMI standard. Readings differing by less than 5, 10 and 15 mmHg for SBP and DBP fulfilled IP recommendations. According to the BHS protocol, for the better observer, the percentage of test device readings differing from the mercury standard by 5, 10 and 15 mmHg or less were: 92.9, 100 and 100% for SBP and 94.9, 98.8 and 99.6% for DBP. The mean differences± standard deviation between the device and mercury sphygmomanometer readings were 1.7±3.1 mmHg for SBP and 1.1±3.2 mmHg for DBP, achieving AAMI requirements. Standard deviation of mean differences were 2.4 for SBP and 2.1 for DBP, following the IP, and 3.1 and 3.2, respectively, for BHS protocol. The variance of all 99 differences (total deviance), with 98 degree of freedom, was 585.6 for SBP and 444.1 for DBP. The 33 differences obtained from the mean differences for each participant (between-subject variance), with 32 degree of freedom, were 275.6 and 152.1, respectively. F test was 1.83 with P = 0.0191 for SBP, and 1.07 (P = 0.3936) for DBP. CONCLUSION: (i) The device achieved the requirements stated by the 2002 IP, fulfilled the standards stated by the AAMI, and on the basis of the standards indicated by the 1993 modified BHS protocol, can be classified as 'A' grade both for SBP and DBP. Therefore, SunTech 247 may be recommended for clinical use, (ii) IP and BHS protocol provide complementary features for device validation; the comparison of total deviance and between-subject variance confirms the estimates of IP authors for SBP
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- 2009
23. Effect of macrolide and fluoroquinolone antibacterials on the risk of ventricular arrhythmia and cardiac arrest: An observational study in Italy using case-control, case-crossover and case-time-control designs
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Hernan Polo Friz, Giovanni Corrao, Paolo Contiero, Antonella Zambon, Zambon, A, Polo Friz, H, Contiero, P, and Corrao, G
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Adult ,Male ,Risk ,medicine.medical_specialty ,Heart disease ,Adolescent ,Population ,Toxicology ,Young Adult ,Internal medicine ,medicine ,Odds Ratio ,Ventricular Dysfunction ,Humans ,Pharmacology (medical) ,Risk factor ,education ,MED/01 - STATISTICA MEDICA ,Antibacterial agent ,Aged ,Pharmacology ,education.field_of_study ,Cross-Over Studies ,business.industry ,Case-control study ,Arrhythmias, Cardiac ,Odds ratio ,Ventricular Arrhythmia, Cardiac Arrest, Case-Control, Case-Crossover, Case-Time-Control ,Middle Aged ,medicine.disease ,Crossover study ,Surgery ,Anti-Bacterial Agents ,Heart Arrest ,Italy ,Research Design ,Case-Control Studies ,Data Interpretation, Statistical ,Observational study ,Female ,Macrolides ,business ,Fluoroquinolones - Abstract
Objective: To compare the effect of macrolide and fluoroquinolone antibacterials on the onset of ventricular arrhythmia and cardiac arrest using three different observational designs. Methods: A population-based case-control study was performed by linking automated databases from the Varese Province of Italy. Cases were all subjects who experienced ventricular arrhythmia or cardiac arrest from July 1998 to December 2003. For each case, up to ten controls were randomly selected after matching for sex, age, practitioner and date of arrhythmia onset. The use of macrolides and fluoroquinolones during two time windows denoted as recent and referent intervals was ascertained. Odds ratios were estimated using case-control, case-crossover and case-time-control approaches. Results: 1275 cases and 9189 controls met the inclusion criteria. Adjusted odds ratios (and corresponding 95% CIs) associated with recent exposure to macrolides were 2.13 (1.34, 3.39), 1.70 (0.88, 3.26) and 1.62 (0.78, 3.34) by using case-control, case-crossover and case-time-control designs, respectively. The corresponding estimates for fluoroquinolones were 3.58 (2.51, 5.12), 1.98 (1.19, 3.29) and 1.59 (0.88, 2.87), respectively. Conclusions: Three observational study designs each using entirely different sets of controls consistently showed that recent use of macrolide and fluoroquinolone antibacterials may be associated with increased risk of ventricular arrhythmia and cardiac arrest. © 2009 Adis Data Information BV. All rights reserved.
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- 2009
24. Accuracy evaluation of the 'Cardiette BP one' ambulatory blood pressure monitor
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Luca Beltrame, Rita Facchetti, Roberto Sega, Michele Bombelli, Laura Primitz, Hernan Polo Friz, Polo Friz, H, Sega, R, Facchetti, R, Primitz, L, Beltrame, L, and Bombelli, M
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Adult ,Male ,medicine.medical_specialty ,Ambulatory blood pressure ,Diastole ,Sphygmomanometer ,Assessment and Diagnosis ,Mean difference ,Internal medicine ,Oscillometry ,Internal Medicine ,medicine ,Humans ,Aged ,Advanced and Specialized Nursing ,Aged, 80 and over ,business.industry ,Reproducibility of Results ,General Medicine ,Blood Pressure Monitoring, Ambulatory ,Middle Aged ,Mercury sphygmomanometer ,Surgery ,Self Care ,Blood pressure ,Blood pressure measurement device ,Ambulatory ,Hypertension ,Accuracy evaluation ,Ambulatory recorder ,Cardiology ,Female ,MED/09 - MEDICINA INTERNA ,Cardiology and Cardiovascular Medicine ,business - Abstract
OBJECTIVE: Blood pressure (BP) 'Cardiette BP one' system (BP one) is an oscillometric ambulatory BP monitor manufactured in Italy in conformity to current regulations for medical devices. We decided to determine the accuracy of measures made with BP one, using the protocol of the British Hypertension Society published in 1990, and revised in 1993, for evaluating the accuracy of BP measurement devices. METHODS: The evaluation included before-use calibration, in-use assessment, after-use calibration, and static device validation that involved 85 participants. RESULTS: The mean difference between manual readings with sphygmomanometer and automatic ones with the device were -0.36±5.74 (mean±SD) for systolic values and 2.52±4.87 for diastolic values. On the basis of the percentages of measurements differing from the mercury sphygmomanometer standard by ≤5, ≤10, and ≤15 mmHg, the device was graded 'A' for systolic and diastolic BP, for low, median, and high BP values. CONCLUSION: On the basis of the standards indicated by the 1993 modified British Hypertension Society protocol, the BP one recorder can be classified as 'A' grade both for systolic and diastolic pressure. © 2008 Lippincott Williams & Wilkins, Inc.
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- 2008
25. Prevalence and clinical significance of a greater ambulatory versus office blood pressure ('reversed white coat' condition) in a general population
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Giovanni Corrao, Elena Banfi, Laura Primitz, Stefano Carugo, Hernan Polo Friz, Giuseppe Mancia, Riccardo Sanvito, Andrea Maria Vertemati, Roberto Sega, Michele Bombelli, Rita Facchetti, Bombelli, M, Sega, R, Facchetti, R, Corrao, G, Polo Friz, H, Vertemati, A, Sanvito, R, Banfi, E, Carugo, S, Primitz, L, and Mancia, G
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Adult ,Male ,medicine.medical_specialty ,Ambulatory blood pressure ,Physiology ,Population ,Blood Pressure ,Left ventricular hypertrophy ,White coat effect ,Internal medicine ,Internal Medicine ,medicine ,Prevalence ,Humans ,Clinical significance ,education ,Aged ,education.field_of_study ,business.industry ,White coat ,Blood Pressure Monitoring, Ambulatory ,Middle Aged ,medicine.disease ,Prognosis ,Physicians' Offices ,Surgery ,Circadian Rhythm ,Blood pressure ,Italy ,Echocardiography ,Ambulatory ,Hypertension ,Cardiology ,Female ,Hypertrophy, Left Ventricular ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Attention has recently been directed to a condition termed 'reversed white coat' because of an average 24 h ambulatory blood pressure (BP) uncharacteristically greater than office BP. No data are available, however, on the prevalence of this condition in the general population, as well as on its relationship to BP, age, gender, antihypertensive treatment and cardiac organ damage. Methods: In 3200 individuals (participation rate 64%), randomly selected to be representative of the residents of Monza (Milan, Italy) for sex and decades of age (25 to 74 years), we measured office BP (average of three measurements, sphygmomanometry), ambulatory BP (automatic readings every 20 min, Spacelabs 90207) and left ventricular mass (echocardiography). Results: A 'reversed white coat' condition (identified when 24-h average ambulatory systolic, diastolic or mean were higher than the corresponding office values) was seen in 15% (diastolic) to 26% (systolic) of the population as a whole. Prevalence was greater (34-40%) when the difference between office and daytime BP was considered but in both instances it remained less than the prevalence of the white-coat phenomenon. A reversed white-coat condition was similarly frequent in males and females and showed a steep reduction with age and increasing office BP values. Prevalence was greater in hypertensive subjects in whom treatment achieved BP control than in untreated or unsatisfactorily treated individuals. Within each quartile of 24-h or office BP, left ventricular mass index adjusted for demographic and biochemical values was similar in reversed white coat versus the remaining subjects. The absence of any association with left ventricular hypertrophy scores against the clinical significance of this phenomenon. © 2005 Lippincott Williams & Wilkins.
26. Barriers and facilitators to the implementation of computerized decision support systems in italian hospitals: A grounded theory study | Barriere e facilitatori all'implementazione dei sistemi di supporto decisionale computerizzati in ospedale: Uno studio 'grounded theory'
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Liberati, E. G., Laura GALUPPO, Gorli, M., Maraldi, M., Ruggiero, F., Capobussi, M., Banzi, R., Kwag, K., Scaratti, G., Nanni, O., Ruggieri, P., Friz, H. P., Cimminiello, C., Bosio, M., Mangia, M., Moja, L., Liberati EG, Galuppo L, Gorli M, Maraldi M, Ruggiero F, Capobussi M, Banzi R, Kwag K, Scaratti G, Nanni O, Ruggieri P, Polo Friz H, Cimminiello C, Bosio M, Mangia M, and Moja L
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Evidence-based medicine ,Perceptions ,Grounded theory - Abstract
INTRODUCTION: Computerized Decision Support Systems (CDSSs) connect health care professionals with high-quality, evidence-based information at the point-of-care to guide clinical decision-making. Current research shows the potential of CDSSs to improve the efficiency and quality of patient care. The mere provision of the technology, however, does not guarantee its uptake. This qualitative study aims to explore the barriers and facilitators to the use of CDSSs as identified by health providers. METHODS: The study was performed in three Italian hospitals, each characterized by a different level of familiarity with the CDSS technology. We interviewed frontline physicians, nurses, information technology staff, and members of the hospital board of directors (n=24). A grounded theory approach informed our sampling criteria as well as the data collection and analysis. RESULTS: The adoption of CDSSs by health care professionals can be represented as a process that consists of six "positionings," each corresponding to an individual's use and perceived mastery of the technology. In conditions of low mastery, the CDSS is perceived as an object of threat, an unfamiliar tool that is difficult to control. On the other hand, individuals in conditions of high mastery view the CDSS as a helpful tool that can be locally adapted and integrated with clinicians' competences to fulfil their needs. In the first positionings, the uptake of CDSSs is hindered by representational obstacles. The last positionings, alternatively, featured technical obstacles to CDSS uptake. DISCUSSION: Our model of CDSS adoption can guide hospital administrators interested in the future integration of CDSSs to evaluate their organizational contexts, identify potential challenges to the implementation of the technology, and develop an effective strategy to address them. Our findings also allow reflections concerning the misalignment between most Italian hospitals and the current innovation trends toward the uptake of computerized decision support technologies.
27. Machine learning and LACE index for predicting 30-day readmissions after heart failure hospitalization in elderly patients.
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Polo Friz H, Esposito V, Marano G, Primitz L, Bovio A, Delgrossi G, Bombelli M, Grignaffini G, Monza G, and Boracchi P
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- Aged, Emergency Service, Hospital, Hospitalization, Humans, Length of Stay, Logistic Models, Machine Learning, Retrospective Studies, Risk Factors, Heart Failure therapy, Patient Readmission
- Abstract
Machine learning (ML) techniques may improve readmission prediction performance in heart failure (HF) patients. This study aimed to assess the ability of ML algorithms to predict unplanned all-cause 30-day readmissions in HF elderly patients, and to compare them with conventional LACE (Length of hospitalization, Acuity, Comorbidities, Emergency department visits) index. All patients aged ≥ 65 years discharged alive between 2010 and 2019 after a hospitalization for acute HF were included in this retrospective cohort study. We applied MICE (Multivariate Imputation via Chained Equations) method to obtain a balanced, fully valued dataset and LASSO (Least Absolute Shrinkage and Selection Operator) algorithm to get the most significant features. Training (80% of records) and test (20%) cohorts were randomly selected. Study population: 3079 patients, 394 (12.8%) presented at least one readmission within 30 days, and 2685 (87.2%) did not. In the test cohort AUCs (IC95%) of XGBoost, Ada Boost Classifier, Random forest, and Gradient Boosting, and LACE Index were: 0.803 (0.734-0.872), 0.782 (0.711-0.854), 0.776 (0.703-0.848), 0.786 (0.715-0.857), and 0.504 (0.414-0.594), respectively, for predicting readmissions. A SHAP analysis was performed to offer a breakdown of the ML variables associated with readmission. Positive and negative predicting values estimates of the different ML models and LACE index were also provided, for several values of readmission rate prevalence. Among elderly patients, the rate of all-cause unplanned 30-day readmissions after hospitalization due to an acute HF was high. ML models performed better than the conventional LACE index for predicting readmissions. ML models can be proposed as promising tools for the identification of subjects at high risk of hospitalization in this clinical setting, enabling care teams to target interventions for improving overall clinical outcomes., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)
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- 2022
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28. Right ventricle assessment in patients with pulmonary embolism at low risk for death based on clinical models: an individual patient data meta-analysis.
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Becattini C, Maraziti G, Vinson DR, Ng ACC, den Exter PL, Côté B, Vanni S, Doukky R, Khemasuwan D, Weekes AJ, Soares TH, Ozsu S, Polo Friz H, Erol S, Agnelli G, and Jiménez D
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- Acute Disease, Biomarkers, Heart Ventricles, Humans, Natriuretic Peptide, Brain, Peptide Fragments, Prognosis, Risk Assessment, Troponin, Pulmonary Embolism, Ventricular Dysfunction, Right
- Abstract
Aims: Patients with acute pulmonary embolism (PE) at low risk for short-term death are candidates for home treatment or short-hospital stay. We aimed at determining whether the assessment of right ventricle dysfunction (RVD) or elevated troponin improves identification of low-risk patients over clinical models alone., Methods and Results: Individual patient data meta-analysis of studies assessing the relationship between RVD or elevated troponin and short-term mortality in patients with acute PE at low risk for death based on clinical models (Pulmonary Embolism Severity Index, simplified Pulmonary Embolism Severity Index or Hestia). The primary study outcome was short-term death defined as death occurring in hospital or within 30 days. Individual data of 5010 low-risk patients from 18 studies were pooled. Short-term mortality was 0.7% [95% confidence interval (CI) 0.4-1.3]. RVD at echocardiography, computed tomography or B-type natriuretic peptide (BNP)/N-terminal pro BNP (NT-proBNP) was associated with increased risk for short-term death (1.5 vs. 0.3%; OR 4.81, 95% CI 1.98-11.68), death within 3 months (1.6 vs. 0.4%; OR 4.03, 95% CI 2.01-8.08), and PE-related death (1.1 vs. 0.04%; OR 22.9, 95% CI 2.89-181). Elevated troponin was associated with short-term death (OR 2.78, 95% CI 1.06-7.26) and death within 3 months (OR 3.68, 95% CI 1.75-7.74)., Conclusion: RVD assessed by echocardiography, computed tomography, or elevated BNP/NT-proBNP levels and increased troponin are associated with short-term death in patients with acute PE at low risk based on clinical models. RVD assessment, mainly by BNP/NT-proBNP or echocardiography, should be considered to improve identification of low-risk patients that may be candidates for outpatient management or short hospital stay., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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29. Acute pulmonary embolism in patients presenting pulmonary deterioration after hospitalisation for non-critical COVID-19.
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Polo Friz H, Gelfi E, Orenti A, Motto E, Primitz L, Donzelli T, Intotero M, Scarpazza P, Vighi G, Cimminiello C, and Boracchi P
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- Aged, Fibrin Fibrinogen Degradation Products, Hospitalization, Humans, Retrospective Studies, SARS-CoV-2, COVID-19, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism epidemiology
- Abstract
Background: Emerging evidence suggests an association between COVID-19 and acute pulmonary embolism (APE)., Aims: To assess the prevalence of APE in patients hospitalised for non-critical COVID-19 who presented clinical deterioration, and to investigate the association of clinical and biochemical variables with a confirmed diagnosis of APE in these subjects., Methods: All consecutive patients admitted to the internal medicine department of a general hospital with a diagnosis of non-critical COVID-19, who performed a computer tomography pulmonary angiography (CTPA) for respiratory deterioration in April 2020, were included in this retrospective cohort study., Results: Study populations: 41 subjects, median (interquartile range) age: 71.7 (63-76) years, CPTA confirmed APE = 8 (19.51%, 95% confidence interval (CI): 8.82-34.87%). Among patients with and without APE, no significant differences were found with regards symptoms, comorbidities, treatment, Wells score and outcomes. The optimal cut-off value of d-dimer for predicting APE was 2454 ng/mL, sensitivity (95% CI): 63 (24-91), specificity: 73 (54-87), positive predictive value: 36 (13-65), negative predictive value: 89 (71-98) and AUC: 0.62 (0.38-0.85). The standard and age-adjusted d-dimer cut-offs, and the Wells score ≥2 did not associate with confirmed APE, albeit a cut-off value of d-dimer = 2454 ng/mL showed an relative risk: 3.21; 95% CI: 0.92-13.97; P = 0.073. Heparin at anticoagulant doses was used in 70.73% of patients before performing CTPA., Conclusion: Among patients presenting pulmonary deterioration after hospitalisation for non-critical COVID-19, the prevalence of APE is high. Traditional diagnostic tools to identify high APE pre-test probability patients do not seem to be clinically useful. These results support the use of a high index of suspicion for performing CTPA to exclude or confirm APE as the most appropriate diagnostic approach in this clinical setting., (© 2021 Royal Australasian College of Physicians.)
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- 2021
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30. Predictors of medium- and long-term mortality in elderly patients with acute pulmonary embolism.
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Polo Friz H, Orenti A, Gelfi E, Motto E, Primitz L, Cavalieri d'Oro L, Giannattasio C, Vighi G, Cimminiello C, and Boracchi P
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Introduction: Data on medium- and long-term prognostic factors for death in elderly patients with acute Pulmonary Embolism (APE) are lacking. The present study aimed to assess sPESI score and the Charlson Comorbidity Index (CCI) as medium- and long-term predictors of mortality in elderly patients with haemodinamically stable APE., Methods: All consecutive patients aged≥65 years old, evaluated at the emergency department (ED) of our hospital from 2010 through 2014, with a final diagnosis of APE, were included in this retrospective cohort study., Results: Study population:162 patients, female:36.5%, median age:79 years old, 74% presented a sPESI score>0, and 61% a CCI≥ 1. All causes mortality: 19.8%, 23.5%, 26.5%, 32.1% and 48.2% at 3, 6 months, 1, 2 and 5 years after APE. Univariate regression analysis: CCI≥1 was associated with a higher mortality at 3, 6 months, 1, 2 and 5 years. Multivariate Cox analysis: CCI≥1 associated with increased mortality at 3 months (HR:4.29; IC95%:1.46-12.59), 6 months (HR:5.33; IC95%:1.84-15.44), 1 year (HR:4.87; IC95%:1.87-12.70), 2 years (HR:3.78; IC95%:1.74-8.25), and 5 years (HR:2.30; IC95%:1.33-3.99). sPESI score≥1 was not found to be related to an increased medium-or long-term mortality. Negative predictive values (IC95%) of CCI≥1 were 93.65% (87.61-99.69), 93.65% (87.61-99.69), 92.06% (85.37-98.76), 87.3% (79.05-95.55) and 71.61% (60.13-83.1) for mortality at 3, 6 months, 1, 2 and 5 years., Conclusion: In elderly patients with a confirmed normotensive APE, unlike sPESI score, CCI showed to be an independent prognostic factor for medium- and long-term mortality. In these patients, after the acute phase following a PE event, the assessment of the comorbidities burden represents the most appropriate approach for predicting medium- and long-term mortality., (© 2020 The Author(s).)
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- 2020
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31. A survey on the views and attitudes of Italian physicians regarding the prophylaxis and treatment of venous thromboembolism.
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Ageno W, Di Minno G, Agnelli G, Cimminiello C, Imberti D, Polo Friz H, Prandoni P, and Scaglione F
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- Anticoagulants adverse effects, Contraindications, Drug, Enoxaparin adverse effects, Health Care Surveys statistics & numerical data, Heparin, Low-Molecular-Weight adverse effects, Heparin, Low-Molecular-Weight therapeutic use, Humans, Mobility Limitation, Time Factors, Anticoagulants therapeutic use, Attitude of Health Personnel, Enoxaparin therapeutic use, Physicians, Venous Thromboembolism drug therapy, Venous Thromboembolism prevention & control
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- 2020
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32. Short and long-term mortality in elderly patients with suspected not confirmed pulmonary embolism.
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Polo Friz H, Orenti A, Brambilla M, Caleffi A, Pezzetti V, Cavalieri d'Oro L, Giannattasio C, Vighi G, Cimminiello C, and Boracchi P
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- Aged, Humans, Prognosis, Retrospective Studies, Risk Factors, Severity of Illness Index, Pulmonary Embolism
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Introduction: Most patients evaluated for suspected pulmonary embolism(PE) conclude the Emergency Department(ED) work-up with a diagnosis of PE not confirmed(PE excluded;PE-E). We aimed to investigate the clinical features, short and long-term mortality, and prognostic factors for death in elderly with PE-E, and to compare these figures with those of patients with PE confirmed(PE-C)., Methods: Consecutive patients ≥65 years old evaluated in the ED for clinically suspected hemodynamically stable acute PE were included in this retrospective cohort study., Results: Study population: 657 patients with suspected PE, PE-C:162(24.65%). When compared with PE-C, patients with PE-E presented a higher prevalence of chronic cardiopulmonary disease (17.37% vs 8.02%, p = 0.003), a lower prevalence of pulse rate >110 (13.13% vs 25.93%; p<0.001), of arterial oxygen saturation <90% (16.16% vs. 25.93%; p = 0.007) and of hospitalized patients (52.93% vs 98.15%; p < 0.001). Thirty-day, 90-day, 1-year, 2-year and 5-year overall mortality was 8.83%, 15.98%, 23.59%, 29.68%, and 51.09%, respectively, differences between PE-E and PE-C non statistically significant. Among patients with PE-E, multivariate analysis showed that simplified Pulmonary Embolism Severity Index score>0 was associated with higher short and long-term mortality (30-day:HR:5.31,p = 0.029; 5 year:HR:2.18, p < 0.001), meanwhile comorbidity (Charlson Comorbidity Index>0) only with higher long-term mortality (30-day: HR:1.60, p = 0.342; 5 year: HR:1.41, p = 0.038)., Conclusion: In real world haemodinamically stable elderly patients evaluated in the ED for suspected PE, short and long-term mortality was markedly high regardless whether PE was confirmed or excluded. At the time to set management and follow up strategies, elderly patients with PE excluded should not be considered a low-risk population., Competing Interests: Declaration of Competing Interest None to declare., (Copyright © 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)
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- 2020
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33. Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.
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Moja L, Polo Friz H, Capobussi M, Kwag K, Banzi R, Ruggiero F, González-Lorenzo M, Liberati EG, Mangia M, Nyberg P, Kunnamo I, Cimminiello C, Vighi G, Grimshaw JM, Delgrossi G, and Bonovas S
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- Aged, Electronic Health Records, Female, Hospital Mortality, Hospitals, General, Humans, Italy, Length of Stay, Male, Middle Aged, Outcome Assessment, Health Care, Decision Support Systems, Clinical, Evidence-Based Medicine methods, Hospital Information Systems, Practice Patterns, Physicians' statistics & numerical data, Precision Medicine methods
- Abstract
Importance: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients., Objective: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care., Design, Setting, and Participants: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018., Interventions: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations., Main Outcomes and Measures: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality., Results: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods., Conclusions and Relevance: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes., Trial Registration: ClinicalTrials.gov identifier: NCT02577198.
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- 2019
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34. Comorbidity burden conditions the prognostic performance of D-dimer in elderly patients with acute pulmonary embolism.
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Polo Friz H, Pezzetti V, Orenti A, Caleffi A, Corno V, Crivellari C, Petri F, Polo Friz M, Punzi V, Teruzzi D, d'Oro LC, Giannattasio C, Vighi G, Cimminiello C, and Boracchi P
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- Aged, Aged, 80 and over, Comorbidity, Emergency Service, Hospital statistics & numerical data, Female, Humans, Male, Proportional Hazards Models, Retrospective Studies, Risk Assessment, Severity of Illness Index, Fibrin Fibrinogen Degradation Products metabolism, Pulmonary Embolism mortality
- Abstract
Introduction: The prognostic accuracy of D-dimer for risk assessment in acute Pulmonary Embolism (APE) patients may be hampered by comorbidities. We investigated the impact of comorbidity burden (CB) by using the Charlson Comorbidity Index (CCI), on the prognostic ability of D-dimer to predict 30 and 90-day mortality in hemodynamically stable elderly patients with APE., Methods: All patients aged >65 years with normotensive APE, consecutively evaluated in the Emergency Department since 2010 through 2014 were included in this retrospective cohort study. Area under the curve (AUC) and ½ Net Reclassification Improvement (NRI) were calculated., Results: Study population: 162 patients, median age: 79.2 years. The optimal cut-off value of CCI score for predicting mortality was ≤1 (Low CB) and >1 (High CB), AUC = 0.786. Higher levels of D-dimer were associated with an increased risk death at 30 (HR = 1.039, 95%CI:1.000-1.080, p = 0.049) and 90 days (HR = 1.039, 95%CI:1.009-1.070, p = 0.012). When added to simplified Pulmonary Embolism Severity Index (sPESI) score, D-dimer increased significantly the AUC for predicting 30-day mortality in Low CB (AUC = 0.778, 95%CI:0.620-0.937, ½NRI = 0.535, p = 0.015), but not in High CB patients (AUC = 0.634, 95%CI:0.460-0.807, ½ NRI = 0.248, p = 0.294). Similarly, for 90-day mortality D-dimer increased significantly the AUC in Low CB (AUC = 0.786, 95%CI:0.643-0.929, ½NRI = 0.424, p-value = 0.025), but not in High CB patients (AUC = 0.659, 95%CI:0.541-0.778, ½NRI = 0.354, p-value = 0.165)., Conclusion: In elderly patients with normotensive APE, comorbidities condition the prognostic performance of D-dimer, which was found to be a better predictor of death in subjects with low CB. These results support multimarker strategies for risk assessment in this population., (Copyright © 2018 Elsevier Inc. All rights reserved.)
- Published
- 2019
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35. Patterns of treatment with antiplatelet therapy after an acute coronary syndrome: Data from a large database in a community setting.
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Cimminiello C, Dondi L, Pedrini A, Ronconi G, Calabria S, Piccinni C, Polo Friz H, Martini N, and Maggioni AP
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- Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome economics, Acute Coronary Syndrome mortality, Adult, Aged, Aged, 80 and over, Ambulatory Care economics, Ambulatory Care trends, Community Health Services economics, Databases, Factual, Drug Costs trends, Drug Prescriptions, Drug Utilization trends, Dual Anti-Platelet Therapy adverse effects, Dual Anti-Platelet Therapy economics, Dual Anti-Platelet Therapy mortality, Female, Guideline Adherence trends, Hospital Costs trends, Humans, Male, Middle Aged, Patient Readmission economics, Patient Readmission trends, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors economics, Practice Guidelines as Topic, Practice Patterns, Physicians' economics, Retrospective Studies, Time Factors, Treatment Outcome, Acute Coronary Syndrome drug therapy, Community Health Services trends, Dual Anti-Platelet Therapy trends, Platelet Aggregation Inhibitors therapeutic use, Practice Patterns, Physicians' trends
- Abstract
Aims: Current guidelines strongly recommend antiplatelet therapy with aspirin plus a P2Y
12 receptor inhibitor (dual therapy) for patients with acute coronary syndrome (ACS). To better understand how antiplatelet treatment is prescribed in clinical practice, the aim of this study was to provide a more detailed description of real-world patients with and without antiplatelet treatment after an ACS, their outcomes at one-year follow-up and the related integrated cost., Methods: The ReS database, including more than 12 million inhabitants, was evaluated. During the accrual period ACS patients discharged alive were identified on the basis of ICD-IX-CM code. Antiplatelet drug prescriptions and healthcare costs were analysed over one-year follow-up., Results: In 2014, of the 25,129 patients discharged alive after an ACS, 5796 (23%) did not receive any antiplatelet therapy during the first month after hospital discharge. Among them, 3846 (66%) subjects were prescribed an antiplatelet drug subsequently, while 7.7% did not receive any antiplatelet treatment during the whole following year. Dual therapy in the subgroup of patients undergoing a revascularization procedure ( n = 8436) was prescribed to 79.2% of cases and to 46.1% ( n = 4009) of medically managed patients. The patients not treated with an antiplatelet treatment in the first month showed the highest one-year healthcare costs, mostly due to hospital re-admissions., Conclusions: This analysis of a large patient community shows that a considerable proportion of patients remained untreated with antiplatelet treatment after an ACS event. A clearer characterization of these subjects can help to improve the adherence to the current guidelines and recommendations.- Published
- 2019
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36. Investigation on Dabigatran Etexilate and Worsening of Renal Function in Patients with Atrial fibrillation: The IDEA Study.
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Molteni M, Crippa M, Orenti A, Polo Friz H, Menghini A, Tramacere P, Marano G, Cimminiello C, and Boracchi P
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- Aged, Aged, 80 and over, Antithrombins pharmacology, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Dabigatran pharmacology, Female, Follow-Up Studies, Humans, Kidney Function Tests trends, Male, Prospective Studies, Antithrombins therapeutic use, Atrial Fibrillation drug therapy, Dabigatran therapeutic use, Kidney drug effects, Kidney physiology
- Abstract
Background and Objectives: Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function., Method: One hundred and seven patients treated long term with dabigatran etexilate for non-valvular atrial fibrillation (NVAF) were followed up for 90 days. DPC, serum creatinine (SCr) and serum cystatin C were prospectively measured. Ninety five patients had complete follow-up data and were evaluable for primary endpoint., Results: Eleven patients had supratherapeutic DPC, defined as DPC higher than 200 ng/ml at study enrolment, but at the end of follow-up no patient showed a persistent increase in SCr. No patients experienced acute kidney injury., Conclusions: Our study shows that no persistent renal detrimental effect is associated with dabigatran treatment. An increase in SCr during dabigatran treatment is reversible and it seems to be unrelated to dabigatran itself.
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- 2019
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37. Non-vitamin k antagonist oral anticoagulants in a European primary care physician survey.
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Cimminiello C, Hatala R, Pakarinen S, Polo Friz H, Fitzmaurice D, and Hobbs FR
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Background: Familiarity and competency in the options for stroke prevention in atrial fibrillation (AF) and the role of non-vitamin K antagonist oral anticoagulants (NOACs) may vary among primary care physicians (PCPs) from different European countries., Aims: To investigate PCP views on prescribing and managing NOACs across Europe and identify perceived unmet needs., Design & Setting: Web-based survey including PCPs with particular interest in cardiovascular medicine., Method: A questionnaire was drawn up, containing 10 questions on initiation and ongoing management of NOACs; use of AF stroke guidelines on NOACs and anticoagulant switching; and perceived information needs., Results: The overall response rate was 42%. The majority of PCPs declared they are responsible for and confident in both initiating and managing NOAC therapy. In some countries, PCPs are not able to initiate NOAC therapy due to administrative barriers (namely, Italy and Slovakia). No single set of guidelines is referred to across all countries and over a fifth of responders indicate they do not follow specific guidelines. The main learning needs reported were more related to initiation than to ongoing management of anticoagulant therapy., Conclusion: According to this self-assessment survey, the experience of most PCPs in management of different aspects of AF appears good and only some felt the need for further training. However, in the light of the importance of this topic as public health issue, intensified efforts aiming at better equipping PCPs to meet their key roles in an integrated service across Europe are overdue.
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- 2018
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38. Antithrombotic therapy for venous thromboembolism in patients with cancer: expert guidance.
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Imberti D, Cimminiello C, Di Nisio M, Marietta M, Polo Friz H, and Ageno W
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- Fibrinolytic Agents pharmacology, Humans, Neoplasms pathology, Venous Thromboembolism pathology, Fibrinolytic Agents therapeutic use, Neoplasms complications, Venous Thromboembolism drug therapy
- Abstract
Introduction: Most of the current clinical guidelines recommend the use of Low-Molecular-Weight Heparins (LMWHs) for cancer-associated thrombosis (CAT). The Hokusai VTE-cancer trial reported the first results of a direct comparison between a direct oral anticoagulant (DOAC), edoxaban, and LMWH in this setting., Areas Covered: This review aims to critically appraise the currently available evidence on the efficacy and safety of anticoagulant agents for the long-term treatment of CAT and to provide an expert opinion and guidance in this field., Expert Opinion: Based on the available evidence, DOACs represent a valid alternative to LMWH for the treatment of CAT for the majority of patients with active cancer. Currently, most solid evidence comes from the Hokusai VTE-cancer study, which showed that edoxaban is non-inferior to the LMWH dalteparin, with a trend toward fewer recurrent venous thromboembolic events, but with more major bleeding events. Similar findings were reported with rivaroxaban, although the study was not sufficiently powered to allow definitive conclusions. The majority of bleeding events occurred in the upper gastrointestinal tract and in patients with gastrointestinal cancer. Thus, LMWH remains the preferred option for patients with gastrointestinal cancer. Additional studies aimed to confirm these findings with other DOACs are now warranted.
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- 2018
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39. Thromboprophylaxis with enoxaparin and direct oral anticoagulants in major orthopedic surgery and acutely ill medical patients: a meta-analysis.
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Cimminiello C, Prandoni P, Agnelli G, Di Minno G, Polo Friz H, Scaglione F, Boracchi P, Marano G, and Harenberg J
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- Anticoagulants pharmacology, Anticoagulants therapeutic use, Clinical Trials, Phase III as Topic, Drug-Related Side Effects and Adverse Reactions complications, Drug-Related Side Effects and Adverse Reactions epidemiology, Enoxaparin adverse effects, Enoxaparin pharmacology, Enoxaparin therapeutic use, Hemorrhage epidemiology, Hemorrhage etiology, Hemorrhage mortality, Heparin, Low-Molecular-Weight adverse effects, Heparin, Low-Molecular-Weight pharmacology, Heparin, Low-Molecular-Weight therapeutic use, Humans, Orthopedic Procedures adverse effects, Pulmonary Embolism drug therapy, Pulmonary Embolism epidemiology, Pulmonary Embolism prevention & control, Thromboembolism drug therapy, Thromboembolism epidemiology, Administration, Oral, Anticoagulants adverse effects, Thromboembolism prevention & control
- Abstract
Subjects undergoing major orthopedic surgery and acutely ill hospitalized medical patients represent a population at medium-high risk for venous thromboembolism (VTE). They are treated with low molecular weight heparin (LMWH) and direct oral anticoagulants [DOACs] for VTE prevention. We conducted a meta-analysis of phase III randomized clinical trials evaluating LMWH enoxaparin versus DOACs for prophylaxis of VTE by combining studies including patients undergoing elective total hip and knee replacement surgery, and acutely ill hospitalized medical subjects. Studies were searched using PubMed, MEDLINE, and EMBASE databases until December 2016. Differences in clinical outcomes for efficacy and safety endpoints between treatment groups were expressed as risk differences with 95% confidence intervals (95% CI), using random effects regression models. Fourteen RCTs were considered (60,467 subjects). Overall mortality, symptomatic deep venous thrombosis, non-fatal pulmonary embolism (PE) major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) are not different between treatment regimens. Treatment with LMWH enoxaparin is associated with a lower risk of fatal PE plus VTE-related death compared therapy with DOACs (RD = 0.040%, 95% CI 0.001-0.080%, p = 0.0434). Subgroup analysis shows an incidence of MB (RD = 0.181%, 95% CI 0.029-0.332%, p = 0.0033) and CRNMB (RD = 0.546%, 95% CI 0.009-1.082%, p = 0.0462) in patients treated with 40 mg OD enoxaparin compared to DOACs. In major orthopedic surgery and acutely ill hospitalized medical patients, DOACs do not offer clear advantages in terms of clinical efficacy compared to enoxaparin. The advantage of the latter in terms of major and CRNMB, when used at a dose of 40 mg, is statistically significant, but small in terms of clinical relevance.
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- 2017
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40. Comorbidity assessment as predictor of short and long-term mortality in elderly patients with hemodynamically stable acute pulmonary embolism.
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Polo Friz H, Corno V, Orenti A, Buzzini C, Crivellari C, Petri F, Polo Friz M, Punzi V, Teruzzi D, Cavalieri d'Oro L, Giannattasio C, Vighi G, Cimminiello C, and Boracchi P
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- Aged, Aged, 80 and over, Comorbidity, Humans, Mortality, Prognosis, Retrospective Studies, Risk Assessment, Pulmonary Embolism diagnosis, Pulmonary Embolism mortality, Severity of Illness Index
- Abstract
Elderly patients presenting with acute pulmonary embolism (PE) frequently have significant underlying comorbidities which may condition the prognosis. The current study aimed to determine the ability of Charlson comorbidity index (CCI) score to predict short and long-term mortality in elderly patients with hemodynamically stable acute PE. All hemodynamically stable patients aged >65 years with acute PE, evaluated in the Emergency Department since 2010 through 2014, were included in this retrospective cohort study. CCI, simplified pulmonary embolism severity index (sPESI) scores and vital status were recorded. Were included 162 patients with confirmed PE, out of 657 suspected cases (24.7%). Median age: 79.2 years, 74.1% presented an sPESI > 1 and 61.1% a CCI > 1. The overall 30, 90-day and 2-year mortality was 11.7% (95%CI 6.6-16.6), 19.8% (95%CI 13.4-25.7) and 31.8% (95%CI 24.1-38.8). For 30-day mortality sPESI showed an AUC 0.642 (95%CI 0.511-0.772) and adding CCI as covariate did not increase its prognostic performance. For 90-day mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.282 (95%CI 1.151-1.429, p-value < 0.001), and sPESI a HR = NS(p-value = 0.267). For 2-year mortality, in an adjusted model including sPESI and CCI, CCI showed a HR 1.295 (95%CI 1.180-1.421, p-value < 0.001) and sPESI a HR = NS(p-value = 0.353). In elderly patients with hemodynamically stable PE, the CCI score was found to be an independent predictor of mortality. CCI shows a significantly better ability to predict 90-day and 2-year mortality than sPESI. The assessment of comorbidity burden by using the CCI score may be proposed as an useful tool to predict mortality in these patients.
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- 2017
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41. Simultaneous validation of the SunTech CT40 automated blood pressure measurement device by the 1993 British Hypertension Society protocol and the Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 standard.
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Polo Friz H, Punzi V, Petri F, Orlandi R, Maggiolini D, Polo Friz M, Primitz L, and Vighi G
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- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Oscillometry, Blood Pressure, Blood Pressure Determination instrumentation, Sphygmomanometers standards
- Abstract
Objective: This study aimed to perform a simultaneous, third-party, independent validation of the oscillometric SunTech CT40 device for blood pressure (BP) measurement, according to the 1993 protocol of the British Hypertension Society and the standard of the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) 81060-2:2013., Participants and Methods: Patient recruitment, study procedures, and data analysis followed the recommendations stated by the protocols. The study was approved by the institutional review board., Results: A total of 94 participants were included, 52 (55.3%) women, mean±SD age: 63.1±18.0 years, mean±SD arm circumference: 35.0±9.0 cm. The average of observers' entry BPs was 146.9±37.2 mmHg for systolic blood pressure (SBP) and 82.2±22.1 mmHg for diastolic blood pressure (DBP). Differences between the standard measurement and the test device within 5, 10, and 15 mmHg, for the better observer, were 79.4, 96.5, and 100.0% for SBP and 82.6, 97.5, and 100.0% for DBP, respectively. The mean±SD differences between the readings obtained using the test device and those obtained by the observers (AAMI/ISO 81060-2:2013 standard criterion 1) were 0.3±5.0 mmHg (SBP) and -0.8±4.3 mmHg (DBP), and the mean±SD differences between average of reference readings and average of test device readings in each patient (criterion 2) were 0.3±3.9 and -0.8±3.5 mmHg for SBP and DBP, respectively., Conclusion: The CT40 BP device achieved A/A grade of the British Hypertension Society protocol and fulfilled the requirements (criteria 1 and 2) of the AAMI/ISO standard. CT40 can be recommended for BP measurement in adults.
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- 2017
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42. What hinders the uptake of computerized decision support systems in hospitals? A qualitative study and framework for implementation.
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Liberati EG, Ruggiero F, Galuppo L, Gorli M, González-Lorenzo M, Maraldi M, Ruggieri P, Polo Friz H, Scaratti G, Kwag KH, Vespignani R, and Moja L
- Subjects
- Humans, Qualitative Research, Decision Support Systems, Clinical, Health Plan Implementation methods, Hospitals
- Abstract
Background: Advanced Computerized Decision Support Systems (CDSSs) assist clinicians in their decision-making process, generating recommendations based on up-to-date scientific evidence. Although this technology has the potential to improve the quality of patient care, its mere provision does not guarantee uptake: even where CDSSs are available, clinicians often fail to adopt their recommendations. This study examines the barriers and facilitators to the uptake of an evidence-based CDSS as perceived by diverse health professionals in hospitals at different stages of CDSS adoption., Methods: Qualitative study conducted as part of a series of randomized controlled trials of CDSSs. The sample includes two hospitals using a CDSS and two hospitals that aim to adopt a CDSS in the future. We interviewed physicians, nurses, information technology staff, and members of the boards of directors (n = 30). We used a constant comparative approach to develop a framework for guiding implementation., Results: We identified six clusters of experiences of, and attitudes towards CDSSs, which we label as "positions." The six positions represent a gradient of acquisition of control over CDSSs (from low to high) and are characterized by different types of barriers to CDSS uptake. The most severe barriers (prevalent in the first positions) include clinicians' perception that the CDSSs may reduce their professional autonomy or may be used against them in the event of medical-legal controversies. Moving towards the last positions, these barriers are substituted by technical and usability problems related to the technology interface. When all barriers are overcome, CDSSs are perceived as a working tool at the service of its users, integrating clinicians' reasoning and fostering organizational learning., Conclusions: Barriers and facilitators to the use of CDSSs are dynamic and may exist prior to their introduction in clinical contexts; providing a static list of obstacles and facilitators, irrespective of the specific implementation phase and context, may not be sufficient or useful to facilitate uptake. Factors such as clinicians' attitudes towards scientific evidences and guidelines, the quality of inter-disciplinary relationships, and an organizational ethos of transparency and accountability need to be considered when exploring the readiness of a hospital to adopt CDSSs.
- Published
- 2017
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43. Patterns and determinants of use of pharmacological therapies for intermittent claudication in PAD outpatients: results of the IDOMENEO study.
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Cimminiello C, Polo Friz H, Marano G, Arpaia G, Boracchi P, Spezzigu G, and Visonà A
- Subjects
- Aged, Ankle Brachial Index, Cilostazol, Female, Humans, Italy, Male, Middle Aged, Multivariate Analysis, Outpatients, Patient Compliance, Polypharmacy, Prospective Studies, Risk Factors, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Intermittent Claudication drug therapy, Peripheral Arterial Disease complications, Platelet Aggregation Inhibitors therapeutic use, Tetrazoles therapeutic use
- Abstract
Background: Peripheral arterial disease (PAD) usually presents with intermittent claudication (IC). The aim of the present study was to assess, in clinical practice, the pattern of use of pharmacological therapies for IC in stable PAD outpatients., Methods: A propensity analysis was performed using data from the IDOMENEO study, an observational prospective multicenter cohort study. The association between any pharmacological symptomatic IC therapy with different variables was investigated using generalized linear mixed models with pharmacological therapy as response variable and binomial error., Results: Study population: 213 patients, male sex 147 (69.0%), mean age 70.0±8.6 years. Only 36.6% was under pharmacological treatment for IC, being cilostazol the most used medication (21.6%). Univariate analysis showed a probability of a patient of being assigned to any pharmacological symptomatic IC therapy of 67.0% when Ankle-Brachial Index (ABI) <0.6 and 29.8% when ABI>0.6 (P=0.0048), and a propensity to avoid pharmacological treatment for patients with a high number of drugs to treat cardiovascular risk factors (probability of 55.2% for <4 drugs and 19.6% for >4 drugs, P=0.0317). Multivariate analysis confirmed a higher probability of assigning treatment for ABI<0.6 (P=0.0274), and a trend to a lower probability in patients under polypharmacy (>4 drugs: OR=0.13, P=0.0546)., Conclusions: In clinical practice, only one third of stable outpatients with IC used symptomatic pharmacological therapy for IC. We found a propensity of clinicians to assign any symptomatic pharmacological IC therapy to patients with lower values of ABI and a propensity to avoid this kind of treatment in patients under polypharmacy.
- Published
- 2017
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44. The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV).
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Imberti D, Marietta M, Polo Friz H, and Cimminiello C
- Abstract
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars approval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients at risk of venous thromboembolism. Also the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly underpowered to draw any conclusions about the safety profile of the drug. In our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their actual, clinical "similarity". On these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and reappraising some critical points regarding the introduction of biosimilars of LMWH in Europe. Moreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the post-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual efficacy and safety of LMWH biosimilars.
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- 2017
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45. [Computerized decision support systems: EBM at the bedside].
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Capobussi M, Banzi R, Moja L, Bonovas S, González-Lorenzo M, Liberati EG, Polo Friz H, Nanni O, Mangia M, and Ruggiero F
- Subjects
- Electronic Health Records, Evidence-Based Medicine, Humans, Italy, Retrospective Studies, Decision Support Systems, Clinical
- Abstract
Introduction: One of the aims of Evidence-Based Medicine is to improve quality and appropriateness of care by the expedition of the knowledge transfer process. Computerized Decision Support Systems (CDSSs) are computer programs that provide alerts to the prescribing doctor directly at the moment of medical examination. In fact, alerts are integrated within the single patient electronic health record. CDSS based on the best available and updated evidence and guidelines may be an efficient tool to facilitate the transfer of the latest results from clinical research directly at the bedside, thus supporting decision-making., Objectives: The CODES (COmputerized DEcision Support) trial is a research program funded by the Italian Ministry of Health and the Lombardy Region. It aims to evaluate the feasibility of the implementation of a CDSS at the hospital level and to assess its efficacy in daily clinical practice., Methods: The CODES project includes two pragmatic RCTs testing a CDSS (i.e. the EBMeDS - MediDSS) in two large Italian hospitals: the first is a general hospital in Vimercate (Lombardy), the second is an oncologic research center in Meldola (Emilia Romagna). The CDSS supports a full spectrum of decisions: therapy, drug interactions, diagnosis, and management of health care services are covered by a hundreds of reminders. However only few reminders are activated per patient, highlighting crucial problems in the delivery of high-quality care. The two trials have similar design and primary outcome, the rate at which alerts detected by the software are resolved by a decision of the clinicians. The project also includes the assessment of barriers and facilitators in the adoption of these new technologies by hospital staff members and the retrospective evaluation of the repeated risks in prescription habits., Results: The trials are ongoing and currently more than 10,000 patients have been randomized. The qualitative analysis revealed a progressive shift in the perception of the tool. Doctors are now seeing it as a trusted second opinion, available 24/7, which is tailored to the needs of the patient. The retrospective analysis showed the opportunity to achieve a better healthcare quality through an active risk management. Aggregating data from whole hospitals emerge rare drug interactions that otherwise would not be recognizable., Discussion: CDSS are promising tools to support clinicians in everyday practice. They can be used as a real time app or to perform retrospective analyses. These data can provide unique resources to hospital management.
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- 2016
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46. Prognostic value of D-dimer in elderly patients with Pulmonary Embolism.
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Polo Friz H, Buzzini C, Orenti A, Punzi V, Molteni M, Primitz L, Cavalieri d'Oro L, Arpaia G, Boracchi P, and Cimminiello C
- Subjects
- Aged, Aged, 80 and over, Cohort Studies, Humans, Multivariate Analysis, Predictive Value of Tests, Prognosis, Pulmonary Embolism blood, Retrospective Studies, Time Factors, Fibrin Fibrinogen Degradation Products analysis, Pulmonary Embolism mortality
- Abstract
In a general population with acute Pulmonary Embolism (PE) elevated D-dimer concentrations associate with increased mortality. The aim of the study was to assess the ability of D-dimer to predict 30 and 90-days mortality in elderly patients with acute PE. Hemodynamically stable patients aged ≥65 years old with confirmed PE were included in this retrospective cohort study. A pulmonary computerized tomography angiography scan, D-dimer concentrations, simplified Pulmonary Embolism Severity Index (sPESI) variables and vital status were available for all patients. The study included 154 confirmed cases of PE (23.5 % of suspected), median age 79.1 years. D-dimer was higher in patients dead than in those alive at 30 (median 14,547 vs. 8340 ng/mL, p = 0.05) and 90 days (13,604 vs. 7973 ng/mL, p = 0.013). When adding D-dimer to sPESI, the discriminant capacity to predict mortality within 30 and 90 days was increased by 0.080 and 0.089, respectively. The contribution of D-dimer to the discriminating ability was NRI = 0.286 (95 % CI -0.198 to 0.770, p value: 0.247) at 30 days and NRI = 0.605 (95 % CI 0.223-0.988, p-value: 0.002) at 90 days.D-dimer concentration was associated with 30 and 90-days mortality and showed a higher discriminant capacity than sPESI alone to predict 90-days mortality. Adding D-dimer concentrations to sPESI score seems to improve its prognostic ability, supporting multivariable risk models as the best approach to estimate prognosis in elderly patients with PE.
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- 2016
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47. Implementing an evidence-based computerized decision support system to improve patient care in a general hospital: the CODES study protocol for a randomized controlled trial.
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Moja L, Polo Friz H, Capobussi M, Kwag K, Banzi R, Ruggiero F, González-Lorenzo M, Liberati EG, Mangia M, Nyberg P, Kunnamo I, Cimminiello C, Vighi G, Grimshaw J, and Bonovas S
- Subjects
- Humans, Quality of Health Care, Decision Support Systems, Clinical, Delivery of Health Care methods, Evidence-Based Medicine methods, Hospitals, General, Patient Care methods, Research Design
- Abstract
Background: Computerized decision support systems (CDSSs) are information technology-based software that provide health professionals with actionable, patient-specific recommendations or guidelines for disease diagnosis, treatment, and management at the point-of-care. These messages are intelligently filtered to enhance the health and clinical care of patients. CDSSs may be integrated with patient electronic health records (EHRs) and evidence-based knowledge., Methods/design: We designed a pragmatic randomized controlled trial to evaluate the effectiveness of patient-specific, evidence-based reminders generated at the point-of-care by a multi-specialty decision support system on clinical practice and the quality of care. We will include all the patients admitted to the internal medicine department of one large general hospital. The primary outcome is the rate at which medical problems, which are detected by the decision support software and reported through the reminders, are resolved (i.e., resolution rates). Secondary outcomes are resolution rates for reminders specific to venous thromboembolism (VTE) prevention, in-hospital all causes and VTE-related mortality, and the length of hospital stay during the study period., Discussion: The adoption of CDSSs is likely to increase across healthcare systems due to growing concerns about the quality of medical care and discrepancy between real and ideal practice, continuous demands for a meaningful use of health information technology, and the increasing use of and familiarity with advanced technology among new generations of physicians. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in primary care and hospital settings, thereby informing future research and healthcare policy questions related to the feasibility and value of CDSS use in healthcare systems. This trial is seconded by a specialty trial randomizing patients in an oncology setting (ONCO-CODES)., Trial Registration: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02577198?term=NCT02577198&rank=1.
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- 2016
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48. [Hypercholesterolemia and cardiovascular risk: advantages and limitations of current treatment options].
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Cimminiello C, Zambon A, and Polo Friz H
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- Humans, Risk Factors, Anticholesteremic Agents therapeutic use, Cardiovascular Diseases etiology, Cardiovascular Diseases prevention & control, Hypercholesterolemia complications, Hypercholesterolemia drug therapy
- Abstract
Cardiovascular disease is the leading cause of premature death in Europe. High blood cholesterol is one of the major cardiovascular risk factors and plays a crucial role in causing cardiovascular disease. A strong positive and linear association between total and LDL cholesterol levels and the risk of cardiovascular events has been widely documented. Every 1.0 mmol/l decrease in LDL cholesterol levels results in a significant reduction in cardiovascular mortality and in the risk of nonfatal myocardial infarction. Lipid-lowering guidelines suggest as first step the use of statins as monotherapy and, in case of failure to achieve the recommended targets, combination therapy of statins with other cholesterol-lowering drugs such as ezetimibe. The results from the recent IMPROVE-IT trial provide evidence that further LDL-cholesterol lowering beyond the recommended targets significantly reduces the rate of cardiovascular events, supporting the concept that "Lower Is Better" while additional long-term data are collected. Non-adherence to statin therapy, often due to adverse drug reactions, results in an increased risk for cardiovascular events. In a non-negligible proportion of patients with hypercholesterolemia receiving maximally tolerated statin therapy, the residual risk remains high. In addition, statin use has been associated with accelerated onset of diabetes in individuals already predisposed to developing diabetes. In conclusion, it is clear that statins are not the universal solution to the problem of high cholesterol levels, and the optimization of lipid-lowering therapy remains a therapeutic challenge.
- Published
- 2016
- Full Text
- View/download PDF
49. The dogma of aspirin: a critical review of evidence on the best monotherapy after dual antiplatelet therapy.
- Author
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Polo Friz H, Molteni M, and Cimminiello C
- Abstract
Dual antiplatelet therapy based on the combination of an adenosine diphosphate (ADP)-receptor antagonist plus aspirin has demonstrated to be more effective in reducing the rate of major ischemic vascular events compared to aspirin monotherapy in some clinical settings. The current controversy on the duration of dual antiplatelet therapy should not conceal another major issue: the choice of the more appropriate antiplatelet monotherapy after the dual treatment phase. The aim of this article is to critically analyze the available evidence in this topic. Data from studies like CAPRIE, MATCH, PROFESS, CHANCE, DAPT and others, raise questions as why antiplatelet monotherapy after the dual phase should only be based on aspirin, in spite of a lack of evidence surprisingly not highlighted by key opinion leaders and experts. We conclude that, whether ADP-receptor antagonist rather than aspirin may be proposed as monotherapy seems not only have no answer but also not place in the current specialists' analysis, as if a dogmatic approach were prevalent. Perhaps the time for an open debate on these topics is ripe.
- Published
- 2015
- Full Text
- View/download PDF
50. A prospective multicentre study on the treatment of cardiovascular risk factors and claudication symptoms in patients with peripheral artery disease (the IDOMENEO study).
- Author
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Cimminiello C, Arpaia G, Polo Friz H, Boracchi P, Marano G, Spezzigu G, and Visonà A
- Subjects
- Aged, Angiography, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Cardiovascular Diseases therapy, Female, Follow-Up Studies, Humans, Incidence, Intermittent Claudication diagnosis, Intermittent Claudication etiology, Italy, Male, Patient Compliance, Peripheral Arterial Disease complications, Peripheral Arterial Disease diagnosis, Prospective Studies, Risk Factors, Treatment Outcome, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Ankle Brachial Index methods, Anticoagulants therapeutic use, Exercise Therapy methods, Hypolipidemic Agents therapeutic use, Intermittent Claudication therapy, Peripheral Arterial Disease therapy
- Abstract
Background: The objective of this prospective multicenter cohort study was to characterise the use of pharmacological and non-pharmacological treatment for cardiovascular disease (CVD) risk factors and intermittent claudication (IC) symptoms in clinical practice patients with peripheral artery disease (PAD), and to determine the care gap with international guidelines and evidence-based therapy., Patients and Methods: From 2011 through 2013, participating centres enrolled consecutive patients with PAD of atherosclerotic, origin demonstrated by ultrasound, ankle brachial index (ABI) < 0.9 and symptoms of IC. A seven item grid was built for the assessment of care gap (percentage of patients eligible for a treatment who did not receive it). cerebrovascular disease or at least two CVD risk factors. Care gap was lower than 25 % for any method to stop smoking, lipid lowering agents, antiplatelet and/or anticoagulation therapy and any kind of exercise program; between 25% and 50% for ACE inhibitors/ angiotensin II antagonist therapy; between 50% and 75% for beta-blocker therapy; and higher than 75% for supervised exercise program and use of cilostazol. Patients with and without CADI cerebrovascular disease were differently treated with clopidogrel (27.3% and 4.8 %, p < 0.001), any antiplatelet/anticoagulant therapy (98.7% and 83.3 %, p <0.001) and beta-blockers (46.8% and 16.0%, p<0.001)., Results: All patients (232) presented at least one CVC risk factor, 90.2% at least two, and 91.5% had either established CAD or, Conclusions: Many gaps with evidence-based recommendations are still present in the pattern of the use of pharmacological and non-pharmacological treatment for CVD risk factors and IC symptoms in clinical practice PAD patients.
- Published
- 2015
- Full Text
- View/download PDF
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