Modelling human choices: MADeM and decision‑making

Research supported by FAPESP 2015/50122-0 and DFG-GRTK 1740/2. RP and AR are also part of the Research, Innovation and Dissemination Center for Neuromathematics FAPESP grant (2013/07699-0). RP is supported by a FAPESP scholarship (2013/25667-8). ACR is partially supported by a CNPq fellowship (grant 306251/2014-0)

Implementation of the Frailty Index in hospitalized older patients: Results from the REPOSI register

Background: Frailty is a state of increased vulnerability to stressors, associated to poor health outcomes. The aim of this study was to design and introduce a Frailty Index (FI; according to the age-related accumulation of deficit model) in a large cohort of hospitalized older persons, in order to benefit from its capacity to comprehensively weight the risk profile of the individual. Methods: Patients aged 65 and older enrolled in the REPOSI register from 2010 to 2016 were considered in the present analyses. Variables recorded at the hospital admission (including socio-demographic, physical, cognitive, functional and clinical factors) were used to compute the FI. The prognostic impact of the FI on in-hospital and 12-month mortality was assessed. Results: Among the 4488 patients of the REPOSI register, 3847 were considered eligible for a 34-item FI computation. The median FI in the sample was 0.27 (interquartile range 0.21\u20130.37). The FI was significantly predictive of both in-hospital (OR 1.61, 95%CI 1.38\u20131.87) and overall (HR 1.46, 95%CI 1.32\u20131.62) mortality, also after adjustment for age and sex. Conclusions: The FI confirms its strong predictive value for negative outcomes. Its implementation in cohort studies (including those conducted in the hospital setting) may provide useful information for better weighting the complexity of the older person and accordingly design personalized interventions

Living alone as an independent predictor of prolonged length of hospital stay and non-home discharge in older patients.

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Prevalence and Determinants of the Use of Lipid-Lowering Agents in a Population of Older Hospitalized Patients: the Findings from the REPOSI (REgistro POliterapie Societ\ue0 Italiana di Medicina Interna) Study

Background: Older patients are prone to multimorbidity and polypharmacy, with an inherent risk of adverse events and drug interactions. To the best of our knowledge, available information on the appropriateness of lipid-lowering treatment is extremely limited. Aim: The aim of the present study was to quantify and characterize lipid-lowering drug use in a population of complex in-hospital older patients. Methods: We analyzed data from 87 units of internal medicine or geriatric medicine in the REPOSI (Registro Politerapie della Societ\ue0 Italiana di Medicina Interna) study, with reference to the 2010 and 2012 patient cohorts. Lipid-lowering drug use was closely correlated with the clinical profiles, including multimorbidity markers and polypharmacy. Results: 2171 patients aged >65\ua0years were enrolled (1057 males, 1114 females, mean age 78.6\ua0years). The patients treated with lipid-lowering drugs amounted to 508 subjects (23.4%), with no gender difference. Atorvastatin (39.3%) and simvastatin (34.0%) were the most widely used statin drugs. Likelihood of treatment was associated with polypharmacy ( 655\ua0drugs) and with higher Cumulative Illness Rating Scale (CIRS) score. At logistic regression analysis, the presence of coronary heart disease, peripheral vascular disease, and hypertension were significantly correlated with lipid-lowering drug use, whereas age showed an inverse correlation. Diabetes was not associated with drug treatment. Conclusions: In this in-hospital cohort, the use of lipid-lowering agents was mainly driven by patients\u2019 clinical history, most notably the presence of clinically overt manifestations of atherosclerosis. Increasing age seems to be associated with lower prescription rates. This might be indicative of cautious behavior towards a potentially toxic treatment regimen

Choice and Outcomes of Rate Control versus Rhythm Control in Elderly Patients with Atrial Fibrillation: A Report from the REPOSI Study

Background: Among rate-control or rhythm-control strategies, there is conflicting evidence as to which is the best management approach for non-valvular atrial fibrillation (AF) in elderly patients. Design: We performed an ancillary analysis from the \u2018Registro Politerapie SIMI\u2019 study, enrolling elderly inpatients from internal medicine and geriatric wards. Methods: We considered patients enrolled from 2008 to 2014 with an AF diagnosis at admission, treated with a rate-control-only or rhythm-control-only strategy. Results: Among 1114 patients, 241 (21.6%) were managed with observation only and 122 (11%) were managed with both the rate- and rhythm-control approaches. Of the remaining 751 patients, 626 (83.4%) were managed with a rate-control-only strategy and 125 (16.6%) were managed with a rhythm-control-only strategy. Rate-control-managed patients were older (p\ua0=\ua00.002), had a higher Short Blessed Test (SBT; p\ua0=\ua00.022) and a lower Barthel Index (p\ua0=\ua00.047). Polypharmacy (p\ua0=\ua00.001), heart failure (p\ua0=\ua00.005) and diabetes (p\ua0=\ua00.016) were more prevalent among these patients. Median CHA2DS2-VASc score was higher among rate-control-managed patients (p\ua0=\ua00.001). SBT [odds ratio (OR) 0.97, 95% confidence interval (CI) 0.94\u20131.00, p\ua0=\ua00.037], diabetes (OR 0.48, 95% CI 0.26\u20130.87, p\ua0=\ua00.016) and polypharmacy (OR 0.58, 95% CI 0.34\u20130.99, p\ua0=\ua00.045) were negatively associated with a rhythm-control strategy. At follow-up, no difference was found between rate- and rhythm-control strategies for cardiovascular (CV) and all-cause deaths (6.1 vs. 5.6%, p\ua0=\ua00.89; and 15.9 vs. 14.1%, p\ua0=\ua00.70, respectively). Conclusion: A rate-control strategy is the most widely used among elderly AF patients with multiple comorbidities and polypharmacy. No differences were evident in CV death and all-cause death at follow-up

Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study

none200nononeVitale, M.; Masulli, M.; Rivellese, A.A.; Bonora, E.; Cappellini, F.; Nicolucci, A.; Squatrito, S.; Antenucci, D.; Barrea, A.; Bianchi, C.; Bianchini, F.; Fontana, L.; Fornengo, P.; Giorgino, F.; Gnasso, A.; Mannucci, E.; Mazzotti, A.; Nappo, R.; Palena, A.P.; Pata, P.; Perriello, G.; Potenziani, S.; Radin, R.; Ricci, L.; Romeo, F.; Santini, C.; Scarponi, M.; Serra, R.; Timi, A.; Turco, A.A.; Vedovato, M.; Zavaroni, D.; Grioni, S.; Riccardi, G.; Vaccaro, O; Rivellese, Angela Albarosa; Cocozza, Sara; Auciello, Stefania; Turco, Anna Amelia; Bonora, Enzo; Cigolini, Massimo; Pichiri, Isabella; Brangani, Corinna; Tomasetto, Elena; Perriello, Gabriele; Timi, Alessia; Squatrito, Sebastiano; Sinagra, Tiziana; Longhitano, Sara; Tropea, Vanessa; Ballardini, Giorgio; Babini, Anna Carla; Ripani, Raffaella; Gregori, Giovanna; Dolci, Maria; Bruselli, Laura; Salutini, Isabella; Mori, Mary; Baccetti, Fabio; Lapolla, Annunziata; Sartore, Giovanni; Burlina, Silvia; Chilelli, Nino Cristiano; Buzzetti, Raffaella; Venditti, Chiara; Potenziani, Stella; Carlone, Angela; Galluzzo†, Aldo; Giordano, Carla; Torregrossa, Vittoria; Corsi, Laura; Cuneo, Giacomo; Corsi, Simona; Tizio, Biagio; Clemente, Gennaro; Citro, Giuseppe; Natale, Maria; Salvatore, Vita; Di Cianni, Graziano; Lacaria, Emilia; Russo, Laura; Iannarelli, Rossella; de Gregorio, Antonella; Sciarretta, Filomena; D’Andrea, Settimio; Montani, Valeria; Cannarsa, Emanuela; Dolcetti, Katia; Cordera, Renzo; Bonabello, Laura Affinito; Mazzucchelli, Chiara; Giorda, Carlo Bruno; Romeo, Francesco; Bonetto, Caterina; Antenucci, Daniela; Baldassarre, Maria Pompea Antonia; Iovine, Ciro; Nappo, Rossella; Ciano, Ornella; Dall’Aglio, Elisabetta; Mancastroppa, Giovanni; Grimaldi, Franco; Tonutti, Laura; Boemi, Massimo; D’Angelo, Federica; Leotta, Sergio; Fontana, Lucia; Lauro, Davide; Rinaldi, Maria Elena; Cignarelli, Mauro; la Macchia, Olga; Fariello, Stefania; Tomasi, Franco; Zamboni, Chiara; Dozio, Nicoletta; Trevisan, Roberto; Scaranna, Cristiana; Del Prato, Stefano; Miccoli, Roberto; Bianchi, Cristina; Garofolo, Monia; Pugliese, Giuseppe; Salvi, Laura; Rangel, Graziela; Vitale, Martina; Anichini, Roberto; Tedeschi, Anna; Corsini, Elisa; Cucinotta, Domenico; Di Benedetto, Antonino; Giunta, Loretta; Ruffo, Maria Concetta; Bossi, Antonio Carlo; Carpinter, Rita; Dotta, Francesco; Ceccarelli, Elena; Bartolo, Paolo Di; Caselli, Chiara; Luberto, Alessandra; Santini, Costanza; Mazzotti, Arianna; Calbucci, Giovanni; Consoli, Agostino; Ginestra, Federica; Calabrese, Maria; Zogheri, Alessia; Ricci, Lucia; Giorgino, Francesco; Laviola, Luigi; Ippolito, Claudia; Tarantino, Lucia; Avogaro, Angelo; Vedovato, Monica; Gnasso, Agostino; Carallo, Claudio; Scicchitano, Caterina; Zavaroni, Donatella; Livraga, Stefania; Perin, Paolo Cavallo; Forrnengo, Paolo; Prinzis, Tania; de Cosmo, Salvatore; Palena, Antonio Pio; Bacci, Simonetta; Mannucci, Edoardo; Lamanna, Caterina; Pata, Pietro; Lettina, Gabriele; Aiello, Antimo; Barrea, Angelina; Lalli, Carlo; Scarponi, Maura; Franzetti, Ivano; Radin, Raffaella; Serra, Rosalia; Petrachi, Francesca; Asprino, Vincenzo; Capra, Claudio; Cigolini, Massimo; Forte, Elisa; Potenziani, Stella; Reggiani, Giulio Marchesini; Forlani, Gabriele; Montesi, Luca; Mazzella, Natalia; Piatti, Pier Marco; Monti, Lucilla; Stuccillo, Michela; Auletta, Pasquale; Petraroli, Ettore; Capobianco, Giuseppe; Romano, Geremia; Cutolo, Michele; de Simone, Giosetta; Caiazzo, Gennaro; Nunziata, Peppe; Sorrentino, Susy; Amelia, Umberto; Calatola, Pasqualino; Capuano, GelsominaVitale, M.; Masulli, M.; Rivellese, A. A.; Bonora, Enzo; Cappellini, F.; Nicolucci, A.; Squatrito, S.; Antenucci, D.; Barrea, A.; Bianchi, C.; Bianchini, FRANCESCA ANTONIA; Fontana, L.; Fornengo, P.; Giorgino, FRANCESCO LIBERO; Gnasso, A.; Mannucci, E.; Mazzotti, Alfredo; Nappo, R.; Palena, A. P.; Pata, P.; Perriello, G.; Potenziani, S.; Radin, R.; Ricci, Laura; Romeo, Francesco; Santini, C.; Scarponi, M.; Serra, Roberto; Timi, A.; Turco, A. A.; Vedovato, M.; Zavaroni, D.; Grioni, S.; Riccardi, Giovanna; Vaccaro, O; Rivellese, Angela Albarosa; Cocozza, Sara; Auciello, Stefania; Turco, Anna Amelia; Bonora, Enzo; Cigolini, Massimo; Pichiri, Isabella; Brangani, Corinna; Tomasetto, Elena; Perriello, Gabriele; Timi, Alessia; Squatrito, Sebastiano; Sinagra, Tiziana; Longhitano, Sara; Tropea, Vanessa; Ballardini, Giorgio; Babini, Anna Carla; Ripani, Raffaella; Gregori, Giovanna; Dolci, Maria; Bruselli, Laura; Salutini, Isabella; Mori, Mary; Baccetti, Fabio; Lapolla, Annunziata; Sartore, Giovanni; Burlina, Silvia; Chilelli, NINO CRISTIANO; Buzzetti, Raffaella; Venditti, Chiara; Potenziani, Stella; Carlone, Angela; Galluzzo†, Aldo; Giordano, Carla; Torregrossa, Vittoria; Corsi, Laura; Cuneo, Giacomo; Corsi, Simona; Tizio, Biagio; Clemente, Gennaro; Citro, Giuseppe; Natale, Maria; Salvatore, Vita; Di Cianni, Graziano; Lacaria, Emilia; Russo, Laura; Iannarelli, Rossella; de Gregorio, Antonella; Sciarretta, Filomena; D’Andrea, Settimio; Montani, Valeria; Cannarsa, Emanuela; Dolcetti, Katia; Cordera, Renzo; Bonabello, Laura Affinito; Mazzucchelli, Chiara; Giorda, Carlo Bruno; Romeo, Francesco; Bonetto, Caterina; Antenucci, Daniela; Baldassarre, Maria Pompea Antonia; Iovine, Ciro; Nappo, Rossella; Ciano, Ornella; Dall’Aglio, Elisabetta; Mancastroppa, Giovanni; Grimaldi, Franco; Tonutti, Laura; Boemi, Massimo; D’Angelo, Federica; Leotta, Sergio; Fontana, Lucia; Lauro, Davide; Rinaldi, Maria Elena; Cignarelli, Mauro; la Macchia, Olga; Fariello, Stefania; Tomasi, Franco; Zamboni, Chiara; Dozio, Nicoletta; Trevisan, Roberto; Scaranna, Cristiana; Del Prato, Stefano; Miccoli, Roberto; Bianchi, Cristina; Garofolo, Monia; Pugliese, Giuseppe; Salvi, Laura; Rangel, Graziela; Vitale, Martina; Anichini, Roberto; Tedeschi, Anna; Corsini, Elisa; Cucinotta, Domenico; Di Benedetto, Antonino; Giunta, Loretta; Ruffo, Maria Concetta; Bossi, Antonio Carlo; Carpinter, Rita; Dotta, Francesco; Ceccarelli, Elena; Bartolo, Paolo Di; Caselli, Chiara; Luberto, Alessandra; Santini, Costanza; Mazzotti, Arianna; Calbucci, Giovanni; Consoli, Agostino; Ginestra, Federica; Calabrese, Maria; Zogheri, Alessia; Ricci, Lucia; Giorgino, FRANCESCO LIBERO; Laviola, Luigi; Ippolito, Claudia; Tarantino, Lucia; Avogaro, Angelo; Vedovato, Monica; Gnasso, Agostino; Carallo, Claudio; Scicchitano, Caterina; Zavaroni, Donatella; Livraga, Stefania; Perin, Paolo Cavallo; Forrnengo, Paolo; Prinzis, Tania; de Cosmo, Salvatore; Palena, Antonio Pio; Bacci, Simonetta; Mannucci, Edoardo; Lamanna, Caterina; Pata, Pietro; Lettina, Gabriele; Aiello, Antimo; Barrea, Angelina; Lalli, Carlo; Scarponi, Maura; Franzetti, Ivano; Radin, Raffaella; Serra, Rosalia; Petrachi, Francesca; Asprino, Vincenzo; Capra, Claudio; Cigolini, Massimo; Forte, Elisa; Potenziani, Stella; Reggiani, Giulio Marchesini; Forlani, Gabriele; Montesi, Luca; Mazzella, Natalia; Piatti, Pier Marco; Monti, Lucilla; Stuccillo, Michela; Auletta, Pasquale; Petraroli, Ettore; Capobianco, Giuseppe; Romano, Geremia; Cutolo, Michele; de Simone, Giosetta; Caiazzo, Gennaro; Nunziata, Peppe; Sorrentino, Susy; Amelia, Umberto; Calatola, Pasqualino; Capuano, Gelsomin

Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial

Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50\ue2\u80\u9375 years with type 2 diabetes inadequately controlled with metformin monotherapy (2\ue2\u80\u933 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15\ue2\u80\u9345 mg) or a sulfonylurea (5\ue2\u80\u9315 mg glibenclamide, 2\ue2\u80\u936 mg glimepiride, or 30\ue2\u80\u93120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57\uc2\ub73 months. The primary outcome occurred in 105 patients (1\uc2\ub75 per 100 person-years) who were given pioglitazone and 108 (1\uc2\ub75 per 100 person-years) who were given sulfonylureas (hazard ratio 0\uc2\ub796, 95% CI 0\uc2\ub774\ue2\u80\u931\uc2\ub726, p=0\uc2\ub779). Fewer patients had hypoglycaemias in the pioglitazone group than in the sulfonylureas group (148 [10%] vs 508 [34%], p<0\uc2\ub70001). Moderate weight gain (less than 2 kg, on average) occurred in both groups. Rates of heart failure, bladder cancer, and fractures were not significantly different between treatment groups. Interpretation In this long-term, pragmatic trial, incidence of cardiovascular events was similar with sulfonylureas (mostly glimepiride and gliclazide) and pioglitazone as add-on treatments to metformin. Both of these widely available and affordable treatments are suitable options with respect to efficacy and adverse events, although pioglitazone was associated with fewer hypoglycaemia events. Funding Italian Medicines Agency, Diabete Ricerca, and Italian Diabetes Society