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1. Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Author

Bertolini, F., Ostuzzi, G., Pievani, M., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carra, G., Corbo, M., D'Agostino, A., De Fazio, P., Magliocco, F., Martinotti, G., Ostinelli, E. G., Piccinelli, M. P., Tedeschi, F., Barbui, C., Boschello, F., Gastaldon, C., Mazzi, M. A., Nose, M., Papola, D., Perini, G., Piccoli, A., Purgato, M., Ruggeri, M., Terlizzi, S., Turrini, G., Raffaele, G., Cavallotti, S., Chirico, M., Ferrato, F., Limosani, I., Mastromo, D., Monzani, E., Porcellana, M., Restaino, F., Annese, P. M., Bolognesi, S., Cerretini, M., De Capua, A., Debolini, S., Del Zanna, M., Fargnoli, F., Giannini, A., Luccarelli, L., Lucii, C., Pierantozzi, E., Tozzi, F., Bardicchia, F., Cardamone, G., Facchi, E., Magnani, N., Soscia, F., Biancosino, B., Zotos, S., Giacomin, M., Pompei, F., Spano, M., Zonta, F., Buzzi, A., Callegred, C., Calzolari, R., Caselli, I., Diurni, M., Giana, E., Ielmini, M., Milano, A., Poloni, N., Sani, E., Zizolfi, D., Alberini, G., Cazzamalli, S., Costantini, C., Di Caro, A., Paronelli, C., Piantanida, S., Piccinelli, M., Alessandro, P., Barbanti, S. V., D'Ippolito, C., Gozzi, M., Moretti, V., Campese, O., Di Capro, L., di Giannantonio, M., Fiori, F., Lorusso, M., Mancini, V., Viceconte, D., Calandra, C., Luca, M., Signorelli, M. S., Suraniti, F., Balzarro, B., Boncompagni, G., Caretto, V., Emiliani, R., Lupoli, P., Menchetti, M., Rossi, E., Storbini, V., Tarricone, I., Terzi, L., Boso, M., Catania, C., De Paoli, G., Risaro, P., Aspesi, F., Bava, M., Bono, A., Brambilla, G., Castagna, G., Lucchi, S., Nava, R., Provenzi, M., Tabacchi, T., Tremolada, M., Verrengia, E., Barchiesi, M., Oriani, M. G., Pacetti, M., Ferro, M., Ghio, L., Beneduce, R., Laffranchini, L., Magni, L. R., Rossi, G., Tura, G. B., Addeo, L., Balletta, G., De Vivo, E., Di Benedetto, R., Parise, V. F., Carpiniello, B., Pinna, F., Pecile, D., Mattei, C., Bonavigo, T., Fabrici, E. P., Panarello, S., Peresson, G., Vitucci, C., Gardellin, F., Strizzolo, S., Cossetta, E., Fizzotti, C., Moretti, D., Di Gregorio, L., Sozzi, F., Colli, G., La Barbera, D., Laurenzi, S., Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, Bolognesi, S, Cerretini, M, De Capua, A, Debolini, S, Del Zanna, M, Fargnoli, F, Giannini, A, Luccarelli, L, Lucii, C, Pierantozzi, E, Tozzi, F, Bardicchia, F, Cardamone, G, Facchi, E, Magnani, N, Soscia, F, Biancosino, B, Zotos, S, Giacomin, M, Pompei, F, Spano, M, Zonta, F, Buzzi, A, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, Suraniti, F, Balzarro, B, Boncompagni, G, Caretto, V, Emiliani, R, Lupoli, P, Menchetti, M, Rossi, E, Storbini, V, Tarricone, I, Terzi, L, Boso, M, Catania, C, De Paoli, G, Risaro, P, Aspesi, F, Bava, M, Bono, A, Brambilla, G, Castagna, G, Lucchi, S, Nava, R, Provenzi, M, Tabacchi, T, Tremolada, M, Verrengia, E, Barchiesi, M, Oriani, M, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E.G., Piccinelli M.P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M.A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., Porcellana M., Restaino F., Annese P.M., Bolognesi S., Cerretini M., De Capua A., Debolini S., Del Zanna M., Fargnoli F., Giannini A., Luccarelli L., Lucii C., Pierantozzi E., Tozzi F., Bardicchia F., Cardamone G., Facchi E., Magnani N., Soscia F., Biancosino B., Zotos S., Giacomin M., Pompei F., Spano M., Zonta F., Buzzi A., Callegred C., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., Cazzamalli S., Costantini C., Di Caro A., Paronelli C., Piantanida S., Piccinelli M., Alessandro P., Barbanti S.V., D'Ippolito C., Gozzi M., Moretti V., Campese O., Di Capro L., di Giannantonio M., Fiori F., Lorusso M., Mancini V., Viceconte D., Calandra C., Luca M., Signorelli M.S., Suraniti F., Balzarro B., Boncompagni G., Caretto V., Emiliani R., Lupoli P., Menchetti M., Rossi E., Storbini V., Tarricone I., Terzi L., Boso M., Catania C., De Paoli G., Risaro P., Aspesi F., Bava M., Bono A., Brambilla G., Castagna G., Lucchi S., Nava R., Provenzi M., Tabacchi T., Tremolada M., Verrengia E., Barchiesi M., Oriani M.G., Pacetti M., Ferro M., Ghio L., Beneduce R., Laffranchini L., Magni L.R., Rossi G., Tura G.B., Addeo L., Balletta G., De Vivo E., Di Benedetto R., Parise V.F., Carpiniello B., Pinna F., Pecile D., Mattei C., Bonavigo T., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., and Laurenzi S.

Subjects
Male, Pediatrics, respectively), 0302 clinical medicine, Delayed-Action Preparation, Brief Psychiatric Rating Scale, Pharmacology (medical), he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, Original Research Article, Prospective Studies, Prospective cohort study, treatment, Mental Disorders, Hazard ratio, whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, Psychiatric Status Rating Scale, Middle Aged, side efects, Psychiatry and Mental health, Italy, Mental Disorder, Female, he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, occurring in almost 40% of the entire sample, side efects, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, respectively), whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, respectively). In multivariate analysis, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Human, Antipsychotic Agents, medicine.drug, Psychopathology, Adult, medicine.medical_specialty, Discontinuation, Follow-Up Studie, Medication Adherence, 03 medical and health sciences, medicine, Humans, Paliperidone, Adverse effect, Settore MED/25 - Psichiatria, discontinuation rates, Psychiatric Status Rating Scales, respectively). In multivariate analysis, business.industry, Long-Acting Antipsychotic, long-acting injectable antipsychotics, Survival Analysis, Confidence interval, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, 030227 psychiatry, Prospective Studie, Antipsychotic Agent, occurring in almost 40% of the entire sample, Delayed-Action Preparations, Neurology (clinical), business, 030217 neurology & neurosurgery, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Follow-Up Studies
Abstract

Background Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00809-w.

Published
2021

2. Clinical correlates of paliperidone palmitate and aripiprazole monohydrate prescription for subjects with schizophreniaspectrum disorders: Findings from the STAR Network Depot Study

Author

Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli F., Ostuzzi G., Crocamo C., Corbo M., D'Agostino A., Martinotti G., Ostinelli E.G., Tabacchi T., Barbui C., Carr G., Nose M., Purgato M., Turrini G., Mazzi M.A., Papola D., Gastaldon C., Terlizzi S., Bertolini F., Piccoli A., Ruggeri M., De Fazio P., Magliocco F., Caroleo M., Raffaele G., Chirico M., Cavallotti S., Lucii C., Bolognesi S., Debolini S., Pierantozzi E., Fargnoli F., Del Zanna M., Giannini A., Luccarelli L., De Capua A., Annese P.M., Cerretini M., Tozzi F., Magnani N., Cardamone G., Bardicchia F., Facchi E., Soscia F., Zotos S., Biancosino B., Zonta F., Pompei F., Callegari C., Zizolfi D., Poloni N., Ielmini M., Caselli I., Giana E., Buzzi A., Diurni M., Milano A., Sani E., Calzolari R., Bortolaso P., Piccinelli M., Cazzamalli S., Alberini G., Piantanida S., Costantini C., Paronelli C., Di Caro A., Moretti V., Gozzi M., D'Ippolito C., Barbanti S.V., Papalini A., Campese O., Fiori F., Lorusso M., Di Capro L., Viceconte D., Mancini V., Suraniti F., Signorelli M.S., Rossi E., Lupoli P., Menchetti M., Terzi L., Boso M., Risaro P., De Paoli G., Catania C., Tarricone I., Caretto V., Storbini V., Emiliani R., Balzarro B., Carra G., Nava R., Bono A., Provenzi M., Brambilla G., Aspesi F., Trotta G., Tremolada M., Castagna G., Bava M., Verrengia E., Lucchi S., Oriani M.G., Barchiesi M., Pacetti M., Aguglia A., Magni L.R., Rossi G., Beneduce R., Tura G.B., Laffranchini L., Mastromo D., Ferrato F., Restaino F., Monzani E., Porcellana M., Limosani I., Ghio L., Ferro M., Parise V.F., Balletta G., Addeo L., De Vivo E., Di Benedetto R., Pinna F., Carpiniello B., Spano M., Giacomin M., Pecile D., Mattei C., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Bonavigo T., Perini G., Boschello F., Strizzolo S., Gardellin F., Di Giannantonio M., Moretti D., Fizzotti C., Cossetta E., Di Gregorio L., Sozzi F., Boncompagni G., La Barbera D., Colli G., Laurenzi S., Calandra C., Luca M., Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli, F, Ostuzzi, G, Crocamo, C, Corbo, M, D'Agostino, A, Martinotti, G, Ostinelli, E, Tabacchi, T, Barbui, C, and Carra, G

Subjects
Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Adult, Antipsychotic Agents, Aripiprazole, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Medication Adherence, Paliperidone Palmitate, Practice Patterns, Physicians', Schizophrenic Psychology, Young Adult, Long-acting injectable antipsychotic, medicine.medical_specialty, medicine.medical_treatment, Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Practice Patterns, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Brief Psychiatric Rating Scale, medicine, Pharmacology (medical), Antipsychotic, Settore MED/25 - Psichiatria, Practice, Physicians', business.industry, Health Knowledge, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Attitudes, Propensity score matching, Observational study, business, 030217 neurology & neurosurgery, medicine.drug, Psychopathology
Abstract

This study, based on the 'Servizi Territoriali Associati per la Ricerca' (STAR) Network Depot Study nationwide baseline data, explored whether individual symptoms severity and clusters might influence the prescription of paliperidone palmitate 1-month (PP1M) vs. aripiprazole monohydrate. The Brief Psychiatric Rating Scale (BPRS) was used to assess psychopathology and relevant symptoms clusters. Drug Attitude Inventory, 10 items, was used to test attitude towards medications. Adherence to treatments was rated according to the Kemp seven-point scale. We assessed for eligibility 451 individuals and, among them, we included 195 subjects (n = 117 who started PPM1 and n = 78 aripiprazole monohydrate). Individuals were comparable in terms of age, gender, treatment years, recent hospitalizations, previous long-acting injectable antipsychotic treatments, additional oral treatments, attitude toward drugs, medication adherence, and alcohol/substance-related comorbidities. Subjects starting PP1M presented higher BPRS overall (P = 0.009), positive (P = 0.015), and negative (P = 0.010) symptom scores compared to subjects starting aripiprazole monohydrate. Results were confirmed by appropriate regression models and propensity score matching analysis. No differences were found comparing the other BPRS subscale scores: affect, resistance, and activation. Clinicians may be more prone to prescribe PPM1, rather than aripiprazole monohydrate, to subjects showing higher overall symptom severity, including positive and negative symptoms. No additional clinical factors influenced prescribing attitudes in our sample.

Published
2020

3. Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy

Author

Ostuzzi, G., Mazzi, M. A., Terlizzi, S., Bertolini, F., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carrà, G., Corbo, M., D'Agostino, A., Gastaldon, C., Lucii, C., Magliocco, F., Martinotti, G., Nosé, M., Ostinelli, E. G., Papola, D., Piccinelli, M. P., Piccoli, A., Purgato, M., Tabacchi, T., Turrini, G., Ruggeri, M., Barbui, C., De Fazio, P., Raffaele, G., Chirico, M., Cavallotti, S., Bolognesi, S., Debolini, S., Pierantozzi, E., Fargnoli, F., Del Zanna, M., Giannini, A., Luccarelli, L., De Capua, A., Annese, P. M., Cerretini, M., Tozzi, F. E., Magnani, N., Cardamone, G., Bardicchia, F., Facchi, E., Soscia, F., Zotos, S., Biancosino, B., Zonta, F., Pompei, F., Zizolfi, D., Poloni, N., Ielmini, M., Caselli, I., Giana, E., Buzzi, A., Diurni, M., Milano, A., Sani, E., Calzolari, Roberta, Cazzamalli, S., Alberini, Gabrio, Piantanida, Silvia, Costantini, C., Paronelli, Chiara, Di Caro, A., Moretti, V., Gozzi, M., D'Ippolito, C., Barbanti, S. V., Alessandro, P., Campese, O., Fiori, F., Lorusso, M., Di Capro, L., Viceconte, D., Mancini, V., Suraniti, F., Signorelli, M. S., Rossi, E., Lupoli, P., Menchetti, M., Terzi, L., Boso, M., Risaro, P., De Paoli, G., Catania, C., Tarricone, I., Caretto, V., Storbini, V., Emiliani, R., Balzarro, B., Nava, R., Bono, A., Provenzi, M., Brambilla, G., Aspesi, F., Tremolada, M., Castagna, G., Bava, M., Verrengia, E., Lucchi, S., Oriani, M. G., Barchiesi, M., Pacetti, M., Magni, L. R., Rossi, G., Beneduce, R., Tura, G. B., Laffranchini, L., Mastromo, D., Ferrato, F., Restaino, F., Monzani, E., Porcellana, M., Limosani, I., Ghio, L., Ferro, M., Parise, V. F., Balletta, G., Addeo, L., De Vivo, E., Benedetto, R. D., Pinna, F., Carpiniello, B., Spano, M., Giacomin, M., Pecile, D., Mattei, C., Fabrici, E. P., Panarello, S., Peresson, G., Vitucci, C., Bonavigo, T., Perini, G., Boschello, F., Strizzolo, S., Gardellin, F., Di Giannantonio, M., Moretti, D., Fizzotti, C., Cossetta, E., Gregorio, L. D., Sozzi, F., Boncompagni, G., Barbera, D. L., Colli, G., Laurenzi, S., Calandra, C., Luca, M., Ostuzzi, Giovanni, Mazzi, Maria Angela, Terlizzi, Samira, Bertolini, Federico, Aguglia, Andrea, Bartoli, Francesco, Bortolaso, Paola, Callegari, Camilla, Caroleo, Mariarita, Carrà, Giuseppe, Corbo, Mariangela, D'Agostino, Armando, Gastaldon, Chiara, Lucii, Claudio, Magliocco, Fabio, Martinotti, Giovanni, Nosé, Michela, Ostinelli, Edoardo Giuseppe, Papola, Davide, Piccinelli, Marco Piero, Piccoli, Alberto, Purgato, Marianna, Tabacchi, Tommaso, Turrini, Giulia, Ruggeri, Mirella, Barbui, Corrado, De Fazio, Pasquale, Raffaele, Gaetano, Chirico, Margherita, Cavallotti, Simone, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua Maria, Cerretini, Massimiliano, Tozzi, Fior-Ella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Zizolfi, Daniele, Poloni, Nicola, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Piccinelli, Marco, Cazzamalli, Sara, Alberini, Gabrio, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti, Silva Veronica, Alessandro, Papalini, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora, Tremolada, Martina, Castagna, Gloria, Bava, Mattia, Verrengia, Enrica, Lucchi, Sara, Oriani, Maria Ginevra, Barchiesi, Michela, Pacetti, Monica, Magni, Laura Rosa, Rossi, Giuseppe, Beneduce, Rossella, Tura, Giovanni Battista, Laffranchini, Laura, Mastromo, Daniele, Ferrato, Farida, Restaino, Francesco, Monzani, Emiliano, Porcellana, Matteo, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Benedetto, Rossella Di, Pinna, Federica, Carpiniello, Bernardo, Spano, Mariangela, Giacomin, Marzio, Pecile, Damiano, Mattei, Chiara, Fabrici, Elisabetta Pascolo, Panarello, Sofia, Peresson, Giulia, Vitucci, Claudio, Bonavigo, Tommaso, Perini, Giovanni, Boschello, Filippo, Strizzolo, Stefania, Gardellin, Francesco, Di Giannantonio, Massimo, Moretti, Daniele, Fizzotti, Carlo, Cossetta, Edoardo, Gregorio, Luana Di, Sozzi, Francesca, Boncompagni, Giancarlo, Barbera, Daniele La, Colli, Giuseppe, Laurenzi, Sabrina, Calandra, Carmela, Luca, Maria, Ostuzzi, G, Mazzi, M, Terlizzi, S, Bertolini, F, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carrà, G, Corbo, M, D'Agostino, A, Gastaldon, C, Lucii, C, Magliocco, F, Martinotti, G, Nosé, M, Ostinelli, E, Papola, D, Piccinelli, M, Piccoli, A, Purgato, M, Tabacchi, T, Turrini, G, Ruggeri, M, Barbui, C, De Fazio, P, Raffaele, G, Chirico, M, Cavallotti, S, Bolognesi, S, Debolini, S, Pierantozzi, E, Fargnoli, F, Del Zanna, M, Giannini, A, Luccarelli, L, De Capua, A, Annese, P, Cerretini, M, Tozzi, F, Magnani, N, Cardamone, G, Bardicchia, F, Facchi, E, Soscia, F, Zotos, S, Biancosino, B, Zonta, F, Pompei, F, Zizolfi, D, Poloni, N, Ielmini, M, Caselli, I, Giana, E, Buzzi, A, Diurni, M, Milano, A, Sani, E, Calzolari, R, Cazzamalli, S, Alberini, G, Piantanida, S, Costantini, C, Paronelli, C, Di Caro, A, Moretti, V, Gozzi, M, D'Ippolito, C, Barbanti, S, Alessandro, P, Campese, O, Fiori, F, Lorusso, M, Di Capro, L, Viceconte, D, Mancini, V, Suraniti, F, Signorelli, M, Rossi, E, Lupoli, P, Menchetti, M, Terzi, L, Boso, M, Risaro, P, De Paoli, G, Catania, C, Tarricone, I, Caretto, V, Storbini, V, Emiliani, R, Balzarro, B, Nava, R, Bono, A, Provenzi, M, Brambilla, G, Aspesi, F, Tremolada, M, Castagna, G, Bava, M, Verrengia, E, Lucchi, S, Oriani, M, Barchiesi, M, Pacetti, M, Magni, L, Rossi, G, Beneduce, R, Tura, G, Laffranchini, L, Mastromo, D, Ferrato, F, Restaino, F, Monzani, E, Porcellana, M, Limosani, I, Ghio, L, Ferro, M, Parise, V, Balletta, G, Addeo, L, De Vivo, E, Benedetto, R, Pinna, F, Carpiniello, B, Spano, M, Giacomin, M, Pecile, D, Mattei, C, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Bonavigo, T, Perini, G, Boschello, F, Strizzolo, S, Gardellin, F, Di Giannantonio, M, Moretti, D, Fizzotti, C, Cossetta, E, Gregorio, L, Sozzi, F, Boncompagni, G, Barbera, D, Colli, G, Laurenzi, S, Calandra, C, and Luca, M

Subjects
Genetics and Molecular Biology (all), Male, Pediatrics, European People, Bipolar Disorder, Cross-sectional study, Economics, Epidemiology, medicine.medical_treatment, assessment, viruses, lcsh:Medicine, Social Sciences, Longitudinal Studie, Biochemistry, Prescription, Geographical locations, 0302 clinical medicine, Mathematical and Statistical Techniques, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), immune system diseases, Medicine and Health Sciences, long-acting intramuscular (LAI) antipsychotics, clinical practice, second-generation antipsychotic (SGA) LAIs, Antipsychotics, Ethnicities, Longitudinal Studies, lcsh:Science, Multidisciplinary, virus diseases, Drugs, Middle Aged, Italian People, Europe, Prescriptions, Italy, Physical Sciences, Aripiprazole, Female, Bivariate Analysis, Statistics (Mathematics), medicine.drug, Human, Research Article, Antipsychotic Agents, Employment, Adult, medicine.medical_specialty, Adolescent, Research and Analysis Methods, 03 medical and health sciences, Mental Health and Psychiatry, medicine, Humans, Paliperidone, Bipolar disorder, European Union, Statistical Methods, Antipsychotic, Cross-Sectional Studie, Pharmacology, Risperidone, business.industry, Mood Disorders, lcsh:R, medicine.disease, 030227 psychiatry, Antipsychotic Agent, Cross-Sectional Studies, Labor Economics, Multivariate Analysis, Schizophrenia, Observational study, lcsh:Q, Population Groupings, People and places, business, 030217 neurology & neurosurgery, Mathematics
Abstract

Background For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, and to explore possible prescribing differences between first- and second-generations LAIs under ordinary clinical practice in Italy. Methods The STAR Network "Depot" Study is an observational, longitudinal, multicenter study involving 35 centers in Italy. In the cross-sectional phase, patients prescribed with LAIs were consecutively recruited and assessed over a period of 12 months. Descriptive statistics and multivariable logistic regression analyses were employed. Results Of the 451 recruited patients, 61% were males. The level of social and working functioning was heterogeneous, as was the severity of disease. Seventy-two per cent of the patients had a diagnosis of the schizophrenia spectrum. Seventy per cent were prescribed with second-generation antipsychotic (SGA) LAIs (mostly paliperidone, aripiprazole and risperidone). Compared to first-generation antipsychotic (FGA) LAIs, patients prescribed with SGA LAIs were more often younger; employed; with a diagnosis of the schizophrenia spectrum or bipolar disorder; with higher levels of affective symptoms; with fewer LAI prescriptions in the past. Discussion LAIs' prescribing practices appear to be more flexible as compared to the past, although this change is mostly restricted to SGA LAIs.

Published
2018

4. Moderators of remission with interpersonal counselling or drug treatment in primary care patients with depression: Randomised controlled trial

Author

Menchetti, M., Rucci, P., Bortolotti, B., Bombi, A., Scocco, P., Kraemer, H. C., Berardi, D., Luciano, C., Lia, L., Manganaro, D., Magnani, M., Nespeca, C., Succu, M., Bellino, S., Bogetto, F., Zizza, M., Colombini, N., Rigatelli, M., Simoni, E., Tedeschin, E., Baranzini, F., Bortolaso, P., Callegari, C., Diurni, G. C. M., Vender, S., Martinelli, V., Politi, P., Sciarini, P., Piselli, Massimiliano, Quartesan, Roberto, Bellomo, A., De Salvia, M., Ferretti, M., Iuso, S., Petito, A., Affatati, V., Todarello, O., Carpiniello, B., Contu, C., Pinna, F., M Menchetti, P Rucci, B Bortolotti, A Bombi, P Scocco, HC Kraemer, D Berardi, and DEPICS group

Subjects
Male, Counseling, SYMPTOMS, Outcome Assessment, MAJOR DEPRESSION, ANTIDEPRESSANT MEDICATION, COGNITIVE THERAPY, MENTAL DISORDERS, PROBLEM SOLVING TREATMENT, PSYCHOTHERAPY, PHARMACOTHERAPY, SIZE, LIFE, INTERPERSONAL COUNSELLING, Anxiety, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, PRIMARY CARE, law, Outcome Assessment, Health Care, Activities of Daily Living, 030212 general & internal medicine, Depression (differential diagnoses), Remission Induction, Smoking, Middle Aged, DEPRESSION, ANTIDEPRESSANTS, Intention to Treat Analysis, Psychiatry and Mental health, Brief, Practice Guidelines as Topic, Serotonin Uptake Inhibitors, Female, Adult, Depressive Disorder, Major, Effect Modifier, Epidemiologic, Humans, Logistic Models, Outcome Assessment (Health Care), Patient Selection, Primary Health Care, Psychiatric Status Rating Scales, Psychotherapy, Brief, Social Adjustment, medicine.symptom, Psychology, Selective Serotonin Reuptake Inhibitors, medicine.medical_specialty, 03 medical and health sciences, Internal medicine, Severity of illness, medicine, Psychiatry, Depressive Disorder, Intention-to-treat analysis, Epidemiologic, Hamilton Rating Scale for Depression, Major, moderator, medicine.disease, Comorbidity, 030227 psychiatry, Clinical trial, Effect Modifier, Health Care, Psychotherapy
Abstract

BackgroundDespite depressive disorders being very common there has been little research to guide primary care physicians on the choice of treatment for patients with mild to moderate depression.AimsTo evaluate the efficacy of interpersonal counselling compared with selective serotonin reuptake inhibitors (SSRIs), in primary care attenders with major depression and to identify moderators of treatment outcome.MethodA randomised controlled trial in nine centres (DEPICS, Australian New Zealand Clinical Trials Registry number: ACTRN12608000479303). The primary outcome was remission of the depressive episode (defined as a Hamilton Rating Scale for Depression score 7 at 2 months). Daily functioning was assessed using the Work and Social Adjustment Scale. Logistic regression models were used to identify moderators of treatment outcome.ResultsThe percentage of patients who achieved remission at 2 months was significantly higher in the interpersonal counselling group compared with the SSRI group (58.7% v. 45.1%, P = 0.021). Five moderators of treatment outcome were found: depression severity, functional impairment, anxiety comorbidity, previous depressive episodes and smoking habit.ConclusionsWe identified some patient characteristics predicting a differential outcome with pharmacological and psychological interventions. Should our results be confirmed in future studies, these characteristics will help clinicians to define criteria for first-line treatment of depression targeted to patients' characteristics.

Published
2014

5. Depression in Primary care: Interpersonal Counseling vs Selective serotonin reuptake inhibitors. The DEPICS Study. A multicenter randomized controlled trial. Rationale and design

Author

Menchetti, M., Bortolotti, B., Rucci, P., Scocco, P., Bombi, A., Berardi, D., Affatati, V., Alberini, G., Baranzini, F., Bellino, S., Bellomo, A., Blasi, T., Bogetto, F., Bortolaso, P., Callegari, C., Carpiniello, B., Colombini, N., Contu, C., Croci, G., De Salvia, M., Diurni, M., Elisei, S., Ferretti, M., Fiore, P., Fusar-Poli, P., Iuso, S., Lacalamita, A., La Ferla, T., Lia, L., Luciano, C. C., Magnani, M., Manganaro, D., Martinelli, V., Martino, I., Montaguti, M. B., Nespeca, C., Petito, A., Pinna, F., Piselli, M., Politi, P., Quartesan, R., Rella, A., Restaino, F., Rigatelli, M., Sciarini, P., Simoni, E., Succui, M., Tedeschini, E., Todarello, O., Vender, S., Zaccagni, L., Zizza, M., Lullini, G., Pedrini, E., D'Onghia, A., Mazza, M., Papagni, S., Menchetti M., Bortolotti B., Rucci P., Scocco P., Bombi A., Berardi D., and DEPICS Study Group.

Subjects
Research design, Counseling, Male, NEUROPSYCHIATRIC INTERVIEW MINI, Outcome Assessment, Psychological intervention, Personal Satisfaction, law.invention, Study Protocol, STRUCTURED INTERVIEW, Randomized controlled trial, law, lcsh:Psychiatry, Surveys and Questionnaires, Outcome Assessment, Health Care, Medicine, Depression (differential diagnoses), METHODOLOGICAL ASPECTS, OUTCOMES, Depression, Primary care, Combined Modality Therapy, Diagnostic and Statistical Manual of Mental Disorders, Psychiatry and Mental health, Selective serotonin reuptake inhibitors, Treatment Outcome, PSYCHOSOCIAL INTERVENTION, Research Design, Brief, Serotonin Uptake Inhibitors, Antidepressant, Female, Attitude to Health, Selective Serotonin Reuptake Inhibitors, Adult, PROBLEM SOLVING TREATMENT, medicine.medical_specialty, Adolescent, lcsh:RC435-571, DISORDERS, Outcome Assessment (Health Care), Depressive Disorder, Major, Humans, Primary Health Care, Psychiatric Status Rating Scales, Interpersonal Relations, Psychotherapy, Brief, Quality of life (healthcare), QUALITY OF LIFE, MAJOR DEPRESSION, PSYCHOTHERAPY, Psychiatry, Intensive care medicine, Depressive Disorder, Primary Health Care, Serotonin Uptake Inhibitors, Psychotherapy, Depressive Disorder, business.industry, Major, Health Care, Psychotherapy, business
Abstract

Background Depression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression. Methods/Design This multi-center randomized controlled trial was conducted in 9 Italian centres with the aim to compare the efficacy of Inter-Personal Counseling, a brief structured psychological intervention, to that of Selective Serotonin Reuptake Inhibitors. Patients with depressive symptoms referred by Primary Care Physicians to psychiatric consultation-liaison services were eligible for the study if they met the DSM-IV criteria for major depression, had a score ≥13 on the 21-item Hamilton Depression Rating Scale, and were at their first or second depressive episode. The primary outcome was remission of depressive symptoms at 2-months, defined as a HDRS score ≤ 7. Secondary outcome measures were improvement in global functioning and recurrence of depressive symptoms at 12-months. Patients who did not respond to Inter-Personal Counseling or Selective Serotonin Reuptake Inhibitors at 2-months received augmentation with the other treatment. Discussion This trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be easily disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000479303

Published
2010

6. Post-menopausal bone density, lactase deficiency and milk consumption

Author

Anna Maria Andreacchio, Lami F, S. Gnudi, Luigi Barbara, Miglioli M, Tatali M, Callegari C, and Levantesi F

Subjects
musculoskeletal diseases, medicine.medical_specialty, Lactose intolerance, Nutrition and Dietetics, Malabsorption, Bone density, business.industry, medicine.medical_treatment, Osteoporosis, Medicine (miscellaneous), Lactase, musculoskeletal system, medicine.disease, humanities, Lactase activity, Menopause, chemistry.chemical_compound, Endocrinology, chemistry, Internal medicine, medicine, Lactose, business
Abstract

To assess the relationship between skeletal integrity and lactose malabsorption, we studied bone mineral content (BMC), current milk and calcium intake and lactose absorption by hydrogen (H2) breath test in 155 post-menopausal women. A statistically significant relationship was found between age, onset of menopause and BMC, and between BMC and current milk intake. Although BMC was reduced in women with lower calcium intake, this relationship failed to reach statistical significance. There was an inverse relationship between mean H2 production and BMC in women 2–5 years after the onset of menopause. These results may indicate that, although the loss of ovarian function is a pre-eminent factor in the development of osteoporosis, milk consumption represents a defensive factor against adult bone loss.

Published
1990
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7. Effect of chemically defined formula diets on pancreatic mass in the rat

Author

Callegari C, Loris Pironi, E. Turchetto, G. L. Cornia, Luigi Barbara, Lami F, and M. Cocchi

Subjects
Male, medicine.medical_specialty, Wet weight, Elemental diet, 030309 nutrition & dietetics, Medicine (miscellaneous), Biology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Pancreatic mass, medicine, Pancreatic hypoplasia, Animals, Pancreas, Food, Formulated, 0303 health sciences, Nutrition and Dietetics, RNA, Rats, Inbred Strains, DNA, Organ Size, medicine.disease, Rats, medicine.anatomical_structure, Endocrinology, chemistry, Standard diet, 030211 gastroenterology & hepatology
Abstract

To establish the effect of chemically defined formula diets on pancreatic mass, 58 male Wistar rats, weighing approximately 200 g, were fed orally one of the following diets for 20 days: standard diet; partially hydrolyzed diet; elemental diet. The diets were isocaloric and provided 73 cal/day per rat. At the end of the experiment, the rats were killed and pancreas removed to assess wet weight and DNA and RNA content. Compared to the controls, the elemental diet caused a reduction in pancreatic wet weight (p less than 0.005), pancreatic DNA (p less than 0.001), and RNA content (p less than 0.001). In the group fed partially hydrolyzed diet, only pancreatic DNA content showed an highly significant reduction when compared with the reference group (p less than 0.001), whereas the value of RNA failed to reach the statistical significance. We found an increase of the ratio mg RNA/mg DNA in the partially hydrolyzed and elemental diet groups. These results suggest that long-term nutrition with the partially hydrolyzed diet, and more strongly with the elemental diet, may induce pancreatic hypoplasia.

8. Epidemiology and outcome of Clostridium difficile infections in patients hospitalized in Internal Medicine: findings from the nationwide FADOI-PRACTICE study

Author

Cioni, Giorgio, Viale, Pierluigi, Frasson, Stefania, Cipollini, Francesco, Menichetti, Francesco, Petrosillo, Nicola, Brunati, Sergio, Spigaglia, Patrizia, Vismara, Chiara, Bielli, Alessandra, Barbanti, Fabrizio, Landini, Giancarlo, Panigada, Grazia, Gussoni, Gualberto, Bonizzoni, Erminio, Gesu, Giovanni Pietro, Costantino, A., Masciari, R., Amato, G., Fontanella, A., Gallucci, F., Improta, L., Poggiano, M. R., Rabitti, P., Uomo, G., Civardi, G., Confalonieri, M., Grandi, M., Sacchetti, C., Baldini, T., Cioni, G., Miglioli, S., Sarti, M., Landini, M. P., Panuccio, D., Romboli, E., Vocale, C., Berti, F., Bonito, L., Gozzo, M. L., Manfellotto, D., Natili, S., Patti, A., Piccolo, P., Pistella, E., Santini, C., Pastorelli, R., Pellegrinotti, M., Quaratino, C. P., Bona, R., Gnerre, P., Lillo, F., Parodi, L., Bovero, A., Santoriello, L., Agnelli, F., Colombo, F., Gesu, G., Lombardi, G., Lanzetti, V., Biagiotti, S., Clerici, P., Mazzone, A., Brusco, G., Magnani, L., Tirella, S., Terulla, C., Manso, E., Nitti, C., Salvi, A., Ciarambino, T., Pepe, C., Politi, C., Frediani, R., Moschella, A., Lodolo, L., Barasolo, G., Bertoncelli, M. C., Milano, F., Campanini, M., Molinari, G. L., Pittau, S., De Bernochi, A., Giusti, M., Montegrosso, G., Errico, M., Mastroianni, F., Tauro, L., Caddori, A., Prasciolu, C. G., Di Naso, C., Romano, M., D'Angelo, A., Genco, L., Mangano, G., Arena, F., Biagioni, C., Cimolato, B., Landini, G., Nozzoli, C., Poli, A., Rossolini, G., Burzigotti, F., Francioni, S., Lenti, S., Galanti, I. A., Belcari, C., Longo, B., Salamone, D., Chiti, I., Lencioni, P., Panigada, G., Teghini, L., Gambacorta, M., Perrotta, U., Battaglia, G., Pizzato, E., Vian, A., De Menis, E., Bordignon, G., Tramontin, P., Doroldi, C., Ravagnan, P., Sartore, P., Leoni, M., Pauletto, P., Rigoli, R., Callegari, C., Sacchetta, A., Vendrame, A., Cioni G, Viale P, Frasson S, Cipollini F, Menichetti F, Petrosillo N, Brunati S, Spigaglia P, Vismara C, Bielli A, Barbanti F, Landini G, Panigada G, Gussoni G, Bonizzoni E, and Gesu G P

Subjects
Diarrhea, Male, medicine.medical_specialty, genetic structures, medicine.drug_class, Antibiotics, Real-Time Polymerase Chain Reaction, lcsh:Infectious and parasitic diseases, Immunoenzyme Techniques, 03 medical and health sciences, 0302 clinical medicine, Medical microbiology, Clostridium difficile, Incidence, Internal Medicine, Outcome, Predictors, Aged, Aged, 80 and over, Anti-Bacterial Agents, Clostridium Infections, Female, Hospital Mortality, Humans, Italy, Length of Stay, Middle Aged, Prospective Studies, Infectious Diseases, Internal medicine, Epidemiology, medicine, 80 and over, lcsh:RC109-216, 030212 general & internal medicine, Prospective cohort study, Clostridioides difficile, business.industry, Incidence (epidemiology), clostridium difficile, incidence, internal medicine, outcome, predictors, aged, aged, 80 and over, anti-bacterial agents, clostridioides difficile, clostridium infections, diarrhea, female, hospital mortality, humans, immunoenzyme techniques, length of stay, male, middle aged, prospective studies, real-time polymerase chain reaction, Tropical medicine, clostridium difficile GDH EPIDEMIOLOGY, 030211 gastroenterology & hepatology, medicine.symptom, business, Research Article
Abstract

Background Clostridium difficile (CD) is a leading cause of diarrhoea among hospitalized patients. The objective of this study was to evaluate the rate, the optimal diagnostic work-up, and outcome of CD infections (CDI) in Internal Medicine (IM) wards in Italy. Methods PRACTICE is an observational prospective study, involving 40 IM Units and evaluating all consecutive patients hospitalized during a 4-month period. CDI were defined in case of diarrhoea when both enzyme immunoassay for GDH, and test for A/B toxin were positive. Patients with CDI were followed-up for recurrences for 4 weeks after the end of therapy. Results Among the 10,780 patients observed, 103 (0.96 %) showed CDI, at admission or during hospitalization. A positive history for CD, antibiotics in the previous 4 weeks, recent hospitalization, female gender and age were significantly associated with CDI (multivariable analysis). In-hospital mortality was 16.5 % in CD group vs 6.7 % in No-CD group (p

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9. Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial

Author

Mario Amore, Barbara D'Avanzo, Angelo Barbato, Davide Papola, Elisa Zanini, Armando D'Agostino, Pasquale De Fazio, Simone Cavallotti, Lorenzo Tarsitani, Luigi Grassi, Andrea Aguglia, Michela Nosè, Rosangela Caruso, Giulia Turrini, Giovanni Ostuzzi, Francesco Amaddeo, Massimo Biondi, Mirella Ruggeri, Cristina Crocamo, Igor Monti, Maria Chiara Alessi, Chiara Di Natale, Giuseppe Carrà, Chiara Gastaldon, Corrado Barbui, Giovanni Martinotti, Paola Bortolaso, Eugenio Aguglia, Laura Giusti, Marianna Purgato, Rita Roncone, Camilla Callegari, Mauro Tettamanti, Alessandro Rodolico, Francesco Bartoli, Ostuzzi, G, Gastaldon, C, Barbato, A, D'Avanzo, B, Tettamanti, M, Monti, I, Aguglia, A, Aguglia, E, Alessi, M, Amore, M, Bartoli, F, Biondi, M, Bortolaso, P, Callegari, C, Carrà, G, Caruso, R, Cavallotti, S, Crocamo, C, D'Agostino, A, De Fazio, P, Di Natale, C, Giusti, L, Grassi, L, Martinotti, G, Nose, M, Papola, D, Purgato, M, Rodolico, A, Roncone, R, Tarsitani, L, Turrini, G, Zanini, E, Amaddeo, F, Ruggeri, M, and Barbui, C

Subjects
medicine.medical_specialty, Medicine (miscellaneous), Antidepressant, Equivalence Trials as Topic, Antidepressants, Depression, Elderly, Pragmatic trial, Randomized clinical trial, Vortioxetine, NO, law.invention, Study Protocol, 03 medical and health sciences, Antidepressants, Depression, Elderly, Pragmatic trial, Randomized clinical trial, Equivalence Trials as Topic, Vortioxetine, Serotonin Uptake Inhibitors, 0302 clinical medicine, Randomized controlled trial, Quality of life, Rating scale, law, Pragmatic Clinical Trials as Topic, medicine, Humans, Multicenter Studies as Topic, Pharmacology (medical), 030212 general & internal medicine, Depression (differential diagnoses), Aged, Depressive Disorder, Major, Depressive Disorder, lcsh:R5-920, business.industry, Major, Guideline, Italy, Serotonin Uptake Inhibitors, Tolerability, Good clinical practice, Physical therapy, lcsh:Medicine (General), business, Selective Serotonin Reuptake Inhibitors, 030217 neurology & neurosurgery
Abstract

Introduction Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome. Methods and analysis This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery–Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled. Ethics and dissemination This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants’ data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards. Trial registration Clinicaltrials.gov: NCT03779789, Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018–001444-66. Trial status Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.

Published
2020
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10. Placental growth factor as a predictive marker of preeclampsia - PREBIO study - PREeclampsia BIOchemical study

Author

Laura Giunti, Patrizia Vergani, Sara Lazzarin, Clelia Callegari, Paola Algeri, Roberta Rovelli, Nadia Roncaglia, Valentina Giardini, Giardini, V, Rovelli, R, Algeri, P, Giunti, L, Lazzarin, S, Callegari, C, Roncaglia, N, and Vergani, P

Subjects
Placental growth factor, medicine.medical_specialty, Predictive marker, Vascular Endothelial Growth Factor Receptor-1, business.industry, Obstetrics, Placenta, Obstetrics and Gynecology, medicine.disease, Preeclampsia, Preeclampsia, biochemical marker, fetal growth restriction, placental dysfunction, placental growth factor, Pre-Eclampsia, Placental dysfunction, Predictive Value of Tests, Pregnancy, Pediatrics, Perinatology and Child Health, Medicine, Humans, Female, Prospective Studies, business, Prospective cohort study, Biomarkers, Placenta Growth Factor
Abstract

Introduction: To evaluate the clinical utility of placental growth factor (PlGF) for the prediction of preeclampsia (PE). Materials and methods: This prospective cohort study included women divided into three groups: (1) pregnancies without preconceptional risk of developing PE; (2) pregnancies with a preconceptional and/or current risk of developing PE; (3) PE-complicated pregnancies (control group). Blood samples were collected every 4-5 weeks or during hospitalization from early second trimester until delivery in the group 1 and 2, at the diagnosis of PE in the group 3. Plasma levels of PlGF were measured using The Triage PlGF test (Alere) and considered pathological under the 5th centile for gestational age. Sensitivity (Sn), specificity (Sp), positive and negative predictive value (PPV, NPV) were calculated. Results: In group 1, 30% of women (3/10) had pathological test but none of them developed PE (Sp 70%, NPV 100%). In group 2 (n = 75), none of the patients with normal test developed PE (0/24), while 39% of women with PlGF < 5th centile (20/51) developed PE (Sn 100%, Sp 44%, PPV 39%, NPV 100%). In group 3 (n = 11) all women except one had a pathological PlGF test (Sn 90%, PPV 100%). Conclusions: Our data support recent studies which identify PlGF as a biochemical marker not only of PE, but also of placental dysfunction. In fact, it is useful for ruling out PE in women at risk because of the high Sn and high NPV: a normal PlGF is related with a positive pregnancy outcome. Therefore, the measurement of this biomarker would simplify PE clinical management and would reduce costs.

Published
2020

11. Analysis of SARS-CoV-2 vertical transmission during pregnancy

Author

Valeria Savasi, Patrizia Vergani, Maria Rita Gismondo, Arsenio Spinillo, Mara Biasin, Clelia Callegari, Francesca Perotti, Daria Trabattoni, Irene Cetin, Selene Cammarata, Alessandro Mancon, Ilaria Beretta, Manuela Nebuloni, Davide Mileto, Mario Clerici, Claudio Fenizia, Fenizia, C, Biasin, M, Cetin, I, Vergani, P, Mileto, D, Spinillo, A, Gismondo, M, Perotti, F, Callegari, C, Mancon, A, Cammarata, S, Beretta, I, Nebuloni, M, Trabattoni, D, Clerici, M, and Savasi, V

Subjects
Amniotic fluid, viruses, Physiology, General Physics and Astronomy, Antibodies, Viral, Umbilical cord, 0302 clinical medicine, 030212 general & internal medicine, Pregnancy Complications, Infectious, lcsh:Science, skin and connective tissue diseases, 030219 obstetrics & reproductive medicine, Multidisciplinary, biology, Transmission (medicine), Middle Aged, medicine.anatomical_structure, In utero, Gestation, Female, pregnancy, Antibody, Coronavirus Infections, Adult, Adolescent, Science, Pneumonia, Viral, Genome, Viral, Article, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, Betacoronavirus, Young Adult, Placenta, medicine, Humans, Pandemics, Inflammation, Pregnancy, business.industry, SARS-CoV-2, fungi, Infant, Newborn, COVID-19, General Chemistry, medicine.disease, Infectious Disease Transmission, Vertical, respiratory tract diseases, body regions, Viral infection, biology.protein, lcsh:Q, vertical transmission, business
Abstract

The impact of SARS-CoV-2 infection during gestation remains unclear. Here, we analyse the viral genome on maternal and newborns nasopharyngeal swabs, vaginal swabs, maternal and umbilical cord plasma, placenta and umbilical cord biopsies, amniotic fluids and milk from 31 mothers with SARS-CoV-2 infection. In addition, we also test specific anti-SARS-CoV-2 antibodies and expression of genes involved in inflammatory responses in placentas, and in maternal and umbilical cord plasma. We detect SARS-CoV-2 genome in one umbilical cord blood and in two at-term placentas, in one vaginal mucosa and in one milk specimen. Furthermore, we report the presence of specific anti-SARS-CoV-2 IgM and IgG antibodies in one umbilical cord blood and in one milk specimen. Finally, in the three documented cases of vertical transmission, SARS-CoV-2 infection was accompanied by a strong inflammatory response. Together, these data support the hypothesis that in utero SARS-CoV-2 vertical transmission, while low, is possible. These results might help defining proper obstetric management of COVID-19 pregnant women, or putative indications for mode and timing of delivery., The impact of SARS-CoV-2 infection in pregnancy remains underexplored. Here, the authors provide a comprehensive characterization of virus and immunological parameters in 31 SARS-CoV-2-infected pregnant women, finding evidence of vertical transmission in two of the mother-child pairs.

Published
2020

12. Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study

Author

Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D’Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Ostuzzi, Giovanni, Nose, Michela, Purgato, Marianna, Turrini, Giulia, Mazzi, Maria, Angela, Papola, Davide, Gastaldon, Chiara, Terlizzi, Samira, Piccoli, Alberto, Ruggeri, Mirella, De Fazio, Pasquale, Magliocco, Fabio, Caroleo, Mariarita, Raffaele, Gaetano, D'Agostino, Armando, Ostinelli, Edoardo, Giuseppe, Chirico, Margherita, Cavallotti, Simone, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua, Maria, Cerretini, Massimiliano, Tozzi, Fiorella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Zizolfi, Daniele, Poloni, Nicola, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Emanuele, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Bortolaso, Paola, Piccinelli, Marco, Cazzamalli, Sara, Caterina, Alberini, Gabro, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti Silva, Veronica, Papalini, Alessandro, Corbo, Mariangela, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria, Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Carra, Giuseppe, Tabacchi, Tommaso, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora, Tremolada, Martina, Castagna, Gloria, Bava, Mattia, Verrengia, Enrica, Lucchi, Sara, Oriani, Maria, Ginevra, Barchiesi, Michela, Pacetti, Monica, Aguglia, Andrea, Magni, Laura, Rosa, Rossi, Giuseppe, Beneduce, Rossella, Tura, Giovanni, Battista, Laffranchini, Laura, Ferrato, Farida, Restaino, Francesco, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo, Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Di Benedetto, Rossella, Pinna, Federica, Carpiniello, Bernardo, Spano, Mariangela, Giacomin, Marzio, Pecile, Damiano, Mattei, Chiara, Fabrici, Elisabetta, Pascolo, Panarello, Sofia, Peresson, Giulia, Vitucci, Claudio, Bonavigo, Tommaso, Perini, Giovanni, Boschello, Filippo, Strizzolo, Stefania, Gardellin, Francesco, Di Giannantonio, Massimo, Fizzotti, Carlo, Cossetta, Edoardo, Di Gregorio, Luana, Sozzi, Francesca, Boncompagni, Giancarlo, La Barbera, Daniele, Colli, Giuseppe, Laurenzi, Sabrina, Luca, Maria, Crocamo, Carlo, Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, and Ostuzzi, G

Subjects
medicine.medical_specialty, psychiatric practice, lcsh:RC435-571, Treatment adherence, viruses, medicine.medical_treatment, antipsychotic, long-acting injectable, prescribing attitudes, survey, immune system diseases, lcsh:Psychiatry, medicine, Psychiatry, Antipsychotic, prescribing attitude, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Original Research, business.industry, lcsh:RM1-950, virus diseases, lcsh:Therapeutics. Pharmacology, Long acting, Psychology (miscellaneous), business
Abstract

Background: Long acting injectable (LAI) antipsychotics have been claimed to ensure treatment adherence and possibly reduce the daily burden of oral formulations. So far, only surveys investigating the theoretical prescribing attitudes of clinicians have been employed. On this basis, we aimed to investigate reasons for prescribing LAIs in a real-world, unselected sample of patients. Methods: The STAR Network Depot Study is an observational, multicentre study consecutively enrolling adults initiating a LAI over a 12-months period. Clinical severity was assessed with the Brief Psychiatric Rating Scale, and patient’s attitude toward medications with the Drug Attitude Inventory 10 items. Psychiatrists recorded reasons for LAI prescribing for each study participant. Responses were grouped into six non-mutually exclusive categories: aggressiveness, patient engagement, ease of drug taking, side-effects, stigma, adherence. Results: Of the 451 patients included, two-thirds suffered from chronic psychoses. Improving patient engagement with the outpatient psychiatric service was the most common reason for prescribing LAIs (almost 80% of participants), followed by increasing treatment adherence (57%), decreasing aggressiveness (54%), and improving ease of drug taking (52%). After adjusting for confounders, logistic regression analyses showed that reasons for LAI use were associated with LAI choice (e.g. first-generation LAIs for reducing aggressiveness). Conclusion: Despite the wide availability of novel LAI formulation and the emphasis on their wider use, our data suggest that the main reasons for LAI use have remained substantially unchanged over the years, focusing mostly on improving patient’s engagement. Further, clinicians follow implicit prescribing patterns when choosing LAIs, and this may generate hypotheses for future experimental studies.

Published
2020

13. Performance of an extended triage questionnaire to detect suspected cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in obstetric patients: Experience from two large teaching hospitals in Lombardy, Northern Italy

Author

Irene Cetin, Clelia Callegari, Patrizia Vergani, Stefania Livio, Chiara Lubrano, Laura La Milia, Sara Ornaghi, Valeria Savasi, Federica Brunetti, Chiara Tasca, Roberta Milazzo, Ornaghi, S, Callegari, C, Milazzo, R, La Milia, L, Brunetti, F, Lubrano, C, Tasca, C, Livio, S, Savasi, V, Cetin, I, and Vergani, P

Subjects
RNA viruses, Questionnaires, Viral Diseases, Pulmonology, Coronaviruses, Artificial Gene Amplification and Extension, Polymerase Chain Reaction, Taste Disorders, Medical Conditions, 0302 clinical medicine, Nasopharynx, Surveys and Questionnaires, Pandemic, Medicine and Health Sciences, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Pathology and laboratory medicine, Virus Testing, 030219 obstetrics & reproductive medicine, Multidisciplinary, Reverse Transcriptase Polymerase Chain Reaction, Obstetrics and Gynecology, Medical microbiology, Hospitals, Infectious Diseases, Taste disorder, Italy, Research Design, Viruses, Medicine, RNA, Viral, Female, pregnancy, SARS CoV 2, Pathogens, medicine.symptom, Coronavirus Infections, Research Article, Adult, medicine.medical_specialty, SARS coronavirus, Science, Health Personnel, Pneumonia, Viral, Context (language use), Research and Analysis Methods, Microbiology, Asymptomatic, Respiratory Disorders, 03 medical and health sciences, Betacoronavirus, Diagnostic Medicine, Internal medicine, medicine, Humans, Molecular Biology Techniques, Hospitals, Teaching, Molecular Biology, Pandemics, Pregnancy, Survey Research, Biology and life sciences, business.industry, SARS-CoV-2, Organisms, Viral pathogens, COVID-19, Covid 19, Reverse Transcriptase-Polymerase Chain Reaction, medicine.disease, Triage, infection, Microbial pathogens, Health Care, Pneumonia, Health Care Facilities, Respiratory Infections, Asymptomatic Diseases, Women's Health, business
Abstract

Objectives1. To assess the performance of an extended questionnaire in identifying cases of SARS-CoV-2 infection among obstetric patients. 2. To evaluate the rate of infection among healthcare workers involved in women's care.Study designA prospective cohort study of obstetric patients admitted to MBBM Foundation and Buzzi Hospital (Lombardy, Northern Italy) from March 16th to May 22nd, 2020. Women were screened on admission by a questionnaire investigating major and minor symptoms of infection and high-risk contacts in the last 14 days. SARS-CoV-2 assessment was performed by RT-PCR on nasopharyngeal swabs. Till April 7th, a targeted SARS-CoV-2 testing triggered by a positive questionnaire was used; from April 8th, a universal testing approach was implemented.ResultsThere were 1,177 women screened by the questionnaire, which yielded a positive result in 130 (11.0%) cases. SARS-CoV-2 RT-PCR was performed in 865 (73.5%) patients, identifying 51 (5.9%) infections. During the first period, there were 29 infected mothers, 4 (13.8%) of whom had a negative questionnaire. After universal testing implementation, there were 22 (3%, 95% CI 1.94% - 4.04%) infected mothers, 13 (59.1%) of whom had a negative questionnaire; rate of infection among asymptomatic women was 1.9%. Six of the 17 SARS-CoV-2-positive women with a negative questionnaire reported symptoms more than 14 but within 30 days before admission. Isolated olfactory or taste disorders were identified in 15.7% of infected patients. Rate of infection among healthcare workers was 5.8%.ConclusionsAn exhaustive triage questionnaire can effectively discriminate women at low risk of SARS-CoV-2 infection in the context of a targeted and a universal viral testing approach. In 15.7% of infected women, correct classification as a suspected case of infection was due to investigation of olfactory and taste disorders. Extension of the assessed time-frame to 30 days may be worth considering to increase the questionnaire's performance.

Published
2020

14. Clinical variables and costs related to healthcare management in patients with somatic symptoms disorder: a retrospective study

Author

Alessandra De Leo, Marco Di Sarno, Alessandro Bellini, Ivano Caselli, Camilla Callegari, Nicola Poloni, Marta Ielmini, Michele Mattia, Caselli, I, Poloni, N, Ielmini, M, Mattia, M, Deleo, A, Di Sarno, M, Bellini, A, and Callegari, C

Subjects
medicine.medical_specialty, Clinical variables, business.industry, Medically unexplained symptom, Psychosomatic medicine, Retrospective cohort study, Community psychiatry, Health care cost, Health administration, Psychiatry and Mental health, Medically unexplained symptoms, Health care costs, Medicine, In patient, business, Intensive care medicine
Abstract

BACKGROUND: Medically unexplained physical symptoms (MUPS) are physical symptoms without a medical explanation. The study provided for the collection of data from hospitalized patients presenting MUPS, aiming to draw a clinical and sociodemographic profile of patients with somatic symptoms disorder (SSD), and to estimate economic costs related to hospital management. METHODS: This observational retrospective study consisted in the evaluation of data referring to all hospitalized patients admitted between 2008 and 2018 in the wards of a teaching hospital in Northern Italy. RESULTS : A total of 273 patients presenting with MUPS have been hospitalized. The sample showed a prevalence of female, married, and workers patients. The most frequent ward involved is neurology, followed by internal medicine and Short Stay Unit. The most common symptoms found are headache, pain, syncope and vertigo. No evidence that having a medical disease predict the developing of somatic symptoms disorder emerged. A personality disorder diagnosis in patients with MUPS was associated with increased probability of having a diagnosis of SSD. A marginally significant positive association also emerged with anxiety disorders, but not with depressive disorder. The overall estimated cost of hospitalization for MUPS is € 475,409.73. C ONCLUSIONS : Further investigations are needed to extend the study on other clinical areas and to clarify the correlates.

Published
2019
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15. Hospitalized Patients with Medically Unexplained Physical Symptoms: Clinical Context and Economic Costs of Healthcare Management

Author

Alessandra De Leo, Marta Ielmini, Alessandro Bellini, Nicola Poloni, Ivano Caselli, Michele Mattia, Camilla Callegari, Celeste Isella, Marco Di Sarno, Poloni, N, Caselli, I, Ielmini, M, Mattia, M, De Leo, A, Di Sarno, M, Isella, C, Bellini, A, and Callegari, C

Subjects
medicine.medical_specialty, Pediatrics, Neurology, lcsh:BF1-990, Context (language use), Disease, Development, Article, Health administration, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Psychosomatic Medicine, Genetics, Medicine, Community Psychiatry, Somatic Symptoms Disorde, Medically Unexplained Physical Symptom, General Psychology, Ecology, Evolution, Behavior and Systematics, Somatic Symptoms Disorder, business.industry, Medically unexplained physical symptoms, Psychosomatic medicine, Health Care Costs, Medically Unexplained Physical Symptoms, 030227 psychiatry, Health Care Cost, lcsh:Psychology, Anxiety, medicine.symptom, business, 030217 neurology & neurosurgery, Psychopathology
Abstract

Medically Unexplained Physical Symptoms (MUPS) are physical symptoms without a medical explanation. This study collected data from hospitalized patients presenting MUPS, aiming to draw a clinical and socio-demographic profile of patients with MUPS, to explore psychopathological correlations of Somatic Symptoms Disorder (SSD) diagnosis, and to estimate economic costs related to hospital management for MUPS. The cross-sectional study consisted in the evaluation of data referring to hospitalized patients admitted between 2008 and 2018 in a teaching hospital in Northern Italy. A total of 273 patients presenting MUPS have been hospitalized. The sample showed a prevalence of female, married and employed patients. The most frequent wards involved are Neurology, Internal Medicine and Short Unit Stay. The most common symptoms found are headache, pain, syncope and vertigo. There is no evidence that a history of medical disease is associated with a diagnosis of SSD. A personality disorder diagnosis in patients with MUPS was associated with increased probability of having a diagnosis of SSD. A marginally significant positive association emerged with anxiety disorders, but not with depressive disorder. The overall estimated cost of hospitalization for patients with MUPS is 475'409.73 &euro, The study provides the investigation of a large number of patients with MUPS and a financial estimate of related hospitalization costs.

Published
2019

16. What is the effect of intertwin delivery interval on the outcome of the second twin delivered vaginally?

Author

Maddalena Incerti, Clelia Callegari, Giuseppe Paterlini, Salvatore Andrea Mastrolia, Letizia Brienza, Patrizia Vergani, Sabrina Cozzolino, Isadora Vaglio Tessitore, Paola Algeri, Algeri, P, Callegari, C, Mastrolia, S, Brienza, L, Vaglio Tessitore, I, Paterlini, G, Incerti, M, Cozzolino, S, and Vergani, P

Subjects
Adult, medicine.medical_specialty, multiple pregnancy, MEDLINE, Twins, Diamniotic twin pregnancy, Young Adult, 03 medical and health sciences, Birth Intervals, 0302 clinical medicine, retrospective observational study, Pregnancy, Medicine, Humans, 030212 general & internal medicine, Cesarean delivery, Retrospective Studies, 030219 obstetrics & reproductive medicine, Second twin, Vaginal delivery, Cesarean Section, business.industry, Obstetrics, Incidence (epidemiology), Infant, Newborn, Pregnancy Outcome, Obstetrics and Gynecology, Retrospective cohort study, Delivery, Obstetric, medicine.disease, Optimal management, Outcome (probability), Vacuum delivery, Neonatal outcomes, Vagina, Pediatrics, Perinatology and Child Health, Pregnancy, Twin, Interval (graph theory), Female, vaginal delivery, business
Abstract

Objective: Optimal management of twin deliveries is controversial. We aimed to assess if intertwin delivery interval, after vaginal delivery of the first twin, may have an influence on adverse neonatal outcomes of the second twin Study design: This is a retrospective observational study including diamniotic twin pregnancies with vaginal delivery of the first twin, between January 2000 and July 2017. Inclusion criteria were diamniotic pregnancies and vaginal delivery of the first twin. We excluded higher twin order, monoamniotic pregnancies, cesarean delivery of the first twin and patients with missing data. Results: A number of 400 diamniotic twin pregnancies met the inclusion criteria and were divided, considering intertwin delivery interval into (1) ≤30 minutes (n = 365); and (2) >30 minutes (n = 35). Considering the two study groups, maternal and first twin characteristics and outcomes were similar. Second twin reported higher incidence of cesarean section and vacuum delivery, but similar incidence of neonatal adverse outcomes, in case of intertwin interval >30 minutes. At multivariate analysis, a difference between second and first twin weight ≥25% was correlated to neonatal adverse outcome, while we did not found this correlation with a cut-off of 30 minutes. Conclusions: In our study, growth discrepancy between twins was significantly correlated to adverse neonatal outcomes, while intertwin delivery time was not an influencing factor. So, in line with this result, in our clinical practice, we do not use a fixed time in which both twins should be delivered, neither in monochorionic nor in dichorionic pregnancies, when fetal wellbeing was demonstrated during labor

Published
2018

17. Neonatal hypoxia of the second twin after vaginal delivery of the first twin: what matters?

Author

Giuseppe Paterlini, Maddalena Incerti, Davide Paolo Bernasconi, Salvatore Andrea Mastrolia, Francesca Pellizzoni, Paola Algeri, Sabrina Cozzolino, Clelia Callegari, Patrizia Vergani, Algeri, P, Callegari, C, Bernasconi, D, Incerti, M, Cozzolino, S, Paterlini, G, Mastrolia, S, Pellizzoni, F, and Vergani, P

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Cardiotocography, multiple pregnancy, Twins, intertwin delivery interval, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pregnancy, medicine, Humans, 030212 general & internal medicine, Hypoxia, Retrospective Studies, 030219 obstetrics & reproductive medicine, Second twin, medicine.diagnostic_test, business.industry, Potential risk, Obstetrics, Vaginal delivery, Infant, Newborn, Obstetrics and Gynecology, Hypoxia (medical), Heart Rate, Fetal, Delivery, Obstetric, Neonatal hypoxia, Optimal management, Case-Control Studies, Pediatrics, Perinatology and Child Health, Pregnancy, Twin, diamniotic twin pregnancy, Female, medicine.symptom, business
Abstract

Objective: Optimal management of twin deliveries is controversial. We aimed to assess potential risk factors correlated to the development of hypoxia in the second twin after vaginal delivery of the first twin. Study design: This is a retrospective observational study including diamniotic twin pregnancies delivering at our Institution at 35 weeks of gestational age or more, weighing ≥1800 g. Hypoxia was defined as at least one of the following: Apgar score 10 minutes, neonatal acidosis (pH ≤7 and/or BE ≥12 mmol/L). Results: A number of 275 diamniotic twin pregnancies met the inclusion criteria and were divided within the following groups: (1) second twin not developing neonatal hypoxia (n = 265); and (2) second twin developing neonatal hypoxia (n = 10). The rate of second twins with neonatal hypoxia during the study period was 3.6% (10/275). Abnormal cardiotocography during the intertwin delivery interval, defined as ACOG category III, was significantly correlated to second twin hypoxia. Of interest, there was no significant difference in the intertwin delivery interval between the study groups. In addition, breech presentation of the second twin did not show to be a risk factor for neonatal hypoxia. None of the second twins developing neonatal hypoxia was reported to have encephalopathy (follow up of at least 24 months). At multivariate analysis, only abnormal cardiotocography was an independent risk factor for second twin hypoxia (OR 17.8, 95% CI 4.1–77.2). Conclusions: In our study, neonatal hypoxia was significantly correlated to abnormal cardiotocography, while intertwin delivery interval was not correlated to the development of this adverse neonatal outcome Objective: Optimal management of twin deliveries is controversial. We aimed to assess potential risk factors correlated to the development of hypoxia in the second twin after vaginal delivery of the first twin. Study design: This is a retrospective observational study including diamniotic twin pregnancies delivering at our Institution at 35 weeks of gestational age or more, weighing ≥1800 g. Hypoxia was defined as at least one of the following: Apgar score 10 minutes, neonatal acidosis (pH ≤7 and/or BE ≥12 mmol/L). Results: A number of 275 diamniotic twin pregnancies met the inclusion criteria and were divided within the following groups: (1) second twin not developing neonatal hypoxia (n = 265); and (2) second twin developing neonatal hypoxia (n = 10). The rate of second twins with neonatal hypoxia during the study period was 3.6% (10/275). Abnormal cardiotocography during the intertwin delivery interval, defined as ACOG category III, was significantly correlated to second twin hypoxia. Of interest, there was no significant difference in the intertwin delivery interval between the study groups. In addition, breech presentation of the second twin did not show to be a risk factor for neonatal hypoxia. None of the second twins developing neonatal hypoxia was reported to have encephalopathy (follow up of at least 24 months). At multivariate analysis, only abnormal cardiotocography was an independent risk factor for second twin hypoxia (OR 17.8, 95% CI 4.1–77.2). Conclusions: In our study, neonatal hypoxia was significantly correlated to abnormal cardiotocography, while intertwin delivery interval was not correlated to the development of this adverse neonatal outcome.

Published
2018

18. Influence of sleep disturbances on age at onset and long-term incidence of major cardiovascular events: The MONICA-Brianza and PAMELA cohort studies

Author

Lorenza Bertù, Giancarlo Cesana, Giovanni Veronesi, Francesco Gianfagna, Guido Grassi, Camilla Callegari, Marco M Ferrario, Saverio Stranges, Gianfagna, F, Veronesi, G, Bertù, L, Cesana, G, Grassi, G, Stranges, S, Callegari, C, and Ferrario, M

Subjects
Adult, Male, Sleep Wake Disorders, medicine.medical_specialty, Pediatrics, Time Factors, Coronary artery diseases, Epidemiology, Population, 030204 cardiovascular system & hematology, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, medicine, Humans, cardiovascular diseases, Prospective Studies, Age of Onset, Prospective cohort study, education, Stroke, Depression (differential diagnoses), Aged, education.field_of_study, Sleep disorder, business.industry, Cardiovascular risk, Depression, Sleep disorders, Medicine (all), Incidence, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Italy, Cardiovascular Diseases, Physical therapy, Age of onset, business, 030217 neurology & neurosurgery, Cohort study, Follow-Up Studies
Abstract

Objective We examined the prospective associations of sleep disturbances and sleep duration with the long-term incidence of major cardiovascular disease (CVD) events, in a large cohort of Italian adult men. Methods A total of 2277 men aged 35–74 years of age and CVD free at baseline from the MONICA-Brianza and PAMELA population-based cohorts were followed up for a median of 17 years, for first coronary heart disease (CHD) or ischemic stroke events (fatal or nonfatal; n = 293). Sleep disturbances, based on the Jenkins Sleep Questionnaire, were categorized as none/some, moderate, or severe. Sleep durations were ≤6 hours (short), seven to eight hours, and ≥9 hours (long) per night. Results At baseline, 855 men (38%) either reported sleep disturbances or were short or long sleepers. The presence of severe sleep disturbances increased the risk of first CVD (hazard ratio [HR] = 1.80, 95% confidence interval [CI] = 1.07–3.03) and CHD events (HR = 1.97, 95% CI = 1.09–3.56), in particular from the age of 48 years onward. In comparison to men sleeping seven to eight hours, long sleepers experienced a higher CVD risk (HR = 1.56, 95% CI = 1.10–2.22), due mainly to ischemic strokes, and starting at older ages (≥60 years). A joint effect between disturbed sleep and short sleep duration on CVD and CHD events was also observed. Adjustments for physical activity and depression did not substantially modify these associations. Conclusion Severe sleep disturbances and long sleep duration were associated with specific CVD endpoints and age at onset, potentially suggesting distinct underlying mechanisms. A short questionnaire discriminating different levels of sleep disturbances and sleep duration should be routinely adopted in CVD prevention programs to identify men at increased risk for early-onset events.

Published
2016

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