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4. A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.

Author

Ruggeri M, Bonetto C, Lasalvia A, De Girolamo G, Fioritti A, Rucci P, Santonastaso P, Neri G, Pileggi F, Ghigi D, Miceli M, Scarone S, Cocchi A, Torresani S, Faravelli C, Zimmermann C, Meneghelli A, Cremonese C, Scocco P, Leuci E, Mazzi F, Gennarelli M, Brambilla P, Bissoli S, Bertani ME, Tosato S, De Santi K, Poli S, Cristofalo D, Tansella M, Ruggeri M, Mirella ME, Bissoli S, Bonetto C, Cristofalo D, De Santi K, Lasalvia A, Lunardi S, Negretto V, Poli S, Tosato S, Zamboni MG, Ballarin M, De Girolamo G, Fioritti A, Neri G, Pileggi F, Rucci P, Bocchio Chiavetto L, Scasselatti C, Zanardini R, Brambilla P, Bellani M, Bertoldo A, Marinelli V, Negretto V, Perlini C, Rambaldelli G, Lasalvia A, Bertani M, Bissoli S, Lazzarotto L, Bardella S, Gardellin F, Lamonaca D, Lasalvia A, Lunardon M, Magnabosco R, Martucci M, Nicolau S, Nifosì F, Pavanati M, Rossi M, Piazza C, Piccione G, Sala A, Sale A, Stefan B, Zotos S, Balbo M, Boggian I, Ceccato E, Dall'Agnola R, Gardellin F, Girotto B, Goss C, Lamonaca D, Lasalvia A, Leoni R, Mai A, Pasqualini A, Pavanati M, Piazza C, Piccione G, Roccato S, Rossi A, Sale A, Strizzolo S, Zotos S, Urbani A, Ald F, Bianchi B, Cappellari P, Conti R, De Battisti L, Lazzarin E, Merlin S, Migliorini G, Pozzan T, Sarto L, Visonà S, Brazzoli A, Campi A, Carmagnani R, Giambelli S, Gianella A, Lunardi L, Madaghiele D, Maestrelli P, Paiola L, Posteri E, Viola L, Zamberlan V, Zenari M, Tosato S, Zanoni M, Bonadonna G, Bonomo M, Santonastaso P, Cremonese C, Scocco P, Veronese A, Anderle P, Angelozz A, Amalric I, Baron G, Candeago EB, Castelli F, Chieco M, Cremonese C, Di Costanzo E, Derossi M, Doriguzzi M, Galvano O, Lattanz M, Lezzi R, Marcato M, Marcolin A, Marini F, Matranga M, Scalabrin D, Zucchetto M, Zadro F, Austoni G, Bianco M, Bordino F, Dario F, De Risio A, Gatto A, Granà S, Favero E, Franceschin A, Friederici S, Marangon V, Pascolo M, Ramon L, Scocco P, Veronese A, Zambolin S, Riolo R, Buffon A, Cremonese C, Di Bortolo E, Friederici S, Fortin S, Marcato M, Matarrese F, Mogni S, Codemo N, Russi A, Silvestro A, Turella E, Viel P, Dominoni A, Andreose L, Boemio M, Bressan L, Cabbia A, Canesso E, Cian R, Dal Piccol C, Dalla Pasqua MM, Di Prisco A, Mantellato L, Luison M, Morgante S, Santi M, Sacillotto M, Scabbio M, Sponga P, Sguotto ML, Stach F, Vettorato MG, Martinello G, Dassiè F, Marino S, Cibiniel L, Masetto I, Marcato M, Cabianca O, Valente A, Caberlotto L, Passoni A, Flumian P, Daniel L, Gion M, Stanziale S, Alborino F, Bortolozzo V, Bacelle L, Bicciato L, Basso D, Navaglia F, Manoni F, Ercolin M, Neri G, Giubilini F, Imbesi M, Leuci E, Mazzi F, Semrov E, Giovanni CS, Taro e Ceno V, Ovest P, Anelli S, Amore M, Bigi L, Britta W, Anna GB, Bonatti U, Borziani M, Crosato I, Galluccio R, Galeotti M, Gozzi M, Greco V, Guagnini E, Pagani S, Maccherozzi M, Marchi F, Melato E, Mazzucchi E, Marzullo F, Pellegrini P, Petrolini N, Volta P, Anelli S, Bonara F, Brusamonti E, Croci R, Flamia I, Fontana F, Losi R, Mazzi F, Marchioro R, Pagani S, Raffaini L, Ruju L, Saginario A, Tondelli MG, Marrama D, Bernardelli L, Bonacini F, Florindo A, Merli M, Nappo P, Sola L, Tondelli O, Tonna M, Torre MT, Tosatti M, Venturelli G, Zampolla D, Bernardi A, Cavalli C, Cigala L, Ciraudo C, Di Bari A, Ferri L, Gombi F, Leurini S, Mandatelli E, Maccaferri S, Oroboncoide M, Pisa B, Ricci C, Poggi E, Zurlini C, Malpeli M, Colla R, Teodori E, Vecchia L, D'Andrea R, Trenti T, Paolini P, Mazzi F, Carpeggiani P, Pileggi F, Ghigi D, Gagliostro M, Pratelli M, Rucci P, Lazzaro S, Antonelli A, Battistini L, Bellini F, Bonini E, Capelli CB, DiDomizio C, Drei C, Fucci G, Gualandi A, Grazia MR, Losi AM, Mazzoni FM, Marangoni D, Monna G, Morselli M, Oggioni A, Oprandi S, Paganelli W, Passerini M, Piscitelli M, Reggiani G, Rossi G, Salvatori F, Trasforini S, Uslenghi C, Veggetti S, Bartolucci G, Baruffa R, Bellini F, Bertelli R, Borghi L, Ciavarella P, DiDomizio C, Monna G, Oggioni A, Paltrinieri E, Rizzardi F, Serra P, Suzzi D, Carlo U, Piscitelli M, Arienti P, Aureli F, Avanzi R, Callegari V, Corsino A, Host P, Michetti R, Pratelli M, Rizzo F, Simoncelli P, Soldati E, Succi E, Bertozzi M, Canetti E, Cavicchioli L, Ceccarelli E, Cenni S, Marzola G, Gallina V, Leoni C, Olivieri A, Piccolo E, Ravagli S, Russo R, Tedeschini D, Verenini M, Abram W, Granata V, Curcio A, Guerra G, Granini S, Natali L, Montanari E, Pasi F, Ventura U, Valenti S, Francesca M, Farneti R, Ravagli P, Floris R, Maroncelli O, Volpones G, Casali D, Miceli M, Bencini A, Cellini M, De Biase L, Barbara L, Charles L, Pratesi C, Tanini A, Cellini M, Miceli M, Loparrino R, Pratesi C, Ulivelli C, Cussoto C, Dei N, Fumanti E, Pantani M, Zeloni G, Bellini R, Cellesi R, Dorigo N, Gullì P, Ialeggio L, Pisanu M, Rinaldi G, Konze A, Cocchi A, Meneghelli A, Bianco M, Modignani L, Frova M, Monzani E, Zanobio A, Malagoli M, Pagani R, Barbera S, Morganti C, Monzani E, Amadè ES, Brambilla V, Montanari A, Caterina G, Lopez C, Marocchi A, Moletta A, Sberna M, Cascio MT, Scarone S, Manzone ML, Barbara B, Mari L, Manzone ML, Razzini E, Bianchi Y, Pellizzer MR, Verdecchia A, Sferrazza MG, Manzone ML, Pismataro R, D'Eril GV, Barassi A, Pacciolla R, Faraci G, Torresani S, Rosmini B, Carpi F, Soelva M, Anderlan M, De Francesco M, Duregger E, Torresani S, Vettori C, Doimo S, Kompatscher E, Soelva M, Torresani S, Forer M, Kerschbaumer H, Gampe A, Nicoletti M, Acerbi C, Aquilino D, Azzali S, Bensi L, Bissoli S, Cappellari D, Casana E, Campagnola N, Dal Corso E, Di Micco E, Gobbi E, Ferri L, Gobbi E, Mairaghi L, Malak S, Mesiano L, Paterlini F, Perini M, Puliti EM, Rispoli R, Rizzo E, Sergenti C, Soave M, Alpi A, Bislenghi L, Bolis T, Colnaghi F, Fascendini S, Grignani S, Meneghelli A, Patelli G, Faravelli C, Casale S, Zimmermann C, Deledda G, Goss C, Mazzi M, Rimondini M, Gennarelli M, Scassellati C, Bonvicini C, Longo S, Bocchio Chiavetto L, Zanardini R, Ventriglia M, Squitti R, Frisoni G, Pievani M, Balestrieri M, Brambilla P, Perlini C, Marinelli V, Bellani M, Rambaldelli G, Bertoldo A, Atzori M, Mazzi F, Carpeggiani P, Beltramello A, Alessandrini F, Pizzini F, Zoccatelli G, Sberna M, Konze A, Politi P, Emanuele E, Brondino N, Martino G, Bergami A, Zarbo R, Riva MA, Fumagalli F, Molteni R, Calabrese F, Guidotti G, Luoni A, Macchi F, Artioli S, Baldetti M, Bizzocchi M, Bolzon D, Bonello E, Cacciari G, Carraresi C, Cascio MT, Caselli G, Furlato K, Garlassi S, Gavarini A, Lunardi S, Macchetti F, Marteddu V, Plebiscita G, Poli S, Totaro S, Bebbington P, Birchwood M, Dazzan P, Kuipers E, Thornicroft G, Pariante C, Lawrie S, Pariante C, and Soares JC

Subjects
Cluster Analysis, Community Mental Health Centers, Humans, Italy, Patient Selection, Psychotic Disorders diagnosis, Psychotic Disorders psychology, Recurrence, Sample Size, Severity of Illness Index, Time Factors, Treatment Outcome, Case Management, Cognitive Behavioral Therapy, Community Mental Health Services, Family Relations, Psychotic Disorders therapy, Research Design
Abstract

Background: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services., Methods/design: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.

Published
2012
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5. Mid-stream vs. first-voided urine collection by using automated analyzers for particle examination in healthy subjects: an Italian multicenter study.

Author

Manoni F, Gessoni G, Alessio MG, Caleffi A, Saccani G, Silvestri MG, Poz D, Ercolin M, Tinello A, Valverde S, Ottomano C, and Lippi G

Subjects
Adolescent, Adult, Aged, Automation, Female, Humans, Italy, Male, Middle Aged, Solubility, Urine Specimen Collection instrumentation, Young Adult, Health, Urinalysis methods, Urination, Urine Specimen Collection methods
Abstract

Background: In analogy with other areas of laboratory diagnostics, the pre-analytical phase is the leading source of variability also in urinalysis. We carried out a multicentric study for comparing results obtained from first-voided and mid-stream urine samples., Methods: Each of the six hospital-based clinical laboratories participating to this study recruited 50 healthy subjects among laboratory staff and/or their relatives. Two consecutive samples of the first morning micturition were collected by vacuum system, the first from the first-void and the second from the mid-stream. Routine urinalysis was performed using dip-stick automated analyzers for chemical examination and automated analyzers for formed particle examination (Sysmex UF-100, Sysmex UF-1000i and Iris iQ-200)., Results: Counts of epithelial cells (EC), erythrocytes (ERY) and leukocytes (LEU) but not for cylinders (CAS) were significantly higher in the first-voided samples. A significantly higher count of EC, ERY and LEU was also observed between females and males in first-voided samples, whereas no significant difference could be found in mid-stream samples. Health related analyzer specific upper reference limits (URL) were CAS≤1, EC≤5, ERY≤19, Leu≤13 for UF-100; CAS≤1, EC≤4, ERY≤15, Leu≤11 for UF-1000i; CAS≤1, EC≤4, ERY≤18, Leu≤10 for iQ200. The overall prevalence of subjects with cellular elements count exceeding URL was also higher in first-voided than in mid-stream samples., Conclusions: Mid-stream urine was confirmed as the most appropriate sample, since the presence of contaminating elements, such as bacteria, analytes and formed particles are minimized.

Published
2011
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