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2. Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial

Author

Giordano A, Martinelli V, Lugaresi A, Pucci E, Granella F, Trojano M, Solari A, Messmer Uccelli M, Ferrari G, Martini F, Radice D, D'Annunzio G, Farina D, Travaglini D, Pietrolongo E, Onofrj M, Torri Clerici V, Bonanno S, Brambilla L, Confalonieri P, Radaelli M, Messina J, Comi G, Tortorella C, Luciannatelli E, Senesi C, Tsantes E, Conti M, Rottoli M, Bellantonio P, Fischetti M, Fantozzi R, Pala A, Traccis S, Di Battista G, Bianchi M, Benedetti M, Gaetani L, Di Filippo M, Carolei A, Totaro R, Lanzillo R, Brescia Morra V, Coppola R, Cottone S, Chiavazza C, Cavalla P, Leonardi C, Aguglia U, Ziuliani C, Valla P, Sasanelli F, Valentino P, Quattrone A, Martino PG, Russo M, Vita G, Immovilli P., Giordano A, Lugaresi A, Confalonieri P, Granella F, Radice D, Trojano M, Martinelli V, Solari A, on behalf of the SIMS-Practice groupa, Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Comi, Giancarlo, on behalf of the SIMS Practice, Group, and Radaelli, Marta

Subjects
Adult, Male, medicine.medical_specialty, Health Knowledge, Attitudes, Practice, Multiple Sclerosis, Adolescent, patient satisfaction, Health literacy, Group B, law.invention, Interviews as Topic, Young Adult, Patient satisfaction, complex health intervention, Randomized controlled trial, Patient Education as Topic, law, Surveys and Questionnaires, Multiple Sclerosi, Clinical endpoint, Medicine, Humans, Prospective Studies, Young adult, Prospective cohort study, disease knowledge, information aid, Internet, business.industry, Multiple sclerosis, multiple sclerosis, clinical practice, Middle Aged, medicine.disease, Health Literacy, Treatment Outcome, Neurology, Italy, Physical therapy, Female, Pamphlets, Neurology (clinical), business, Comprehension
Abstract

Background: The SIMS-Trial showed that the ‘Sapere Migliora’ information aid (IA) for newly diagnosed people with multiple sclerosis (PwMS) effectively improved patient knowledge and satisfaction with care. Objectives: The objectives of this paper are to assess the effectiveness of the IA in clinical practice and to compare the whole IA with the take-home booklet/website component alone. Methods: After updating the IA and replacing the CD with a website, a prospective, open-label non-randomised controlled trial compared the whole IA (group A, five SIMS-Trial centres) to take-home (group B, 16 centres). One month after the intervention, participants completed the MS Knowledge Questionnaire (MSKQ), care satisfaction questionnaire (COSM-R) (primary study outcomes), Hospital and Anxiety Depression Scale, and ad hoc questionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012–March 2013). Drop-outs were four of 77 (5%, group A) and 11/82 (13%, group B). Primary endpoint (highest tertile both for MSKQ and COSM-R section 2 scores) was achieved by 38/77 (49%) group A and 33/82 (40%) group B ( p = 0.25). Attainment of secondary outcomes was also similar between groups. Conclusions: This study shows that the entire IA is not superior to the booklet/website alone, and that both are comparable in efficacy to the intervention arm of the SIMS-Trial. Trial registration number: ISRCTN78940214.

Published
2014
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3. Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial

Author

Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Martinelli, V, Pucci E, Solari A., Messmer Uccelli, M, Ferrari, G, Martini, F, D'Annunzio, G, Farina, D, Travaglini, D, Pietrolongo, E, Onofrj, M, Torri Clerici, V, Bonanno, S, Brambilla, L, Radaelli, M, Messina, J, Comi, G, Tortorella, C, Luciannatelli, E, Senesi, C, Tsantes, E, Conti, M, Rottoli, M, Bellantonio, P, Fischetti, M, Fantozzi, R, Pala, A, Traccis, S, Di Battista, G, Bianchi, M, Benedetti, M, Gaetani, L, Di Filippo, M, Carolei, A, Totaro, R, Lanzillo, R, Brescia Morra, V, Coppola, R, Cottone, S, Chiavazza, C, Cavalla, P, Leonardi, C, Aguglia, U, Ziuliani, C, Valla, P, Sasanelli, F, Valentino, P, Quattrone, A, Martino, Pg, Russo, M, Vita, Giuseppe, and Immovilli, P.

Subjects
Multiple sclerosis, complex health intervention, Multiple sclerosis, complex health intervention, information aid, disease knowledge, patient satisfaction, clinical practice, patient satisfaction, disease knowledge, information aid, clinical practice
Published
2014

4. Cognitive Impairment Is Related to Cerebrospinal Fluid Neurofilament Levels in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis. A Functional MRI Study (P04.104)

Author

Tortorella, C., primary, Romano, R., additional, Ruggieri, M., additional, Direnzo, V., additional, Mastrapasqua, M., additional, Iaffaldano, P., additional, Taurisano, P., additional, Fazio, L., additional, Luciannatelli, E., additional, Popolizio, T., additional, Blasi, G., additional, Bertolino, A., additional, and Trojano, M., additional

Published
2012
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5. Low serum urate levels are associated to female gender in multiple sclerosis patients.

Author

Zoccolella S, Tortorella C, Iaffaldano P, Direnzo V, D'Onghia M, Luciannatelli E, Paolicelli D, Livrea P, and Trojano M

Subjects
Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, Sex Factors, Multiple Sclerosis blood, Sex Characteristics, Uric Acid blood
Abstract

Background: Urate is a natural antioxidant and may prevent CNS tissue damage and the clinical manifestations of experimental autoimmune encephalitis. Results from clinical studies are conflicting and the contribution of urate to the pathogenesis of Multiple Sclerosis (MS) remains uncertain., Objective: To evaluate serum urate levels in MS patients and their relationships with clinical, demographic and MRI variables., Methods: Levels of non-fasting serum uric acid and creatinine were determined by an automated enzymatic assay and glomerular filtration rate was assessed in 245 MS patients, in 252 age/sex-matched neurological controls (NC) and in 59 Healthy controls (HC)., Results: Median serum urate levels did not differ between MS patients (3.8 mg/dL), HC (4.0 mg/dl) and NC (4.0 mg/dL). Serum urate levels were lower in females than in males in all groups (p = <0.0001). In female-MS, serum urate levels (3.2 mg/dL) were lower compared to those in female HC (3.8; p = 0.01) and NC (3.5 mg/dL; p = 0.02), whereas in male-MS they(4.8 mg/dL) did not differ from those in male HC (4.5 mg/dl) and NC (4.8 mg/dL). Urate concentrations trended to be lower in Clinically isolated syndromes suggestive of MS (3.7 mg/dL) and in relapsing MS (3.7 mg/dL), compared to patients with progressive MS (4.4 mg/dL; p = 0.06), and in patients with an annual relapse rate (ARR) >2 (3.3 mg/dL) than in those with an ARR ≤2: 3.9 mg/dL; p = 0.05). Significant lower serum urate levels were found in females than in males in all clinical MS subtypes (p<0.01), separately evaluated. Female sex (beta: -0.53; p<0.00001) was the most significant determinant of serum urate concentrations in MS patients on multivariate regression analysis., Conclusions: Our findings suggest that low urate levels could be of significance in predominantly inflammatory phases of MS even at the early stage and mainly in females.

Published
2012
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