Publications by authors named "Mario A Battaglia"

20 Publications

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Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis.

Ann Neurol 2021 Jan 21. Epub 2021 Jan 21.

Department of Neuroscience, Mental Health, and Sensory Organs, Sapienza University of Rome, Rome, Italy.

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS).

Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results.

Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18-4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (<1 month) of methylprednisolone was also associated with a worse outcome (OR = 5.24, 95% CI = 2.20-12.53, p = 0.001). Results were confirmed by the PS-weighted analysis and by all the sensitivity analyses.

Interpretation: This study showed an acceptable level of safety of therapies with a broad array of mechanisms of action. However, some specific elements of risk emerged. These will need to be considered while the COVID-19 pandemic persists. ANN NEUROL 2021.
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http://dx.doi.org/10.1002/ana.26028DOI Listing
January 2021

Impact of the COVID-19 pandemic on persons with multiple sclerosis: Early findings from a survey on disruptions in care and self-reported outcomes.

J Health Serv Res Policy 2020 Dec 18:1355819620975069. Epub 2020 Dec 18.

President, Italian Multiple Sclerosis Foundation and Professor, Department of Life Sciences, University of Siena, Italy.

Objective: To describe the disruptions in care experienced by persons with Multiple Sclerosis in Italy due to the COVID-19 pandemic and the self-reported impact on their health and wellbeing.

Methods: A cross-sectional online survey was completed by 2722 persons with Multiple Sclerosis, after Italy instituted a national lockdown in response to the pandemic.

Results: Persons with Multiple Sclerosis reported that the pandemic caused broad disruptions to usual health and social care services, which impacted on their health and wellbeing. Disruptions in care were consistently associated with negative self-reported impacts on the expected progression of the disease, on out-of-pocket expenditure and on carer's stress. Psychological consequences were associated with interruption to usual psychological support, and concerns about the safety of care delivered in person.

Conclusions: The quality of life of persons with Multiple Sclerosis depends greatly on prompt access to a broad range of health and care services. Negative psychological impacts reported by persons with Multiple Sclerosis with less severe disabilities show that accessible integrated services are crucial for maintenance of their wellbeing. Most persons with Multiple Sclerosis with more severe disability experienced negative impacts on perceived health. Their carers compensating for lack of social input resulted in care overburden. As continuity of care is crucial for persons with Multiple Sclerosis, as well as for persons with chronic conditions in general, strategies must be in place to ensure it is included in future pandemic response plans.
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http://dx.doi.org/10.1177/1355819620975069DOI Listing
December 2020

Mam36 and Abilhand as outcome measures of multiple sclerosis hand disability: an observational study.

Eur J Phys Rehabil Med 2020 Dec 11. Epub 2020 Dec 11.

Italian Multiple Sclerosis Society Research Foundation - FISM, Genoa, Italy.

Background: Impaired upper limb functionality and dexterity are common in people with multiple sclerosis (PwMS) and lead to increased dependency and reduced quality of life.

Aim Of The Study: To Compare the ability of the Manual Abilites Measure 36 (MAM-36) and the Abilhand questionnaire to recognize an involvement of the upper limbs in PwMS, and to compare their results with those of other patient reported outcomes (PRO) evaluating disability, functional independence, symptoms of anxiety and depression, fatigue and quality of life.

Design: Observational study.

Setting: Outpatient.

Population: 51 PwMS (mean age 56,31 years, age range 33-82 years, 72,5% females).

Methods: For each patient were collected MAM-36, Abilhand questionnaire, expanded disability status scale (EDSS), Functional Independence measure (FIM), Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS) and Life Satisfaction Index (LSI).

Results: A strong correlation between MAM-36 and the Abilhand questionnaire (Spearman r: 0.79; p<0.0001) were found. We obtained a significant correlation between MAM-36 and EDSS (Spearman r: -0.5; p= 0.0002), FIM (Spearman r: 0.55; p<0.0001); we did not observe a correlation with MFIS (Spearman r: -0.33; p: 0.02); moreover we found a similar trend between Abilhand and EDSS (Spearman r: -0.47; p= 0.0005), FIM (Spearman r: 0.61; p<0.0001), MFIS (Spearman r: -0.41; p: 0.002).

Conclusions: In PwMS the assessment of upper limbs is fundamental since it closely related to the level of disability of the person. Both MAM-36 and Abilhand Questionnaire are equally able to detect upper limb dysfunctions in PwMS.

Clinical Rehabilitation Impact: Both MAM-36 and Abilhand can be used for upper limbs evaluation, within a multidimensional approach that seems to be the best way to evaluate PwMS.
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http://dx.doi.org/10.23736/S1973-9087.20.06446-1DOI Listing
December 2020

EAN Guideline on Palliative Care of People with Severe, Progressive Multiple Sclerosis.

J Palliat Med 2020 11 29;23(11):1426-1443. Epub 2020 May 29.

The Tizard Centre, University of Kent, Canterbury, United Kingdom.

Patients with severe, progressive multiple sclerosis (MS) have complex physical and psychosocial needs, typically over several years. Few treatment options are available to prevent or delay further clinical worsening in this population. The objective was to develop an evidence-based clinical practice guideline for the palliative care of patients with severe, progressive MS. This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Formulation of the clinical questions was performed in the Patients-Intervention-Comparator-Outcome format, involving patients, carers and healthcare professionals (HPs). No uniform definition of severe MS exists: in this guideline, constant bilateral support required to walk 20 m without resting (Expanded Disability Status Scale score >6.0) or higher disability is referred to. When evidence was lacking for this population, recommendations were formulated using indirect evidence or good practice statements were devised. Ten clinical questions were formulated. They encompassed general and specialist palliative care, advance care planning, discussing with HPs the patient's wish to hasten death, symptom management, multidisciplinary rehabilitation, interventions for caregivers and interventions for HPs. A total of 34 recommendations (33 weak, 1 strong) and seven good practice statements were devised. The provision of home-based palliative care (either general or specialist) is recommended with weak strength for patients with severe, progressive MS. Further research on the integration of palliative care and MS care is needed. Areas that currently lack evidence of efficacy in this population include advance care planning, the management of symptoms such as fatigue and mood problems, and interventions for caregivers and HPs.
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http://dx.doi.org/10.1089/jpm.2020.0220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7583337PMC
November 2020

An "all-wheel drive" proposal to accelerate clinical research in common and rare neurological diseases.

Neurol Sci 2020 Apr 19;41(4):789-793. Epub 2019 Dec 19.

Italian Multiple Sclerosis Foundation, Genoa, Italy.

The complex biology of neurological diseases calls for collaborative efforts that may increase the success rate of clinical research. Models have been proposed, but concrete actions remain insufficient. Based on recent considerations from basic science, from science of patient input and from an analysis of scientific resources in Italy, we here explain why our country may represent an appropriate environment for such actions. Furthermore, we sketch operational framework and business model to be applied in order to accelerate, in parallel, the development of therapies in common and rare diseases.
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http://dx.doi.org/10.1007/s10072-019-04189-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160195PMC
April 2020

Increasing prevalence of multiple sclerosis in Tuscany, Italy.

Neurol Sci 2020 Feb 6;41(2):397-402. Epub 2019 Nov 6.

Department of Life Sciences, University of Siena, 53100, Siena, Italy.

Background And Rationale: An increase of prevalence and incidence of multiple sclerosis (MS) has been reported in several countries, especially taking into account a long-term evaluation. This increasing trend often reflects improved case identification and ascertainment due to the refinement of diagnostic criteria. The aim of this study was to update the prevalence rate of MS in Tuscany (central Italy) as of 2017, and to assess if there has been an increasing trend of prevalence in this Region considering a short period of analysis, from 2014 to 2017.

Methods: To capture prevalent cases, a case-finding algorithm based on administrative data, previously created and validated, was used. As data sources, we considered hospital discharge records, drug-dispensing records, disease-specific exemptions from copayment to health care, home and residential long-term care, and inhabitant registry.

Results: As of January 1, 2017, 7809 cases were identified, of which 69.4% were females and 30.6% were males. Considering temporal variation, an increasing trend was observed, with standardized rates rising from 189.2 in 2014 to 208.7 per 100,000 in 2017.

Conclusions: Results confirm that prevalence increases every year, probably mainly due to the difference between incidence and mortality, resulting in an increasing trend. Moreover, administrative data may accurately identify MS patients in a routinary way and monitor this cohort along disease care pathways.
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http://dx.doi.org/10.1007/s10072-019-04090-0DOI Listing
February 2020

MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis.

Trials 2019 May 9;20(1):263. Epub 2019 May 9.

Department of Medicine (Neurology), University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Background: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. Mesenchymal stem cells (MSC) have been shown to prevent inflammation and neurodegeneration in animal models of MS, but no large phase II clinical trials have yet assessed the exploratory efficacy of MSC for MS.

Methods/design: This is an academic, investigator-initiated, randomized, double-blind, placebo-compared phase I/II clinical trial with autologous, bone-marrow derived MSC in MS. Enrolled subjects will receive autologous MSC at either baseline or at week 24, through a cross-over design. Primary co-objectives are to test safety and efficacy of MSC treatment compared to placebo at 6 months. Secondary objectives will evaluate the efficacy of MSC at clinical and MRI levels. In order to overcome funding constraints, the MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) study has been designed to merge partially independent clinical trials, following harmonized protocols and sharing some key centralized procedures, including data collection and analyses.

Discussion: Results will provide patients and the scientific community with data on the safety and efficacy of MSC for MS. The innovative approach utilized to obtain funds to support the MESEMS trial could represent a new model to circumvent limitation of funds encountered by academic trials.

Trial Registration: Andalusia: NCT01745783 , registered on Dec 10, 2012. Badalona: NCT02035514 EudraCT, 2010-024081-21. Registered on 2012. Canada: ClinicalTrials.gov, NCT02239393 . Registered on September 12, 2014. Copenhagen: EudraCT, 2012-000518-13 . Registered on June 21, 2012. Italy: EudraCT, 2011-001295-19, and ClinicalTrials.gov, NCT01854957 . Retrospectively registered on May 16, 2013. London: Eudra CT 2012-002357-35, and ClinicalTrials.gov, NCT01606215 . Registered on May 25, 2012. Salzburg: EudraCT, 2015-000137-78 . Registered on September 15, 2015. Stockholm: ClinicalTrials.gov, NCT01730547 . Registered on November 21, 2012. Toulouse: ClinicalTrials.gov, NCT02403947 . Registered on March 31, 2015.
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http://dx.doi.org/10.1186/s13063-019-3346-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6507027PMC
May 2019

Steps towards Collective Sustainability in Biomedical Research.

Trends Mol Med 2018 05 24;24(5):429-432. Epub 2018 Mar 24.

Department of Research, Italian Multiple Sclerosis Foundation, Genoa, Italy. Electronic address:

The optimism surrounding multistakeholder research initiatives does not match the clear view of policies that are needed to exploit the potential of these collaborations. Here we propose some action items that stem from the integration between research advancements with the perspectives of patient-advocacy organizations, academia, and industry.
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http://dx.doi.org/10.1016/j.molmed.2018.03.001DOI Listing
May 2018

Motor Imagery as a Function of Disease Severity in Multiple Sclerosis: An fMRI Study.

Front Hum Neurosci 2017 11;11:628. Epub 2018 Jan 11.

Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.

Motor imagery (MI) is defined as mental execution without any actual movement. While healthy adults usually show temporal equivalence, i.e., isochrony, between the mental simulation of an action and its actual performance, neurological disorders are associated with anisochrony. Unlike in patients with stroke and Parkinson disease, only a few studies have investigated differences of MI ability in multiple sclerosis (MS). However, the relationship among disease severity, anisochrony and brain activation patterns during MI has not been investigated yet. Here, we propose to investigate MI in MS patients using fMRI during a behavioral task executed with dominant/non-dominant hand and to evaluate whether anisochrony is associated with disease severity. Thirty-seven right-handed MS patients, 17 with clinically isolated syndrome (CIS) suggestive of MS and 20 with relapsing-remitting MS (RR-MS) and 20 right-handed healthy controls (HC) underwent fMRI during a motor task consisting in the actual or imaged movement of squeezing a foam ball with the dominant and non-dominant hand. The same tasks were performed outside the MRI room to record the number of actual and imagined ball squeezes, and calculate an Index of performance (IP) based on the ratio between actual and imagined movements. IP showed that a progressive loss of ability in simulating actions (i.e., anisochrony) more pronounced for non-dominant hand, was found as function of the disease course. Moreover, anisochrony was associated with activation of occipito-parieto-frontal areas that were more extensive at the early stages of the disease, probably in order to counteract the changes due to MS. However, the neural engagement of compensatory brain areas becomes more difficult with more challenging tasks, i.e., dominant vs. non-dominant hand, with a consequent deficit in behavioral performance. These results show a strict association between MI performance and disease severity, suggesting that, at early stages of the disease, anisochrony in MI could be considered as surrogate behavioral marker of MS severity.
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http://dx.doi.org/10.3389/fnhum.2017.00628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5768615PMC
January 2018

Multiple sclerosis spatial cluster in Tuscany.

Neurol Sci 2017 Dec 10;38(12):2183-2187. Epub 2017 Oct 10.

Agenzia regionale di sanità della Toscana, Florence, Italy.

Tuscany (Central Italy) is a high-risk area for multiple sclerosis (MS) with a prevalence of 188 cases per 100,000 at 2011, and it is characterized by a heterogeneous geographic distribution of this disease. Our objective was to update prevalence at 2013 and to evaluate the presence of spatial clusters in Tuscany. The MS prevalence was evaluated on 31 December 2013 using a validated case-finding algorithm, based on administrative data. To identify spatial clusters, we calculated standardized morbidity ratios (SMRs) for each Tuscan administrative municipality. In addition to the classical approach, we applied the hierarchical Bayesian model to overcome random variability due to the presence of small number of cases per municipality. We identified 7330 MS patients (2251 males and 5079 females) with an overall prevalence of 195.4/100,000. The SMR for each Tuscan municipality ranged from 0 to 271.4, but this approach produced an extremely non-homogeneous map. On the contrary, the Bayesian map was much smoother than the classical one. The posterior probability (PP) map showed prevalence clusters in some areas in the province of Massa-Carrara, Pistoia, and Arezzo, and in the municipalities of Siena, Florence, and Barberino Val d'Elsa. Our prevalence data confirmed that Tuscany is a high-risk area, and we observed an increasing trend during the time. Using the Bayesian method, we estimated area-specific prevalence in each municipality reducing the random variation and the effect of extreme prevalence values in small areas that affected the classical approach.
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http://dx.doi.org/10.1007/s10072-017-3120-5DOI Listing
December 2017

Multiple Sclerosis Epidemiology in Europe.

Adv Exp Med Biol 2017 ;958:141-159

Department of Life Science, University of Siena, via Aldo Moro 2, 53100, Siena, Italy.

Multiple sclerosis is characterized by a non-homogeneous distribution around the world. Some authors in past described a latitude gradient, with increasing risk from the equator to North and South Poles, but this theory is still controversial. Regarding Europe, there are many articles in the literature concerning the epidemiology of this disease but, unfortunately, they are not always comparable due to different methodologies, they do not cover all countries in the continent, and most of them reported data of small areas and rarely at a national level. In 2012 there were 20 national registries that could help to describe the epidemiology of the disease and, in addition, there is an European Register for Multiple Sclerosis that collect data from already existing national or regional MS registries and databases. Another valid alternative to obtain epidemiological data, also at national level, in a routinely and cost-saving way is through administrative data that are of increasing interest in the last years.
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http://dx.doi.org/10.1007/978-3-319-47861-6_9DOI Listing
September 2017

Funding Medical Research Projects: Taking into Account Referees' Severity and Consistency through Many-Faceted Rasch Modeling of Projects' Scores.

J Appl Meas 2015 ;16(2):129-52

Luigi Tesio, Department of Neurorehabilitation Sciences, Istituto Auxologico Italiano, IRCCS, Via Giuseppe Mercalli 32, 20122 Milano, Italy,

The funding policy of research projects often relies on scores assigned by a panel of experts (referees). The non-linear nature of raw scores and the severity and inconsistency of individual raters may generate unfair numeric project rankings. Rasch measurement (many-facets version, MFRM) provides a valid alternative to scoring. MFRM was applied to the scores achieved by 75 research projects on multiple sclerosis sent in response to a previous annual call by FISM-Italian Foundation for Multiple Sclerosis. This allowed to simulate, a posteriori, the impact of MFRM on the funding scenario. The applications were each scored by 2 to 4 independent referees (total = 131) on a 10-item, 0-3 rating scale called FISM-ProQual-P. The rotation plan assured "connection" of all pairs of projects through at least 1 shared referee.The questionnaire fulfilled satisfactorily the stringent criteria of Rasch measurement for psychometric quality (unidimensionality, reliability and data-model fit). Arbitrarily, 2 acceptability thresholds were set at a raw score of 21/30 and at the equivalent Rasch measure of 61.5/100, respectively. When the cut-off was switched from score to measure 8 out of 18 acceptable projects had to be rejected, while 15 rejected projects became eligible for funding. Some referees, of various severity, were grossly inconsistent (z-std fit indexes less than -1.9 or greater than 1.9). The FISM-ProQual-P questionnaire seems a valid and reliable scale. MFRM may help the decision-making process for allocating funds to MS research projects but also in other fields. In repeated assessment exercises it can help the selection of reliable referees. Their severity can be steadily calibrated, thus obviating the need to connect them with other referees assessing the same projects.
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July 2015

Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: a multicentre randomized non-inferiority trial.

PLoS One 2014 17;9(11):e113371. Epub 2014 Nov 17.

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.

Unlabelled: For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥ 2 relapses in the last 2 years) were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR) over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150) were randomized in 2 groups (77 azathioprine, 73 β interferons). At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons). Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19-0.37) in the azathioprine and 0.39 (95% CI 0.30-0.51) in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01). MRI outcomes were analyzed in 97 patients (50 azathioprine and 47 β interferons). Annualized new T2 lesion rate was 0.76 (95% CI 0.61-0.95) in the azathioprine and 0.69 (95% CI 0.54-0.88) in the interferon group. Treatment discontinuations due to adverse events were higher (20.3% vs. 7.8%, p = 0.03) in the azathioprine than in the interferon group, and concentrated within the first months of treatment, whereas in the interferon group discontinuations occurred mainly during the second year. The results of this study indicate that efficacy of azathioprine is not inferior to that of β interferons for patients with relapsing-remitting multiple sclerosis. Considering also the convenience of the oral administration, and the low cost for health service providers, azathioprine may represent an alternative to interferon treatment, while the different side effect profiles of both medications have to be taken into account.

Trial Registration: EudraCT 2006-004937-13.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113371PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4234663PMC
February 2016

Multiple sclerosis registries in Europe - results of a systematic survey.

Mult Scler 2014 Oct 28;20(11):1523-32. Epub 2014 Apr 28.

University Hospital, Switzerland.

Background: Identification of MS registries and databases that are currently in use in Europe as well as a detailed knowledge of their content and structure is important in order to facilitate comprehensive analysis and comparison of data.

Methods: National MS registries or databases were identified by literature search, from the results of the MS Barometer 2011 and by asking 33 national MS societies. A standardized questionnaire was developed and sent to the registries' leaders, followed by telephone interviews with them.

Results: Twenty registries were identified, with 13 completing the questionnaire and seven being interviewed by telephone. These registries differed widely for objectives, structure, collected data, and for patients and centres included. Despite this heterogeneity, common objectives of the registries were epidemiology (n=10), long-term therapy outcome (n=8), healthcare research (n=9) and support/basis for clinical trials (n=8). While physician-based outcome measures (EDSS) are used in all registries, data from patients' perspectives were only collected in six registries.

Conclusions: The detailed information on a large number of national MS registries in Europe is a prerequisite to facilitating harmonized integration of existing data from MS registries and databases, as well as comprehensive analyses and comparison across European populations.
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http://dx.doi.org/10.1177/1352458514528760DOI Listing
October 2014

Upper limb motor rehabilitation impacts white matter microstructure in multiple sclerosis.

Neuroimage 2014 Apr 25;90:107-16. Epub 2013 Dec 25.

Department of Experimental Medicine, Section of Human Physiology and Centro Polifunzionale di Scienze Motorie, University of Genoa, Genoa, Italy. Electronic address:

Upper limb impairments can occur in patients with multiple sclerosis, affecting daily living activities; however there is at present no definite agreement on the best rehabilitation treatment strategy to pursue. Moreover, motor training has been shown to induce changes in white matter architecture in healthy subjects. This study aimed at evaluating the motor behavioral and white matter microstructural changes following a 2-month upper limb motor rehabilitation treatment based on task-oriented exercises in patients with multiple sclerosis. Thirty patients (18 females and 12 males; age=43.3 ± 8.7 years) in a stable phase of the disease presenting with mild or moderate upper limb sensorimotor deficits were randomized into two groups of 15 patients each. Both groups underwent twenty 1-hour treatment sessions, three times a week. The "treatment group" received an active motor rehabilitation treatment, based on voluntary exercises including task-oriented exercises, while the "control group" underwent passive mobilization of the shoulder, elbow, wrist and fingers. Before and after the rehabilitation protocols, motor performance was evaluated in all patients with standard tests. Additionally, finger motor performance accuracy was assessed by an engineered glove. In the same sessions, every patient underwent diffusion tensor imaging to obtain parametric maps of fractional anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity. The mean value of each parameter was separately calculated within regions of interest including the fiber bundles connecting brain areas involved in voluntary movement control: the corpus callosum, the corticospinal tracts and the superior longitudinal fasciculi. The two rehabilitation protocols induced similar effects on unimanual motor performance, but the bimanual coordination task revealed that the residual coordination abilities were maintained in the treated patients while they significantly worsened in the control group (p=0.002). Further, in the treatment group white matter integrity in the corpus callosum and corticospinal tracts was preserved while a microstructural integrity worsening was found in the control group (fractional anisotropy of the corpus callosum and corticospinal tracts: p=0.033 and p=0.022; radial diffusivity of the corpus callosum and corticospinal tracts: p=0.004 and p=0.008). Conversely, a significant increase of radial diffusivity was observed in the superior longitudinal fasciculi in both groups (p=0.02), indicating lack of treatment effects on this structure, showing damage progression likely due to a demyelination process. All these findings indicate the importance of administering, when possible, a rehabilitation treatment consisting of voluntary movements. We also demonstrated that the beneficial effects of a rehabilitation treatment are task-dependent and selective in their target; this becomes crucial towards the implementation of tailored rehabilitative approaches.
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http://dx.doi.org/10.1016/j.neuroimage.2013.12.025DOI Listing
April 2014

The effect of Nintendo® Wii® on balance in people with multiple sclerosis: a pilot randomized control study.

Mult Scler 2013 Aug 15;19(9):1219-21. Epub 2013 Jan 15.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.

Improvement of sensory strategies is a relevant part of balance rehabilitation in multiple sclerosis (MS). This study aimed to Assess the effectiveness of visual-feedback exercises in improving balance in MS. We divided 36 patients into Wii and control-treated groups that underwent balance rehabilitation. Outcomes were obtained for Berg Balance Scale (BBS), Modified Fatigue Impact Scale, and sway area under conditions of opened and closed eyes. BBS showed a statistically significant improvement (from 49.6 to 54.6 points, p < 0.05) in the Wii group. Interactive visual-feedback exercises such as Wii could be more effective than the current standard protocol in improving balance disorders in MS.
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http://dx.doi.org/10.1177/1352458512472747DOI Listing
August 2013

Presenting evidence-based health information for people with multiple sclerosis: the IN-DEEP project protocol.

BMC Med Inform Decis Mak 2012 Mar 16;12:20. Epub 2012 Mar 16.

Centre for Health Communication and Participation, Australian Institute for Primary Care and Ageing, La Trobe University, Melbourne, Australia.

Background: Increasingly, evidence-based health information, in particular evidence from systematic reviews, is being made available to lay audiences, in addition to health professionals. Research efforts have focused on different formats for the lay presentation of health information. However, there is a paucity of data on how patients integrate evidence-based health information with other factors such as their preferences for information and experiences with information-seeking. The aim of this project is to explore how people with multiple sclerosis (MS) integrate health information with their needs, experiences, preferences and values and how these factors can be incorporated into an online resource of evidence-based health information provision for people with MS and their families.

Methods: This project is an Australian-Italian collaboration between researchers, MS societies and people with MS. Using a four-stage mixed methods design, a model will be developed for presenting evidence-based health information on the Internet for people with MS and their families. This evidence-based health information will draw upon systematic reviews of MS interventions from The Cochrane Library. Each stage of the project will build on the last. After conducting focus groups with people with MS and their family members (Stage 1), we will develop a model for summarising and presenting Cochrane MS reviews that is integrated with supporting information to aid understanding and decision making. This will be reviewed and finalised with people with MS, family members, health professionals and MS Society staff (Stage 2), before being uploaded to the Internet and evaluated (Stages 3 and 4).

Discussion: This project aims to produce accessible and meaningful evidence-based health information about MS for use in the varied decision making and management situations people encounter in everyday life. It is expected that the findings will be relevant to broader efforts to provide evidence-based health information for patients and the general public. The international collaboration also permits exploration of cultural differences that could inform international practice.
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http://dx.doi.org/10.1186/1472-6947-12-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3315402PMC
March 2012

Multiple sclerosis in twins from continental Italy and Sardinia: a nationwide study.

Ann Neurol 2006 Jan;59(1):27-34

Neurology and Center for Experimental Neurological Therapy, S. Andrea Hospital, University of Rome La Sapienza, Via di Grottarossa 1035-1039, 00189 Rome, Italy.

Knowledge about the balance between heritable and nonheritable risk in multiple sclerosis (MS) is based on twin studies in high-prevalence areas. In a study that avoided ascertainment limitations and directly compared continental Italy (medium-prevalence) and Sardinia (high-prevalence), we ascertained 216 pairs from 34,549 patients. This gives a twinning rate of 0.62% among MS patients, significantly less than that of the general population. In continental Italy, probandwise concordance was 14.5% (95% confidence interval, 5.1-23.8) for monozygotic and 4.0% (95% confidence interval, 0.8-7.1) for dizygotic twins. Results in Sardinia resemble those in northern populations but in limited numbers. Monozygotic concordance was 22.2% (95% confidence interval, 0-49.3) probandwise, but no concordant dizygotic pairs were identified. A questionnaire on 80 items possibly related to disease cause was administered to 70 twin pairs, 135 sporadic patients, and 135 healthy volunteers. Variables positively (7) or negatively (2) associated with predisposition and concordance in twins largely overlapped and were mainly linked to infection. If compared with previous studies, our data demonstrate that penetrance in twins appears to correlate with MS prevalence. They highlight the relevance of nonheritable variables in Mediterranean areas. The apparent underrepresentation of MS among Italian twins draws attention to protective factors, shared by twins, that may influence susceptibility.
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http://dx.doi.org/10.1002/ana.20683DOI Listing
January 2006

The FIM instrument in the United States and Italy: a comparative study.

Am J Phys Med Rehabil 2002 Mar;81(3):168-76

Salvatore Maugeri Foundation, IRCCS, Department of Rehabilitation and the Unit of Research, Functional Assessment and Quality Assurance in Rehabilitation, Pavia, Italy.

Objective: To compare FIM instrument ratings between Italy and the United States.

Design: This study utilized 169,835 United States and 4,536 Italian FIM instrument records for stroke with the left side of the body affected, stroke with the right side of the body affected, and orthopedic conditions.

Results: Case-mix, patient age, and admission and discharge FIM instrument scores were similar. The delays between onset of disability and admission to rehabilitation and lengths of stay in rehabilitation were 2-4 times longer in Italy. In Italy, some 88-95% of the subjects were discharged to the community vs. 74-88% in the United States. Hierarchies of FIM instrument ratings across the motor and cognitive items were similar, but there were interesting differences. The hierarchical patterns showed that dressing, bathing, perineal hygiene, and tub or shower transfer were relatively more difficult in Italy compared with the Unites States, whereas walking was easier in Italy compared to the United States.

Conclusion: The Italian health care payment system offers less incentive for early discharges from acute care and rehabilitation. In Italy, nursing homes are less accessible, whereas family support is more available. Apparently less intensive treatment is applied in Italy, where a minimum time per day for rehabilitation services is not mandatory for payment. Occupational therapy is not used in Italy and the focus is more on physical therapy.
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http://dx.doi.org/10.1097/00002060-200203000-00003DOI Listing
March 2002

The costs of multiple sclerosis: a cross-sectional, multicenter cost-of-illness study in Italy.

J Neurol 2002 Feb;249(2):152-63

Department of Neurological Sciences, University of Florence, Italy.

Objectives: To estimate the socio-economic impact of multiple sclerosis (MS) in Italy.

Methods: Outpatients with MS were enrolled at 44 centres across Italy. Socio-demographic, clinical and resource utilization data were collected using a validated questionnaire. Each patient completed a weekly diary of expenses due to MS over a three-month period. Direct health care costs and indirect costs (lack of productivity for the patient and for caregivers) were assessed for the whole population and were compared among five groups, categorised by disease severity (EDSS score). An analysis of variance was carried out on socio-demographic variables.

Results: For the total population of 566 patients, the mean direct cost over three months was ITL 2,134,000, the mean indirect cost was ITL 7,775,000. Costs were significantly higher for male patients (p < 0.05) and showed a significant increase with increasing age (p < 0.0005), disease duration (p < 0.0005) and disease severity (p < 0.0005). Costs for patients in a progressive phase were significantly higher (p < 0.0005). There were no significant geographical differences among the regions of Italy.

Conclusions: This study confirms that MS represents a high economic burden, with indirect costs greatly exceeding direct costs. Unpaid caregivers remain the culturally accepted mode of care for MS patients in Italy and this study illustrates the impact of their loss of earnings. As costs increase with disease progression, these findings suggest that treatment efforts should focus on patients in the early stages of MS, in order to slow down disease progression.
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http://dx.doi.org/10.1007/pl00007858DOI Listing
February 2002