Publications by authors named "Paolo Confalonieri"

59 Publications

Immune Soluble Factors in the Cerebrospinal Fluid of Progressive Multiple Sclerosis Patients Segregate Into Two Groups.

Front Immunol 2021 10;12:633167. Epub 2021 Mar 10.

Molecular Neuroimmunology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Santa Lucia, Rome, Italy.

Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis (MS) are characterized by neurological deficits caused by a permanent neuronal damage, clinically quantified by the expanded disability status scale (EDSS). Neuronal tissue damage is also mediated by immune infiltrates producing soluble factors, such as cytokines and chemokines, which are released in the cerebrospinal fluid (CSF). The mechanisms regulating the production of a soluble factor are not completely defined. Using multiplex bead-based assays, we simultaneously measured 27 immune soluble factors in the CSF collected from 38 patients, 26 with PP-MS and 12 with SP-MS. Then, we performed a correlation matrix of all soluble factors expressed in the CSF. The CSF from patients with PP-MS and SP-MS had similar levels of cytokines and chemokines; however, the stratification of patients according to active or inactive magnetic resonance imaging (MRI) unveils some differences. Correlative studies between soluble factors in the CSF of patients with PP-MS and SP-MS revealed two clusters of immune mediators with pro-inflammatory functions, namely IFN-γ, MCP-1, MIP-1α, MIP-1β, IL-8, IP-10, and TNF-α (group 1), and anti-inflammatory functions, namely IL-9, IL-15, VEGF, and IL-1ra (group 2). However, most of the significant correlations between cytokines of group 1 and of group 2 were lost in patients with more severe disability (EDSS ≥ 4) compared to patients with mild to moderate disability (EDSS < 4). These results suggest a common regulation of cytokines and chemokines belonging to the same group and indicate that, in patients with more severe disability, the production of those factors is less coordinated, possibly due to advanced neurodegenerative mechanisms that interfere with the immune response.
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http://dx.doi.org/10.3389/fimmu.2021.633167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988186PMC
March 2021

Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register.

Neurotherapeutics 2021 Feb 2. Epub 2021 Feb 2.

Department "G.F. Ingrassia", MS center, University of Catania, Policlinico G. Rodolico, V. Santa Sofia 78, 95123, Catania, Italy.

The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48-0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76-1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58-0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.
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http://dx.doi.org/10.1007/s13311-020-01001-6DOI Listing
February 2021

Living with severe multiple sclerosis: Cost-effectiveness of a palliative care intervention and cost of illness study.

Mult Scler Relat Disord 2021 Jan 15;49:102756. Epub 2021 Jan 15.

Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Via Celoria 11, 20133 Milan, Italy. Electronic address:

Background: Little is known about the economic consequences of living with severe multiple sclerosis (SMS).

Aims: To assess the cost-effectiveness of a home-based palliative approach (HPA) for people with SMS (pwSMS). To assess direct healthcare costs in this population.

Methods: PwSMS from three Italian centers received (2:1 ratio) HPA or usual care over six months. Direct healthcare costs were collected on a monthly basis. Incremental cost-effectiveness was gauged from a national healthcare system (NHS) and a personal perspective, considering the Palliative Outcome Scale-Symptoms-MS (POS-S-MS) and the EuroQol five-dimension descriptive system quality-adjusted life years (EQ-5D-3L QALYs), both completed at baseline, after three and six months.

Results: Of 78 randomized pwSMS, 76 (50 HPA, 26 usual care) were analyzed. Mean QALYs were close to zero, and the mean group difference was -0.006 (95% CI -0.057 to 0.044). The mean baseline-adjusted cost difference was € -394 (95% confidence interval, CI -3,532 to 2,743). POS-S-MS cost-effectiveness showed a slight mean reduction of symptom burden (-1.9; 95% CI -1.1 to 5.0) with unchanged costs. Mean direct costs due to MS were € 23,195/year, almost equally distributed between NHS (€ 13,108) and pwSMS (€ 10,087). Personal care, medications and home rehabilitation accounted for 80% of total expenditures. Most personal care costs were covered by pwSMS, and these costs were 3/4 of pwSMS out-of-pocket.

Conclusions: The slight reduction of symptom burden produced by the HPA was not associated with an increase in costs. NHS and pwSMS almost equally sustained these costs.

Trial Registration: Current Controlled Trials ISRCTN73082124.
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http://dx.doi.org/10.1016/j.msard.2021.102756DOI Listing
January 2021

The Impact of the SARS-CoV-2 Outbreak on the Psychological Flexibility and Behaviour of Cancelling Medical Appointments of Italian Patients with Pre-Existing Medical Condition: The "ImpACT-COVID-19 for Patients" Multi-Centre Observational Study.

Int J Environ Res Public Health 2021 01 5;18(1). Epub 2021 Jan 5.

Department of Infectious-Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, 37024 Verona, Italy.

Psychological distress imposed by the SARS-CoV-2 outbreak particularly affects patients with pre-existing medical conditions, and the progression of their diseases. Patients who fail to keep scheduled medical appointments experience a negative impact on care. The aim of this study is to investigate the psychosocial factors contributing to the cancellation of medical appointments during the pandemic by patients with pre-existing health conditions. Data were collected in eleven Italian hospitals during the last week of lockdown, and one month later. In order to assess the emotional impact of the SARS-CoV-2 outbreak and the subject's degree of psychological flexibility, we developed an ad hoc questionnaire (ImpACT), referring to the Acceptance and Commitment Therapy (ACT) model. The Impact of Event Scale-Revised (IES-R), the Depression, Anxiety and Stress Scale (DASS) and the Cognitive Fusion Questionnaire (CFQ) were also used. Pervasive dysfunctional use of experiential avoidance behaviours (used with the function to avoid thought, emotions, sensations), feelings of loneliness and high post-traumatic stress scores were found to correlate with the fear of COVID-19, increasing the likelihood of cancelling medical appointments. Responding promptly to the information and psychological needs of patients who cancel medical appointments can have positive effects in terms of psychological and physical health.
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http://dx.doi.org/10.3390/ijerph18010340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7794735PMC
January 2021

Prevalence and patterns of subclinical motor and cognitive impairments in non-disabled individuals with early multiple sclerosis: a multicenter cross-sectional study.

Ann Phys Rehabil Med 2021 Jan 14:101491. Epub 2021 Jan 14.

Rehabilitation Department, CRRF Mons L Novarese, 13040 Loc. Trompone, Moncrivello VC, Italy.

Background: Motor and cognitive disorders appear early in the course of multiple sclerosis (MS) and develop gradually over time.

Objective: To study the frequency and pattern of subtle functional disorders in people with MS (PwMS) with no overt signs of disability in an early phase of the disease and their association with walking impairments in daily activities.

Methods: In this cross-sectional study, we recruited PwMS with an Expanded Disability Status Scale (EDSS) score ≤ 2.5 and disease duration ≤ 5 years. Participants were assessed with functional scales rating walking endurance (6-Min Walk Test), perceived walking ability (Twelve-item Multiple Sclerosis Walking Scale), balance (Fullerton Advanced Balance scale_short), manual dexterity (Nine Hole Peg Test), fatigue (Fatigue Severity Scale), and cognitive impairments (Brief International Cognitive Assessment).

Results: About 90% of the 82 PwMS (mean [SD] EDSS score 1.5 [0.7] and disease duration 2.2 [1.7] years) showed endurance values below the expected score; almost 30% showed impairment, and for 57%, perceived walking ability score was abnormal. Balance was impaired in 48% of participants, as was manual dexterity (29%) and fatigue (24%), but only a few showed cognitive impairments. Only 11% of PwMS had no abnormal score on the scales used in the assessment. As compared with EDSS score 0 to 1.5, with EDSS score 2 to 2.5, performance was worse for endurance (difference ±61.0 m, p=0.016), perceived walking ability (-11 points, p=0.002), balance (+1.9 points, p=0.005), manual dexterity (-2.8 sec, p=0.004), and fatigue (-1.3 points, p=0.013). Factors that predicted perceived walking ability were balance (B = -1.37, p<0.001) and fatigue (B = 5.11, p<0.001) rather than endurance (B = -0.01, p=048).

Conclusion: Even PwMS with no clinical disability and classified as having "no problem walking" present walking and other functional deficits when assessed with specific functional tests. The addition of specific tools could better identify subtle motor and cognitive deficits. Finally, the assessment of balance disorders and fatigue is important to understand individuals' perceived walking impairments in daily activities.
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http://dx.doi.org/10.1016/j.rehab.2021.101491DOI Listing
January 2021

The IN-DEEP project "INtegrating and Deriving Evidence, Experiences, Preferences": a web information model on magnetic resonance imaging for people with multiple sclerosis.

J Neurol 2020 Aug 2;267(8):2421-2431. Epub 2020 May 2.

Scientific Direction, Carlo Besta Foundation and Neurological Institute, via Celoria 11, 20133, Milan, Italy.

Introduction: The IN-DEEP project aims to provide people with multiple sclerosis (PwMS) with evidence-based information on magnetic resonance imaging (MRI) in diagnosis and monitoring the disease through a website, and to collect their opinions on the clarity of the website's contents and its usefulness.

Methods And Analysis: A multidisciplinary advisory board committee was set up. We investigated the experience, attitude and information needs on MRI through three meetings with 24 PwMS, facilitated by an expert researcher and an observer. We developed the website on the basis of input from PwMS and systematic reviews and guidelines, assessed with AMSTAR and AGREE II. We sought feedback from nine PwMS who pilot-tested the beta-version of the website, during a meeting and through phone interviews and judged whether the contents were clear, understandable and useful, and the website was easily navigable. The website is in Italian.

Results: The website ( https://www.istituto-besta.it/in-deep-risonanza-magnetica2 ) provides two levels of information, different layouts and visualization of data covering MRI diagnostic accuracy, sensitivity and specificity, contents on how MRI can monitor PwMS over time to determine changes in the condition and evaluate treatment effects, practical information on how to prepare for the exam, educational tools and a glossary. The website was judged clear and useful by a sample of PwMS.

Conclusions: The website is a tool to address PwMS information needs on the role of MRI. It could be used by neurologists to facilitate communication with PwMS.
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http://dx.doi.org/10.1007/s00415-020-09864-7DOI Listing
August 2020

Assessing balance in non-disabled subjects with multiple sclerosis: Validation of the Fullerton Advanced Balance Scale.

Mult Scler Relat Disord 2020 Jul 13;42:102085. Epub 2020 Apr 13.

IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro 66, 20148 Milan Italy.

Objective: To validate the Fullerton Advanced Balance (FAB) scale for high-functioning non-disabled people with multiple sclerosis (PwMS).

Design: Cross-sectional study.

Participants: A convenience sample of early-diagnosed PwMS (N = 82; Expanded Disability Status Scale score ≤ 2.5) with disease duration ≤ 5 years and a control group of healthy volunteers (N = 45).

Main Outcome Measures: FAB scale, Timed Up and Go test (TUG), 6 Min Walk Test (6MWT) and 25 Foot Walk Test (25FWT).

Results: Six of the ten original FAB scale items were selected to represent a unidimensional construct. Only one factor with eigenvalues > 1.0 (1.90) was found. The new version of the scale reported a Cronbach alpha value of 0.65, and it was also statistically significantly correlated with TUG (r = -0.48). The new six-item scale, dubbed the FAB-short scale (FAB-s), discriminated between healthy volunteers and PwMS; moreover, both the FAB-s and the TUG test discriminated between the two PwMS subgroups: EDSS=0-1.5 (no disability) and EDSS=2-2.5 (minimal disability).

Conclusions: FAB-s is a unidimensional clinical tool for assessing balance. The scale is a promising instrument for detecting subtle changes in balance performance in high-functioning PwMS.
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http://dx.doi.org/10.1016/j.msard.2020.102085DOI Listing
July 2020

Local Dynamic Stability of Gait in People With Early Multiple Sclerosis and No-to-Mild Neurological Impairment.

IEEE Trans Neural Syst Rehabil Eng 2020 06 30;28(6):1389-1396. Epub 2020 Apr 30.

Poor dynamic balance, such as poor walking stability, is a hallmark of multiple sclerosis. Instrumental measures of local dynamic stability (LDS, e.g. short-term Lyapunov's exponents, sLyEs) are genuine measures of walking stability and increasingly used as dynamic balance indicators. The current work aims to investigate if people with multiple sclerosis (PWMS) with no clinical evidence of gait impairment suffer poor LDS of gait. Eighty PWMS with minimal impairment (EDSS ≤2.5) and twenty controls completed the Six-Minute Walk Test (6MWT) at their maximum speed, wearing inertial sensors. sLyEs were calculated from trunk vertical, mediolateral and anteroposterior (sLyE) acceleration. PWMS also completed a full clinical assessment including gait, balance and fatigue. Gait speed was lower in PWMS than controls (-15%), while sLyEs were larger in PWMS (+12%), even when adjusting for the different gait speed. High sLyE was associated with low gait speed, high impact of disease (including high fatigue) and poor balance, the three variables returned by a principal component analysis of the dataset of clinical measures. PWMS suffer poor LDS of gait, as indicated by large sLyEs. The association between high sLyE and poor balance supports the validity of sLyE as a dynamic balance measure. The inverse relationship between sLyE and gait speed is in line with the view that good balance is decisive for high gait speed. Finally, these findings are in line with the vicious circle linking poor balance and fatigue in PWMS, with fatigue worsening balance and poor balance leading to fatigue.
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http://dx.doi.org/10.1109/TNSRE.2020.2991636DOI Listing
June 2020

A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.

PLoS One 2020 9;15(4):e0231380. Epub 2020 Apr 9.

School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.

Introduction: An Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (group relaxation).

Methods: Single-blind phase II randomized controlled trial (RCT) and nested qualitative study (ISRCTN registration number: 38971970). Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors were measured at baseline, after seven, 12 and 24 weeks. READY participants completed the purpose-built satisfaction questionnaire after 12 weeks. After trial completion, the control group also received READY. One-to-one participant interviews were conducted within three months of finishing the READY groups.

Results: Four intervention groups were conducted with 39 participants (20 READY, 19 relaxation). Two patients (READY) withdrew before beginning the intervention due to unexpected work commitments. Feasibility and acceptability of READY were good, with high participant engagement and satisfaction. No statistical effects of READY were detected vs relaxation. Thirty participants were interviewed (18 READY; 12 relaxation + READY). Content data analysis revealed seven overarching themes: "Attitudes towards participation"; "Perceptions of program composition"; "Program impacts on life domains"; "Program active elements"; "Program improvement trajectories"; "Program differences and similarities"; "Suggested READY improvements".

Conclusion: READY was well accepted by MS patients with varied socio-demographic and clinical characteristics. Qualitative (but not quantitative) data provided evidence in favour of READY. Our findings will inform methodological and intervention refinements for the multi-centre RCT that will follow.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231380PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7145197PMC
July 2020

Severe thrombocytopenia during Natalizumab therapy: A case report.

J Neurol Sci 2020 02 22;409:116587. Epub 2019 Nov 22.

Multiple Sclerosis Unit, A. Perrino's Hospital, Brindisi, Italy; Neurological Department, A. Perrino's Hospital, Brindisi, Italy.

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http://dx.doi.org/10.1016/j.jns.2019.116587DOI Listing
February 2020

Assessing measurement invariance of MSQOL-54 across Italian and English versions.

Qual Life Res 2020 Mar 9;29(3):783-791. Epub 2019 Nov 9.

Department of Psychology, University of Turin, Turin, Italy.

Purpose: The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is a specific multiple sclerosis (MS) health-related quality of life inventory consisting of 52 items organized into 12 subscales plus two single items. No study was found in literature assessing its measurement invariance across language versions. We investigated whether MSQOL-54 items provide unbiased measurements of underlying constructs across Italian and English versions.

Methods: Three constrained levels of measurement invariance were evaluated: configural invariance where equivalent numbers of factors/factor patterns were required; metric invariance where equivalent factor loadings were required; and scalar invariance where equivalent item intercepts between groups were required. Comparative fit index (CFI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR) fit indices and their changes between nested models were used to assess tenability of invariance constraints.

Results: Overall, the dataset included 3669 MS patients: 1605 (44%) Italian, mean age 41 years, 62% women, 69% with mild level of disability; 2064 (56%) English-speaking (840 [41%] from North America, 797 [39%] from Australasia, 427 [20%] from UK and Ireland), mean age 46 years, 83% women, 54% with mild level of disability. The configural invariance model showed acceptable fit (RMSEA = 0.052, CFI = 0.904, SRMR = 0.046); imposing loadings and intercepts equality constraints produced negligible worsening of fit (ΔRMSEA < 0.001, ΔCFI = - 0.002, ΔSRMR = 0.002 for metric invariance; ΔRMSEA = 0.003, ΔCFI = - 0.013, ΔSRMR = 0.003 for scalar invariance).

Conclusions: These findings support measurement invariance of the MSQOL-54 across the two language versions, suggesting that the questionnaire has the same meaning and the same measurement paramaters in the Italian and English versions.
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http://dx.doi.org/10.1007/s11136-019-02352-0DOI Listing
March 2020

Impact of natural menopause on multiple sclerosis: a multicentre study.

J Neurol Neurosurg Psychiatry 2019 11 12;90(11):1201-1206. Epub 2019 Jun 12.

Multiple Sclerosis Centre, Gallarate Hospital, ASST Valle Olona, Gallarate, Italy.

Objective: To study the effect of natural menopause on multiple sclerosis clinical course.

Methods: This was an observational, retrospective, multicentre, cohort study. Menopause onset was defined by the final menstrual period (FMP) beyond which no menses occurred for 12 months. We included multiple sclerosis (MS) patients with FMP occurred after 2005 and a recorded follow-up of at least 2 years pre-FMP and post-FMP. We excluded patients with primary progressive course, iatrogenic menopause and with other confounders that could mask menopause onset. We compared relapse-rate and expanded disability status scale (EDSS) scores pre-FMP and post-FMP, searching for possible interactions with age, disease duration, cigarette smoking and nulliparity status.

Results: 148 patients were included (mean observation: 3.5 years pre-FMP and post-FMP). Most patients (92%) received disease-modifying therapies, mainly first-lines. After menopause the annualised relapse rate (ARR) significantly decreased (from 0.21±0.31 to 0.13± 0.24; p=0.005), while disability worsened (increase of mean 0.4 vs 0.2 points after menopause; p<0.001). Older age and long-lasting disease were associated with ARR reduction (p=0.013), but not with disability worsening. Cigarette smokers showed a trend to a higher disability accumulation after menopause (p=0.059).

Conclusion: Natural menopause seems to be a turning point to a more progressive phase of MS. Relapse rate is also reduced after menopause, but this effect could be driven most by ageing and shifting to progressive phase in patients with long-lasting disease. Cigarette smoking could speed up disability progression after menopause.
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http://dx.doi.org/10.1136/jnnp-2019-320587DOI Listing
November 2019

Participant perspectives of a home-based palliative approach for people with severe multiple sclerosis: A qualitative study.

PLoS One 2018 12;13(7):e0200532. Epub 2018 Jul 12.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.

Background: We performed a qualitative study to investigate the experiences of participants in a multicentre randomized controlled trial on a home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) and their caregivers. Our aim was to explore the strengths and challenges of the intervention, and circumstances that may have influenced its efficacy.

Methods: Participants to the qualitative study were the patients, their caregivers, patient referring physicians, and the teams who delivered the HPA intervention. We performed semi-structured one-on-one interviews with 12 patients and 15 informal caregivers chosen using a maximum variation strategy, two focus group meetings with patient referring physicians (4 participants each), and one with the HPA teams (9 participants).

Results: From data analysis (framework method) 38 sub-categories emerged, which were grouped into 10 categories and 3 themes: 'expectations,' 'met and unmet needs', and 'barriers'. Intervention benefits were improved control of symptoms and reduced sense of isolation of the patient-caregiver dyads. Limitations were: factors related to experimental design (difficulty of dyads in identifying examiner and team roles, additional burden for caregivers); team issues (insufficient team building /supervision, competing priorities); limitations of the intervention itself (insufficient length, lack of rehabilitation input); and external factors (resource limitations, under-responsive services/professionals). The referring physician focus groups provided little experiential data.

Conclusions: The HPA reduced patient symptoms and sense of isolation in patients and caregivers. The indirect role of the HPA teams, and insufficient length of the intervention were key limitations. The experimental design imposed additional burdens on the dyads. Key barriers were the paucity of available services, the demanding administrative procedures, and lack of networking facilities. These findings suggest that two major requirements are necessary for home palliative care to be effective in this patient population: HPA teams well-connected with MS rehabilitation services, and care delivered over the long-term, with variable intensity.

Trial Registration: Current Controlled Trials ISRCTN73082124 (Registered 19/06/2014).
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0200532PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042757PMC
January 2019

eMSQOL-29: Prospective validation of the abbreviated, electronic version of MSQOL-54.

Mult Scler 2019 05 15;25(6):856-866. Epub 2018 May 15.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.

Background: We recently devised a shortened version of the 54-item Multiple Sclerosis Quality of Life (MSQOL-54) in paper (MSQOL-29, consisting of 25 items forming 7 subscales and 4 single items, and one filter question for 3 'sexual function' items) and electronic format (eMSQOL-29).

Objectives: To prospectively assess eMSQOL-29 psychometric properties, acceptability/equivalence versus MSQOL-29.

Methods: Multiple sclerosis (MS) patients ( n = 623; Expanded Disability Status Scale (EDSS) range 0.0-9.0) completed eMSQOL-29, Hospital Anxiety and Depression Scale, Functional Assessment of MS (FAMS), European Quality of life Five Dimensions-3L, and received EDSS and Symbol Digit Modalities Test (SDMT). Equivalence versus MSQOL-29 was assessed in 242 patients (randomized cross-over design).

Results: 'Sexual function' items were filtered out by 273 patients (47%). No multi-item scale had floor effect, while five had ceiling effect. Cronbach's alpha range was 0.88-0.90. Confirmatory factor analysis showed good overall fit and the two-factor solution for composite scores was confirmed. Criterion validity was sub-optimal for 'cognitive function' (vs SDMT, r = 0.25) and 'social function' (vs FAMS social function, r = 0.38). eMSQOL-29 equivalence was confirmed and its acceptability was good.

Conclusion: eMSQOL-29 showed good internal consistency, factor structure and no floor effect, while most subscales had some ceiling effect. Criterion validity was sub-optimal for two subscales. Equivalence and acceptability were good.
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http://dx.doi.org/10.1177/1352458518774935DOI Listing
May 2019

Older age, higher perceived disability and depressive symptoms predict the amount and severity of work-related difficulties in persons with multiple sclerosis.

Disabil Rehabil 2019 09 16;41(19):2255-2263. Epub 2018 Apr 16.

a Neurology, Public Health and Disability Unit , Neurological Instiute C. Besta, IRCCS Foundation , Milan , Italy.

This cross-sectional study aims to identify the predictors of work-related difficulties in a sample of employed persons with multiple sclerosis as addressed with the Multiple Sclerosis Questionnaire for Job Difficulties. Hierarchical linear regression analysis was conducted to identify predictors of work difficulties: predictors included demographic variables (age, formal education), disease duration and severity, perceived disability and psychological variables (cognitive dysfunction, depression and anxiety). The targets were the questionnaire's overall score and its six subscales. A total of 177 participants (108 females, aged 21-63) were recruited. Age, perceived disability and depression were direct and significant predictors of the questionnaire total score, and the final model explained 43.7% of its variation. The models built on the questionnaire's subscales show that perceived disability and depression were direct and significant predictors of most of its subscales. Our results show that, among patients with multiple sclerosis, those who were older, with higher perceived disability and higher depression symptoms have more and more severe work-related difficulties. The Multiple Sclerosis Questionnaire for Job Difficulties can be fruitfully exploited to plan tailored actions to limit the likelihood of near-future job loss in persons of working age with multiple sclerosis. Implications for rehabilitation Difficulties with work are common among people with multiple sclerosis and are usually addressed in terms of unemployment or job loss. The Multiple Sclerosis Questionnaire for Job Difficulties is a disease-specific questionnaire developed to address the amount and severity of work-related difficulties. We found that work-related difficulties were associated to older age, higher perceived disability and depressive symptoms. Mental health issues and perceived disability should be consistently included in future research targeting work-related difficulties.
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http://dx.doi.org/10.1080/09638288.2018.1461937DOI Listing
September 2019

Managing the transition (ManTra): a resource for persons with secondary progressive multiple sclerosis and their health professionals: protocol for a mixed-methods study in Italy.

BMJ Open 2017 Aug 23;7(8):e017254. Epub 2017 Aug 23.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C Besta, Milano, Italy.

Introduction: 15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource.

Methods And Analysis: Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol).

Ethics And Dissemination: The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan ; G D'Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The results will be published in peer-reviewed journals, presented at conferences and a lay summary sent to participants.
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http://dx.doi.org/10.1136/bmjopen-2017-017254DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724224PMC
August 2017

Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis.

Mult Scler 2018 04 6;24(5):663-674. Epub 2017 Apr 6.

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

Background: Evidence on the efficacy of palliative care in persons with severe multiple sclerosis (MS) is scarce.

Objective: To assess the efficacy of a home-based palliative approach (HPA) for adults with severe MS and their carers.

Methods: Adults with severe MS-carer dyads were assigned (2:1 ratio) to either HPA or usual care (UC). At each center, a multi-professional team delivered the 6-month intervention. A blind examiner assessed dyads at baseline, 3 months, and 6 months. Primary outcome measures were Palliative care Outcome Scale-Symptoms-MS (POS-S-MS) and Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW, not assessed in severely cognitively compromised patients).

Results: Of 78 dyads randomized, 76 (50 HPA, 26 UC) were analyzed. Symptom burden (POS-S-MS) significantly reduced in HPA group compared to UC ( p = 0.047). Effect size was 0.20 at 3 months and 0.32 at 6 months, and statistical significance was borderline in per-protocol analysis ( p = 0.062). Changes in SEIQoL-DW index did not differ in the two groups, as changes in secondary patient and carer outcomes.

Conclusion: HPA slightly reduced symptoms burden. We found no evidence of HPA efficacy on patient quality of life and on secondary outcomes.
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http://dx.doi.org/10.1177/1352458517704078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946675PMC
April 2018

Psychosocial difficulties of individuals with multiple sclerosis: the PARADISE-24 questionnaire.

Int J Rehabil Res 2016 Dec;39(4):339-345

Departments of aNeuroimmunology and Neuromuscular Diseases bNeurosurgery, Radiotherapy Unit cNeurology, Public Health and Disability Unit, Neurological Institute Carlo Besta IRCCS Foundation, Milan, Italy.

The aim of this study is to identify the most relevant psychosocial difficulties (PSDs) experienced by persons with multiple sclerosis (PwMS); to evaluate the relation between an overall level of PSDs measured with the PARADISE-24 and other variables; to assess which factors may predict PARADISE-24 overall score. Adults PwMS were consecutively enrolled and completed a battery of eight self-reported instruments (i.e. SCQ, EUROHIS-QOL 8, BRS, BFI-10, JSPE, OSS-3, WHODAS-12, PARADISE-24). A clinical evaluation was performed for each patient and the Expanded Disability Status Scale (EDSS) score was determined by neurologists. A total of 80 PwMS, mean age 41.0, 65% women, 62% married, and 76.3% working, 86.3% relapsing-remitting MS, with an EDSS median score of 1.5, took part in the study. The mean disease duration was 7.7 years. The most frequently reported PSDs involved motor and emotional functioning. Free of charge access to medicines; health treatments and family, friends and health professionals' assistance represented the most important facilitators. WHODAS-12 and EUROHIS-QOL 8 were excluded from regression because of their strong correlation with PARADISE-24. EDSS, BRS, OSS-3, and neuroticism were the main predictors of the PARADISE-24 score. Despite MS heterogeneity, a common pattern of PSDs can be observed among PwMS. The level of physical impairment and personal resilience were the main predictors of the overall level of PSDs in PwMS, with a lower but significant additional role played by social support and personality traits. Attention to PSDs and their predictors, using PARADISE-24, can help clinicians to plan tailored and personalized rehabilitation programs.
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http://dx.doi.org/10.1097/MRR.0000000000000194DOI Listing
December 2016

Identification of a gene expression signature in peripheral blood of multiple sclerosis patients treated with disease-modifying therapies.

Clin Immunol 2016 Dec 5;173:133-146. Epub 2016 Oct 5.

Neurology IV - Neuroimmunology and Neuromuscular Diseases Unit, Neurological Institute "Carlo Besta", Milan, Italy. Electronic address:

Multiple Sclerosis (MS) is an inflammatory disease with neurodegenerative alterations, ultimately progressing to neurological handicap. Therapies are effective in counteracting inflammation but not neurodegeneration. Biomarkers predicting disease course or treatment response are lacking. We investigated whether altered gene and protein expression profiles were detectable in the peripheral blood of 78 relapsing remitting MS (RR-MS) patients treated by disease-modifying therapies. A discovery/validation study on RR-MS responsive to glatiramer acetate identified 8 differentially expressed genes: ITGA2B, ITGB3, CD177, IGJ, IL5RA, MMP8, P2RY12, and S100β. A longitudinal study on glatiramer acetate, Interferon-β, or Fingolimod treated RR-MS patients confirmed that 7 out of 8 genes were downregulated with reference to the different therapies, whereas S100β was always upregulated. Thus, we identified a peripheral gene signature associated with positive response in RR-MS which may also explain drug immunomodulatory effects. The usefulness of this signature as a biomarker needs confirmation on larger series of patients.
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http://dx.doi.org/10.1016/j.clim.2016.10.002DOI Listing
December 2016

Difficulties in adjustment to multiple sclerosis: vulnerability and unpredictability of illness in the foreground.

Disabil Rehabil 2017 05 20;39(9):897-903. Epub 2016 May 20.

a Department of Neuroimmunology and Neuromuscular Diseases - Neurological Institute C. Besta IRCCS Foundation , Milan , Italy.

Purpose: Multiple Sclerosis (MS) is a progressive neurological disease characterized by an unpredictable risk to develop relevant disability over time. Few studies focused on the core psychological features of difficulties in adjustment to MS. This qualitative study aims to explore the illness experience of people with difficulties in adjustment to MS, paying more attention to both illness representation and shifting perspective.

Method: Nineteen persons with difficulties in adjustment to MS participated in the study and their interviews were analyzed using thematic analysis.

Results: Considering the Shifting Perspective Model, illness is rigidly placed in the foreground, and wellness decisively pushed in the background, with a lack of flexibility in shifting between the two perspectives. The thematic analysis delineated three main topics: illness representation; coping strategies; relationships with others. The illness representation is characterized by invalidating symptoms; unclear cause; sudden onset; unpredictable course and uncertain prognosis; severe impact on person's functioning; and low sense of internal control. Participants reported to mainly use emotion-focused coping strategies.

Conclusions: Adjustment can be supported activating psychological intervention addressed to patients' illness representations and more flexibility in the shifting between illness and wellness in the foreground. Implications for Rehabilitation Adjustment to MS is influenced by illness perception. It is important to pay more attention to contents about vulnerability and unpredictability associated to MS. With regards to the Shifting Perspectives Model, difficulties in adjustment are related to the rigidity that prevents an adequate shift between the two perspectives (illness and wellness), with the predominance of the illness perspective in the foreground. Hence, it is important to assess the shifting perspectives preference and flexibility, and the contents of illness representation of a person with MS. Clinicians can support process of adjustment, activating psychological intervention addressed to patients' illness representations and promotion of a more flexibility in the shifting between illness and wellness in the foreground. The Illness Representation Model should be enriched by a social component, able to take into consideration the impact of the disease on interactions with others.
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http://dx.doi.org/10.3109/09638288.2016.1170212DOI Listing
May 2017

A 12-month prospective, observational study evaluating the impact of disease-modifying treatment on emotional burden in recently-diagnosed multiple sclerosis patients: The POSIDONIA study.

J Neurol Sci 2016 May 20;364:105-9. Epub 2016 Feb 20.

Medical Department, Teva Italia, Milano, Italy.

Introduction: Depression and anxiety are common among patients with multiple sclerosis (MS) and are frequently present at the time of MS diagnosis.

Methods: POSIDONIA was a 12-month, observational, prospective study conducted in Italy to evaluate the impact of disease-modifying treatment (DMT) on emotional burden in patients with recently-diagnosed MS. The Hospital Anxiety and Depression Scale (HADS), specifically HADS anxiety (HADS-A) and depression (HADS-D) subscale scores, the Short-Form 36 Health Survey (SF-36) and the Impact of Event Scale - Revised (IES-R) were used to measure patient-reported outcomes. The Hamilton Depression Rating Scale (HDRS), HDRS-17, was used as a measure of healthcare provider-reported outcomes. The primary study outcome was change from baseline in feelings of anxiety and depression over 12months (via HADS).

Results: Of 250 enrolled patients, 222 (88.8%) completed the study. At baseline, mean HADS total, HADS-A and HADS-D subscale scores were within the normal range. There were no significant changes over time in mean HADS total and HADS-A and HADS-D subscale scores, although the subgroup of patients with baseline scores indicative of anxiety or depression tended to improve over time. Both the HDRS and IES-R total scores improved over time, but there were no statistically significant changes in SF-36.

Conclusion: In the patient population of the POSIDONIA study depression and anxiety were present in a minority of patients thus not allowing to detect the impact of starting DMT. However DMT appears to have a positive effect in patients with measurable anxiety or depression at baseline.
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http://dx.doi.org/10.1016/j.jns.2016.02.047DOI Listing
May 2016

Development of a Short Version of MSQOL-54 Using Factor Analysis and Item Response Theory.

PLoS One 2016 14;11(4):e0153466. Epub 2016 Apr 14.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.

Background: The Multiple Sclerosis Quality of Life-54 (MSQOL-54, 52 items grouped in 12 subscales plus two single items) is the most used MS specific health related quality of life inventory.

Objective: To develop a shortened version of the MSQOL-54.

Methods: MSQOL-54 dimensionality and metric properties were investigated by confirmatory factor analysis (CFA) and Rasch modelling (Partial Credit Model, PCM) on MSQOL-54s completed by 473 MS patients. Their mean age was 41 years, 65% were women, and median Expanded Disability Status Scale (EDSS) score was 2.0 (range 0-9.5). Differential item functioning (DIF) was evaluated for gender, age and EDSS. Dimensionality of the resulting short version was assessed by exploratory factor analysis (EFA) and CFA. Cognitive debriefing of the short instrument (vs. the original) was then performed on 12 MS patients.

Results: CFA of MSQOL-54 subscales showed that the data fitted the overall model well. Two subscales (Role Limitations--Physical, Role Limitations--Emotional) did not fit the PCM, and were removed; two other subscales (Health Perceptions, Social Function) did not fit the model, but were retained as single items. Sexual Satisfaction (single-item subscale) was also removed. The resulting MSQOL-29 consisted of 25 items grouped in 7 subscales, plus 4 single items. PCM fit statistics were within the acceptability range for all MSQOL-29 items except one which had significant DIF by age. EFA and CFA indicated adequate fit to the original two-factor (Physical and Mental Health Composites) hypothesis. Cognitive debriefing confirmed that MSQOL-29 was acceptable and had lost no key items.

Conclusions: The proposed MSQOL-29 is 50% shorter than MSQOL-54, yet preserves key quality of life dimensions. Prospective validation on a large, independent MS patient sample is ongoing.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0153466PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831784PMC
August 2016

Development and assessment of a website presenting evidence-based information for people with multiple sclerosis: the IN-DEEP project.

BMC Neurol 2016 Mar 2;16:30. Epub 2016 Mar 2.

Unit of Neuroepidemiology, Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group, Neurological Institute C. Besta IRCCS Foundation, Via G. Celoria 11, 20133, Milan, Italy.

Background: People with multiple sclerosis (MS) are increasingly using the Internet in the daily management of their condition. They search for high-quality information in plain language, from independent sources, based on reliable and up-to-date evidence. The Integrating and Deriving Evidence, Experiences and Preferences (IN-DEEP) project in Italy and Australia aimed to provide people with MS and family members with an online source of evidence-based information, starting from their information needs. This paper reports on the Italian project's website.

Methods: Contents, layout and wording were developed with people with MS and pilot-tested. The website was evaluated using an online 29-item questionnaire for ease of language, contents, navigation, and usefulness of information aimed at people with MS, family members and the general population.

Results: The website ( http://indeep.istituto-besta.it/) is structured in multiple levels of information. The first topic was interferons-β for people with relapsing-remitting MS. In all, 433 people responded to the survey (276 people with MS, 68 family members and 89 others). The mean age was 45 years, almost 90% had a high school diploma, about 80% had relapsing-remitting MS, and the median disease duration was seven years. About 90% judged the website clear, understandable, useful, and easy to navigate. Ninety percent of people with MS and family members would recommend it to others. Sixty-two percent reported they felt confident in making decisions on interferons-β after reading the website.

Conclusions: The model was judged clear and useful. It could be adapted to other topics and diseases. Clinicians may find it useful in their relationship with patients.
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http://dx.doi.org/10.1186/s12883-016-0552-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4776365PMC
March 2016

Cognitive function alone is a poor predictor of health-related quality of life in employed patients with MS: results from a cross-sectional study.

Clin Neuropsychol 2016 02 1;30(2):201-15. Epub 2016 Mar 1.

b Neurology, Public Health and Disability Unit , Neurological Institute C. Besta IRCCS Foundation , Milan , Italy.

Objective: Depression, anxiety, disease severity, and cognitive functions impact on the quality of life of people with MS. However, the majority of studies were not based on multivariate models and did not target employed patients. The aim of this study was to investigate predictors of HRQoL in persons with MS in the workforce considering cognitive, psychological, disease severity, and disability-related variables.

Methods: Cross-sectional study. Hierarchical block regression analyses were conducted to identify predictors of physical and mental components of HRQoL, measured with the MSQOL-54. Candidate predictors included cognitive functioning (a selection of Rao's BRB-NT), sample features (age, education, MS duration), depressive symptoms (BDI-II), anxiety (STAI-Y), disability (WHODAS 2.0), and MS severity (EDSS): those that correlated with PCS and MCS with p < .250 and those that correlated with other predictors with coefficients >.800 were excluded from regression analyses.

Results: In total, 181 patients (60.8% females, mean age 39.6, median EDSS 1.5) were included. In both models, cognitive variables had a poor explicative power. The models improved significantly when psychological, as well as, disease severity and disability variables were added. R(2) of complete models was 0.732 for the physical component, 0.697 for the mental one: BDI-II, STAI-State and, some WHODAS 2.0 scales were significant predictors of HRQoL.

Conclusions: Monitoring anxiety, depressive symptoms, and level of disability through self-reported questionnaires may provide useful suggestions to improve the HRQoL of persons with MS in the workforce, permitting to address possible problems in the work context and plan corrective actions.
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http://dx.doi.org/10.1080/13854046.2016.1142614DOI Listing
February 2016

Multiple Sclerosis Questionnaire for Job Difficulties (MSQ-Job): definition of the cut-off score.

Neurol Sci 2016 May 3;37(5):777-80. Epub 2016 Feb 3.

Neurology, Public Health and Disability Unit, Neurological Institute C. Besta IRCCS Foundation, Via Celoria 11, 20133, Milan, Italy.

Multiple Sclerosis (MS) mainly affects people of working age. The Multiple Sclerosis Questionnaire for Job Difficulties (MSQ-Job) was designed to measure difficulties in work-related tasks. Our aim is to define cut-off score of MSQ-Job to identify potential critical situations that might require specific attention. A sample of patients with MS completed the MSQ-Job, WHODAS 2.0 and MSQOL-54 respectively for work difficulties, disability and health-related quality of life (HRQoL) evaluation. K-means Cluster Analysis was used to divide the sample in three groups on the basis of HRQoL and disability. ANOVA test was performed to compare the response pattern between these groups. The cut-off score was defined using the receiver operating characteristic (ROC) curve analyses for MSQ-Job total and count of MSQ-Job items scores ≥3: a score value corresponding to the maximum of the sensitivity-to-specificity ratio was chosen as the cut-off. Out of 180 patients enrolled, twenty were clustered in the higher severity group. The area under the ROC curve was 0.845 for the MSQ-Job total and 0.859 for the count of MSQ-Job items scores ≥3 while the cut-off score was 15.8 for MSQ-Job total and 8 for count of items scored ≥3. We recommend the use of MSQ-Job with this calculation as cut-off for identifying critical situations, e.g. in vocational rehabilitation services, where work-related difficulties have a significant impact in terms of lower quality of life and higher disability.
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http://dx.doi.org/10.1007/s10072-016-2495-zDOI Listing
May 2016

Patient expression of emotions and neurologist responses in first multiple sclerosis consultations.

PLoS One 2015 1;10(6):e0127734. Epub 2015 Jun 1.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.

Background: Anxiety and depression are common in people with multiple sclerosis (MS), but data on emotional communication during MS consultations are lacking. We assessed patient expressions of emotion and neurologist responses during first-ever MS consultations using the Verona Coding Definitions of Emotional Sequences (VR-CoDES).

Methods: We applied VR-CoDES to recordings/transcripts of 88 outpatient consultations (10 neurologists, four MS Italian centers). Before consultation, patients completed the Hospital Anxiety and Depression Scale (HADS). Multilevel sequential analysis was performed on the number of cues/concerns expressed by patients, and the proportion of reduce space responses by neurologists.

Results: Patients expressed 492 cues and 45 concerns (median 4 cues and 1 concern per consultation). The commonest cues were verbal hints of hidden worries (cue type b, 41%) and references to stressful life events (type d, 26%). Variables independently associated with number of cues/concerns were: anxiety (HADS-Anxiety score >8) (incidence risk ratio, IRR 1.08, 95% CI 1.06-1.09; p<0.001); patient age (IRR 0.98, 95% CI 0.98-0.99; p<0.001); neurologist age (IRR 0.94, 95% CI 0.92-0.96; p=0.03); and second opinion consultation (IRR 0.72, 95% CI 0.60-0.86; p=0.007). Neurologists reacted to patient emotions by reducing space (changing subject, taking no notice, giving medical advice) for 58% of cues and 76% of concerns. Anxiety was the only variable significantly associated with 'reduce space' responses (odds ratio 2.17, 95% CI 1.32-3.57; p=0.003).

Conclusions: Patient emotional expressions varied widely, but VR-CoDES cues b and d were expressed most often. Patient anxiety was directly associated with emotional expressions; older age of patients and neurologists, and second opinion consultations were inversely associated with patient emotional expression. In over 50% of instances, neurologists responded to these expressions by reducing space, more so in anxious patients. These findings suggest that neurologists need to improve their skills in dealing with patient emotions.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0127734PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452259PMC
March 2016

Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.

Trials 2015 Apr 23;16:184. Epub 2015 Apr 23.

Fondazione Italiana Sclerosi Multipla, Via Operai 40, 16149, Genoa, Italy.

Background: Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers.

Methods/design: This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient's caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner's visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients' caring physicians).

Discussion: The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention.

Trial Registration: The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.
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http://dx.doi.org/10.1186/s13063-015-0695-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4409986PMC
April 2015

Unmet needs of people with severe multiple sclerosis and their carers: qualitative findings for a home-based intervention.

PLoS One 2014 6;9(10):e109679. Epub 2014 Oct 6.

Unit of Neuroepidemiology, Foundation IRCCS Neurological Institute C. Besta, Milan, Italy.

Background: Few data on services for people with severe multiple sclerosis (MS) are available. The Palliative Network for Severely Affected Adults with MS in Italy (PeNSAMI) developed a home palliative care program for MS patients and carers, preceded by a literature review and qualitative study (here reported).

Objective: To identify unmet needs of people with severe MS living at home by qualitative research involving key stakeholders, and theorize broad areas of intervention to meet those needs.

Method: Data were collected from: at least 10 personal interviews with adults with severe MS (primary/secondary progressive, EDSS≥8.0); three focus group meetings (FGs) of carers of people with severe MS; and two FGs of health professionals (HPs). Grounded theory guided the analysis of interview and FG transcripts, from which the areas of intervention were theorized.

Results: Between October 2012 and May 2013, 22 MS patients, 30 carers and 18 HPs participated. Forty-eight needs themes were identified, grouped into 14 categories and four domains. Seven, highly interdependent intervention areas were theorized. Patients had difficulties expressing needs; experiences of burden and loneliness were prominent, chiefly in dysfunctional, less affluent families, and among parent carers. Needs differed across Italy with requirements for information and access to services highest in the South. All participants voiced a strong need for qualified personnel and care coordination in day-to-day home care. Personal hygiene emerged as crucial, as did the need for a supportive network and preservation of patient/carer roles within family and community.

Conclusions: Unmet needs transcended medical issues and embraced organizational and psychosocial themes, as well as health policies. The high interdependence of the seven intervention areas theorized is in line with the multifaceted approach of palliative care. At variance with typical palliative contexts, coping with disability rather than end-of-life was a major concern of patients and carers.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0109679PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4186842PMC
December 2015