Influence of cognition on the correlation between objective and subjective upper limb measures in people with multiple sclerosis.

BACKGROUND: A comprehensive assessment of upper limb (UL) function is mandatory in people with multiple sclerosis (PwMS), and the use of multiple objective and subjective measures is advisable. Findings on the role of cognitive impairment on the assessment of UL function are scant and inconclusive. The present study investigated the influence of cognitive function on the distribution of objective and subjective UL measures and on their association. METHODS: In the cross-sectional study, subjects with a diagnosis of MS, age ≥ 18 years, right-hand dominance, no presence of orthopedic UL impairment, or other neurological diseases were recruited. The assessment protocol included the Nine-Hole Peg Test (9-HPT), Box and Block Test (BBT), and hand grip strength (HGS), a validated PROM (MAM-36), and the Symbol Digit Modalities Test (SDMT). RESULTS: Two hundred forty-six PwMS were recruited (158 females, mean age = 51.65 ± 13.45 years; mean EDSS = 5.10 ± 1.88) Subject with mild-to-moderate cognitive impairment (SDMT ≤ - 2 SD of normative values) scored lower on the 9-HPT and higher on the BBT and MAM-36 when compared with subject with no cognitive impairment. Cognitive impairment showed a small but significant effect on the association between 9-HPT scores and the MAM-36. DISCUSSION: Findings suggest that cognitive impairment is associated with subjects' performance on 9-HPT, BBT, and MAM-36 (but not HGS), resulting in scores indicating a poorer UL function. Interestingly, cognitive impairment slightly affected the congruence between subjective and objective UL measures, although only minor differences in the correlation pattern across groups reporting different cognitive performances emerged.

Correlation between patient-reported manual ability and three objective measures of upper limb function in people with multiple sclerosis.

BACKGROUND AND PURPOSE: Upper limb (UL) function is often affected in people with multiple sclerosis (PwMS) and is typically assessed through objective measures, including the Nine Hole Peg Test (9-HPT), Box and Block Test (BBT), and Hand Grip Strength (HGS). It is important to include the subjective perspective of PwMS in the assessment. This study aims to evaluate associations between Manual Ability Measure-36 (MAM-36) and 9-HPT, BBT, and HGS in MS. METHODS: The cross-sectional study included five Italian centers. Inclusion criteria were age ≥ 18 years, MS diagnosis, and stable disease course. Exclusion criteria were bilateral UL paralysis, and concomitant orthopedic or neurological diseases. RESULTS: A total of 199 PwMS were included: 128 female, mean age = 50.7 ± 13.0 years, 119 relapsing-remitting MS (RRMS), 31 primary and 49 secondary progressive MS, mean disease duration = 14.0 ± 10.4, years, mean Expanded Disability Status Scale (EDSS) = 4.6 ± 2.0. The MAM-36 showed small correlations with 9-HPT, BBT, and HGS. Correlations between MAM-36 and 9-HPT and BBT were highest among subjects with EDSS ≥ 6 and progressive MS. MAM-36 and HGS showed the highest correlations in subjects with EDSS ≤ 5 and RRMS. Combining 9-HPT and HGS provided the strongest predictive power over the MAM-36. CONCLUSIONS: Correlations between objective measures and MAM-36 were small to moderate, meaning that objective measures do not match subjects' perception of UL function. The combination of 9-HPT and HGS measures can help improve the assessment of UL function in activities of daily living.

Italian translation and psychometric validation of the ABILHAND-26 and its correlation with upper limb objective and subjective measures in multiple sclerosis subjects.

BACKGROUND: Upper limb (UL) function is affected in about 50% of people with Multiple Sclerosis (PwMS). In the last decade, Patient Reported Outcome Measures (PROM) are playing an important role in clinical trial and practice. ABILIHAND-26 is a PROM that assess self-perceived manual ability defined as the capacity to manage daily activities using the upper limbs. The aim of the study is to translate the ABILHAND-26 into Italian, to explore its psychometric properties examining the associations with demographics, clinical variables, 9-Hole Peg Test (9-HPT) and Manual Ability Measures-36 (MAM-36). MATERIALS AND METHODS: Subjects were recruited in five Italian neurological centers. They were evaluated through ABILHAND-26, 9-HPT and MAM-36. Confirmatory factor analysis and Rasch analysis were adopted to investigate the psychometric properties of the ABILHAND-26. RESULTS: Two hundred and forty-five patients were recruited. Rasch analyses showed adequate functioning and supported the unidimensionality of the scale. ABILHAND-26 showed negative correlations with age and disease duration, moderate negative correlation with EDSS and the 9-HPT scores for both arms and strong positive associations (ρ ≥ .84) with the MAM-36. Difference in ABILHAND-26 scores only emerged when comparing patients with severe disability (EDSS ≥ 6) with patients with either mild or moderate disability. t) and when comapring relapsing-remitting and secondary progressive patients. CONCLUSION: The Italian version of the ABILHAND-26 is now available. It shows adequate reliability of the score, moderate criterion validity and strong convergent validity. ABILHAND-26 could represent a valid assessment for self-perceived ability to perform manual activity, especially for PwMS with moderate-to-high level of disability.

Italian translation and psychometric validation of the Manual Ability Measure-36 (MAM-36) and its correlation with an objective measure of upper limb function in patients with multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system with an unpredictable course. During its course, deficits affecting upper limb functions may occur. Hence, there is a need for self-administered scales providing a comprehensive assessment of upper limb functions. The Manual Ability Measure-36 (MAM-36), which investigates patients' performance in activities of daily living requiring upper limb function, has not been adapted and validated in the Italian context. OBJECTIVES: We develop an Italian translation and validation of the MAM-36 in a population of people with MS (PwMS), explore its psychometric properties and investigate its associations with clinical data and the Nine Hole Peg Test (9-HPT). RESEARCH PLAN AND METHODS: The multicentre study involved five Italian neurological centres. Subjects were evaluated using EDSS, 9-HPT and the MAM-36 scale. We used confirmatory factor analysis and Rasch analysis to investigate the properties of the MAM-36. RESULTS: We enrolled 218 PwMS. Results supported the unidimensionality of the MAM-36, and adequate functioning of rating scale and items. Additionally, the MAM-36 showed weak negative associations with age and disease duration, and moderate associations with EDSS and 9-HPT scores. DISCUSSION: The adapted MAM-36 showed adequate psychometric properties. However, indications of problematic targeting to PwMS with low disability emerged. For this reason, use of the scale appears to be more suitable among patients with moderate-to-severe disability.

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

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).

The clinical value of Coop/Wonca charts in assessment of HRQoL in a large cohort of relapsing-remitting multiple sclerosis patients: Results of a multicenter study.

BACKGROUND: Multiple sclerosis (MS) is a chronic neurological disease impacting patients' health-related quality of life (HRQoL). Since MS specific HRQoL questionnaire are often time consuming; thus, simple, feasible and ease administering instruments are needed to assess MS HRQoL in clinical practice and clinical trials. Hence, aim of our study was to investigated the HRQoL in a large cohort of MS patients using the Coop/Wonca charts. METHODS: This was multicenter, independent, non-sponsored, observational study, including patients from 40 Italian MS centers. Inclusion criteria were Expanded Disability Status Scale score between 1.0 and 5.5; stable disease at enrolment. HRQoL was assessed, using six Coop/Wonca charts for physical fitness, feelings, daily activities, social activities, changes in health, health condition, and the Composites Scores of Multiple Sclerosis Quality of Life-54 (MSQoL-54), physical health composite summary (PHCS) and the mental health composite summary (MHCS). RESULTS: Out of 648, 593 relapsing-remitting MS patients, 415 (70%) women, mean age years, 417 (70%) were finally enrolled. We found a inter-rater agreement of 0.8, ranging from 0.64 to 0.91, as expressed by the alpha coefficient. Intra-rater agreement was 0.82, ranging from 0.78 to 0.96. Coop/Wonca charts were scored with a Likert method from one to five (corresponding to best and worst HRQoL respectively). According to this scoring, study population was stratified into three categories (score 1-2 corresponding to better HRQoL; score 3 corresponding to neutral profile; score 4-5 corresponding to worse HRQoL). Coop/Wonca charts resulted significantly correlated with PHCS and with MHCS.

Interferon-beta-1a treatment has a positive effect on quality of life of relapsing-remitting multiple sclerosis: results from a longitudinal study.

PURPOSE: The impact of interferon beta (IFNß) therapy on a patient's quality of life (QoL) has not been completely clarified. This multicenter, independent, observational and longitudinal study was aimed to evaluate the impact of different pharmaceutical formulations of IFNß-1a on QoL in patients affected by relapsing-remitting multiple sclerosis (RRMS). METHODS: The multiple sclerosis quality of life-54 questionnaire was used to assess patients' QoL. RESULTS: 394 (66%) patients completed the two-year study; 152 were treated with IFNß-1a i.m. weekly injected (group a), 152 with IFNß-1a 44 µg s.c. injected three times a week (group b) and 90 were untreated (group c). After two years, a significant increase was found in the physical health composite score (Δ = +3.1 in group a, Δ = +3 in group b, p < 0.05 in both), mental health composite score (Δ = +4.7 in group a, Δ = +5.5 in group b, p < 0.001 in both), in eight MSQoL sub-items of group a and in seven sub-items in group b. Conversely, the untreated group showed a slight decrease in seven domains. The variable "therapy with DMDs" was associated with improved QoL. CONCLUSION: QoL of RRMS could be improved by IFNß-1a treatment, despite natural history data which seem to demonstrate that QoL could get worse over the time.

Psychometric properties of the Italian version of the Guy's Neurological Disability Scale.

The aim of this study was to assess the reliability, validity and sensitivity of the Guy's Neurological Disability Scale (GNDS) translated into Italian and administered to Italian-speaking patients with multiple sclerosis (MS). In total, 202 outpatients with MS were enrolled in the study; 153 had relapsing-remitting (RR) MS and 49 had secondary progressive (SP) MS; 189 healthy individuals were recruited as control subjects. Inter-rater agreement, as expressed by the alpha coefficient, was 0.83. Intra-rater agreement was 0.91. Compared with the healthy subjects, the MS patients recorded significantly higher mean total scores on the Italian version of the GNDS. The mean GNDS total score of the patients with RRMS was significantly lower than that of the patients with SPMS. Cross-sectional correlations between the GNDS and the Expanded Disability Status Scale were significant in the whole sample (r=0.77; p<0.001), in the RRMS patients (r=0.65, p<0.01), and in those with SPMS (r=0.48, p<0.05). In conclusion, the Italian version of the GNDS emerges as a valid assessment instrument with adequate basic psychometric properties.

Clinical efficacy issues in the treatment of multiple sclerosis: update of natalizumab.

Multiple sclerosis is a frequent neurologic disease, which causes sensory impairment, fatigue, cognitive deficits, imbalance, loss of mobility, spasticity, and bladder and bowel dysfunction. Several new therapies have been introduced in the past decade, but additional drugs are needed to slow disease progression and reduce disability. Natalizumab (NA) is an α4 integrin antagonist, effective in decreasing the development of brain lesions in experimental models and in several studies of patients with MS. Six randomized controlled trials of NA in MS have been published in the last 10 years. Overall, 2,688 relapsing-remitting MS subjects have been enrolled in these studies. Hence, there are already sufficient data to draw some conclusions about the effectiveness of NA in the treatment of MS, although for definitive considerations it would be reasonable to wait for the observational phase IV studies of clinical practice to complete. Moreover, the medical community is concerned with the safety of NA, particularly with the risk of developing progressive multifocal leukoencephalopathy while on NA therapy. From the analyses of the six cases, it seems that the overall risk is around 1/1,000 and could increase with the number of NA infusions.

Predictors of quality of life among patients with multiple sclerosis: an Italian cross-sectional study.

The Functional Assessment of Multiple Sclerosis (FAMS) quality of life (QoL) instrument is a disease-specific, self-report questionnaire that was developed originally for US English-speaking patients. Here, the psychometric properties of the FAMS QoL questionnaire for Italian-speaking patients with multiple sclerosis (MS) are evaluated and compared with the results from the original FAMS validation survey (n=377). Eighteen Italian centers and 344 patients with MS participated in the study. The overall reliability (as expressed by Cronbach's alpha value) of the FAMS score, and its subscale scores, was always over the threshold of 0.8. Patients with benign MS showed a better overall QoL compared with patients with relapsing-remitting MS (RRMS; p=0.017), whereas patients with RRMS had a better QoL than patients with primary progressive MS (PPMS). No difference in QoL was found between patients with PPMS and those with secondary progressive MS. The Italian FAMS questionnaire is a valid measure to assess the QoL concerns of patients with MS. FAMS is also easy to administer and is well accepted by patients.