Abuse in individuals with multiple sclerosis: the SocialMS Italian study.

Introduction: Abuse is a social determinant of health (SDH) which consists in behaviors used to gain or maintain power and control, including physical, sexual, financial, emotional or psychological actions [1]. In general, individuals with disabilities are at higher risk of abuse; and diseases like Multiple Sclerosis (MS) can cause both physical and cognitive disability [2],[3]. However, no studies have explored abuse prevalence and risk factors in Italian individuals with MS [4]. Aims: To estimate the prevalence of abuse in individuals with MS in Italy exploring a wide range of other SDH. Methods: The SocialMS is a cross-sectional observational study based on anonymous surveys submitted to patients followed up in 67 MS centers. Disability was self-assessed by the Patient Determined Disease Steps (PDDS) scale. Descriptive statistics, parametric and non-parametric tests and cluster analysis were performed; Gradient Boosting Machine (GBM) was used as an exploratory screening and logistic regression models were performed to quantify the impact of MS itself on increased risk of abuse. Results: We included 1,004 patients (mean (sd) age: 44.1 (11.6), 68.8% females, median (IQR) PDDS: 1.0 (0.0, 3.0)). A total of 235 individuals (23.4%) were victim of at least one form of abuse over the course of life: emotional or psychological (n=203, 20.2%, mainly in the workplace, in the relationship with the partner and within family), physical (n=56, 5.6%, mainly in the relationship with the partner and within family), financial (n=42, 4.2%, mainly in the relationship with the partner and in the workplace) and sexual (n=25, 2.5%, mainly in the relationship with the partner, within family and in other contexts) (Figure 1). Victims of abuse were younger (p<0.001), lived alone (p=0.001), were smokers (p=0.018), with higher BMI (p<0.001) and comorbidities (p=0.036), younger at diagnosis (p=0.001) and more disabled (p=0.029). Abuse was more frequent in individuals who were females (p=0.048), non-heterosexual (p<0.001), with lower literacy (p=0.001) and with financial difficulties (p<0.001) but victims of abuse received more tangible support (p=0.004). Geographical area (South and Center vs North), lower literacy or educational level and financial difficulties had a stronger impact on financial abuse compared to other forms. According to GBM, the characteristics with higher relative influence in characterizing the risk of any form of abuse were household income, BMI, age and age at diagnosis, personal income, living alone or only with children, sexual orientation and health literacy. A total of 539 individuals (54%) believed that MS itself could increase the risk of any forms of abuse, of whom 29 for personal experience, and factors associated in univariable analysis were progressive phenotype (OR=1.69 (95%CI=1.16; 2.46)), longer disease duration (OR=1.02 (1.00; 1.03)), number of treatments (OR=1.11 (1.00; 1.23)) and greater PDDS (1.19 (1.11; 1.27)). However, PDDS was the only factor which was statistically significant in the multivariable model (OR=1.18 (1.09; 1.27)). Cluster analysis identified two subgroups of participants: in cluster 2 (n=157) all patients were victims of at least one form of abuse and experienced a greater number of forms of abuse compared to cluster 1 (median(IQR): 1.0 [1.0, 2.0] vs 0.0 [0.0, 0.0], p<0.001) and all the forms of abuse were more common (emotional or psychological abuse: 99.4% vs 5.5%; sexual abuse: 12.7% vs 0.6%; physical abuse: 23.6% vs 2.2%; financial abuse: 13.4% vs 2.5%, p<0.001). Moreover, 68.8% of participants in cluster 2 perceived the potential impact of MS itself on the increased risk of abuse, of whom 13.4% for personal experience. Conclusion: We characterized abuse phenotypes from clustering, we conducted robust identification of independent predictors from high-dimensional ML-based screening of predictors, and we observed the impact of MS disability on risk of abuse. Findings show the necessity of 1) identifying actionable targeted interventions to address modifiable SDH and to support victims of abuse (e.g., training of health-care providers, social and psychological services) , 2) treating the Person with MS, not only MS, 3) increasing the awareness among the health-care practitioners and the general population that preventing MS-related disability can also have an impact on many hidden aspects of patients' lives. This work emphasizes the ethical and social importance of protecting the most vulnerable individuals.

Background and purposeThe validity, reliability, and longitudinal performance of the Patient‐Determined Disease Steps (PDDS) scale is unknown in people with multiple sclerosis (MS) with mild to moderate disability. We aimed to examine the psychometric properties and longitudinal performance of the PDDS.MethodsWe included relapsing–remitting MS patients with an Expanded Disability Status Scale (EDSS) score of less than 4. Validity and test–retest reliability was examined. Longitudinal data were analysed with mixed‐effect modelling and Cohen's kappa for concordance in confirmed disability progression (CDP).ResultsWe recruited a total of 1093 participants, of whom 904 had complete baseline data. The baseline correlation between PDDS and EDSS was weak (ρ = 0.45, p < 0.001). PDDS had stronger correlations with patient‐reported outcomes (PROs). Conversely, EDSS had stronger correlations with age, disease duration, Kurtzke's functional systems and processing speed test. PDDS test–retest reliability was good to excellent (concordance correlation coefficient = 0.73–0.89). Longitudinally, PDDS was associated with EDSS, age and depression. A higher EDSS score was associated with greater PDSS progression. The magnitude of these associations was small. There was no concordance in CDP as assessed by PDDS and EDSS.ConclusionThe PDDS has greater correlation with other PROs but less correlation with other MS‐related outcome measures compared to the EDSS. There was little correlation between PDDS and EDSS longitudinally. Our findings suggest that the PDDS scale is not interchangeable with the EDSS.

BackgroundMultiple sclerosis (MS) is a leading cause of neurological disability among young and middle-aged adults worldwide, and disability is measured using a variety of approaches, including patient reported outcome measures (PROMs) such as the Patient Determined Disease Steps (PDDS) scale. There is limited evidence for the validity of inferences from the middle-range of scores on the PDDS (i.e., 3 “gait disability” – 6 “bilateral support”), but that range of scores seemingly represents moderate disability characterized by varying levels of walking dysfunction.PurposeThe current study examined whether the middle-range of scores from the PDDS reflect varying levels of walking dysfunction among people with MS.MethodParticipants (N = 374) completed the Patient Determined Disease Steps (PDDS) scale, Multiple Sclerosis Walking Scale-12 (MSWS-12), timed 25-foot walk (T25FW), six-minute walk (6 MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an Expanded Disability Status Scale (EDSS) score as part of screening and baseline data collection for a clinical trial of exercise training in MS. We undertook a series of linear trend analyses that examined differences in the outcomes of EDSS, T25FW, 6 MW, MSWS-12, MFIS subscales, and MSIS-29 subscales across the 4 levels of PDDS scores (i.e., 3–6).ResultsThere were statistically significant and strong linear trends for EDSS (F1,370 = 306.1, p < .0001, η2 = 0.48), T25FW (F1,370 = 161.0, p < .0001, η2 = 0.32), 6 MW (F1,370 = 178.9, p < .0001, η2 = 0.34), and MSWS-12 (F1,370 = 97.0, p < .0001, η2 = 0.24). There was a strong correlation between PDDS and EDSS scores (rs = 0.695, 95% CI = 0.643, 0.748). Both PDDS and EDSS scores had strong correlations with walking outcomes, yet weaker correlations with measures of fatigue and QOL.ConclusionThe PDDS could serve as a simple, inexpensive, and rapidly administered PROM for remote screening and early detection of walking dysfunction for initial eligibility into clinical trials and practice for managing mobility-specific disability in MS.RegistrationThe study was registered on ClinicalTrials.gov on March 19, 2018 (NCT03468868).

The Expanded Disability Status Scale (EDSS) is commonly used to measure and quantify disabilities in patients with multiple sclerosis (MS). The patient-determined disease steps (PDDS) scale is a patient-reported measure of disability that is useful in MS. However, the Arabic version of the PDDS has only been tested in Jordanian patients. Although both populations share similar Arabic languages, it is plausible that differences in dialects and educational systems could alter the generalizability of the tool. In this prospective study, patients with MS were asked to complete a printed translated version of the (PDDS), and the results were compared to their EDSS scores, functional system scores, and walking speed measures. Patients with relapsing or progressive MS were included in the study. Spearman rho rank-order correlation coefficients (P) were used to measure the correlation between the PDDS and other variables. We considered previously reported P values > .1, .3, and .5 as small, moderate, and strong correlations, respectively. A total of 79 patients completed the study. The PDDS showed a strong correlation with the EDSS (P = .69, 95% confidence interval 0.55–0.79, P < .001). PDDS is associated with cerebellar, pyramidal, and bladder dysfunctions. It was also moderately correlated with the timed-25-foot walk test and timed-up-and-go test. The Arabic version of the PDDS performed similarly to English and other languages when tested on a cohort of patients with MS.

BackgroundThe Patient Determined Disease Steps (PDDS) is a promising patient-reported outcome (PRO) of disability in multiple sclerosis (MS). To date, there is limited evidence regarding the validity of PDDS scores, despite its sound conceptual development and broad inclusion in MS research. This study examined the validity of the PDDS based on (1) the association with Expanded Disability Status Scale (EDSS) scores and (2) the pattern of associations between PDDS and EDSS scores with Functional System (FS) scores as well as ambulatory and other outcomes.Methods96 persons with MS provided demographic/clinical information, completed the PDDS and other PROs including the Multiple Sclerosis Walking Scale-12 (MSWS-12), and underwent a neurological examination for generating FS and EDSS scores. Participants completed assessments of cognition, ambulation including the 6-minute walk (6 MW), and wore an accelerometer during waking hours over seven days.ResultsThere was a strong correlation between EDSS and PDDS scores (ρ = .783). PDDS and EDSS scores were strongly correlated with Pyramidal (ρ = .578 &ρ = .647, respectively) and Cerebellar (ρ = .501 &ρ = .528, respectively) FS scores as well as 6 MW distance (ρ = .704 &ρ = .805, respectively), MSWS-12 scores (ρ = .801 &ρ = .729, respectively), and accelerometer steps/day (ρ = -.740 &ρ = -.717, respectively).ConclusionThis study provides novel evidence supporting the PDDS as valid PRO of disability in MS.

Background: Patient Determined Disease Steps (PDDS) scale is a patient-reported outcome measure to assess disability in persons with multiple sclerosis (pwMS). This scale can be used as an alternative to Expanded Disability Status Scale (EDSS) as it is a costly, more time-consuming, and clinician-based method. This study aimed to conduct Turkish translation and cross-cultural adaptation of PDDS and investigate its psychometric properties. Methods: Turkish translation and cross-cultural adaptation of PDDS was conducted. Its psychometric properties including validity (i.e. content, criterion, and construct) and test-retest reliability (relative and absolute) were investigated in 100 pwMS. Results: PDDS had a significant strong correlation with EDSS (rs = 0.61, p < .001). Regression model to predict EDSS scores from PDDS scores was significant (p < .001, R2 = 0.67). Both PDDS and EDSS were significantly correlated with age, disease duration, walking speed and endurance, perceived impact of MS on walking, functional mobility, working memory and information processing speed, visual memory, manual dexterity, and health-related quality of life (p < .05). No significant difference was observed in the correlation coefficients of PDDS and EDSS (p > .05). Relative test-retest reliability was found high [ICC = 0.99 (95%CI = 0.99, 0.99)]. Absolute test-retest reliability was high as the Bland-Altman analyses showed no significant systematic bias between the repeated assessments. A narrow range of the limits of agreement indicated that PDDS had high stability and low variation between first and second assessments. Conclusion: Turkish version of PDDS presented high validity and test-retest reliability in pwMS.

BackgroundLimited data define what constitutes a minimal clinically important difference (MCID) on the EuroQol 5-Dimension (EQ-5D) health status index in persons with multiple sclerosis (PwMS). We sought to estimate the MCID for the EQ-5D health index in North American PwMS.MethodsPwMS completing the Patient Determined Disease Steps (PDDS) scale, 12-Item Multiple Sclerosis Walking Scale (MSWS-12) and EQ-5D as part of the North American Research Committee on Multiple Sclerosis (NARCOMS) registry’s spring 2011 update and supplemental survey were included in this retrospective, cross-sectional study. Distribution-based (standard error of measurement [SEM], 0.50 standard deviation [SD] and 0.33 SD unit) approaches were used to estimate a range of MCIDs for the EQ-5D based upon disease severity groups determined by the PDDS and MSWS-12 tertiles.ResultsA total of 3,044 participants were included. Moderately strong correlations between the EQ-5D and the PDDS and MSWS-12 were observed (Spearman’s r = -0.56 and -0.59, respectively, p < 0.0001 for both). MCID estimates based on PDDS score categories ranged from 0.065-0.158 (SEMs), 0.059-0.142 (0.50 SDs) and 0.039-0.095 (0.33 SDs). MCID estimates as measured by MSWS-12 tertile categories ranged from 0.068-0.098 (SEMs), 0.061-0.088 (0.50 SDs), and 0.041-0.059 (0.33 SDs). Across both the PDDS and tertiles of MSWS-12, MCID estimates tended to be larger as disease severity worsened. Mean weighted MCID estimates ranged from 0.05-0.084 for both the PDDS and MSWS-12 tertiles.ConclusionMCID estimates for the EQ-5D in PwMS were within the range of estimates seen for other disease states and appeared to be larger in those reporting more severe disease.

Social determinants of health (SDH) can influence some outcomes related to multiple sclerosis (MS), including disability accrual and disease progression. The relationship between SDH and MS is complex, due to interplay between factors and bidirectionality. Inequities also occur in countries with universal health care system like Italy. To identify and synthesize the existing and emerging literature on several SDH in the Italian population with MS: sex, gender and sexuality; race, ethnicity and geographical area; education; employment; socioeconomic status; domestic abuse; healthcare access; food access, diet, and obesity; pollution; social support. Eleven PubMed search strings identified studies published in the past decade and material from ECTRIMS 2024 congress was examined. In total, 214 studies were included, contributing to 284 SDH findings. More than one-third of the papers focused on sex and gender while just one on domestic abuse; many articles presented results on several SDH simultaneously, especially for education and employment (N = 14) and healthcare access and social support (N = 10). Bidirectional associations between SDH and MS were documented and several unmet needs and disparities were shown. Disproportionality in thematic areas of research was observed and some gaps were identified; the importance of accounting for SDH in the healthcare context emerged.

Background: The purpose of this study was to evaluate the validity and reliability of the Persian version of Patient Determined Disease Steps (PDDS) in both patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD). Methods: One hundred and forty-five patients were enrolled between May and September 2020 by consecutive sampling. Participants were asked to complete timed 25-foot walk (T25FW), 12-item Multiple Sclerosis Walking Scale (MSWS-12), and Multiple Sclerosis Quality of Life-54 (MSQOL-54). Patients also completed Timed Up and Go (TUG) and six-minute walk (6MW) tests. Construct validity was assessed by calculating correlation between PDDS and ambulatory and demographic items. The intra-class correlation coefficient (ICC) was used to evaluate reliability. Results: One hundred and eleven patients with MS and 34 with NMOSD with disease duration of 7.6 ± 5.8 years were enrolled. Twenty-seven percent were men and mean Expanded Disability Status Scale (EDSS) was 1.8 ± 1.8. There was a significant positive correlation between EDSS and PDSS (rho = 0.64, P < 0.001) which was evident in MS subgroups and NMOSD [secondary progressive MS (SPMS): rho = 0.64, P < 0.001; relapsing-remitting MS (RRMS): rho = 0.47, P < 0.001; NMOSD: rho = 0.52, P = 0.001]. PDDS had also significant positive correlation with TUG, T25FW, and MSWS-12. PDDS had also significant negative correlation with 6MW test. PDDS had weak correlation with demographic variables. The ICC was calculated as 0.99 for PDDS. Conclusion: The Persian version of PDDS provides valid and reliable instrument to assess MS/NMOSD-related disability.

Most available Italian studies indicate that the prevalence of multiple sclerosis (MS) in Italy is lower than 20 per 100,000. Much higher prevalence figures, however, have been recently found in small communities in Sicily. On this basis, it has been suggested that the frequency the MS in Italy has been seriously underestimated and that the true prevalence for MS is probably similar to that established for northern European countries. This paper reports the results of a survey of MS in the various public health districts of the province of Ferrara. The public health districts are homogeneous medical units serving small populations and therefore represent ideal areas for epidemiological purposes. The total prevalence rate of probable MS for the whole province has been found to be at least 26.9 per 100,000. This result supports the view that the frequency of MS in Italy is higher than that indicated by most published studies, but not that Italy is an area of high risk for MS.

The study estimates the cost of multiple sclerosis (MS) in Italy quantifying the impact of the rehabilitation on cost of illness. Patients with MS were enrolled at MS clinical centres, in rehabilitation units and among members with MS of the Italian MS Society across the Italy. The MS costs were captured with a questionnaire and were estimated taking into account both healthcare and non-healthcare costs as well as the productivity losses. Mean total annual costs per patients were €37,948, increasing for different disease severity: from €22,750 at an EDSS score of 0-3 to €63,047 at an EDSS score equal to or more than 7. €3,418 was due to rehabilitation (about 26.7% of direct healthcare costs) and of these 44% was attributable to admission to rehabilitation. The multivariate analysis showed a consistent trend toward increased total cost with progressive severity of MS, with presence of relapses, while the total cost decreases with a better quality of life. The burden increases as the MS becomes more severe and with relapse occurrence, moreover we observed high costs due to admission to rehabilitation suggesting that different rehabilitation setting might be considered to reduce the financial burden and increase the quality of life for person with MS.

Objective: To validate administrative claims-based case definitions for diabetes, hypertension, and hyperlipidemia in multiple sclerosis (MS) patients, and to determine the prevalence of these comorbidities in MS as compared to the general population. Background Although the impact of comorbidity on MS is of increasing interest, methods for comorbidity measurement in MS are poorly developed. Design/Methods: We used provincial administrative (health) claims data from Manitoba, Canada to identify persons with MS and an age, sex and geographically matched cohort from the general population. We developed case definitions for diabetes, hypertension, and hyperlipidemia using ICD-9/10 codes and prescription claims. We compared the case definitions against medical records in persons with MS to determine sensitivity, specificity, positive and negative predictive value, and agreement as measured by kappa (κ). To examine temporal trends in the age-adjusted prevalence of these conditions we applied the validated case definitions to administrative data from 1984-2006. Results: Depending on the definition, agreement between administrative case definitions and medical records ranged from κ = 0.51-0.69 for diabetes, κ = 0.21-0.71 for hyperlipidemia, and κ = 0.52-0.75 for hypertension. In 2005, the age-adjusted prevalence of diabetes in the MS population was 7.61% (95% confidence interval: 6.63-8.60), similar to the general population (8.28% [7.82-8.75]); rate ratio [RR] 0.91; 0.76-1.09). The age-adjusted prevalence of hypertension was 20.8% (19.1-22.5) in the MS population and 22.5% (21.7-23.3) in the general population (RR 0.91; 0.78-1.07). The age-adjusted prevalence of hyperlipidemia was 13.8% (12.4-15.1), in the MS and 15.1% (14.5-15.8) in the general population (RR 0.90; 0.67-1.22). The prevalence of all three conditions rose in the MS and general populations over the study period. Conclusions: Administrative data are a valid data source for surveillance of diabetes, hypertension, and hyperlipidemia in MS. The prevalence of these comorbidities is rising, and is similar in the MS and general populations. Supported by: Multiple Sclerosis Society of Canada. Disclosure: Dr. Marrie has nothing to disclose. Dr. Yu has nothing to disclose. Dr. Leung has nothing to disclose. Dr. Elliott has nothing to disclose. Dr. Blanchard has nothing to disclose.

ObjectiveTo examine the relationship between visit-to-visit systolic blood pressure (SBP) variability and patient-reported outcome measure of disability in multiple sclerosis (MS) patients.DesignA retrospective cohort study of individuals with MS who...

This study estimates the direct costs of multiple sclerosis (MS) in Italy from the perspective of the National Health System. Patients diagnosed with MS for ≥1 year prior to study entry were included in the analysis; neurological disability was assessed using the Expanded Disability Status Scale (EDSS). Cost variables were analyzed according to: MS phenotype, disease course over the previous year and EDSS rating. A total of 510 patients were included in the analysis. Overall costs were significantly higher for relapsing-remitting MS and secondary progressive MS than for primary progressive MS (P < 0.05). Costs were higher for EDSS scores 0.0-3.5 and 4.0-6.0 than for scores > 6.0 (P < 0.05). The extrapolated data gave an estimated annual direct cost of MS per patient of <euro>18,030. In conclusion, relapsing-remitting MS or secondary progressive MS phenotypes and lower estimated EDSS scores appear to be associated with higher costs.

There are very few scientific papers (and only on de-limited areas) about incidence and prevalence of the multiple sclerosis (MS) in Italy. We analysed 2011-2015 national data by correlating INPS database with ISTAT data. Materials: we assessed 10,725 MS invalids. We compared geographical distribution of MS patients with the Italian census. We found a MS mean incidence equal to 3.54 patients every 100,000 Italian residents. The female MS mean incidence was 4.52 versus the male mean incidence of 2.52 (p<0.001). MS incidence is growing up from 2011 to 2015. Incidence values, for 100,000 inhabitants, become from 2.8 to 4.0 (female from 3.6 to 5.2 and male from 1.9 to 2.7). During 2011-2015 period, the MS patients median age decreases of two years (p<0.01). We couldn't calculate the MS prevalence because we do not have an official database managed by a national authority. This work wishes to be a stimulus to investigate more deeply and to promote public health in the care of the multiple sclerosis patients. We propose our work to realize a base more appropriate health planning on the national and regional territories for MS patients care.