Author Of 5 Presentations
LB1158 - COVID-19 pandemic and mental distress in Multiple Sclerosis: implications for clinical management (ID 1300)
Abstract
Background
in multiple sclerosis (MS), disease-related factors and dysfunctional coping might favour the development of mental distress induced by COVID-19 containment measures.
Objectives
to explore the relationship between mental distress, disability and coping strategies in the Italian MS population under lockdown.
Methods
Structural equation modeling (SEM) was applied to information collected via web-survey to identify modifiable factors that could account for mental distress. Information about the following domains was collected: (1) socio-demographic features; (2) general and MS related health status; (3) changes in lifestyle; (4) COVID-19 infection and risk perception; (5) physical disability assessed via the Patient-Determined Disease Steps (PDDS) scale and the Upper Extremity Function – Short Form (UEF) from the Quality of Life in Neurological Disorders (Neuro-QoL) measurement system; (6) cognitive function investigated using the Cognition Function– Short Form from the Neuro-QoL. Abstract reasoning, logical thinking and, in part, sustained attention, were measured using six Raven-like matrices; (7) mental distress: four domains from the Neuro-QoL were explored. Specifically, sleep disturbances, anxiety feelings, depressive symptoms, emotional dyscontrol; (8) coping strategies: individual response to lockdown was assessed using 18 items from the COPE-NVI-25, evaluating five independent coping strategies: avoidance (AV), social support (SS), positive attitude (PA), problem solving (PS) and turning to religion (TR).
Results
845 subjects (497 MS and 348 controls) were included in the study. MS patients showed higher scores than controls for depression (p=0.005), but not for anxiety, emotional dyscontrol or sleep disturbances. The SEM explained 74% of the variance observed in depression score. Within the model, three latent factors were characterized from measured variables: motor disability and cognitive dysfunction contributed to disability (β=0.509 and β=0.836, p<0.001); positive attitude and exercise contributed to active attitude (β=0.386 and β=0.297, p<0.001); avoidance, social support and watching TV contributed to passive attitude (β=0.301, β=0.243 and β=0.212, p<0.001). As per the relationship between latent factors and their influence on depression, disability contributed to passive attitude (β=0.855, p<0.001) while both passive and active attitude significantly influenced depression (β=0.729 and β=-0.456, p<0.001).
Conclusions
As practical implication of our model, favoring exercise would enhance active attitude and its positive impact on mental well-being while, at the same time, reducing the negative impact of disability on depression, representing a valuable tool for the long term management of COVID-19 related mental distress in MS.
LB1191 - Validation of the Italian version of the Multiple sclerosis intimacy and sexuality questionnaire-19 (ID 1991)
Abstract
Background
People with Multiple sclerosis (MS) may experience sexual dysfunction throughout the disease course. Prevalence for sexual dysfunction in MS ranges from 70 to 90 %, higher than in healthy controls (about 50%). Clinicians do not always ask for sexual dysfunction both for the limited timeframe for clinical assessment and the intimate nature of the subject. Hence, the use of self-reported questionnaires would be useful in clinical practice. However, validated scales to assess sexual dysfunction in MS for Italian patients are lacking.
Objectives
We aimed at validating Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) for Italian MS patients.
Methods
We included both male and female MS patients. Each patient completed the Italian translation of the MSISQ-19, the Beck Depression Inventory (BDI-II), the Modified Fatigue Impact Scale (MFIS), the State-Trait Anxiety Inventory (STAI-Y) questionnaire, the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol), the Female Sexual Function Index (FSFI, for female) and the International Index of Erectile Function (IIEF for male). Construct validity for the Italian version of the MSISQ-19 was explored by the exploratory factor analysis and the Cronbach’s alpha coefficient. Test-retest stability and concurrent internal and external validity was examined by Pearson’ correlation coefficients.
Results
We enrolled 369 MS patients (323 female). Mean MSISQ-19 total score was 37.2 ± 15.2 (range 18 - 89) with a sexual dysfunction prevalence of 59% in male MS patients and 41% in female MS patients. Cronbach’s alpha was 0.92 for the MSISQ-19. MSISQ-19 test and retest total scores correlated between each other (r=0.48, p=0.01). MSISQ-19 total score also correlated with primary, secondary and tertiary subscales (p<0.001), with the EDSS (r=0.19, p<0.001) and all other neuropsychological scales.
Conclusions
The Italian Version of the MSISQ-19 showed satisfactory internal consistency and reliability with moderately adequate test-retest reproducibility, suggesting that the Italian MSISQ-19 questionnaire provides a valuable measure of sexual dysfunction in the Italian population.
LB1193 - The Framingham cardiovascular risk score and 5-year progression of multiple sclerosis (ID 2012)
Abstract
Background
Cardiovascular risk factors and comorbidities can affect the prognosis of multiple sclerosis (MS). The Framingham risk score is an algorithm that can estimate the 10-year risk of developing macrovascular disease.
Objectives
To evaluate possible association between the Framingham risk score at baseline, and MS relapses, disability and disease-modifying therapy choices over 5-year follow-up.
Methods
This is a retrospective cohort study including 251 MS subjects. At baseline, we calculated the Framingham risk score considering the following variables: age, sex, diabetes, smoking, systolic blood pressure, and body mass index. MS outcomes including relapses, disability and treatments were collected over 5 years. Cox proportional regression models were employed to estimate hazard ratios (HR).
Results
1-point increase in the Framingham risk score was associated with 31% higher risk of relapse (HR=1.31; 95%CI=1.03, 1.68), 19% higher risk of reaching of EDSS 6.0 (HR=1.19; 95%CI=1.05, 3.01), and 62% higher risk of disease modifying treatment escalation (HR=1.62; 95%CI=1.22, 3.01).
Conclusions
Higher cardiovascular risk was associated with higher risk of relapses, disability, and treatment escalation in MS. Early identification, correction and treatment of cardiovascular comorbidities should be carefully considered within MS management.
P0085 - Harmonization of real-world studies in multiple sclerosis: retrospective analysis from the RIReMS group (ID 687)
Abstract
Background
Worldwide multiple sclerosis (MS) centers have coordinated their efforts to use data acquired in clinical practice for real-world observational studies.
Objectives
In this retrospective study, we aim to harmonize outcome measures, and to evaluate their heterogeneity within the Rising Italian Researchers in MS (RIReMS) study group.
Methods
RIReMS members filled in a structured questionnaire evaluating the use of different outcome measures in clinical practice. Thereafter, thirty-four already-published papers from RIReMS centers were used for heterogeneity analyses, using the DerSimonian and Laird random-effects method to compute the between-study variance (τ2).
Results
Based on questionnaire results, we defined basic modules for diagnosis and follow-up, consisting of outcome measures recorded by all participating centers at the time of diagnosis, and, then, at least annually; we also defined more detailed/optional modules, with outcome measures recorded less frequently and/or in the presence of specific clinical indications. Looking at heterogeneity, we found 5-year variance in age at onset (ES=27.34; 95%CI=26.18, 28.49; p<0.01; τ2=4.76), and 7% in female percent (ES=66.42; 95%CI=63.08, 69.76; p<0.01; τ2=7.15). EDSS variance was 0.2 in studies including patients with average age <36.1 years (ES=1.96; 95%CI=1.69, 2.24; p<0.01; τ2=0.19), or from 36.8 to 41.1 years (ES=2.70; 95%CI=2.39, 3.01; p<0.01; τ2=0.18), but increased to 3 in studies including patients aged >41.4 years (ES=4.37; 95%CI=3.40, 5.35; p<0.01; τ2=2.96). The lowest variance of relapse rate was found in studies with follow-up duration ≤2 years (ES=9.07; 95%CI=5.21, 12.93; p=0.02; τ2=5.53), whilst the lowest variance in EDSS progression was found in studies with follow-up duration >2 years (ES=5.41; 95%CI=3.22, 7.60; p=0.02; τ2=1.00).
Conclusions
We suggest common sets of biomarkers to be acquired in clinical practice, that can be used for research purposes. Also, we provide researchers with specific indications for improving inclusion criteria and data analysis, ultimately allowing data harmonization and high-quality collaborative studies.
P0644 - Spinal cord atrophy in a primary progressive multiple sclerosis trial: improved sample size using GBSI (ID 686)
Abstract
Background
Spinal cord atrophy is a common feature of multiple sclerosis (MS), can be detected in vivo using MRI, and is one of the main substrates of disease progression. In our previous studies, we have adapted the boundary shift integral (BSI) technique developed for the brain, to be applied to the spinal cord, obtaining the first registration-based method for longitudinal assessment of spinal cord atrophy.
Objectives
We aim to 1) compare spinal cord atrophy measurements using segmentation- and registration-based methods, with possible implications for clinical trial design (e.g., measurement variability, image noise floor); 2) compare spinal cord atrophy measurements obtained from routine brain (C1-2) and dedicated spinal cord MRI (C1-2 and C2-5), using segmentation- and registration-based methods; 3) explore possible clinical correlates, also in relation to conventional brain MRI measures; and 4) explore possible treatment effect.
Methods
We included 220 primary-progressive multiple sclerosis patients from a phase 2 clinical trial, with baseline and week-48 3DT1-weighted MRI of the brain and spinal cord (1x1x1mm3), acquired separately. We obtained segmentation-based cross-sectional spinal cord area (CSA) at C1-2 (from both brain and spinal cord MRI) and C2-5 levels (from spinal cord MRI) using DeepSeg, and, then, we computed corresponding GBSI.
Results
Depending on the spinal cord segment, we included 67.4-98.1% patients for CSA measurements, and 66.9-84.2% for GBSI. Spinal cord atrophy measurements obtained with GBSI had lower measurement variability, than corresponding CSA. Looking at image noise floor, the lowest median standard deviation of the MRI signal within the cerebrospinal fluid surrounding the spinal cord was found on brain MRI at C1-2 level. Spinal cord atrophy derived from brain MRI was related to corresponding measures from dedicated spinal cord MRI, more strongly for GBSI than CSA. Spinal cord atrophy measurements using GBSI, but not CSA, were associated with upper and lower limb motor progression. No treatment effect was detected for any spinal cord atrophy measurements.
Conclusions
Notwithstanding reduced measurement variability, clinical correlates, and possibility of using brain acquisitions, spinal cord atrophy using GBSI should remain a secondary outcome measure in MS studies, until further advancements increase the quality of acquisition and reliability of processing.
Presenter Of 2 Presentations
P0085 - Harmonization of real-world studies in multiple sclerosis: retrospective analysis from the RIReMS group (ID 687)
Abstract
Background
Worldwide multiple sclerosis (MS) centers have coordinated their efforts to use data acquired in clinical practice for real-world observational studies.
Objectives
In this retrospective study, we aim to harmonize outcome measures, and to evaluate their heterogeneity within the Rising Italian Researchers in MS (RIReMS) study group.
Methods
RIReMS members filled in a structured questionnaire evaluating the use of different outcome measures in clinical practice. Thereafter, thirty-four already-published papers from RIReMS centers were used for heterogeneity analyses, using the DerSimonian and Laird random-effects method to compute the between-study variance (τ2).
Results
Based on questionnaire results, we defined basic modules for diagnosis and follow-up, consisting of outcome measures recorded by all participating centers at the time of diagnosis, and, then, at least annually; we also defined more detailed/optional modules, with outcome measures recorded less frequently and/or in the presence of specific clinical indications. Looking at heterogeneity, we found 5-year variance in age at onset (ES=27.34; 95%CI=26.18, 28.49; p<0.01; τ2=4.76), and 7% in female percent (ES=66.42; 95%CI=63.08, 69.76; p<0.01; τ2=7.15). EDSS variance was 0.2 in studies including patients with average age <36.1 years (ES=1.96; 95%CI=1.69, 2.24; p<0.01; τ2=0.19), or from 36.8 to 41.1 years (ES=2.70; 95%CI=2.39, 3.01; p<0.01; τ2=0.18), but increased to 3 in studies including patients aged >41.4 years (ES=4.37; 95%CI=3.40, 5.35; p<0.01; τ2=2.96). The lowest variance of relapse rate was found in studies with follow-up duration ≤2 years (ES=9.07; 95%CI=5.21, 12.93; p=0.02; τ2=5.53), whilst the lowest variance in EDSS progression was found in studies with follow-up duration >2 years (ES=5.41; 95%CI=3.22, 7.60; p=0.02; τ2=1.00).
Conclusions
We suggest common sets of biomarkers to be acquired in clinical practice, that can be used for research purposes. Also, we provide researchers with specific indications for improving inclusion criteria and data analysis, ultimately allowing data harmonization and high-quality collaborative studies.
P0644 - Spinal cord atrophy in a primary progressive multiple sclerosis trial: improved sample size using GBSI (ID 686)
Abstract
Background
Spinal cord atrophy is a common feature of multiple sclerosis (MS), can be detected in vivo using MRI, and is one of the main substrates of disease progression. In our previous studies, we have adapted the boundary shift integral (BSI) technique developed for the brain, to be applied to the spinal cord, obtaining the first registration-based method for longitudinal assessment of spinal cord atrophy.
Objectives
We aim to 1) compare spinal cord atrophy measurements using segmentation- and registration-based methods, with possible implications for clinical trial design (e.g., measurement variability, image noise floor); 2) compare spinal cord atrophy measurements obtained from routine brain (C1-2) and dedicated spinal cord MRI (C1-2 and C2-5), using segmentation- and registration-based methods; 3) explore possible clinical correlates, also in relation to conventional brain MRI measures; and 4) explore possible treatment effect.
Methods
We included 220 primary-progressive multiple sclerosis patients from a phase 2 clinical trial, with baseline and week-48 3DT1-weighted MRI of the brain and spinal cord (1x1x1mm3), acquired separately. We obtained segmentation-based cross-sectional spinal cord area (CSA) at C1-2 (from both brain and spinal cord MRI) and C2-5 levels (from spinal cord MRI) using DeepSeg, and, then, we computed corresponding GBSI.
Results
Depending on the spinal cord segment, we included 67.4-98.1% patients for CSA measurements, and 66.9-84.2% for GBSI. Spinal cord atrophy measurements obtained with GBSI had lower measurement variability, than corresponding CSA. Looking at image noise floor, the lowest median standard deviation of the MRI signal within the cerebrospinal fluid surrounding the spinal cord was found on brain MRI at C1-2 level. Spinal cord atrophy derived from brain MRI was related to corresponding measures from dedicated spinal cord MRI, more strongly for GBSI than CSA. Spinal cord atrophy measurements using GBSI, but not CSA, were associated with upper and lower limb motor progression. No treatment effect was detected for any spinal cord atrophy measurements.
Conclusions
Notwithstanding reduced measurement variability, clinical correlates, and possibility of using brain acquisitions, spinal cord atrophy using GBSI should remain a secondary outcome measure in MS studies, until further advancements increase the quality of acquisition and reliability of processing.