An expert patient program for people living with multiple sclerosis improves knowledge and empowerment: a pre-test, post-test multicenter implementation study.

PurposeMany clinical trials comparing the outcomes of open surgical repair (OSR) versus endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) have been conducted, with varying results. Surprisingly, few outcomes studies have closely examined perceived physical and mental health-related quality of life (HRQOL) factors through a validated survey tool. The purpose of this prospective observational study was to describe the trajectory of HRQOL measures, from baseline to 1 year after surgery, in patients undergoing OSR or EVAR for AAA, and to explore for differences in physical and mental composite scores and their construct domains (subscales) using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36®) tool.Patients and methodsOver an 18-month period, a small sample of patients undergoing elective AAA repair in a community hospital setting were prospectively enrolled. Fifteen patients undergoing OSR and twenty patients undergoing EVAR were studied. Physical and mental HRQOL parameters were assessed using the SF-36.ResultsNo significant differences in demographic and clinical variables were found between the OSR and EVAR groups. In the multivariable linear models with repeated measures, both groups showed a significant decline in physical health composite scores 30 days after the surgical procedure (P < 0.01). However, although the OSR group showed a statistically significant decline in three of the four physical health domains, the EVAR group declined in only one physical health domain. Only the OSR group showed a significant decline in three of the four mental health domains at 30 days; however, the decline of these domains was not reflected in the group’s mental health composite scores. By 90 days after surgery, both groups were not significantly different from their baseline in physical or mental health composite scores, or in any of their respective physical health domains.ConclusionIn this small sample of patients undergoing AAA repair, EVAR resulted in less physical and emotional decline than OSR in the early postoperative period. However, patients in both groups may return to near baseline status at 90 days.

Background and objectivesTo translate and adapt the Multiple Sclerosis Quality of Life-29 into Arabic (MSQOL-29-Ar) and assess its psychometric properties in people with multiple sclerosis (MS).MethodsGenerally, 101 Arabic-speaking adults with MS aged 21 to 60 were recruited. Construct validity was tested by correlating MSQOL-29-Ar with the Arabic Functional Assessment of Multiple Sclerosis (FAMS-AR) and Multiple Sclerosis International Quality of Life (MusiQOL). Known-group validity was assessed by correlating the scale's Physical Health Composite (PHC) and Mental Health Composite (MHC) scores with the demographic and clinical data. Test-retest reliability, internal consistency, standard error of measurement (SEM), minimal detectable change (MDC95), limit of agreement (LOA), responsiveness, and floor/ceiling effects were also investigated.ResultsPHC and MHC scores correlated strongly with FAMS-ARA (r = 0.76 and 0.70, respectively).PHC scores were associated with age, employment, and MS chronicity, while MHC scores correlated with the Expanded Disability Status Scale. Internal consistency was acceptable (PHC α = 0.80; MHC α = 0.90), with excellent test-retest reliability (PHC r = 0.76; MHC r = 0.90). SEM (1.4-1.6) and MDC95 (4.3-3) were low. Responsiveness analysis indicated moderate accuracy (AUC = 0.70-0.75) with on-floor/ceiling effects.ConclusionMSQOL-29-Ar is valid and reliable for assessing HQOL in people with MS, making it suitable for clinical and rehabilitation settings.

While obesity is a known risk factor of the development of multiple sclerosis (MS), its impact on MS disease progression remains unclear. We aimed to investigate the influence of body mass index (BMI) on disease activity and progression, cognitive performance, and health-related quality of life in patients with MS. Patients from an incident population-based case-control study (n = 3,249) were categorized based on BMI status at diagnosis and followed up after diagnosis through the Swedish MS registry. Outcomes included changes in the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale 29, and Symbol Digit Modalities Test. The mean follow-up time was 10.6 years (SD 6.1). Linear mixed models were used to analyze long-term changes while Cox regression models assessed the risk of 24-week confirmed disability worsening, time to reach EDSS score 3 and EDSS score 4, the appearance of new lesions on MRI, patient-reported physical and psychological worsening, and processing speed worsening. Obesity, compared with healthy weight, was associated with a 0.02-point faster annual increase in the EDSS score (β for EDSS score x time 0.02, 95% CI 0.00-0.04). In addition, obesity was linked to a higher risk of reaching EDSS score 3 (HR 1.43, 95% CI 1.17-1.75) and EDSS score 4 (HR 1.40, 95% CI 1.07-1.73) and an increased risk of physical and psychological worsening. New lesions on MRI were more frequent among those with overweight and obesity, compared with those with healthy weight (HR 1.21, 95% CI 1.02-1.44 and HR 1.29, 95% CI 1.03-1.62, respectively). Among those who had not changed BMI group during follow-up, the associations between obesity and unfavorable outcomes became more pronounced, and the HR of cognitive disability worsening was 1.51 (95% CI 1.09-2.09) among those with obesity, compared with nonobese participants. In participants with MS, obesity was associated with faster disease progression, poorer health-related quality of life, and more rapid cognitive decline. Both overweight and obesity were associated with higher MRI activity.

Body composition in ambulatory women with multiple sclerosis

This meta-analysis systematically explored predictive factors for the progression of multiple sclerosis (MS). Computerized searches were conducted in Pubmed, OVID, Web of science, Willey Library, and EMbase from inception to August 2023. Patients with MS were divided into the deterioration group, defined as those with an increase in the Expanded Disability Status Scale (EDSS) score of ≥ 1.0 for a baseline EDSS ≤ 5.5 or ≥ 0.5 for a baseline EDSS > 5.5 during the follow-up period, and the non-deterioration group, comprising patients who exhibited no significant changes in EDSS over the same period. This study analyzed the impact of specific predictors, including age at onset, sex (male), smoking status, disease duration, number of relapses, EDSS score, prodromal neurological symptoms, and the use of disease-modifying therapies (DMTs) on MS progression. Of 3647 retrieved, 14 studies were finally included. Meta-analysis showed that sex (male) [odds ratio (OR) = 1.15, 95% confidence interval (CI): 1.05-1.26, P < 0.01], smoking [OR = 1.92, 95%CI: 1.41-2.60, P < 0.01], relapses frequency [OR = 1.05, 95%CI: 1.02-1.08, P < 0.01], EDSS score [OR = 1.54, 95%CI: 1.10-2.15, P = 0.01], and DMTs use [OR = 0.38, 95%CI: 0.26-0.55, P < 0.01] significant influenced MS progression, while age at onset, disease duration, and prodromal neurological symptoms were not significant. Sex (male), smoking, a higher number of relapses, EDSS score, and DMTs are predictors of MS deterioration. Hence, particular attention should be given to these risk factors when assessing MS deterioration.

Objective: Identify relapsing multiple sclerosis (RMS) patients with aggressive disease characterized by rapid disability progression. Background Criteria for identifying RMS patients with aggressive disease, which would be useful for clinical decision making and trial design, are currently unavailable. Design/Methods: The Multiple Sclerosis Collaborative Research Group (MSCRG) study was a phase 3, double-blind, placebo-controlled trial of intramuscular interferon beta-1a (IM IFNβ-1a) in patients with RMS. Patients received IM IFNβ-1a 30 μg or placebo once weekly for up to 2 years. Patients were required to have a baseline Expanded Disability Status Scale (EDSS) score of 1.0–3.5. Patients with a ≥2.0-point increase in EDSS score resulting in a score ≥4.0 by study end were considered to have aggressive RMS. The risk of a poor long-term outcome, defined as an EDSS score ≥8.0 at 8 years of follow-up, was calculated as an odds ratio from a logistic regression model comparing patients with and without aggressive RMS. Results: Few patients (n=39) had EDSS ≥4.0 over 2 years. Only 25 patients met the criteria for aggressive RMS. Among these patients, mean disease duration was 5.1±3.85 years, mean baseline age was 37.2±6.35 years, and mean baseline EDSS was 2.8±0.74. More patients in the placebo group (22%) than in the IM IFNβ-1a group (7%) met the criteria for aggressive RMS at 2 years ( P =0.0072). Thirteen patients reached the EDSS milestone of 8.0 (severe disability) by the end of the 8-year follow-up. The odds ratio for attaining severe disability was 31.4 (95% confidence interval, 7.7–127.8; P Conclusions: The proposed definition for aggressive RMS characterized by rapid EDSS progression appeared to be useful in identifying patients at high risk for a more severe long-term disease course with greater accumulation of physical disability. Supported by: Biogen Idec Inc. Disclosure: Dr. Scott has received personal compensation for activities with Novartis, Biogen Idec, Teva Neuroscience, and Genzyme as a consultant or speaker. Dr. Scott has received research support from the Pittsburgh Foundation. Dr. Laforet has received personal compensation for activities with Biogen Idec Inc. as an employee.Dr. Laforet holds stock and/or stock options in Biogen Idec Inc., which sponsored research in which Dr. Laforet was involved as an investigator. Dr. You has received personal compensation for activities with Biogen Idec as an employee.

Physical health and mental health functional status during and following hospitalization for an acute respiratory illness

The role of pregnancy in relapsing-remitting MS prognosis: A five-year study.

To explore whether time to diagnosis, time to treatment initiation, and age to reach disability milestones have changed in patients with clinically isolated syndrome (CIS) according to different multiple sclerosis (MS) diagnostic criteria periods. This retrospective study was based on data collected prospectively from the Barcelona-CIS cohort between 1994 and 2020. Patients were classified into 5 periods according to different MS criteria, and the times to MS diagnosis and treatment initiation were evaluated. The age at which patients with MS reached an Expanded Disability Status Scale (EDSS) score ≥3.0 was assessed by Cox regression analysis according to diagnostic criteria periods. Last, to remove the classic Will Rogers phenomenon by which the use of different MS criteria over time might result in a changes of prognosis, the 2017 McDonald criteria were applied, and age at EDSS score ≥3.0 was assessed by Cox regression. In total, 1,174 patients were included. The median time from CIS to MS diagnosis and from CIS to treatment initiation showed a 77% and 82% reduction from the Poser to the McDonald 2017 diagnostic criteria periods, respectively. Patients of a given age diagnosed in more recent diagnostic criteria periods had a lower risk of reaching an EDSS score ≥3.0 than patients of the same age diagnosed in earlier diagnostic periods (reference category Poser period): adjusted hazard ratio (aHR) 0.47 (95% confidence interval 0.24-0.90) for McDonald 2001, aHR 0.25 (0.12-0.54) for McDonald 2005, aHR 0.30 (0.12-0.75) for McDonald 2010, and aHR 0.07 (0.01-0.45) for McDonald 2017. Patients in the early-treatment group displayed an aHR of 0.53 (0.33-0.85) of reaching age at EDSS score ≥3.0 compared to those in the late-treatment group. Changes in prognosis together with early-treatment effect were maintained after the exclusion of possible bias derived from the use of different diagnostic criteria over time (Will Rogers phenomenon). A continuous decrease in the time to MS diagnosis and treatment initiation was observed across diagnostic criteria periods. Overall, patients diagnosed in more recent diagnostic criteria periods displayed a lower risk of reaching disability. The prognostic improvement is maintained after the Will Rogers phenomenon is discarded, and early treatment appears to be the most likely contributing factor.

This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS). A randomized controlled trial over a 12-month period was carried out in 2009. One hundred and twenty men aged 40 years and above with a diagnosis of TDS (serum total testosterone <12 nmol l(-1) and total Aging Male Symptom (AMS) scores ≥27) were invited to participate. Interventions comprised intramuscular injection of either placebo or 1000 mg testosterone undecanoate, given at weeks 0, 6, 18, 30 and 42. This paper presents the secondary analysis of QoL changes measured in the scores of Short-Form-12 (SF-12) scale at baseline, weeks 30 and 48 after the first injection. A total of 56/60 and 58/60 men from the active treatment and placebo group, respectively, completed the study. At week 48, before adjusting for baseline differences, the QoL of men in the treatment group improved significantly in five out of the eight domains on SF-12. The physical health composite scores improved 4.0 points from a baseline of 41.9±7.0 in the treatment group compared to 0.8 point from a baseline of 43.7±7.1 in the placebo group (F=3.652, P=0.027). The mental health composite scores improved 4.4 points from a baseline of 37.1±9.0 in the treatment group compared to 1.0 points from a baseline of 37.6±7.9 in the placebo group (F=4.514, P=0.018). After adjusting for baseline differences, significant improvement was observed in mental health composite scores, but not in physical health composite scores. Long-acting testosterone undecanoate significantly improved the mental health component of QoL in men with TDS.

This cost-of-illness analysis based on information from 1.549 patients in The Netherlands is part of a Europe-wide study on the costs of multiple sclerosis (MS). The objective was to analyze the costs and quality of life (QOL) related to the level of disease severity and progression. Patients from three specialized MS centres participated in the survey by answering a mail questionnaire (response rate, 52%). In addition to details on the disease (type of disease, relapses, level of functional disability), the questionnaire asked for information on all resource consumption, medical, non-medical, work absence, early retirement and informal care as well as QOL (expressed as utility). The mean age of the cohort was 47 years, and 7.6% of patients were 65 years of age or more. Forty-eight percent of patients had mild disease [Expanded Disability Status Scale (EDSS) score of 0-3], 40% moderate disease (EDSS score of 4-6.5) and 11% severe disease (EDSS score of 7 and above). The mean EDSS score in the sample was 3.9 (median 4.0), with a utility of 0.61. Costs and utility are highly correlated with disease severity. Workforce participation decreases from around 75 to 80% in early disease to less than 5% in the very late stages. Hospitalization is very infrequent in early disease, representing less than euro 500 per year for patients at EDSS scores below 6, but increases steeply for patients at an EDSS score of 7 and above. Ambulatory care increases fivefold between early and late disease, while services rise from basically no cost to almost euro 8.000 per year at an EDSS score of 7 and euro 19.000 per year at EDSS scores of 8-9. Productivity losses are multiplied by 10 in late disease, while informal care increases from euro 300 per year at EDSS scores of 0-1 to nearly euro 15.000 per year at EDSS scores of 8-9. Hence, total mean costs per patient are driven essentially by the distribution of the severity levels in the sample, increasing from euro 9.300 per year at EDSS scores of 0-1 to euro 50.000 per year at an EDSS score of 7 and euro 78.000 per year at EDSS scores of 8-9. The same is true for utility, which decreases from 0.85 to 0.05 as the disease becomes severe. However, the utility loss compared to the age- and gender-matched general population is high at all levels of the disease (0.25 at an EDSS score of 2 to 0.4 at EDSS scores of 5-6), leading to an estimated annual loss of 0.24 quality-adjusted life-years (QALYs) per patient. Relapses for patients with an EDSS score below 5 are associated with a cost of around euro 2.800 and a utility loss of 0.15 during the quarter in which they occur.

Effectiveness and safety of ofatumumab in treatment-naive and oral DMT-switched multiple sclerosis patients: a multicenter observational study in China.

The study objective was to analyse the costs and quality of life (QOL) of multiple sclerosis (MS) related to disease severity in Sweden as part of a study in nine European countries. Information on demographics, disease, resource utilisation, informal care needs, work capacity and QOL (utility) was collected using a questionnaire that was sent to patients registered with the Swedish organisation of patients with neurological disabilities (Neurologiskt Handikappades Riksförbund). The study used a prevalence-based and cross-sectional approach, and costs were estimated from a societal perspective. A total of 1,339 patients were included in the analysis. Seventy-three percent of patients were female, and the mean age was 53 years (standard deviation [SD], 12 years). The mean Expanded Disability Status Scale (EDSS) score was 5.1 (SD, 2.2); only 29% of patients had mild disease (EDSS score <4), 46% had moderate disease and 25% had severe disease (EDSS score > or =7). Costs were significantly correlated with disease severity, increasing sevenfold from around euro 16.000 at EDSS scores of 0-1 to euro 116.000 at EDSS scores of 8-9. At the same time, utility decreased with worsening disease from 0.825 to 0.047, with a mean established at 0.546 (SD, 0.287). This is significantly lower than utilities for an age- and gender-matched sample of the general population, which would be estimated at 0.80-0.85. Patients with a relapse during the last 3 months had a significant cost increase, of euro 3.080, and a utility loss of 0.088. Costs and utilities are highly correlated with EDSS score, and the mean cost per patient in the sample is thus heavily influenced by the severity distribution in the sample. Compared to European estimates, patients with moderate and severe disease in our sample appear to be overrepresented, and costs can therefore not be directly extrapolated to the overall MS population in Sweden without adjustment. When correcting for estimated actual prevalence and use of disease modifying drugs (DMDs), the total cost of MS in Sweden is estimated at euro 600 million. Compared to an earlier cost study in 1998 that included a similar sample, and adjusting for differential timing and estimated national use of DMDs, costs have increased by approximately 5% between 1998 and 2005.

ObjectiveTo assess the effectiveness of glatiramer acetate (GA) compared to other multiple sclerosis (MS) therapies in routine clinical practice.Materials and methodsObservational cohort study carried out in MS patients treated with GA (GA cohort) or other MS therapies –switched from GA– (non-GA cohort). Study data were obtained through review of our MS patient database. The primary endpoint was the Expanded Disability Status Scale (EDSS) scores reached at the end of treatment/last check-up.ResultsA total of 180 patients were included: GA cohort n = 120, non-GA cohort n = 60. Patients in the GA cohort showed better EDSS scores at the end of treatment/last check-up (mean ± SD, 2.8 ± 1.8 vs. 3.9 ± 2.2; P = 0.001) and were 1.65 times more likely to show better EDSS scores compared to the non-GA cohort (odds ratio, 0.606; 95%CI, 0.436–0.843; P = 0.003). Patients in the GA cohort showed longer mean time to reach EDSS scores of 6 (209.1 [95%CI, 187.6–230.6] vs. 164.3 [95%CI, 137.0–191.6] months; P = 0.004) and slower disability progression (hazard ratio, 0.415 [95%CI, 0.286–0.603]; P < 0.001). The annualized relapse rate was lower in the GA cohort (mean ± SD, 0.5 ± 0.5 vs. 0.8 ± 0.5; P = 0.001) and patients’ quality of life was improved in this study cohort compared to the non-GA cohort (mean ± SD, 0.7 ± 0.1 vs. 0.6 ± 0.2; P = 0.01).ConclusionsGA may slow down the progression of EDSS scores to a greater extent than other MS therapies, as well as achieving a greater reduction in relapses and a greater improvement in patients’ quality of life. Switching from GA to other MS therapies has not proved to entail a better response to treatment.

Background: Multiple sclerosis (MS) is a disease which has a variable clinical presentation followed by a variable clinical course. Therefore, accuracy of clinical rating scales to measure disability at initial clinical presentation and during follow-up visits is essential to accurately capture the variability inherent in this disease. This is particularly vital when attempting to identify the efficacy of interventions. Objective: This observational study in veterans with MS compared the Kurtkze Expanded Disability Status Scale (EDSS) and the Total Functional Independence Measure (TFIM) scale as measures of MS-related disability. Methods: We retrospectively reviewed the electronic charts of 76 veterans with MS who are regularly followed in our VA MS clinic. Local Institutional Review Board approval was obtained for the protocol. Data were analyzed using SAS (SAS System for Windows, version 9.2, SAS Institute Inc., Cary, NC, USA). Chi-square and Fisher exact tests were used to assess categorical variables. Kruskal–Wallis tests evaluated the relationships between MS types [relapsing–remitting MS (RR), secondary progressive MS (SP), primary progressive MS (PP) and clinical isolated syndrome (CIS)] and the initial TFIM, EDSS and Impairment Index (II) scores. Results: The EDSS score accurately measured MS-related impairment at initial evaluation and follow-up relative to an II. However, the EDSS score did not change over time, compared to the TFIM suggesting reduced sensitivity of the EDSS for detecting change in MS-related disability over time. Conclusions: This suggests TFIM scale is a more sensitive measure of MS-related disability than EDSS for use in future MS clinical trials.Implications for RehabilitationThis study highlights that given the paucity of scales to which EDSS has been compared, TFIM is a valuable adjunct to EDSS in measuring MS-related disability.TFIM is able to accurately measure the severity of MS-related disability and help provide for services patients with MS-related disability would need.TFIM is an easy to administer and a sensitive scale to measure the change in MS-related disability following interventions.