Influence of Education, Cognition, and Physical Disability on Quality of Life of Romanian Patients with Multiple Sclerosis-A Cohort Study.

Background and Objectives: objective measures of disability and neurological impairmentare used to search for disease activity and monitor disease evolution in multiple sclerosis (MS). These are sometimes in disagreement with subjective quality-of-life measures. We aimed to establish the relations between the Multiple Sclerosis Quality of Life instrument (MSQOL-54) and objective measures of neurological impairment. Materials and Methods: 107 patients with MS were evaluated with the Single Digit Modalities Test (SDMT) for cognition, Nine Holes Peg Test (9HPT) for upper limb function, 25 Feet Walk Test (25FWT) for gait, and EDSS for global disability in a cohort study. Age and education level were recorded as sociodemographic factors. Results: the median EDSS was 3.5 (IQR 2.5); average SDMT score was 30.38 ± 13.54; and 9HPT speed was significantly higher for the dominant upper limb (0.3 ± 0.1 pegs/s versus 0.28 ± 0.11 pegs/s) (p = 0.016). The mental health composite score of the MSQOL-54 correlated with the SDMT, education level, and EDSS. Education level correlated with cognition and quality of life. The physical health composite score of the MSQOL-54 correlated with motor-function parameters and with SDMT. The motor-function parameters correlated well among themselves. A linear regression model found an important influence of SDMT and education level on the mental health composite score of the MSQOL-54. Although the linear regression model predicting the physical health composite score from physical disability parameters was statistically sound, none of the determinants had a significant individual influence. Conclusions: the subscores of the MSQOL-54 correlated well with the objective parameters. The strongest correlations were those with the cognitive function. Correlations with physical disability were less powerful, probably reflecting their indirect and more limited influence on quality of life compared to cognition and perception of disability.

Applying multidimensional computerized adaptive testing to the MSQOL-54: a simulation study.

BACKGROUND: The Multiple Sclerosis Quality of Life-54 (MSQOL-54) is one of the most commonly-used MS-specific health-related quality of life (HRQOL) measures. It is a multidimensional, MS-specific HRQOL inventory, which includes the generic SF-36 core items, supplemented with 18 MS-targeted items. Availability of an adaptive short version providing immediate item scoring may improve instrument usability and validity. However, multidimensional computerized adaptive testing (MCAT) has not been previously applied to MSQOL-54 items. We thus aimed to apply MCAT to the MSQOL-54 and assess its performance. METHODS: Responses from a large international sample of 3669 MS patients were assessed. We calibrated 52 (of the 54) items using bifactor graded response model (10 group factors and one general HRQOL factor). Then, eight simulations were run with different termination criteria: standard errors (SE) for the general factor and group factors set to different values, and change in factor estimates from one item to the next set at < 0.01 for both the general and the group factors. Performance of the MCAT was assessed by the number of administered items, root mean square difference (RMSD), and correlation. RESULTS: Eight items were removed due to local dependency. The simulation with SE set to 0.32 (general factor), and no SE thresholds (group factors) provided satisfactory performance: the median number of administered items was 24, RMSD was 0.32, and correlation was 0.94. CONCLUSIONS: Compared to the full-length MSQOL-54, the simulated MCAT required fewer items without losing precision for the general HRQOL factor. Further work is needed to add/integrate/revise MSQOL-54 items in order to make the calibration and MCAT performance efficient also on group factors, so that the MCAT version may be used in clinical practice and research.

Viability of a MSQOL-54 general health-related quality of life score using bifactor model.

BACKGROUND: MSQOL-54 is a multidimensional, widely-used, health-related quality of life (HRQOL) instrument specific for multiple sclerosis (MS). Findings from the validation study suggested that the two MSQOL-54 composite scores are correlated. Given this correlation, it could be assumed that a unique total score of HRQOL may be calculated, with the advantage to provide key stakeholders with a single overall HRQOL score. We aimed to assess how well the bifactor model could account for the MSQOL-54 structure, in order to verify whether a total HRQOL score can be calculated. METHODS: A large international database (3669 MS patients) was used. By means of confirmatory factor analysis, we estimated a bifactor model in which every item loads onto both a general factor and a group factor. Fit of the bifactor model was compared to that of single and two second-order factor models by means of Akaike information and Bayesian information criteria reduction. Reliability of the total and subscale scores was evaluated with Mc Donald's coefficients (omega, and omega hierarchical). RESULTS: The bifactor model outperformed the two second-order factor models in all the statistics. All items loaded satisfactorily (≥ 0.40) on the general HRQOL factor, except the sexual function items. Omega coefficients for total score were very satisfactory (0.98 and 0.87). Omega hierarchical for subscales ranged between 0.22 to 0.57, except for the sexual function (0.70). CONCLUSIONS: The bifactor model is particularly useful when it is intended to acknowledge multidimensionality and at the same time take account of a single general construct, as the HRQOL related to MS. The total raw score can be used as an estimate of the general HRQOL latent score.

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

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.

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

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.

Application of tRNS to improve multiple sclerosis fatigue: a pilot, single-blind, sham-controlled study.

We evaluated the effects of transcranial random noise stimulation (tRNS) on fatigue in 17 subjects with relapsing-remitting multiple sclerosis with low physical disability. Two different patient groups underwent real or sham stimulation for 10 days, targeting the primary motor cortex of the dominant side or contralateral to the most compromised limb. In the 'real group', beneficial effects were observed using the Modified Fatigue Impact Scale (p = 0.04; physical subscale: p = 0.03), the subscales 'change in health' (p = 0.006) and 'role limitations due to physical problems' (p = 0.001) of the Multiple Sclerosis Quality of Life-54, and by assessing the patient impression of perceived fatigue (p = 0.005).

Validation of the Disease-specific Questionnaire MSQoL-54 in Bosnia and Herzegovina Multiple Sclerosis Patients Sample.

INTRODUCTION: The purpose of this study was to validate Bosnian translation of disease specific quality of life measure MSQoL-54 which is widely used in practice. MATERIAL AND METHODS: Previously translated and culturally adopted MSQoL-54 questionnaire used in this study has been provided and licensed by Optum Inc. The questionnaire was validated in 62 MS patients seen at Neurology clinic at University Clinical Center Sarajevo, during April 2016 until May 2016. Internal reliabilities of Bosnian version MSQoL-54 were assessed for multiple item scales by using Cronbach's alpha coefficient. Clinical validity was assessed comparing means of the two summary MSQoL-54 scores by the EDSS score. Pearson's (r) correlation coefficient was used to investigate the relationship between the composite scores and the main clinical and demographic variables. RESULTS: Patients' participation was satisfactory and all scales fulfilled the usual psychometric standards. Highly significant inverse relationship was found between both composite scores and clinical characteristics of the disease and the EDSS. The lowest internal consistency reliability is found on social function scale (0.743), overall quality of life (0.782) and pain (0.833). The highest internal consistency reliability is found on role limitations due to physical problems (0.959), physical health (0.962) and role limitations due to emotional problems (0.966). The mean value of MSQoL-54 PHC (Physical Health Composite) and MHC (Mental Health Composite) were 49.82±18.90 (36.05-61.38) 51.84±22.22 (34.93-70.20) respectively. Our study has shown that the Bosnian version of MSQoL-54 is easy to administer and well accepted by patients and may be useful as clinical outcome measures in patients with MS.

Quality of life of MS patients in Trinidad and Tobago: Anomaly or adaptation?

BACKGROUND AND OBJECTIVE: There has been growing interest in quality of life associated with multiple sclerosis but the research has been overwhelmingly carried out in developed countries. This study aimed to assess quality of life of multiple sclerosis patients in Trinidad and Tobago. METHODS: All multiple sclerosis patients were asked to complete demographic, EQ-5D-5L and MSQOL-54 questionnaires. EQ-5D data were compared with population norms for Trinidad and Tobago. MSQOL-54 data were compared with results from a matching cohort of non-MS respondents. Regression analyses were used to explore the association between MSQOL-54 scales and EQ-5D utility. RESULTS: The 97 patients were mainly urban, highly educated and 75% female. EQ-5D-5L data showed more frequent and more severe problems and lower index values than the population and patients of other chronic illness clinics in Trinidad and Tobago. MSQOL-54 results showed that patients were more affected by physical items, but had high scores on mental and emotional items when compared with the matching cohort and patients in other countries. CONCLUSION: The low prevalence and demographics of patients suggest the possibility of undetected cases in rural areas and/or among less educated groups. Further investigation into the high levels of mental and emotional health among patients may lead to the design of interventions to help patients of multiple sclerosis and other illnesses.

Sexual problems in MS: Sex differences and their impact on quality of life.

BACKGROUND: Low sexual function and satisfaction are common problems among people with multiple sclerosis (PwMS), but the literature on which patient variables are associated with these issues is inconsistent. OBJECTIVE: To investigate the associations between sexual function and satisfaction in PwMS with clinical, demographic, and patient-reported quality of life (QOL) measures and determine if sex differences exist. METHODS: This analysis includes PwMS enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital (CLIMB), who completed patient-reported outcome measures: Multiple Sclerosis Quality of Life-54 (MSQOL-54), Modified Fatigue Impact Scale (MFIS), and Center for Epidemiologic Studies Depression Scale (CES-D). Regression models were used to analyze associations between patient variables and function and satisfaction. Results were stratified by sex. Cross-sectional and longitudinal data were used. RESULTS: 702 PwMS (526 females,176 males, mean age 42.2 +/-11.1, median EDSS 1.5) were included in the cross-sectional analysis. Data from 341 PwMS were used in the three-year longitudinal analysis. Increasing age, disease duration, and disability were associated with reduced sexual function and satisfaction to the same degree in males and females. However, sex differences existed in the strength of associations with QOL variables. There was no significant longitudinal change in females or males. CONCLUSIONS: Age and disease duration were associated with reduced sexual function and satisfaction in males and females. In females, function was significantly associated with disability and satisfaction with fatigue. Males had stronger associations with sexual function in domains related to emotional well-being, health perceptions, and overall QOL. Males had stronger associations with satisfaction in emotional and social functioning and physical health domains. These findings can help better understand the multidimensional problems of sexual function and satisfaction in PwMS and better guide patient care.

The effect of pelvic floor exercise program on incontinence and sexual dysfunction in multiple sclerosis patients.

PURPOSE: Multiple sclerosis (MS) is a chronic neuroinflammatory disease of the central nervous system that involves different neurological areas. In addition to lower urinary tract symptoms (LUTS), sexual dysfunction (SD), and psychopathological effects, MS sometimes seriously impairs the quality of life (QoL). We hypothesize that the pelvic floor exercise program (PFEP) could improve bladder, sexual function, depression, and QoL in MS patients. METHODS: Patients diagnosed with MS completed the Incontinence Questionnaire Short Form (ICIQ-SF), the Beck Depression Inventory (BDI), the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire, and either the Female Sexual Function Index (FSFI) or the Sexual Health Inventory for Men (SHIM). Maximum bladder volumes (MBV) and post-voiding residual (PVR) volumes were measured using ultrasonography. The patients who regularly completed the PFEP for 12 weeks were asked to fill out the questionnaires again, and their MBV and PVR were remeasured. RESULTS: Seventy-two patients with relapsing-remitting multiple sclerosis (RRMS) were included in the study. Forty-two (58.3%) RRMS patients reached the end of the study. The patients' post-PFEP average MBV statistically increased (p = 0.01). In contrast, no statistically significant difference was found in the PVR (p = 0.2). After exercise, the FSFI values in women increased (p = 0.02), and ICIQ-SF and BDI values in all the RRMS patients statistically decreased (p = 0.004, p = 0.01, respectively), but there was no improvement in the MSQoL-54 score (p > 0.05). CONCLUSION: PFEP, which causes a reduction in LUTS by enhancing the MBV of RRMS patients, can be seen as an investment in the future in terms of reducing depression in MS patients and preventing or delaying SD in women.

Quality of life among Sudanese patients with multiple sclerosis in Khartoum state using (MSQoL-54) questionnaire.

OBJECTIVE: To assess the quality of life, physical and mental factors, determine association between age, education status, disease duration and MSQOL-54 physical and Mental Health Composite scores among Sudanese patients with multiple sclerosis. This cross-section study was conducted among 32 MS patients at the National center for Neurological Science, Khartoum from January 2017 to June 2018. Using Multiple sclerosis Quality of life (MSQoL-54) questionnaire. RESULTS: Thirty two MS patients were participated in this study, 30 (94%) were females and 2 (6%) were males, 25 (78.1%) were found in age group < 40 years overall score of MSQoL-54 was 66.4 ± 21.9, Physical Health Composite (PHC) was 71.6 ± 21.3 and Mental Health Composite (MHC) was 61.2 ± 22.4. This study indicated that, non-graduated, advanced age and longer disease duration was significantly associated with poor Physical Health Composite and Mental Health Composite.

Ketogenic diets attenuate cyclooxygenase and lipoxygenase gene expression in multiple sclerosis.

BACKGROUND: Adapted ketogenic diet (AKD) and caloric restriction (CR) have been suggested as alternative therapeutic strategies for inflammatory, hyperproliferative and neurodegenerative diseases. Pro-inflammatory eicosanoids have been implicated in the pathogenesis of multiple sclerosis since they augment vascular permeability and induce leukocyte migration into the brain. We explored the impact of ketogenic diets on gene expression of biosynthetic enzymes for pro- (ALOX5, COX1, COX2) and anti-inflammatory (ALOX15) eicosanoids in patients with relapsing-remitting multiple sclerosis. METHODS: 60 adults were prospectively recruited for this six months randomized controlled trial and the impact of dietary treatment on the Multiple Sclerosis Quality of Life-54 index (ClinicalTrials.gov (NCT01538355) has previously been published. Here we explored 24 patients (8 controls, 5 on CR and 11 on AKD). For statistical analysis we combined the two diet groups to a single pooled treatment group. FINDINGS: Inter-group comparison indicated that expression of the pro-inflammatory ALOX5 in the pooled treatment group was significantly (p < 0.05) reduced when compared with the control group. Moreover, intra-group comparison (same individuals before and after dietary treatment) suggested significantly impaired expression of other pro-inflammatory enzymes, such as COX1 (p < 0.001) and COX2 (p < 0.05). Finally, pretreatment cross-group analysis revealed a significant positive correlation between expression of pro-inflammatory ALOX5 and COX2 and an inverse correlation of ALOX5 and COX1 expression with the MSQoL-54 index. INTERPRETATION: Ketogenic diets can reduce the expression of enzymes involved in the biosynthesis of pro-inflammatory eicosanoids. Pharmacological interference with eicosanoid biosynthesis might constitute a strategy supplementing current therapeutic approaches for MS.

Validation of The Slovenian Version of Multiple Sclerosis Quality of Life (MSQOL-54) Instrument.

PURPOSE: To cross-culturally adapt and validate Multiple Sclerosis Quality of Life-54 (MSQOL-54) instrument. METHODS: The study which enrolled 134 Slovenian multiple sclerosis (MS) patients was conducted from March to December 2013. The internal consistency of the MSQOL-54 instrument was evaluated by Cronbach's alpha coefficient (α), and its dimensionality assessed by the principal component analysis (PCA). RESULTS: The whole instrument had high internal consistency (α=0.88), as well as the majority of its twelve subscales (α=0.83-0.94). The results of the PCA showed two components with eigenvalue greater than 1, explaining 59.4% of the cumulative variance. Further results indicated good construct validity of the instrument with the physical health-related-quality-of-life subscales loading highly on the physical component, and mental health-related-quality-of-life subscales loading highly on the mental component. CONCLUSION: The Slovenian version of the MSQOL-54 instrument proved to be an internally consistent and accurate tool, well accepted by the Slovenian MS patients. The adequate psychometric properties warrant the scientifically sound version of the MSQOL-54 instrument, which is from now on at disposal to all health professionals dealing with MS patients in Slovenia.

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.

Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: a randomised controlled feasibility study.

BACKGROUND: People with Multiple Sclerosis (PwMS) are less physically active than the general population and pragmatic approaches designed to equip them with the skills and confidence to participate in long-term physical activity are required. OBJECTIVE: The objective of this study was to determine the feasibility of a pragmatic exercise intervention in PwMS. METHODS: A voluntary sample of 30 PwMS (male n = 4, female n = 26; mean age = 40 years; range = 24-49 years), with mild to moderate disability (EDSS ≤ 5.5), were recruited from eligible participants attending outpatient clinics. A total of 28 participants were randomised to a 10 week pragmatic exercise intervention (2× supervised and 1× home-based session per week) or usual care. Clinical, functional and quality of life (MSQoL-54) outcomes were assessed at baseline, immediately and 3 months after the intervention. RESULTS: Attrition was low (2 participants lost to immediate follow-up and 4 participants lost to 3 month follow-up), with high compliance rates (>75% of all sessions). The intervention group achieved progression of exercise volume (24.3 ± 7.0 to 30.9 ± 5.5 min per session), intensity (60.4 ± 8.8 to 67.7 ± 6.9% HR max) and training impulse (min × average HR=training impulse/load [arbitrary units; AU]) (2600 ± 1105 to 3210 ± 1269AU) during the intervention, whilst significantly increasing(P = 0.050) their physical composite score (MSQOL-54) at 10 weeks and readiness to exercise (P = 0.003) at 3 months compared with usual care. CONCLUSION: This pragmatic intervention was feasible for PwMS, but further research is needed to assess its long-term impact on physical activity behaviour.