Can inpatient multidisciplinary rehabilitation improve health-related quality of life in MS patients on the long term - The Danish MS Hospitals Rehabilitation Study.

BACKGROUND: Inpatient multidisciplinary rehabilitation (MDR) can improve health-related quality of life (HRQoL) in multiple sclerosis (MS) patients. However, the evidence of a long-term benefit is limited. OBJECTIVES: To investigate the long-term effectiveness of inpatient MDR on HRQoL in MS patients. METHODS: We conducted a randomized controlled partial crossover trial with 427 MS patients. RESULTS: Statistical significant long-term improvements in HRQoL were found in three of the six outcome measures at 12-month follow-up. Three in four suggested minimal clinically important differences (MCIDs) were unmet. CONCLUSION: These results indicate that the administration of inpatient MDR may lead to long-lasting improvements in HRQoL in MS patients.

Can we trust self-reported walking distance when determining EDSS scores in patients with multiple sclerosis? The Danish MS hospitals rehabilitation study.

BACKGROUND: In multiple sclerosis (MS), the Expanded Disability Status Scale (EDSS) reflects disease severity. Although parts of the EDSS are dependent on actual walking distance, self-reported statements are often applied. OBJECTIVES: The purpose of the present study was, therefore, to compare self-reported walking distance to actual walking distance to outline how this influences EDSS scoring. METHODS: MS patients with EDSS 4.0-7.5 (n = 273) were included from the Danish MS hospitals rehabilitation study (n = 427). All patients subjectively classified their maximal walking distance according to one of seven categories (>500; 300-499; 200-299; 100-199; 20-99; 5-19; 0-4 m). Subsequently, actual maximal walking distance was assessed and EDSS was determined from both self-reported walking distance (EDSSself-report) and actual walking distance (EDSSactual). RESULTS: In 145 patients (53%), self-reported walking distance was misclassified when compared to the actual walking distance. Misclassification was more frequent in patients using walking aids (64% vs. 44%, p < 0.05) and in patients with primary progressive MS (69%, p < 0.05). Misclassification of walking distance corresponded to incorrect EDSS scores (EDSSself-report vs EDSSactual) of ⩾0.5 point in 24%. CONCLUSION: In MS patients with EDSS 4.0-7.5, 53% misclassified their walking distance yielding incorrect EDSS scores in 24%. Therefore, correct EDSS determination must be based on measurement of actual walking distance.

Longer term effectiveness of inpatient multidisciplinary rehabilitation on health-related quality of life in MS patients: a pragmatic randomized controlled trial - The Danish MS Hospitals Rehabilitation Study.

BACKGROUND: There is insufficient evidence to support the effectiveness of multidisciplinary rehabilitation on the health-related quality of life (HRQoL) of MS patients. OBJECTIVES: To evaluate the longer term effectiveness of inpatient multidisciplinary rehabilitation on the HRQoL of MS patients. METHODS: The study was a two-hospital, pragmatic, randomized controlled trial with a 6-month follow-up. Patients aged 18-65 years with MS and Expanded Disability Status Scale scores ≤7.5 were randomly assigned (1:1) to 4 weeks of inpatient multidisciplinary rehabilitation (20 days of scheduled rehabilitation) or 6 months on a wait list. The outcome measures were Functional Assessment in Multiple Sclerosis (FAMS), Multiple Sclerosis Impact Scale-29 (MSIS-29), EQ-5D-5L and 15D. RESULTS: We randomized 213 patients to the wait-list control group and 214 patients to the treatment group. Trends in favour of the treatment group were observed across all measures. However, the difference was significant in only two of the six measures. The treatment effect was -2.7 (95% CI: -5.6 to (-0.1)), p = 0.046) for the MSIS-29 Psychological and 0.017 (95% CI: 0.005-0.030, p = 0.008) for the 15D. FAMS, which we used to calculate the sample size, was not significant. CONCLUSION: The results indicated that inpatient multidisciplinary rehabilitation is effective in improving the HRQoL of MS patients after 6 months.

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention.

BACKGROUND: Multiple sclerosis (MS) is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation. METHODS/DESIGN: Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months) or usual admission (after an average waiting time of eight months). They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization. DISCUSSION: The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials (ISRCTN05245917).

Multimethodological validation of the modified fatigue impact scale in a Danish population of people with Multiple Sclerosis.

OBJECTIVE: To provide a multimethodological validation of MFIS in compliance with the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines using a Danish population of patients with Multiple Sclerosis (pwMS). METHODS: Factor analytic and multidimensional Rasch analytic methods were applied to investigate the structural validity of MFIS. We employed measurement and bi-factor models to address divergence and convergence. McDonalds ω was used to assess reliability. Cross-cultural and nomological validity was assessed in relation to relevant external populations and constructs, respectively. Responsiveness was evaluated following one month of multi-disciplinary rehabilitation (MDR). RESULTS: Based on data from 424 Danish MS patients, the MFIS showed an acceptable fit to both factor analytic and multidimensional Rasch models. MFIS was found to be dominated by a general factor but with considerable substructure present. Sufficient divergence was found between cognitive and physical subdomains, but not the psychosocial subscale. Mc Donald's ωt of 0.96 indicated good reliability of the scale, however, with low specific reliability of the psychosocial subscale. Homogeneity across Danish and European populations of pwMS supported cross-cultural validity. Explorative factor analysis of the nomological network of MFIS revealed expected convergence with cognitive and physical aspects. MFIS showed good responsiveness as indicated by moderate to large effect sizes following MDR. CONCLUSION: The Danish version of the MFIS showed good reliability, a good structural, cross-cultural, and nomological validity an acceptable fit to a multidimensional Rasch analysis, and a good responsiveness. The psychosocial subscale of the MFIS however should be interpreted with caution.

Associations between fatigue impact and lifestyle factors in people with multiple sclerosis - The Danish MS hospitals rehabilitation study.

BACKGROUND: The lack of medical treatment options to reduce fatigue in patients with multiple sclerosis (MS) emphasize the importance of identifying potential non-pharmacological modifiable factors, as this may help advance current treatment strategies. The aim of this study was to identify potential modifiable lifestyle factors as well as patient- and disease-related characteristics, that are associated with fatigue in a large sample of clinically well-characterized patients with MS. METHODS: This study was a secondary analysis of a pragmatic randomized controlled trial of inpatient multidisciplinary rehabilitation in Denmark. MS patients aged 18 to 65 years and with a disease severity score ≤ 7.5 according to the Expanded Disability Status Scale participated. Data on patient- and disease-related characteristics, fatigue impact (Modified Fatigue Impact Scale (MFIS)), and on lifestyle factors (tobacco smoking, alcohol intake, and physical activity), were collected at baseline. A linear mixed model was used to compare MFIS total, physical, cognitive, and psychosocial scores across subgroups of selected characteristics. Regression analyses were used to examine associations between lifestyle factors and MFIS total, physical, cognitive, and psychosocial scores. RESULTS: In the sample of 417 MS patients, median age was 51 years, 69% were female, median time since diagnosis was 8 years, with 41% having relapsing remitting MS. Higher MFIS total scores were observed in MS patients with shorter time since diagnosis, being a tobacco smoker, and not undertaking regular physical activity. Somewhat similar findings were observed for MFIS subscores (physical, cognitive, psychosocial), especially MFIS physical scores. In the multivariate analyses, physical activity was significantly associated with fatigue impact on total, physical and psychosocial functioning. Tobacco smoking was significantly associated with fatigue impact on psychosocial functioning. Alcohol intake was not associated with fatigue impact. None of the lifestyle factors were associated with fatigue impact on cognitive functioning. In the adjusted models time since diagnosis was significantly associated with fatigue impact on total, physical and cognitive functioning, as was disease severity with fatigue impact on physical and cognitive functioning. CONCLUSION: Physical activity showed the most pronounced associations with fatigue impact on physical and psychosocial functioning, while the impact on cognitive functioning showed a trend. Tobacco smoking contributed significantly to impact on psychosocial functioning, while alcohol intake did not contribute to fatigue impact. Introducing or supporting maintenance of physical activity/exercise and cessation of tobacco smoking seems to be a useful approach for rehabilitation services to help patients with MS manage fatigue.

Personalised inpatient multidisciplinary rehabilitation elicits clinically relevant improvements in physical function in patients with multiple sclerosis - The Danish MS Hospitals Rehabilitation Study.

PURPOSE: Evidence of the effects of inpatient multidisciplinary rehabilitation (MDR) on physical function in patients with multiple sclerosis (MS) is limited, particularly whether clinically relevant improvements can be achieved. The aim of this study, therefore, was to investigate the effects of personalised inpatient MDR on the physical function of MS patients. METHODS: Embedded in the Danish MS Hospitals Rehabilitation Study, a pragmatic study was performed in MS patients undergoing four weeks of inpatient MDR specifically targeting physical function. Outcomes were assessed at baseline (n = 142), at discharge (n = 137) and at six months follow-up (n = 126) using the six-minute walk test (6MWT), six-spot step test (SSST), five times sit to stand test (5STS), nine-hole peg test (NHPT), dynamic gait index (DGI) and 12-item MS walking scale (MSWS). RESULTS: From Baseline-to-Discharge, significant and clinically relevant improvements were found in all measures of walking capacity (6MWT, SSST, 5STS, DGI and MSWS; p < 0.05) along with significant (but not clinically relevant) improvements in upper extremity function (NHPT; p < 0.05). Whilst comparable improvements were observed within subgroups of MS phenotype (relapsing-remitting [RR] vs. secondary + primary progressive [SP + PP]), disease severity (moderate [EDSS2.5-5.5] vs. severe [EDSS6.0-7.5]) and age (young/middle-aged [Age24-59] vs. old [Age60-65]), an attenuated adaptation was nevertheless observed for 6MWT in the most affected and vulnerable subgroups (i.e. SP + PP, EDSS6.0-7.5 and Age60-65). The significant improvements in walking capacity and upper extremity function persisted at six months follow-up but did not exceed anymore the thresholds regarded as clinically relevant. CONCLUSION: The results provide novel evidence that personalised inpatient MDR targeting physical function in MS patients elicits significant and clinically relevant improvements in physical function.

[Effective rehabilitation of hospitalized patients with multiple sclerosis]. / Rehabilitering under indlæggelse af patienter med multipel sklerose har effect.

Globally, the number of people suffering from multiple sclerosis (MS) is more than two million, and MS is characterized by increasing symptom development over time. The socio-economic costs are enormous. Therefore, effective management of MS is of great importance. Multidisciplinary rehabilitation (MR) seeks to prevent and stop loss of function and trains the patients to deal with symptoms and challenges that will arise in the future. Because there is a need for high-quality evidence of the effectiveness of MR, the MS hospitals in Denmark have initiated the largest study of its kind on MR.