Validation of the Finnish version of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and evaluation of the applicability of the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) and the Fatigue Scale for Motor and Cognitive Functions (FSMC)

Objectives Cognitive impairment is frequent in multiple sclerosis (MS) as approximately half of the patients manifest some degree of cognitive impairment. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) has been designed for brief cognitive evaluation. The purpose of the study was to validate the BICAMS along with the Finnish versions of one self-rating questionnaire each for cognition and fatigue.Methods A total of 65 MS patients and 45 healthy controls (HC) were assessed with the BICAMS, the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), and the Fatigue Scale for Motor and Cognitive Functions (FSMC) twice, approximately within nine days.Results MS patients scored markedly lower than the HCs on each of the three tests of the BICAMS. Of the patients, 60% scored at least 1.5 SD below the mean of the HCs on at least one test; 49% on the SDMT, 26% on the CVLT-II, and 28% on the BVMT-R. Correlation coefficients for the repeated measurement were between 0.75 and 0.89 for the three tests in the whole study sample. MS patients reported more cognitive symptoms and more fatigue than the HCs. Cronbach's alpha was 0.94 for the MSNQ and 0.98 for the FSMC. Correlation coefficient for the repeated measurement was 0.91 for the MSNQ and between 0.92 and 0.94 for the FSMC scores for the whole study sample.Conclusions The present study supports the validity of the Finnish version of the BICAMS. The SDMT was the most sensitive of the three BICAMS tests and showed cognitive impairment in half of the patients. The Finnish versions of the MSNQ and the FSMC proved useful tools in approaching concerns related to cognition and fatigue

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

Introduction Cost assessment modelling (CAM) of treatments in highly active relapsing multiple sclerosis was conducted. Methods The CAM was developed using the R programming language. The PICOSTEPS health technology assessment framework was applied in the CAM. Modelled patients were 280 adults with highly active relapsing multiple sclerosis eligible for disease-modifying treatment. Intervention was cladribine tablets, a new and reimbursed oral treatment for highly active relapsing multiple sclerosis in Finland. Comparators included fingolimod, the most used oral reimbursed treatment for the highly active disease, and natalizumab, the most used intravenous treatment, and a treatment mix (80% use fingolimod, 20% use natalizumab) in Finland. Outcomes presented expected annual and cumulative drug-associated costs in the overall population and per patient. Setting was modelled public specialist care in Finland. Time was set to 4 years, without discounting. Effects covered expected drug-associated costs (screening, acquisition, administration, monitoring, adverse events, travelling, productivity). Perspective was a limited societal perspective. Sensitivity analyses regarding all PICOSTEPS components were conducted. Results Cladribine tablets were projected to be cost saving in comparison to fingolimod, natalizumab and treatment mix. The respective modelled savings were euro4,598,742, euro16,249,701 and euro6,928,934 in the overall population, and euro16,424, euro58,035 and euro24,746 per patient, respectively, during the 4 years. The most important cost driver was drug costs, representing 96.3%, 96.0% and 83.4% of modelled costs associated with cladribine tablets, fingolimod and natalizumab, respectively. Cladribine tablets sustained their affordability in the sensitivity analyses. From the perspective of health care payer, cladribine tablets' savings were projected to be euro4,514,509, euro15,145,366 and euro6,640,680 in the overall population, and euro16,123, euro54,091 and euro23,717 per patient in comparison to fingolimod, natalizumab and treatment mix, respectively. Conclusion Based on the CAM, cladribine tablets were projected to robustly save modelled drug-associated costs in comparison to fingolimod, natalizumab and their mix in Finland.Peer reviewe

MS-tauti ja kognitiivinen toimintakyky

MS-taudin kognitiivisia oireita käsittelevä tutkimus on lisääntynyt eksponentiaalisesti 30 viime vuoden aikana. Kognitiiviset oireet tunnistetaan nykyään MS-taudin ydinoireiksi. Kognitiivisia häiriöitä, joista tyypillisimpiä ovat tiedonkäsittelyn hidastuminen ja muistivaikeudet, esiintyy arviolta joka toisella MS-tautia sairastavalla. Häiriöt voivat vaikuttaa laajasti potilaan elämänlaatuun. Tulevaisuudessa oireiden systemaattinen seuranta jo sairastumisen varhaisvaiheesta lähtien saattaisi auttaa hyödyntämään kognitiivista toimintakykyä sairauden etenemisen ja hoidon tehon seurannassa. Hyvä aivoterveys ja aktiivinen kognitiivisen toimintakyvyn käyttö todennäköisesti hidastavat oireiden ilmaantumista. Kognitiivisten häiriöiden kuntoutuksessa tarvitaan holistista otetta sekä monimuotoisten kuntoutusmenetelmien hyödyntämistä.</p

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

Introduction Cost assessment modelling (CAM) of treatments in highly active relapsing multiple sclerosis was conducted. Methods The CAM was developed using the R programming language. The PICOSTEPS health technology assessment framework was applied in the CAM. Modelled patients were 280 adults with highly active relapsing multiple sclerosis eligible for disease-modifying treatment. Intervention was cladribine tablets, a new and reimbursed oral treatment for highly active relapsing multiple sclerosis in Finland. Comparators included fingolimod, the most used oral reimbursed treatment for the highly active disease, and natalizumab, the most used intravenous treatment, and a treatment mix (80% use fingolimod, 20% use natalizumab) in Finland. Outcomes presented expected annual and cumulative drug-associated costs in the overall population and per patient. Setting was modelled public specialist care in Finland. Time was set to 4 years, without discounting. Effects covered expected drug-associated costs (screening, acquisition, administration, monitoring, adverse events, travelling, productivity). Perspective was a limited societal perspective. Sensitivity analyses regarding all PICOSTEPS components were conducted. Results Cladribine tablets were projected to be cost saving in comparison to fingolimod, natalizumab and treatment mix. The respective modelled savings were euro4,598,742, euro16,249,701 and euro6,928,934 in the overall population, and euro16,424, euro58,035 and euro24,746 per patient, respectively, during the 4 years. The most important cost driver was drug costs, representing 96.3%, 96.0% and 83.4% of modelled costs associated with cladribine tablets, fingolimod and natalizumab, respectively. Cladribine tablets sustained their affordability in the sensitivity analyses. From the perspective of health care payer, cladribine tablets' savings were projected to be euro4,514,509, euro15,145,366 and euro6,640,680 in the overall population, and euro16,123, euro54,091 and euro23,717 per patient in comparison to fingolimod, natalizumab and treatment mix, respectively. Conclusion Based on the CAM, cladribine tablets were projected to robustly save modelled drug-associated costs in comparison to fingolimod, natalizumab and their mix in Finland

MS-taudin diagnoosi, lääkehoito ja kuntoutus

Mitä uutta päivityksessä? MS-taudin lääkehoito aloitetaan heti McDonaldin diagnostisten kriteereiden täytyttyä. Henkilöitä, joilla todetaan kliinisesti eriytynyt oireyhtymä (KEO) ja suurentunut riski saada MS-tauti (MS-tautiin sopivia muutoksia magneettikuvauksissa (MK) ja selkäydinnesteessä), seurataan MK:lla 3-6 kuukauden välein vuoden ajan ensimmäisestä kuvauksesta. Akuutti pahenemisvaihe hoidetaan suonensisäisellä tai suun kautta otettavalla jättiannoksisella kortikosteroidilla. Ensisijainen lääkehoito on beetainterferoni tai glatirameeriasetaatti. Beetainterferonihoidossa olevilta mitataan 12 ja 24 kuukauden kuluttua hoidon aloituksesta MxA-vaste. Jos vaste puuttuu toistetuissa määrityksissä, hoitoa on vaihdettava, ja mikäli vaste on vähäinen, mittaus toistetaan. Beetainterferoni- tai glatirameeriasetaattihoidosta huolimatta aktiivisen MS-taudin toissijainen lääkehoito on natalitsumabi. Immunomoduloiva hoito lopetetaan, mikäli tauti muuttuu toissijaisesti eteneväksi eikä ole enää immunologisesti aktiivinen. English summary: Update on Current Care guidelines: Diagnostics, treatment and rehabilitation of multiple sclerosis Treatment is initiated when the McDonald criteria for relapsing-remitting multiple sclerosis (RRMS) are fulfilled. High-risk patients with clinically isolated syndrome are followed using magnetic resonance imaging for one year after the first imaging. Interferon-β or glatiramer acetate are the first-line immunomodulating drugs (IMD) for RRMS. MxA protein is measured 12 and 24 months after initiation of Interferon-β to evaluate possible development of neutralizing antibodies. If MxA protein may not be detected repeatedly interferon-β treatment is discontinued. If the disease is active in spite of treatment with first-line IMD, natalizumab may be considered as a second-line therapy. IMD is stopped when the transition to secondary progressive phase has occurred (or upon transition to secondary progressive phase)

Research on lower extremity health in patients with multiple sclerosis: a scoping review

Background: Multiple sclerosis (MS) often affects ambulation and the function of the lower limbs. However, little is known about how much research has been conducted on lower extremity health in patients with MS.Objective: To analyse empirical studies and their evidence on lower extremity health in patients with MS, in order to identify the need for future studies in key areas.Methods: A systematic scoping review was conducted. A literature search of Medline (PubMed), CINAHL (EBSCO) and the Cochrane Library databases was performed. The search covered the period up to 15 January 2020 from the earliest records available. This led to the inclusion of 42 empirical articles. The data were analysed using content analysis and quantification techniques.Results: The research on lower extremity health focused primarily on two main areas: gait and lower extremity muscle strength. Lower extremity health was assessed using a variety of methods, most of which consisted of objective physical tests and gait analysis. Patients with MS had many problems with the health of their lower extremities, which manifested in walking difficulties, balance problems, muscle weaknesses and spasticity. In the feet, pes cavus, claw toes, oedema and altered foot sensation were common.Conclusions: MS affects lower limb and foot health, and these problems can affect patients' daily lives. However, the extent of these problems is poorly understood, partly due to the dearth of research on lower limb and foot health. Therefore, further research is warranted in order to better understand the impact of MS on foot and lower limb health in everyday life.</p

The activities and participation categories of the ICF Core Sets for multiple sclerosis from the patient perspective

Purpose: To validate the activities and participation components of The International Classification of Functioning, Disability and Health (ICF). Methods: In this cross-sectional study, 113 Finnish community-dwelling persons with MS were assessed using a semi-structured interview provided by the Canadian Occupational Performance Measure (COPM) to capture participants’ self-perceived problems in everyday activities and participation. Problems were linked to the ICF categories. Results: Participants identified 527 of the most important occupational performance problems. They covered all chapters of the ICF Activities and Participation components. Forty-one categories out of a total 53 ICF activities and participation categories of the Comprehensive ICF Core Set and four out of five categories of the Brief ICF Core Set were reported on by the participants. The most common category in this sample, ‘d920 Recreation and leisure’ (145 problems/27.5%), is not included in the Brief ICF Core Set. Conclusions: Most, but not all, ICF activities and participation categories of the ICF Core Sets for MS could be confirmed from the perspective of persons with MS. It is worth considering to add category ‘d920 Recreation and leisure’ to the Brief ICF Core Set.peerReviewe

Validity and reliability of the Fatigue Severity Scale in Finnish multiple sclerosis patients

BackgroundFatigue is one of the most debilitating symptoms in multiple sclerosis (MS) considerably interfering with patients’ daily functioning. Both researchers and clinicians need psychometrically robust methods to evaluate fatigue in MS.ObjectivesThe objective of this study was (i) to evaluate the psychometric properties of the Finnish version of the Fatigue Severity Scale (FSS) and (ii) to describe the results among patients with MS.MethodsIn total, 553 patients with MS (mean age, 53.8 years; standard deviation [SD], 11.4; 79% women: mean patient-defined disease severity, Expanded Disability Status Scale [EDSS] 4.0, SD, 2.5) completed the self-administered questionnaires including the FSS. A standard procedure was used for the translation of the FSS.ResultsThe mean (SD) score for the FSS was 4.5 (1.7); in 65% of the patients, the score was ≥4.0. The data quality of the FSS was excellent, with 99.6% of computable scale scores. Floor and ceiling effects were minimal. The FSS showed high internal consistency (Cronbach's alpha, 0.95). Unidimensionality was supported based on confirmatory factor analysis with the comparative fit index being 0.94. The FSS showed moderate/high correlations with the perceived burden of the disease, quality of life and disease severity, whereas, age or gender did not have a significant effect on the FSS score.ConclusionsThe Finnish version of the FSS showed satisfactory reliability and validity and thus can be regarded as a feasible measure of self-reported fatigue.</div

Psychometric evaluation of the Finnish version of the impact on participation and autonomy questionnaire in persons with multiple sclerosis

Objective: The objective of this study was to evaluate the psychometric properties of the impact on participation and autonomy (IPA) questionnaire. The Finnish version of IPA (IPAFin) was translated into Finnish using the protocol for linguistic validation for patient-reported outcomes instruments. Methods: A total of 194 persons with multiple sclerosis (MS) (mean age 50 years SD 9, 72% female) with moderate to severe disability participated in this study. A confirmatory factor analysis (CFA) was used to confirm the four factor structure of the IPAFin. The work and educational opportunities domain was excluded from analysis, because it was only applicable to 51 persons. Internal consistency was investigated by calculating Cronbach’s alpha. Results: CFA confirmed the construct validity of the IPA (standardized root mean square residual (SRMR) = 0.06, comparative fit index (CFI) = 0.93, Tucker–Lewis index =0.93, root mean square error of approximation (RMSEA) = 0.06), indicating a good fit to the model. There was no difference in the models for females and males. Cronbach’s alpha for the domains ranged between 0.80 and 0.91, indicating good homogeneity. Conclusions: The construct validity and reliability of the IPAFin is acceptable. IPAFin is a suitable measure of participation in persons with MS.peerReviewe