Outcome Measures in Multiple Sclerosis

Author(s):  
Robert M. Herndon

This chapter discusses the challenges involved in measuring disease activity and progression in multiple sclerosis and how different aspects of the disease are measured in clinical trials. Metrics have been developed to assess multiple aspects of the disease., These include, in addition to more global instruments, measures of specific functions such as, cognition, mobility, quality of life, fatigue, and so on. These scales are discussed along with their strengths and weaknesses.

2009 ◽  
Vol 36 (10) ◽  
pp. 2356-2361 ◽  
Author(s):  
DINESH KHANNA ◽  
OLIVER DISTLER ◽  
JEROME AVOUAC ◽  
FRANK BEHRENS ◽  
PHILIP J. CLEMENTS ◽  
...  

There have been steady efforts to develop a combined response index for systemic sclerosis (CRISS). A parallel and equally successful effort has been made by an Expert Panel on Outcome Measures in PAH related to Systemic Sclerosis (EPOSS) to measure effect in treatment of pulmonary arterial hypertension of systemic sclerosis (PAH-SSc). CRISS conducted a Delphi process combined with expert review to identify 11 candidate domains for inclusion in a core set of outcomes for SSc clinical trials: soluble biomarkers, cardiac, digital ulcers, gastrointestinal, global health, health related quality of life (HRQOL) and function, musculoskeletal, pulmonary, Raynaud’s, renal, and skin. Tools within domains were also agreed upon. Concentrating on one aspect of disease, PAH, EPOSS also conducted a Delphi process and judged the following domains as the most appropriate for randomized controlled trials in PAH-SSc: lung vascular/pulmonary arterial pressure, cardiac function, exercise testing; severity of dyspnea, discontinuation of treatment; quality of life/activities of daily living; global state; and survival. Possible useful tools within each domain were also agreed on. Patient derived, physician derived, and objective measures of response will be included and combined with the idea that each reflects different aspects of PAH (EPOSS) and overall disease (CRISS) although this assumption may not prove true and can be separated if statistically and clinically valid to do so. In either case, prospective studies will require measurement of all domains, and tools are required and will be developed to define appropriate combined measures of response. CRISS and EPOSS are being developed through the OMERACT process. Through Delphi process and literature review significant progress has been made for both indices, and prospective data are being collected.


Medicines ◽  
2019 ◽  
Vol 6 (3) ◽  
pp. 95 ◽  
Author(s):  
Christina Tryfonos ◽  
Maria Mantzorou ◽  
Dimitris Fotiou ◽  
Michael Vrizas ◽  
Konstantinos Vadikolias ◽  
...  

Background: Multiple sclerosis (MS) constitutes a chronic progressive demyelinating disease which negatively affects the central nervous system. MS symptoms detrimentally affect the quality of life, as well as the life expectancy of MS patients. In this aspect, the present study aims to critically summarize and evaluate the currently available clinical studies focusing on the potential beneficial effects of dietary supplements on controlling MS symptomatology and relapse. Methods: PubMed database was comprehensively searched, using relative keywords to identify clinical trials that investigated the beneficial effects of dietary supplementation against MS symptomatology and progression. 40 clinical trials were found, which were divided into categories. Results: Nutritional status of MS patients, as well as supplementation have been suggested as potential factors affecting progression. Several substantial studies have documented a systematically high prevalence of vitamin A, B12 and D3 deficiency amongst MS patients. At present, clinical data have suggested that most of the dietary supplements under study may exert antioxidant and anti-inflammatory properties, improving depression symptomatology and quality of life overall. However, malnutrition risk in MS patients has not been adequately explored in order for more precise conclusions to be drawn. The supplements that may have a positive effect on MS are vitamins, fatty acids, antioxidants, phytochemicals and melatonin. Conclusions: Several dietary supplements may decrease inflammation and fatigue, also increasing also autoimmunity tolerance in MS patients, and thus improving quality of life and life expectancy. Currently, there is no effective clinical indication for applying dietary supplementation as complementary treatment against MS symptomatology.


2013 ◽  
Vol 123 (11) ◽  
pp. 792-801 ◽  
Author(s):  
George A. Jelinek ◽  
Emily J. Hadgkiss ◽  
Tracey J. Weiland ◽  
Naresh G. Pereira ◽  
Claudia H. Marck ◽  
...  

2003 ◽  
Vol 9 (4) ◽  
pp. 411-419 ◽  
Author(s):  
A Riazi ◽  
J C Hobart ◽  
D L Lamping ◽  
R Fitzpatrick ◽  
A J Thompson

The selection of measures of quality of life used in clinical trials of multiple sclerosis (MS) should be evidence-based. Head-to -head comparison of measures facilitates the selection of measures. The aim of the study was to compare the psychometric properties of the physical and psychological dimensions in three measures of quality of life to aid choice of the most appropriate scale for use in clinical trials of MS. O ne hundred and twenty-one people with MS (rehabilitation =57; steroids =64) completed a selection of health measures before and after treatment. The psychometric properties of three measures of physical function (MSIS-29 physical, SF-36 physical functioning, FA MS mobility) and three measures of psychological function (MSIS-29 psychological, SF-36 mental health, FA MS emotional well-being) were compared by examining data quality, scaling assumptions, acceptability, reliability, validity and responsiveness. Physical (0.63- 0.71) and psychological (0.70-0.75) scales were substantially correlated indicating they measure related constructs. The MSIS-29 physical and psychological scales satisfied all criteria for internal consistency reliability (physical =0.91; psychological =0.89) and validity. The SF-36 physical scale had a notable floor effect (20%). The FA MS mobility scale had lower reliability (a=0.78) compared to other measures. The MSIS-29 physical (effect size=0.91) and psychological (effect size =0.62) scales were the most responsive. In these three samples, the MSIS-29 had better measurement properties for combined physical and psychological health than the SF-36 and the FA MS.


2015 ◽  
Vol 38 (5) ◽  
pp. 482-486 ◽  
Author(s):  
Mahdie Taheri ◽  
Hossein Negahban ◽  
Neda Mostafaee ◽  
Reza Salehi ◽  
Hamed Tabesh

Author(s):  
G. Chupryna

The research is dedicated to studying the clinical, neurophysiological, neuroimaging, neuropsychological, immunopathological manifestations of MS on the background of comorbid pathology, evaluation of complex treatment.The features of the manifestations of fatigue, depression, pain, cognitive impairment, sleep disorders in patients with MS based on comorbidity and impact of violations on the quality of life. On the basis of the study of risk factors, the analysis revealed the features of development of MS in conditions of comorbid pathology. Based on the factors studied, a pathogenetic model of the character of the effect of comorbidity on the course of MS with regard to prognostic signs for clinical, psychoemotional, neurophysiological and neuroimaging indicators has been created, and it is possible to individually assess the risk of development and progression of MS. Efficacy and comparative analysis of the use of complex (medicaments and non-medicaments) treatment was revealed, the frequency of exacerbations decreased and the effect on the course of the disease with MS taking into account the comorbid pathology and heterogeneity of clinical-neurological and psychoemotional disorders, clinical, neuropsychological, neuroimaging, neuroimaging signs of disease activity.


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