Heesen C, Haase R, Melzig S, Poettgen J, Berghoff M, Paul F, et al. Perceptions on the value of bodily functions in multiple sclerosis. Acta Neurol Scand. 2018;137:356–62.
Article CAS PubMed Google Scholar
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS walking scale (MSWS-12). Neurology. 2003;60:31–6.
Article CAS PubMed Google Scholar
Krieger SC, Cook K, De Nino S, Fletcher M. The topographical model of multiple sclerosis: a dynamic visualization of disease course. Neurol Neuroimmunol Neuroinflamm. 2016;3:e279.
Article PubMed PubMed Central Google Scholar
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983;33:1444–52.
Article CAS PubMed Google Scholar
Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008;14:383–90.
Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, et al. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017;23:704–10.
Article PubMed PubMed Central Google Scholar
Stellmann JP, Neuhaus A, Gotze N, Briken S, Lederer C, Schimpl M, et al. Ecological validity of walking capacity tests in multiple sclerosis. PLoS ONE. 2015;10:e0123822.
Article CAS PubMed PubMed Central Google Scholar
Gehr S, Kaiser T, Kreutz R, Ludwig W-D, Paul F. Suggestions for improving the design of clinical trials in multiple sclerosis-results of a systematic analysis of completed phase III trials. EPMA J. 2019;10:425–36.
Article PubMed PubMed Central Google Scholar
European Medicines Agency Committee For Medicinal Products For Human Use (CHMP), REFLECTION PAPER ON THE REGULATORY GUIDANCE FOR THE USE OF HEALTH-RELATED, QUALITY OF LIFE (HRQL) MEASURES IN THE EVALUATION OF MEDICINAL PRODUCTS [Internet]. 2005 [cited 2022 Mar 14]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-healthrelated-quality-life-hrql-measures-evaluation_en.pdf
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims [Internet]. 2009 [cited 2022 Mar 14]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims
Hohol MJ, Orav EJ, Weiner HL. Disease steps in multiple sclerosis: a simple approach to evaluate disease progression. Neurology. 1995;45:251–5.
Article CAS PubMed Google Scholar
Learmonth YC, Motl RW, Sandroff BM, Pula JH, Cadavid D. Validation of patient determined disease steps (PDDS) scale scores in persons with multiple sclerosis. BMC Neurol. 2013;13:37.
Article PubMed PubMed Central Google Scholar
Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10:589–95.
Article CAS PubMed Google Scholar
Kieseier BC, Pozzilli C. Assessing walking disability in multiple sclerosis. Mult Scler. 2012;18:914–24.
Engelhard MM, Patek SD, Lach JC, Goldman MD. Real-world walking in multiple sclerosis: separating capacity from behavior. Gait Posture. 2018;59:211–6.
Motl RW, Pilutti L, Sandroff BM, Dlugonski D, Sosnoff JJ, Pula JH. Accelerometry as a measure of walking behavior in multiple sclerosis. Acta Neurol Scand. 2013;127:384–90.
Article CAS PubMed Google Scholar
Motl RW, Snook EM. Confirmation and extension of the validity of the multiple sclerosis walking Scale-12 (MSWS-12). J Neurol Sci. 2008;268:69–73.
Pilutti LA, Dlugonski D, Sandroff BM, Suh Y, Pula JH, Sosnoff JJ, et al. Further validation of multiple sclerosis walking scale-12 scores based on spatiotemporal gait parameters. Arch Phys Med Rehabil. 2013;94:575–8.
Goldman MD, Ward MD, Motl RW, Jones DE, Pula JH, Cadavid D. Identification and validation of clinically meaningful benchmarks in the 12-item multiple sclerosis walking scale. Mult Scler. 2017;23:1405–14.
Baert I, Smedal T, Kalron A, Rasova K, Heric-Mansrud A, Ehling R, et al. Responsiveness and meaningful improvement of mobility measures following MS rehabilitation. Neurology. 2018;91:e1880–92.
Mehta L, McNeill M, Hobart J, Wyrwich KW, Poon J-L, Auguste P, et al. Identifying an important change estimate for the multiple sclerosis walking Scale-12 (MSWS-12v1) for interpreting clinical trial results. Mult Scler J Exp Transl Clin. 2015;1:2055217315596993.
PubMed PubMed Central Google Scholar
Hobart J, Ziemssen T, Feys P, Linnebank M, Goodman AD, Farrell R, et al. Assessment of clinically meaningful improvements in self-reported walking ability in participants with multiple sclerosis: results from the Randomized, Double-Blind, phase III ENHANCE trial of prolonged-release Fampridine. CNS Drugs. 2019;33:61–79.
Article CAS PubMed Google Scholar
Marzal-Alfaro MB, Martin Barbero ML, Garcia Dominguez J, Romero-Delgado F, Martinez Gines ML, Herranz A, et al. Impact of fampridine on quality of life: clinical benefit in real-world practice. Eur J Hosp Pharm. 2018;25:138–43.
Oveisgharan S, Karimi Z, Abdi S, Sikaroodi H. The use of brain stimulation in the rehabilitation of walking disability in patients with multiple sclerosis: a randomized double-blind clinical trial study. Iran J Neurol. 2019;18:57–63.
PubMed PubMed Central Google Scholar
Marangoni BEM, Pavan K, Tilbery CP. Cross-cultural adaptation and validation of the 12-item multiple sclerosis walking scale (MSWS-12) for the brazilian population. Arq Neuropsiquiatr. 2012;70:922–8.
Nakhostin Ansari N, Naghdi S, Mohammadi R, Hasson S. Multiple sclerosis walking Scale-12, translation, adaptation and validation for the persian language population. Gait Posture. 2015;41:420–4.
Solaro C, Trabucco E, Signori A, Cella M, Messmer Uccelli M, Brichetto G, et al. Italian validation of the 12-item multiple sclerosis walking scale. Mult Scler Int. 2015;2015:540828.
CAS PubMed PubMed Central Google Scholar
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000;25:3186–91.
Article CAS PubMed Google Scholar
Stellmann J-P, Neuhaus A, Lederer C, Daumer M, Heesen C. Validating predictors of disease progression in a large cohort of primary-progressive multiple sclerosis based on a systematic literature review. PLoS ONE. 2014;9:e92761.
Article PubMed PubMed Central Google Scholar
Heinrich I, Rosenthal F, Patra S, Schulz K-H, Welsch GH, Vettorazzi E, et al. Arm ergometry to improve mobility in progressive multiple sclerosis (AMBOS)-Results of a pilot randomized controlled trial. Front Neurol. 2021;12:644533.
Article PubMed PubMed Central Google Scholar
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17:162–73.
Terwee CB, Bot SDM, de Boer MR, van der Windt DAWM, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60:34–42.
Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: a systematic review of empirical tests. Soc Sci Med. 2022;292:114523.
Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, et al. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999;122(Pt 5):871–82.
Fischer JS, Rudick RA, Cutter GR, Reingold SC. The multiple sclerosis functional composite measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler. 1999;5:244–50.
Article CAS PubMed Google Scholar
McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995;4:293–307.
Article CAS PubMed Google Scholar
McGuigan C, Hutchinson M. Confirming the validity and responsiveness of the multiple sclerosis walking Scale-12 (MSWS-12). Neurology. 2004;62:2103–5.
Article CAS PubMed Google Scholar
Grobelny A, Behrens JR, Mertens S, Otte K, Mansow-Model S, Krüger T, et al. Maximum walking speed in multiple sclerosis assessed with visual perceptive computing. PLoS ONE. 2017;12:e0189281.
Article PubMed PubMed Central Google Scholar
Strzok S, Cleanthous S, Pompilus F, Cano SJ, Marquis P, Cohan S, et al. Development of a gait module to complement the 12-item multiple sclerosis walking scale: a mixed methods study. Mult Scler J Exp Transl Clin. 2018;4:2055217318783766.
Comments (0)