Multiple Sclerosis Performance Test: Technical Development and Usability
Jane K Rhodes, David Schindler, Stephen M Rao, Fernando Venegas, Efrosini T Bruzik, Wendy Gabel, James R Williams, Glenn A Phillips, Colleen C Mullen, Jaime L Freiburger, Lyla Mourany, Christine Reece, Deborah M Miller, Francois Bethoux, Robert A Bermel, Lauren B Krupp, Ellen M Mowry, Jay Alberts, Richard A Rudick, Jane K Rhodes, David Schindler, Stephen M Rao, Fernando Venegas, Efrosini T Bruzik, Wendy Gabel, James R Williams, Glenn A Phillips, Colleen C Mullen, Jaime L Freiburger, Lyla Mourany, Christine Reece, Deborah M Miller, Francois Bethoux, Robert A Bermel, Lauren B Krupp, Ellen M Mowry, Jay Alberts, Richard A Rudick
Abstract
Introduction: In the clinic, the assessment of patients with multiple sclerosis (MS) is typically qualitative and non-standardized.
Objectives: To describe the MS Performance Test (MSPT), an iPad Air® 2 (Apple, Cupertino, CA, USA)-based neurological assessment platform allowing patients to input relevant information without the aid of a medical technician, creating a longitudinal, clinically meaningful, digital medical record. To report results from human factor (HF) and usability studies, and the initial large-scale implementation in a practice setting.
Methods: The HF study examined use-error patterns in small groups of MS patients and healthy controls (n = 14), the usability study assessed the effectiveness of patient interaction with the tool by patients with a range of MS disability (n = 60) in a clinical setting, and the implementation study deployed the MSPT across a diverse population of patients (n = 1000) in a large MS center for routine clinical care.
Results: MSPT assessments were completed by all users in the HF study; minor changes to design were recommended. In the usability study, 73% of patients with MS completed the MSPT, with an average administration time of 32 min; 85% described their experience with the tool as satisfactory. In the initial implementation for routine care, 84% of patients with MS completed the MSPT, with an average administration time of 28 min.
Conclusion: Patients with MS with varying disability levels completed the MSPT with minimal or no supervision, resulting in comprehensive, efficient, standardized, quantitative, clinically meaningful data collection as part of routine medical care, thus allowing for large-scale, real-world evidence generation.
Funding: Biogen.
Trial registration: NCT02664324.
Keywords: Digital assessment; Functional performance outcome measures; Multiple sclerosis; Multiple sclerosis functional composite; Neuro-QoL; Neurology; PerfOs.
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References
- Inusah S, Sormani MP, Cofield SS, et al. Assessing changes in relapse rates in multiple sclerosis. Mult Scler. 2010;16(12):1414–1421. doi: 10.1177/1352458510379246.
- Karabudak R, Dahdaleh M, Aljumah M, et al. Functional clinical outcomes in multiple sclerosis: current status and future prospects. Mult Scler Relat Disord. 2015;4(3):192–201. doi: 10.1016/j.msard.2015.03.004.
- Meyer-Moock S, Feng YS, Maeurer M, Dippel FW, Kohlmann T. Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. BMC Neurol. 2014;14:58. doi: 10.1186/1471-2377-14-58.
- Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278–286. doi: 10.1212/WNL.0000000000000560.
- Rudick RA, Cutter G, Reingold S. The multiple sclerosis functional composite: a new clinical outcome measure for multiple sclerosis trials. Mult Scler. 2002;8(5):359–365. doi: 10.1191/1352458502ms845oa.
- Ontaneda D, LaRocca N, Coetzee T, Rudick R, NMSS MSFC Task Force Revisiting the multiple sclerosis functional composite: proceedings from the National Multiple Sclerosis Society (NMSS) task force on clinical disability measures. Mult Scler. 2012;18(8):1074–1080. doi: 10.1177/1352458512451512.
- Balcer LJ, Raynowska J, Nolan R, et al. Validity of low-contrast letter acuity as a visual performance outcome measure for multiple sclerosis. Mult Scler. 2017;23(5):734–747. doi: 10.1177/1352458517690822.
- Rudick RA, Miller D, Bethoux F, et al. The Multiple Sclerosis Performance Test (MSPT): an iPad-based disability assessment tool. J Vis Exp. 2014;88:e51318.
- Motl RW, Cohen JA, Benedict R, et al. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017;23(5):704–710. doi: 10.1177/1352458517690823.
- Benedict RH, DeLuca J, Phillips G, et al. Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis. Mult Scler. 2017;23(5):721–733. doi: 10.1177/1352458517690821.
- Feys P, Lamers I, Francis G, et al. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017;23(5):711–720. doi: 10.1177/1352458517690824.
- National Multiple Sclerosis Society. Multiple sclerosis functional composite (MSFC) scoring and training manual, revised. 2001. . Accessed 18 Dec 2018.
- Rosato R, Testa S, Oggero A, Molinengo G, Bertolotto A. Quality of life and patient preferences: identification of subgroups of multiple sclerosis patients. Qual Life Res. 2015;24(9):2173–2182. doi: 10.1007/s11136-015-0952-4.
- Miller DM, Allen R. Quality of life in multiple sclerosis: determinants, measurement, and use in clinical practice. Curr Neurol Neurosci Rep. 2010;10(5):397–406. doi: 10.1007/s11910-010-0132-4.
- Smith A. Symbol digit modalities test. Los Angeles: Western Psychological Services; 1973.
- Rao SM, NMSS Cognitive Function Study Group . A manual for the brief repeatable batter of neuropsychological test in multiple sclerosis. New York: National Multiple Sclerosis Society; 1990.
- Baier ML, Cutter GR, Rudick RA, et al. Low-contrast letter acuity testing captures visual dysfunction in patients with multiple sclerosis. Neurology. 2005;64(6):992–995. doi: 10.1212/01.WNL.0000154521.40686.63.
- Kraft GH, Amtmann D, Bennett SE, et al. Assessment of upper extremity function in multiple sclerosis: review and opinion. Postgrad Med. 2014;126(5):102–108. doi: 10.3810/pgm.2014.09.2803.
- Kaufman M, Moyer D, Norton J. The significant change for the Timed 25-foot Walk in the multiple sclerosis functional composite. Mult Scler. 2000;6(4):286–290. doi: 10.1177/135245850000600411.
- Rao SM, Losinski G, Mourany L, et al. Processing speed test: validation of a self-administered, iPad®-based tool for screening cognitive dysfunction in a clinic setting. Mult Scler. 2017;23(14):1929–1937. doi: 10.1177/1352458516688955.
- Cella D, Lai JS, Nowinski CJ, et al. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012;78(23):1860–1867. doi: 10.1212/WNL.0b013e318258f744.
- Miller DM, Bethoux F, Victorson D, et al. Validating neuro-QoL short forms and targeted scales with people who have multiple sclerosis. Mult Scler. 2016;22(6):830–841. doi: 10.1177/1352458515599450.
- Cella D. Development and initial validation of patient-reported item banks for use in neurological research and practice. 2015. . Accessed 18 Dec 2018.
- International Organization for Standardization. ISO13485:2016: medical devices—quality management systems—requirements for regulatory purposes. 2016. . Accessed 18 Dec 2018.
- Svanaes D, Das A, Alos OA. The contextual nature of usability and its relevance to medical informatics. In: Andersen SK, Klein MCA, Schulz S, Aarts J, Mazzoleni MC, editors. eHealth beyond the horizon—get IT there. Clifton: IOS; 2008.
Source: PubMed
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