MSCopilot, a new multiple sclerosis self-assessment digital solution: results of a comparative study versus standard tests

被引:42
作者
Maillart, E. [1 ]
Labauge, P. [2 ]
Cohen, M. [3 ]
Maarouf, A. [4 ,5 ]
Vukusic, S. [6 ,7 ,8 ]
Donze, C. [9 ]
Gallien, P. [10 ]
De Seze, J. [11 ]
Bourre, B. [12 ]
Moreau, T. [13 ]
Louapre, C. [1 ]
Mayran, P. [14 ]
Bieuvelet, S. [15 ]
Vallee, M. [15 ]
Bertillot, F. [15 ]
Klaeyle, L. [15 ]
Argoud, A-L [15 ]
Zinai, S. [15 ]
Tourbah, A. [16 ,17 ,18 ]
机构
[1] Hop La Pitie Salpetriere, Dept Neurol, Paris, France
[2] Montpellier Univ Hosp, Dept Neurol, Montpellier, France
[3] Nice Univ Hosp, Dept Neurol, Nice, France
[4] Aix Marseille Univ, AP HM, CRMBM, CNRS, Marseille, France
[5] Pole Neurosci Clin, Marseille, France
[6] Hosp Civils Lyon, Dept Neurol, Bron, France
[7] Univ Lyon 1, INSERM 1028, Lyon, France
[8] Univ Lyon 1, CNRS UMR 5292, Lyon, France
[9] Grp Hosp Inst Catholique Lille, Dept Phys & Rehabil Med, Lille, France
[10] Pole St Helier, Phys Rehabil Med, Rennes, France
[11] Strasbourg Univ, Dept Neurol, Hop Civil, Strasbourg, France
[12] Rouen Univ Hosp, Dept Neurol, Rouen, France
[13] Dijon Univ Hosp, Dept Neurol, Dijon, France
[14] PM St, Garches, France
[15] Hop La Pitie Salpetriere, Brain & Spine Inst ICM, Ad Scientiam, Paris, France
[16] Reims Univ Hosp, Dept Neurol, URCA, Reims, France
[17] 2027 Paris 8 Univ, LPN EA, St Denis, Reunion, France
[18] Univ Versailles St Quentin En Yvelines, Serv Neurol, Paris Saclay, Hop Univ Paris Ile de France Guest,AP HP, Paris, France
关键词
eHealth; health information technology; mobile application; multiple sclerosis; Multiple Sclerosis Functional Composite (MSFC); reliability; smartphone app; validity; FUNCTIONAL COMPOSITE; OUTCOME MEASURES; EQUIVALENCE;
D O I
10.1111/ene.14091
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background and purpose Assessing patients' disability in multiple sclerosis (MS) requires time-consuming batteries of hospital tests. MSCopilot is a software medical device for the self-assessment of patients with MS (PwMS), combining four tests: walking, dexterity, cognition and low contrast vision. The objective was to validate MSCopilot versus the Multiple Sclerosis Functional Composite (MSFC). Methods This multicentre, open-label, randomized, controlled, crossover study enrolled 141 PwMS and 76 healthy controls (HCs). All participants performed MSCopilot and MSFC tests at day 0. To assess reproducibility, 46 PwMS performed the same tests at day 30 +/- 3. The primary end-point was the validation of MSCopilot versus MSFC for the identification of PwMS against HCs, quantified using the area under the curve (AUC). The main secondary end-point was the correlation of MSCopilot z-scores with MSFC z-scores. Results In all, 116 PwMS and 69 HCs were analysed. The primary end-point was achieved: MSCopilot performance was non-inferior to that of MSFC (AUC 0.92 and 0.89 respectively; P = 0.3). MSCopilot and MSFC discriminated PwMS and HCs with 81% and 76% sensitivity and 82% and 88% specificity respectively. Digital and standard test scores were highly correlated (r = 0.81; P < 0.001). The test-retest study demonstrated the good reproducibility of MSCopilot. Conclusion This study confirms the reliability of MSCopilot and its usability in clinical practice for the monitoring of MS-related disability.
引用
收藏
页码:429 / 436
页数:8
相关论文
共 18 条
[1]   Disability outcome measures in multiple sclerosis clinical trials: current status and future prospects [J].
Cohen, Jeffrey A. ;
Reingold, Stephen C. ;
Polman, Chris H. ;
Wolinsky, Jerry S. .
LANCET NEUROLOGY, 2012, 11 (05) :467-476
[2]   Development of a multiple sclerosis functional composite as a clinical trial outcome measure [J].
Cutter, GR ;
Baier, ML ;
Rudick, RA ;
Cookfair, DL ;
Fischer, JS ;
Petkau, J ;
Syndulko, K ;
Weinshenker, BG ;
Antel, JP ;
Confavreux, C ;
Ellison, GW ;
Lublin, F ;
Miller, AE ;
Rao, SM ;
Reingold, S ;
Thompson, A ;
Willoughby, E .
BRAIN, 1999, 122 :871-882
[3]   Psychometrics and normative data for the Multiple Sclerosis Functional Composite: replacing the PASAT with the Symbol Digit Modalities Test [J].
Drake, A. S. ;
Weinstock-Guttman, B. ;
Morrow, S. A. ;
Hojnacki, D. ;
Munschauer, F. E. ;
Benedict, R. H. B. .
MULTIPLE SCLEROSIS JOURNAL, 2010, 16 (02) :228-237
[4]  
*EUR MED AG COMM M, 2015, EMACHMP7718152011
[5]   The Multiple Sclerosis Functional Composite measure (MSFC): an integrated approach to MS clinical outcome assessment [J].
Fischer, JS ;
Rudick, RA ;
Cutter, GR ;
Reingold, SC .
MULTIPLE SCLEROSIS JOURNAL, 1999, 5 (04) :244-250
[6]   Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: A meta-analytic review [J].
Gwaltney, Chad J. ;
Shields, Alan L. ;
Shiffman, Saul .
VALUE IN HEALTH, 2008, 11 (02) :322-333
[7]   e-Health and multiple sclerosis: An update [J].
Lavorgna, Luigi ;
Brigo, Francesco ;
Moccia, Marcello ;
Leocani, Letizia ;
Lanzillo, Roberta ;
Clerico, Marinella ;
Abbadessa, Gianmarco ;
Schmierer, Klaus ;
Solaro, Claudio ;
Prosperini, Luca ;
Tedeschi, Gioacchino ;
Giovannoni, Gavin ;
Bonavita, Simona .
MULTIPLE SCLEROSIS JOURNAL, 2018, 24 (13) :1657-1664
[8]   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 [J].
Meyer-Moock, Sandra ;
Feng, You-Shan ;
Maeurer, Mathias ;
Dippel, Franz-Werner ;
Kohlmann, Thomas .
BMC NEUROLOGY, 2014, 14
[9]   ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis [J].
Montalban, X. ;
Gold, R. ;
Thompson, A. J. ;
Otero-Romero, S. ;
Amato, M. P. ;
Chandraratna, D. ;
Clanet, M. ;
Comi, G. ;
Derfuss, T. ;
Fazekas, F. ;
Hartung, H. P. ;
Havrdova, E. ;
Hemmer, B. ;
Kappos, L. ;
Liblau, R. ;
Lubetzki, C. ;
Marcus, E. ;
Miller, D. H. ;
Olsson, T. ;
Pilling, S. ;
Selmaj, K. ;
Siva, A. ;
Sorensen, P. S. ;
Sormani, M. P. ;
Thalheim, C. ;
Wiendl, H. ;
Zipp, F. .
EUROPEAN JOURNAL OF NEUROLOGY, 2018, 25 (02) :215-237
[10]  
MONTALBAN X, 2018, FLOODLIGHT SMARTPHON, pP624