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.
