De Angelis Marcello, Lavorgna Luigi, Carotenuto Antonio, Petruzzo Martina, Lanzillo Roberta, Brescia Morra Vincenzo, Moccia Marcello
Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, 80138 Naples, Italy.
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", 81100 Naples, Italy.
J Clin Med. 2021 May 26;10(11):2328. doi: 10.3390/jcm10112328.
Clinical trials in multiple sclerosis (MS) have been including digital technology tools to overcome limitations in treatment delivery and disease monitoring. In March 2020, we conducted a systematic search on pubmed.gov and clinicaltrials.gov databases (with no restrictions) to identify all relevant published and unpublished clinical trials, in English language, including MS patients, in which digital technology was applied. We used "multiple sclerosis" and "clinical trial" as the main search words, and "app", "digital", "electronic", "internet" and "mobile" as additional search words, separately. Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Digital technology has been used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms (e.g., electronic recording of motor performance). Other clinical trials have been using digital technology for monitoring symptoms that would be otherwise difficult to detect (e.g., fatigue, balance), for measuring treatment adherence and side effects, and for self-assessment purposes. Collection of outcome measures is progressively shifting from paper-based on site, to internet-based on site, and, in the future, to internet-based at home, with the detection of clinical and treatment features that would have remained otherwise invisible. Similarly, remote interventions provide new possibilities of motor and cognitive rehabilitation.
多发性硬化症(MS)的临床试验一直在纳入数字技术工具,以克服治疗实施和疾病监测方面的局限性。2020年3月,我们在pubmed.gov和clinicaltrials.gov数据库上进行了无限制的系统检索,以识别所有以英文发表的和未发表的、纳入MS患者且应用了数字技术的相关临床试验。我们分别使用“多发性硬化症”和“临床试验”作为主要检索词,以及“应用程序”“数字”“电子”“互联网”和“移动”作为附加检索词。数字技术是临床试验干预措施的一部分,用于提供心理治疗和运动康复,包括健身游戏、电子训练和机器人辅助锻炼。数字技术已被用于标准化先前存在的结局指标,实现自动采集、减少不一致性并改善症状检测(例如,运动表现的电子记录)。其他临床试验一直在使用数字技术来监测难以检测的症状(例如,疲劳、平衡),测量治疗依从性和副作用,并用于自我评估。结局指标的收集正逐渐从现场纸质方式,转变为现场基于互联网的方式,未来还将转变为在家基于互联网的方式,从而发现原本可能无法察觉的临床和治疗特征。同样,远程干预为运动和认知康复提供了新的可能性。