在炎症性关节炎的临床试验中,利用数字医疗技术加强以患者为中心的结果评估。

IF 15 1区 医学 Q1 RHEUMATOLOGY Lancet Rheumatology Pub Date : 2024-07-29 DOI:10.1016/S2665-9913(24)00186-3
Dylan McGagh, Kaiyang Song, Hang Yuan, Andrew P Creagh, Sally Fenton, Wan-Fai Ng, Jennifer C Goldsack, William G Dixon, Aiden Doherty, Laura C Coates
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引用次数: 0

摘要

所有炎症性关节炎(即类风湿性关节炎、银屑病关节炎、轴性脊柱关节炎和幼年特发性关节炎)的共同点是活动能力下降,表现为关节疼痛、肿胀、僵硬,最终导致关节损伤。在这些疾病中,人们已经达成共识,认为有必要在随机对照试验中将与活动能力相关的结果(如功能能力和体力活动)作为核心领域。这些核心领域中的现有终点完全依赖于自我报告问卷,这些问卷记录了患者对其症状和活动的看法。这些问卷都是主观性的,很容易受到回忆偏差的影响,而且无法捕捉到随时间变化的细微差别。在针对帕金森病、杜氏肌肉萎缩症、慢性阻塞性肺病和心力衰竭等疾病的随机对照试验中,一些早期采用者已经整合了基于传感器的数字健康技术(DHT)得出的终点来测量身体功能和活动。尽管有这些应用,但在招募炎症性关节炎患者的临床试验中,还没有基于传感器的 DHT 衍生终点。借鉴医学界的案例研究,我们概述了开发基于传感器的新型 DHT 衍生终点的机遇和挑战,这些终点能捕捉到与炎症性关节炎患者最相关的症状和疾病表现。
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Digital health technologies to strengthen patient-centred outcome assessment in clinical trials in inflammatory arthritis.

Common to all inflammatory arthritides, namely rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and juvenile idiopathic arthritis, is a potential for reduced mobility that manifests through joint pain, swelling, stiffness, and ultimately joint damage. Across these conditions, consensus has been reached on the need to capture outcomes related to mobility, such as functional capacity and physical activity, as core domains in randomised controlled trials. Existing endpoints within these core domains rely wholly on self-reported questionnaires that capture patients' perceptions of their symptoms and activities. These questionnaires are subjective, inherently vulnerable to recall bias, and do not capture the granularity of fluctuations over time. Several early adopters have integrated sensor-based digital health technology (DHT)-derived endpoints to measure physical function and activity in randomised controlled trials for conditions including Parkinson's disease, Duchenne's muscular dystrophy, chronic obstructive pulmonary disease, and heart failure. Despite these applications, there have been no sensor-based DHT-derived endpoints in clinical trials recruiting patients with inflammatory arthritis. Borrowing from case studies across medicine, we outline the opportunities and challenges in developing novel sensor-based DHT-derived endpoints that capture the symptoms and disease manifestations most relevant to patients with inflammatory arthritis.

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来源期刊
Lancet Rheumatology
Lancet Rheumatology RHEUMATOLOGY-
CiteScore
34.70
自引率
3.10%
发文量
279
期刊介绍: The Lancet Rheumatology, an independent journal, is dedicated to publishing content relevant to rheumatology specialists worldwide. It focuses on studies that advance clinical practice, challenge existing norms, and advocate for changes in health policy. The journal covers clinical research, particularly clinical trials, expert reviews, and thought-provoking commentary on the diagnosis, classification, management, and prevention of rheumatic diseases, including arthritis, musculoskeletal disorders, connective tissue diseases, and immune system disorders. Additionally, it publishes high-quality translational studies supported by robust clinical data, prioritizing those that identify potential new therapeutic targets, advance precision medicine efforts, or directly contribute to future clinical trials. With its strong clinical orientation, The Lancet Rheumatology serves as an independent voice for the rheumatology community, advocating strongly for the enhancement of patients' lives affected by rheumatic diseases worldwide.
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