Rist Cassie, Karlsson Niklas, Necander Sofia, Da Silva Carla A
Clinical Development, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Patient Centered Science, Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
ERJ Open Res. 2022 Mar 14;8(1). doi: 10.1183/23120541.00541-2021. eCollection 2022 Jan.
Physical activity contributes to improving respiratory symptoms. However, validated end-points are few, and there is limited consensus about what is a clinically meaningful improvement for patients. This review summarises the evidence to date on the range of physical activity end-points used in COPD, asthma and idiopathic pulmonary fibrosis (IPF) whilst evaluating their appropriateness as end-points in trials and their relation to patients' everyday life.
Trials reporting physical activity end-points were collected using Citeline's database Trialtrove; this was supplemented by searches in PubMed.
The daily-patient-reported outcome (PRO)active and clinical visit-PROactive physical activity composite end-points appeared superior at capturing the full experience of physical activity in patients with COPD and were responsive to bronchodilator intervention. Time spent in moderate-to-vigorous physical activity is a recently validated end-point for IPF that correlates with exercise capacity and quality of life. Step count appears the best available physical activity measure for asthma, which consistently declines with worse disease status. However, evidence suggests a time lag before significant improvement in step count is seen which may reflect the impact of human behaviour on physical activity.
Physical activity represents a challenging domain to accurately measure. This is the first review evaluating physical activity measures used specifically within the respiratory field. Whilst physical activity can be effectively captured using PROactive in patients with COPD, this review highlights the unmet need for novel patient-focused end-points in asthma and IPF which would offer opportunities to develop efficacious medicines with impact on patients' therapeutic care and quality of life.
体育活动有助于改善呼吸症状。然而,经过验证的终点指标很少,对于什么是对患者具有临床意义的改善,人们的共识有限。本综述总结了迄今为止关于慢性阻塞性肺疾病(COPD)、哮喘和特发性肺纤维化(IPF)中使用的体育活动终点指标范围的证据,同时评估了它们作为试验终点指标的适用性及其与患者日常生活的关系。
使用Citeline的Trialtrove数据库收集报告体育活动终点指标的试验;通过在PubMed中进行检索对其进行补充。
每日患者报告结局(PRO)主动和临床访视-PRO主动体育活动综合终点指标在捕捉COPD患者的完整体育活动体验方面似乎更具优势,并且对支气管扩张剂干预有反应。中度至剧烈体育活动所花费的时间是IPF最近验证的一个终点指标,它与运动能力和生活质量相关。步数似乎是哮喘现有的最佳体育活动测量指标,随着疾病状况恶化,步数持续下降。然而,有证据表明,步数出现显著改善之前存在时间滞后,这可能反映了人类行为对体育活动的影响。
体育活动是一个难以准确测量的领域。这是第一篇评估专门在呼吸领域使用的体育活动测量指标的综述。虽然使用PRO主动可以有效地捕捉COPD患者的体育活动情况,但本综述强调了哮喘和IPF中以患者为中心的新型终点指标的未满足需求,这将为开发对患者治疗护理和生活质量有影响的有效药物提供机会。