Patients’ perspectives on a drug safety monitoring system for immune-mediated inflammatory diseases based on patient-reported outcomes

Patient-reported outcomes (PROs) on adverse drug reactions (ADRs) are increasingly used in cohort event monitoring (CEM) to obtain a better understanding of patients’ real-world experience with drugs. Despite the leading role for patients, little is known about their perspectives on CEM systems. In a cross-sectional open survey following the rationale of the Technology Acceptance Model, we aimed to obtain insight in patients’ perspectives on the perceived usefulness, ease of use and attitude toward using a PRO-based drug safety monitoring system for ADRs attributed to biologics. Patients considered structural reporting of ADRs in web-based questionnaires as useful and not burdensome. It was preferred to link the questionnaire frequency to regular hospital consultations or the biologic administration schedule. Various respondents were interested in sharing questionnaires with their medical specialist (49.0%) or pharmacist (34.2%), and suggested to minimize the questionnaire frequency in case of an unaltered situation or absence of ADRs. Patients’ perspectives should be considered in the setup of PRO-based CEM studies, as this contributes to data quality and patient centeredness. Since incorporation of patients’ perspectives in CEM studies is indispensable, a delicate balance should be found between user-friendliness and study aims.

患者报告的药物不良反应（ADRs）结果在队列事件监测（CEM）中的应用日益广泛，旨在更深入地理解患者对药物在真实世界中的使用体验。尽管患者在其中扮演着主导角色，但对其在CEM系统中的观点知之甚少。遵循技术接受模型的理念，我们通过一项横断面开放式调查，旨在深入了解患者对基于患者报告结果（PRO）的药物安全性监测系统在生物制剂相关ADRs中的感知有用性、易用性以及态度。患者认为，在基于网络的问卷中结构化报告ADRs是有益且不具负担的。他们更倾向于将问卷的频率与常规医院咨询或生物制剂的给药计划相联系。不同的受访者表示有兴趣与他们的医疗专家（49.0%）或药剂师（34.2%）分享问卷，并建议在未发生变化或不存在ADRs的情况下尽量减少问卷的频率。在基于PRO的CEM研究的设置中，应考虑患者的观点，因为这有助于提升数据质量和以患者为中心的研究理念。鉴于在CEM研究中纳入患者的观点是不可或缺的，应在用户友好性与研究目标之间寻求一种微妙的平衡。