Patients’ and health-care professionals’ perspectives on adverse drug reaction burden attributed to the use of biological DMARDs: a qualitative study

Previous studies showed a discrepancy between health-care professionals’ (HCPs’) and patients’ perspective on adverse drug reaction (ADR) burden. However, it is unclear which factors make an ADR burdensome. We aimed to give insight into why ADRs are perceived as burdensome by inflammatory rheumatic disease (IRD) patients, and whether this differs from the HCPs’ perspective. A qualitative study was conducted using Dutch Biologic Monitor data. Participants received bimonthly questionnaires on experienced ADRs attributed to biological DMARDs and were asked to elaborate on ADR burden using a Likert-type scale and an open-ended question for clarification. Data of 440 IRD patients were analyzed following thematic analysis. A similar analysis was done with semi-structured interviews with 13 HCPs. We identified seven themes associated with ADR burden: ‘effect on medication prescription,’ ‘impact on appearance,’ ‘impact on autonomy,’ ‘impact on daily life,’ ‘psychological consequences,’ ‘distressing aspects of ADR,’ and ‘physical consequences.’ Identical themes were identified by HCPs, although they identified most subthemes in ‘psychological consequences,’ and less subthemes in ‘impact on daily life’ and ‘impact on autonomy.’ Patients describe perceived ADR burden in both physical and psychological themes. The HCPs’ perspective is comparable, but mostly focuses on psychological impact.

既往研究显示，医护人员（Health-Care Professionals, HCPs）与患者对药物不良反应（Adverse Drug Reaction, ADR）负担的认知存在差异，但目前尚不明确究竟是哪些因素令药物不良反应被感知为负担。本研究旨在探究炎性风湿性疾病（Inflammatory Rheumatic Disease, IRD）患者为何会将药物不良反应视为负担，并对比其与医护人员的认知差异。本研究采用荷兰生物制剂监测（Dutch Biologic Monitor）数据库数据开展质性研究：研究对象每两个月接受一次问卷调查，内容涉及自身经历的生物改善病情抗风湿药（biological DMARDs）相关药物不良反应，并需通过李克特量表（Likert-type scale）与开放性问题详细阐述药物不良反应负担情况以作补充说明。本研究对440名炎性风湿性疾病患者的数据采用主题分析法（thematic analysis）进行分析；同时对13名医护人员开展半结构化访谈（semi-structured interviews），并采用相同分析方法处理访谈数据。研究共识别出7个与药物不良反应负担相关的主题：“对用药方案的影响”“对外貌的影响”“对自主性的影响”“对日常生活的影响”“心理后果”“药物不良反应的困扰性表现”以及“躯体后果”。医护人员也识别出了完全一致的主题，但他们更多聚焦于“心理后果”下的子主题，而对“对日常生活的影响”与“对自主性的影响”下的子主题识别较少。患者会从躯体与心理两个维度阐述自身感知到的药物不良反应负担，医护人员的认知与患者具有相似性，但更多关注心理层面的影响。