Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Skeletal Biology and Engineering Research Centre, Department of Development and Regeneration, KU Leuven-University of Leuven, Leuven, Belgium.
BMJ Open. 2019 Mar 27;9(3):e023606. doi: 10.1136/bmjopen-2018-023606.
Including the patient perspective is important to achieve optimal outcomes in the treatment of rheumatoid arthritis (RA). Ample qualitative studies exist on patient outcomes in RA. A Belgian study recently unravelled what matters most to patients throughout the overwhelming and rapidly evolving early stage of RA. The present study, European Qualitative research project on Patient-preferred outcomes in Early Rheumatoid Arthritis (EQPERA) was created to contribute to a more universal understanding of patient-preferred health and treatment outcomes by integrating the perspectives of patients with early RA from three European countries.
In EQPERA, a qualitative, explorative, longitudinal study will be implemented in The Netherlands and Sweden, parallel to the methods applied in the previously conducted Belgian study. In each country, a purposive sample of patients with early RA will be individually interviewed 3-6 months after start of the initial RA treatment and subsequently, the same participants will be invited to take part in a focus group 12-18 months after RA treatment initiation. Data collection and analysis will be independently conducted by the local research teams in their native language. A meta-analysis of the local findings will be performed to explore and describe similarities, differences and patterns across countries.
Ethics approval was granted by the responsible local ethics committees. EQPERA follows the recommendations of the Declaration of Helsinki. Two main papers are foreseen (apart from the data reporting on the local findings) for peer-reviewed publication.
纳入患者视角对于类风湿关节炎(RA)的治疗获得最佳结果至关重要。已经有大量关于 RA 患者结局的定性研究。最近,比利时的一项研究揭示了在 RA 早期阶段,患者最关注的是什么,这一阶段病情复杂且迅速发展。本研究——欧洲早期类风湿关节炎患者偏好结局定性研究(EQPERA)旨在通过整合来自三个欧洲国家的早期 RA 患者的观点,对患者偏好的健康和治疗结局有更普遍的理解。
在 EQPERA 中,将在荷兰和瑞典同时开展一项定性、探索性、纵向研究,方法与之前进行的比利时研究相同。在每个国家,将对处于早期 RA 治疗开始后 3-6 个月的患者进行有目的的抽样,进行个体访谈,随后邀请相同的参与者在 RA 治疗开始后 12-18 个月参加焦点小组。数据收集和分析将由当地研究团队用其母语独立进行。将对当地研究结果进行荟萃分析,以探索和描述国家间的相似点、差异和模式。
已获得负责的当地伦理委员会的伦理批准。EQPERA 遵循《赫尔辛基宣言》的建议。除了对当地研究结果的报告外,预计还将发表两篇主要论文供同行评审。