The Parker Institute, Copenhagen University Hospital, Bispebjerg, Frederiksberg, Denmark.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal, Sciences, Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK.
Patient. 2018 Oct;11(5):515-526. doi: 10.1007/s40271-018-0306-8.
Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava, an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases.
The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE). CM, a structured group process, was used to identify patients' opinions and concerns regarding the e-Device. Patients used this information in iterative PD sessions to create personal e-Device prototypes in cooperation with a designer and a healthcare professional. SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders.
The study recruited 14 patients, two doctors, two nurses, one medical secretary, and four other public servants. Three CM workshops revealed four key considerations: technical usability, physical design, concerns, and enthusiasm. Four personalized prototypes were developed during PD sessions. SE confirmed that the identified considerations were pivotal for the implementation and adaptation of the e-Device.
This study is the first to apply a composite, qualitative research model when introducing an e-Device for the treatment and management of rheumatic disease. Results show that input from patients and other stakeholders using the Parker Model can add value to the development and implementation of an e-Device.
半结构式访谈和焦点小组等定性方法可用于评估设备技术在临床实践中的适用性和相关性，但单独使用时，往往缺乏普遍性。本研究旨在评估使用综合三步定性方法（帕克模型）的表面有效性和可行性，以告知皮下自我管理生物制剂、培塞利珠单抗（CZP）的机电设备（e 设备）ava 的开发和实施，用于治疗风湿性疾病。
帕克模型结合概念映射（CM）、参与式设计（PD）和利益相关者评估（SE）。CM 是一种结构化的小组过程，用于确定患者对 e 设备的意见和关注。患者在迭代 PD 会议中使用这些信息与设计师和医疗保健专业人员合作创建个人 e 设备原型。SE 是根据对患者和疾病管理利益相关者的半结构化小组和个人访谈进行的。
该研究招募了 14 名患者、两名医生、两名护士、一名医疗秘书和四名其他公务员。三次 CM 研讨会揭示了四个关键考虑因素：技术可用性、物理设计、关注点和热情。在 PD 会议期间开发了四个个性化原型。SE 证实，所确定的考虑因素对于 e 设备的实施和调整至关重要。
这是首次在引入用于治疗和管理风湿性疾病的 e 设备时应用综合定性研究模型。结果表明，患者和其他利益相关者使用帕克模型提供的投入可以为 e 设备的开发和实施增加价值。
