Background Patients' participation in design, development, and implementation of new device technologies is essential to ensure added value in patients' disease management.
Objectives To explore the applicability and relevance of ava®, an electromechanical device (e-Device), as an alternative method for subcutaneous administration of certolizumab pegol.
Methods The Parker Model is an innovative 3-step qualitative research approach, which combined concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE) to evaluate the e-Device (Figure). CM was applied through workshops, with the participation of patients, using a structured group process focusing on relevant themes to identify issues and concerns with the e-Device. Patients used this information in a series of iterative PD sessions; patients participated in 3 interactive sessions to create a personal e-Device prototype in cooperation with a designer and a medical expert. This was followed by a common group session. Finally, SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders.
Results The study included 9 rheumatoid arthritis (RA) patients, 4 psoriatic arthritis (PsA) patients, 1 ankylosing spondylitis (AS) patient, 2 doctors, 2 nurses, 1 medical secretary, and 4 key public servants involved in the disease management of the selected rheumatic diseases. Saturation was reached after 3 CM patient workshops, generating 121 statements, which were organized by the participants into themes. Through content analysis of the results from the 3 workshops, 4 concepts were generated: technical usability, physical design, concerns, and enthusiasm. These data were used in the iterative PD sessions, resulting in 4 new proposed prototypes. Finally, SE demonstrated that the identified concepts were pivotal for both facilitating and hampering device implementation, thus creating value when introducing the new e-Device.
Conclusions Patient participation in the 3-step qualitative Parker Model identified important aspects to consider when designing and implementing an innovative device for the treatment and management of RA, PsA, and AS. This is the first time a composite, qualitative research model has been applied when introducing a new device to support these disease areas. The responses from patients and disease-management stakeholders indicated that it is key to include patient input in the design and adaptation of devices alongside education and communication with stakeholders. These resources can help ensure added value when developing devices for the management of RA, PsA, and AS using biologic medicines.
Acknowledgements This study was funded by UCB Pharma and the Oak Foundation. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. Editorial services were provided by Costello Medical Consulting.
Disclosure of Interest T. Jørgensen Speakers bureau: Abbvie, Biogen, Novartis, Roche, UCB Pharma, L. Klokker: None declared, M. Skougaard: None declared, H. Asmussen Consultant for: The Parker Institute, UCB Pharma, A. Lee: None declared, I. Mountian Employee of: UCB Pharma, H. Gudbergsen: None declared, L. Kristensen Speakers bureau: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen Pharmaceuticals, MSD, Novartis, Pfizer, UCB Pharma