BackgroundThe development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA).ObjectiveThe aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems.MethodsThe formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe.ResultsThe formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics’ working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other’s feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a ‘tipping point’ during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment.ConclusionsA formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health ...

Background and ObjectiveQualitative 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.MethodsThe 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.ResultsThe 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.ConclusionsThis 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.Electronic supplementary materialThe online version of this article (10.1007/s40271-018-0306-8) contains supplementary material, which is available to authorized users.

BACKGROUND The development of digital health solutions for current health care settings requires an understanding of the complexities of the health care system, organizational setting, and stakeholder groups and of the underlying interplay between stakeholders and the technology. The digital health solution was founded on the basis of an information and communication technology platform and point-of-care devices enabling home-based monitoring of disease progression and treatment outcome for patients with rheumatoid arthritis (RA). OBJECTIVE The aim of this paper is to describe and discuss the applicability of an iterative evaluation process in guiding the development of a digital health solution as a technical and organizational entity in three different health care systems. METHODS The formative evaluation comprised the methodologies of contextual understanding, participatory design, and feasibility studies and included patients, healthcare professionals, and hardware and software developers. In total, the evaluation involved 45 patients and 25 health care professionals at 3 clinical sites in Europe. RESULTS The formative evaluation served as ongoing and relevant input to the development process of the digital health solution. Through initial field studies key stakeholder groups were identified and knowledge obtained about the different health care systems, the professional competencies involved in routine RA treatment, the clinics’ working procedures, and the use of communication technologies. A theory-based stakeholder evaluation achieved a multifaceted picture of the ideas and assumptions held by stakeholder groups at the three clinical sites, which also represented the diversity of three different language zones and cultures. Experiences and suggestions from the patients and health care professionals were sought through participatory design processes and real-life testing and actively used for adjusting the visual, conceptual, and practical design of the solution. The learnings captured through these activities aided in forming the solution and in developing a common understanding of the overall vision and aim of this solution. During this process, the 3 participating sites learned from each other’s feed-back with the ensuing multicultural inspiration. Moreover, these efforts also enabled the consortium to identify a ‘tipping point’ during a pilot study, revealing serious challenges and a need for further development of the solution. We achieved valuable learning during the evaluation activities, and the remaining challenges have been clarified more extensively than a single-site development would have discovered. The further obstacles have been defined as has the need to resolve these before designing and conducting a real-life clinical test to assess the outcome from a digital health solution for RA treatment. CONCLUSIONS A formative evaluation process with ongoing involvement of stakeholder groups from 3 different cultures and countries have helped to inform and influence the development of a novel digital health solution, and provided constructive input and feedback enabling the consortium to control the development process.

BackgroundPatients' participation in design, development, and implementation of new device technologies is essential to ensure added value in patients' disease management.ObjectivesTo explore the applicability and relevance of ava®, an electromechanical device (e-Device), as an alternative method for subcutaneous administration of certolizumab pegol.MethodsThe 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.ResultsThe 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.ConclusionsPatient 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.AcknowledgementsThis 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 InterestT. Jørgensen Speakers bureau: Abbvie, Biogen, Novartis, Roche, UCB Pharma, L. Klokker: None declared, M. Skouga...