Case study describing the pillars, personnel, and process of developing the TARDIS:REFLUX smartphone app

Abstract

BackgroundRegulations governing data protection for NHS patients and limited expertise within the health-care professions restrict development of smartphone applications (apps) as clinical and research adjuncts. Our aim was to show the feasibility of, and define the roadmap for, developing apps as clinical and research instruments within an NHS environment. We focused on gastro-oesophageal reflux (GOR) in children, because this is a common disorder. Symptoms occur daily yet are reviewed infrequently by clinicians, often at 3-month intervals. When questionnaires are used, they are applied retrospectively, need interval recall, and are delivered on paper. Epidemiological understanding of GOR is limited by the paucity of symptom data. To address this challenge we developed an iPhone app to Track Activity in Relation to reflux DISease (TARDIS:REFLUX). MethodsWe developed a questionnaire for parents of children with GOR to prospectively capture symptom frequency and key events. A project proposal describing data collection requirements and security arrangements drove project specification. Funding, ethics, and institutional Caldicott Guardian approvals were obtained. After tender, app developers were identified and the app built. A software application was designed to transfer data from users' phones to a central, secure database. A web interface for review of transmitted data was designed. FindingsThe four pillars of this app are a data collector, a data transfer protocol, a central database, and a data viewer. The roadmap for health-care app development in an NHS environment is characterised as follows. Data specification: clinical data collection requirements defined (task duration 2 weeks). Wire-framing the data collector: mock-up diagrams used to translate the data collection questionnaire into app views (2 weeks). User interface design: data collector and native data store coded (4 months). User management: user registration, login protocols, and level of access coded (1 month). Data security and ethics approval: systems-level security protocol and Intergrated Research Approval System application to obtain NHS Research Ethics Committee approval (NREC 12/NW/0837; 4 months). Data management, transfer, and storage: an application program interface to provide data transfer from users' iPhones to the central database (3 months). Data viewer: online dashboard enabling secure access and review of data in central database. The app was subjected to beta-testing through a two-step iterative process involving app target users (3 months). A randomised crossover study, in which users compare a paper questionnaire against the TARDIS:REFLUX app, is ongoing. A focus group (n=8) was convened to test usability. Seven participants successfully downloaded the app with no crashes during the session. Users needed a mean of 6·8 s (SD 2·8) to login and 6·9 s (3·0) to record a symptom. The app received a good mean usability rating of 84 out of 100 (systems usability scale). InterpretationThe TARDIS:REFLUX app shows feasibility and provides a roadmap for development of apps as clinical and research adjuncts. It allows real-time remote tracking of GOR symptoms in children to enhance clinical care. The data architecture is robust and secure and meets NHS data protection standards. Development of software for use on patient-held smartphones reduces the cost of development and allows large-scale use. The willingness of smartphone users to share data can be used to collect patient-level epidemiological data. To enable the development of efficacious and secure apps, the technical guidance given to both researchers and ethics committee members must be updated. Specifically, frameworks for secure storage, encryption, and transfer of data from smartphone devices to NHS data stores need development and dissemination. FundingUCL Grand Challenges Small Grants Fund. The funding source had no role in study design; data collection, analysis, or interpretation; in the writing of the report; or in the decision to submit for publication.