Patient-centered Design Grounded in User and Clinical Realities: Towards Valid Digital Health

Valid design of patient-centered digital health or health information technology (IT) systems is based on a thorough and accurate understanding of both “user reality” and “clinical reality.” Type 1 Design Error (User-Reality Error) occurs when designers do not accommodate user characteristics, tasks, context of use, needs, or preferences. Type 2 Design Error (Clinical-Reality Error) occurs when designers do not accommodate the clinical reality, including biomedical knowledge, clinical workflows, and organizational requirements. Both types of errors can invalidate the design, leading to products being rejected by patient end-users or their healthcare delivery systems, product non-use or inappropriate use, and risk of harm. This paper describes our attempts to achieve valid health IT design and avoid the two design errors. We performed iterative, patient-centered design to prototype a mobile application, Power to the Patient (P2P), supporting heart failure self-care management. Our multidisciplinary team of human factors, cardiology, and design experts developed and iteratively refined requirements based on data collection, review, and testing with patient research participants, a patient advisory board, a clinical advisory board, and experts on the team. We describe our process and reflect on working with multiple stakeholders toward the goal of valid health IT design.