A Versatile and Scalable Platform That Streamlines Data Collection for Patient-Centered Studies: Usability and...

Area of Science:

• Biomedical Informatics
• Clinical Research Technology
• Patient-Reported Outcomes

Background:

• The Food and Drug Administration Center for Biologics Evaluation and Research (CBER) established the Biologics Effectiveness and Safety (BEST) Initiative to improve understanding of patient experiences with regulated products.
• Existing data collection challenges, especially for rare diseases, highlighted the need for a comprehensive platform for patient and caregiver engagement in studies.
• CBER recognized the necessity for a centralized system for study design, deployment, participant enrollment, consent, and secure data participation.

Purpose of the Study:

• To raise awareness about the Survey of Health and Patient Experience (SHAPE) platform.
• To detail the design, development, and unique features of the SHAPE platform.
• To describe SHAPE's functionality, application, quality improvement, open-source availability, and future enhancement plans.

Main Methods:

• The SHAPE platform utilizes a Google Cloud environment with distinct administrator and participant applications, plus an API.
• Leveraging the open-source Ionic Framework, SHAPE supports cross-platform app development (iOS, Android, PWA) from a single codebase.
• Integration with the 1upHealth platform enables secure, one-time electronic health record data pulls via HL7® FHIR® API, following an agile development process with stakeholder engagement.

Main Results:

• SHAPE empowers study coordinators to design, develop, and deploy questionnaires for direct patient/caregiver endpoint collection.
• Electronic health record integration validates and enhances data accuracy, with data downloadable in HL7® FHIR®-formatted JSON files.
• Demonstrated applicability through a hypothetical type 1 diabetes study and an ongoing metachromatic leukodystrophy pilot for rare disease natural history studies.

Conclusions:

• SHAPE serves as an intuitive and comprehensive data collection tool applicable to diverse clinical studies.
• The platform's versatility, scalability, and customizability support multiple use cases for capturing patient perspectives and clinical data.
• SHAPE provides valuable data for regulators, clinicians, researchers, and patient advocacy groups to inform drug development and enhance patient outcomes.