Usability on the p-medicine infrastructure: an extended usability concept

Area of Science:

• Health-care Information Technology (IT)
• Software Engineering
• Clinical Research

Background:

• Usability testing is crucial for health-care software, widely accepted by clinicians and researchers.
• Existing usability assessment methods require specific objectives, evaluation criteria, and monitoring procedures.
• Good Clinical Practice (GCP) mandates additional usability testing for health-care IT systems.

Purpose of the Study:

• To describe the p-medicine project's Extended Usability Concept (EUC).
• To detail the integration of usability testing in health-care software development.
• To highlight key tools like ObTiMA and Ontology Annotator (OA) within the EUC.

Main Methods:

• Development of an Extended Usability Concept (EUC) tailored for the p-medicine project.
• Iterative feedback loops to software developers throughout the design and development process.
• Focus on specific tools: ObTiMA for usability testing and Ontology Annotator (OA) for data handling.

Main Results:

• The EUC addresses ease of use, likeability, and usefulness in demanding trial center environments.
• It incorporates critical aspects such as confidentiality, source document use, and Standard Operating Procedures (SOA).
• Ensures data reliability through quality control for accuracy, completeness, legibility, consistency, and timeliness.

Conclusions:

• The p-medicine EUC provides a comprehensive framework for ensuring high-quality, reliable health-care IT.
• This approach meets stringent GCP criteria and supports efficient usability assessment in mixed research environments.
• The described tools (ObTiMA, OA) are integral to the successful implementation of the EUC.