Human-centered Design of a Personal Health Record System for Metabolic Syndrome Management Based on the ISO 9241-210:2010 Standard

Background: Previous studies have demonstrated the effectiveness of information and communication technologies to support healthy lifestyle interventions. In particular, personal health record systems (PHR-Ss) empower self-care, essential to support lifestyle changes. Approaches such as the user-centered design (UCD), which is already a standard within the software industry (ISO 9241-210:2010), provide specifications and guidelines to guarantee user acceptance and quality of eHealth systems. However, no single PHR-S for metabolic syndrome (MS) developed following the recommendations of the ISO 9241-210:2010 specification has been found in the literature.

Objective: The aim of this study was to describe the development of a PHR-S for the management of MS according to the principles and recommendations of the ISO 9241-210 standard.

Methods: The proposed PHR-S was developed using a formal software development process which, in addition to the traditional activities of any software process, included the principles and recommendations of the ISO 9241-210 standard. To gather user information, a survey sample of 1,187 individuals, eight interviews, and a focus group with seven people were performed. Throughout five iterations, three prototypes were built. Potential users of each system evaluated each prototype. The quality attributes of efficiency, effectiveness, and user satisfaction were assessed using metrics defined in the ISO/IEC 25022 standard.

Results: The following results were obtained: 1) a technology profile from 1,187 individuals at risk for MS from the city of Popayan, Colombia, identifying that 75.2% of the people use the Internet and 51% had a smartphone; 2) a PHR-S to manage MS developed (the PHR-S has the following five main functionalities: record the five MS risk factors, share these measures with health care professionals, and three educational modules on nutrition, stress management, and a physical activity); and 3) usability tests on each prototype obtaining the following results: 100% effectiveness, 100% efficiency, and 84.2 points in the system usability scale.

Conclusion: The software development methodology used was based on the ISO 9241-210 standard, which allowed the development team to maintain a focus on user's needs and requirements throughout the project, which resulted in an increased satisfaction and acceptance of the system. Additionally, the establishment of a multidisciplinary team allowed the application of considerations not only from the disciplines of software engineering and health sciences but also from other disciplines such as graphical design and media communication. Finally, usability testing allowed the observation of flaws in the designs, which helped to improve the solution.