A human-centered design methodology to enhance the usability, human factors, and user experience of connected health systems: a three-phase methodology.

peer-reviewedDesign processes such as human-centered design, which involve the end user throughout the product development and testing process, can be crucial in ensuring that the product meets the needs and capabilities of the user, particularly in terms of safety and user experience. The structured and iterative nature of human-centered design can often present a challenge when design teams are faced with the necessary, rapid, product development life cycles associated with the competitive connected health industry. We wanted to derive a structured methodology that followed the principles of human-centered design that would allow designers and developers to ensure that the needs of the user are taken into account throughout the design process, while maintaining a rapid pace of development. In this paper, we present the methodology and its rationale before outlining how it was applied to assess and enhance the usability, human factors, and user experience of a connected health system known as the Wireless Insole for Independent and Safe Elderly Living (WIISEL) system, a system designed to continuously assess fall risk by measuring gait and balance parameters associated with fall risk. We derived a three-phase methodology. In Phase 1 we emphasized the construction of a use case document. This document can be used to detail the context of use of the system by utilizing storyboarding, paper prototypes, and mock-ups in conjunction with user interviews to gather insightful user feedback on different proposed concepts. In Phase 2 we emphasized the use of expert usability inspections such as heuristic evaluations and cognitive walkthroughs with small multidisciplinary groups to review the prototypes born out of the Phase 1 feedback. Finally, in Phase 3 we emphasized classical user testing with target end users, using various metrics to measure the user experience and improve the final prototypes. We report a successful implementation of the methodology for the design and development of a system for detecting and predicting falls in older adults. We describe in detail what testing and evaluation activities we carried out to effectively test the system and overcome usability and human factors problems. We feel this methodology can be applied to a wide variety of connected health devices and systems. We consider this a methodology that can be scaled to different-sized projects accordingly.PUBLISHEDpeer-reviewe

Overcoming Challenges to Inclusive User-based Testing of Health Information Technology with Vulnerable Older Adults: Recommendations from a Human Factors Engineering Expert Inquiry

Objectives: Involving representative users in usability testing of health information technology (HIT) is central to user-centered design. However, (vulnerable) older adults as representative users have unique requirements. Aging processes may affect physical capabilities and cognitive skills, which can hamper testing with this demographic and may require special attention and revised protocols. This study was performed to provide expert-based recommendations for HIT user-testing with (vulnerable) older adults to support inclusive HIT design and evaluation. Methods: First, we conducted a structured workshop with ten experts in HIT implementation and research, recruited through purposeful sampling, to generate insights into how characteristics of older adults may influence user-testing. Next, five Human Factor researchers experienced in HIT user-testing with (vulnerable) older adults validated the results and provided additional textual insights to gain consensus on the most important recommendations. A thematic analysis was performed on the resulting inquiries. Applied codes were based on the User-Centered Design framework. Results: The analysis resulted in nine recommendations for user-testing of HIT with older adults, divided into three main themes: (1) empathetic approach and trust-building, (2) new requirements for testing and study design, and (3) adjustments to usability evaluation methods. For each theme a checklist of relevant items to follow-up on the recommendation is provided. Conclusions: The recommendations generated through expert inquiry contribute to more effective usability testing of HIT with older adults. This provides an important step towards improved accessibility of HIT amongst older adults through inclusive user-centered design

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies

Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered

Quality of human-computer interaction - results of a national usability survey of hospital-IT in Germany

<p>Abstract</p> <p>Background</p> <p>Due to the increasing functionality of medical information systems, it is hard to imagine day to day work in hospitals without IT support. Therefore, the design of dialogues between humans and information systems is one of the most important issues to be addressed in health care. This survey presents an analysis of the current quality level of human-computer interaction of healthcare-IT in German hospitals, focused on the users' point of view.</p> <p>Methods</p> <p>To evaluate the usability of clinical-IT according to the design principles of EN ISO 9241-10 the IsoMetrics Inventory, an assessment tool, was used. The focus of this paper has been put on suitability for task, training effort and conformity with user expectations, differentiated by information systems. Effectiveness has been evaluated with the focus on interoperability and functionality of different IT systems.</p> <p>Results</p> <p>4521 persons from 371 hospitals visited the start page of the study, while 1003 persons from 158 hospitals completed the questionnaire. The results show relevant variations between different information systems.</p> <p>Conclusions</p> <p>Specialised information systems with defined functionality received better assessments than clinical information systems in general. This could be attributed to the improved customisation of these specialised systems for specific working environments. The results can be used as reference data for evaluation and benchmarking of human computer engineering in clinical health IT context for future studies.</p

RADIOLOGICAL IMPACT OF RELEASES BY THE DUTCH NON-NUCLEAR INDUSTRIAL-PROCESSES

All materials used in industrial processes contain the naturally occurring radionuclides 40K, and 238U and 232Th with their decay products. Although the concentrations are usually small the total mass of these materials is quite substantial. Radioactive nuclides may end up in enhanced concentrations in residual products which are partially stored as solid materials, partially released in open water or in air. The latter two ways may lead to an appreciable radiological burden of (parts of) the population. In a literature study the radiological impact of the release of radionuclides by the non-nuclear Dutch industry has been estimated. This estimate was achieved by starting with a crude model based on mass flow and radionuclide concentrations, followed by the introduction of various steps of sophistication based on additional information on technologies used in industrial processes. Based on these estimates, industries have been classified according to ris

Anatomy of a failure: A sociothechnical evaluation of a laboratory physician order entry system implementation

Objective: To investigate the human, social and organizational issues surrounding a Computerized Physician Order Entry system for Laboratory ordering (CPOE-L) implementation process and to analyze their interrelated effects on the system implementation failure in an academic medical setting. Second, to provide lessons learned and recommendations on to how to manage challenges of human, social and organizational nature surrounding CPOE-L implementations. Methods: The themes surrounding CPOE introduction were identified by a heuristic analysis of literature on CPOE implementations. The resulting set of themes was applied as a reference model for 20 semi-structured interviews conducted during the CPOE-L implementation process with 11 persons involved in the CPOE-L project and in reviewing all CPOE- L related project documentation. Data was additionally gathered by user questionnaires, by user discussion rounds and through an ethnographical study performed at the involved clinical and laboratory departments. In analyzing the interview transcripts, project documentation and data from user questionnaires and discussion rounds a grounded theory approach was applied by the evaluation team to identify problem areas or issues deserving further analysis. Results: Outlined central problem areas concerning the CPOE- L implementation and their mutual relations were depicted in a conceptual interpretative model. Understanding of clinical workflow was identified as a key theme pressured by organizational, human and social issues ultimately influencing the entire implementation process in a negative way. Vast delays in CPOE introduction, system immaturity and under-functionality could all be directly attributed to a superficial understanding of workflow. Consequently, final CPOE integration into clinical and laboratory workflows was inhibited by both end-users as well as department managers and withdrawal of the CPOE- L system became inevitable. Conclusion: This case study demonstrates which human, social and organizational issues relevant to CPOE implementation cumulatively led to a failure outcome of the CPOE- L pilot introduction. The experiences and considerations described in this paper show important issues for CPOE systems to be successfully introduced and to be taken into account in future CPOE implementations. Understanding and consideration of (clinical) workflow aspects by project managers and the involved clinical organization is of extreme importance from the very start of a CPOE implementation process. (C) 2009 Elsevier Ireland Ltd. All rights reserve