Evolution of Human Factors Research and Studies of Health Information Technologies: The Role of Patient Safety

Abstract

SummaryObjectives: The objective of this survey paper is to present and explain the impact of recent regulations and patient safety initiatives (EU, US and Canada) on Human Factors (HF) /Usability studies and research focusing on Health Information Technology (HIT). Methods: The authors have selected the most prominent of these recent regulations and initiatives, which rely on validated HF and usability methods and concepts and aim at enhancing the specific process of identification and prevention of technology-induced errors throughout the lifecycle of HIT. Results: The analysis highlights several points of consensus: 1) safety initiatives or regulations applicable to Medical Devices (MD) tend to extend to HIT, 2) Usability is considered a fundamental dimension of HIT safety, 3) HF/Usability methods and the overall Human Centred Design (HCD) approach are considered efficient solutions to ensure the design of safe and usable HIT. However, it appears that MD manufacturers, and a fortiori HIT designers and developers are still far from being able to routinely apply HCD to their products Discussion and conclusion: On the research side, we need to analyze manufacturers' difficulties with the application of the HCD process and imposed standards. For each given category of HIT, we need to identify the fundamental usability dimensions and design principles likely to impact patient safety independently of workplace settings or organizations. These should be described in terms of usability flaws, corresponding usage problems experienced by users and related outcomes. This approach requires good quality and well structured reporting of Human Factors / Usability research studies on HIT.

Developing a framework for evidence-based grading and assessment of predictive tools for clinical decision support

“…They are conducted either retrospectively or concurrently, where each method has its own way of detecting usability problems [115]. The near live simulations provide users, during testing, with an opportunity to go through different clinical scenarios while the system captures interaction challenges and usability problems [116, 117]. Some researchers add learnability, memorability and freedom of errors to the measures of usability.…”

Human-Centered Design of a Clinical Decision Support for Anemia Screening in Children with Inflammatory Bowel Disease

“…6,7 Clinical decision support systems (CDSSs) integrated into electronic health records (EHRs) provide an opportunity to deliver evidence-based recommendations that are well integrated into systems of care. [8][9][10][11] Human-centered design (HCD) has been applied to the development of CDSS [12][13][14][15] to improve integration of CDSS tools into clinical workflows and to improve usability with the goals of improving patient safety, enhancing clinical outcomes, and improving process efficiency, among other aims. 12,13,16,17 HCD involves indepth analysis of work systems and care processes 12,16,18 to inform design of a CDSS prototype, which undergoes iterative redesign using human factors (HF) principles, 12,19,20 taking into account the five "rights" of clinical decision support (CDS).…”

“…21 Key gaps in the research of HCD of CDSS include methods of translating requirements into build and demonstration of how HCD contributes to design. 14,22…”

Development and Validation of SafeHIT: An Instrument to Assess the Self-Reported Safe Use of Health Information Technology

“…• Instruments validated 55,56 5 HIT use Workarounds Alternative procedures are employed by health care practitioners to accomplish a task in response to a misfit between HIT and existing work processes. 57,58 • Semistructured interviews and findings from previous studies [58][59][60] 5…”