Adopting human factors in early phase and experimental medicine research: A nested pilot study observing controlled human infection with SARS-CoV-2

Abstract

Aims: The influence of human factors on safety in healthcare settings is well established, with targeted interventions reducing risk and enhancing team performance. In experimental and early phase clinical research participant safety is paramount and safeguarded by guidelines, protocolized care and staff training; however, the real-world interaction and implementation of these risk-mitigating measures has never been subjected to formal system-based assessment.

Methods: Independent structured observations, systematic review of study documents, and interviews and focus groups were used to collate data on three key tasks undertaken in a clinical research facility (CRF) during a SARS CoV-2 controlled human infection model (CHIM) study. The Systems Engineering Initiative for Patient Safety (SEIPS) was employed to analyse and categorize findings, and develop recommendations for safety interventions.

Results: High levels of team functioning and a clear focus on participant safety were evident throughout the study. Despite this, latent risks in both study-specific and CRF work systems were identified in all four SEIPS domains (people, environment, tasks and tools). Fourteen actionable recommendations were generated collaboratively. These included inter-organization and inter-study standardization, optimized checklists for safety critical tasks, and use of simulation for team training and exploration of work systems.

Conclusions: This pioneering application of human factors techniques to analyse work systems during the conduct of research in a CRF revealed risks unidentified by routine review and appraisal, and despite international guideline adherence. SEIPS may aid categorization of system problems and the formulation of recommendations that reduce risk and mitigate potential harm applicable across a trials portfolio.

Keywords: clinical trials; human factors; methodology; patient safety; translational research.

FIGURE 1

The varieties of human work. Conceptualizing human work is important when considering how outcomes are achieved and what impacts the success and/or safety of the task in hand. Shorrock has described four basic varieties of human work. Work as done is, simply put, what actually happens in the workplace and is best analysed by direct observation; work as imagined is how people think work is done at the frontline and is influenced by various factors including past experience, knowledge of the work that is being undertaken and personal bias; work as disclosed is what people say or write about their work; and work as prescribed is the formal description (usually written, e.g., as an SOP) of how work should be done. The figure depicts the four basic varieties of human work (described by Shorrock ²⁰ ) revealing areas of overlap and of difference for each type.

FIGURE 2

The Systems Engineering Initiative for Patient Safety(SEIPS). SEIPS, , , was designed by systems engineers and human factors scientists in collaboration with healthcare providers to be a framework for analysing healthcare systems, examining work processes and designing interventions to improve patient safety.The figure provides an overview of the model with patient at the centre of the healthcare system described within socio‐organizational contexts. Key factors influencing patient safety are divided into people (e.g., clinical teams, family members or the patient themselves), environments (e.g., physical, cultural), tasks (which may involve multiple interdependent teams) and tools and technologies, all of which are influenced in turn by external environmental factors (e.g., regulatory bodies or government policy). The SEIPS model recognizes the adaptive nature of healthcare systems with a feedback loop from outcomes back into the work system. SEIPS 101 describes a series of simplified ways of using SEIPS to analyse work in healthcare. The PETT (People, Environments, Task, Tools and technology) scan is one example which can be used in many contexts to consider facilitators and barriers to safe practice (e.g., to examine tasks involved in a ward round or to analyse a safety incident and consider contributory factors). It was chosen for this study as it was designed to be straightforward to use in any clinical context.