METHODS
We conducted a single-centre, single-trial, observational analysis, based at the NIHR Oxford Clinical Research Facility (OxCRF). This 13 bed CRF provides a resource for experimental and early phase clinical research across the Medical Sciences Division of the University of Oxford and Oxford University Hospitals NHS Foundation Trust (OUHT). The study observed was COV-CHIM01: A Dose Finding Human Experimental Infection Study With SARS-CoV-2 in Healthy Volunteers (NCT04864548, Department of Paediatrics, University of Oxford). This dose escalation challenge study sought to identify the dose of SARS-CoV-2 required to achieve a 50% infection rate in healthy volunteers, enabling discovery science and, if successful, facilitating the targeted evaluation of therapeutics in future studies. Selection of COV-CHIM01 for human factors evaluation was based on the incorporation of multiple complex protocol elements, the high level of multi-disciplinary working necessitated and the enhanced risk associated with non-compliance with specified standard operating procedures (SOPs) given the potential for transmission of infection.
Three Phases of work were conducted: i) Preliminary data gathering and task prioritisation : Staff from the OxCRF and Department of Paediatrics study team (COV-CHIM study team) were consulted on three separate occasions via a combination of interview, focus group and email to identify protocol elements that represented greater relative risk either due to complexity or risk of exposure to live virus. Relevance to research beyond the index study was also considered. ii)Task analysis : Three tasks were selected for inclusion: Inoculation of participants with the pathogen; in-room assessments of inoculated participants by staff; and transfer from the OxCRF to the main OUHT hospital for study investigations. Two investigators (one clinician [HH], one non-clinical chartered human factors specialist [LM]) used structured observations to analyse work procedures, observing three specific tasks and general work activities in real time, and assessing the usability of artefacts including equipment, SOPs and study protocols. The observations focused on capturing an understanding of ‘work as done’, and review of SOPs and other study documents on understanding ‘work as imagined’ (see Figure 1). Observations during the three tasks and for general work activities in OxCRF were categorised using a human factors framework designed for healthcare, the Systems Engineering Initiative for Patient Safety (SEIPS see Figure 2) Person, Environment, Task, Tools and technology (PETT) scan . iii) Designing recommendations : This was undertaken collaboratively with Oxford Simulation Teaching and Research (OxSTaR), OxCRF and COV-CHIM study teams.
Data collection visits were made between February and March 2022. Observers were embedded in the work environment and made all visits together, observations being undertaken once for each task. To mitigate the risk of the investigators being exposed to live virus during inoculation, a contemporaneous audio-visual feed was reviewed from a nearby office using the pre-installed OxCRF CCTV system and an additional microphone placed in the participant’s room. No recordings were made. Direct observation of the transfer of participants to the hospital for CT scanning was deemed impossible due to the risk of investigator contact with infected participants and the potential for distraction of the study team en-route to the scanner. Consequently these observations were made in real time using a simulated journey with a member of the study team acting as a study participant. Observations for each task ended after a period of reflection with OxCRF and COV-CHIM study team staff and study participants (if they wished) when comments about the procedure could be openly discussed and recorded. Informed consent was gained from staff and participants involved in each of the observed tasks. Trial documentation and protocols were reviewed both independently and in conjunction with trial staff to understand their perspective and interpretation. Specific points about the methodology for each task are summarised in Table 1.
To design and prioritise recommendations (Phase iii) five focus group discussions were facilitated by HH and LM with multidisciplinary staff from both OxCRF and the COV-CHIM study team. An additional summative discussion of the study results confirming agreement on recommendations was held including all staff and the leads for both OxCRF (DR) and the COV-CHIM study team (HMcS).
The study represented a collaboration between OxSTaR (in the Nuffield Department of Clinical Neurosciences), OxCRF and the Department of Paediatrics. The human factors protocol was reviewed by the Research Governance Ethics and Assurance team at the University of Oxford and deemed not to require further ethical approval in addition to COV-CHIM01 (21/UK/0001). Informed consent for observation was obtained from all trial volunteers as well as OxCRF and COV-CHIM study team staff. No participant identifiable data was collected. This human factors study was registered on the OUHT Ulysses platform (project number 7381).