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).