Methods
RPE
RECRUITMENT
The design team brought together front-line clinical staff based in the Wythenshawe Hospital Acute intensive care unit (ICU) of Manchester University National Health Service (NHS) Foundation Trust (MFT), an experienced product design consultancy (Designing Science, Middlesex, UK) and the technical expertise of the School of Engineering at the University of Manchester (UoM). The study protocol, analysis plan and recruitment metrics were registered and reported at ClinicalTrials.gov (NCT04681365). Participating staff were provided with participant information sheets, a detailed explanation and demonstration of the safe use of Bubble-PAPR, and written consent was obtained. User needs assessment was conducted through a series of workplace diary card exercises documenting typical activities undertaken by front-line healthcare staff, synthesised in focus groups. Staff were invited to participate (by email and posters in rest areas) from clinical locations where RPE was mandated within the hospital. The first two respondents from each area were recruited to the diary card and focus group activities. Rapid design and evaluation cycles occurred based on the identified user needs. In addition, evaluation of early prototypes occurred in simulated clinical environments, collecting usability data from participants.