Discussion
SECONDARY, HEARING IMPAIRMENTS
Our project developed an innovative prototype PAPR explicitly designed for prolonged healthcare use in high-risk clinical environments. Bubble-PAPR achieved its primary purpose of protecting staff by exceeding recognised safety standards for PAPRs, while also being rated significantly higher for comfort (the primary outcome), perceived safety, and communication with colleagues and patients (secondary outcomes) than usual FFP3 face masks. Bubble-PAPR was used in all relevant simulated and clinical scenarios identified by detailed staff diary cards, making the results of this study extremely relevant to hospital-based healthcare workers.Bubble-PAPR was rapidly developed based on the lived experiences of front-line staff during the early stages of the COVID-19 pandemic, addressing the unmet needs of reliable, high-quality, universal and available RPE with improved comfort and communication when compared with usual FFP3 face masks. Staff overwhelmingly recognised the importance of facial visualisation when communicating with colleagues and patients. When combined with the improved comfort of wearing a PAPR over usual RPE, participants rated Bubble-PAPR consistently highly across all comparator domains.This relatively simple evaluation study was preceded by a rapid design and prototyping phase, producing a working prototype within a few weeks. Despite the speed and agility demonstrated by the design team, we adhered to relevant conformity standards for PAPRs, following a tiered evaluation within the governance structure of an approved and regulated research project. Bubble-PAPR was only introduced into higher-risk environments following review by the trial safety committee. This structured approach contrasted with some other rapidly developed or adopted pandemic RPE systems.Our study has some limitations. Some of the endpoints were self-reported by participating staff and not independently verified. This included communication between colleagues, and between staff and patients. However, staff were performing their usual clinical duties while wearing Bubble-PAPR and any limitations of two-way communication were recognised and reported. The design of Bubble-PAPR addressed many of the issues identified by the same staff who subsequently evaluated the prototype. While our study protocol allowed evaluation only within our trust owing to the ‘in-house’ manufacturing exemption for testing, it is not unreasonable to expect similar results if our prototype were evaluated elsewhere. Although this may be considered a weakness of the study, many of the shortcomings of the PPE provided to front-line health workers around the world are well described and are essentially the same as those identified in our project.Our study did not directly evaluate the patient experience with staff wearing different RPE. However, the patient experience was reflected in the user specifications identified around communication, and anecdotal feedback was positive from patients, especially around facial visibility and verbal and non-verbal communication. In addition, when contrasted with FFP3 face masks, speech and language therapists reported that demonstrating speech and swallow exercises was suddenly possible with Bubble-PAPR and that the transparent nature of the hood overcame the communication barriers that can be so devastating for those with hearing impairments.