I suppose it would make you feel safer from having the vaccine in your - thinking about it, it would. Yes, it probably would - yes, it would make me feel safer, yes (Participant 17, male, medical arm)

Discussion

ENT triallists faced considerable challenges in Spring 2020 at the outset of the COVID pandemic. Many routine clinical services were suspended and non-COVID research was paused to new recruits. However, ongoing MACRO research participants continued in the study, and sites adapted as best they could during this challenging period. Participants described a lot of understanding, but many felt uninformed about the status of the trial and their clinical situation, even 6-9 months later. As a trial team we have since put procedures in place to ensure that trial participants are better informed, both from a clinical and research perspective, in case of future interruptions to NHS services.
Our experience from talking to these research participants are that if the safety concerns could be alleviated through provision of pre-visit information, excellent waiting room management and consideration about minimising contact with the wider public during trial visits. With this in place, there are minimal barriers to restarting recruitment to the MACRO trial from a patient perspective as soon as restrictions allow, and ENT regains capacity to do so.
A key strength of this study was use of qualitative methods permitted exploration of CRS patient perspectives during the COVID pandemic and provide a valuable insight into potential barriers to trial recruitment. However, our sample was drawn from 5 of the 15 ENT sites, and perspectives may have differed at the other trial sites.

Conclusion

CRS patients are willing to consider trial participation if safety concerns are addressed. Other triallists should be confident to approach patients about taking part in a clinical trial, especially as the vaccine roll-out continues and COVID confidence improves.
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