Table 4.

Main themes related to practitioner concerns about recruitment, consent and the practicalities or logistics of conducting EcLiPSE before and after training identified in qualitative questionnaire free-text responses (n = 125), interviews (n = 10) and 6 focus groups (n = 36)

Concerns before training		Concerns after training
Recruitment and consent	Practical or logistical	Recruitment and consent	Practical or logistical
Main themes identified in n = 62 free-text responses to Part A question: Do you have any concerns about seeking RWPC/deferred consent? and n = 48 and Part A question: Do you have any concerns about recruiting to EcLiPSE? and in n = 9/10 interviews and in n = 3/6 focus groups	Main themes identified in n = 95 open-ended responses to questionnaire Part A question: Do you think there will be any practical or logistical difficulties with conducting EcLiPSE? and n = 9/10 interviews and in n = 3/6 focus groups	Main themes identified in n = 32 free-text responses to Part B question: Do you have any concerns or anxieties specific to this trial including the consent approach we have discussed? and n = 5/10 interviews and in n = 1/6 focus groups	Main themes identified in n = 32 free-text responses to Part B question: Do you think there will be any practical or logistical difficulties with conducting EcLiPSE? and n = 4/10 interviews and in n = 1/6 focus groups
Lack of knowledge about the trial ‘I do not know enough about the study to confidently recruit.’ (P9, SIV questionnaire, female ED nurse) ‘Get our heads round the purpose of the study.’ P8, interview, female, nurse ‘Lack of familiarity.’ (P3, focus group 1, male, physician)	Staffing ‘Deferred consent over the weekend.’ (P55, SIV questionnaire Part A, female, physician) ‘At the time it was only going to be myself and […], my research nurse, and I knew that that could put a lot of pressure on us if we had to be available pretty much 365 days a year.’ (P1, interview, male, physician)	Seems feasible but experience needed ‘I guess we will have to give it a go.’ (P7, SIV questionnaire Part B, female, nurse) ‘Just my own inexperience of using the deferred consent approach however it seems much more feasible now I have completed the training.’ (P128, questionnaire Part B, female, physician) ‘My experience of it is that I need more experience of it. Because I feel a bit cautious.’ (P3, focus group 1, female, physician)	Staff availability for consent ‘Logistics of ensuring 7-day provision of consenting team members.’ (P21, SIV questionnaire Part B, male, physician) ‘We did miss a patient because he (trained consenting staff member) wasn’t around, and it was over a weekend and we don’t work at the weekend, so there has been an eligible patient.’ (P1, telephone interview, female, nurse). ‘People are trained and people are happy to do it, but we haven’t yet tested it when there‘s potentially one person who is able to do it, but the shop floor is crazy. We’ll see what happens over the winter with that.’ (P1, focus group 1, male, physician)
Lack of experience in RWPC ‘I feel nervous about deferred consent issue purely because this is new for me.’ (P50, SIV questionnaire Part A, female, nurse) ‘I guess we had initial reservations about the deferred consent and how that would work because it was something that was very much new to us’ (P4, interview, female, physician) ‘I’d never used deferred consent before. So it’s the first study that we’re using it.’ (P1, focus group 4, female, nurse)	Staff awareness ‘Familiarity of ED staff with process’ (P3, SIV questionnaire Part A, female, nurse) Doctors may forget it if not trained and aware (P7, SIV questionnaire, female, nurse) ‘The big concern I had was just making sure that everyone was, I suppose, on board with the process. So remembering that the EcLiPSE is ongoing… and if you do remember that the EcLiPSE study is on, you know what to do when they come in.’ (P7, interview, male, physician)	Parents‘ responses to RWPC ‘Negative reaction from parents.’ (P27, SIV questionnaire Part B, female, nurse) ‘It’s brilliant looking at videos and all the rest of it but you never actually know what’s going to happen until you’re in that situation yourself. I think most of us don’t have kids, we’re all a bit nervous about approaching the parents. You’re like, oh my God, what are they going to say, what are they going to do?’ (P6, interview, female, nurse) ‘I didn’t think many parents would be too impressed with it (RWPC), personally.’ (P6, focus group 5, female, nurse)	Dissemination of training ‘Need to create the same awareness as an accepted means of research methodology’ (P124, SIV questionnaire Part B, female, physician) ‘I realised that to try and let the whole children’s hospital know that we’re doing this study is actually quite a challenge in itself.’ (P5, interview, male, physician). ‘Then we realised that as the doctors change, we’ve also then got to remind everyone to resend the email to hopefully get it cascaded round the rest of the medical team. So you have to keep doing that and try and keep everyone aware.’ (P3, focus group 6, male, nurse)
Lack of knowledge about RWPC ‘But I think probably our main, not that it was a concern, I guess more thoughts, was how would the deferred consent work really.’ (P4, interview, female, physician) ‘I had a lot of concerns. I really thought it wasn’t going to work.’ (P1, focus group 2, female, nurse)	Dissemination of training ‘Training a large amount of staff.’ (P100, SIV questionnaire Part A, female, nurse)
How to explain RWPC to parents ‘How to word it to parents may be the bigger issue.’ (P91, SIV questionnaire Part A, female, physician) ‘How to approach it with the parents, like some one-liners’ (P3, interview, female, nurse) ‘I didn’t know if I was actually going to be able to converse with them, if I was going to be articulate enough. I was so terrified I just thought I was going to mess it up and nobody was ever going to say yes to me.’ (P3, focus group 5, female, nurse)	Research in a resuscitation situation ‘In acute situation therefore need to prioritise clinical care.’ (P45, questionnaire Part A, female, physician) ‘I thought, oh God, this sounds horrendous. Literally I was thinking, how is this going to work? This is going to be a nightmare.’ (P3, focus group 3, female, physician)
How parents would respond to RWPC ‘Concerned if parents angry that not asked consent prior to getting drug.’ (P27, SIV questionnaire Part A, female, nurse) ‘I was concerned that that might lead to some potentially conflicting, slightly awkward conversations.’ (P1, interview, male, physician) ‘I was a bit dubious about it, yes, because I’d never experienced deferred consent and I’d not been in research that long so it was a bit... I was of the thought that people might be greeted by a punch in the face or a similar sort of verbal aggression.’ (P3, focus group 6, male, nurse)	Buy-in – getting all staff on board ‘Not full time shop floor job role. Difficult to control for other people who may be less interested in our department being involved.’ (P121, SIV questionnaire Part A, female, physician) ‘It (the problem) wasn’t from the point of deferred consent, it was more from the fact that we have got to try and get all the A&E team on board with a research project.’ (P7, interview, male, nurse) ‘So that was my main concern before the SIV, was just, who else would be willing to do the deferred consent? I’ve got some trainees who would be excellent at it but they’re only going to be around for 6 months and then you’d have to keep training people, so it was making sure that the permanent members of our team would be on board.’ (P2, interview, male, physician)

SIV site initiation visit