Illustrative quotations from participants
| Themes and subthemes | Topic | Quotation |
| Theme 1: opt-out consent operationalised as verbal opt-in consent | ||
| Verbal consent—professionals | ‘You were going backwards and forwards to see if they wanted to do it or not. And sometimes you felt a bit like you were harassing them because you needed to have a decision’. (HP07) | |
| Verbal consent—parents | ‘They gave us I think two days or one day to make the decision … I just had to give verbally confirmation’. (P04) | |
| Reasons—electronic patient record | ‘When you go into [the electronic patient record] to randomise it, it asked if you had consent from parents … So it was difficult to say it was an opt-out’. (HP05) | |
| Reasons—unfamiliarity | ‘We only really have practised consenting for trials, we haven’t really practised opting out, and I think maybe our language is wrong… it needs to be much, much clearer how that conversation works… Is it that we’ll come back to you and ask you, ‘Do you want to opt out,’ which sounds very much like, ‘Do you want to opt in?’ Or is that if families don’t come back to us with an opt-out then they are in?’ (HP04). | |
| Reasons—ethical concern | ‘I would actually find it really challenging … I would be uncomfortable to put everything on(the parents’)responsibility’. (HP09) | |
| Theme 2: opt-out consent normalises participation while preserving parental choice | ||
| Normalisation | ‘Because a lot of the time they just want normal practice, what everyone else is doing … they don’t actually want to make the decision, but they want to feel like they’ve made a decision’. (HP07) | |
| Opt-out consent does not compromise parents’ right to choose. | ‘Unless we are excluding ourselves you will be enrolled… it’s just our choice, isn't it? Somebody’s giving you a choice, you join or you exclude yourself, it’s down to you’. (P04) | |
| Preferring not to actively choose | ‘With everything that was going on it seemed quite insignificant, so we just passed the decision over to the doctors’. (P08) | |
| Theme 3: opt-out consent as an ongoing process of informed choice | ||
| Same imperative to secure fully informed choice | ‘I don’t think just because you’re opting out that’s an excuse to be less informative’. (HP02). | |
| Parents had enough information. | ‘Someone explains the situation … and then [you] make an informed decision about it’. (P10) | |
| Parents appreciated a concise information leaflet. | ’The last thing I wanted was to sit down and read a leaflet’. (P02) | |
| Brief information was proportionate. | ‘It’s very simple, everything is really clear … on the other studies because it involved medication … you required more information to make you to decide’. (P04) | |
| Parents valued explanation from staff. | ‘The way they explained it to me, I was comfortable with it … it’s that human interaction beforehand, that explaining that helps’. (P10) | |
| Parents felt overwhelmed. | ‘I was not of sane mind, like we didn’t know if [the baby] was going to live or not, so to then discuss studies when it’s not really about his personal care, you kind of ignore it’. (P11). | |
| Traumatic context might affect understanding. | ‘At lot of it was blurry … I really didn’t comprehend what they were trying to say. I just said ‘yes’ because it was overwhelming and it was a lot’. (P05) | |
| Professionals confirmed ongoing consent before intervention. | ‘I gave them the option that you can opt out anytime … Before we gave a transfusion we are saying that, ‘They are part of the WHEAT trial, are you happy that we are following exactly as the WHEAT trial?’’ (HP10) | |
| Parents used opt-out consent to defer decision making. | ‘I was happy to put him onto the study because I was like, ‘I don’t really need to make this decision for sure until we find out whether he’s actually going to have a blood transfusion’… What made me feel better was that at any point we could say ‘No, we don’t want to do this anymore’. (P01) | |
| Theme 4: consent without a consent form | ||
| Benefit to professionals | ‘The paper trail was great … beautifully easy’. (HP04) | |
| Benefit to parents | ‘From a parental perspective, they don’t have to sign a document which they will feel more responsible for doing’. (HP09) | |
| Risk to professionals | ‘Almost to cover your own back so that in two weeks’ time, ‘Well, they didn’t tell me that’. And they’ve not signed anything, it’s just my word’. (HP06) | |
| Some parents request paperwork | ‘They were saying that we have to get something on paper, like evidence, so I printed twice the enrolment data from (the electronic patient record)’. (HP03) | |
| Parents satisfied | ‘She then explained that it was an opt-out trial and therefore we didn’t need to sign a consent form… I thought it was okay’. (P01) | |
| Theme 5: choosing to opt out of a comparative effectiveness trial | ||
| Wanting ‘normal care’ | Normal care understood as care at this unit | ‘(Parents say), ‘We will just do whatever you guys are normally practising here’ … because that’s the only hospital that’s known to them’. (HP09) |
| Using examples of staff who have experience in other units | ‘We say, ‘Where [that nurse] has worked previously, their normal treatment would be not to feed’ … [parents] can see it in front of them, that there are places close by who may not feed, but we feed and other places don’t and other places do’. (HP05) | |
| Having normal care means not having to take responsibility for a decision | ‘Any kind of standard care the baby will receive will take this kind of relief from [parents], that they don’t have to make that decision’. (HP03) ‘I didn’t want to be the one that had made the decision to change what the treatment would have been, because had that then gone wrong and caused a problem, that would have been due to my decision’. (P01) | |
| A belief that feeding is better | Importance and topic of trial not fully understood | ‘It was just generally getting an idea of what the outlook is when you’re in the two different groups, and I think she was telling me that in their opinion it was always very similar and that they therefore thought that it wouldn’t make a difference’. (P01) |
| Difficult to explain clinical equipoise without undermining confidence | ‘It’s always a slightly odd conversation … If I was a parent I’d think, ‘Well haven’t they learned how to feed babies yet?’’ (HP02) | |
| Health professionals had personal views | ‘Feeding and its putative relation to NEC, I don’t believe there’s any connection myself’. (HP02) ‘Not all staff bought into the idea of … stopping feeds over 11 hours … I don’t know whether that came about in their consenting processes as well’. (HP01) | |
| Parents had intuitive views of feeding during transfusion. | ‘Parents say ‘Why would you stop feeds, because feeding is such a natural thing?’’ (HP01). | |
| Concern about length of time feeds withheld | ‘Parents mainly pick up the fact that 12 hours, that’s quite a long period of time’. (HP03) | |
| Parents concerned about hunger and weight gain | ‘Anytime that they’re not fed it stresses us out…Because they’re only born a pound and so every little gram helps’. (P11) | |
| Some parents would have subsequently opted out if baby was not randomised to their preferred arm | ‘If he had been put in the group where he would have had IV fluids then we would have withdrawn him from the study at that point’. (P08) | |
| Parents encouraged to defer opting out until after randomisation | ‘I told them, ‘Don’t worry, we’ll just randomise them and then we will see, if they are in the feeding group anyway it won’t make a difference, [and] they can actually opt out any time’’. (HP10) | |