Retrospective acceptability of a FEVER pilot trial mapped to Sekhon et al’s acceptability framework
| Group nd data collection method(s) | Affective attitude | Burden | Ethicality | Intervention coherence | Opportunity costs | Perceived effectiveness | Self-efficacy |
| Parents Interviews | ‘I think it’s a brilliant idea, so I’m all, I’m all for it’ (P80, interview mother, permissive). Decliners also approve the trial ‘They seem to be quick let’s give them paracetamol. we’ve always been like a kind of, a hold off (…) I think sometimes paracetamol can hide other things going on as well.’ (P83, interview, mother, permissive, decliner) | Not invasive: ‘I mean if it was more of an invasive study, I might have had to query it a little bit more but I was happy with everything’ (Parent 53, interview, father, restrictive). Not in discomfort while ventilated. | Not causing harm to their child: ‘I just thought, There’s no harm in letting her into the study’ (P78, interview, mother, restrictive). Wish to help others ‘if it’s gonna help other people then yeah’ (P85, interview, father, restrictive). RWPC was acceptable. | Involved treatment which parents were familiar with; that logically made sense and that was ‘Clearly explained.’ (P74, interview, mother, permissive) | 37.5°C, very acceptable as normal practice at home. 39.5°C acceptable if child is not in discomfort | Understand how a fever may logically help a child. | Valued ability to withdraw or decline consent. ‘I was happy enough for him to undergo the trial but if at any point the nurses thought he could do with the Calpol, or I thought he could, then I wanted the trial to stop it could do.” (P49, interview, mother, permissive) |
| When being weaned of ventilator Some children displayed discomfort/distress. | ≥39.5°C not acceptable if the child is in pain or distress. | Concerns about negative impact due to child’s pre-existing medical conditions. | |||||
| Staff Focus group and survey | 85% (n=81/95) trial acceptable. 95% (n=95/100, four missing): 37°C acceptable. 53% (n=42/79): 39.5°C acceptable. | If the child is not conscious or not in pain no burden. | Parents think the trial is acceptable; therefore, it is ethical to randomise their children. 89.4% (n=42/48) satisfied with the use of RWPC. | If trained by trial team, then 39.5°C acceptable. | Mixed views, some observed no negative side effects and reported no costs. | Seeing as believing, ‘It’s a really good, valuable study to see on a larger scale.’ (P04, Staff, FG5) | Valued being involved in trial design. Ability to follow the protocol mixed, n=52/96 (54%): ‘technically very easy to follow.’ (P06, Staff, FG1) |
Key: shaded fields highlight potentially unacceptable aspects of the trial.
FG, Focus group; RCT, randomised control trial; RWPC, research without prior consent.