Table 2

Prospective acceptability of a FEVER pilot trial mapped to Sekhon et al’s acceptability framework

Group and data collection methodAffective attitudeBurdenEthicalityIntervention coherenceOpportunity costsPerceived effectivenessSelf-efficacy
Parents
Interviews
100% stated they would consent for their child to take part in a FEVER RCT.
Would consent with a 40°C threshold, but 39.5°C–39.9°C more acceptable:
I think 39.5(°C). But again you guys know best I’m just saying …that’s very hot’. (P17, father, non-bereaved)
The intervention was not invasiveBelief; it is important to help other children in the future.
Use of RWPC is necessary: ‘I understand there’s not really another way you can do it’ (P01, mother, non-bereaved)
Logically ‘make sense’ (P02, mother, bereaved).
PIS: ‘it’s simple for them to read’. (P06, mother, bereaved)
Children would still be given all other kinds of care/interventions.When study rationale was explained parents understood how allowing a fever could have a positive impact: ‘Fever is meant to be like part of a fighting off, healing process isn't it?’. (P07, mother, non-bereaved).The intervention was something parents understood and said that they could support.
Important to approach for RWPC when parents have the capacity to make an informed decision.
Concerns about unnecessary discomfort/pain in higher threshold.Many suggested changes to the PIS to assist understanding and decision-making.Concerns about loss of non-antipyretics effects of paracetamol, eg, reducing risk of seizures/rigours and pain relief.
Staff
Focus group
82% (45/55, one missing) indicated 39.5°C was an acceptable permissive temperature threshold.
18.2% suggested 40°C was acceptable.
Only 20.4% suggested 37.5°C was acceptable as may lead to unnecessary intervention.
Watching a child be in pain or experience negative side effects: ‘Incredibly difficult to wait and watch’. (P05, Staff, FG5). The trial would be more acceptable if limited to ventilated children.Mixed views on RWPC, n=25/49, (51%) thought acceptable based on past experience and the emergency situation.Understanding that optimal temperature thresholds are unknownConcerns about the loss of non-antipyretic effects for example, discomfort relief, reducing risk of seizures/rigours, decreased cardio work load.Evidence to support the trial: ‘Well there is, there is a bit of science which suggests we should let the temperature get higher’. (P01, Staff, FG3)No perceived issues with taking a temperature. Query method that is going to be used.
Concerns about use of RWPC for an intervention that may not be supported by parents.Want more clinical evidence as it goes against experiential knowledge (eg, administering antipyretic at 38°C).Staff with no experience of RWPC had concerns it would negatively impact on trust and the ‘working relationship’. (P03, Staff, FG1)Waiting for the permissive threshold would go against their clinical training or ‘gut instinct’. (P05, Staff, FG2)Nurses stated that they may not follow the protocol if a child was upset, combative and in discomfort.
  • Key: shaded fields highlight potentially unacceptable aspects of the trial.

  • FG, Focus group; PIS, participant information sheets; RCT, randomised control trial; RWPC, research without prior consent.