Table 3 Findings mapped against the Theoretical Framework of Acceptability

Parents

Interviews

28/31 (90%) would hypothetically provide consent for their child to take part if they were approached about the trial.

The intervention of not measuring GRV is less invasive than conducting GRV “I just think that extra intervention, if it’s not actually doing anything positive, then is it really necessary” (P18, mother, PICU & NNU)

Conversely measuring GRV was also seen as acceptable as their child would be receiving normal or ‘standard’ clinical care as most units in the UK measure GRV: “Well that's just the way it is.” (P20, mother, PICU)

Belief it is important to help other children in the future.

Important not to put your own child in additional risk or discomfort.

The proposed study question “makes perfect sense” (P23, father, PICU).

The draft participant information sheet is “very clear” (P23, father, PICU), “very straightforward” (P01, mother, NNU)

Suggested further improved by summarising key points and more detail on benefits.

NNU parents were concerned about the risk of delayed diagnosis of bowel or stomach problems, or missing signs of an infection.

NNU and PICU parents worried about the risk of vomiting into lungs,

“nine times out of ten if they shot it back in, she was sick” (P15, NNU, father)

Both groups of parents focused on the risk of increased pain or discomfort.

When study rationale was explained parents understood how not measuring GRV might:

-Reduce infections,

-Improve overall health “if they’re getting calories on board quicker, they’ll start to feel better quicker” (P09, mother, NNU)

-Reported reduced discomfort and pain.

The intervention was something parents understood and said they could support

Conversations about research when their child was still critically ill: “would have to be very carefully approached” (P15, father, NNU). To prevent them from saying no due to situational incapacity.

Practitioners

Focus groups and interviews

Of the forty-six practitioners (95.8%) who answered the question, ‘how acceptable is it to conduct the proposed trial?’ The majority, 84% (n=39/46) indicated it was ‘acceptable’ or ‘very acceptable’

One arm [measuring GRV] standard care.

Less invasive

Not ethical to put a child at additional risk.

It is not ethical to conduct unnecessary procedures.

Consistent evidence based practice is important.

Generally a clear understanding of the proposed trail. However a few were confused about the difference between checking the gastric residual volume, by aspirating the entire stomach contents, and simply confirming the position of the feeding tube (by testing the pH) involving testing a small amount of fluid.

Concerns about increasing the risk of adverse events (AE), causing discomfort and pain or vomiting. not identifying early signs of: infections, gut obstructions or feed intolerances, lung injury (ARDS) NEC, stenosis of pyloric sphincter.

In contrast, some practitioners stated that measuring GRV was, on its own, “completely meaningless” (P06, interview, doctor, NNU)

There were mixed views on the importance of the clinical question. However they highlighted the value of increasing “nutritional intake by not checking [GRV], in the majority of patients” (P02, interview, dietitian, PICU) and reduced risk of hospital related infection

All practitioners said that the trial was practically possible to conduct

Six participants, from a range of clinical backgrounds, described how they would “feel uncomfortable” (P06, FG3, senior nurse, PICU) about changing this ‘normal’ practice for a trial: “without the evidence” (P07, FG2, research nurse, PICU) to support such a change.