Opportunities for Enhancing Patient Recruitment in Clinical Research

Insisting on prospective consent in paediatric critical care research may be throwing the baby out with the bathwater

“…9 A general lack of research evidence in the paediatric critical care population has resulted in the most vulnerable and severely ill patients often being subjected to untested medical procedures and medications. 6 Tasker et al 11 found approximately only 1% of children admitted to paediatric intensive care were enrolled in randomised controlled trials. Current literature indicates off-label paediatric prescriptions occur in Europe at a rate of 45-60% with rates as high as 90% for paediatric and neonatal intensive care patients.…”

“…The literature describes parental support for the concept of deferred consent in paediatric emergency and/or critical care research, depending on the nature of the trial 8,9,11,14,19 . One study surveyed the level of support for deferred consent and found 91% of parents were satisfied with the consent process 20 .…”

“…16 Several sources challenge the term 'deferred consent' as a misnomer since it is unfeasible to obtain permission to perform an intervention that has already occurred, and it may be contradictory to treating patients with respect. 3,11 Miller 17 proposes the concept is nonsensical and should be more accurately termed 'ratification'. He suggests deferred consent implies the right to refuse but it is impossible to refuse something that has already happened and there is no justification for placing patients at risk in the interests of future patients or for the benefit of health-care advancement.…”

“…This ensures ongoing ambiguity around the concept, with the argument against deferred consent suggesting it undermines autonomy by diminishing the right to voluntary participation in research 16 . Several sources challenge the term ‘deferred consent’ as a misnomer since it is unfeasible to obtain permission to perform an intervention that has already occurred, and it may be contradictory to treating patients with respect 3,11 . Miller 17 proposes the concept is nonsensical and should be more accurately termed ‘ratification’.…”

Focus on paediatrics

“…The "gap" is a ratio of 100-to-1, i.e., only one patient recruited to an RCT for every 100 patients admitted for PICU care [1]. This "focus on paediatrics" therefore explores how this gap might be closed.…”