Consent in Pediatric Critical Care Randomized Control Trails: A Systematic Review
Hanney I, Duffett M, Choong K, Menon K, Cook DJ.
Aims & objectives
Consent in randomized controlled trials (RCTs) can be challenging if immediate intervention is required or if the parents are unable to consider participation because of emotional stress. To describe the consent models and consent rates in pediatric critical care RCTs.
We included published English-language RCTs from the Evidence in Pediatric Intensive Care database (epicc.mcmaster.ca) of RCTs administering any intervention to children in a pediatric critical care unit. We excluded trials conducted in pre-term infants and cross-over trials.
We included 243 RCTs (1986 to 2013) from 32 different countries. 7 (2.9%) of trials reported the use of any approach other than written consent from the child or their parent or guardian (2 waived consent, 2 deferred consent, 2 verbal and 1 sought consent from one group) and 13 (5.3%) reported that they sought assent from the child. 20 (8.2%) reported consent was obtained prior to PICU admission. 74 (30.6%) of the RCTs reported a consent rate. The median (interquartile range) consent rate was 90% (72%, 97%). Using linear regression the of year of publication, commercial funding, prophylactic or pharmaceutical interventions, and pre-PICU consent were not independently associated with increased consent rate. Only 4 (1.6%) reported some characteristics of those who did not consent.
Alternative approaches such as deferred and waived consent were used in few studies. There are opportunities to improve the quality of reporting; very few trials reported the information necessary to determine the representativeness of those that consented to participate.