(1485) A Scoping Review of Literature to Improve Research Consenting Practices in Critically Ill Children

Introduction: Clinical trials are imperative to advance care for critically ill patients. Recruitment for pediatric trials poses unique challenges including use of a surrogate decision-maker, limited recruitment windows, and recruitment during stressful times. Limited data around enrollment rates describes underreporting and variation of enrollment. We conducted a scoping review of the existing literature to evaluate strategies to improve enrollment rates for critically ill children participating in clinical studies.

Methods: A scoping review of the literature was done through November 2023. An iterative process was used to translate and refine the search. Two screeners independently reviewed titles, abstracts and full text of eligible articles. Inclusion criteria were critically ill children < 18 years, a clinical study of interventions to improve enrollment, and included a description of interventions or factors targeted at consent. We excluded studies that were non-human, hypothetical, in a non-health care setting, or an inability to translate to English language. Conflicts were resolved via group discussion.

Results: 2531 studies were screened. Of those 2495 did not meet inclusion criteria, leaving 36 full-text studies that were assessed. Seventeen were excluded due to wrong study design and non-ICU setting. Ultimately, 19 studies were included in the review. The studies spanned from 2001 to 2019 with 7 randomized controlled trials, 3 qualitative, 3 observational, 2 cohort, 2 cross-sectional studies, and 2 survey/questionnaires. Study ICU locations included 8 Neonatal, 10 Pediatric, and 1 pediatric cardiac ICU. There was a total of 2788 participants. A summary of findings included no impact on consent rates with co-enrollment in multiple clinical trials, tele-simulation training of research staff did not change enrollment rates, time constraints and parental social differences often limited enrollment. Adding sites had a positive effect on enrollment rates.

Conclusions: While there is limited research demonstrating strategies to improve enrollment rates for pediatric critical care trials, increasing sites improves enrollment rates. Parental social differences also suggest community engagement will help in future design of studies, practice, and education for those involved in research enrollment.