Improving randomized controlled trial evidence in pediatric critical care: the perspectives of trialists
Duffett M, Swinton M, Cook DJ.
Aims & objectives
The care of all critically ill children should be informed by evidence from large high-quality randomized controlled trials (RCTs). Unfortunately such evidence is not always available. Our objective was to identify acceptable, feasible and effective strategies to improve the quality, quantity and impact of evidence from RCTs in pediatric critical care.
Qualitative descriptive study based on semi-structured interviews with pediatric critical care researchers who have successfully completed and published an RCT.
Participants were 26 trialists from 8 countries. Most participants (25 [93%]) were from high-income countries, 9 (33%) had published more than 1 RCT, 17 (63%) had published a multicentre RCT, and 8 (30%) had published a multinational RCT. An important theme that emerged was “building communities” — groups of individuals with similar interests, shared experiences, and common values, who are bound together by professional and personal relationships. Participants described a sense of community as a source of motivation and as a means to enable larger, more rigorous trials by enhancing collaboration, increasing researcher and clinician engagement, and creating and maintaining enthusiasm. Strategies to build communities focused on the importance of face-to-face interactions (both professional and social), capable leadership, and trust. Another important theme was “getting started as an investigator.” Participants stressed the importance of specific research training (in addition to clinical training) and high-quality experiential education collaborating on other people’s projects, guided by effective mentorship. Also important was ensuring fair recognition and academic credit for all research contributions, not just for being the principal investigator. Participants also made specific suggestions for improving the design and conduct trials.
Experienced trialists shared practical strategies to increase the rigor, efficiency, and impact of individual trials. They also identified several methods to improve the pediatric critical care research enterprise including building a sense of community and key formal and informal training opportunities for new investigators.