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Published on: September 20, 2019
High-Quality Randomized Controlled Trials in Pediatric Critical Care: A Survey of Barriers and Facilitators
Mark Duffett1, Karen Choong, Jennifer Foster
11Departments of Pediatrics, McMaster University, Hamilton, ON, Canada. 2Departments of Pediatrics and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 3Department of Pediatrics, Dalhousie University, Halifax, NS, Canada. 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 5Departments of Pediatrics and Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada.
Insights
Lack of funding and time are major barriers to conducting high-quality randomized controlled trials in pediatric critical care globally. Research networks and protected time are key facilitators for improving evidence generation in this field.
Area of Science:
- Pediatric Critical Care Research
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- High-quality, adequately powered randomized controlled trials (RCTs) are crucial for advancing pediatric critical care.
- A significant gap exists in the availability of such evidence, hindering optimal patient care.
- Understanding the challenges and enablers of conducting RCTs in this specialized field is essential.
Purpose of the Study:
- To identify barriers and facilitators for conducting high-quality RCTs in pediatric critical care.
- To gather insights from trialists actively involved in this research area.
- To inform strategies for improving the generation of robust evidence in pediatric critical care.
Main Methods:
- A self-administered online survey was distributed to authors of pediatric critical care RCTs published between 1986 and June 2015.
- Respondents rated the importance of identified barriers and the effectiveness of potential facilitators on a seven-point scale.
- Data were collected from 116 researchers across 25 countries.
Main Results:
- Lack of funding was identified as the most significant barrier to conducting pediatric critical care RCTs.
- Key facilitators included protected research time, 24/7 participant recruitment capability, research network collaboration, dedicated government funding, and academic department support.
- Differences in barrier importance ratings were observed based on respondent experience and country income level, while facilitator perceptions were more consistent.
Conclusions:
- Inadequate funding and insufficient protected time represent substantial global obstacles to pediatric critical care RCTs.
- Implementing strategies like research networks and securing dedicated funding are vital for enhancing the conduct of rigorous trials.
- The findings provide actionable insights for the pediatric critical care research community to overcome barriers and promote high-quality evidence generation.
Objectives:
High-quality, adequately powered, randomized controlled trials are needed to inform the care of critically ill children. Unfortunately, such evidence is not always available. Our objective was to identify barriers and facilitators of conducting high-quality randomized controlled trials in pediatric critical care, from the perspective of trialists in this field.
Design:
Self-administered online survey. Respondents rated the importance of barriers and effectiveness of facilitators on seven-point scales.
Setting:
Authors of 294 pediatric critical care randomized controlled trials (published 1986 to June 2015).
Subjects:
One hundred sixteen researchers from 25 countries participated.
Interventions:
None.
Measurements And Main Results:
Respondents reported a median (Q1, Q3) of 21 years (15, 26 yr) of experience and 41 (36%) had authored more than one randomized controlled trial. More survey respondents, compared with nonrespondents, had published more than one trial (35% vs 26%; p = 0.002) and their trials were more often cited (median citations/yr, 2.4 vs 1.5; p < 0.001). Of the barriers listed, the five most important were primarily related to lack of funding. The five facilitators perceived as most effective were protected time for research, ability to recruit participants 24 hours per day/7 days per week, conducting randomized controlled trials in collaboration with a research network, funding from government agencies specifically for randomized controlled trials in critically ill children, and academic department support for conducting randomized controlled trials. Respondent experience and country income level were associated with differences in importance ratings for eight of 41 barriers. There were fewer such differences for facilitators.
Conclusions:
Lack of funding and time are major barriers to conducting pediatric critical care randomized controlled trials worldwide. Although barriers varied among country income levels, the facilitators of such trials were more consistent. In addition to increased funding, respondents identified other strategies such as research networks that are within the purview of the pediatric critical care research community, to facilitate the conduct of rigorous randomized controlled trials.
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