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Published on: September 20, 2019
Consent Rates Reported in Published Pediatric Randomized Controlled Trials
Julia A Lonhart1, Ashley R Edwards1, Swati Agarwal2
1Stanford University School of Medicine, Palo Alto, CA.
Insights
The average consent rate for pediatric randomized controlled trials (RCTs) is 82.6%, but nearly a quarter of trials report rates below 70%. Improved consent reporting is needed for future pediatric clinical research.
Area of Science:
- Pediatric clinical research
- Medical ethics
- Biostatistics
Background:
- Informed consent is crucial in pediatric randomized controlled trials (RCTs).
- Understanding reported consent rates and their variability is essential for ethical research planning.
- Previous assessments of consent rates in pediatric RCTs are limited.
Purpose of the Study:
- To determine the average reported consent rate for published pediatric RCTs.
- To investigate whether consent rates vary based on trial characteristics such as funding and therapeutic area.
- To identify trends and areas for improvement in consent reporting for pediatric research.
Main Methods:
- A systematic review of pediatric RCTs published in 2009, 2010, and 2015 was conducted.
- Trials with missing or unclear consent data were excluded.
- Random effects meta-regression was used to calculate the weighted average consent rate.
Main Results:
- The average consent rate across 278 included pediatric RCTs was 82.6%.
- Consent rates were higher for vaccination trials and industry-funded trials compared to behavioral or government-funded trials.
- Approximately 26% of trials reported consent rates below 70%, with US trials showing a higher probability of lower consent rates.
Conclusions:
- While the average consent rate is high, suboptimal reporting exists in a significant portion of pediatric RCTs.
- Consent reporting has improved but remains an area needing attention for future pediatric research.
- Findings can inform the design of future pediatric RCTs, though data from unpublished trials are also needed.
Objective:
To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics.
Study Design:
A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate.
Results:
Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was <70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of <70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category.
Conclusions:
Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of <70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.
