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Pediatricians' attitudes toward randomized controlled trials involving children
Patrina H Y Caldwell1, Phyllis N Butow, Jonathan C Craig
1Centre for Kidney Research, the Children's Hospital at Westmead, Sydney, Australia.
The Journal of Pediatrics
|December 4, 2002
Summary
Pediatricians
Area of Science:
- Pediatric Research
- Clinical Trials
- Medical Ethics
Background:
- Understanding pediatrician attitudes is crucial for enhancing pediatric clinical trial participation.
- Pediatric randomized controlled trials (RCTs) are vital for advancing child health but face recruitment challenges.
Purpose of the Study:
- To investigate pediatricians' perspectives on children's involvement in randomized controlled trials (RCTs).
- To identify potential barriers and facilitators influencing pediatrician support for pediatric trial participation.
Main Methods:
- Qualitative study utilizing focus group discussions with 16 pediatricians and 5 trainees.
- Semistructured interviews were conducted and analyzed using thematic linkage and constant comparative methods.
Main Results:
- Pediatricians perceive parents weigh risks and benefits when deciding on trial participation.
- Factors influencing decisions include child's condition, parental beliefs, and physician-investigator relationships.
- Perceived gains (professional, patient care, scientific advancement) and risks (inconvenience, harm, relationship damage) were identified.
- Prior research experience correlated with greater perceived gains and knowledge of RCTs.
Conclusions:
- Enhancing children's participation in trials requires increasing pediatrician awareness and involvement in RCTs.
- Improving the perceived balance of gains and risks for all stakeholders is essential.
- Educational initiatives and direct trial involvement can foster greater pediatrician support for pediatric research.