Objective: To examine pediatricians' attitudes toward children's
participation in randomized controlled trials (RCTs) and identify possible
barriers to participation. Study design: Qualitative analysis of focus group discussions involving
16 pediatricians and 5 trainees from a pediatric teaching hospital in Australia.
Doctors varied in occupation, experience, research activity, age, sex,
ethnicity, and parenthood experience. A professional facilitator conducted the
semistructured group discussions. The transcribed audiotapes were analyzed by
theme linkage by using the constant comparative method. Results: Pediatricians believed parents balanced perceived gains and
risks when deciding about trial participation. They thought the child's
condition, parents' health beliefs and personal attributes, and the doctors'
beliefs and relationship with the investigators influenced parents' attitudes.
Perceived gains included professional benefits for pediatricians, improved
patient care, convenience for the families and themselves, and scientific
advancement. Perceived risks included inconvenience, inadequate resources, and
potential harms to the patient and doctor-patient relationship. Pediatricians
with previous research experience were most knowledgeable about RCTs and
perceived greatest gains from trial participation. Pediatricians' personal
treatment preferences hindered trial support. Conclusions: This study suggests that children's participation in trials
will be enhanced by increasing pediatricians' awareness of RCTs through
education and involvement in trials and by improving the gains-risk balance. (J
Pediatr 2002;141:798-803)
From the Centre for Kidney Research, the
Children's Hospital at Westmead; the Department of Paediatrics and Child
Health, Medical Psychological Unit, and Department of Public Health and
Community Medicine, University of Sydney, Australia.
Supported in part by the Centre for Kidney
Research at the Children's Hospital at Westmead. P. Caldwell was supported by
the University of Sydney Postgraduate Award Scholarship.
Submitted for publication Mar 11, 2002;
revision received June 19, 2002;
accepted Aug 5, 2002.
Reprint requests: Patrina Caldwell, BMed,
Centre for Kidney Research, The Children's Hospital at Westmead, Locked Bag
4001 Westmead NSW 2145, Sydney, Australia.
Randomized
trials and recruitment tribulations: Rethinking the research enterprise
Journal of Pediatrics
December 2002 Volume 141 Number 6
Richard C. Wasserman, MD, MPH
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MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
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-- Albert Einstein, letter to a friend, 1901
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-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
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-- Sandy Gottstein
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