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December 2002 • Volume 141 • Number 6

 

 

Original Articles
Pediatricians' attitudes toward randomized controlled trials involving children

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.
   
• Copyright © 2002, Mosby, Inc. All rights reserved.
   
• 0022-3476/2002/$35.00 + 0  9/21/129173
   
• doi:10.1067/mpd.2002.129173

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