Attitudes of paediatricians to children's participation in randomised controlled trials

PHY Caldwell¹, PN Butow², JC Craig³

1. Centre for Kidney Research, The Children's Hospital at Westmead.
2. Medical Psychology Unit, University of Sydney.
3. Dept Public Health and Community Medicine, University of Sydney.

Aim: Recruitment of participants to randomised controlled trials is critical to their success, but factors influencing children's participation are completely unexplored. This study aims to analyze attitudes of paediatricians to children's participation in RCTs, and identify potential barriers to participation.

Methods: Twenty-one paediatricians and trainees from the Children's Hospital at Westmead participated in four focus groups. Doctors varied in position, experience, research activity, age, gender, ethnicity and parenthood experience. Audiotapes of the focus groups were transcribed, and data were organized, coded and shaped with linking of key themes.

Results: Paediatricians thought parental beliefs, parental characteristics and children's conditions affected parental attitudes to trials and the paediatrician's own beliefs and relationship with the investigators influenced their attitudes. These factors impacted on the balance of perceived gains and risks. Subgroup analysis showed differences in response between "active" participants with previous research experience, and "passive" participants with no experience. "Active" participants perceived more gains from trial participation and were more knowledgeable about RCT procedures. Lack of personal equipoise was a significant barrier for participation in both groups.

Conclusion: The balance of perceived gains and risks may be changed by exploring issues of equipoise and educating paediatricians about RCT conduct, leading to improvements in recruitment to paediatric RCTs.

Presented at a meeting of the Australasian Epidemiological Association, Sydney, September 2001.

Correspondence:
Dr Patrina Caldwell
PatrinaC@chw.edu.au