Paediatricians’ attitudes to randomised controlled trials involving children

Patrina H. Y. Caldwell, B Med, Dip Paeds¹ Phyllis N. Butow, BA (Hons), MPH, MClinPsych, PhD³ Jonathan C. Craig, MBChB, MM (ClinEpi), DCH, FRACP, PhD ^2,4

1.Centre for Kidney Research, the Children’s Hospital at Westmead
2. Department of Paediatrics and Child Health, University of Sydney
3. Medical Psychological Unit, University of Sydney
4. Department of Public Health and Community Medicine, University of Sydney

Background: Randomised controlled trials (RCTs) are the “gold standard” for assessing intervention efficacy. However, recruitment is often problematic, particularly for children. Although doctors’ reluctance to enrol patients is a serious obstacles to trial success, little is known about paediatricians’ attitudes to trials. With the increasing recognition of the need to include children as participants in RCTs, it has become even more important to explore barriers to children’s participation in trials.This study aims to examine paediatricians’ attitudes and identify possible barriers to trial recruitment.

Method: Qualitative analysis of focus group discussions involving 21 paediatricians from a tertiary paediatric hospital in Australia. Doctors varied in occupation, experience, research activity, age, gender, ethnicity and parenthood experience. Data were organised, coded and shaped with linking of key themes using the constant comparative method.

Result:Paediatricians believed parents balanced perceived gains and risks when deciding about trial participation. They thought the child’s condition, parents’ health beliefs and personal attributes, the doctors’ beliefs and relationship with the investigators influenced parents’ attitudes. Perceived gains included professional benefits for paediatricians, 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. Paediatricians with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation. Paediatricians’ personal treatment preferences hindered trial support.

Conclusion:This study suggests that children’s participation in trials will be enhanced by increasing paediatricians’ awareness of RCTs through education and involvement in trials, and improving the gains-risk balance by reducing risks and increasing gains whenever possible.

Presented at the International Clinical Trials Symposium, Darling Harbour, Sydney NSW Australia 21-23 Oct 2002

Correspondence
P Caldwell
Centre for Kidney Research
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145 Sydney Australia
Tel: +61 2 9845 3037
Fax: +6 12 9845 3038
Email:Patrina Caldwell