Parents’ attitudes to randomised controlled trials involving children

Patrina H. Y. Caldwell, B Med, Dip Paeds ^1,2
Phyllis N. Butow, BA (Hons), MPH, MClinPsych, PhD ³
Jonathan C. Craig, MBChB, MM (ClinEpi), DCH, FRACP, PhD ^1,2,4

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: The recruitment of children to randomised controlled trials (RCTs) is often problematic. Parents play a key role in decisions for trial participation for children. This study explores parents’ attitudes to trials, identifying factors that influence the decision for trial participation and parents' perception of risks and benefits. It also compares responses of parents of children with health problems of varying severity.

Method:Qualitative analysis of focus group discussions involving 33 parents from a tertiary paediatric hospital and a local school in Sydney, Australia. Parents varied in age, gender, ethnicity, level of education, geographic locality, research experience and child’s health status. Data were organised, coded and shaped with linking of key themes using the constant comparative method.

Result:Parents are influenced by risk-benefit considerations in decisions about trial participation for their child. Perceived benefits include the opportunity to access new treatments, better care of their child, greater access to healthcare professionals and health information, meeting others in similar circumstances, the offer of hope and altruistic benefits. Perceived risks include the risk of side effects, being randomised to ineffective treatments and the inconvenience of participation. The weighting of the decision for trial participation are also influenced by parental factors (parents’ beliefs and knowledge about trials and emotional response to trial participation), child factors (the child’s health status and preference about trial participation), trial factors (the use of placebos and the inherent uncertainties of trial participation) and doctor factors (doctor’s recommendations and communication of trial information).

Conclusion:Educating parents about trials, improving communication between trialists, paediatricians and parents, increasing incentives while decreasing inconveniences and providing decision aids for parents may help increase parents’ willingness to participate in trials.

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