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

Aim: To explore parents’ attitudes to randomised controlled trials (RCTs) involving children.

Method:Qualitative analysis of focus group discussions involving 33 parents. Parents were recruited from the Children’s Hospital at Westmead, including from the Oncology Unit (“oncology parents” with children who have life threatening illness), the Renal Treatment Centre (“renal parents” with children who have chronic conditions), various research groups involved in RCTs (“trial parents”), hospital wards (“hospital parents” with children who are inpatients), and from a local primary school (“school parents” with healthy children). 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 Paediatric Research Seminar, The Children's Hospital at Westmead, Sydney NSW 2145 Australia, 29 July 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