Parents' attitudes to children's participation in randomized controlled trials.

OBJECTIVE: To explore parents' attitudes to children's participation in randomized controlled trials. STUDY DESIGN: Qualitative analysis of focus group discussions involving 33 parents from a pediatric teaching hospital and local school in Australia. Parents varied in age, gender, ethnicity, level of education, research experience, and child's health status. The transcribed discussions were analyzed by theme linkage using the constant comparative method. RESULTS: Parents balance risks and benefits when deciding about trial participation for their child. Perceived benefits include the offer of hope, better care of their child, the opportunity to access new treatments, healthcare professionals and health information, meeting others in similar circumstances, and helping others. Perceived risks include potential side effects, being randomized to ineffective treatments, and the inconvenience of participation. The decision for trial participation is also influenced by parental factors (parents' knowledge, beliefs, and emotional responses), child factors (the child's health status and preference about participation), trial factors (the use of placebos and uncertainties of participation), and doctor factors (doctor's recommendations and communication of trial information). CONCLUSIONS: Educating parents about trials, improving communication between trialists, pediatricians, and parents, increasing incentives while decreasing inconveniences, and providing decision aids for parents may increase parents' willingness to participate in trials.

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.