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

Full Abstract

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.

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Author information

Author/s: Caldwell, Patrina H y (PH); Butow, Phyllis N (PN); Craig, Jonathan C (JC);

Affiliation: Centre for Kidney Research, the Children's Hospital at Westmead, Australia. Patrinac(-atsign-)chw.edu.au

Journal and publication information

Publication Type: Journal Article; Research Support, Non-U.S. Gov't

Journal: The Journal of pediatrics (J Pediatr), published in United States. (Language: eng)

Reference: 2003-May; vol 142 (issue 5) : pp 554-9

Dates: Created 2003/05/20; Completed 2003/07/07; Revised 2007/11/15;

PMID: 12756389, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: J Pediatr. 2004 Jan;144(1):140; author reply 140. (PMID: 14722535)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Male
Middle Aged
Parents - education
Patient Selection
Randomized Controlled Trials as Topic
Risk Factors

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