Pediatricians' attitudes toward randomized controlled trials involving children

Caldwell, Patrina H Y; Butow, Phyllis; Craig, Jonathan C.

doi:10.1067/mpd.2002.129173

Cited by 71 publications

(83 citation statements)

References 35 publications

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“…115 Practitioners also cite time constraints as a barrier to recruitment in paediatric trials. 119 They are also concerned about the impact of research on the doctor-patient relationship, 119,120 the use of placebo and randomisation, 111,119 the practical burden of participation for families, 111 potential harms to participants and unpleasant procedures, such as venepuncture. 111,119 Some practitioners describe an allegiance to the patient, which they regard as being in conflict with the uncertainty inherent in trials, 120 and believe that families are liable to be confused by, or mistrust, trials.…”

Section: Barriers To Recruitmentmentioning

confidence: 99%

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Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Shilling

Williamson²,

Hickey³

et al. 2011

Health Technol Assess

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Section: Barriers To Recruitmentmentioning

confidence: 99%

“…In one focus group study, some paediatricians described how they disliked approaching parents and felt 'rejected' if parents said 'no' to a trial, while others described discomfort at expressing uncertainty because they were concerned it might damage parents' trust in their expertise. 119 …”

mentioning

confidence: 99%

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Shilling

Williamson²,

Hickey³

et al. 2011

Health Technol Assess

View full text Add to dashboard Cite

show abstract

“…The use of pragmatic trials where there are no additional burdens of testing and monitoring beyond the requirements of routine clinical care [37-40] may also alleviate some of these concerns, including the use of placebos [55]. Participation may also be improved by having trained investigators who understand the complexities of conducting trials in children, appropriate facilities that meet the needs of children and a designated trials co-ordinator to facilitate recruitment and trial conduct [45,93,100]. Increasingly the importance of engaging children and families in the recruitment, consent and design of trials has also been recognized [99].…”

Section: Attitudes To Participation In Trialsmentioning

confidence: 99%

“…decision for their child [87]. Mason & Allmark propose that parents' consent in trials is vital to socially recognise parental roles, but does not offer added protection for neonates to that provided by appropriate research ethics, safety monitoring and governance procedures and parent's knowledge of these measures would improve decision making [113].…”

Section: Informed Consent and Assentmentioning

confidence: 99%

“…The most frequently cited suggestions from interviews and focus groups for improving informed consent related to allowing parents more time to make their decision, the amount and type of information provided, organization of the consent meeting, communication style and providing additional materials [115]. Although consent by parents or guardians is a legal requirement for trials, the autonomy of children should be respected and investigators also need to include them in decision making as much as they are capable [27,87,116]. Children's dissent should also be respected, particularly if their dissent is different from their usual response to the same procedure in normal clinical care.…”

Section: Informed Consent and Assentmentioning

confidence: 99%

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