Recruitment of children in randomized controlled trials
PHY Caldwell¹ , JC Craig ² and PN Butow ³
1. Centre for Kidney Research, New Children’s Hospital
2. Department of Public Health and Community Medicine, University of Sydney
3. Medical Psychological Unit, University of Sydney
Introduction:
Increasingly, the need for the inclusion
of children in randomised controlled trials (RCTs) is recognised. However, the
recruitment of children to trials is often problematic. The study of the RCT
recruitment process is a relatively new but important area of research, with
little work on the recruitment of children.
Studies:
Recruitment strategies for recruitment to RCTs:
a systematic review of controlled trials and observational studies.
Aim: to assess the effectiveness of different methods of recruiting
participants to RCTs.
Methods: This review followed the guidelines of the Cochrane Collaboration for question formulation, literature searching, critical appraisal and data extraction identifying randomised and observational studies that compared two or more methods of recruiting participants to RCTs. Outcome measures were accrual rates, proportion enrolled by each method and cost of recruitment per participant.
Results: From 4340 potentially eligible studies, 38 studies (43 substudies) were included -6 RCTs, 2 quasi RCTs, 12 cohort studies, 22 cross sectional analytical studies and 1 before-after study included. Overall 48605 participants were randomised into trials from over 4,000,000 people approached for trial participation.
Conclusions: Interventions used to enroll patients in trials are very heterogeneous, with personalized methods having a higher accrual rate compared with other methods. However, the low proportions of participants enrolled by this method suggests strategies where large numbers of potential participants are approached may be more cost effective.
Paediatricians’ attitudes to randomised controlled
trials involving children.
Aim: to examine paediatricians’ attitudes
to paediatric RCTs.
Methods: Qualitative analysis of focus group discussions involving 21 paediatricians from the Children’s Hospital at Westmead (CHW).
Results: Paediatricians believed parents balanced perceived gains and risks when deciding about trial participation. They thought the child’s condition, parents’ health beliefs and personal attributes, the doctors’ beliefs and relationship with the investigators influenced parents’ attitudes. Perceived gains included professional benefits for paediatricians, 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. Those with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation. Personal treatment preferences hindered trial support.
Conculsions: Increasing paediatricians’ awareness of RCTs through education and involvement in trials, and improving the gains-risk balance by reducing risks and increasing gains whenever possible may enhance trial participation.
Parents’ attitudes to randomised controlled trials involving children.
Aim: to explores parents’ attitudes to children’s participation in
RCTs.
Methods: Qualitative analysis of focus group discussions involving
33 parents from CHW and from a local primary school.
Results: Parents are
influenced by risk-benefit considerations in decisions about trial participation.
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).
Conculsions: 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
Questionnaire on physician and paediatricians’ attitudes
to randomised controlled trials.
Aim: to explore and compare adult physician and paediatricians’
attitudes to RCTs.
Methods: The “Physician Oriented Profile” is a questionnaire developed
as a tool for assessing doctors’ treatment philosophies which was thought
to determine their likelihood of referring patients to trials. This questionnaire
was applied to a random sample of 500 adult physicians and paediatricians
from the Royal Australasian College of Physicians.
Results: pending
The assessment of current recruitment strategies and exploration of doctors’ and parents’ attitudes to trials should result in the development of more effective recruitment, improving trial success in the future.
Presented at From Cell to Society 3, Research Conference 2002, College of Health Sciences, University of Sydney, 18 - 19 Sept 2002 Leura, NSW, Australia
Correspondence
Patrina Caldwell
Centre for Kidney Research
The Children’s Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
Tel: +61 2 9845 3039
Fax: +6 12 9845 3038
Email:Patrina Caldwell