Should randomised controlled trials be the “gold standard” for research on preventive interventions for children?
| DOI | https://doi.org/10.1108/17466661111190929 |
| Date | 09 December 2011 |
| Published date | 09 December 2011 |
| Pages | 228-235 |
| Author | Sarah Stewart‐Brown,Rebecca Anthony,Lynsey Wilson,Sarah Winstanley,Nigel Stallard,Helen Snooks,Douglas Simkiss |
Should randomised controlled trials be the
‘‘gold standard’’ for research on preventive
interventions for children?
Sarah Stewart-Brown, Rebecca Anthony, Lynsey Wilson, Sarah Winstanley, Nigel Stallard,
Helen Snooks and Douglas Simkiss
Abstract
Purpose – Randomised controlled trials (RCTs) have been offered a privileged position in terms of the
evidence base for preventive interventions for children, but practical and theoretical issues challenge
this research methodology. This paper aims to addressthis issue.
Design/methodology/approach – This paper analyses practical and methodological issues of using
RCTs within children’s preventive services and presents the results of a qualitative study using data
collected from parents who were asked to take part in an RCTof a preventive intervention.
Findings – Well recognised issues include the impossibility of blinding participants, the problem of
identifying a pre-eminent outcome measure for complex interventions, and problems with limiting
access to equivalent interventions in real world settings. A further theoretical problem is the exclusion
from RCTs of families who are most ready to change, resulting in a reduced level of intervention
effectiveness. Qualitative evidence from one recent RCT suggests that this problem could be operating
in some prevention trials. Increasing sample sizes can overcome some of these problems, but the cost
of the necessarily huge trials becomes disproportionate to the intervention?
Originality/value – Given the limitations on RCTs in preventive settings, the paper argues their
privileged position in terms of research evidence maybe undeserved.
Keywords Methodology, Randomised controlled trials, Preventive interventions, Research,
Children (age groups)
Paper type Research paper
Background
The randomised controlled trial (RCT) occupies a privileged position in health care research,
at the top of the hierarchy of evidence, but within the fields of public health, social
care and education, there is debate about whether this approach deserves such privilege.
Views range from those, which acknowledge that RCTs, are just not possible in some
situations, but should always be done when they are (Bonell et al., 2011) to those who claim,
they are rarely helpful. Amongst the latter are academics working in health promotion who
have declared that in their field RCTs are, in most cases, ‘‘inappropriate, misleading and
unnecessarily expensive’’ (WHO, 1998, p.2).
There are many good reasons for the privileged position of RCTs in health care research.
Evaluation studies are prone to bias because practitioners and professionals are usually
keen to believe that what they do is useful and clients and patients are often keen to please
and will say they are better when they are not. Observational studies are criticised because
groups are rarely balanced in terms of symptom severity, age, or other important participant
characteristics, leading to difficulties in interpretation. These biases are well documented,
have occurred often in evaluation studies and have misled practitioners, commissioners and
policy makers. They are effectively dealt with by double blind randomisation and on this the
advocates of RCTs rest their case. This reasoning lay behind the decision of the team that
undertook the research for Allen’s (2011) review Early Intervention: The Next Steps that good
PAGE 228
j
JOURNAL OF CHILDREN’S SERVICES
j
VOL. 6 NO. 4 2011, pp. 228-235, QEmerald Group Publishing Limited, ISSN 1746-6660 DOI 10.1108/17466661111190929
Sarah Stewart-Brown is a
Professor of Public Health
at The University of
Warwick, Coventry, UK.
Rebecca Anthony,
Lynsey Wilson and
Sarah Winstanley are
Research Fellows at
Swansea University,
Swansea, UK.
Nigel Stallard is a Professor
of Statistics, based at The
University of Warwick,
Coventry, UK.
Helen Snooks is a Professor
and Deputy Director of the
Clinical Trials Unit at
Swansea University,
Swansea, UK.
Douglas Simkiss is an
Associate Professor, at The
University of Warwick,
Coventry, UK.
Get this document and AI-powered insights with a free trial of vLex and Vincent AI
Get Started for FreeStart Your Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant
-
Access comprehensive legal content with no limitations across vLex's unparalleled global legal database
-
Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength
-
Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities
-
Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting
Start Your Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant
-
Access comprehensive legal content with no limitations across vLex's unparalleled global legal database
-
Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength
-
Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities
-
Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting
Start Your Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant
-
Access comprehensive legal content with no limitations across vLex's unparalleled global legal database
-
Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength
-
Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities
-
Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting
Start Your Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant
-
Access comprehensive legal content with no limitations across vLex's unparalleled global legal database
-
Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength
-
Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities
-
Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting
Start Your Free Trial of vLex and Vincent AI, Your Precision-Engineered Legal Assistant
-
Access comprehensive legal content with no limitations across vLex's unparalleled global legal database
-
Build stronger arguments with verified citations and CERT citator that tracks case history and precedential strength
-
Transform your legal research from hours to minutes with Vincent AI's intelligent search and analysis capabilities
-
Elevate your practice by focusing your expertise where it matters most while Vincent handles the heavy lifting