Research in children raises special considerations in ethics, medicine, and
statistics. Articles are arranged by date with the most recent entries at the top. You
can find outside resources at the bottom of
this page. Other entries about children in research can be found in the
children in research page at the
StATS website.
2008
[[There is no material yet from my new site.]]
Outside resources:
- Koelch M, Singer H, Prestel A, et al. "...because I am something special"
or "I think I will be something like a guinea pig": information and assent of
legal minors in clinical trials - assessment of understanding, appreciation
and reasoning. Child and Adolescent Psychiatry and Mental Health. 2009;3(1):2.
Available at: http://www.capmh.com/content/3/1/2 [Accessed January 30, 2009].
Description: Children do not have the legal capacity to formally consent to
participate in research. Respect for the individual, however, still requires
us to seek assent from a child before they participate. How much can a child
truly understand about the research hypothesis? This study examined a group of
children between the ages of 7 and 15 diagnosed with attention
deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional
defiant disorder. Children understood the general procedures being conducted
in the research but had more difficulty with abstract concepts such as the
need for a placebo and their individual chance of receiving a placebo.
- Clinical trials: the viewpoint
of children. Description: How well do children understand the research
process? This paper summarizes a semi-structured interviews of 30 children
from 8 to 16 years old. Most of these children understood that there were
risks associated with participating in a clinical trial and had a variety of
opinions about financial incentives.
- Making a difference: the
clinical research programme for children. Description: This paper
identifies ten highly cited research trials involving children and discusses
how these trials have had an impact on practice. The authors also describe a
recent initiative, the Medicines for Children Research Network.
- Pediatric Drug Studies Seen as
Obligation of Other Parents' Kids Description: This webpage summarizes
the research of Davis and Matthew Davis, who surveyed parents about medical
research in children. While most parents wanted to see research that insured
safe medicines for children, most would not agree to let their own children
participate in research studies.
- du Prie M. Standards for Research in Child Health. Description:
This website is an effort to develop guidleines for pediatric research that is
evidence-based where possible and a consensus among experts where there is no
evidence. Available at:
http://www.starchildhealth.org/ [Accessed October 11, 2009].
All of the material above this paragraph is licensed under a
Creative Commons Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2010-04-11. The material
below this paragraph links to my
old website, StATS. Although I wrote all of the material
listed below, my ex-employer, Children's Mercy Hospital, has claimed copyright
ownership of this material. The brief excerpts shown here are included under
the fair use provisions of U.S. Copyright laws.
2008
2007
- Stats: What, exactly, is a child?
(November 19, 2007). I'm updating a talk on research issues associated
with pediatric treatments. Before I start throwing around terms like "paediatric"
and "child," I should take some time to note that these terms have some
ambiguity in them.
- Stats: What makes pediatric research
different? (August 29, 2007). I may be asked to give a repeat performance
of Stats #53: Signal Detection Strategies for Paediatric Treatments. This is a
three hour class that I gave last year in London. A different group is
interested in pretty much the same topic. Looking at the title and abstract, I
am a bit uncomfortable with it, so here's an alternative.
- Stats: Conflict of interest in the
Wakefield MMR study (July 26, 2007). An interesting case study in conflict
of interest (perhaps a bit too complex to be described fairly in this brief
weblog entry) involves a controversial paper. The lead author of this paper,
Wakefield A; Murch S, Anthony A, Linnell J, Casson D, Malik M, Berelowitz M,
Dhillon A, Thomson M, Harvey P, Valentine A, Davies S, Walker-Smith J
(February 28 1998). Ileal-lymphoid-nodular hyperplasia, non-specific
colitis, and pervasive developmental disorder in children 637-641. The
Lancet - Vol. 351, Issue 9103. DOI:10.1016/S0140-6736(97)11096-0, is Andrew
Wakefield. Dr. Wakefield has alleged on the basis of twelve children referred
to his clinic that there was a link between the MMR vaccine and the
development of autism.
2006
- Stats: Medical concerns about
research in children (November 3, 2006). Children are not little adults
and you need to respect the important differences between them. Some of the
differences make research more difficult and some make the research easier.
- Stats: Statistical
concerns in research studies involving children (November 2, 2006). The
statistical design and analysis issues for research involving children are not
really that much different than for adults, but there are three areas that you
need to pay special attention to: sample size issue, subgroup analysis, and
validity/reliability of measurements. I want to summarize some of these issues
and offer some concrete examples.
- Stats: Searching for
pediatric articles on Medline (October 26, 2006). A recent publication
Age-Specific Search Strategies for Medline. Monika Kastner, Nancy L
Wilczynski, Cindy Walker-Dilks, Kathleen Ann McKibbon, Brian Haynes. J Med
Internet Res 2006 (Oct 25); 8(4):e25 examines search strategies for articles
relevant to geriatric medicine, adult medicine, pediatric medicine, neonatal
medicine, and obstetrics. For studies of pediatric medicine, the most
sensitive search used the following terms: child:.mp. OR adolescent.mp. OR
infan:.mp. which had a sensitivity of 98% and a specificity of 81%.
- Stats: Ethical concerns about
research in children (October 17, 2006). I am giving a talk in London
about the differences in research when children are involved. One major aspect
of these differences is that the ethical and regulatory requirements change.
- Stats: Case studies for
differences in research in children (October 16, 2006). I want to include
several case studies about issues relating to the differences in research in
children. Here are some articles with full free text on the web which I think
might generate a lot of interesting discussion.
- Stats: Differences between
children and adults (October 13, 2006). A recently published report from
the Institute of Medicine, Emergency Care for Children--Growing Pains, has a
very nice table in the introduction that highlights some of the differences
between children and adults. This material is very helpful for a talk I am
preparing, so I have adapted this material and placed it below.
- Stats: Two talks for PharmaIQ (September
19, 2006). I may be giving a couple of talks for for PharmaIQ, a division
of the International Quality & Productivity Center (IQPC). The first has the
title "Signal Detection Strategies for Paediatric Treatments" and the second
has the title "Control charts for continuous monitoring of the number needed
to harm."
Closely related categories:
What now?
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entries
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This work is licensed under a
Creative
Commons Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2010-04-11.
