P.Mean >> Category >> Children in research (created 2007-07-11).

Research in children raises special considerations in ethics, medicine, and statistics. Articles are arranged by date with the most recent entries at the top. Also see Category: Ethics in research. You can find outside resources at the bottom of this page.

2008

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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. J Cherrill, H Hudson, C Cocking, V Unsworth, L Franck, J McIntyre and I Choonara. Archives of Disease in Childhood 2007;92:712-713 doi:10.1136/adc.2006.114207. [Medline] [Abstract] [Full text] [PDF]. 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. Rosalind L Smyth. Archives of Disease in Childhood 2007;92:835-837; doi:10.1136/adc.2006.113357. [Full text] [PDF]. 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.

Journal article: Judith Groch. Pediatric Drug Studies Seen as Obligation of Other Parents' Kids. MedPage Today. 2008. [Accessed on November 20, 2011]. http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/9421. 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].

Creative Commons License 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.

2007

10. 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.

9. 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.

8. 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

7. 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.

6. 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.

5. 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%.

4. 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.

3. 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.

2. 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.

1. 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."

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Creative Commons License 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.