| The experiences of children enrolled in pediatric oncology research: implications for assent. | |
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MedLine Citation:
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PMID: 20351001 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful. |
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Authors:
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Yoram Unguru; Anne M Sill; Naynesh Kamani |
Publication Detail:
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Type: Comparative Study; Journal Article Date: 2010-03-29 |
Journal Detail:
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Title: Pediatrics Volume: 125 ISSN: 1098-4275 ISO Abbreviation: Pediatrics Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-04-02 Completed Date: 2010-04-27 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: United States |
Other Details:
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Languages: eng Pagination: e876-83 Citation Subset: AIM; IM |
Affiliation:
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Division of Pediatric Hematology/Oncology, Herman and Walter Samuelson Children's Hospital at Sinai, 2401 W Belvedere Ave, Baltimore, MD 21215-5271, USA. yunguru@lifebridgehealth.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Age Factors Biomedical Research Child Clinical Trials as Topic / methods, psychology* Female Health Knowledge, Attitudes, Practice* Humans Informed Consent / psychology* Male Medical Oncology Patient Participation / methods, psychology* Questionnaires Research Subjects / psychology* Young Adult |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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