التفاصيل البيبلوغرافية
| العنوان: |
Parents' and children's comprehension and decision in a paediatric early phase oncology trial: a prospective study. |
| المؤلفون: |
Béranger, Agathe, Bouazza, Naïm, de Haut de Sigy, Amélie, Foubert-Wenc, Anne-Charlotte, Davous, Dominique, Aerts, Isabelle, Geoerger, Birgit, Auvrignon, Anne, Brethon, Benoît, Leblond, Pierre, Corradini, Nadège, André, Nicolas, Martinez, Hélène, Dupont, Jean-Claude K., Doz, François, Chappuy, Hélène |
| المصدر: |
Archives of Disease in Childhood; Oct2019, Vol. 104 Issue 10, p947-952, 6p |
| مصطلحات موضوعية: |
COMPREHENSION in children, PARENTS, LONGITUDINAL method, INFORMED consent (Medical law), ONCOLOGY |
| مستخلص: |
Objective: To analyse parents' and children's understanding of consent information and assess their decision-making process in paediatric oncology.Design: Prospective observational study.Settings: Eleven French paediatric oncology units.Patients: Parents and children who have been asked to give consent for participation in an early phase trial.Interventions: Thirty-seven children and 119 parents were questioned using an audio-recorded semistructured interview.Main Outcome Measures: The participants' understanding of nine elements of the informed consent was assessed by comparing their answers with the informed consent leaflet. Their decision-making process was also evaluated.Results: Most parents and children had an excellent understanding regarding their participation in a clinical trial (respectively 88.2% and 48.6%), the right to withdraw (76.5% and 43.2%) and the prospects of collective benefits (74.8% and 48.6%). By contrast, less than half of the parents and few of the children correctly understood the alternatives (respectively 47.5% and 27%), the risks related to participation (44.5% and 10.8%), the prospects of individual benefits (33.6% and 10.8%) and the purpose of the clinical trial (12.6% and 2.7%). Twenty-six (70.3%) children participated in the decision-making process. Most parents and children felt they had no choice but to participate in the trial to have access to a new anticancer treatment.Conclusions: What might appear to be a poor understanding of the research protocol may actually correspond to the families' interpretation of the situation as a coping mechanism. All children (except infants) should get age-tailored information in order for them to have a meaningful involvement in research. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
