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Arch Dis Child. 2018 Nov 24. doi: 10.1136/archdischild-2018-315237. [Epub ahead of print]

Parents' and children's comprehension and decision in a paediatric early phase oncology trial: a prospective study.

Author information

1
Unité de recherche clinique, hôpital Cochin-Necker, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, Île-de-France, France.
2
CHU Saint Louis, Espace éthique région Ile-de-France, Paris, France.
3
Centre Oncologie SIREDO (Soins, Innovation et Recherche pour enfants, adolescents et jeunes adultes atteints de cancer), Institut Curie, Paris, France.
4
Département d'oncologie pédiatrique et pour adolescents, Gustave Roussy, Villejuif, France.
5
Hémato-Immuno-Oncologie Pédiatrique, hôpital Armand Trousseau, AP-HP, Université Pierre et Marie Curie, Paris, France.
6
Hématologie immunologie pédiatrique, hôpital Robert Debré, AP-HP, Université Paris Diderot, Paris, France.
7
Oncologie pédiatrique, Centre Oscar Lambret, Centre régional de lutte contre le cancer, Lille, France.
8
Service d'hématologie et oncologie pédiatrique, hôpital Mère-Enfant, Nantes, France.
9
Institut d'hématologie et d'oncologie pédiatrique (IHOPe), Centre régional de lutte contre le cancer, Centre Léon Bérard, Lyon, France.
10
Hématologie et oncologie pédiatrique, hôpital de la Timone, AP-HM, Marseille, France.
11
INSERM UMR 911, Centre de recherche en oncologie biologique et en oncopharmacologie, Université Aix-Marseille, Marseille, France.
12
Hospinnomics, Paris School of Economics, Assistance Publique-Hôpitaux de Paris, Paris, France.
13
Université Paris Descartes, Université Paris Descartes, Paris, France.
14
Urgences pédiatriques, hôpital Armand Trousseau, AP-HP, Université Pierre et Marie Curie, Paris, France.

Abstract

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.

KEYWORDS:

communication; consent; information; research protocols; understanding

Conflict of interest statement

Competing interests: NA reports personal fees and non-financial support from Pierre Fabre, BMS, outside the submitted work. FD reports financial relationships with Novartis, Sandoz, Boehringer Ingelheim, Servier, Roche and Bayer, outside the submitted work. AB, NB, AdHdS, ACFW, DD, IA, BG, AA, BB, PL, NC, HM, JCKD and CH have nothing to disclose.

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