Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study.
Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to examine just age limits for alleged competence to consent in children, we evaluated feasibility of a standardized assessment tool, and investigated cutoff ages for children's competence to consent to PGT. We performed a pilot study, including 17 pediatric outpatients between 6 and 18 years at risk for an autosomal dominantly inherited cardiac disease, eligible for predictive genetic testing. The reference standard for competence was established by experts trained in the relevant criteria for competent decision-making. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) served as index test. Data analysis included raw agreement between competence classifications, difference in mean ages between children judged competent and judged incompetent, and estimation of cutoff ages for judgments of competence. Twelve (71 %) children were considered competent by the reference standard, and 16 (94 %) by the MacCAT-T, with an overall agreement of 76 %. The expert judgments disagreed in most cases, while the MacCAT-T judgments agreed in 65 %. Mean age of children judged incompetent was 9.3 years and of children judged competent 12.1 years (p = .035). With 90 % sensitivity, children younger than 10.0 years were judged incompetent, with 90 % specificity children older than 11.8 years were judged competent. Feasibility of the MacCAT-T in children is confirmed. Initial findings on age cutoffs are indicative for children between the age of 12 and 18 to be judged competent for involvement in the informed consent process. Future research on appropriate age-limits for children's alleged competence to consent is needed.
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, The Netherlands. i.hein@debascule.com.
Irma M
IM
Hein
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, The Netherlands.
Pieter W
PW
Troost
Department of Clinical Methods and Public Health, Academic Medical Center, Amsterdam, The Netherlands.
Robert
R
Lindeboom
Department of Clinical Genetics, Academic Medical Center, Amsterdam, The Netherlands.
Imke
I
Christiaans
Department of Psychology, Law and Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.
Thomas
T
Grisso
Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, and Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands.
Johannes B
JB
van Goudoever
Department of Child and Adolescent Psychiatry, Academic Medical Center, Meibergdreef 5, 1105 AZ, Amsterdam, The Netherlands.
Ramón J L
RJ
Lindauer
D000293:Adolescent; D002648:Child; D032882:Comprehension; D003657:Decision Making; D005240:Feasibility Studies; D005260:Female; D005820:Genetic Testing / Q000379:methods*; D006330:Heart Defects, Congenital / Q000175:diagnosis* / Q000235:genetics; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D057828:Informed Consent By Minors / Q000523:psychology*; D008297:Male; D016743:Mental Competency / Q000523:psychology*; D033242:Minors / Q000523:psychology*; D010865:Pilot Projects
Decision-making; Genetic testing; Informed consent; Mental competence; Minors; Sensitivity and specificity