Cited by 148Ethics and Legal Issues in Pediatric HealthcareEthics in Clinical ResearchHealthcare Decision-Making and Restraints

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Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research

Hein, Irma M., Troost, Pieter W., Lindeboom, Robert, Benninga, Marc A., Zwaan, C. Michel, van Goudoever, Johannes B., Lindauer, Ramón J. L.·2014·JAMA Pediatrics

DOI 10.1001/jamapediatrics.2014.1694

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Abstract

IMPORTANCE: An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. OBJECTIVES: To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. DESIGN, SETTING, AND PARTICIPANTS: This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. EXPOSURES: Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. MAIN OUTCOMES AND MEASURES: Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. RESULTS: Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver operating characteristics curve, 0.90). In children younger than 9.6 years, competence was unlikely (sensitivity, 90%); in those older than 11.2 years, competence was probable (specificity, 90%). The optimal cutoff age was 10.4 years (sensitivity, 81%; specificity, 84%). CONCLUSIONS AND RELEVANCE: The MacCAT-CR demonstrated strong psychometric properties. In children aged 9.6 to 11.2 years, consent may be justified when competence can be demonstrated in individual cases by the MacCAT-CR. The results contribute to a scientific underpinning of regulations for clinical research directed toward children.

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Applied logistic regression
(1990) · Choice Reviews Online · doi:10.5860/choice.27-3338 · Cited by 35,305
Principles of Biomedical Ethics
(2012) · Thieves of Virtue · doi:10.7551/mitpress/9079.003.0009 · Cited by 13,453
The Equivalence of Weighted Kappa and the Intraclass Correlation Coefficient as Measures of Reliability
Fleiss, J. L., & Cohen, J. (1973) · Educational and Psychological Measurement · doi:10.1177/001316447303300309 · Cited by 3,354
What you see may not be what you get: a brief, nontechnical introduction to overfitting in regression-type models
Babyak, M. A. (2004) · Psychosomatic Medicine · doi:10.1097/01.psy.0000127692.23278.a9 · Cited by 2,061
Assessment of Patients' Competence to Consent to Treatment
Appelbaum, P. S. (2007) · New England Journal of Medicine · doi:10.1056/nejmcp074045 · Cited by 1,427
Rasch Models
Fischer, G. H., & Molenaar, I. W. (1995) · Springer eBooks · doi:10.1007/978-1-4612-4230-7 · Cited by 1,143
The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions
(1997) · Psychiatric Services · doi:10.1176/ps.48.11.1415 · Cited by 704
Informed Consent, Parental Permission, and Assent in Pediatric Practice
Bartholome, W. G. (1995) · PEDIATRICS · doi:10.1542/peds.96.5.981 · Cited by 653
Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments
Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R. (2006) · American Journal of Psychiatry · doi:10.1176/ajp.2006.163.8.1323 · Cited by 464
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)
Kreutzer, J. S., DeLuca, J., & Caplan, B. (2010) · Springer eBooks · doi:10.1007/978-0-387-79948-3_4894 · Cited by 270

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Authors: Hein, I. M., Troost, P. W., Lindeboom, R., Benninga, M. A., Zwaan, C. M., van Goudoever, J. B., & Lindauer, R. J. L.
Affiliations: Amsterdam UMC Location University of Amsterdam (NL)
Erasmus MC (NL)
Department of Pediatrics, Emma Children’s Hospital, Academic Medical Center, Amsterdam, the Netherlands5Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands
Corresponding author: Hein, Irma M.
ORCID: Hein, Irma M.
Lindeboom, Robert
Benninga, Marc A.
Zwaan, C. Michel
Lindauer, Ramón J. L.
Venue: JAMA Pediatrics
Publisher: American Medical Association (AMA)
Published: 2014-12-01
Volume: 168
Issue: 12
Pages: 1147
ISSN: 1072-4710 (ISSN-L)
2168-6203
DOI: 10.1001/jamapediatrics.2014.1694
OpenAlex: W2027083136
Cited by: 148
References: 24
Citations by year: 2026: 5 · 2025: 8 · 2024: 21 · 2023: 16 · 2022: 11 · 2021: 17 · 2020: 17 · 2019: 9 · 2018: 11 · 2017: 5 · 2016: 13 · 2015: 13 · 2014: 2
FWCI: 10.35
Type: journal article
Language: en
Open access: closed
Locations: Archives of Pediatrics and Adolescent Medicine (publishedVersion)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Pure Amsterdam UMC (submittedVersion)
Topics: Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Ethics and Legal Issues in Pediatric Healthcare
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Social Sciences › Psychology › Clinical Psychology › Healthcare Decision-Making and Restraints
Keywords: capacity to consent, children's participation in research, informed consent, competency assessment instrument, inter-rater reliability, criterion validity, children and adolescents, clinical research
MeSH terms: Adolescent, Age Factors, Child, Female, Humans, Male, Prospective Studies, Psychometrics, Surveys and Questionnaires, Sensitivity and Specificity, Reproducibility of Results, Mental Competency, Comprehension, Biomedical Research, Informed Consent By Minors

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Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research

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