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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
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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In the citing paper
“A change-over occurred between 9.6 and 11.2 years, and the cross-over point was estimated at 10.4 years [8].”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the citing paper
“A recent study demonstrated that generally children older than 11.2 years may be competent to consent to clinical research [8].”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the citing paper
“The study demonstrated that age limits for children to be deemed competent to decide on research participation could be estimated as follows: children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the citing paper
“Results of a recent study on children’s competence to consent to clinical research showed that the MacCAT could also be validly and reliably used in children.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the citing paper
“In the same study, the four domains representing competence in most jurisdictions (understanding, appreciation, reasoning, and expressing a choice) appeared to constitute a single trait in children.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
In the citing paper
“In the clinical research context, children of 11.2 years and above were generally competent.”
From Medical decision-making in children and adolescents: developmental and neuroscientific aspects (2017) · cites this paper as [8]
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Self-citation
Metadata
- 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.
- 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
- 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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