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

Autor: Ramón J. L. Lindauer, Johannes B. van Goudoever, Irma M. Hein, Robert Lindeboom, C. Michel Zwaan, Pieter W. Troost, Marc A. Benninga
Přispěvatelé: Adult Psychiatry, APH - Amsterdam Public Health, Master Evidence Based Practice, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Paediatric Gastroenterology, ARD - Amsterdam Reproduction and Development, Paediatrics, Child Psychiatry, Pediatrics, Pediatric surgery, ICaR - Circulation and metabolism
Rok vydání: 2014
Předmět:
Zdroj: Hein, I M, Troost, P W, Lindeboom, R, Benninga, M A, Zwaan, C M, van Goudoever, J B & Lindauer, R J L 2014, ' Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children's Competence to Consent to Clinical Research ', JAMA Pediatrics, vol. 168, no. 12, pp. 1147-1153 . https://doi.org/10.1001/jamapediatrics.2014.1694
JAMA pediatrics, 168(12), 1147-1153. American Medical Association
JAMA Pediatrics, 168(12), 1147-1153. American Medical Association
ISSN: 2168-6203
2168-6211
DOI: 10.1001/jamapediatrics.2014.1694
Popis: 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.
Databáze: OpenAIRE
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