Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children's Competence to Consent to Clinical Research
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.
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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Reference:
Hein IM,Troost PW,Lindeboom R,Benninga MA,Zwaan CM,Goudoever JBv,Lindauer RJL, | 2014
In: JAMA Pediatrics, ISSN 2168-6203 | 168 | 12 | 1147-1153
http://archpedi.jamanetwork.com/article.aspx
In: JAMA Pediatrics, ISSN 2168-6203 | 168 | 12 | 1147-1153
http://archpedi.jamanetwork.com/article.aspx
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