title: Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.
abstract: OBJECTIVE
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Irma M
authors.initials: IM
authors.lastname: Hein
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Pieter W
authors.initials: PW
authors.lastname: Troost
authors.affiliation: Department of Clinical Methods and Public Health, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Lindeboom
authors.affiliation: Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Benninga
authors.affiliation: Department of Pediatric Oncology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
authors.forename: C Michel
authors.initials: CM
authors.lastname: Zwaan
authors.affiliation: Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands5Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Goudoever
authors.affiliation: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Ramón J L
authors.initials: RJ
authors.lastname: Lindauer
mesh_terms: D000293:Adolescent; D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D032882:Comprehension; D005260:Female; D006801:Humans; D057828:Informed Consent By Minors; D008297:Male; D016743:Mental Competency; D011446:Prospective Studies; D011594:Psychometrics / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires / Q000592:standards*