Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for measuring children's competence to consent to clinical research

JAMA Pediatrics

Volumn 168, Issue 12, 2014, Pages 1147-1153

  Hein, Irma M ^a   Troost, Pieter W ^a   Lindeboom, Robert ^a   Benninga, Marc A ^b   Zwaan, C Michel ^c   Van Goudoever, Johannes B ^b,d   Lindauer, Ramón J L ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b EMMA CHILDREN S HOSPITAL   (Netherlands)

^c SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ARTICLE; CHILD; CLINICAL ASSESSMENT; CLINICAL RESEARCH; COMPETENCE; CONTROLLED STUDY; CORRELATION COEFFICIENT; CRITERION RELATED VALIDITY; DECISION MAKING; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; FEMALE; GASTROENTEROLOGY; GENERAL MENTAL DISEASE ASSESSMENT; HOSPITAL PATIENT; HUMAN; IMMUNOLOGY; INFORMED CONSENT; INTERRATER RELIABILITY; MACARTHUR COMPETENCE ASSESSMENT TOOL FOR CLINICAL RESEARCH; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; ONCOLOGY; OPHTHALMOLOGY; OUTPATIENT DEPARTMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSYCHOMETRY; PULMONOLOGY; RANDOMIZED CONTROLLED TRIAL; RECEIVER OPERATING CHARACTERISTIC; REPRODUCIBILITY; SCHOOL CHILD; SEMI STRUCTURED INTERVIEW; SENSITIVITY AND SPECIFICITY; SOCIAL COMPETENCE; AGE; COMPREHENSION; ETHICS; MEDICAL RESEARCH; MENTAL CAPACITY; QUESTIONNAIRE; STANDARDS;

ADOLESCENT; AGE FACTORS; BIOMEDICAL RESEARCH; CHILD; COMPREHENSION; FEMALE; HUMANS; INFORMED CONSENT BY MINORS; MALE; MENTAL COMPETENCY; PROSPECTIVE STUDIES; PSYCHOMETRICS; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84925222622     PISSN: 21686203     EISSN: 21686211     Source Type: Journal    
DOI: 10.1001/jamapediatrics.2014.1694     Document Type: Article

References (26)

1. 't Jong GW, Vulto AG, de Hoog M, Schimmel KJ, Tibboel D, van den Anker JN. A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital. Pediatrics. 2001;108(5):1089-1093.
2. Knox CA, Burkhart PV. Issues related to children participating in clinical research. J Pediatr Nurs. 2007;22(4):310-318.
3. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. New York, NY: Oxford University Press; 2008.
4. Appelbaum PS. Clinical practice: assessment of patients' competence to consent to treatment. N Engl J Med. 2007;357(18):1834-1840.
5. Appelbaum PS, Grisso T. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Sarasota, FL: Professional Resource Press; 2001.
6. de Vries MC, Bresters D, Engberts DP,Wit JM, van Leeuwen E. Attitudes of physicians and parents towards discussing infertility risks and semen cryopreservation with male adolescents diagnosed with cancer. Pediatr Blood Cancer. 2009;53(3):386-391.
7. de Vries MC, Wit JM, Engberts DP, Kaspers GJ, van Leeuwen E. Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation. Pediatr Blood Cancer. 2010;55(1):123-128.
8. Hein IM, Daams J, Troost PW, Lindeboom R, Lindauer RJL. Accuracy of assessment instruments for patients' competence to consent to medical treatment or research [published online May 7, 2014]. Cochrane Collaboration. doi:10.1002/14651858.CD011099. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011099/full. Accessed April 15, 2014.
9. Altavilla A, Manfredi C, Baiardi P, et al. Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr. 2012;101(1):e27-e32. doi:10.1111/j.1651-2227.2011.02401.x.
10. American Academy of Pediatrics Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics. 1995;95(2):314-317.
11. Hein IM, Troost PW, Lindeboom R, de Vries MC, Zwaan CM, Lindauer RJ. Assessing children's competence to consent in research by a standardized tool: a validity study. BMC Pediatr. 2012;12:156. doi:10.1186/1471-2431-12-156.
12. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, Saks ER. Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry. 2006;163(8):1323-1334.
13. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):1415-1419.
14. Cairns R, Maddock C, Buchanan A, et al. Reliability of mental capacity assessments in psychiatric in-patients. Br J Psychiatry. 2005;187:372-378.
15. Babyak MA. What you see may not be what you get: a brief, nontechnical introduction to overfitting in regression-type models. Psychosom Med. 2004;66(3):411-421.
16. Owen GS, Richardson G, David AS, Szmukler G, Hayward P, Hotopf M. Mental capacity to make decisions on treatment in people admitted to psychiatric hospitals: cross sectional study. BMJ. 2008;337:a448. doi:10.1136/bmj.39580.546597.BE.
17. Palmer BW, Dunn LB, Appelbaum PS, et al. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry. 2005;62(7):726-733.
18. Vollmann J, Bauer A, Danker-Hopfe H, Helmchen H. Competence of mentally ill patients: a comparative empirical study. Psychol Med. 2003; 33(8):1463-1471.
19. Fleiss JL, Cohen J. The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas. 1973;33:613-619.
20. Verhelst ND, Glas CAW, Verstralen HHFM. OPLM: One Parameter Logistic Model: Computer Program and Manual. Arnhem, the Netherlands: CITO; 2005.
21. Fischer GH, Molenaar IW. Rasch Models: Foundations, Recent Developments and Applications. New York, NY: Springer-Verlag; 1995: chap 2 and 12.
22. Hosmer DW, Lemeshow S. Applied Logistic Regression. New York, NY: Wiley; 2014.
23. Joffe S, Fernandez CV, Pentz RD, et al. Involving children with cancer in decision-making about research participation. J Pediatr. 2006;149(6):862-868.
24. Martenson EK, Fägerskiöld AM. A review of children's decision-making competence in health care. J Clin Nurs. 2008;17(23):3131-3141.
25. Grisso T, Vierling L.Minors' consent to treatment: a developmental perspective. Prof Psychol. 1978;9(3):412-427.
26. Grisso T, Appelbaum PS. MacArthur Competence Assessment Tool for Treatment (MacCAT-T). Sarasota, FL: Professional Resource Press; 1998.