MacArthur Competence Assessment Tool For Clinical Research Research Articles

The informed consent in the mature minor: Understanding and decision-making capacity

IntroductionThe informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor. Material and methodsSystematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion. ResultsOf the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6–21 years) in healthy and sick children. ConclusionsThe semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis.

To perform a meta-analysis of clinical studies on the differences in treatment or research decision-making capacity among patients with Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), and healthy comparisons (HCs). A systematic search was conducted on Medline/Pubmed, CINAHL, PsycINFO, Web of Science, and Scopus. Standardized mean differences and random-effects model were used in all cases. The United States, France, Japan, and China. Four hundred and ten patients with MCI, 149 with AD, and 368 HCs were included. The studies we included in the analysis assessed decisional capacity to consent by the MacArthur Competence Assessment Tool for Treatment (MAcCAT-T), MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), Capacity to Consent to Treatment Instrument (CCTI), and University of California Brief Assessment of Capacity to Consent (UBACC). We identified 109 potentially eligible studies from 1672 records, and 7 papers were included in the meta-analysis. The meta-analysis showed that there was significant impairment in a decision-making capacity in MCI patients compared to the HCs group in terms of Understanding (SMD = -1.04, 95% CI: -1.31 to -0.77, P < 0.001; I2 = 52%, P = 0.07), Appreciation (SMD = -0.51, 95% CI: -0.66 to -0.36, P < 0.001; I2 = 0%, P = 0.97), and Reasoning (SMD = -0.62, 95% CI: -0.77, -0.47, P < 0.001; I2=0%, P =0.46). MCI patients scored significantly higher in Understanding (SMD = 1.50, 95% CI: 0.91, 2.09, P = 0.01, I2 = 78%, P = 0.00001) compared to patients affected by AD. Patients affected by MCI are at higher risk of impaired capacity to consent to treatment and research compared to HCs, despite being at lower risk compared to patients affected by AD. Clinicians and researchers need to carefully evaluate decisional capacity in MCI patients providing informed consent.

El consentimiento informado en el menor maduro: comprensión y capacidad de decisión

IntroductionThe informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor. Material and methodsSystematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion. ResultsOf the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6-21 years) in healthy and sick children. ConclusionsThe semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

Capacity to provide informed consent among adults with bipolar disorder

BackgroundIdentifying correlates of capacity to provide informed consent among individuals with bipolar disorder is essential for patient protection. As part of a clinical trial involving approved, standard treatments, we investigated relationships between clinical characteristics and capacity to provide informed consent in adults with bipolar disorder using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). After administering the MacCAT-CR, continuing participants in the trial were capable of and provided informed consent. MethodsTrained, board-certified psychiatrists administered the MacCAT-CR to potential study participants (N = 50) after they provided informed consent, but prior to initiation of study procedures. ResultsHigher Schedule for Assessment of Positive Symptoms (SAPS) scores were significantly correlated with worse MacCAT-CR Understanding and Appreciation (p < 0.04) subscale scores; lower Hamilton Depression Rating Scale (HDRS) scores and higher Clinical Global Impression-Severity (CGI-S) scores were significantly correlated with worse Reasoning and Understanding subscale scores (p < 0.03); and patients with comorbid substance use disorders (SUD) had better Appreciation and Reasoning subscale scores (p < 0.05). LimitationsThe MacCAT-CR identifies areas where participants need explanation. However, there is not a predetermined score to indicate understanding of study procedures and therefore input from a trained clinician is needed to determine capacity to provide informed consent. ConclusionsOur findings suggest that certain measures of illness severity are associated with lower levels of capacity to provide informed consent among adults with bipolar disorder. This study provides important information for clinicians and researchers to consider when obtaining informed consent in this population.

Assessing capacity to consent for research in cognitively impaired older patients.

BackgroundThe number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research.ObjectivesThe aim of this review was to draw up an inventory of assessment tools evaluating older patients’ capacity to consent specifically applicable to clinical research, which could be used in routine practice.MethodsTwo authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered.ResultsAmong the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited.ConclusionThe MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients.

Spanish Validation of the MacArthur Competence Assessment Tool for Clinical Research Interview for Assessing Patients' Mental Capacity to Consent to Clinical Research.

The aim of the study was to assess a Spanish adaptation of a method that determines the categorical capacity status of potential participants in research projects. The sample consisted of 120 subjects (40 general medicine inpatients, 40 psychiatric inpatients, and 40 healthy controls). The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview and Mini-Mental State Examination (MMSE) were used. A feasibility study was carried out and reliability and validity calculations were made against the expert-judgment gold standard. The mean duration of the MacCAT-CR was 13 min. For the MacCAT-CR understanding, appreciation, reasoning, and expressing a choice subscales, the intraclass coefficient correlation (interrater reliability) was .93, .88, .90, and .50, respectively, and internal consistency (Cronbach's alpha) was .96, .94, and .95, respectively. Patients considered to be incompetent for expert-judgment obtained lower scores in the MacCAT-CR interview. The Spanish version of the MacCAT-CR is feasible, reliable, and valid for assessing the capacity of patients to give consent in research.

The MacArthur Competence Assessment Tools for assessing decision-making capacity in schizophrenia: A meta-analysis

ObjectiveThis meta-analysis aimed to examine the decisional capacity measured by the MacArthur Competence Assessment Tools (MacCAT) in schizophrenia. MethodEnglish (PubMed, PsycINFO, Embase, Cochrane Library databases and the Cochrane Controlled Trials Register) and Chinese (Wan Fang Database and Chinese National Knowledge Infrastructure) databases were systematically and independently searched from 1995 until August 1, 2016. Weighted and standardized mean differences were calculated. The random effects model was used in all cases. ResultsAltogether 10 studies were identified, with 7 studies using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and 3 studies using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T). The meta-analysis showed that there was significant impairment in decision-making capacity in schizophrenia patients compared to the healthy control group in terms of Understanding (SMD=−0.81, 95% CI: −1.06 to −0.56, P<0.001), Reasoning (SMD=−0.57, 95% CI: −0.80 to −0.34, P<0.001), Appreciation (SMD=−0.87, 95% CI: −1.20 to −0.53, P<0.001), and Expression a choice (SMD=−0.24, 95% CI: −0.43 to −0.05, P=0.01). ConclusionCompared to the control group, schizophrenia patients are more likely to have impaired decision-making capacity in clinical research and treatment as measured by the MacCAT instruments. Researchers and clinicians need to consider the impaired decisional capacity in schizophrenia patients providing informed consent.

The Influence of Age, Health Literacy, and Affluence on Adolescents' Capacity to Consent to Research.

While adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents' capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents' capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents' capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.

Decision-making capacity for research participation among addicted people: a cross-sectional study.

BackgroundInformed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research.Methods53 subjects with DSM-5 diagnoses of a Substance Use Disorder (SUD) and 50 non psychiatric comparison subjects (NPCs) participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research (MacCAT–CR) and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale.ResultsNPCs performed the best on the MacCAT–CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7 % SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research.ConclusionsThe findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing.

Psychopathology, psychopharmacological properties, decision-making capacity to consent to clinical research and the willingness to participate among long-term hospitalized patients with schizophrenia

Many studies discuss factors related to the decision-making capacity to consent to clinical research (DMC) of patients with schizophrenia. However, these studies rarely approached willingness to participate and the association between psychopharmacological properties (e.g., antipsychotic-induced side effects) and DMC. This study aimed to explore factors related to DMC and willingness to participate in patients with schizophrenia. All 139 patients with schizophrenia were assessed with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and other measures. A linear regression model was used to find the predictors of MacCAT-CR scores. A logistic regression model was used for exploring the predictors of willingness to participate. Patients with more severe negative symptoms performed poorly in DMC outcomes. In addition, females, those with fewer years of education and reduced cognitive function are more likely to experience difficulties in decision-making. Forty-three subjects (30.4%) chose to participate. Patients with higher level of positive symptoms, longer length of stay, higher burden of anticholinergics and users of atypical antipsychotics were more likely to participate in a clinical study which aimed to “enhance cognition”. These finding suggest that research investigators should consider many variables for patients who require more intensive screening for impaired DMC.

Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.

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. 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. 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. 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. Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. 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%). 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.

Child and Parent Understanding of Clinical Trials: The Semi-Structured Comprehension Interview

Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95% confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95% CI = 0.86–0.97) and reasoning (ICC = 0.97, 95% CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95% CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95% CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95% CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95% CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation.

Motivations of Patients With Diabetes to Participate in Research

Background: While research on the motivations of research participants has focused primarily on vulnerable populations at risk of exploitation, there is little research on the motivations and reasons of general medical patients participating in research. Given a significant increase in research studies recruiting participants with diabetes, we sought to understand better the motivations of patients with diabetes considering a general medical research protocol. Methods: The analyses presented here compare the reasoning and willingness to participate in a hypothetical research study of medically ill subjects (patients with diabetes, n = 51) with non-ill (n = 57) subjects. Responses on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Mini-Mental State Examination (MMSE) and Short-Form 36 (SF-36). Results: Overall, 44% of the group with diabetes and 56% of the comparison group indicated a willingness to participate in the research study. The reasons diabetic and comparison groups offered for willingness or unwillingness to participate in research did not differ significantly: 75% mentioned reasons related to treatment, 63% altruism; none mentioned money. Of those patients with diabetes who would not participate in research, 94% cited risk, and 89% expressed an aversion to research. Conclusions: The present study suggests that when research is not related to their diagnosis, persons with diabetes do not differ significantly from non-ill comparison subjects in their motivations to participate in research. Given the similarity of our subjects’ motivations to those of other medically ill populations, it may be that investigators can now focus more closely on the decision-making characteristics of their patients involved in clinical research rather than on their diagnoses.

Validation of Chinese version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) in patients with schizophrenia spectrum disorders

There is a lack of validated instruments assessing the decision-making capacity to consent to clinical research of patients with schizophrenia spectrum disorders who speak Chinese. This study aimed to determine the validity and reliability of the Chinese version of MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). The MacCAT-CR using a hypothetical study, the Positive and Negative Syndrome Scale (PANSS), the Mini-Mental State Examination (MMSE) assessed 139 patients with schizophrenia or schizoaffective disorder. The Cronbach's alpha coefficient was 0.74. The intra-class coefficients for understanding, appreciation, and reasoning scores ranged from 0.53 to 0.81. Regarding validity, the understanding, appreciation and reasoning scores were negatively correlated with the PANSS (r ranged from −0.27 to −0.33), and the negative subscale score (r ranged from −0.31 to −0.37) as well as positively correlated with the MMSE (r ranged from 0.26 to 0.43). All pvalues were less than 0.01. The factor analysis explained 57.6 % of the total variance; specifically, Components 1 and 2 contributed 44.5% and 13.1 % of the variance respectively. These findings indicate that the Chinese version of the MacCAT-CR is a reliable and valid instrument to assess the decision-making capacity to consent to clinical research of patients with schizophrenia spectrum disorders.

Evaluating Decisional Capacity in Older Adults and Individuals with Alzheimer's Disease

Individuals with Alzheimer's disease (AD) and some older adults are at risk of impaired decisional capacity for enrollment in clinical research trials. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a semi-structured interview that was developed to help investigators evaluate four commonly recognized dimensions of competence (understanding, appreciation, reasoning, and choice), remains among the best and most widely used tools to assess decisional capacity. However, the gold standard remains expert judgment.

The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception.

Research on deep brain stimulation (DBS) for treatment-resistant depression appears promising, but concerns have been raised about the decisional capacity of severely depressed patients and their potential misconceptions about the research. We assessed 31 DBS research participants with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a well-validated capacity measure, and with a scale to measure therapeutic misconception, which occurs when subjects do not recognize key differences between treatment and clinical research. Correlations with baseline depressive symptoms were explored. Subjects' performance on the MacCAT-CR was excellent, but therapeutic misconception was still apparent. A trend toward significance was found in the correlation between baseline depression ratings and total therapeutic misconception score. Responses to open-ended prompts revealed both reassuring and concerning statements related to expectations of risk, benefit, and individualization. Even severely depressed patients did not manifest impairments in their capacity to consent to DBS research. Therapeutic misconception, however, remained prevalent.

ENROLLING IN DEEP BRAIN STIMULATION RESEARCH FOR DEPRESSION: INFLUENCES ON POTENTIAL SUBJECTS' DECISION MAKING

Ethical concerns regarding early-phase clinical trials of DBS for treatment-resistant depression (TRD) include the possibility that participants' decisions to enroll might be motivated by unrealistic expectations of personal benefit or minimization of risks. Thematic analyses were conducted on a sample of 26 adults considering participation in two DBS trials. Influences on the decision making of these potential DBS trial participants were derived from responses to questions posed in the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a semi-structured interview designed to evaluate decisional capacity to consent to research. Participants cited numerous factors as influential in their enrollment decisions, including perceived lack of other treatment options, desire to take initiative, beliefs about DBS as a novel treatment, possibility of DBS efficacy, hoped-for improvements, potential risks and disadvantages of DBS or clinical trial participation, and altruism. No individual expressed a set of motivations or influencing factors that suggested compromised decision-making capacity or diminished voluntariness of decision making. These results suggest that individuals make the decision to enroll in early-phase trials of DBS for TRD based on a number of complex and sometimes idiosyncratic considerations, and that the trials that were studied utilized sufficiently robust informed consent processes. These findings offer evidence that the emerging research area of DBS can be advanced in an ethically sound manner, provided that safeguards and processes for discussing trials with participants are carefully and proactively enacted.

How is informed consent related to emotions and empathy? An exploratory neuroethical investigation

ContextInformed consent is crucial in daily clinical practice and research in medicine and psychiatry. A recent neuroethical investigation explored the psychological factors that are crucial in determining whether or not...

A Memory and Organizational Aid Improves Alzheimer Disease Research Consent Capacity: Results of a Randomized, Controlled Trial

Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent. Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid. Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level. Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms. AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning. A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.

Report of an Initial Pilot Study on the Feasibility of Using the MacArthur Competence Assessment Tool for Clinical Research in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was used in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and co-morbid oppositional defiant disorder (ODD) and in their parents. The aims were to test feasibility and to determine children's understanding of the elements of disclosure for a clinical drug trial and their competence to assent. The contents and language of MacCAT-CR were adapted to be age appropriate for the children. Twelve children (mean age, 9.87 [7.7-12.2]; mean intelligence quotient [IQ], 97 [72-122]) and either the mother or father of each child were interviewed. Psychologists rated the interviews and, in addition to MacCAT-CR, competence was assessed by trained clinicians. The MacCAT-CR was practicable, and the time required was acceptable. Interrater reliability was excellent in children. Children performed less well than parents on this test (children;s vs. parents' scores: Understanding 5.86 vs. 9.08, appreciation 2.64 vs. 4.96, reasoning 3.05 vs. 4.63, respectively). Whereas clinicians assessed all children as competent, lack of competence became apparent in the MacCAT-CR. The practicability and the interrater reliability suggest that the MacCAT-CR is feasible in children, but the question of whether competence is assessed validly remains unsolved in the absence of external validation. The differences between assessment by clinicians and the low scores obtained in the MacCAT-CR suggest that children may give assent even if they do not understand completely. The results of this initial pilot study may help in the planning of further investigations intended to improve information about studies and assessment of assent/consent.