Enhancing Informed Consent for Research and Treatment

Dunn, Laura B.; Jeste, Dilip V.

doi:10.1016/s0893-133x(00)00218-9

Cited by 221 publications

(181 citation statements)

References 75 publications

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“…Oral and written presentation is an established effective method for improving understanding and comprehension. [35][36][37][38][39] Children responded to questions orally. On the basis of responses (ie, initial understanding), prompts were included to ensure that children comprehended each question's intent.…”

Section: Instrument Designmentioning

confidence: 99%

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

2010

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BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

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Section: Instrument Designmentioning

confidence: 99%

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

2010

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“…30 Participants were informed that they could discontinue participation at any time. Written informed consent was obtained after a complete description of the study had been provided.…”

Section: Informed Consent Proceduresmentioning

confidence: 99%

Cognitive performance predicts treatment decisional abilities in mild to moderate dementia

Gurrera¹,

Moye²,

Karel³

et al. 2006

Neurology

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Objective-To examine the contribution of neuropsychological test performance to treatment decision-making capacity in community volunteers with mild to moderate dementia.Methods-The authors recruited volunteers (44 men, 44 women) with mild to moderate dementia from the community. Subjects completed a battery of 11 neuropsychological tests that assessed auditory and visual attention, logical memory, language, and executive function. To measure decision making capacity, the authors administered the Capacity to Consent to Treatment Interview, the Hopemont Capacity Assessment Interview, and the MacCarthur Competence Assessment Tool-Treatment. Each of these instruments individually scores four decisional abilities serving capacity: understanding, appreciation, reasoning, and expression of choice. The authors used principal components analysis to generate component scores for each ability across instruments, and to extract principal components for neuropsychological performance.Results-Multiple linear regression analyses demonstrated that neuropsychological performance significantly predicted all four abilities. Specifically, it predicted 77.8% of the common variance for understanding, 39.4% for reasoning, 24.6% for appreciation, and 10.2% for expression of choice. Except for reasoning and appreciation, neuropsychological predictor (β) profiles were unique for each ability.Conclusions-Neuropsychological performance substantially and differentially predicted capacity for treatment decisions in individuals with mild to moderate dementia. Relationships between elemental cognitive function and decisional capacity may differ in individuals whose decisional capacity is impaired by other disorders, such as mental illness.Capacity for treatment decisions hinges on four legal standards, or abilities [1][2][3][4] : understanding (comprehension of diagnostic and treatment information), appreciation (personalization of information through integration with one's values, beliefs, and expectations), reasoning (evaluation of treatment alternatives in light of potential consequences for everyday life), and expression of choice (communication of a treatment Address correspondence and reprint requests to: Dr. Ronald J. Gurrera, VA Boston Healthcare System, 940 Belmont Street (116A), Brockton, MA 02301; Ronald.Gurrera@med.va.gov or Ronald_Gurrera@hms.harvard.edu. Disclosure: The authors report no conflicts of interest. It is logical to examine the neuropsychological correlates of decisional abilities for ways in which to refine their assessment, 8,19,24 and preliminary studies are encouraging with respect to the feasibility of this approach. 8,25,26 The authors evaluated the contribution of neuropsychological task performance to decisional abilities in community volunteers with mild to moderate dementia. They hypothesized that each ability would be significantly predicted by a distinct subset of neuropsychological tasks, and that understanding would be most, and expression of choice least, strongly associated with neuropsychologi...

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“…In countries where these items are regulated, with clear guidelines for ECT practitioners to follow, the data on ECT audits makes for sobering and disturbing reading. [19][20][21] It is unlikely that in South Africa, with its complete absence of guidelines, that an ECT audit conducted here would show that our local ECT practitioners fare any better than our overseas counterparts.…”

Section: Reviewmentioning

confidence: 81%

“…20,21 Risk disclosure has been shown to be very poor, leading some authors to suggest that informed consent is "mythical" and like a "fairytale" when it comes to advancing patients rights to self determination. 20 In the case of ECT, recent publications have shown that despite efforts on the part of practitioners, patients perceptions are not good. Indeed a full one-third of patients in a report from the United Kingdom indicated that they felt coerced into having ECT.…”

Section: Consent To Ectmentioning

confidence: 99%

Consent procedures and electroconvulsive therapy in South Africa : impact of the Mental Health Care Act

Segal¹,

Thom

2006

Afr. J. Psych

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Enhancing Informed Consent for Research and Treatment

Cited by 221 publications

References 75 publications

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent

Cognitive performance predicts treatment decisional abilities in mild to moderate dementia

Consent procedures and electroconvulsive therapy in South Africa : impact of the Mental Health Care Act

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