Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group

Coyne, Cathy A.; Xu, Ronghui; Raich, Peter C.; Plomer, Kathy; Dignan, Mark; Wenzel, Lari; Fairclough, Diane L.; Habermann, Thomas M.; Schnell, Linda; Quella, Susan K.; Cella, David

doi:10.1200/jco.2003.07.022

Cited by 181 publications

(200 citation statements)

References 17 publications

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“…For example, participants of all ages had an average knowledge of approximately 50%. Although age is associated with knowledge about the research, which was also evident in other pediatric studies 10,40,42 , children from 6 to 15 years demonstrated ability to understand the TMRC research information disclosed in the FPIC process. It should be stressed that this study considered that the children had contact with the research information when responses given coincided with the information disclosed in the assent process.…”

Section: Discussionmentioning

confidence: 60%

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Lobato

Gazzinelli²,

Pedroso³

et al. 2016

Rev. Bioét.

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The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants. Keywords: Informed consent. Research, ethics. Child-Adolescent-Comprehension. Bioethics. Resumo Conhecimento de crianças sobre o termo de assentimento livre e esclarecidoEste estudo tem como objetivo descrever o conhecimento de crianças e adolescentes sobre as informações divulgadas pelo termo de assentimento em pesquisa clínica pediátrica, além de relatar as atitudes dos participantes. Trata-se de estudo experimental com abordagem quantitativa, realizado em municípios do Nordeste de Minas Gerais com 142 participantes de 7 a 15 anos, escolhidos para estudo clínico sobre esquistossomose. Essas crianças e adolescentes participaram do processo de assentimento, com a utilização do termo correspondente. Avaliaram-se os participantes com questionário semiestruturado. O conhecimento médio dos participantes sobre as informações da pesquisa foi 41,22%, com apenas 1,4% apresentando alto grau de conhecimento. Concluiu-se que a maioria das crianças desconhece as informações sobre a investigação e seus direitos enquanto participantes de pesquisa. Palavras-chave: Consentimento livre e esclarecido. Ética em pesquisa. Criança-Adolescente-Compreensão. Bioética. Resumen Conocimientos de los niños sobre el documento de consentimiento libre e informadoEste estudio tiene como objetivo describir los conocimientos de los niños y adolescentes sobre la información divulgada por el documento de consentimiento en la investigación clínica pediátrica, además de describir las actitudes de los participantes. Se trata de un estudio experimental con un enfoque cuantitativo, llevado a cabo en ciudades del noreste de Minas Gerais, Brasil, con 142 participantes, de 7 a 15 años de edad, seleccionados para un estudio clínico sobre esquistosomiasis. Estos niños y adolescentes participaron en el proceso de consentimiento mediante el documento de consentimiento correspondiente. Se evaluó a los participantes con un cuestionario semiestructurado. El conocimiento promedio de los participantes sobre la información de la encuesta fue del 41,22%, siendo que solo un 1,4% presentó un alto grado de conocimiento. Se concluye que la mayoría de los niños desconoce las informacione...

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Section: Discussionmentioning

confidence: 60%

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Lobato

Gazzinelli²,

Pedroso³

et al. 2016

Rev. Bioét.

View full text Add to dashboard Cite

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“…Studies reported in the literature examined this question with single-item measures of the reasons patients gave for enrolling or not enrolling in a clinical trial and, similarly, the reasons physicians gave for offering trial participation to patients (particularly for patients Ն65 years of age) [10, [12][13][14][15][16]. We reviewed this literature and prepared two questionnaires for patients and one for physicians to complete.…”

Section: Study Questionnairesmentioning

confidence: 99%

“…Both the Patient Participation and Patient Refusal questionnaires were based primarily on items used in a study by Ellis et al [12]. Additional factors included in the patient questionnaires were also adapted from other previously published studies [13][14][15][16]. These items were designed and reported as individual outcomes as opposed to aggregate total or subscale scores.…”

Section: Study Questionnairesmentioning

confidence: 99%

A Prospective Analysis of the Influence of Older Age on Physician and Patient Decision-Making When Considering Enrollment in Breast Cancer Clinical Trials (SWOG S0316)

et al. 2012

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After completing this course, the reader will be able to:1. Cite reasons given by patients older than 65 years for their decisions to participate or not to participate in clinical trials. 2. Cite reasons given by physicians for their decisions not to enroll patients older than 65 years in clinical trials or discuss enrollment with these patients.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME Results. A total of 1,079 patients were registered and eligible and 909 (84%) returned for follow-up. The major reason for nonaccrual was either trial unavailability or ineligibility (60%). Older patients were less likely to be eligible for trials (65% for age >65 years vs. 78% for age <65 years). If eligible, trial participation rates did not differ significantly by age (34% for age >65 years vs. 40% for age <65 years). Patients >65 years more often were concerned about side effects, had friends opposed to participation, or believed that participation would not benefit other generations. When trials were available and patients were eligible, physicians discussed trial participation with 76% of patients <65 years versus 58% of patients >65 years of age. For patients >65 years, 11% of physicians indicated age as a reason they did not enroll a patient in a clinical trial. ABSTRACTConclusion. Trial unavailability or patient ineligibility were the major reasons for lack of enrollment in breast cancer clinical trials for patients of all ages in this prospective study. Older patients were less likely to be eligible for trials, but if eligible they participated at similar rates to younger patients.

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“…In a study in the USA, it was noted that the ICD is prepared for high-school (class 12) or higher education level patients, whereas the general education level of the population is primary-school level. When the intelligibility level is lowered to the level of class 5, it is seen that the ICD is more easily understood (17).…”

Section: How Should We Increase the Rate Of Reading Icd?mentioning

confidence: 99%