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Informed Consent and Assent in Adolescent Oncology Research.

机译：青少年肿瘤学研究的知情同意和同意。

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摘要

Purpose: The primary objective of this descriptive longitudinal study was to describe the informed consent and assent experience for adolescents, their parents and the providers participating in informed consent and assent discussions.;Patients and Methods: A descriptive, longitudinal mixed methods design was implemented in two pediatric oncology clinics in two large urban metropolitan settings. The study involved qualitative (semi-structured interviews) at two time points and quantitative (PIF, AIF, CRRRF, and QuIC) data collection at one time point with adolescents, their parents, and providers following the informed consent and assent discussion for the cancer trial. A non-probability sample of 4 adolescents, 4 mothers, and 3 providers were included through serial enrollment.;Analysis: Combined qualitative and quantitative data analyses included: thematic analysis of interview transcripts, analysis of the QuIC using descriptive statistics, comparison of interview themes with QuIC descriptive data for similarities and differences and an overall description of the informed consent and informed assent discussions using all demographic (PIF and AIF) and health data sources (CRRRF) in relation to quality consent factors (QuIC) and qualitative interview themes.;Results: Themes from interviews with adolescents and mothers included: adolescent strength and desire to understand, fear and helplessness, the good provider, the bad provider, roadmap, altruism and bad memory. Themes from interviews with providers included: connecting with the adolescent and their family, adolescent and family strengths, and timelines and the rush. QuIC results revealed low scores for objective understanding of key elements of consent and assent contrasted with relatively high scores for subjective understanding consent and assent elements. Inconsistencies in thoughts and experiences were identified with participants 'feeling' more informed than they actually were and evidence of deficiencies in memory and understanding related to essential elements of the consent and assent discussions.;Conclusion: Findings from the pilot descriptive study suggest further exploration of adolescent and parent viewpoints on what they value as important in the content and delivery of informed consent and assent. Understanding the origin of participants' misunderstanding of the key elements of consent and assent may illuminate areas for future interventions focused on improving the quality of informed consent and assent.
机译：目的：该描述性纵向研究的主要目的是描述青少年，他们的父母和参加知情同意和同意讨论的提供者的知情同意和同意经验。患者和方法：在两个大都市地区设有两家儿科肿瘤诊所。该研究涉及两个时间点的定性（半结构式访谈），并在知情同意并同意讨论癌症后，在一个时间点与青少年，父母及其提供者进行定量（PIF，AIF，CRRRF和QuIC）数据收集试用。通过连续入选，纳入了4名青少年，4名母亲和3名提供者的非概率样本;分析：定性和定量数据组合分析包括：访谈笔录的主题分析，使用描述性统计数据对QuIC的分析，访谈主题的比较QuIC具有描述性和差异性的描述性数据，并使用与质量同意因子（QuIC）和定性访谈主题相关的所有人口统计信息（PIF和AIF）和健康数据源（CRRRF）对知情同意和知情同意的讨论进行了总体描述;结果：对青少年和母亲的采访主题包括：青少年的力量和理解力，恐惧和无助的愿望，良好的提供者，不良的提供者，路线图，利他主义和不良的记忆。与提供者进行访谈的主题包括：与青少年及其家庭联系，青少年和家庭优势，时间表和匆忙。 QuIC的结果显示，客观了解同意和同意的关键要素得分较低，而主观理解同意和同意的要素得分相对较高。认为思想和经验不一致，参与者“感觉”比实际情况更充分，并且存在与同意和同意的讨论的基本要素有关的记忆力和理解力不足的证据；结论：试验性描述性研究的发现表明需要进一步探索青少年和父母的观点，即他们在知情同意和同意的内容和交付中所重视的观点。了解参与者对同意和同意的关键要素的误解的根源可能会为将来着重提高知情同意和同意质量的干预措施提供启发。

著录项

  • 作者

    Poston, Rebecca Deal.;

  • 作者单位

    University of Virginia.;

  • 授予单位 University of Virginia.;
  • 学科 Health Sciences Medical Ethics.;Health Sciences Nursing.
  • 学位 Ph.D.
  • 年度 2012
  • 页码 162 p.
  • 总页数 162
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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