Center for Bioethics and Medical Humanities, Medical College of Wisconsin, Milwaukee, Wisconsin.
National Marrow Donor Program, Minneapolis, Minnesota; Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.
Biol Blood Marrow Transplant. 2018 Oct;24(10):2145-2151. doi: 10.1016/j.bbmt.2018.04.014. Epub 2018 Apr 18.
Because of the complexity of hematopoietic cell transplant trial treatments, informed consent forms are often long and difficult to read. We evaluated a 2-column easy-to-read informed consent (ETRIC) form that incorporates elements of health literacy and readability in participants and centers participating in Blood and Marrow Transplant Clinical Trials Network (BMT CTN) clinical trials. In a randomized study 198 adult patients from 25 centers potentially eligible to participate in 4 BMT CTN interventional trials were randomized to the ETRIC form or a standard consent form for that trial. Both forms were written at no more than an eighth-grade reading level. The primary endpoint was objective comprehension score on the Quality of Informed Consent, part A (QuIC-A) instrument. In a parallel evaluation study, 2 moderators conducted semistructured interviews of 49 investigators, research staff, and institutional review board (IRB) members at 9 BMT CTN trial sites. The mean QuIC-A scores were comparable in 152 patients (77%) assessable for the primary endpoint (ETRIC form, 80.5; standard form, 81.8; P = .37). In regression analysis there was no significant association between the consent type and QuIC-A score. In the evaluation study dominant themes identified on qualitative analyses included general comfort and willingness to use the ETRIC template and that its formatting and layout enhancements would offer additional value to research participants, investigators, and IRBs. IRB language preferences and requirements, length, and prior experience with alternative consent formats were perceived as barriers. Among patients considering participation in BMT CTN clinical trials, the formatting enhancements of the ETRIC form did not alter comprehension of the trial. Despite local challenges to implementation, trial sites generally viewed the ETRIC form favorably and expressed willingness to use it over standard consent form.
由于造血细胞移植试验治疗的复杂性，知情同意书通常很长且难以阅读。我们评估了一种 2 列易读的知情同意书（ETRIC），该同意书纳入了健康素养和可读性要素，参与者和参与血液和骨髓移植临床试验网络（BMT CTN）临床试验的中心也可以使用。在一项随机研究中，来自 25 个中心的 198 名成年患者可能有资格参加 4 项 BMT CTN 干预试验，他们被随机分配到 ETRIC 表格或该试验的标准同意书。这两种表格的书写难度均不超过 8 年级阅读水平。主要终点是知情同意质量的客观理解评分，部分 A（QuIC-A）工具。在一项平行评估研究中，2 名主持人对 9 个 BMT CTN 试验点的 49 名研究人员、研究人员和机构审查委员会（IRB）成员进行了半结构化访谈。在可评估主要终点的 152 名患者中（77%），QuIC-A 评分相当（ETRIC 表格，80.5；标准表格，81.8；P = 0.37）。在回归分析中，同意类型与 QuIC-A 评分之间没有显著关联。在评估研究中，定性分析确定的主要主题包括对 ETRIC 模板的一般舒适度和使用意愿，以及其格式化和布局增强将为研究参与者、研究人员和 IRB 提供额外价值。IRB 语言偏好和要求、长度以及对替代同意书格式的先前经验被视为障碍。在考虑参与 BMT CTN 临床试验的患者中，ETRIC 表格的格式增强并未改变对试验的理解。尽管实施过程中存在局部挑战，但试验点普遍对 ETRIC 表格持积极态度，并表示愿意使用该表格而不是标准同意书。
