Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the eastern cooperative oncology group
Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the eastern cooperative oncology group
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DOI：
10.1200/jco.2003.07.022
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发表时间：
2003-03-01
影响因子：
45.3
通讯作者：
Cella, D
中科院分区：
文献类型：
--
作者：
Coyne, CA;Xu, RH;Cella, D
目的：研究表明，大多数医疗诊断和治疗同意文件的阅读水平高于大多数美国人的阅读水平。本研究假设使用易于阅读的同意声明，与标准的同意声明相比，将导致更高的患者对临床治疗方案的理解，更低的患者焦虑，更高的患者满意度和更高的患者收益。方法：在3个肿瘤合作组的成员或附属机构共44个机构进行随机对照试验。研究机构被随机分配，对被招募参加选定的癌症治疗试验的患者，要么使用易于阅读的同意声明，要么使用标准的同意声明。共对207名患者进行了电话访谈，以评估研究结果。结果：干预组患者的同意焦虑明显低于对照组患者，满意度明显高于对照组患者。患者的理解和状态焦虑不受干预的影响。父母研究的应计比率在两个研究组之间也没有显著差异。结论：临床试验知情同意声明可以修改为更容易阅读，而不会遗漏关键信息。患者的焦虑和满意度会受到同意书的影响。这些研究结果的普遍性受到患者样本特征的限制。90%的样本是白人女性，成人医学读写能力快速评估的平均得分约为64分，表明读写能力达到或超过九年级。(C) 2003年由美国临床肿瘤学会出版。
Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual.Methods: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes.Results: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups.Conclusion: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade. (C) 2003 by American Society of Clinical Oncology.