Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology
Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology
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DOI：
10.1002/pon.1070
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发表时间：
2007-04-01
期刊：
影响因子：
3.6
通讯作者：
Brady, Jane
中科院分区：
文献类型：
--
作者：
Hack, Thomas F.;Whelan, Tim;Brady, Jane
背景资料：本研究的目的是系统地比较两种录音带格式的信息提供知情同意参加乳腺肿瘤临床试验，并建立一个咨询记录协议的可行性，以临床治疗trial. Method。参与者是69名新诊断的乳腺癌妇女和21名来自加拿大5个癌症中心的肿瘤学家。将患者随机分为三组：1.标准化录音带; 2.谘询录音带;或3.都是录音带患者在临床试验咨询后立即收到录音带。患者的结果包括感知被告知有关临床试验，知识的信息提供知情同意的临床试验，并在consultation.Results的沟通满意度：咨询录音带包含较少的试验相关信息比标准化的录音带，但没有差异的临床试验知识或感知被告知跨干预组。患者表示轻微的显着偏好咨询录音带超过standardized audiotape.Conclusions：患者倾向于接受自己的咨询录音带超过标准化的录音带。大多数肿瘤学家认为录音带干预是可行的，但考虑到在现有临床试验上尝试“背负”一项随机对照试验时出现的累积挑战，他们对参与更大规模的研究不太热情。版权所有（c）2006约翰威利父子有限公司。
Background: The purpose of this study was to systematically compare two audiotape formats for the delivery of information relevant to informed consent to participate in a clinical trial in breast oncology, and to establish the feasibility of adding a consultation recording protocol to a clinical treatment trial.Method. Participants were 69 women with newly diagnosed breast cancer and 21 oncologists from 5 Canadian cancer centers. Patients were block randomized to one of three groups: 1. standardized audiotape; 2. consultation audiotape; or 3. both audiotapes. Patients received their tapes immediately following the clinical trial consultation. Patient outcomes included perception of being informed about clinical trials, knowledge of information relevant to providing informed consent to a clinical trial, and satisfaction with communication during the consultation.Results: The consultation audiotapes contained less trial-related information than the standardized audiotape but there were no differences in clinical trial knowledge or perception of being informed across the intervention groups. Patients expressed a marginally significant preference for consultation audiotapes over standardized audiotapes.Conclusions: Patients tended to prefer receiving an audiotape of their own consultation over a standardized audiotape. The majority of oncologists considered the audiotape intervention feasible but were less enthusiastic about being involved in a larger study given the accrual challenges that arose when trying to 'piggy-back' one randomized controlled trial on an existing clinical trial. Copyright (c) 2006 John Wiley & Sons, Ltd.