Participants' understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START.
Participants' understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START.
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DOI：
10.1186/1745-6215-15-375
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发表时间：
2014-09-25
期刊：
影响因子：
2.5
通讯作者：
Ohuchi N
中科院分区：
文献类型：
--
作者：
Shiono YN;Zheng YF;Kikuya M;Kawai M;Ishida T;Kuriyama S;Ohuchi N
通常很难招募健康志愿者参加随机对照试验（RCT），因为参与者对试验的正确理解存在障碍。本研究旨在评价参与RCT的健康志愿者对知情同意（IC）过程的理解程度。此外，与理解程度相关的因素进行了调查。J-START（日本STrategic抗癌随机对照试验）是一项RCT，旨在研究40至49岁女性中超声筛查乳腺癌的有效性。为了评估参与者对J-START的理解，我们在日本各地的五个研究中心注册当天向376名日本女性发放了问卷。受访者被要求在两周内完成匿名问卷。我们使用日本版的知情同意质量量表（QuIC）评估了对IC的客观理解和主观理解。然后，我们分析了妇女的理解是穷人的特点，并澄清提供信息和他们的研究协议的理解之间的关联。客观和主观理解的平均QuIC得分分别为78.2和82.2（各100分）。这些是参与者对RCT理解的普遍可接受的评分。然而，有四个领域得分较低，表明理解较差：（1）研究的实验性质，（2）潜在的风险或不适，（3）对自己的好处，（4）补偿。健康的志愿者通常都很好地理解J-START。然而，有些领域需要改进。为了便于参加者理解，有必要提供培训，以减少各医疗中心之间提供信息程序的差异，并努力提供一致的信息和条件。J-START于2007年7月1日在日本大学医院医学信息网络临床试验注册处（UMIN-CTR）注册（注册号：UMIN 000000757）。
It is often difficult to enrol healthy volunteers into a randomized controlled trial (RCT) as there are barriers to participants’ proper understanding of a trial. This study aimed to evaluate degrees of understanding of the informed consent (IC) process among healthy volunteers who participated in an RCT. Additionally, factors associated with degree of understanding were investigated. The J-START (the Japan STrategic Anti-cancer Randomized controlled Trial) is an RCT investigating the effectiveness of ultrasonography screening for breast cancer in women aged 40 to 49 years. To evaluate participants’ understanding of the J-START, we administered questionnaires to 376 Japanese women on the day of enrolment at five study sites across Japan. The respondents were asked to complete the anonymous questionnaire within 2 weeks. We assessed objective understanding and perceived subjective understanding of IC using a Japanese version of the Quality of Informed Consent scale (QuIC). Then we analyzed the characteristics of women whose understanding was poor, and clarified the association between providing information and their understanding of the study protocol. The average QuIC scores were 78.2 and 82.2 (out of 100 each) for objective and subjective understanding, respectively. These are generally acceptable scores for participants’ understanding of an RCT. However, there were four domains with low scores, indicating poor understanding: (1) experimental nature of the study, (2) potential risks or discomfort, (3) benefit to self, and (4) compensation. Healthy volunteers generally well understood the J-START. Nevertheless, there were some domains in need of improvement. In order to facilitate participants’ understanding, it is necessary to provide training to reduce differences in information-providing procedures between medical centres and to endeavour to provide consistent information and conditions. The J-START was registered with the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000000757), on July 1, 2007.
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