Evaluation of Participant Comprehension of Information Received in an Exercise and Diet Intervention Trial: The DR's EXTRA Study
Evaluation of Participant Comprehension of Information Received in an Exercise and Diet Intervention Trial: The DR's EXTRA Study
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DOI：
10.1159/000254484
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发表时间：
2010-01-01
期刊：
影响因子：
3.5
通讯作者：
Laitinen, Tomi
中科院分区：
文献类型：
--
作者：
Lansimies-Antikainen, Helena;Pietila, Anna-Maija;Laitinen, Tomi
背景：知情同意程序是健康研究的法律和伦理基石，对于确保健康研究参与者真正理解他们收到的信息至关重要。临床研究往往无法提供数据来澄清参与者理解了多少。目的：了解老年志愿者对健康研究的理解程度。方法：研究对象为随机抽样的1410名年龄在57-78岁的男性和女性，他们参加了一项为期4年的随机对照干预试验，研究体育锻炼和饮食对动脉粥样硬化、内皮功能和认知的影响。随机化3个月后向所有自愿参与者(n=1,324)发放知情同意问卷。此外，在随机化两年后，对参与者在与理解相关的干预试验中的长期延续进行评估。结果：有效率为91%。大多数受访者(89%)对收到的信息的清晰度感到满意。此外，参与者对收到的信息的理解似乎对整个研究人群中的82%是足够的。与背景变量相比，高等教育(p<；0.001)和对自身健康的满意度(p=0.01)与对所提供信息的充分理解有关。此外，感觉自己健康的参与者更有可能在两年后继续参与干预。结论：这项研究的结果表明，老年研究参与者对收到的信息有足够的理解。然而，我们的结果表明，对于受教育程度较低或主观感觉健康受损的参与者，应特别努力。这项研究强调了研究人员需要批判性地分析信息的质量和提供信息的方式。这在长期的跟踪研究中尤其重要。版权所有(C)2009 S.Karger AG，巴塞尔
Background: The informed consent process is the legal and ethical cornerstone of health research and is essential to ensure that participants in health research really understand the information they receive. Clinical studies often fail to provide data that clarify how much participants have understood. Objective: To evaluate the comprehension of older volunteer participants in health research. Methods: The subjects are a random population sample of 1,410 men and women aged 57-78 years, who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. A questionnaire about informed consent was given to all willing participants (n = 1,324) 3 months after the randomization. In addition, participants' long-term continuation in the intervention trial with relation to understanding was evaluated 2 years after the randomization. Results: The response rate was 91%. The majority of respondents (89%) were satisfied with the intelligibility of received information. In addition, the participants' comprehension of the information received seemed to be adequate in 82% of the whole study population. Compared to back-ground variables, higher education (p < 0.001) and satisfaction with one's own health (p = 0.01) were associated with adequate comprehension of the provided information. Furthermore, participants who felt themselves to be healthy were more likely to continue participating in the intervention after 2 years. Conclusions: The findings of this study indicated sufficient understanding of received information in older research participants. However, our results indicate that special efforts should be made with participants with lower educational levels or subjective feelings of impaired health. This study highlights the need for researchers to critically analyze the quality of information and how it is provided. This is especially important in long-term follow-up studies. Copyright (C) 2009 S. Karger AG, Basel