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本文引用的文献

1
Is it ethical to deny genetic research participants individualised results?拒绝向基因研究参与者提供个性化结果是否符合伦理道德?
J Med Ethics. 2009 Apr;35(4):209-13. doi: 10.1136/jme.2007.024034.
2
Cohort profile: west of Scotland twenty-07 study: health in the community.队列简介:苏格兰西部2007研究:社区健康
Int J Epidemiol. 2009 Oct;38(5):1215-23. doi: 10.1093/ije/dyn213. Epub 2008 Oct 17.
3
The search for clarity in communicating research results to study participants.在向研究参与者传达研究结果时力求清晰明了。
J Med Ethics. 2008 Sep;34(9):e17. doi: 10.1136/jme.2008.025122.
4
Communicating the results of clinical research to participants: attitudes, practices, and future directions.向参与者传达临床研究结果:态度、做法及未来方向。
PLoS Med. 2008 May 13;5(5):e91. doi: 10.1371/journal.pmed.0050091.
5
The emergence of an ethical duty to disclose genetic research results: international perspectives.披露基因研究结果的伦理责任的出现:国际视角
Eur J Hum Genet. 2006 Nov;14(11):1170-8. doi: 10.1038/sj.ejhg.5201690. Epub 2006 Jul 26.
6
How well do people recall risk factor test results? Accuracy and bias among cholesterol screening participants.人们对风险因素检测结果的记忆程度如何?胆固醇筛查参与者中的准确性和偏差。
Health Psychol. 2006 May;25(3):425-32. doi: 10.1037/0278-6133.25.3.425.
7
Offering results to research participants.向研究参与者提供研究结果。
BMJ. 2006 Jan 28;332(7535):188-9. doi: 10.1136/bmj.332.7535.188.
8
Receiving a summary of the results of a trial: qualitative study of participants' views.收到试验结果总结:对参与者观点的定性研究
BMJ. 2006 Jan 28;332(7535):206-10. doi: 10.1136/bmj.38675.677963.3A. Epub 2006 Jan 9.
9
Ethical dilemmas: feeding back results to members of a longitudinal cohort study.伦理困境:向纵向队列研究的参与者反馈结果
J Med Ethics. 2005 Mar;31(3):153. doi: 10.1136/jme.2004.010140.
10
Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report.药物遗传学,伦理问题:对纳菲尔德生物伦理委员会报告的综述
J Med Ethics. 2005 Mar;31(3):144-8. doi: 10.1136/jme.2004.007229.

对纵向研究中临床数据书面反馈的回应:一项探索伦理影响的定性研究

Response to written feedback of clinical data within a longitudinal study: a qualitative study exploring the ethical implications.

机构信息

MRC/CSO Social and Public Health Sciences Unit, 4 Lilybank Gardens, Glasgow G12 8RZ, UK.

出版信息

BMC Med Res Methodol. 2011 Jan 27;11:10. doi: 10.1186/1471-2288-11-10.

DOI:10.1186/1471-2288-11-10
PMID:21272336
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3041784/
Abstract

BACKGROUND

There is a growing ethical imperative to feedback research results to participants but there remains a striking lack of empirical research on how people respond to individualised feedback. We sought to explore longitudinal study participants' response to receiving individual written feedback of weight-related and blood results, and to consider the balance of harms against benefits.

METHODS

A qualitative study with face-to-face and telephone interviews conducted with 50 men and women who had participated in the fifth and most recent wave of the cohort study 'West of Scotland Twenty-07' and received a feedback letter containing body mass index (BMI), body fat percentage, cholesterol and glycated haemoglobin A1c (HbA1c) results.

RESULTS

Expectations of, and response to, the feedback of their individual results varied. Whilst half of the participants were on the whole 'pleased' with their results or held neutral views, half reported negative responses such as 'shock' or 'concern', particularly in relation to the weight-related results. Participants who were overweight and obese used the most negative language about their results, with some being quite distressed and reporting feelings of powerlessness, low self-image and anxiety over future health. Nevertheless, some people reported having implemented lifestyle changes in direct response to the feedback, resulting in significant weight-loss and/or dietary improvements. Others reported being motivated to change their behaviour. Age and gender differences were apparent in these narratives of behaviour change.

CONCLUSIONS

The potential harm caused to some participants may be balanced against the benefit to others. More evaluation of the impact of the format, content and means of individualised feedback of research findings in non-trial studies is required given the growing ethical imperative to offer participants a choice of receiving their results, and the likelihood that a high percentage will choose to receive them.

摘要

背景

向参与者反馈研究结果的伦理要求日益强烈,但对于人们如何对个体化反馈做出反应,仍缺乏引人注目的实证研究。我们试图探讨长期研究参与者对收到与体重和血液相关的个体化书面反馈的反应,并考虑权衡利弊。

方法

这是一项定性研究,对参加过第五次也是最近一次队列研究“苏格兰西部 2007 年研究”的 50 名男性和女性进行了面对面和电话访谈,他们收到了一封载有体重指数(BMI)、体脂百分比、胆固醇和糖化血红蛋白 A1c(HbA1c)结果的反馈信。

结果

对反馈其个人结果的期望和反应各不相同。虽然一半的参与者总体上对他们的结果感到“满意”或持中立态度,但一半的参与者报告了负面反应,如“震惊”或“担忧”,特别是与体重相关的结果。超重和肥胖的参与者使用了最负面的语言来描述他们的结果,有些人感到非常苦恼,并报告了无力感、低自我形象和对未来健康的焦虑。然而,一些人报告说他们已经根据反馈直接实施了生活方式的改变,导致了显著的体重减轻和/或饮食改善。其他人则报告说他们受到了激励,想要改变自己的行为。在这些关于行为改变的叙述中,年龄和性别差异明显。

结论

对于一些参与者来说,可能造成的潜在伤害可能与对其他人的好处相平衡。鉴于提供参与者选择接收其结果的伦理要求日益强烈,并且很可能很大一部分人会选择接收结果,因此需要对非试验研究中研究结果个体化反馈的格式、内容和方式的影响进行更多的评估。