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流行病学研究中的同意模式:来自25000多名应答者的证据。

Patterns of consent in epidemiologic research: evidence from over 25,000 responders.

作者信息

Dunn Kate M, Jordan Kelvin, Lacey Rosie J, Shapley Mark, Jinks Clare

机构信息

Primary Care Sciences Research Centre, Keele University, Keele, Staffordshire, United Kingdom.

出版信息

Am J Epidemiol. 2004 Jun 1;159(11):1087-94. doi: 10.1093/aje/kwh141.

DOI:10.1093/aje/kwh141
PMID:15155293
Abstract

Ethical guidelines in the United Kingdom require written consent from participants in epidemiologic studies for follow-up or review of medical records. This may cause bias in samples used for follow-up or medical record review. The authors analyzed data from seven general population surveys conducted in the United Kingdom (1996-2002), to which over 25,000 people responded. Associations of age, gender, and symptom under investigation with consent to follow-up and consent to review of medical records were examined. Consent to follow-up was approximately 75-95% among survey responders under age 50 years but fell among older people, particularly females. Consent to follow-up was also higher among responders who had the symptom under investigation (pooled odds ratio = 1.61, 95% confidence interval: 1.36, 1.92). Consent to review of medical records followed a similar pattern. Patterns of consent were relatively consistent and represented a high proportion of responders. Males, younger people, and subjects reporting the symptom under investigation were more likely to give consent, and these groups may be overrepresented in follow-up samples or reviews of medical records. Although consent is high among responders, the additive effect of nonresponse and nonconsent can substantially reduce sample size and should be taken into account in epidemiologic study planning.

摘要

英国的伦理准则要求流行病学研究的参与者提供书面同意,以便对其医疗记录进行随访或审查。这可能会导致用于随访或医疗记录审查的样本出现偏差。作者分析了在英国进行的七项一般人群调查(1996 - 2002年)的数据,超过25000人对这些调查做出了回应。研究了年龄、性别以及所调查症状与随访同意和医疗记录审查同意之间的关联。50岁以下的调查受访者中,随访同意率约为75% - 95%,但在老年人中,尤其是女性中,同意率有所下降。在所调查症状的受访者中,随访同意率也更高(合并比值比 = 1.61,95%置信区间:1.36,1.92)。医疗记录审查同意情况遵循类似模式。同意模式相对一致,且在受访者中占比很高。男性、年轻人以及报告所调查症状的受试者更有可能给予同意,并且这些群体在随访样本或医疗记录审查中可能占比过高。尽管受访者中的同意率很高,但无回应和不同意的累加效应会大幅减少样本量,在流行病学研究规划中应予以考虑。

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