The effect of seeking consent on the representativeness of patient cohorts: iron-deficiency anaemia and colorectal cancer
The effect of seeking consent on the representativeness of patient cohorts: iron-deficiency anaemia and colorectal cancer
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DOI：
10.1111/j.1463-1318.2011.02724.x
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发表时间：
2011-11-01
影响因子：
3.4
通讯作者：
Wilson, S.
中科院分区：
文献类型：
--
作者：
Damery, S.;Ryan, R.;Wilson, S.
目的本研究旨在确定在寻求个体患者同意时可能发生的选择偏倚水平，通过比较同意者和不同意者的特征，在诊断为缺铁性贫血（IDA）的患者队列中请求访问医疗记录。对同意偏好进行了部分调查，比较了提供或不提供同意访问其记录的患者的社会人口学特征，结果在599例患者中，425例（71.0%）收到了同意书。在有效回复中，371名（62.7%）受访者明确同意，47名（7.9%）拒绝。同意者和不同意者的特征在年龄、性别和剥夺四分位数方面有所不同。不同意与年轻有关（40-60岁vs 60+岁;双变量OR = 2.84; 95% CI = 2.01-4.02），女性（OR = 1.62; 95%CI = 1.13-2.34）和社会经济贫困结论当前的科研管理框架在保护个人权利和发展良好的科研基础以改善整个社会的医疗服务之间存在冲突。如果流行病学研究只包括那些同意查阅其记录的个人的数据，那么由此产生的选择偏差可能会对研究结果的科学有效性和普遍性产生影响，并最终影响患者护理的质量。
Aim The study aimed to establish the level of selection bias that may occur should individual patient consent be sought, by comparing characteristics of consenters and nonconsenters to a request for access to medical records within a cohort of patients diagnosed with iron-deficiency anaemia (IDA).Method A cohort study and cross-sectional survey was carried out of consent preferences that compared the sociodemographic characteristics of patients providing or not providing consent for access to their records, the consent rates by participant subgroup and the predictors of consent/nonconsent.Results Of 599 patients mailed requesting consent for access to their medical records, 425 (71.0%) responses were received. Of the valid responses, explicit consent was granted by 371 (62.7%) respondents, with 47 (7.9%) refusals. The characteristics of consenters and nonconsenters differed with regard to age, gender and deprivation quartile. Nonconsent was associated with younger age (40-60 years vs 60+ years; bivariate OR = 2.84; 95% CI = 2.01-4.02), female gender (OR = 1.62; 95% CI = 1.13-2.34) and being socioeconomically deprived (OR = 1.61; 95% CI = 1.15-2.26).Conclusion The current research governance framework demonstrates a conflict between protecting the rights of the individual and the development of a sound research base to improve the delivery of healthcare services for society as a whole. If epidemiological research includes data only from individuals who have given consent for access to their records, the resulting selection bias may have consequences for the scientific validity and generalizability of research findings, and ultimately the quality of patient care.