Bias from. requiring explicit consent from all participants in observational research: Prospective, population based study
Bias from. requiring explicit consent from all participants in observational research: Prospective, population based study
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DOI：
10.1136/bmj.38624.397569.68
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发表时间：
2005-10-22
影响因子：
--
通讯作者：
Warlow, C
中科院分区：
文献类型：
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作者：
Al-Shahi, R;Vousden, C;Warlow, C
目的评价同意参加观察性研究的成年人和不同意参加观察性研究的成年人之间的差异。设计前瞻性、基于人群的队列研究。在苏格兰各地设置初级和二级保健。参与者187名成年人(年龄=16岁)在1999-2002年首次诊断为脑动静脉畸形时居住在苏格兰。干预通过参与者的全科医生寄送的邮寄同意书。主要结果衡量同意和未同意的人在首次提出研究时的人口学和临床特征以及随访结果的差异。结果111名成年人(59%)同意参与研究。这些同意者与非同意者在年龄、性别或社会经济地位方面没有显著差异。然而，同意的人比非同意的人更有可能活着和独立，并伴有癫痫发作。在随访期内，受试者接受介入治疗的可能性明显更大。虽然受试者的存活率显著提高，但他们更有可能在后续行动中癫痫发作。当对整个队列进行分析时，有颅内出血表现的患者继发出血的风险更高，但仅限于受试者时并不是如此。结论我们发现同意参与基于观察记录的研究的成年人与不同意或不能同意的成年人之间存在差异。明确同意使用个人可识别数据的一揽子要求可能会对疾病登记、流行病学研究和卫生服务研究产生偏见。
Objective To evaluate the differences between adults who consent to participate in observational research, and those who do not.Design Prospective, population based cohort study.Setting Primary and secondary care throughout Scotland.Participants 187 adults (aged >= 16 years) resident in Scotland at the time of their first diagnosis of a brain arteriovenous malformation in 1999-2002.Intervention Postal consent form sent via participants' general practitioner.Main outcome measures Differences between consenters and non-consenters in demographic and clinical features at first presentation, and outcome during follow-up.Results 111 adults (59%) consented to participate in the study. These consenters were not significantly different from non-consenters in age, sex, or socioeconomic status at first presentation. However, consenters were significantly more likely than non-consenters to present alive and independent, and with a seizure. During follow-up, consenters were Significantly more likely to receive interventional treatment. Although consenters' survival was significantly better, they were more likely to have a seizure during follow-up. Presentation with intracranial haemorrhage conferred a higher risk of subsequent haemorrhage when the whole cohort was analysed, but not when it was restricted to consenters.Conclusions We have found differences between adults who consent to participate in observational records-based research and those who do not, or cannot, consent. Blanket requirements for explicit consent for the use of individuals' identifiable data can bias disease registers, epidemiological studies, and health services research.