Written informed consent and selection bias in observational studies using medical records: systematic review.
Written informed consent and selection bias in observational studies using medical records: systematic review.
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DOI：
10.1136/bmj.b866
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发表时间：
2009-03-12
期刊：
影响因子：
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通讯作者：
Brouwers MC
中科院分区：
文献类型：
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作者：
Kho ME;Duffett M;Willison DJ;Cook DJ;Brouwers MC
目的确定知情同意是否会在使用病历数据的前瞻性观察性研究中引入选择偏倚，以及此类研究的同意率。设计系统性综述。数据来源：Embase、Medline和科克伦图书馆，截至2008年3月，相关文章的参考文献列表，以及电子引文检索。研究选择前瞻性观察性研究，报告参与者和非参与者的特征，以获得知情同意，使用他们的病历。独立选择研究，一式两份;第三位评审员解决分歧。数据提取参与者和非参与者的年龄、性别、种族、教育、收入或健康状况，每项研究的参与率，以及这些计算对选择和报告偏倚威胁的敏感性。结果在1650篇引文中，17篇独特的研究符合纳入标准，并有可分析的数据。在所有结果中，参与者和非参与者之间存在差异;然而，在方向和影响程度上缺乏一致性。第161章？604例合格患者，66.9%同意使用其病历中的数据。结论参与者和非参与者之间的显著差异可能会威胁到观察性研究结果的有效性，这些研究需要同意使用病历中的数据。为了确保隐私立法不会对使用医疗记录的观察性研究产生不适当的偏见，研究伦理委员会就强制同意的必要性做出深思熟虑的决定是必要的。
Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161?604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.