Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease
Selection bias resulting from the requirement for prior consent in observational research: a community cohort of people with ischaemic heart disease
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DOI：
10.1136/hrt.2006.111591
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发表时间：
2007-09-01
期刊：
影响因子：
5.7
通讯作者：
Glynn, Liam
中科院分区：
文献类型：
--
作者：
Buckley, Brian;Murphy, Andrew W.;Glynn, Liam
目的：评估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。设置：35个随机的爱尔兰全科诊所。参会人员：干预：2005 - 6年的病历检索、邮寄问卷和知情同意书。主要结果测量：知情同意者和非知情同意者在人口统计学和预后危险因素方面的差异。结果：随访时，1592例（98.9%）患者找到了图表。1269名患者收到了样本，876名（69%）被退回。其中，574人（65.5%）同意参与进一步研究。Logistic回归确定了四个特征作为问卷应答者同意参与进一步研究的独立阳性预测因素：接受经皮腔内冠状动脉成形术与同意的几率增加相关，比值比（OR）为1.77（95% CI 1.09 - 2.86），最后记录的血压为140/ 90 mm Hg（OR = 1.45（1.00 - 2.09）），最后记录的总胆固醇水平，5 mmol/ L（OR = 1.71（1.16至2.54）），并且是既往吸烟者而不是当前吸烟者或非吸烟者结论：这项研究表明，在缺血性心脏病，在欧洲的日常临床重要性的疾病的观察性研究的同意偏见的潜在影响。它表明，临床上重要的预后变量可能与同意的偏好。未来的队列，取决于事先书面同意，可能包含不成比例的那些谁作出了健康的生活方式的决定，以前从治疗中受益或其临床风险因素已经得到很好的管理。因此，这种研究的普遍性可能会降低，治疗的效果可能会被过度或低估。
Objective: To evaluate differences between adults who consent to participate in observational research and those who do not.Design: Prospective, population- based cohort study.Setting: 35 randomised Irish general practices. Participants: 1609 adults with ischaemic heart disease identified in 2000 - 1.Intervention: Medical records search, postal questionnaire and consent form in 2005 - 6.Main outcome measures: Differences in demographic and prognostic risk factors between consenters and non- consenters.Results: At follow- up, charts were located for 1592 patients ( 98.9%). Questionnaires were sent to 1269 patients and 876 were returned ( 69%). Of these, 574 ( 65.5%) gave consent for participation in further research. Logistic regression identified four characteristics as independently positively predictive of consent to participation in further research among questionnaire responders: having undergone percutaneous transluminal coronary angioplasty was associated with an increased odds of consent, with an odds ratio ( OR) of 1.77 ( 95% CI 1.09 to 2.86), as was a last recorded blood pressure,140/ 90 mm Hg ( OR = 1.45 ( 1.00 to 2.09)), a last recorded total cholesterol level,5 mmol/ l ( OR = 1.71 ( 1.16 to 2.54)) and being an exsmoker rather than a current smoker or non- smoker ( OR = 1.73 ( 1.17 to 2.57)).Conclusions: This research demonstrates the potential impact of consent bias in observational research on ischaemic heart disease, a disease of everyday clinical importance in Europe. It demonstrates that clinically important prognostic variables may be associated with consent preferences. Future cohorts, dependent upon prior written consent, may contain disproportionate numbers of those who have made healthy lifestyle decisions, have previously benefited from treatment or whose clinical risk factors are already well managed. As a result, the generalisability of such research may be diminished and the effects of treatments over- or underestimated.