Herrmann N, Amsel J, Lynch E
Am J Public Health. 1981 Dec;71(12):1314-9. doi: 10.2105/ajph.71.12.1314.
This paper describes efforts to solicit hospital and physician participation for a case-control study of the etiology of colon cancer in the five Pennsylvania counties of the Philadelphia metropolitan area. Forty-seven of the 70 hospitals in this region were eligible for inclusion in the study. Thirty-seven (79%) agreed to participate, 27 of them within six months of initial contact. The median time to approval of participation was three months and the median number of separate contacts was nine. At least five participating hospitals submitted the protocol to their lawyers and nine required that special procedures be developed for release of patient information. Two hundred fourteen of 256 listed attending physicians were eligible for participation; 161 (75%) permitted all patients to be contacted 23 (11%) permitted some patients to be contacted; 30 (14%) refused all patient contact. A significant association between type of specialty and type of permission was found (p approximately .005). Concerns about confidentiality and lack of personal advantage were frequently cited by non-participants. The validity of case-control studies relying on hospital or physician ascertainment of cases is seriously challenged by such lengthy delays and lack of participation which can result in a biased pool of potential cases.
本文描述了为在费城大都市区宾夕法尼亚州的五个县开展一项关于结肠癌病因的病例对照研究,争取医院和医生参与所做的努力。该地区70家医院中有47家符合纳入该研究的条件。其中37家(79%)同意参与,其中27家在初次接触后的六个月内同意。参与获批的中位时间为三个月,单独联系的中位次数为九次。至少有五家参与研究的医院将方案提交给了律师,九家要求制定特殊程序以获取患者信息。列出的256名主治医生中有214名符合参与条件;161名(75%)允许联系所有患者,23名(11%)允许联系部分患者,30名(14%)拒绝联系所有患者。研究发现专业类型与许可类型之间存在显著关联(p约为0.005)。未参与者经常提到对保密性的担忧和缺乏个人利益。如此长时间的拖延和缺乏参与可能导致潜在病例库出现偏差,这严重挑战了依赖医院或医生确定病例的病例对照研究的有效性。