Rawson N S
Division of Community Health, Faculty of Medicine, School of Pharmacy, Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
Pharmacoepidemiol Drug Saf. 2001 Dec;10(7):607-12. doi: 10.1002/pds.632.
To describe the process of obtaining access to the administrative health care utilization data of the Canadian province of Saskatchewan and the ethical issues involved.
The report focuses on the process of obtaining data for two recent studies. In the first, associations between aplastic anemia and agranulocytosis and prior drug use were evaluated, while the second is an examination of anti-arrhythmia drug utilization. In these studies, data from files containing computerized information on prescription drug use, hospitalizations, physician services and cancer registrations were linked together and also with information from hospital charts, physician records and death registrations.
Data on individual patients are available from the Saskatchewan data-files after the removal of identifying variables, and access to external information from hospitals, physicians, death registrations and the patients themselves is possible. However, researchers must accept that data considered to be only indirectly relevant to the objectives of the study or which, due to small numbers, may potentially identify either patients or physicians will only be released in aggregate form.
Access to the Saskatchewan data-files and to external information from hospitals, physicians and death registrations is normally straightforward. Restrictions that are applied are discussed.
描述获取加拿大萨斯喀彻温省行政医疗保健利用数据的过程以及所涉及的伦理问题。
本报告重点关注为两项近期研究获取数据的过程。第一项研究评估再生障碍性贫血和粒细胞缺乏症与先前用药之间的关联，第二项研究则是对抗心律失常药物利用情况的检查。在这些研究中，来自包含处方药使用、住院治疗、医生服务和癌症登记等计算机化信息的文件中的数据被链接在一起，同时还与来自医院病历、医生记录和死亡登记的信息相链接。
去除识别变量后，可从萨斯喀彻温省的数据文件中获取个体患者的数据，并且可以获取来自医院、医生、死亡登记以及患者自身的外部信息。然而，研究人员必须接受，那些被认为与研究目标仅间接相关或因数量较少可能潜在识别患者或医生的数据，将仅以汇总形式发布。
获取萨斯喀彻温省的数据文件以及来自医院、医生和死亡登记的外部信息通常较为直接。文中讨论了所实施的限制措施。
