Rotelli Matthew D
1 Global Pharmacokinetics, Pharmacodynamics, and Pharmacometrics-Bio-Medicines, Eli Lilly and Company, Indianapolis, IN, USA.
Ther Innov Regul Sci. 2015 May;49(3):342-347. doi: 10.1177/2168479015578155.
In the field of health care, researchers and decision makers are increasingly turning toward retrospective observational studies of administrative claims and electronic health record databases to improve outcomes for patients. For many important questions, randomized studies have not been conducted, and even when they have been, such studies often inadequately reflect the realities of patients' lives or care. However, use of retrospective studies not only increases methodological complexity but also requires more subjectivity for those attempting to perform statistical analysis. The hurdles for establishing the reproducibility of such research to ensure accuracy and generalizability are therefore also higher, as are the requirements for transparency to limit the impact of bias. The ethical statistical practitioner will therefore need to take additional steps to enable results to be interpreted and acted upon with confidence. These include increased transparency regarding the impact of database selection, database quality, database content, and design decisions on the robustness of statistical conclusions. A number of approaches to increase the reproducibility of retrospective health care research are also presented, along with some discussion regarding responsibilities of data owners, statistical practitioners, publishers, and users of results.
在医疗保健领域，研究人员和决策者越来越倾向于对行政索赔和电子健康记录数据库进行回顾性观察研究，以改善患者的治疗效果。对于许多重要问题，尚未进行随机研究，即使进行了随机研究，此类研究往往也无法充分反映患者的生活或护理实际情况。然而，使用回顾性研究不仅会增加方法的复杂性，而且对于试图进行统计分析的人员而言，还需要更多的主观性。因此，确保此类研究的可重复性以保证准确性和普遍性的障碍更高，限制偏差影响的透明度要求也更高。因此，有道德的统计从业者将需要采取额外措施，以便能够自信地解释结果并据此采取行动。这些措施包括提高数据库选择、数据库质量、数据库内容以及设计决策对统计结论稳健性影响的透明度。还介绍了一些提高回顾性医疗保健研究可重复性的方法，并对数据所有者、统计从业者、出版商和结果使用者的责任进行了一些讨论。
