Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations
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- 作者：Elisabetta Patorno (1)
Amanda R. Patrick (1)
Elizabeth M. Garry (1)
Sebastian Schneeweiss (1)
Victoria G. Gillet (1)
Dorothee B. Bartels (2) (3)
Elvira Masso-Gonzalez (2)
John D. Seeger (1) - 关键词：Cardiovascular outcomes ; Epidemiological methods ; Glucose ; lowering medications ; Observational studies ; Review
- 刊名：Diabetologia
- 出版年：2014
- 出版时间：November 2014
- 年：2014
- 卷：57
- 期：11
- 页码：2237-2250
- 全文大小：546 KB
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Amanda R. Patrick (1)
Elizabeth M. Garry (1)
Sebastian Schneeweiss (1)
Victoria G. Gillet (1)
Dorothee B. Bartels (2) (3)
Elvira Masso-Gonzalez (2)
John D. Seeger (1)
1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women鈥檚 Hospital and Harvard Medical School, 1620 Tremont Street (Suite 3030), Boston, MA, 02120, USA
2. Corporate Department Global Epidemiology, Boehringer Ingelheim GmbH, Ingelheim, Germany
3. Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany - ISSN：1432-0428
文摘
Background Recent years have witnessed a growing body of observational literature on the association between glucose-lowering treatments and cardiovascular disease. However, many of the studies are based on designs or analyses that inadequately address the methodological challenges involved. Methods We reviewed recent observational literature on the association between glucose-lowering medications and cardiovascular outcomes and assessed the design and analysis methods used, with a focus on their ability to address specific methodological challenges. We describe and illustrate these methodological issues and their impact on observed associations, providing examples from the reviewed literature. We suggest approaches that may be employed to manage these methodological challenges. Results From the evaluation of 81 publications of observational investigations assessing the association between glucose-lowering treatments and cardiovascular outcomes, we identified the following methodological challenges: 1) handling of temporality in administrative databases; 2) handling of risks that vary with time and treatment duration; 3) definitions of the exposure risk window; 4) handling of exposures that change over time; and 5) handling of confounding by indication. Most of these methodological challenges may be suitably addressed through application of appropriate methods. Conclusions/interpretation Observational research plays an increasingly important role in the evaluation of the clinical effects of diabetes treatment. Implementation of appropriate research methods holds the promise of reducing the potential for spurious findings and the risk that the spurious findings will mislead the medical community about risks and benefits of diabetes medications.