Self-controlled observational study designs, such as the case-crossover design and the self-controlled case series, are reviewed, and their respective rationale, strengths and limitations are compared. Although no single design is generally superior to the others, they share the trait of being robust towards confounders that are stable over time. The self-controlled designs can be particularly useful when using secondary healthcare data for pharmacoepidemiological research and might be useful in screening for adverse drug effects. The main limitations of self-controlled designs are that they are amenable only to transient effects; some may be inefficient with long-term exposure; and they may be sensitive towards trends in exposure.
Bibliografisk noteISI Document Delivery No.: AJ6FY Times Cited: 2 Cited Reference Count: 24 Hallas, J. Pottegard, A. Novartis; Pfizer; Menarini; MSD; Nycomed; Astellas; Alkabello; Danish Association of Pharmaceutical Manufacturers; Novmtis; Astra Zeneca; Lundbeck; Leo Phatmaceuticals; Ferring Jesper Hallas has participated in research projects funded by Novartis, Pfizer, Menarini, MSD, Nycomed, Astellas and Alkabello with grants paid to the institution where he was employed. He has personally received fees for teaching or consulting from the Danish Association of Pharmaceutical Manufacturers and from Nycomed, Pfizer, Novmtis, Astra Zeneca, Lundbeck, Menarini, Leo Phatmaceuticals and Ferring. Anton Pattegard has participated in research projects funded by Astellas. 2 WILEY-BLACKWELL HOBOKEN J INTERN MED
- adverse drug effects design epidemiology methods SEQUENCE-SYMMETRY-ANALYSIS ACUTE MYOCARDIAL-INFARCTION CASE-CROSSOVER ACTIVE SURVEILLANCE PHYSICAL EXERTION ADVERSE EVENTS PRESCRIPTION SAFETY RISK DYSPEPSIA