Drug safety studies and measures of effect using the self-controlled case series design

2012 ◽  
Vol 22 (1) ◽  
pp. 108-110 ◽  
Author(s):  
Kumanan Wilson ◽  
Steven Hawken
Circulation ◽  
2018 ◽  
Vol 138 (4) ◽  
pp. 356-363 ◽  
Author(s):  
Tzu-Ting Chen ◽  
Yi-Chun Yeh ◽  
Kuo-Liong Chien ◽  
Mei-Shu Lai ◽  
Yu-Kang Tu

Background: Invasive dental treatments (IDTs) can yield temporary bacteremia and have therefore been considered a potential risk factor of infective endocarditis (IE). It is hypothesized that, through the trauma caused by IDTs, bacteria gain entry to the bloodstream and may attach to abnormal heart valves or damaged heart tissue, giving rise to IE. However, the association between IDTs and IE remains controversial. The aim of this study is to estimate the association between IDTs and IE. Methods: The data in this study were obtained from the Health Insurance Database in Taiwan. We selected 2 case-only study designs, case-crossover and self-controlled case series, to analyze the data. The advantage of these methods is that confounding factors that do not vary with time are adjusted for implicitly. In the case-crossover design, a conditional logistic regression model with exposure to IDTs was used to estimate the risks of IE following an IDT with 4, 8, 12, and 16 weeks delay, respectively. In the self-controlled case series design, a conditional Poisson regression model was used to estimate the risk of IE for the risk periods of 1 to 4, 5 to 8, 9 to 12, and 13 to 16 weeks following an IDT. Results: In total, 9120 and 8181 patients with IE were included in case-crossover design and self-controlled case series design, respectively. In the case-crossover design, 277 cases and 249 controls received IDTs during the exposure period, and the odds ratio was 1.12 (95% confidence interval, 0.94–1.34) for 4 weeks. In the self-controlled case series design, we observed that 407 IEs occurred during the first 4 weeks after IDTs, and the age-adjusted incidence rate ratio was 1.14 (95% confidence interval, 1.02–1.26) for 1 to 4 weeks after IDTs. Conclusions: In both study designs, we did not observe a clinically larger risk for IE in the short periods after IDTs. We also found no association between IDTs and IE among patients with a high risk of IE. Therefore, antibiotic prophylaxis for the prevention of IE is not required for the Taiwanese population.


2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  

2011 ◽  
Vol 139 (12) ◽  
pp. 1805-1817 ◽  
Author(s):  
Y. G. WELDESELASSIE ◽  
H. J. WHITAKER ◽  
C. P. FARRINGTON

SUMMARYThe self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.


2013 ◽  
Vol 32 (19) ◽  
pp. 3290-3299 ◽  
Author(s):  
Stanley Xu ◽  
Simon J. Hambidge ◽  
David L. McClure ◽  
Matthew F. Daley ◽  
Jason M. Glanz

Drug Safety ◽  
2013 ◽  
Vol 36 (S1) ◽  
pp. 83-93 ◽  
Author(s):  
Marc A. Suchard ◽  
Ivan Zorych ◽  
Shawn E. Simpson ◽  
Martijn J. Schuemie ◽  
Patrick B. Ryan ◽  
...  

2013 ◽  
Vol 178 (12) ◽  
pp. 1750-1759 ◽  
Author(s):  
C. Zeng ◽  
S. R. Newcomer ◽  
J. M. Glanz ◽  
J. A. Shoup ◽  
M. F. Daley ◽  
...  

2019 ◽  
Vol 107 (2) ◽  
pp. 321-322 ◽  
Author(s):  
Meijia Zhou ◽  
Charles E. Leonard ◽  
Warren B. Bilker ◽  
Sean Hennessy

2011 ◽  
Vol 10 (3) ◽  
pp. 337-340 ◽  
Author(s):  
Anthony Grosso ◽  
Ian Douglas ◽  
Raymond MacAllister ◽  
Irene Petersen ◽  
Liam Smeeth ◽  
...  

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