Description Usage Format Details Source References Examples
The OMOP Ryan et al.(2013) reference set of test cases that contains both positive and negative controls.
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A set of 399 negative and positive controls or couples of adverse event and drug.
AE
a character vector indicating adverse events
ATC
The Anatomical Therapeutic Chemical (ATC) code
statu
a numeric vector indicating if positive (1) or negative (0) control
To evaluate and compare the performances of the competing methods, we use the OMOP Ryan et al.(2013) reference set of test cases that contains both positive and negative controls. Four adverse events (i.e. d = 4) were studied in this reference set : acute myocardial infarction (AMI), acute kidney injury (AKI), acute liver injury (ALI), and upper gastro-intestinal bleeding (GIB). There are three-hundred and ninety-nine test cases where 165 positive controls and 234 negative controls were identified across the four adverse events of interest. More details are given by Table 1. Ryan et al. (2013) indicate that the majority of positive controls for AKI and GIB were supported by randomized clinical trial evidence, while the majority of positive controls for ALI and AMI were only based on published case reports. Then a positive control is a pair (drug and adverse event) which is supported by randomized clinical trial evidence or based on published case reports whereas a negative control is not met by neither of the these methods.
Ryan, P., Schuemie, M., Welebob, E., Duke, J., Valentine, S., and Hartzema, A. (2013). Defining a reference set to support methodological research in drug safety. Drug safety, 36(1), 33-47.
Ryan, P., Schuemie, M., Welebob, E., Duke, J., Valentine, S., and Hartzema, A. (2013). Defining a reference set to support methodological research in drug safety. Drug safety, 36(1), 33-47.
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