@article{si_evaluating_2020,
	title = {Evaluating the {Ability} of {Economic} {Models} of {Diabetes} to {Simulate} {New} {Cardiovascular} {Outcomes} {Trials}: {A} {Report} on the {Ninth} {Mount} {Hood} {Diabetes} {Challenge}},
	volume = {23},
	issn = {1098-3015},
	shorttitle = {Evaluating the {Ability} of {Economic} {Models} of {Diabetes} to {Simulate} {New} {Cardiovascular} {Outcomes} {Trials}},
	url = {http://www.sciencedirect.com/science/article/pii/S1098301520321124},
	doi = {10.1016/j.jval.2020.04.1832},
	abstract = {Objectives
The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication.
Methods
Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class.
Results
Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME–calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit.
Conclusions
The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed.},
	language = {en},
	number = {9},
	urldate = {2020-10-26},
	journal = {Value in Health},
	author = {Si, Lei and Willis, Michael S. and Asseburg, Christian and Nilsson, Andreas and Tew, Michelle and Clarke, Philip M. and Lamotte, Mark and Ramos, Mafalda and Shao, Hui and Shi, Lizheng and Zhang, Ping and McEwan, Phil and Ye, Wen and Herman, William H. and Kuo, Shihchen and Isaman, Deanna J. and Schramm, Wendelin and Sailer, Fabian and Brennan, Alan and Pollard, Daniel and Smolen, Harry J. and Leal, José and Gray, Alastair and Patel, Rishi and Feenstra, Talitha and Palmer, Andrew J.},
	month = sep,
	year = {2020},
	keywords = {Mount Hood Diabetes Challenge, WP8, cardiovascular outcomes trial, computer modeling, diabetes},
	pages = {1163--1170},
}