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1.
arxiv; 2021.
Preprint in English | PREPRINT-ARXIV | ID: ppzbmed-2108.06568v3

ABSTRACT

The ordinal endpoint is prevalent in clinical studies. For example, for the COVID-19, the most common endpoint used was 7-point ordinal scales. Another example is in phase II cancer studies, efficacy is often assessed as an ordinal variable based on a level of response of solid tumors with four categories: complete response, partial response, stable disease, and progression, though often a dichotomized approach is used in practices. However, there lack of designs for the ordinal endpoint despite Whitehead et al. (1993, 2017), Jaki et al. (2003) to list a few. In this paper, we propose a generic group sequential schema based on Bayesian methods for ordinal endpoints, including three methods, the proportional-odds-model (PO)-based, non-proportional-odds-model (NPO)-based, and PO/NPO switch-model-based designs, which makes our proposed methods generic to be able to deal with various scenarios. We conducted extensive simulations to demonstrate the desirable performances of the proposed method and an R package BayesOrdDesign has also been developed.


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COVID-19
2.
arxiv; 2020.
Preprint in English | PREPRINT-ARXIV | ID: ppzbmed-2006.06416v2

ABSTRACT

The sudden onset of the coronavirus (SARS-CoV-2) pandemic has resulted in tremendous loss of human life and economy in more than 210 countries and territories around the world. While self-protections such as wearing mask, sheltering in place and quarantine polices and strategies are necessary for containing virus transmission, tens of millions people in the U.S. have lost their jobs due to the shutdown of businesses. Therefore, how to reopen the economy safely while the virus is still circulating in population has become a problem of significant concern and importance to elected leaders and business executives. In this study, mathematical modeling is employed to quantify the profit generation and the infection risk simultaneously from the point of view of a business entity. Specifically, an ordinary differential equation model was developed to characterize disease transmission and infection risk. An algebraic equation is proposed to determine the net profit that a business entity can generate after reopening and take into account the costs associated of several protection/quarantine guidelines. All model parameters were calibrated based on various data and information sources. Sensitivity analyses and case studies were performed to illustrate the use of the model in practice.

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