net efficacy adjusted for risk (near) a simple procedure for measuring riskbenefit balance经过风险调整的净效果(附近)一个简单的程序测量riskbenefit平衡.pdfVIP

Net Efficacy Adjusted for Risk (NEAR): A Simple Procedure for Measuring Risk:Benefit Balance ´ ´ ´ ´ ´ ´ Jose N. Boada*, Carlos Boada, Mar Garcıa-Saiz, Marcelino Garcıa, Eduardo Fernandez, Eugenio Gomez Clinical Pharmacology Unit, Pharmacovigilance Centre, University Hospital of Canary Islands, University of La Laguna, La Laguna, Santa Cruz de Tenerife, Spain Abstract Background: Although several mathematical models have been proposed to assess the risk:benefit of drugs in one measure, their use in practice has been rather limited. Our objective was to design a simple, easily applicable model. In this respect, measuring the proportion of patients who respond favorably to treatment without being affected by adverse drug reactions (ADR) could be a suitable endpoint. However, remarkably few published clinical trials report the data required to calculate this proportion. As an approach to the problem, we calculated the expected proportion of this type of patients. Methodology/Principal Findings: Theoretically, responders without ADR may be obtained by multiplying the total number of responders by the total number of subjects that did not suffer ADR, and dividing the product by the total number of subjects studied. When two drugs are studied, the same calculation may be repeated for the second drug. Then, by constructing a 2 62 table with the expected frequencies of responders with and without ADR, and non-responders with and without ADR, the odds ratio and relative risk with their confidence intervals may be easily calculated and graphically represen