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Xie F.,McMaster University | Xie F.,Father Sean oSullivan Research Center | Pickard A.S.,University of Illinois at Chicago | Krabbe P.F.M.,University of Groningen | And 4 more authors.
PharmacoEconomics | Year: 2015

Multi-attribute utility-based instruments (MAUIs) assess health status and provide an index score on the full health-dead scale, and are widely used to support reimbursement decisions for new healthcare interventions worldwide. A valuation study is a key part of the development of MAUIs, with the primary goal of developing a scoring algorithm through eliciting societal preferences. We developed the 21-item Checklist for REporting VAluaTion StudiEs (CREATE) by following a modified two-round Delphi panel approach plus an email survey. CREATE is intended to promote good reporting practice as well as guiding developers to thoroughly and carefully think through key methodological elements in designing valuation studies. © 2015, The Author(s). Source


Trademark
Evidera Inc. | Date: 2015-07-17

Computer software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields. Providing temporary use of web-based software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields.


Trademark
Evidera Inc. | Date: 2015-07-17

Computer software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields. Providing temporary use of web-based software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields.


Eremenco S.,Evidera Inc. | Coons S.J.,Critical Path Institute | Paty J.,Quintiles | Coyne K.,Evidera Inc. | Bennett A.V.,University of North Carolina at Chapel Hill
Value in Health | Year: 2014

The objective of this report was to address the use and mixing of data collection modes within and between trials in which patient-reported outcome (PRO) end points are intended to be used to support medical product labeling. The report first addresses the factors that should be considered when selecting a mode or modes of PRO data collection in a clinical trial, which is often when mixing is first considered. Next, a summary of how to "faithfully" migrate instruments is presented followed by a section on qualitative and quantitative study designs used to evaluate measurement equivalence of the new and original modes of data collection. Finally, the report discusses a number of issues that must be taken into account when mixing modes is deemed necessary or unavoidable within or between trials, including considerations of the risk of mixing at different levels within a clinical trial program and mixing between different types of platforms. In the absence of documented evidence of measurement equivalence, it is strongly recommended that a quantitative equivalence study be conducted before mixing modes in a trial to ensure that sufficient equivalence can be demonstrated to have confidence in pooling PRO data collected by the different modes. However, we also strongly discourage the mixing of paper and electronic field-based instruments and suggest that mixing of electronic modes be considered for clinical trials and only after equivalence has been established. If proceeding with mixing modes, it is important to implement data collection carefully in the trial itself in a planned manner at the country level or higher and minimize ad hoc mixing by sites or individual subjects. Finally, when mixing occurs, it must be addressed in the statistical analysis plan for the trial and the ability to pool the data must be evaluated to then evaluate treatment effects with mixed modes data. A successful mixed modes trial requires a "faithful migration," measurement equivalence established between modes, and carefully planned implementation to minimize the risk of increased measurement error impacting the power of the trial to detect a treatment effect. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Source


Marsh K.,Evidera Inc. | Ganz M.L.,Evidera Inc. | Hsu J.,Harvard University | Strandberg-Larsen M.,Copenhagen University | And 2 more authors.
Value in Health | Year: 2016

There is growing awareness of the impact of human activity on the climate and the need to stem this impact. Public health care decision makers from Sweden and the United Kingdom have started examining environmental impacts when assessing new technologies. This article considers the case for incorporating environmental impacts into the health technology assessment (HTA) process and discusses the associated challenges. Two arguments favor incorporating environmental impacts into HTA: 1) environmental changes could directly affect people's health and 2) policy decision makers have broad mandates and objectives extending beyond health care. Two types of challenges hinder this process. First, the nascent evidence base is insufficient to support the accurate comparison of technologies' environmental impacts. Second, cost-utility analysis, which is favored by many HTA agencies, could capture some of the value of environmental impacts, especially those generating health impacts, but might not be suitable for addressing broader concerns. Both cost-benefit and multicriteria decision analyses are potential methods for evaluating health and environmental outcomes, but are less familiar to health care decision makers. Health care is an important and sizable sector of the economy that could warrant closer policy attention to its impact on the environment. Considerable work is needed to track decision makers' demands, augment the environmental evidence base, and develop robust methods for capturing and incorporating environmental data as part of HTA. © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Source

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