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August 20, 2017

FDA Workshop on Modeling and Statistical Methods for the Regulatory Assessment of Tobacco Products

December 5-6, 2013 | Food and Drug Administration (FDA), Rockville, MD In a session on Population Models to Account for Quality-of-Life Measures, Dr. Ware presented a talk entitled, "Improving Quality of Life Outcomes Measures for Use in Tobacco Research: Lessons from Population Surveys and Clinical Research." Presentations in this session and a panel discussion covered methods for assessing changes in quality-of-life and other measures, which demonstrate the effects on morbidity due to tobacco use. The conference, hosted by the Center for Tobacco Products (CTP), was intended to stimulate discussion among academic researchers, industry participants, FDA scientists, and other stakeholders on the challenges and opportunities associated with using computer statistical modeling to assess the effects of tobacco products on population health.
August 20, 2017

Standardizing and Integrating Disease-specific and Generic Patient-reported Outcome Measures

June 24th 2015:  Center on Behavior and Health (VCBH), University of Vermont, Burlington, Vermont Dr. Ware lectured on conceptual and methodological milestones in patient-reported outcomes (PRO) measurement development.  He introduced a new generation of disease-specific PROs that fill the gap between widely-used disease-specific measures that are not health-related quality of life (QOL) and generic QOL measures that are not disease-specific.  Dr. Ware showed how both the content and scoring of disease-specific QOL impact measures has been standardized across diseases to enable norm-based scoring and interpretation of disease-specific PROs in the chronically-ill US population.  Results from a pilot demonstration test in an ongoing surgical registry illustrated how a powerful new adaptive survey logic can automatically adapt PROs to capture the impact of multiple chronic conditions to make comprehensive measurement more practical.
August 20, 2017

Health-Related Quality of Life Assessment – State of the Art 2014: Lecture and Smoking-specific Outcomes Research Workshop

January 27th – 28th, 2014 | Group R&D, British American Tobacco (Investments) Ltd., Southampton, UK Dr. Ware presented an invited lecture covering noteworthy milestones in the history of patient-reported outcomes (PRO) including a new generation of standardized disease-specific PROs, the QOL Disease-specific Impact Scale (QDIS®), that fill the gap between widely-used disease-specific measures that do not measure quality of life (QOL) and generic QOL measures that do not measure disease-specific outcomes.  In his workshop, Dr. Ware showed how both the content and scoring of condition-specific QOL impact measures, including measures of the QOL impact attributed to smoking, can be standardized across conditions using QDIS and how norm-based scoring can make interpretation much easier. Dr. Ware also presented examples of how to test whether survey respondents who have multiple conditions such as arthritis and asthma are able to make valid ratings of the QOL impact of each condition using QDIS.  Another consideration of particular importance in smoking research that focuses on otherwise well smokers (free of chronic health problems) is the range of PRO measurement and whether the measurement “ceiling” is high enough to detect improvements with decreased tobacco exposure.  The ceiling effect observed for the SF-36® Physical Functioning scale (59%) was lowered using JWRG’s new QGEN® Physical Functioning alternative scale (35%), enabling detection of a more favorable functional outcome with reduced toxicant prototype exposure that would otherwise have been missed in a recent clinical trial.  Support for this lecture and workshop was provided by an unrestricted research grant to John […]
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