Heterogeneity, Sensitivity, Resistance, Effectiveness

• Activity Number: 360
• Type: Contributed
• Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Section on Statistics in Epidemiology
• Author(s): Lev Sverdlov*+
• Keywords: Heterogeneity ; Sensitivity ; Effectiveness ; Treatment-Outcome Complex ; Clinical trials ; Observational studies

Abstract

There is growing evidence that various segments of a clinical trial population can react to standard treatment differently both quantitatively and qualitatively. Subgroup analysis can show that treatment effect can be modified by specific patient characteristics. The major evidence of heterogeneity, however, is that while a certain proportion of the population has the outcome of interest, the rest of it does not. Stemming from the concept of treatment-outcome complex we have introduced a concept of sensitivity vs. resistance towards treatment (2011), i.e., a permanent, or at least a long-term patient capacity of developing the outcome of interest in response to specific treatment. Assuming that a positive outcome can be treatment induced or spontaneous, the effect of treatment should be measured as a proportion of treatment induced positive outcomes and the effectiveness of treatment should be measured as a proportion of patients sensitive to the treatment among those exposed to the treatment. The approach towards analysis of sensitivity will be presented and implications of the concept of sensitivity vs. resistance for clinical trials and observational studies will be discussed.