Biostatistics / Study Design

We will work with NIH staff and the demonstration project teams to create initial guidance and technical documents regarding study design and biostatistical issues. Initial guidance and best practice documents will also address additional gaps and limitations that will be unveiled as the UH2 grants are planned. Understanding which methods can be directly applied in a distributed data setting, which can potentially be modified for the distributed data setting, and which will require individual level data will be among the critical issues this core addresses.

As the UH2 and UH3 projects are funded we will identify new issues and add additional content and case studies. We will ally with NIH collaborators, UH2 and UH3 investigators, and academic institutions to gather additional input into key methodological issues. Areas in need of methods development will become apparent, and we will work to address these methodology challenges with our collaborators. One method that will be developed as part of the Collaboratory work is an approach to handling informative missing follow-up data when using the EHR as the basis for follow-up data collection. Specifically, those that are less healthy with more chronic conditions have more visits per year. If an intervention is effective in improving general health than those that received the intervention are more likely to have missing follow-up data compared to those that did not receive the intervention. Ignoring this missing data issue can lead to biased results (e.g. for this example one may conclude that the effective intervention is not effective).