Members: Lusine Abrahamyan MD, MPH, PhD(c); Nancy Dreyer PhD, MPH; Margaret Hux MSc; Nandan Kenkeremath JD, BS; Isabelle Morin MSc; Steven Takemoto PhD; Michelle Prichard Turner MS, BS

Current Manuscript Project: Good Research Practices for Analysis of Comparative Effectiveness in Patient Registry Data
This paper will cover the following topics:  what CER is and why it is a currently a focus of interest, what are registries and how they compare to other study types to address CER - pragmatic trials, (vs RCTs), administrative databases.   Definition of bias / the concern - selection bias and bias due to missing data …definitions / explanations of how this happens – the major challenge for analysis and a brief summary of the analysis methods that we will be describing to deal with these issues as well as a selection of comparable samples vs statistical methods to obtain a balanced comparison.

Background:
Observational registries of specific patient groups offer an attractive opportunity to evaluate real-world effectiveness and cost-effectiveness of treatments. Good research practices for data analysis and interpretation will increase our ability to conduct comparative research within patient registries.

Tracking real-world health outcomes has become increasingly important and is a critical component in the national health care debate. While Randomized Control Trials (RCTs) are the “gold standard” in that they provide the strongest form of evidence in assessing effectiveness, i.e. of product efficacy, RCTs are conducted under idealized conditions using selected populations.  Other data sources can contribute significantly to the evidence base (e.g., demonstrating how a drug works in populations or under conditions not studied in the trial, or relative to another drug not included in the study)1. Background continued…