Table 1 Framework for pooling datasets into a real-world comparator cohort
Step | Subcomponent steps |
|---|---|
1. Pre-specification | a. A priori research question and processes for statistical analyses and dataset selection |
2. Assess dataset eligibility | a. Assess metadata of all datasets & variables for clinical relevance, reliability, and harmonizability |
b. Quantitatively assess non-outcome characteristics and sample size after cohort selection | |
c. Determine the eligibility for the final pooled analysis of each dataset according to the prespecified process | |
3. Outcomes analyses | a. Primary analyses |
b. Assessment of heterogeneity in outcomes | |
c. Sensitivity analyses |