Table 1.
Combinations of Confounder Summary Score, Confounding Adjustment Method, Data-Sharing Approach, and Outcome Type Evaluated
Confounding adjustment method & data-sharing approach | Statistical analysis performed at the analysis center | |
---|---|---|
Binary outcomea | Time-to-event outcomeb | |
Propensity score | ||
Stratification | ||
Pooled individual-level | PS- and site-stratified (Reference) | PS- and site-stratified (Reference) |
Risk-set | PS- and site-stratified | Case-centered logistic regressionc |
Summary-tabled | PS- and site-stratified | PS- and site-stratified conditional Poisson regression |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Matching | ||
Pooled individual-level | PS-matched, site-stratified (Reference) | PS-matched, site-stratified (Reference) |
Risk-set | PS-matched, site-stratified | Case-centered logistic regression |
Summary-table | PS-matched, site-stratified | PS-matched, site-stratified conditional Poisson regression |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Inverse probability weighting | ||
Pooled individual-level | Inverse probability weighted, site-stratified (Reference) | Inverse probability weighted, site-stratified (Reference) |
Risk-set | Inverse probability weighted, site-stratified | Inverse probability weighted, site-stratified |
Summary-table | Not established | Not established |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Matching weighting | ||
Pooled individual-level | Matching weighted, site-stratified (Reference) | Matching weighted, site-stratified (Reference) |
Risk-set | Matching weighted, site-stratified | Matching weighted, site-stratified |
Summary-table | Not established | Not established |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Disease risk score | ||
Stratification | ||
Pooled individual-level | DRS- and site-stratified (Reference) | DRS- and site-stratified (Reference) |
Risk-set | DRS- and site-stratified | Case-centered logistic regression |
Summary-table | DRS- and site-stratified | DRS- and site-stratified conditional Poisson regression |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Matching | ||
Pooled individual-level | DRS-matched, site-stratified (Reference) | DRS-matched, site-stratified (Reference) |
Risk-set | DRS-matched, site-stratified | Case-centered logistic regression |
Summary-table | DRS-matched, site-stratified | DRS-matched, site-stratified conditional Poisson regression |
Effect-estimate | Inverse variance-weighted meta-analysis | Inverse variance-weighted meta-analysis |
Inverse probability weighting | ||
Pooled individual-level | Not established | Not established |
Risk-set | Not established | Not established |
Summary-table | Not established | Not established |
Effect-estimate | Not established | Not established |
Matching weighting | ||
Pooled individual-level | Not established | Not established |
Risk-set | Not established | Not established |
Summary-table | Not established | Not established |
Effect-estimate | Not established | Not established |
Note: DRS= disease risk score; PS= propensity score
Unless otherwise specified, logistic regression was used to obtain estimates of odds ratios and their 95% confidence intervals for binary outcomes.
Unless otherwise specified, Cox proportional hazards regression was used to obtain estimates of hazard ratios and their 95% confidence intervals for time-to-event outcomes.
Case-centered logistic regression is a logistic regression model with the proportion of exposed outcome events among all events as the dependent variable and the log odds of having the study exposure in the risk-set as the independent variable, specified as an offset (9). Each risk-set, anchored by a unique outcome event time, comprises patients who experienced the outcome and patients who were still at risk of developing the outcome at that time point. When combined with confounder summary scores, the risk-set is created within a matched cohort or stratum defined by the confounder summary score within a site. In this particular analysis, each risk-set comprised the patient or patients who developed the outcome plus all other at-risk patients belonging to the same propensity score stratum at the time of the event within each site.
In situations where the regression-based analysis was not feasible for the summary-table data-sharing approach, we used the Mantel-Haenszel method to compute a weighted estimate for the desired effect estimate.