Table 2.
Primary analytical methods, continuity corrections, assumptions, and outcomes
| Method, measure, effect type, and data sources | Single zero event trials | Zero total event trials | Continuity correction | Assumptions to satisfy or difficulties to consider | Outcomes |
|---|---|---|---|---|---|
| Peto, odds ratio, fixed effect | |||||
| IPD only, IPD+RECORD, IPD+summary, IPD+summary+RECORD | Included | Excluded | None | Event rates <1%, balanced groups (treatment arms), small/moderate treatment effects | Analyses with IPD only: composite outcome, heart failure, myocardial infarction, cardiovascular related deaths, non-cardiovascular related deaths Analyses including summary data: myocardial infarction, cardiovascular related deaths |
| Mantel-Haenszel or Dersimonian and Laird (inverse variance), odds ratio or relative risk, fixed or random effects | |||||
| IPD only, IPD+RECORD, IPD+summary, IPD+summary+RECORD | Included | Excluded or Included | Constant continuity correction of 0.5 or treatment arm continuity correction | Sample must be “large” overall (crude totals across all studies needs to be ≥5),44 might perform comparably or better than Peto’s method at even rates of 5-10%44 | Analyses with IPD only: composite outcome, heart failure, myocardial infarction, cardiovascular related deaths, non-cardiovascular related deaths Analyses including summary data: myocardial infarction, cardiovascular related deaths |
IPD=individual patient level data; RECORD=Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes study.