Table 5.

Analytic designs of included pragmatic trials

Characteristic	Number of trials (n = 63)
Measures of occurrence for primary outcome
Absolute risk, rate, or mean reported numerically for all trial arms	61 (97%)
Absolute risk, rate, or mean reported graphically only	2 (3%)
Measures of association for primary outcome
Absolute difference measure only	25 (40%)
Relative comparison measure only	17 (27%)
Both absolute and relative measures	18 (29%)
Neither absolute nor relative measures: p-values only	4 (6%)
Primary effect of interest
Intention to treat only	41 (65%)
+ Per protocol	22 (35%)
Statistical approach to estimating per protocol effect	(n=22)
Per-protocol population only†	20 (91%)
+ Statistical adjustment for non-adherence	1 (4%)
+ Other	1 (4%)
Sensitivity analyses for estimating per protocol effect	(n=22)
No, single approach used	17 (77%)
Yes, multiple approaches used (including multiple methods of defining per-protocol population)	5 (23%)
Statistical approach to loss to follow-up, for trials not using time to event outcomes	(n = 55)
Complete case only	31 (86%)
Multiple imputation	7 (13%)
Worst case imputation	3 (5%)
Complete case with sensitivity analysis: multiple imputation	4 (7%)
Complete case with sensitivity analysis: worst-case and/or best-case imputation	2 (4%)
Last observation carried forward or linear interpolation	3 (5%)
Imputation, method not specified	1 (2%)
Best case imputation	1 (2%)
Unclear or not reported	3 (5%)

^†Per-protocol population analysis is conducted by restricting to those individuals who adhered to their trial assignment with no additional statistical adjustment for selection into this subsample.