Table 2 Comparison of simulated responder analysis results using non-response imputation, impute-before-dichotomizing and dichotomize-then-impute multiple imputation1
Dropout model | Imputation method | % Responders Trt A | % Responders Trt B | Difference in proportions (95% CI) | % Bias | Coverage of the 95% CI | Power |
|---|---|---|---|---|---|---|---|
1: Lack of efficacy | NRI | 17.6 | 6.9 | 10.6 (1.7, 19.5) | −29.2 | 81.3 | 0.64 |
DTI MI | 26.5 | 10.7 | 15.9 (5.4, 26.4) | 6.0 | 95.2 | 0.77 | |
DTI MI with CV | 24.5 | 9.7 | 14.8 (4.6, 25.0) | −1.3 | 94.9 | 0.74 | |
IBD MI | 25.7 | 10.8 | 14.9 (4.5, 25.3) | −0.6 | 95.2 | 0.70 | |
IBD MI with CV | 24.1 | 9.9 | 14.1 (4.0, 24.3) | −5.7 | 94.3 | 0.69 | |
2: Differing mechanism | NRI | 17.6 | 7.9 | 9.6 (0.3, 18.7) | − 35.7 | 77.2 | 0.55 |
DTI MI | 26.5 | 10.5 | 16.0 (5.5, 26.5) | 6.7 | 94.8 | 0.77 | |
DTI MI with CV | 24.7 | 9.8 | 14.8 (4.7, 25.0) | −1 | 94.3 | 0.74 | |
IBD MI | 25.7 | 10.8 | 14.9 (4.5, 25.3) | −0.7 | 94.9 | 0.69 | |
IBD MI with CV | 24.2 | 10.1 | 14.1 (3.9, 24.3) | −5.8 | 94.5 | 0.68 | |
3: Differing mechanism, reversed | NRI | 18.3 | 6.9 | 11.4 (2.4, 20.4) | −24.1 | 86.3 | 0.69 |
DTI MI | 26.1 | 10.5 | 15.5 (5.1, 26.0) | 3.7 | 93.4 | 0.74 | |
DTI MI with CV | 24.2 | 9.7 | 14.5 (4.4, 24.6) | −3.4 | 93.4 | 0.72 | |
IBD MI | 25.8 | 10.8 | 15.0 (4.6, 25.5) | 0.2 | 94.1 | 0.70 | |
IBD MI with CV | 24.2 | 10.0 | 14.2 (4.0, 24.4) | −5.4 | 93.4 | 0.68 | |
4: Differential dropout rates | NRI | 21.5 | 5.3 | 16.2 (7.2, 25.3) | 8.5 | 93.8 | 0.94 |
DTI MI | 26.0 | 10.8 | 15.2 (4.8, 25.7) | 1.8 | 93.8 | 0.71 | |
DTI MI with CV | 24.8 | 9.1 | 15.6 (5.6, 25.7) | 4.5 | 93.3 | 0.79 | |
IBD MI | 25.6 | 10.9 | 14.7 (4.3, 25.1) | −1.8 | 94.5 | 0.69 | |
IBD MI with CV | 24.6 | 9.4 | 15.2 (5.1, 25.3) | 1.7 | 94.8 | 0.77 | |
5: Lack of efficacy, sensitivity of mechanism | NRI | 16.5 | 6.7 | 9.7 (1.1, 18.4) | −35 | 75.4 | 0.59 |
DTI MI | 26.6 | 10.5 | 16.1 (5.6, 26.5) | 7.1 | 93.7 | 0.76 | |
DTI MI with CV | 24.4 | 9.6 | 14.8 (4.6, 24.9) | −1.5 | 94.3 | 0.72 | |
IBD MI | 25.8 | 10.8 | 15.0 (4.6, 25.5) | 0.4 | 94.3 | 0.68 | |
IBD MI with CV | 24.0 | 9.9 | 14.2 (4.0, 24.3) | −5.5 | 93.6 | 0.67 | |
6: Lack of efficacy and tolerability | NRI | 18.0 | 7.1 | 10.9 (2.0, 19.9) | −27.1 | 83.8 | 0.67 |
DTI MI | 26.3 | 10.6 | 15.7 (5.2, 26.2) | 4.7 | 93.7 | 0.77 | |
DTI MI with CV | 24.4 | 9.7 | 14.7 (4.6, 24.9) | −1.9 | 93.8 | 0.75 | |
DTI MI with AE | 26.5 | 11.0 | 15.5 (5.0, 26.0) | 3.4 | 93.3 | 0.74 | |
IBD MI | 25.6 | 10.8 | 14.8 (4.4, 25.2) | −1.2 | 93.0 | 0.69 | |
IBD MI with CV | 24.1 | 10.0 | 14.2 (4.0, 24.3) | −5.5 | 93.8 | 0.69 | |
IBD MI with AE | 25.7 | 10.9 | 14.8 (4.3, 25.2) | −1.5 | 93.2 | 0.69 |