Bias† in proposed vs. published responder criteria
| Assumed percent maintaining C-peptide at 6 months | |||||
|---|---|---|---|---|---|
| Criterion | 20% | 30% | 40% | 50% | 60% |
| 100% | +0.2 | +0.0 | −0.4 | +0.0 | −0.3 |
| 92.5% | +4.0 | +4.9 | +4.9 | +5.3 | 0+4.9 |
| 87.2% | +7.4 | +8.7 | +9.1 | +9.3 | +8.6 |
| Assumed percent maintaining C-peptide at 1 year | |||||
| Criterion | 20% | 30% | 40% | 50% | 60% |
| 100% | +0.0 | −0.3 | +0.1 | −0.2 | −0.1 |
| 92.5% | +2.0 | +2.0 | +2.7 | +2.5 | +2.6 |
| 87.2% | +3.5 | +3.9 | +4.8 | +4.5 | +4.5 |
| Assumed percent maintaining C-peptide at 2 years | |||||
| Criterion | 20% | 20% | 20% | 20% | 20% |
| 100% | −0.1 | −0.3 | −0.1 | +0.0 | −0.0 |
| 92.5% | +1.8 | +2.0 | +2.5 | +2.8 | +2.6 |
| 87.2% | +3.4 | +4.0 | +4.5 | +4.9 | +4.5 |
Values denoted by + (or −) “0.0” were such that they were slightly above (below) zero and rounded to zero.
†Bias is defined to be proportion in excess (+) or in deficit (−) of the assumed percent retaining C-peptide in the population.