Table 1.
Analysis | Model | Trial QALYs, (s) | Model QALYs, (s) | Q2 | R 2 | MAE | MSE | Bias | n |
---|---|---|---|---|---|---|---|---|---|
Model QALYs v. model QALYs (base case) | OM1 | 2.573 (1.087) | 2.423 (0.953) | 0.786 | 0.805 | 0.289 | 0.253 | −0.150 | 14,729 |
OM2 | 2.573 (1.087) | 2.445 (0.951) | 0.822 | 0.837 | 0.265 | 0.210 | −0.127 | 14,729 | |
Model life-years v. trial life-years | OM1 | 3.226 (1.352) | 3.028 (1.190) | 0.797 | 0.819 | 0.342 | 0.372 | −0.199 | 14,729 |
OM2 | 3.226 (1.352) | 3.058 (1.188) | 0.829 | 0.846 | 0.314 | 0.313 | −0.168 | 14,729 | |
Extreme sensitivity analyses testing performance metrics | |||||||||
Model life-years v. trial QALYs | OM1 | 2.573 (1.087) | 3.028 (1.190) | 0.596 | 0.809 | 0.522 | 0.477 | 0.455 | 14,729 |
OM2 | 2.573 (1.087) | 3.058 (1.188) | 0.609 | 0.840 | 0.517 | 0.461 | 0.485 | 14,729 | |
Model QALYs v. trial life-years | OM1 | 3.226 (1.352) | 2.423 (0.953) | 0.423 | 0.814 | 0.887 | 1.056 | −0.803 | 14,729 |
OM2 | 3.226 (1.352) | 2.445 (0.951) | 0.462 | 0.841 | 0.865 | 0.984 | −0.781 | 14,729 | |
Subgroup analyses by participant characteristics at randomization | |||||||||
Age <65 y | OM1 | 2.630 (1.098) | 2.568 (1.010) | 0.879 | 0.883 | 0.184 | 0.145 | −0.061 | 8,500 |
OM2 | 2.630 (1.098) | 2.555 (1.005) | 0.886 | 0.892 | 0.186 | 0.137 | −0.075 | 8,500 | |
Age ≥65 y | OM1 | 2.495 (1.066) | 2.225 (0.830) | 0.649 | 0.718 | 0.433 | 0.399 | −0.270 | 6,229 |
OM2 | 2.495 (1.066) | 2.296 (0.849) | 0.727 | 0.768 | 0.373 | 0.311 | −0.200 | 6,229 | |
No prior MI, IHD, or stroke | OM1 | 2.694 (1.129) | 2.570 (1.015) | 0.840 | 0.853 | 0.241 | 0.204 | −0.125 | 8,188 |
OM2 | 2.694 (1.129) | 2.595 (1.023) | 0.865 | 0.874 | 0.216 | 0.172 | −0.100 | 8,188 | |
Prior MI, IHD, or stroke | OM1 | 2.421 (1.011) | 2.240 (0.834) | 0.693 | 0.726 | 0.349 | 0.313 | −0.181 | 6,541 |
OM2 | 2.421 (1.011) | 2.258 (0.815) | 0.747 | 0.778 | 0.327 | 0.259 | −0.162 | 6,541 | |
<5 y diabetes duration | OM1 | 2.658 (1.155) | 2.568 (1.060) | 0.847 | 0.853 | 0.218 | 0.204 | −0.090 | 2,712 |
OM2 | 2.658 (1.155) | 2.568 (1.046) | 0.863 | 0.870 | 0.216 | 0.182 | −0.090 | 2,712 | |
≥5 y diabetes duration | OM1 | 2.554 (1.070) | 2.390 (0.925) | 0.770 | 0.794 | 0.305 | 0.263 | −0.163 | 12,017 |
OM2 | 2.554 (1.070) | 2.418 (0.926) | 0.810 | 0.829 | 0.276 | 0.217 | −0.136 | 12,017 |
IHD, ischemic heart disease; MAE, mean absolute error; MI, myocardial infarction; MSE, mean squared error; n, number of trial participants included in this analysis; OM1, United Kingdom Prospective Diabetes Study Outcomes Model version 1; OM2, United Kingdom Prospective Diabetes Study Outcomes Model version 2; QALY, quality-adjusted life-year; Q2 = 1 − MSE/S2; QALYs, quality-adjusted life-years; SD, standard deviation; , mean; (s), standard deviation.
For bias, zero indicates no bias, positive (negative) values indicate that the model overestimates (underestimates) trial QALYs, and larger absolute values indicate higher levels of bias.