Table 4.
Expected results from the WISDOM trial
| Risk group | Cancer ≥ stage IIB, no. |
Exposure time, y |
Hazard rate |
Mean risk difference |
P(R < 0)* | Mammograms, no. |
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Personalized | Annual | Personalized | Annual | Personalized | Annual | (95% confidence interval) | Personalized | Annual | |||
| Total trial time | |||||||||||
| High | 6.5 | 6.0 | 1851 | 1850 | 0.352 | 0.324 | −0.028 | (−0.393 to 0.343) | .56 | 2035 | 1058 |
| Elevated | 18.7 | 18.6 | 20 950 | 20 948 | 0.089 | 0.089 | 0.000 | (−0.059 to 0.056) | .50 | 11 997 | 12 000 |
| Average | 12.1 | 14.3 | 30 028 | 30 031 | 0.040 | 0.048 | 0.007 | (−0.026 to 0.040) | .33 | 6978 | 17 206 |
| Low | 5.0 | 4.9 | 21 494 | 21 492 | 0.023 | 0.023 | −0.001 | (−0.028 to 0.028) | .52 | 5776 | 12 311 |
| Overall† | 42.3 | 43.7 | 74 324 | 74 320 | 0.057 | 0.059 | 0.002 | (−0.023 to 0.026) | .44 | 26 786 | 42 576 |
| Time within complete screening cycles | |||||||||||
| High | 6.4 | 5.6 | 1520 | 1320 | 0.419 | 0.424 | 0.005 | (−0.456 to 0.481) | .49 | 2035 | 1058 |
| Elevated | 17.4 | 17.4 | 14 935 | 14 933 | 0.117 | 0.116 | 0.000 | (−0.080 to 0.076) | .50 | 11 997 | 12 000 |
| Average | 9.4 | 13.3 | 15 649 | 21 405 | 0.060 | 0.062 | 0.003 | (−0.049 to 0.051) | .46 | 6978 | 17 206 |
| Low | 4.5 | 4.5 | 16 798 | 15 320 | 0.027 | 0.029 | 0.003 | (−0.034 to 0.041) | .43 | 5776 | 12 311 |
| Overall† | 37.6 | 40.8 | 48 901 | 52 978 | 0.077 | 0.077 | 0.000 | (−0.032 to 0.035) | .45 | 26 786 | 42 576 |
| Time within complete screening cycles with entry mammogram | |||||||||||
| High | 4.3 | 3.7 | 1518 | 1322 | 0.281 | 0.282 | 0.000 | (−0.394 to 0.400) | .49 | 2843 | 1868 |
| Elevated | 11.6 | 11.7 | 14 930 | 14 931 | 0.078 | 0.078 | 0.000 | (−0.062 to 0.061) | .50 | 21 154 | 21 154 |
| Average | 6.5 | 9.0 | 15 649 | 21 401 | 0.042 | 0.042 | 0.000 | (−0.041 to 0.042) | .50 | 20 102 | 30 327 |
| Low | 4.5 | 4.2 | 16 794 | 15 318 | 0.027 | 0.027 | 0.000 | (−0.030 to 0.033) | .47 | 5776 | 21 707 |
| Overall† | 26.9 | 28.6 | 48 891 | 52 973 | 0.055 | 0.054 | 0.000 | (−0.027 to 0.027) | .51 | 49 875 | 75 055 |
The table shows the expected total number of stage IIB or higher cancers, total exposure time, and hazard rate in the Women Informed to Screen Depending on Measures of Risk (WISDOM) trial, by study arm, risk strata, and analysis approach. Computed risk differences between the annual and personalized arm with 95% confidence intervals are also shown. P(R < 0) shows the estimated probability that the risk difference is less than 0. Deviations from .5 indicate bias (in favor of the annual arm P[R < 0] > .5 and vice versa if P[R < 0] < .5). The results are based on the simulation model and are averaged across 5000 simulations.
Overall results are weighted against the inverse of the total exposure time in each stratum.