Summary of analysis results
| Outcome and analysis | Intervention (n=2275) | Control (n=2278) | Adjusted treatment effect estimate (95% CI) | P value |
| Primary analysis* | ||||
| Total number of slips | 2633 | 4110 | ||
| Mean (SD) | 1.16 (2.9) | 1.80 (4.6) | IRR 0.63 (0.57 to 0.70) | <0.001 |
| CACE sensitivity analyses* | ||||
| Receiving shoes within 7 weeks, n (%) | 1523 (66.9) | 0 (0.0) | IRR 0.65 (0.58 to 0.73) | <0.001 |
| Receiving shoes within 14 weeks, n (%) | 1930 (84.8) | 0 (0.0) | IRR 0.65 (0.59 to 0.73) | <0.001 |
| Continuous score (out of a possible 12), mean (SD) | 5.2 (4.4) | 0.0 (0.0) | IRR 0.95 (0.94 to 0.97) | <0.001 |
| Secondary analyses* | ||||
| 1+slip, n (%) | 804 (35.6) | 1020 (45.4) | OR 0.58 (0.50 to 0.66) | <0.001 |
| 1+fall†, n (%) | 80 (3.5) | 107 (4.7) | OR 0.73 (0.54 to 0.99) | 0.04 |
| Number of falls from a slip, mean (SD) | 0.02 (0.22) | 0.03 (0.23) | IRR 0.51 (0.28 to 0.92) | 0.03 |
| Number of falls not from a slip, mean (SD) | 0.13 (0.9) | 0.33 (2.1) | IRR 0.82 (0.50 to 1.34) | 0.44 |
| Time to first slip, 0.33 percentile days (95% CI) | 46 (34 to 60) | 27 (25 to 32) | HR 0.73 (0.67 to 0.80) | <0.001 |
*over 14 weeks.
†including those resulting from a slip and those not resulting from a slip.
%, percentage; CACE, complier average causal effect; CI, confidence interval; HR, hazard ratio; IRR, incidence rate ratio; n, number; OR, odds ratio; SD, standard deviation.