Outcomes | Total (n = 374)a | Experimental group (n = 156) | Reference group (n = 145) | Control group (n = 73) |
---|---|---|---|---|
Total exposure, db | ||||
 Mean (SD) | 271 (115) | 271 (117) | 279 (108) | 258 (124) |
 Median (interquartile range) | 342 (177–360) | 343 (170–361) | 342 (205–358) | 341 (152–364) |
 No. of falls observed | 382 | 141 | 199 | 42 |
Primary Outcomec | ||||
 Incidence rate ratio (95% CI), adjustedd |  | 0.74 (0.49 to 1.12) | Comparator | 0.43 (0.25 to 0.75) |
 Incidence rate ratio (95% CI), adjustedd |  | 1.71 (0.98 to 2.99) | 2.30 (1.33 to 4.00) | Comparator |
 Incidence rate ratio (95% CI), unadjusted |  | 0.64 (0.42 to 0.97) | Comparator | 0.41 (0.23 to 0.71) |
 Incidence rate ratio (95% CI), unadjusted |  | 1.58 (0.90 to 2.77) | 2.46 (1.41 to 4.29) | Comparator |
Secondary Analyses | ||||
 Estimated falls per person-years (95% CI), (adjusted) | 1.41 (1.14 to 1.67) | 1.33 (0.94 to 1.73) | 1.80 (1.27 to 2.32) | 0.78 (0.41 to 1.15) |
 Estimated falls per person-years (95% CI), (unadjusted) | 1.52 (1.23 to 1.81) | 1.33 (0.93 to 1.72) | 2.07 (1.46 to 2.67) | 0.84 (0.44 to 1.24) |
 Incidence rate difference (95% CI), adjustede |  | –0.46 (–1.12 to 0.19) | Comparator | –0.55 (–1.10 to –0.12) |
 Incidence rate difference (95% CI), adjustedf |  | 0.55 (0.12 to 1.10) | 1.02 (0.38 to 1.65) | Comparator |
No. of falls, No. (%) of participants | ||||
 0 | 217 (58) | 90 (58) | 81 (56) | 46 (63) |
 1 | 73 (20) | 31 (20) | 25 (17) | 17 (23) |
 2 | 41 (11) | 19 (12) | 15 (10) | 7 (10) |
 3 | 20 (5) | 10 (6) | 9 (6) | 1 (1) |
 ≥ 4 | 23 (6) | 6 (4) | 15 (10) | 2 (3) |
 No. (%) of participants with ≥ 1 fall | 157 (42) | 66 (42) | 64 (44) | 27 (37) |
 No. of severeg falls observed, n | 59 | 26 | 24 | 9 |
 Hazard ratio for repeated falls (95% CI) |  | 0.68 (0.43 to 1.08) | Comparator | 0.47 (0.29 to 0.75) |
 Hazard ratio for repeated falls (95% CI) |  | 1.45 (0.91 to 2.31) | 2.12 (1.33 to 3.40) | Comparator |
 Hazard ratio to first fall (95% CI) |  | 0.92 (0.65 to 1.30) | Comparator | 0.83 (0.53 to 1.31) |
 Hazard ratio to first fall (95% CI) |  | 1.11 (0.70 to 1.74) | 1.20 (0.76 to 1.89) | Comparator |
 Hazard ratio to second fall (95% CI) |  | 0.81 (0.51 to 1.27) | Comparator | 0.50 (0.25 to 1.01) |
 Hazard ratio to second fall (95% CI) |  | 1.60 (0.79 to 3.25) | 1.99 (0.99 to 4.00) | Comparator |