Table 1.
Primary outcomes and secondary analyses
| 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 | |
aThirty-one participants were omitted from these analyses because they did not start the intervention and never sent a fall diary and hence were never at risk of falling
bValues are without participants who had 0 follow-up time, i.e. without those who never received an intervention and never sent a falls diary (i.e. they were never at risk of falling)
cThe differences in incidence rate ratio were 0.55 (95% CI 0.12 to 1.10; P = 0.045) for experimental group and 1.02 (95% CI 0.38 to 1.65; P = 0.002) for reference group versus control group; and 0.46 (95% CI –1.12 to 0.19; P = 0.166) for experimental group versus reference group
dIncidence rate ratio from adjusted negative binomial regression. Adjusted for the stratification variables: risk category (moderate or high), urban or rural region, age greater or lower than 80 years
eIncidence rate difference of the experimental group and control group versus the reference group
fIncidence rate difference of the experimental group and reference group versus the control group
gSevere falls means falls requiring medical treatment (i.e. with serious or moderate injuries)