Table 4.
Effect size (withdrawn compared with active treatment) 95% confidence intervals and denominators for study outcomes
| Outcome | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Whether exacerbation or not during study period (odds ratio) | Time to first exacerbation (mean (M) or median (m)) | Frequency of exacerbation requiring course of steroids or antibiotics(rate ratio (rr) or hazard ratio (hr)) | Lung function(mean difference in change from baseline) | Total SGRQ score (mean difference in change from baseline) | Walking distance in 6 minutes (mean difference in change from baseline) | Borg exercise tolerance test (units) | |||||||
| COPE | 1.5 | (0.9 to 2.5) (n = 242)a |
34.6 (M) |
(15.4 to 53.8) (not clear) |
1.5 (hr) | (1.1 to 2.1) (not clear) |
-38 ml | (-79.5 to 1.6) (n = 242) | 2.5 | (0.4 to 4.6) (not clear) |
9.4 m | (-4.5 to 23.2) (n = 172) |
-0.3 | (-0.7 to 0.3) (n = 173) |
| COSMIC | 0.9 | (0.6 to 1.4) (n = 373)b |
Not measured | 1.2 (rr) |
(0.9 to 1.5) (n = 373) |
-4.1% | (-6.6 to -1.6) (not clear) |
0.9 | (-.1.3 to 3.1) (not clear) |
Not measured | Not measured | |||
| WISP | 1.0 | (0.6 to 1.8) (n = 260)b |
19 (m) |
Not givenc | 1.3 (rr) |
(1.0 to 1.6) (n = 260) |
-23 ml | (-101.5 to 55.5) (not clear) |
-0.45 | Unable to estimate | Not measured | Not measured | ||
| O'Brien | Not measured | Not measured | Not measured | -11.3% | (-23.4 to 0.8) | Not measured | -32 ft | (-771 to 707) | Unable to estimated | |||||
a all of these exacerbations were moderate - in this trial investigators did not measure exacerbations not requiring treatment
b these exacerbations were mild, moderate or severe
c median = 44 days in withdrawn group (CI 29-59) v. 63 (CI 53-74) days in steroid group, P = 0.05
d incorrect confidence interval given in publication.