TABLE 2.
Influence of blinding of participants on patient‐reported outcome results
| Type of trial | All cohort (n = 98) | Open‐label (N = 61) | Blinded (N = 37) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PRO difference between treatment arms |
Better PRO N (%) |
No difference N (%) |
Worse PRO N (%) |
Total N |
Better PRO N (%) |
No difference N (%) |
Worse PRO N (%) |
Total N |
Better PRO N (%) |
No difference N (%) |
Worse PRO N (%) |
Total N |
| Traditional clinical endpoint difference between arms | ||||||||||||
| Better Clinical Outcomes | 31 (56.4) | 14 (25.4) | 10 (18.2) | 55 | 15 (41.7) | 12 (33.3) | 9 (25.0) | 36 | 16 (84.2) | 2 (10.5) | 1 (5.3) | 19 |
| No difference | 13 (36.1) | 20 (55.6) | 3 (8.3) | 36 | 7 (35.0) | 11 (55.0) | 2 (10.0) | 20 | 6 (37.5) | 9 (56.2) | 1 (6.3) | 16 |
| Worse Clinical Outcomes | 3 (42.8) | 2 (28.6) | 2 (28.6) | 7 | 2 (40.0) | 1 (20.0) | 2 (40.0) | 5 | 1 (50.0) | 1 (50.0) | 0 (0.00) | 2 |
| Total | 47 | 36 | 15 | 98 | 24 | 24 | 13 | 61 | 23 | 12 | 2 | 37 |
Results are classified as better PRO if they are favoring the experimental arm, equivalence if no difference at all is observed, or half of the dimensions are favoring each treatment arm, and worse PRO if they are favoring the standard arm. The same classification was made for clinical endpoints.
All chi‐square tests were nonsignificant.