TABLE 1.
Randomized clinical trial (RCT) demographic characteristics according to blinding of participants and personnel
| Variable | Total | Open‐Label | Blinded | ||||
|---|---|---|---|---|---|---|---|
| No. | (%) | No. | (%) | No. | (%) | P | |
| 110 | (100) | 68 | (100) | 42 | (100) | ||
| Basic RTC demographics | |||||||
| International | .13 | ||||||
| No | 65 | (59.1) | 44 | (64.7) | 21 | (50.0) | |
| Yes | 45 | (40.9) | 24 | (35.3) | 21 | (50.0) | |
| Industry supported (fully or in part) | <.001 | ||||||
| No | 45 | (40.9) | 37 | (54.4) | 8 | (19.1) | |
| Yes | 65 | (59.1) | 31 | (45.6) | 34 | (80.9) | |
| Overall study sample size | .38 | ||||||
| ≤200 patients | 44 | (40.0) | 25 | (36.8) | 19 | (45.2) | |
| >200 patients | 66 | (60.0) | 43 | (63.2) | 23 | (54.8) | |
| Disease stage | .04 | ||||||
| Only Advanced / metastatic | 43 | (39.1) | 21 | (30.9) | 22 | (52.4) | |
| Only non‐metastatic / local | 47 | (42.7) | 31 | (45.6) | 16 | (38.1) | |
| Both | 20 | (18.2) | 16 | (23.5) | 4 | (9.5) | |
| Broad treatment type | |||||||
| Radiotherapy | 36 | (32.7) | 25 | (36.8) | 11 | (26.2) | .25 |
| Surgery | 14 | (12.7) | 9 | (13.2) | 5 | (11.9) | .84 |
| Chemotherapy | 21 | (19.1) | 12 | (17.7) | 9 | (21.4) | .62 |
| HT | 45 | (40.9) | 31 | (45.6) | 14 | (33.3) | .20 |
| Difference between treatment arms in the clinical primary end point | .87 | ||||||
| No | 40 | (44.0) | 26 | (43.3) | 14 | (45.2) | |
| Yes | 51 | (56.0) | 34 | (56.7) | 17 | (54.8) | |
| OS difference favouring experimental treatment | .66 | ||||||
| No | 42 | (38.2) | 28 | (41.2) | 14 | (33.3) | |
| Yes | 13 | (11.8) | 7 | (10.3) | 6 | (14.3) | |
| N/A (in case OS was not assessed) | 55 | (50.0) | 33 | (48.5) | 22 | (52.4) | |
| PRO‐related basic characteristics | |||||||
| Most frequent PRO instruments | |||||||
| EORTC questionnaires | 31 | (28.2) | 22 | (32.4) | 9 | (21.4) | .22 |
| FACT questionnaires | 27 | (24.6) | 15 | (22.1) | 12 | (28.6) | .44 |
| Visual Analogue Scale | 11 | (10.0) | 6 | (8.8) | 5 | (11.9) | .60 |
| Length of PRO assessment during RCT | .05 | ||||||
| ≤6 mo | 29 | (26.4) | 17 | (25.0) | 12 | (28.6) | |
| ≤1 y | 20 | (18.2) | 12 | (17.7) | 8 | (19.0) | |
| >1 y | 57 | (51.8) | 39 | (57.3) | 18 | (42.9) | |
| Unknown | 4 | (3.6) | 0 | (0) | 4 | (9.5) | |
| Secondary paper on PRO | .94 | ||||||
| No | 79 | (71.8) | 49 | (72.1) | 30 | (71.4) | |
| Yes | 31 | (28.2) | 19 | (27.9) | 12 | (28.6) | |
Abbreviations: EORTC, European Organization for Research and Treatment of Cancer; FACT, Functional Assessment of Cancer Therapy; HT, hormone therapy; OS, overall survival; PRO, patient‐reported outcomes; RCT, randomized controlled trial.