Metric and domain | Round 1 scores | Round 2 scores | Round 3 scores | % of consensus meeting participants voting to retain item | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1–3 | 4–6 | 7–9 | 10 | 1–3 | 4–6 | 7–9 | 10 | 1–3 | 4–6 | 7–9 | 10 | |||
n (%) respondents per rating category (1-3 ‘not important’, 4-6 ‘important but not critical’, 7-9 ‘critical’, 10 unable to score) | ||||||||||||||
Recruitment and retention | 1. Total actual recruitment versus total target recruitment a,c | 1 (0.5) | 36 (17.1) | 172 (81.5) | 2 (0.9) | 0 | 16 (7.6) | 194 (91.9) | 1 (0.5) | 0 | 14 (6.6) | 197 (93.4) | 0 | 100 |
2. Time from the site opening to first participant randomised | 8 (3.8) | 108 (51.2) | 94 (44.5) | 1 (0.5) | 3 (1.4) | 118 (55.9) | 90 (42.7) | 0 | 5 (2.4) | 126 (59.7) | 80 (37.9) | 0 | ||
3. Number of days/weeks since the most recent participant was randomised | 21 (10.0) | 112 (53.1) | 77 (36.5) | 1 (0.5) | 12 (5.7) | 142 (67.3) | 57 (27.0) | 0 | 11 (5.2) | 155 (73.5) | 45 (21.3) | 0 | ||
4. Percentage of potential participants screened who have been randomised | 4 (1.9) | 88 (41.7) | 117 (55.5) | 2 (0.9) | 2 (0.9) | 83 (39.3) | 125 (59.2) | 1 (0.5) | 0 | 76 (36) | 134 (63.5) | 1 (0.5) | ||
5. Percentage of potential participants who could have been screened, who were screened | – | – | – | – | 13 (6.2) | 97 (46.0) | 92 (43.6) | 9 (4.3) | 10 (4.7) | 90 (42.7) | 103 (48.8) | 8 (3.8) | ||
6. Percentage of potential participants screened who were eligible | – | – | – | – | 9 (4.3) | 106 (50.2) | 93 (44.1) | 3 (1.4) | 6 (2.8) | 110 (52.1) | 92 (43.6) | 3 (1.4) | ||
7. Percentage of potential participants eligible who have consented b,c | – | – | – | – | 8 (3.8) | 81 (38.4) | 119 (56.4) | 3 (1.4) | 3 (1.4) | 77 (36.5) | 128 (60.7) | 3 (1.4) | 95 | |
8. Percentage of potential participants who have consented and have been randomiseda | – | – | – | – | 5 (2.4) | 71 (33.6) | 131 (62.1) | 4 (1.9) | 2 (0.9) | 57 (27) | 150 (71.1) | 2 (0.9) | 35 | |
9. Percentage of randomised participants who have withdrawn consent to continue in the studya,c | 8 (3.8) | 76 (36.0) | 125 (59.2) | 2 (0.9) | 4 (1.9) | 60 (28.4) | 147 (69.7) | 0 | 4 (1.9) | 46 (21.8) | 161 (76.3) | 0 | 83 | |
10. Percentage of randomised participants lost to follow-upa | 10 (4.7) | 59 (28.0) | 140 (66.4) | 2 (0.9) | 3 (1.4) | 38 (18) | 169 (80.1) | 1 (0.5) | 3 (1.4) | 24 (11.4) | 183 (86.7) | 1 (0.5) | 22 | |
11. Percentage of screening logs returned on time out of all those that should have been returned | 40 (19.0) | 135 (64.0) | 33 (15.6) | 3 (1.4) | 29 (13.7) | 159 (75.4) | 22 (10.4) | 1 (0.5) | 23 (10.9) | 167 (79.1) | 20 (9.5) | 1 (0.5) | ||
12. Percentage of screening items completed of those required | 32 (15.2) | 105 (49.8) | 67 (31.8) | 7 (3.3) | 20 (9.5) | 114 (54) | 72 (34.1) | 5 (2.4) | 18 (8.5) | 117 (55.5) | 72 (34.1) | 4 (1.9) | ||
13. Percentage of randomised participants with a consent form that is incomplete or inaccuratea | 11 (5.2) | 51 (24.2) | 148 (70.1) | 1 (0.5) | 8 (3.8) | 31 (14.7) | 172 (81.5) | 0 | 9 (4.3) | 14 (6.6) | 187 (88.6) | 1 (0.5) | 13 | |
14. Percentage of all expected forms that have been receiveda | 8 (3.8) | 69 (32.7) | 128 (60.7) | 6 (2.8) | 4 (1.9) | 50 (23.7) | 154 (73) | 3 (1.4) | 39 | |||||
15. Percentage of randomised participants with any issues or problems with consenta | 10 (4.7) | 68 (32.2) | 129 (61.1) | 4 (1.9) | 6 (2.8) | 53 (25.1) | 150 (71.1) | 2 (0.9) | 4 (1.9) | 34 (16.1) | 169 (80.1) | 4 (1.9) | 26 | |
16. Percentage of randomised participants for whom documentation of consent is missing from their medical recordsa | 15 (7.1) | 69 (32.7) | 123 (58.3) | 4 (1.9) | 9 (4.3) | 47 (22.3) | 154 (73) | 1 (0.5) | 7 (3.3) | 31 (14.7) | 172 (81.5) | 1 (0.5) | 0 | |
Data quality | 17. Percentage of randomised participants with the time between data collection and either data entry (electronic case report form) or central receipt of paper case report form within the target timeframe | 12 (5.7) | 129 (61.1) | 66 (31.3) | 4 (1.9) | 8 (3.8) | 156 (73.9) | 45 (21.3) | 2 (0.9) | 7 (3.3) | 170 (80.6) | 32 (15.2) | 2 (0.9) | |
18. Percentage of randomised participants with a query/queries for primary outcome data a,c | 4 (1.9) | 59 (28.0) | 145 (68.7) | 3 (1.4) | 3 (1.4) | 36 (17.1) | 170 (80.6) | 2 (0.9) | 4 (1.9) | 23 (10.9) | 182 (86.3) | 2 (0.9) | 65 | |
19. Percentage of randomised participants with query/queries for secondary outcome data | 16 (7.6) | 128 (60.7) | 65 (30.8) | 2 (0.9) | 8 (3.8) | 156 (73.9) | 46 (21.8) | 1 (0.5) | 8 (3.8) | 162 (76.8) | 40 (19) | 1 (0.5) | ||
20. Time taken between sending a data query and resolution of the query | 17 (8.1) | 140 (66.4) | 52 (24.6) | 2 (0.9) | 10 (4.7) | 164 (77.7) | 36 (17.1) | 1 (0.5) | 9 (4.3) | 167 (79.1) | 34 (16.1) | 1 (0.5) | ||
21. Percentage of randomised participants with complete data for primary and important secondary outcomesa,c | 2(0.9) | 44 (20.9) | 163 (77.3) | 2 (0.9) | 1 (0.5) | 20 (9.5%) | 189 (89.6) | 1 (0.5) | 1 (0.5) | 11 (5.2) | 198 (93.8) | 1 (0.5) | 96 | |
22. Percentage of randomised participants with complete data | 3 (1.4) | 85 (40.3) | 120 (56.9) | 3 (1.4) | 0 | 88 (41.7) | 122 (57.8) | 1 (0.5) | 0 | 91 (43.1) | 119 (56.4) | 1 (0.5) | ||
23. Percentage of unresolved serious adverse event queries > 30 calendar days from the date the query was generated a | 3 (1.4) | 44 (20.9) | 163 (77.3) | 1 (0.5) | 1 (0.5) | 24 (11.4) | 186 (88.2) | 0 | 1 (0.5) | 12 (5.7) | 198 (93.8) | 0 | 9 | |
24. Total number of adverse events and serious adverse events reported per number of randomised participants | 32 (15.2) | 101 (47.9) | 74 (35.1) | 4 (1.9) | 19 (9) | 130 (61.6) | 59 (28.0) | 3 (1.4) | 17 (8.1) | 138 (65.4) | 53 (25.1) | 3 (1.4) | ||
25. Number of serious adverse events reported per number of randomised participants | 25 (11.8) | 84 (39.8) | 98 (46.4) | 4 (1.9) | 16 (7.6) | 90 (42.7) | 102 (48.3) | 3 (1.4) | 15 (7.1) | 102 (48.3) | 91 (43.1) | 3 (1.4) | ||
26. Number of adverse events reported per number of randomised participants b,c | 40 (19) | 106 (50.2) | 60 (28.4) | 5 (2.4) | 27 (12.8) | 136 (64.5) | 45 (21.3) | 3 (1.4) | 24 (11.4) | 148 (70.1) | 36 (17.1) | 3 (1.4) | 81 | |
Protocol compliance | 27. Percentage of randomised participants with at least one protocol violation a,c | 6 (2.8) | 78 (37) | 124 (58.8) | 3 (1.4) | 1 (0.5) | 64 (30.3) | 145 (68.7) | 1 (0.5) | 0 | 47 (22.3) | 163 (77.3) | 1 (0.5) | 76 |
28. Percentage of randomised participants receiving allocated intervention as intended per protocol a,c | 2 (0.9) | 48 (22.7) | 158 (74.9) | 3 (1.4) | 0 | 19 (9.0) | 191 (90.5) | 1 (0.5) | 0 | 11 (5.2) | 199 (94.3) | 1 (0.5) | 100 | |
29. Number of missed visits per number of randomised participants a | 7 (3.3) | 93 (44.1) | 107 (50.7) | 4 (1.9) | 5 (2.4) | 75 (35.5) | 128 (60.7) | 3 (1.4) | 4 (1.9) | 52 (24.6) | 152 (72) | 3 (1.4) | 10 | |
30. Number of late visits per number of randomised participants | 18 (8.5) | 128 (60.7) | 61 (28.9) | 4 (1.9) | 10 (4.7) | 157 (74.4) | 41 (19.4) | 3 (1.4) | 9 (4.3) | 162 (76.8) | 37 (17.5) | 3 (1.4) | ||
31. Number of critical or major audit findings per number of randomised participants a | 6 (2.8) | 43 (20.4) | 152 (72) | 10 (4.7) | 4 (1.9) | 23 (10.9) | 179 (84.8) | 5 (2.4) | 3 (1.4) | 14 (6.6) | 190 (90) | 4 (1.9) | 0 | |
Staff | 32. Number of contacts from site staff to the central trial team within a given time period | 79 (37.4) | 112 (53.1) | 14 (6.6) | 6 (2.8) | 76 (36) | 124 (58.8) | 6 (2.8) | 5 (2.4%) | 81 (38.4) | 120 (56.9) | 6 (2.8) | 4 (1.9) | |
33. Time between protocol amendment being sent and principal investigator sign-off | 22 (10.4) | 110 (52.1) | 73 (34.6) | 6 (2.8) | 16 (7.6) | 127 (60.2) | 65 (30.8) | 3 (1.4) | 15 (7.1) | 140 (66.4) | 53 (25.1) | 3 (1.4) | ||
34. Cumulative number of staff included on the delegation of duties log | – | – | – | – | 105 (49.8) | 87 (41.2) | 12 (5.7) | 7 (3.3) | 116 (55.0) | 83 (39.3) | 7 (3.3) | 5 (2.4) |