Table 2 Inclusion and characteristics of progression criteria by application stage and outcome
Outline application (Stage 1) | Full application (Stage 2) | |||||
|---|---|---|---|---|---|---|
Total | Invited | Rejected | Total | Awarded | Rejected | |
Progression criteria reporting | (n = 95) | (n = 52)a | (n = 43) | (n = 49)a | (n = 35) | (n = 14) |
Yes | 48 (51%) | 24 (46%)a | 24 (56%) | 36 (73%) | 26 (74%) | 10 (71%) |
Stipulated in Stage 1 and Stage 2 | N/A | N/A | N/A | 23 (65%)a | 17 (65%) | 6 (60%) |
Stipulated in stage two only | N/A | N/A | N/A | 13 (36%) | 9 (35%) | 4 (40%) |
No | 47 (49%) | 28 (54%) | 19 (44%) | 13 (27%) | 9 (26%) | 4 (29%) |
Characteristics of progression criteria | (n = 48) | (n = 24) | (n = 24) | (n = 36) | (n = 26) | (n = 10) |
Format | ||||||
Distinct threshold / STOP-GO | 18 (38%) | 8 (33%) | 10 (42%) | 10 (27%) | 9 (35%) | 1 (10%) |
Distinct threshold / STOP-GO +b | 15 (31%) | 8 (33%) | 7 (29%) | 11 (31%) | 9 (35%) | 2 (20%) |
Traffic light system / STOP-AMEND-GO | 5 (10%) | 3 (13%) | 2 (8%) | 8 (22%) | 3 (12%) | 5 (50%) |
Traffic light system / STOP-AMEND-GO +b | 4 (8%) | 2 (8%) | 2 (8%) | 5 (14%) | 3 (12%) | 2 (20%) |
Non-numerical | 6 (13%) | 3 (13%) | 3 (13%) | 2 (6%) | 2 (8%) | 0 (0%) |
Presentation | ||||||
Text | 45 (94%) | 23 (96%) | 22 (92%) | 32 (89%) | 23 (88%) | 9 (90%) |
Table | 3 (6%) | 1 (4%) | 2 (8%) | 4 (11%) | 3 (12%) | 1 (10%) |
Areas of feasibility informing progression criteriac | ||||||
Recruitment | 41 (85%) | 22 (92%) | 19 (79%) | 31 (86%) | 21 (81%) | 10 (100%) |
Retention | 27 (56%) | 13 (54%) | 14 (58%) | 24 (67%) | 16 (62%) | 8 (80%) |
Acceptability of intervention or trial (participants) | 19 (40%) | 9 (38%) | 10 (42%) | 15 (42%) | 10 (38%) | 5 (50%) |
Data completion or missing data | 16 (33%) | 7 (29%) | 9 (38%) | 11 (31%) | 7 (27%) | 4 (40%) |
Non/compliance or adherence (participants) | 13 (27%) | 4 (17%) | 9 (38%) | 13 (36%) | 11 (42%) | 2 (20%) |
Consent or refusal rate | 9 (19%) | 4 (17%) | 5 (21%) | 6 (17%) | 6 (23%) | 0 (0%) |
Acceptability of intervention or trial (non-participants) | 8 (17%) | 5 (21%) | 3 (13%) | 11 (31%) | 8 (31%) | 3 (30%) |
Intervention fidelity | 7 (15%) | 1 (4%) | 6 (25%) | 9 (25%) | 7 (27%) | 2 (20%) |
Safety or adverse events | 6 (13%) | 5 (21%) | 1 (4%) | 7 (19%) | 6 (23%) | 1 (10%) |
Determine/estimate definitive trial sample size | 6 (13%) | 4 (17%) | 2 (8%) | 4 (11%) | 4 (15%) | 0 (0%) |
Completion or withdrawal | 5 (10%) | 2 (8%) | 3 (13%) | 4 (11%) | 4 (15%) | 0 (0%) |
Randomisation | 5 (10%) | 1 (4%) | 4 (17%) | 3 (8%) | 2 (8%) | 1 (10%) |
Other | 35 (73%) | 18 (75%) | 17 (71%) | 31 (86%) | 23 (88%) | 8 (80%) |
Qualitative research informs progression criteria | ||||||
Yes | 20 (42%) | 10 (42%) | 10 (42%) | 18 (50%) | 12 (46%) | 6 (60%) |
No | 18 (38%) | 8 (33%) | 10 (42%) | 14 (39%) | 11 (42%) | 3 (30%) |
No qualitative research component | 10 (21%) | 6 (25%) | 4 (17%) | 4 (11%) | 3 (12%) | 1 (1%) |
Justification or rationale for progression criteria given | ||||||
Yes | 9 (19%) | 3 (13%) | 6 (25%) | 7 (19%) | 5 (19%) | 2 (20%) |
For some criteria | 7 (15%) | 5 (21%) | 2 (9%) | 5 (14%) | 4 (15%) | 1 (10%) |
No | 32 (67%) | 16 (67%) | 16 (67%) | 24 (67%) | 17 (65%) | 7 (70%) |
Application details who decided on progression criteria | ||||||
Yes | 1 (2%) | 0 (0%) | 1 (4%) | 1 (3%) | 0 (0%) | 1 (10%) |
No | 47 (98%) | 24 (100%) | 23 (96%) | 35 (97%) | 26 (100%) | 9 (90%) |
Application details who will assess progression criteria | ||||||
Yes | 8 (17%) | 3 (13%) | 5 (21%) | 9 (25%) | 6 (23%) | 3 (30%) |
No | 40 (83%) | 21 (88%) | 19 (79%) | 27 (75%) | 20 (77%) | 7 (70%) |