Characteristics of progression criteria reported in external randomised pilot trial publications
| Completed (n=37) n (%) | Protocol (n=123) n (%) | Total (n=160) n (%) | |
| Feasibility outcomes informing progression criteria | |||
| All | 14 (38) | 39 (32) | 53 (33) |
| Some | 22 (59) | 77 (63) | 99 (62) |
| None | 1 (3) | 2 (2) | 3 (2) |
| Unclear* | 0 (0) | 5 (4) | 5 (3) |
| Reported process for establishing progression criteria | |||
| Who decided on progression criteria | |||
| Reported | 4 (11) | 8 (6) | 12 (8) |
| Not reported | 33 (89) | 115 (94) | 148 (93) |
| Rationale for progression criteria | |||
| Reported for all progression criteria | 8 (22) | 20 (16) | 28 (18) |
| Reported for some criteria only | 4 (11) | 12 (10) | 16 (10) |
| Not reported | 25 (68) | 91 (74) | 116 (73) |
| Progression criteria format | |||
| Research method informing progression criteria | |||
| Quantitative | 32 (86) | 93 (76) | 125 (78) |
| Quantitative and qualitative (mixed methods) | 5 (14) | 29 (24) | 34 (21) |
| Unclear | 0 (0) | 1 (1) | 1 (1) |
| Qualitative research contribution | |||
| Informs progression criteria | 5 (14) | 29 (24) | 34 (21) |
| Does not inform progression criteria | 14 (38) | 60 (49) | 74 (46) |
| Qualitative research methodology not used | 18 (49) | 34 (28) | 52 (33) |
| Quantitative progression criteria target format | |||
| Distinct threshold | 34 (92) | 99 (80) | 133 (83) |
| Traffic light system | 2 (5) | 18 (15) | 20 (13) |
| Other | 1 (3) | 6 (5) | 7 (4) |
| Reported process for assessing progression criteria to inform the progression decision | |||
| Process for progression decision-making | |||
| Reported | 16 (43) | 58 (47) | 74 (46) |
| Not reported | 21 (57) | 65 (53) | 86 (54) |
| Who is involved in assessing progression criteria | |||
| Reported | 5 (14) | 30 (24) | 35 (22) |
| Not reported | 32 (86) | 93 (76) | 125 (78) |
| Peer reviewer reports | |||
| Progression criteria mentioned in peer reviewer report | |||
| Yes | 19 (51) | 67 (54) | 86 (54) |
| Peer review comment theme | |||
| Progression criteria were not specified | 6 (32) | 29 (44) | 35 (41) |
| Unclear whether progression criteria were specified | 1 (5) | 4 (6) | 5 (6) |
| Progression criteria rationale or justification query | 5 (26) | 15 (22) | 20 (23) |
| Other | 7 (37) | 19 (29) | 26 (30) |
| No | 15 (41) | 52 (42) | 67 (42) |
| Peer reviewer report unavailable | 3 (8) | 4 (3) | 7 (4) |
Percentages may not sum up to 100 due to rounding.
*Feasibility uncertainties are not completely defined in the objectives and outcomes; key methodological uncertainties have been identified from those stipulated in the progression criteria.