Table 1.
Details of the design of the internal pilots
| Frequency (%) | ||
|---|---|---|
| Data sources | ||
| Commissioning briefs | 28a (100%) | |
| Project descriptions | 41 (72%) | |
| Summary of changes from first stage/feedback about full application | 41 (72%) | |
| Monitoring notes | 56 (98%) | |
| Progress report history | 56 (98%) | |
| Protocols (current version available online) | 57 (100%) | |
| Protocols (any previous versions available online) | 37 (65%) | |
| Where was the internal pilot first proposed? | ||
| Funder-led | Researcher-led | |
| Commissioning brief | 8 (29%) | N/A |
| Outline | 6 (27%) | 14 (64%) |
| Outline feedback | 6b (27%) | 7c (32%) |
| Full application | 0 (0%) | 0 (0%) |
| Full application feedback | 2 (9%) | 1 (5%) |
| Total | 22d (100%) | 22d (100%) |
| Trials with progression criteria specified in the latest available version of the protocol | ||
| Yes | 36 (63%) | |
| No | 21 (37%) | |
| If yes, specified in previous available versions? | ||
| Yes | 19 (86%) | |
| No | 3 (14%) | |
| Previous versions not available | 14 | |
| Component(s) of progression criteriae | ||
| Target number for recruitment within a specified period | 54 (96%) | |
| In a specified number of sites? | ||
| Yes | 4 (7%) | |
| No | 50 (93%) | |
| Retention/primary outcome ascertainment rate | 16 (29%) | |
| Rate of treatment adherence | 13 (23%) | |
| Rate of randomisation over time | 11 (20%) | |
| Rate of randomisation by site? | ||
| Yes | 8 (73%) | |
| No | 3 (27%) | |
| Number of sites recruiting | 10 (18%) | |
| Consent rate | 8 (14%) | |
| Number of sites opened | 5 (9%) | |
| Proportion of eligible participants | 3 (5%) | |
| Otherf | 4 (7%) | |
aDenominator 28 as only applicable for the 28 funder-led trials
bThe outline feedback suggested amendments to an additional 6 internal pilots, 4 of which were initially proposed in the commissioning brief and 2 which were proposed in the outline
cThe outline feedback suggested amendments to an additional 8 internal pilots, all of which were initially proposed in the outline
d5 unknown for funder-led trials; 8 unknown for researcher-led trials; commissioning brief denominator = 28
eCriteria was not specified for 1 internal pilot so denominator taken as 56
fNumber of UK participants; number receiving rescue treatments; outcome assessments conducted according to protocol; number of sites that completed the intervention course