Table 3.
Details of the outcomes of internal pilots
| Changes made to the design of the main trial? (Yes/No) | Frequency (%) |
|---|---|
| Yes, conduct of recruitment | 10 (18%) |
| Inclusion criteria widened | 2 (20%) |
| Increased number of sites | 2 (20%) |
| The predicted recruitment rate for the rest of the trial was amended | 1 (10%) |
| Recruitment extended for the main trial | 1 (10%) |
| Reduced the number of arms in the trial and the sample size | 1 (10%) |
| TSC recommended sample size re-estimation given observed complication rate difference | 1 (10%) |
| Simplified of inclusion/exclusion criteria; shortened of case report forms | 1 (10%) |
| Widened inclusion criteria; increased number of sites | 1 (10%) |
| Yes, impact on outcome data | 1 (2%) |
| Clarifications made to the protocol; flexibility added to location of outcome assessments | 1 (100%) |
| Yes, in terms of both recruitment and outcome data | 1 (2%) |
| Change of eligibility criteria; change to secondary outcomes; inclusion of a sub-trial | 1 (100%) |
| Yes, no further information given | 2 (4%) |
| No | 43 (75%) |
| Total | 57 (100%) |
TSC Trial Steering Committee