Group 1: study elements captured in pilot studies, feasibility studies and pilot/feasibility studies
| Study elements | Pilot studies only (n=6) | Feasibility studies only (n = 2) | Pilot/feasibility studies (n = 7) | ||||||
| Assessed (A): n (%) | Recommended changes (RC): n (%) | A and RC: n (%) | Assessed (A): n (%) | Recommended changes (RC): n (%) | A and RC: n (%) | Assessed (A): n (%) | Recommended changes (RC): n (%) | A and RC: n (%) | |
| Testing recruitment | 6 (100.0) | 3 (50.0) | 3 (50.0) | 2 (100.0) | 1 (50.0) | 1 (50.0) | 7 (100.0) | 3 (42.9) | 3 (42.9) |
| Determining sample size and/or number available | 5 (83.3) | 1 (16.6) | 0 | 1 (50.0) | 2 (100.0) | 1 (50.0) | 5 (71.4) | 1 (14.3) | 1 (14.3) |
| Follow-up/dropout | 4 (66.6) | 3 (50.0) | 3 (50.0) | 0 | 1 (50.0) | 0 | 5 (71.4) | 2 (28.6) | 1 (14.3) |
| Hypothesis testing | 2 (33.3) | 0 | 0 | 1 (50.0) | 0 | 0 | 1 (14.3) | 0 | 0 |
| Resources | 4 (66.6) | 3 (50.0) | 2 (33.3) | 2 (100.0) | 0 | 0 | 5 (71.4) | 1 (14.3) | 1 (14.3) |
| Randomisation | 4 (66.6) | 0 | 0 | 0 | 0 | 0 | 6 (85.7) | 1 (14.3) | 1 (14.3) |
| Blinding | 0 | 0 | 0 | 0 | 0 | 0 | 2 (28.6) | 0 | 0 |
| Outcome measures | 5 (83.3) | 4 (66.6) | 4 (66.6) | 2 (100.0) | 1 (50.0) | 1 (50.0) | 6 (85.7) | 4 (57.1) | 3 (42.9) |
| Control group | 0 | 0 | 0 | 0 | 0 | 0 | 1 (14.3) | 0 | 0 |
| Data collection | 3 (50.0) | 0 | 0 | 0 | 1 (50.0) | 0 | 3 (42.9) | 1 (14.3) | 0 |
| Clinical outcomes | 3 (50.0) | 2 (33.3) | 1 (16.6) | 1 (50.0) | 0 | 0 | 3 (42.9) | 0 | 0 |
| Dose/efficacy/safety | 2 (33.3) | 1 (16.6) | 1 (16.6) | 0 | 0 | 0 | 2 (28.6) | 0 | 0 |
| Acceptability | 4 (66.6) | 0 | 0 | 1 (50.0) | 0 | 0 | 6 (85.7) | 0 | 0 |
| Feasibility | 5 (83.3) | 0 | 0 | 2 (100.0) | 0 | 0 | 7 (100.0) | 0 | 0 |
| Suggests further study | 5 (83.3) | 4 (66.6) | 4 (66.6) | 2 (100.0) | 2 (100.0) | 2 (100.0) | 7 (100.0) | 7 (100.0) | 7 (100.0) |
| Median number of participants (IQR) [range] | 47.5 (39.25–85) [21–99] | 14 (7–21) [0–28] | 58 (35.5–173) [29-313] | ||||||