Group 2: study elements captured in external pilot and feasibility studies
| Study elements | External pilot study (n=48) | External feasibility study (n=11) | ||
| Assessed n (%) | Recommended changes n (%) | Assessed n (%) | Recommended changes (n) | |
| Testing recruitment | 24 (50.0) | 3 (6.3) | 8 (72.7) | 0 |
| Determining sample size and/or number available | 24 (50.0) | 1 (2.1) | 4 (36.4) | 1 (9.1) |
| Follow-up/dropout | 16 (33.3) | 0 | 3 (27.3) | 0 |
| Hypothesis testing | 10 (20.8) | 0 | 2 (18.2) | 0 |
| Resources | 2 (4.2) | 0 | 1 (9) | 0 |
| Randomisation | 7 (14.6) | 0 | 3 (27.3) | 0 |
| Blinding | 4 (8.3) | 1 (2.1) | 0 | 0 |
| Outcome measures | 10 (20.8) | 1 (2.1) | 1 (9.1) | 0 |
| Control group | 3 (6.3) | 0 | 0 | 0 |
| Data collection | 6 (12.5) | 0 | 2 (18.2) | 0 |
| Clinical outcomes | 12 (25.0) | 0 | 1 (9.1) | 0 |
| Dose/efficacy/safety | 14 (29.2) | 1 (2.1) | 0 | 0 |
| Acceptability | 17 (35.4) | 0 | 4 (36.4) | 0 |
| Feasibility | 20 (41.7) | 0 | 8 (72.7) | 0 |
| Suggests further study | 8 (16.6) | 1 (2.1) | 1 (9.1) | 0 |
| Delivery of intervention | 8 (16.6) | 2 (4.2) | 0 | 0 |
| Testing/developing materials | 3 (6.3) | 0 | 1 (9.1) | 0 |