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 |