From: Pilot trials in physical activity journals: a review of reporting and editorial policy
Item | Description | Feasibility of future definitive trial (n = 7) | Feasibility of novel intervention (n = 7) | Non-feasibility (n = 17) | Total (n = 31) |
---|---|---|---|---|---|
1a | Words in title | ||||
 Pilot | 2 (28) | 5 (71) | 12 (71) | 19 (61) | |
 Feasibility | 5 (71) | 3 (43) | 0 (0) | 8 (26) | |
 Randomised | 5 (71) | 3 (43) | 1 (6) | 9 (29) | |
2a | Introduction | ||||
 Rationale for future definitive trial | 7 (100) | 7 (100) | 17 (100) | 31 (100) | |
 Rationale for pilot trial | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
2b | Objectives | ||||
 Objectives to assess the feasibility of a future definitive trial | 7 (100) | 0 (0) | 0 (0) | 7 (23) | |
3a | Design | ||||
 Parallel | 4 (57) | 5 (71) | 8 (47) | 17 (55) | |
 Crossover | 0 (0) | 0 (0) | 6 (35) | 6 (19) | |
 Cluster | 2 (29) | 0 (0) | 0 (0) | 2 (6) | |
 Waitlist control | 1 (14) | 1 (14) | 1 (6) | 3 (10) | |
 Other | 0 (0) | 1 (14) | 2 (12) | 3 (10) | |
5 | Treatment groups | ||||
 Median number of treatment groups (IQR) | 2 (0) | 2 (0) | 2 (0) | 2 (0) | |
 Control group | 7 (100) | 5 (71) | 11 (65) | 23 (74) | |
6a | Aspects of feasibility addressed | ||||
 Process (e.g. recruitment and retention rates) | 7 (100) | 4 (57) | – | 11 (35)* | |
 Resources (e.g. cost, time, equipment) | 4 (57) | 0 (0) | – | 4 (13)* | |
 Management (e.g. data entry and storage) | 0 (0) | 0 (0) | – | 0 (0)* | |
 Scientific (e.g. dose) | 7 (100) | 6 (86) | – | 13 (42)* | |
 Sample size (inform sample size in future definitive trial) | 4 (57) | 0 (0) | – | 4 (13)* | |
 Feedback (qualitative or quantitative feedback from participants and staff) | 7 (100) | 5 (71) | – | 12 (39)* | |
 Median number of aspects addressed by each trial (IQR) | 4 (1) | 2 (2) | – | 3 (2)* | |
6c | Criteria for progression to future definitive trial | 0 (0) | 0 (0) | – | 0 (0)* |
7a | Participant numbers | ||||
 Sample size calculation | 1 (14) | 0 (0) | 3 (18) | 4 (13) | |
 Rationale for sample size | 4 (57) | 1 (14) | – | 5 (36)* | |
12a | Analysis | ||||
 Hypothesis testing | 3 (43) | 7 (100) | 16 (94) | 26 (84) | |
20 and 21 | Discussion | ||||
 Sources of potential bias | 2 (29) | 2 (29) | 4 (24) | 8 (26) | |
 Remaining uncertainty about feasibility | 5 (71) | 1 (14) | – | 6 (43)* | |
 Generalisability to future definitive trial | 3 (43) | 0 (0) | – | 3 (21)* | |
22a |  Implications for future definitive trial | 7 (100) | 3 (43) | – | 10 (71)* |
Progression planned | |||||
 Definitive RCT planned without any changes | 0 (0) | 0 (0) | – | 0 (0)* | |
 Definitive RCT planned with changes from the pilot trial | 6 (86) | 1 (14) | – | 7 (50)* | |
 Definitive RCT not planned because of major problems with feasibility | 1 (14) | 0 (0) | – | 1 (7)* | |
 Unclear | 0 (0) | 6 (86) | – | 6 (43)* | |
Progression realised | |||||
 Definitive trial completed | 3 (43) | 0 (0) | – | 3 (21)* | |
 Definitive trial registered | 1 (14) | 1 (14) | – | 1 (7)* | |
 Definitive trial not registered | 0 (0) | 2 (29) | – | 2 (14)* | |
 No information | 3 (43) | 4 (57) | – | 8 (57)* |