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Table 4 Results from data extraction stratified by category of pilot trial (results given as number (%) unless otherwise specified)

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)*

  1. *Percentage of the 14 FDT and FNI trials