Table 3

Intentions reported in completed external randomised pilot trial results publications

n (%)
Progression criteria met
 All17 (46)
 None4 (11)
 Some13 (35)
 Unclear3 (8)
Progression decision
 Proceed/future RCT is feasible30 (81)
  With intended design0 (0)
  With amendments28 (93)
  Not reported whether changes will be made to definitive RCT design2 (7)
  Funding intentions
  Funding for definitive RCT identified4 (13)
   Non-industry3 (75)
   Unclear1 (25)
  Expected funding for definitive RCT not reported26 (87)
  Timing intentions
  Time frame of expected progression reported1 (3)
  Time frame of expected progression not reported29 (97)
 Conduct further pilot/feasibility work4 (11)
 Not proceed/future RCT is not feasible3 (8)
Justification reported for the progression decision reported
 Yes36 (97)
 No1 (3)
Comment on data quality (eg, proportion of missing/incomplete data from questionnaires or results)
 Yes27 (73)
 No10 (27)
Comment on refinement of hypotheses
 Yes1 (3)
 No36 (97)
Published protocol available
 Yes16 (43)
 No1 (3)
Alternative available (eg, trial registration or REC submission)20 (54)
Progression criteria in earlier trial record (protocol or registration)
 No change10 (28)
 Yes change26 (72)
  Reasons for change reported1 (4)
  No reason for change reported3 (12)
  Progression criteria were not reported in the earlier trial record22 (85)
  • Percentages may not sum up to 100 due to rounding.

  • RCT, randomised controlled trial; REC, Research Ethics Committee.