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Table 4 Specified factors that inform assessment of trial feasibility in addition to, or instead of, progression criteria

From: Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications

Specified factors by corresponding authors of publications that reported progression criteriaa

 

(n=33)

 Qualitative data

12 (36%)

  Process evaluation

5 (15%)

  Participant feedbackb

3 (9%)

  Qualitative interview data

3 (9%)

  Qualitative data about implementation

1 (3%)

 Trial design

6 (18%)

  Outcome measures

3 (9%)

  Data collection

1 (3%)

  Performance of trial pathways

1 (3%)

  Protocol adherence

1 (3%)

  Selection bias

1 (3%)

 Recruitment

5 (15%)

  Recruitment processes and ability to recruit

4 (12%)

  Difficulty with screening

1 (3%)

 Contextual challenges

4 (12%)

  COVID-19

2 (6%)

  Healthcare context

2 (6%)

  Changing policy

1 (3%)

 Implementation of the trial

3 (9%)

  Resources required

2 (6%)

  Enthusiasm of researchers

1 (3%)

  Number of recruiting sites needed

1 (3%)

 Funding considerations

3 (9%)

 Indication of efficacy or effectiveness

3 (9%)

 Interest, acceptability or uptake of intervention

3 (9%)

 Expectations of collaborators

1 (3%)

 Retention or attrition

1 (3%)

Specified factors by corresponding authors of publications that did not report progression criteriac

 

(n=32)

 Qualitative data

17 (53%)

  Acceptability to participantsb

11 (34%)

  Participant feedbackb

3 (9%)

  Qualitative data about implementation

3 (9%)

  Qualitative interview data

2 (6%)

  Acceptability to healthcare providersb

2 (6%)

  Process evaluation

1 (3%)

 Recruitment

14 (44%)

  Recruitment rate

11 (34%)

  Recruitment processes

2 (6%)

  Consent rate

1 (3%)

  Recruitment time

1 (3%)

 Indication of efficacy or effectiveness

10 (31%)

 Trial design

10 (31%)

  Sample size required for the definitive RCT

5 (16%)

  Data collection

3 (9%)

  Ability to do internal pilot as part of future def RCT

1 (3%)

  Need to further development the intervention (not possible in an RCT)

1 (3%)

 Retention or attrition

9 (28%)

 Interest, acceptability or uptake of intervention

9 (28%)

  Intervention adherence or engagement

5 (16%)

  Completion or withdrawal rates

3 (9%)

  Willingness to be randomised

1 (3%)

 Implementation of the intervention

7 (22%)

  Intervention delivery

3 (9%)

  Intervention fidelity

2 (6%)

  Intervention feasibility

1 (3%)

  Complexity of the intervention

1 (3%)

 Implementation of the trial

4 (13%)

  Acceptability or willingness of healthcare professionals

2 (6%)

  Patient acceptability of study procedures

1 (3%)

  Resources required

1 (3%)

 Safety or adverse events

3 (9%)

 Contextual challenges

1 (3%)

  Healthcare context

1 (3%)

 Funding considerations

1 (3%)

  1. Most participants mentioned more than one factor
  2. aResponses presented were reported by 33 of 34 trialists who considered other factors, in addition to their progression criteria, to assess trial feasibility
  3. bUnclear whether participant feedback and acceptability data were collected through formal qualitative research methods
  4. cResponses presented were reported by 32 of 34 trialists who authored pilot trial publications that did not include progression criteria