Table 1 Continuation criteria VVEIN pilot study
| Â | Proceed to RCT | Proceed to RCT following some changes to the protocol | Do not proceed to RCT unless problems can be overcome |
|---|---|---|---|
Recruitment | Recruitment of ≥ 80% study participants within 4 months | Recruitment of ≥ 60% study participants within 4 months [41] | Recruitment of < 60% study participants within 4 months |
Retention | Retention of ≥ 80% of study participants for follow-up | Retention of ≥ 60% of study participants for follow-up | Retention of < 60% of study participants for follow-up |
Feasibility and acceptability | dHET intervention on day ward acceptable to > 75% of study personnel (score of 4 or 5 on Likert scale) and patients involved (score of 28 or above on CSQ-8) | dHET intervention on day ward acceptable to > 50–74% of study personnel (score of 4 or 5 on Likert scale) and patients involved (score of 28 or above on CSQ-8) | dHET intervention on day ward acceptable to < 50% of study personnel (score of 4 or 5 on Likert scale) and patients involved (score of 28 or above on CSQ-8) |
Non-adherence | Non-adherence to the intervention in < 10% (dHET and/or DOS questionnaires incomplete) | Non-adherence to the intervention in > 11–20% (dHET and/or DOS questionnaires incomplete) | Non-adherence to the intervention in > 21% (dHET and/or DOS questionnaires incomplete) |