Table 2

Progression criteria

CriteriaStopAdjustProgress
Proportion of eligible patients identified from screening logs<10%10%–20%>20%
Number of eligible patients randomised over 24 months (site: SJUH)≤2 per month3–4 per month≥5 per month
Number of eligible patients randomised over 18 months (site: BRI)<1 per month1–2 per month≥3 per month
Adequacy of participant blinding (according to Bang Blinding Index)Index <−0.5
Or index >0.5
Index −0.2 to −0.5
Or index 0.2–0.5
Index 0 to −0.19
Or index 0–0.19
Average compliance to the study treatment schedule<10/20 stimulations across 10 days10–15/20 stimulations across 10 days≥16/20 stimulations across 10 days
Proportion of missing clinical outcome data>40%15%–30%<15%
Proportion of randomised patients lost to follow-up>40%15%–30%<15%
Incidence of complications or serious complications>20% increase in complications5%–20% increase in complications<5% increase in complications
  • BRI, Bradford Royal Infirmary; SJUH, St James’s University Hospital.