Table 2

Progression criteria

Feasibility objectives and related data to be collectedGo criteria to proceed to full trialCriteria to reassess and adjust full trial protocolStop criteria
Study population
1. Consent rates of eligible womenRate >25% of eligible women agreeing to participate.Rate between 11% and 24% women agreeing to participateRate <10% of eligible women agreeing to participate
Study outcomes
2. Proportion of women in either intervention or control group for whom the allocated treatment is adhered to.Adherence to allocated treatment in >80% of study sample.Adherence to allocated treatment in between 51% and 79% of study sample.Adherence to allocated treatment in <50% of study sample.
RCT processes
3. Collection of data on clinical outcomes.Complete data available of >80% of study sample.Missing data between 21% and 49% of study sample.Data missing of >50% of study sample.
  • RCT, randomised controlled trial.