Table 1 Trial objectives, outcome measures, pre-specified criteria as to whether to proceed to main trial
Objectives | Outcome Measures | Time point(s) of evaluation | Stop / Go Criteria | Stop / Go Categorisation |
|---|---|---|---|---|
1. To identify rate of matching patient ID in BSA routine records and likely missing outcome data | Matching patient name, date of birth, gender and contract number the service is delivered under against record of attending for NHS urgent dental practice care in the Business Service Authority (BSA) database The denominator is those recruited at baseline from NHS dental practice who would be expected to be in the BSA system | Baseline and 4 months (where possible) | ≥ 95% successfully matched | Green |
90–95% successfully matched | Amber | |||
< 90% successfully matched | Red | |||
4. To identify rate of completeness of valid OHIP outcome data | Percentage of participants providing valid* OHIP data at baseline and follow up (i.e. respond to 12 items or more) | Baseline and 4 months | ≥ 80% of participants | Green |
60–80% of participants | Amber | |||
< 60% of participants | Red | |||
7. To identify if recruitment rates are feasible | Number of patients recruited across all types of sites | Baseline | 60 patients recruited | Green |
40–59 patients recruited | Amber | |||
< 40 patients recruited | Red | |||
10. To determine fidelity of intervention delivery | Observations of participants to determine % allocated patients who are observed to receive at least some of the intervention (receive at least some of the intervention material) | Baseline | ≥ 80% allocated patients who are observed receive at least some of the intervention material (either/and booklet or online) | Green |
60–80% receive at least some of the intervention material | Amber | |||
< 60% receive at least some of the intervention material it | Red |