Table 5 Feasibility objectives and endpoints of Diamond study
Feasibility objectives | Endpoints assessment |
|---|---|
Eligibility: number of patients included and number excluded (+ reasons) from the trial. | The minimum representative sample size to be recruited from those eligible sufficient participants to allow the definitive trial results to be generalizable. |
Recruitment: ability to recruit patients into the intervention from those attending primary care | The minimum recruitment rate per site per month to make the required sample size adequate for a definitive trial possible within a reasonable timeframe. |
Retention: across the duration of the intervention and return of a fully completed diary | The minimum number of data completion in the diaries sufficient to allow the definitive trial results to be generalizable. |
Trial medicine compliance | Do participants comply with intervention medicines sufficiently to make a definitive trial worthwhile? |
Acceptability of the patient diaries, patients’ willingness to complete them, and the importance of telephone/text contact | Qualitative interview |
Antibiotics and co-consultations are needed | The rates of antibiotics use and re-consultation |
To inform sample size for future trials | The rate of outcome measures in the intervention groups compatible with conducting a definitive trial in China, with an achievable sample size, within a reasonable timeframe |