Table 1 Feasibility objectives and endpoints for the HATRIC trial
Feasibility objective | Endpoint used to evaluate |
|---|---|
Eligibility: number of patients included and number excluded (+ reasons) from the trial | On site screening logs |
Recruitment: ability to recruit patients into the intervention from those attending primary care | On site enrolment records—monthly rate/site adjusted for site list size |
Randomisation: willingness to be randomised | Proportion of eligible patients recruited |
Retention: across the duration of the intervention and return of a fully completed diary | Quantitative data from enrolment Withdrawal rate from study Completion of outcome measures |
Intervention compliance | Diary data and returned medication |
Patient preference for liquid/tablet formulation | Diary data Returned medication Recruitment data |
Establish the frequency of collecting EQ5D questionnaire and identifying the key resources associated with the intervention and potential influence on service usage Establish methods of data collection for the health economics analysis | Development of health economic protocol and collection of outcome data EQ-5D-5L questionnaire and case note review |
Acceptability of the patient diaries, patients’ willingness to complete them, and the importance of telephone/text contact | Quantitative data collection—percentage of patients returning completed diaries |
Success of delayed antibiotic strategy | Diary data on day antibiotics commenced |
Need for stratification by antibiotic strategy in main study | Proportion allocated to immediate and delayed antibiotic strategy |
To inform sample size for future trials | Rate of outcome measures in the control group |
Quality of life measurements and resource use | Identify the key resource items to be collected and how often to collect EQ-5D-5L in the full trial |