Concept | Data source(s) | Progression criteria | Final decision | ||
---|---|---|---|---|---|
Stop (unless there are clear and modifiable contextual or design issues that account for thisa) | Amend | Go | |||
GP practice recruitment | Recruitment records held by research nurse(s) | If ≤ 5 GP practices are recruited within 8 months | If 6–9 GP practices are recruited and/or it takes longer than predicted (6–8 months) | If ≥ 10 GP practices are recruited to take part in ≤ 6 months | Go: 12 GP practices were recruited within 6 months |
GP practice retention | Retention records held by research nurse(s) | If ≤ 5 GP practices are retained for the required period | If 6–9 GP practices can be retained for the required period | If ≥ 10 GP practices can be retained for the required period | Amend: 9 GP practices were retained until the end of the study period |
Patient recruitment | Recruitment records held by Research Fellow/Assistant | If ≤ 59 patients are recruited within 5 monthsb | If 60–95 patients are recruited within 5 monthsb | If ≥ 96 patients are recruited within 5 monthsb | Amend: 68 patients were recruited within 4 monthsc |
Patient retention | Retention records held by Research Fellow/Assistant | If ≤ 49% of patients are retained for the required period | If 50–79% of patients are retained for the required period | If ≥ 80% of patients are retained for the required period | Amend: 69.1% (47 of 68) of patients were retained in the study (i.e. had GP record data available for primary outcome analysis) |
Completeness of outcome data | Data collected during the study (CRFs, questionnaires) | If ≤ 49% of each patient self-repor, and GP-reported outcome measure is complete | If 50–79% of each patient self-report and GP-reported outcome measure is complete | If ≥ 80% of each patient self-report and GP-reported outcome measure is complete | Go: 93.9% of primary and secondary outcome data were complete (see Additional file 2) |