Table 9.
Final decisions for each progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the PolyPrime study
| 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) |
aThis includes aspects of study and/or data collection procedures that may be modified in advance of a full-scale definitive cRCT
bNote that if ethics amendments are made to study recruitment procedures during this time period, the 5-month recruitment period may be extended (up to 8 months) to enable sufficient time to assess patient recruitment rates
cPatient recruitment underway from the end of January 2020 to mid-March 2020; paused from mid-March to mid-September 2020; recruitment underway again from mid-September 2020 to mid-November 2020, i.e. approximately 4 months. Recruitment was stopped in mid-November 2020 to allow for sufficient time to undertake follow-up