Concept | Data source(s) | Progression criteria | ||
---|---|---|---|---|
Stop (unless there are clear and modifiable contextual or design issues that account for thisa) | Amend | Go | ||
Pharmacy recruitment | Recruitment records held by the research team | If ≤ 5 pharmacies are recruited within 8 months | If 6–9 pharmacies are recruited and/or it takes longer than predicted (> 4–6 months) | If ≥ 10 pharmacies are recruited to take part in ≤ 4 months |
Pharmacy retention | Retention records held by the research team | If ≤ 49% of pharmacies are retained for the required period | If 50–79% of pharmacies are retained for the required period | If ≥ 80% of pharmacies are retained for the required period |
Patient recruitment | Study documentation completed by pharmacy staff | If ≤ 59 patients are recruited within 6 monthsb or alternativelyc if ≤ 49% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months | If 60–95 patients are recruited within 6 monthsb or alternativelyc if 50–79% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months | If ≥ 96 patients are recruited within 6 monthsb or alternativelyc if ≥ 80% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months |
Patient retention | Study documentation completed by pharmacy staff | 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 |
Fidelity of pharmacist training package: delivery | Audio-recordings of pharmacist workshops | If ≤ 49% of planned training components are delivered by the researchers | If 50–79% of planned training components are delivered by the researchers | If ≥ 80% of planned training components are delivered by the researchers |
Fidelity of pharmacist training package: receipt | Audio-recordings of pharmacist workshops | If ≤ 49% of delivered training components are received by pharmacists as intended | If 50–79% of delivered training components are received by pharmacists as intended | If ≥ 80% of delivered training components are received by pharmacists as intended |
Post-workshop feedback survey | If ≤ 49% of pharmacists report that they feel prepared to take part in the study | If 50–79% of pharmacists report that they feel prepared to take part in the study | If ≥ 80% of pharmacists report that they feel prepared to take part in the study | |
Acceptability of pharmacist training day | Post-workshop feedback survey | If ≤ 49% of pharmacists report that the training day was acceptable | If 50–79% of pharmacists report that the training day was acceptable | If ≥ 80% pharmacists report that the training day was acceptable |
Fidelity of intervention delivery | Audio-recordings of a sample of patient sessions | If ≤ 49% of BCTs are delivered to patients when appropriate | If 50–79% of BCTs are delivered to patients when appropriate | If ≥ 80% of BCTs are delivered to patients when appropriate |
Fidelity of intervention receipt | Audio-recordings of a sample of patient sessions | If ≤ 49% of delivered BCTs are received by patients as intended | If 50–79% of delivered BCTs are received by patients as intended | If ≥ 80% of delivered BCTs are received by patients as intended |
Acceptability of intervention to pharmacists | Post-intervention delivery qualitative interviews | If ≤ 49% of pharmacists report that the intervention was acceptable | If 50–79% of pharmacists report that the intervention was acceptable | If ≥ 80% pharmacists report that the intervention was acceptable |
Acceptability of intervention to patients | Post-intervention delivery feedback survey | If ≤ 49% of patients report that the intervention is acceptable | If 50–79% of patients report that the intervention is acceptable | If ≥ 80% of patients report that the intervention is acceptable |
Enactment of treatment principles | Audio-recordings of a sample of patient sessions | If ≤ 49% of patients engaged with (or used) the delivered (or recommended) BCTs | If 50–79% of patients engaged with (or used) the delivered (or recommended) BCTs | If ≥ 80% of patients engaged with (or used) the delivered (or recommended) BCTs |
Missing data | Data collected during the study (questionnaires, dispensing data) | If ≥ 50% of the main outcome data are missing | If 21–49% of the main outcome data are missing | If ≤ 20% of the main outcome data are missing |