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 | |||
Pharmacy recruitment | Recruitment records held by 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 | Go: 12 pharmacies were recruited within 3 months. |
Pharmacy retention | Retention records held by 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 | Go: 92% of pharmacies (i.e. 11) were retained until the end of the study 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 2 patients per month for any 3 consecutive months | If 60-95 patients are recruited within 6 monthsb or alternativelyc if 50-79% of pharmacies achieve a monthly recruitment rate of 2 patients per month for any 3 consecutive months | If ≥ 96 patients are recruited within 6 monthsb or alternativelyc if ≥ 80% of pharmacies achieve a monthly recruitment rate of 2 patients per month for any 3 consecutive months | Amend: 60 patients were recruited within 12 monthsb (extension to 12 months was made following amendments to screening/recruitment procedures). |
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 | Amend: 78.3% of patients were retained in the study (i.e. had either dispensing or self-reported adherence data available for primary outcome analysis). 73.3% of patients had data available for dispensing data analysis and 61.7% of patients had self-reported adherence data available for analysis. |
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 | Amend: 30.1% of primary and secondary outcome data were missing (see additional file 4). |
Fidelity of pharmacist training package: delivery | Audio-recordings of pharmacist workshopsd | 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 | Go: 87% (13/15) of the planned training components (i.e. BCTs) included in the training practice were delivered by the researchersd |
Fidelity of pharmacist training package: receipt | Post-workshop feedback surveyd | 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 | Go: 93% (n = 13) of pharmacists reported feeling ‘very prepared’ (n = 8) or ‘somewhat prepared’ (n = 5) in the post-workshop feedback surveyd |
Audio-recordings of pharmacist workshopsd | 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 | This data source did not contribute to the decision-making process for this concept (see reasons for this in the results section). | |
Acceptability of pharmacist training day | Post-workshop feedback surveyd | 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 | Go: 100% of pharmacists (n = 14) rated the training day as completely acceptable (n = 12) or acceptable (n = 2) in the post-workshop feedback surveyd |
Acceptability of intervention to pharmacists | Post-intervention delivery qualitative interviewsd | 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 | This concept was not assessed (see reasons for this in the ‘Results’ section). |
Acceptability of intervention to patients | Post-intervention delivery feedback surveyd | 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 | Go: 88.6% (n = 39) of patients who completed the feedback survey (n = 44) reported the S-MAP intervention was completely acceptable (n = 22) or acceptable (n = 17). Three patients had no opinion and data were missing for two patients who completed the surveyd |
Fidelity of intervention delivery | Audio-recordings of a sample of patient sessionsd | 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 | Go: 90.5% of BCTs were appropriately delivered to patients in the sample of audio-recorded sessions (data were available for six patients from six pharmacies)d |
Fidelity of intervention receipt | Audio-recordings of a sample of patient sessionsd | 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 | Go: 83.2% of BCTs were received by patients as intended in the sample of audio-recorded sessions (data were available for six patients from six pharmacies)d |
Enactment of treatment principlesd | Audio-recordings of a sample of patient sessionsd | 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 | Go: 100% of patients engaged with or used the recommended BCTs in the sample of audio-recorded sessions (data were suitable for analysis for four patients from four pharmacies)d |