Table 6.
Final decisions for each of the progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the S-MAP pilot 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 | |||
| 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 |
aThis includes aspects of the study/intervention that may be modified in advance of a larger definitive trial
bTo enable sufficient time to assess patient recruitment procedures the patient recruitment period may be extended up to a maximum of 12 months (post-training) if major ethics amendments are made during the pilot study
cThe alternative ‘rate-related’ criterion recognises that successful patient recruitment procedures may take some time to establish
dThe supporting data for this concept has not been reported in this paper—instead it will be reported as part of the process evaluation study paper