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Table 6 Final decisions for each of the progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the S-MAP pilot study

From: A non-randomised pilot study of the Solutions for Medication Adherence Problems (S-MAP) intervention in community pharmacies to support older adults adhere to multiple medications

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
  1. aThis includes aspects of the study/intervention that may be modified in advance of a larger definitive trial
  2. 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
  3. cThe alternative ‘rate-related’ criterion recognises that successful patient recruitment procedures may take some time to establish
  4. 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