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Table 2 Feasibility objectives, progression criteria, data collection methods, and outcomes reported

From: Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study

 

Feasibility objectives

Questions to be answered

Pre-specified progression criteria

Quantitative methods

Qualitative methods

Outcomes reported

1

Evaluation of recruitment and retention

Can we recruit and retain eligible patient participants in the questionnaire study?

 ≥ 20% of eligible patients consent to participate

 ≥ 70% of participants complete 3-month follow-up questionnaire

Study flow, self-reported participant questionnaires

 

Flowchart, recruitment and retention rates, participant characteristics

2

Evaluation of participant data collection

How appropriate are the data collection procedures to evaluate the intervention in the intended population?

N/A

Self-reported participant questionnaires, prescribing data from electronic primary care record

Semi-structured interviews with participants

• Completion rates/missing data

• Qualitative evaluation of data collection methods

3

Evaluation of intervention uptake

What proportion of those invited schedule and attend a PROMPPT review?

 > 50% of MOPP participants invited to attend at least one PROMPPT review consultation

Study flow

Semi-structured interviews with participants

• Rates of intervention uptake by eligible participants

• Qualitative evaluation of acceptability according to TFA domains

4

Evaluation of intervention acceptability and credibility

Is the intervention credible and acceptable to patient participants?

• Mean acceptability/credibility score ≥ 5

• Evidence from interviews about intervention acceptability

Acceptability questionnairea

Semi-structured interviews with participants

• Acceptability questionnaire scores

• Qualitative evaluation of acceptability according to TFA domains

5

Evaluation of the fidelity of intervention delivery

Do practice pharmacists deliver the intervention as the training intended?

N/A

Practice pharmacist-complete case report forms (CRFs)

• Audio-recorded consultations

• Semi-structured interviews

Delivery of key intervention components as per protocol

  1. aAcceptability questionnaire comprised of the theoretical framework of acceptability (TFA, items 1–8 scored on 0–5 scale) [25] and a modified acceptability and credibility measure (items 9–12, scored on 0–10 scale) derived from an existing measure [26]