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Table 9 Final decisions for each progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the PolyPrime study

From: An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

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

GP practice recruitment

Recruitment records held by research nurse(s)

If ≤ 5 GP practices are recruited within 8 months

If 6–9 GP practices are recruited and/or it takes longer than predicted (6–8 months)

If ≥ 10 GP practices are recruited to take part in ≤ 6 months

Go: 12 GP practices were recruited within 6 months

GP practice retention

Retention records held by research nurse(s)

If ≤ 5 GP practices are retained for the required period

If 6–9 GP practices can be retained for the required period

If ≥ 10 GP practices can be retained for the required period

Amend: 9 GP practices were retained until the end of the study period

Patient recruitment

Recruitment records held by Research Fellow/Assistant

If ≤ 59 patients are recruited within 5 monthsb

If 60–95 patients are recruited within 5 monthsb

If ≥ 96 patients are recruited within 5 monthsb

Amend: 68 patients were recruited within 4 monthsc

Patient retention

Retention records held by Research Fellow/Assistant

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: 69.1% (47 of 68) of patients were retained in the study (i.e. had GP record data available for primary outcome analysis)

Completeness of outcome data

Data collected during the study (CRFs, questionnaires)

If ≤ 49% of each patient self-repor, and GP-reported outcome measure is complete

If 50–79% of each patient self-report and GP-reported outcome measure is complete

If ≥ 80% of each patient self-report and GP-reported outcome measure is complete

Go: 93.9% of primary and secondary outcome data were complete (see Additional file 2)

  1. aThis includes aspects of study and/or data collection procedures that may be modified in advance of a full-scale definitive cRCT
  2. bNote that if ethics amendments are made to study recruitment procedures during this time period, the 5-month recruitment period may be extended (up to 8 months) to enable sufficient time to assess patient recruitment rates
  3. cPatient recruitment underway from the end of January 2020 to mid-March 2020; paused from mid-March to mid-September 2020; recruitment underway again from mid-September 2020 to mid-November 2020, i.e. approximately 4 months. Recruitment was stopped in mid-November 2020 to allow for sufficient time to undertake follow-up