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Table 1 Feasibility question, outcome, method of collection, pre-specified criteria for success

From: Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy

Category

Feasibility research question

Outcome (method of collection)

Pre-specified criteria for success

Process

What is the recruitment, refusal, and drop-out rate of participants, pharmacists, and family physicians?

Number of clinicians and participants enrolled

Number of patient participants enrolled, not interested, and dropped out of study before 6-month period (master file)

50% of invited pharmacists and family physicians enrol

20% of invited patients enrol

Less than 20% enrolled patients withdraw

What are the challenges with determining to extent to which participants meet eligibility criteria?

Description (recruitment file, researcher call notes)

Ability to mitigate challenges that arise during recruitment and eligibility checking in larger trial

What is the nature of challenges in terms of participants’ understanding of, and ability to respond to, the surveys?

Description (field notes by research team)

Ability to mitigate challenges that arise during data collection appointments in larger trial

What is the number and nature of any instances of unblinding?

Description (field notes by the research team)

Less than 10 instances of unblinding; all instances can be mitigated in larger trial

Resources

What is the length of time to complete the surveys?

Duration of visits, number of participants needing multiple visits to complete collection for time point (program records)

Less than 50% of participants require more than 1 visit to complete data collection; less than 2 h required for data collection visits

How much travel time does the research team do to complete visits?

Estimated time (recruitment file)

Less than 50% of visits require ≥ 30 min of travel time

Management

What is the nature of data entry problems?

Description (field notes by research team)

Ability to mitigate common data entry errors (e.g., data missing at random, data syncing issues, problems with database) in larger trial

Scientific

What is the nature of any adverse events associated with the intervention or study process?

Number and description (field notes by research team, 1 week, 3- and 6-month check-in data collection forms)

No serious adverse events associated with the intervention or study process

What is the variance, potential floor and ceiling effects, for research outcomes?

Range of scores for each variable (according to survey)

No floor or ceiling effects detected; moderate to high levels of variance detected