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Table 3 Key feasibility outcomes and the associated progression criteria

From: Cytisine compared to combination nicotine replacement therapy to reduce cigarette consumption in relapsed smokers: protocol for a pilot randomized controlled trial

 

Go

Amend

Stop

Recruitment

 1. Screened/month

10 or more

5 to 9

4 or fewer

 2. Recruited/month

7 or more

4 to 6

3 or fewer

 3. % recruited of screened

70% or more

31% to 69%

Less than 30%

Engagement

 4. Research visit (2 of 2)

70% or more

31% to 69%

Less than 30%

 5. Nurse counselling visit (at least 3 of 4 attended)

70% or more

31% to 69%

Less than 30%

Adherence

 6. Adherence to drug allocation assignment

80% or more

50% to 79%

Less than 50%

 7. Adherence to cytisine taper

80% or more

50% to 79%

Less than 50%

 8. Study surveys completed

80% or more

50% to 79%

Less than 50%

 9. Log if cigarette use

80% or more

50% to 79%

Less than 50%

 10. Biochemical verification of smoking status

80% or more

50% to 79%

Less than 50%

Retention

 11. Loss to follow up

Less than 20%

20% to 50%

More than 50%

Intervention Assessment

 12. Feasibility of nurse counselling visit (at least 3 visits offered)

70% or more

31% to 69%

Less than 30%

  1. • 9 or more (75% +) “Go”—minor revisions prior to proceeding
  2. • 6 to 8 (50–75%) “Go”—major revisions prior to proceeding
  3. • 5 or fewer (Less than 50%) “Go”—stop proceeding