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Table 1 Details of baseline and follow-up outcomes

From: Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial

 

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Call 1

Call 2

Call 3

Call 4–5

Timing Description

Week 0 Screening, Baseline and Randomisation

Quit date (QD) Endpoint

One month after QD Endpoint

Three months after QD Endpoint

Six and 12 months after QD Endpoint

Case Record Form (CRF)

CRF-A

CRF-B

CRF-R

C-QD

C-1

C-3

C-6, C-12

General data

 Eligibility criteria

X

      

 Consent

X

X

     

 Age, gender, ethnicity, education

 

X

     

 Height

 

X

     

 Weight

 

X

   

X

X

 Current medicationd

 

X

 

X

X

X

X

 Health state

 

X

   

X

X

 Alcohol and cannabis use

 

X

     

 Pregnancy

X

  

X

X

X

X

Smoking information

 Type of tobacco smoked

 

X

     

 Cigarettes smoked per dayb

 

X

 

X

X

X

X

 Age started

 

X

     

 Years smoked

 

X

     

 Time to first cigarette upon waking

 

X

     

 Household smoking

 

X

     

 Around others that use e-cigarettes

 

X

     

 Previous quit attempts and method

 

X

     

 Motivation to quit

 

X

     

 Nicotine withdrawal and urge to smoke

 

X

   

X

 

 Any smoking in last seven days

    

X

X

X

 Any smoking since Quit date

    

X

X

X

 Lapse and relapse back to smoking

    

X

X

X

 Biochemical verification in quitterse

      

X

Follow-up details

 Quit date verified

   

X

   

 Contact detailsf

  

X

X

X

X

X

 Treatment allocation

  

X

    

 Date products delivered

  

X

    

Use of other cessation methods

 Type of cessation method used

    

X

X

X

Other outcomes

 Acceptability

     

X

 

 Medication use and compliance

   

X

X

X

 

 Crossover

   

X

X

X

X

 Health-related quality of life

 

X

   

X

X

 Changes to e-cigarettea

   

X

X

X

X

 Dual use

    

X

X

X

 Continuation of allocated treatment

      

X

 Adverse eventsc

   

X

X

X

X

 Serious adverse eventsc

   

X

X

X

X

 Cost information

      

X

  1. QD Quit Date
  2. a In those allocated e-cigarettes
  3. b Or pack size, and how long each pack lasts, in people who smoke roll-your-own tobacco
  4. c Separate adverse event form completed
  5. d Separate medication form completed
  6. e A face-to-face meeting to verify quitting status at six months, in those that state they are smokefree
  7. f Separate contact detail form collected