Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Proportion of participants with verified continuous smoking abstinence |
Defined as self-report of smoking not more than five cigarettes from the Quit date (day 0) and confirmed by standardized exhaled carbon-monoxide (CO) measurement with a Bedfont Smokerlyzer, (=9 ppm signifying abstinence). Sensitivity analysis will be undertaken looking at different cut-offs for the CO measurement, given lack of consensus about the best reading to use. |
Six months post-quit date |
|
| Secondary |
Age |
Date of birth will be recorded to enable the age at baseline to be reported for each treatment group (presented as a mean, with the associated standard deviation) |
Assessed at baseline |
|
| Secondary |
Gender |
Gender will be reported as the proportion of male, female, and gender diverse at baseline, for each treatment group |
Assessed at baseline |
|
| Secondary |
Ethnicity (self-reported) |
Ethnicity will be reported as the proportion of Maori, Pacific or Other at baseline, for each treatment group. |
Assessed at baseline |
|
| Secondary |
Education |
Education level will be reported as the proportion of participants with "less than 12 years of schooling" or "equal or more than 12 years of schooling" or "refuse to answer" at baseline, for each treatment group. |
Assessed at baseline |
|
| Secondary |
Age started smoking |
The age participants started smoking will be reported, with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Number of years of continuous smoking |
Participant's will be asked how many years they have been smoking continuously, with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Type of cigarettes smoked |
Type of cigarettes smoked will be reported as the proportion smoking factory-made only, roll-your-own tobacco only or both at baseline, for each treatment group |
Assessed at baseline |
|
| Secondary |
Number of cigarettes smoked per day |
The number of cigarettes smoked per day will be asked, with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Mean pack size (Factory-made cigarettes) |
Participants who smoke factory-made cigarettes will be asked what pack size they normally purchase (e.g. Pack of 20) with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Median pack size (Factory-made cigarettes) |
Participants who smoke factory-made cigarettes will be asked what pack size they normally purchase (e.g. Pack of 20), with results presented as a median (with the associated interquartile range) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Mean pouch size (Roll your-own tobacco) |
Participants who smoke roll your-own tobacco will be asked what pouch size they normally purchase (e.g. Pack of 20) with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Median pouch size (Roll your-own tobacco) |
Participants who smoke roll your-own tobacco will be asked what pouch size they normally purchase (e.g. Pack of 20), with results presented as a median (with the associated interquartile range) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Time taken to smoke the contents of a pack or pouch |
Participants will be asked how many days it takes for them to smoke the contents of a pack or pouch, with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Level of cigarette dependence |
The level of cigarette dependence will be determined using the Heaviness of Smoking Index (HSI), which is a two-item measure based on: 1) the number of cigarettes smoked per day (cpd), categorized as: 10 or fewer cpd = 0 points; 11-20 cpd = 1 point; 21-30 cpd = 2 points; 31 cpd or more = 3 points), and 2) the time to first cigarette of the day, categorized as: within 5 minutes = 3 points, 6-30 minutes = 2 points; 31-60 minutes = 1 point; More than 60 minutes = 0 points. The HSI total score is calculated by summing these two items and has a range of 0 to 6, where higher scores indicate greater dependence. The proportion of participants with low cigarette dependence (total scores: 0-2), moderate cigarette dependence (total scores:3-4) and high cigarette dependence (total scores: 5-6) will be reported for each treatment group. |
Assessed at baseline |
|
| Secondary |
At least one quit attempt in the past 12 months |
The proportion of participants who report at least one quit attempt in the past 12 months, will be reported for each treatment group. |
Assessed at baseline |
|
| Secondary |
Time quit, for last quit attempt |
Of those who report at least one quit attempt in the past 12 months, the longest time participants managed to stop smoking for (in days) will be reported, with results presented as a median (with the associated interquartile range) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Methods used in previous quit attempt |
Of those who report at least one quit attempt in the past 12 months, the proportion reporting use of particular methods they used will be summarized for each treatment group. Methods will include nicotine patches, nicotine gum, nicotine lozenges, nicotine mouth spray, zyban (buproprion), nortriptyline (norpress), varenicline (champix), Quitline, community-based smoking cessation services, nicotine e-cigarette (vape), nicotine-free e-cigarette (vape), nothing, and other (free text option). |
Assessed at baseline |
|
| Secondary |
Reduction in the number of cigarettes smoked in the past 12 months |
The proportion of participants who have cut down on the number of cigarettes they smoked in the past 12 months will be reported as "Yes" or "No" for each treatment group. |
Assessed at baseline |
|
| Secondary |
Motivation to quit |
Motivation to quit in the next two weeks will be measured using a five point Likert Scale (where 1=not very motivated and 5=very motivated), with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Chances of giving up smoking |
Chances of giving up smoking for good this time, will be measured using a five point Likert Scale (where 1=extremely low and 5=extremely high), with results presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline |
|
| Secondary |
Living with other people who smoke tobacco |
The proportion of participants living with other people who smoke tobacco will be reported as "Yes", "No", or "Sometimes" for each treatment group |
Assessed at baseline |
|
| Secondary |
Living with other people who use nicotine e-cigarettes (vapes) |
The proportion of participants living with other people who use nicotine e-cigarettes (vapes) will be reported as "Yes", "No", or "Sometimes" for each treatment group. |
Assessed at baseline |
|
| Secondary |
Has close friends who use nicotine e-cigarettes (vapes) |
The proportion of participants living with close friends who use nicotine e-cigarettes (vapes) will be reported as "Yes" or "No" for each treatment group. |
Assessed at baseline |
|
| Secondary |
Alcohol use |
Alcohol use will be measured using the three item Alcohol Use Disorders Identification Test (AUDIT-C). Item 1 asks "How often have you had a drink containing alcohol in the past year" with options of: Never (score=0); Monthly or less (score=1); 2-4 times per month (score=2); 2-3 times per week (score=3); 4 or more times a week (score=4). Item 2 asks "How many drinks do you usually have if you are drinking" with options of: 1 or 2 (score=0); 3 or 4 (score=1); 5 or 6 (score=2); 7 to 9 (score=3); 10 or more (score=4). Item 3 asks "How often have you had six or more drinks on one occasion in the past year?" with options of: Never (score=0); Less than monthly (score=1); Monthly (score=2); Weekly (score=3); Daily or almost daily (score=4). A total score ranges from 0 to 12. Higher scores indicate greater risk of alcohol dependence. Results will be presented as a mean (with the associated standard deviation) for male, female and gender diverse for each treatment group. |
Assessed at baseline |
|
| Secondary |
Cannabis use |
Participants will be asked if they have used cannabis for recreational or non-medical purposes in the last 12 months, shown as the percentage reporting 'Yes' or 'No'. |
Assessed at baseline |
|
| Secondary |
Self-reported continuous smoking abstinence |
Defined as the proportion of participants who self-report smoking not more than five cigarettes, reported by treatment group |
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Self-reported 7-day point prevalence smoking abstinence |
Defined as the proportion of participants who self-report having smoked no cigarettes (not even a puff) in the past seven days, reported by treatment group |
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in the number of cigarettes smoked per day (if smoking) by participants |
Number of cigarettes smoked per day (if smoking) by participants, presented as summary statistics (mean, median, standard deviation, IQR) |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Reduction in smoking by participants |
Defined as reducing cigarette consumption by at least 25% in terms of numbers of cigarettes smoked per day |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Time to first lapse back to smoking by participants |
Defined as time to first cigarette smoked from the quit date, even a single puff |
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Time to first relapse back to smoking by participants |
Defined as time to smoking more than five cigarettes a day for three or more days in a row. |
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Proportion of participants who use other smoking cessation methods |
Participants will be asked about the use of NRT and other nicotine products, and non-NRT methods of cessation such as Zyban (buproprion), clonidine, nortriptyline, varenicline, acupuncture, Quitline etc. |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Health-related quality of life (five domains) |
Measured using the EQ-5D-5L - a standardized measure of health-related quality of life developed by the EuroQol Group. EQ-5D-5L is not an abbreviation. The EQ-5D-5L consists of five questions - each describe a different dimension of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems. moderate problems, severe problems, extreme problems (labelled 1-5). Answers will be valued (weighted to New Zealand population norms) and transformed into a utility score using a scoring algorithm, and presented as a mean (with the associated standard deviation) for each treatment group. |
Assessed at baseline, three, six and 12 months post-quit date |
|
| Secondary |
Health-related quality of life (self-rated health) |
The EQ-5D-5L also includes a visual analogue scale, where the respondent records their self-rated health on a 1-100 scale where the endpoints are labelled 'The best health you can imagine' (labelled 100) and 'The worst health you can imagine' (labelled 0). The EQ VAS score will be summarized using the mean (and the associated standard deviation) by treatment group. |
Assessed at baseline, three, six and 12 months post-quit date |
|
| Secondary |
Participant compliance with cytisine use |
Defined as having taken =80% of the required number of tablets over the three-month intervention period. |
Measured at three months post quit date. |
|
| Secondary |
Number of cytisine tablets taken by participants |
Based on number of pills remaining, to be reported for each cytisine treatment group (presented as a mean, with the associated standard deviation) |
Measured at one and three months post quit date. |
|
| Secondary |
Daily use of the allocated treatment by participants |
Proportion of participants who are currently using the allocated treatment (Yes/No), reported by treatment group |
Measured at quit date (day 0), then at one month post quit date. |
|
| Secondary |
Reasons for not using allocated treatment |
Proportion of participants who report any given reason for non-use of treatment, reported according to treatment group |
Measured at quit date (day 0), then at one month post quit date. |
|
| Secondary |
Frequency of use of the e-cigarette, by participants allocated e-cigarettes |
Participants allocated e-cigarettes will be asked how often they currently vape, with answer options of: not at all; daily; every couple of days; at least weekly; or other (free text option). The proportion of participants answering each option will reported according to each treatment group that received e-cigarettes. |
Measured at three months post quit date. |
|
| Secondary |
Number of nicotine pods used, by participants allocated e-cigarettes |
Based on number of pods remaining to be reported for each e-cigarette treatment group (presented as a mean, with the associated standard deviation) |
Measured at one and three months post quit date. |
|
| Secondary |
Signs and symptoms of nicotine withdrawal in participants |
Measured using the Mood and Physical Symptoms Scale (MPSS) which consists 5-point ratings of depressed mood, irritability, restlessness, hunger and difficulty concentrating. The MPSS score is calculated by summing all 5 items (scored 1-5: not at all, slightly, moderately, very, extremely) and has a range of 5 to 25, where higher scores indicate greater nicotine withdrawal. Scores will be presented as a mean with the associated standard deviation, for each treatment group. |
Measured at baseline and at three months (end of treatment). |
|
| Secondary |
Urge to smoke in participants |
Measured using a 6-point rating of time spent with an urge to smoke (scored 0-5: not at all, a little of the time, some of the time, a lot of the time, almost all of the time, all of the time), and the strength of these urges over the past week (scored 0-5: no urges, slight, moderate, strong, very strong, extremely strong). Participants who tick 'Not at all' for time spent with urges to smoke, then skip to the next section of questions and don't answer the question on strength of urges. For these participants the strength of urges is set at 0, therefore, this question will then have values 0 to 5. The urge score is calculated by summing the two urges questions and has a range 0 to 10, where higher scores indicate greater urge to smoke. Scores will be presented as a mean with the associated standard deviation, for each treatment group. |
Measured at baseline and at three months (end of treatment). |
|
| Secondary |
Treatment switching (crossover from cytisine-only to e-cigarette) |
Participants allocated cytisine only, will be asked if they accessed and used an e-cigarette during the trial, with results reported as the proportion at each time period. |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Treatment switching (crossover from cytisine-only to e-cigarette): nicotine content of e-cigarette |
Participants allocated cytisine only, who accessed and used an e-cigarette during the trial will be asked if the device had nicotine in it or not, with results reported as proportions at each time period |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Treatment switching (crossover from e-cigarette-only to cytisine) |
Participants allocated e-cigarettes only will be asked whether they accessed and used cytisine during the trial, with results reported as proportions at each time period. |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Treatment switching (crossover from e-cigarette-only to cytisine): source of cytisine |
Participants allocated e-cigarettes-only, who accessed (but were not allocated) cytisine, will be asked how they obtained the cytisine, with results reported as proportions for each stated option at each time period. |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change in e-cigarette use |
Participants allocated to the e-cigarette groups will be asked whether they changed the type of e-cigarette device and/or the nicotine strength and/or flavour they used in the e-cigarettes provided. If they did, they will be asked when they did this, and what the device type, nicotine strength and/or flavour was. |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Dual use of treatment and tobacco by participants |
Defined as daily use of both the allocated treatment and continued daily smoking of cigarettes. |
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Continuation of product use by participants |
Defined as continued use of the allocated treatment by participants after the end of the designed three-month treatment period. |
Measured at six (in all) and 12 months (in a subsample). |
|
| Secondary |
Acceptability of allocated product |
Participants will be asked for their views on the use of the allocated product as a cessation aid, that is what participants liked or disliked about using the product(s): Answers will be provided as free text. |
Measured at three months post-quit date (end of treatment) |
|
| Secondary |
Participants recommendations regarding the allocated product |
Participants will be asked if they would recommend the allocated treatment to another person who smoked but wanted to quit.(answer options of: Yes; No; Did not use product). |
Measured at three months post-quit date (end of treatment) |
|
| Secondary |
Number of participants with self-reported adverse events |
Participants will be asked about any new, unusual, unexpected health events during or since starting treatment, and whether they felt they were related to treatment. Serious adverse events will be classified as non-serious or serious (death, life threatening, hospitalization, persistent or sustained disability/incapacity, congenital abnormality/birth defect, significant medical event). The likelihood of causality will be assessed using the World Health Organization Standardized Case Causality Assessment Tool (certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable). |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Number of self-reported adverse events |
Participants will be asked about any new, unusual, unexpected health events during or since starting treatment, and whether they felt they were related to treatment. Serious adverse events will be classified as non-serious or serious (death, life threatening, hospitalization, persistent or sustained disability/incapacity, congenital abnormality/birth defect, significant medical event). The likelihood of causality will be assessed using the World Health Organization Standardized Case Causality Assessment Tool (certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable). |
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in body mass index |
Self-reported height (in cm) and weight (kg) will be measured at baseline and combined to determine baseline body mass index (kg/m2). Self-reported weight (kg) will be asked at three and six months to determine change in body mass index from baseline to three and six months in those participants that have quit smoking at these timepoints, compared to those that have not quit smoking. |
Asked at three and six months post-quit date |
|
| Secondary |
Change from baseline in frequency of shortness of breath in participants |
Self-reported frequency of shortness of breath will be measured at baseline (How often do you get short of breath? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Self-reported frequency of shortness of breath will be re-assessed at follow-up using the same criteria to determine change in frequency of shortness of breath from baseline to three and six months post quit (and at 12 months post-quit date in a subsample). |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in frequency of coughing in participants |
Self-reported frequency of coughing will be measured at baseline (How often do you cough? Response options are: Not at all; A little of the time; Some of the time; A lot of the time; All of the time). Self-reported frequency of coughing will be re-assessed at follow-up using the same criteria, to determine change in frequency of coughing from baseline to three and six months post quit (and at 12 months post-quit date in a subsample). |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in asthma severity, in those participants with asthma |
Participants will be asked at baseline if have have asthma (self-reported: Yes/No). Participants who report that they do have asthma will be asked at follow-up whether their asthma has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in severity of chronic pain, in those participants with chronic pain. |
Participants will be asked at baseline if have have chronic pain (self-reported: Yes/No). Participants who report that they do have chronic pain will be asked at follow-up whether their chronic pain has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in severity of Chronic Obstructive Pulmonary Disease (COPD), in those participants with COPD. |
Participants will be asked at baseline if have have COPD (self-reported: Yes/No). Participants who report that they do have COPD will be asked at follow-up whether their COPD has been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Change from baseline in severity of mental health concerns, in those participants with mental health concerns. |
Participants will be asked at baseline if they are currently receiving treatment for any mental health concerns (self-reported: depression; schizophrenia or related disorder; anxiety; another mental health concern ). Participants who report that they are currently receiving treatment for any mental health concerns will be asked at follow-up whether their mental health symptoms have been: much worse; a bit worse; about the same; a bit better; or much better since starting the study. |
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Concomitant medication |
Information about types of medication currently used |
Assessed at baseline, quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample) |
|
| Secondary |
Mean number of text-based behavioral support messages received by participants |
Number of text-based behavioral support messages received by participants during the six months, reported as a mean, with associated standard deviation |
Assessed at six months |
|
| Secondary |
Median number of text-based behavioral support messages received by participants |
Number of text-based behavioral support messages received by participants during the six months, reported as a median, with associated interquartile range |
Assessed at six months |
|
| Secondary |
Marginal cost per quitter |
If combination treatment is better than monotherapy, a cost-effectiveness analysis will be undertaken. The total number of cigarettes smoked between quit date (QD) and 6-month follow-up (FU) will be multiplied by the mean cigarette cost. The total number of cytisine tablets used by participants between QD and 6-month FU will be multiplied by the tablet cost. The total number of e-cigarette pods used by participants between QD and 6-month FU will be multiplied by the pod cost. The total cost will be the sum of the above. The cost-per-quitter will be the total cost by quit status (using self-reported continuous smoking abstinence). The incremental cost-effectiveness ratio will be the total cost and quitting status. The cost-per-person reducing their daily cigarette consumption will be assessed by crossing the total cost by a binary variable created for the reduction of at least 25% in the number of cigarettes smoked per day between QD and 6-month FU. |
Assessed at six months |
|
