Intervention Review

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Interventions for smoking cessation in Indigenous populations

  1. Kristin V Carson1,*,
  2. Malcolm P Brinn1,
  3. Matthew Peters2,
  4. Antony Veale3,
  5. Adrian J Esterman4,
  6. Brian J Smith5

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 18 JAN 2012

Assessed as up-to-date: 12 MAY 2011

DOI: 10.1002/14651858.CD009046.pub2


How to Cite

Carson KV, Brinn MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in Indigenous populations. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD009046. DOI: 10.1002/14651858.CD009046.pub2.

Author Information

  1. 1

    The Queen Elizabeth Hospital, Clinical Practice Unit, Adelaide, South Australia, Australia

  2. 2

    The University of Sydney, Medicine, Concord Clinical School, Sydney, NSW, Australia

  3. 3

    The Queen Elizabeth Hospital, Respiratory Medicine, Adelaide, South Australia, Australia

  4. 4

    University of South Australia, Adelaide, South Australia, Australia

  5. 5

    The Queen Elizabeth Hospital, Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia

*Kristin V Carson, Clinical Practice Unit, The Queen Elizabeth Hospital, 4A Main Building, 28 Woodville Road Woodville South, Adelaide, South Australia, 5011, Australia. kristin.carson@health.sa.gov.au.

Publication History

  1. Publication Status: New
  2. Published Online: 18 JAN 2012

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Characteristics of included studies [ordered by study ID]
Bramley 2005a

MethodsCountry: New Zealand

Design: Randomised Controlled Trial

Objective/s: To determine whether a smoking cessation service using mobile phone text messaging is as effective for Māori as non-Māori

Study Site: Done remotely via phone (not location dependent)

Programme name: STOMP study (STOp smoking by Mobile Phone)

Methods of analysis: Chi-squared analyses compared proportion quit by treatment group with estimation of relative risk, 95% confidence intervals and two-sided p values; Fagerström and number of cigarettes smoked compared with analysis of covariance; Logistic regression used for baseline effect modifiers and confounders; Participants without follow-up data were assumed smoking in the primary analysis

Cluster adjustment made: None reported though not necessary for this study as subjects are not clustered within a specific location


ParticipantsEligible for study (n-value): n=1705 overall population including Non-Māori

Recruited: n=176 for intervention and n=179 for control

Completed: 6 weeks n=160 for intervention and n=168 for control; 26 weeks n=80 for intervention and n=112 for control

Age: Median (IQR - Inter-Quartile Range): Intervention 24 (19-33); Control 25 (20-32)

Gender: Female: Intervention n=132 (75%); Control n=131 (73.2%)

Ethnicity: Māori

Socio-economic status: Income level <$15,000: Intervention n=43 (24.4%); Control n=37 (20.7%); $15-30,000: Intervention n=83 (47.2); Control n=78 (43.6%); >$30,000: Intervention n=49 (27.8%); Control n=63 (35.2%); Did not answer: Intervention n=1 (0.6%); Control n=1 (0.6%)

Recruitment means: Māori radio station advertising, mailing lists to Māori students attending tertiary institutions, advertisements in a Māori student magazine, hospital staff e-mail lists, faxes to Māori health providers, via Māori smoke-free networks and providers; Non-targeted advertising included newspapers, web-sites, magazines and Quitline


InterventionsTheoretical basis: No specific theoretical basis mentioned however text messaging as a new communications medium is being used

Intervention description/s: Smoking cessation service using mobile phone text messaging; Regular, personalised text messages providing smoking cessation advice, support and distraction; Included a database of over 1000 text messages with a list of approximately 140 developed by Māori researchers related to the Māori language and included general support messages and information on Māori customs and traditions to produce an individualised program; A quit day was negotiated and five text messages were sent per day for the week leading up to the quit day in addition to the four weeks following; On the quit day free outgoing text messages also began as a means of distraction and communicating the need for support; Six weeks after randomisation (and coinciding with the end of the free text month) the intervention became less intensive with the number of messages reduced from five a day to three a week until the 26 week period

Control description/s: No smoking-related information though they received one text message per fortnight reminding them to complete follow-up; If follow-up was complete they were rewarded with a free month of text messaging; No restrictions were placed on other smoking cessation strategies by trial participants (i.e. additional mobile phone based services may have existed)

Duration of intervention: 26 weeks (6 months)

Intervention delivered by: Telecommunications (Vodafone customers only)


OutcomesMethod of outcome collection: Baseline and follow-up data collected by mobile phone or text messaging

Pre-specified outcome data: Prevalence of current non-smoking 6 weeks post-randomisation; secondary outcomes included self-reported non-smoking at 12 and 26 weeks

Validation: In a sub-set – Salivary cotinine

Follow-up period: Six months

Number of follow-up periods reported: Three - 6, 12 and 26 weeks

Process measures: None reported, however because each patient received the text message directly to their mobile the implementation level would be close to 100% providing the text messages were received


NotesDefinition of point prevalence: Not smoking in the past week


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentral telephone randomisation algorithm used

Allocation concealment (selection bias)Low riskCentral telephone randomisation with sequence concealment until intervention was assigned

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded to the intervention

Blinding of outcome assessment (detection bias)
All outcomes
Low riskFollow-up phone calls were made by staff who were unaware of the treatment allocation

Incomplete outcome data (attrition bias)
All outcomes
Low riskPatients with missing outcome data were assumed to be smoking; Sensitivity analyses performed to assess impact of missing data; 45% attrition in the intervention group compared to 31% for the control

Selective reporting (reporting bias)Low riskNo selective reporting identified; Authors state that data were analysed following a pre-specified analysis plan

Imbalance of outcome measures at baselineLow riskAnalysis of covariance occurred

Comparanility of intervention and control group characteristics at baselineLow riskBaseline characteristics reported and similar for all groups – age, gender, income level and smoking dependence/history

Protection against contaminationUnclear riskAuthors mention no restrictions were placed on the use of other smoking cessation strategies i.e. trial tested the addition of mobile phone-based services to existing practice but no further information provided

Selective recruitment of participantsLow riskn-values and methods of recruitment described and similar across groups

Other biasHigh riskIncentive of one month free text messaging not offered to the intervention population; authors state some control’s may have thought their free text month was dependant on reporting quitting and may have affected the result in favour of control

Holt 2005

MethodsCountry: New Zealand

Design: Randomised controlled trial; double blind, parallel group study

Objective/s: To determine the effectiveness of bupropion for smoking cessation in Māori

Study Site: Wellington and Kapiti regions in New Zealand – single centre study

Programme name: Not provided

Methods of analysis: For the primary analysis comparisons of smoking status occurred through normal approximation to the binomial distribution and expressed as differences in proportions and risk ratios; Secondary analysis used generalised estimating equations by treatment status and time of observation using an exchangeable correlation structure to model the repeated measures; Adverse effects were calculated using the total number of subjects allocated to a particular intervention as the denominator to calculate proportions, expressed as risk ratios and confidence intervals; Exploratory analysis also occurred with a break point at 26 weeks

Cluster adjustment made: Not applicable


ParticipantsEligible for study (n-value): n=300 attended public information meeting

Recruited: 2:1 randomisation occurred (two to bupropion: one to placebo); n=88 intervention; n=46 control

Completed: n=56 intervention; n=22

Age: Mean (SD) years; Intervention: 41.7 (9.2); Control: 38.0 (11.1)

Gender: Women/total; Intervention: n=61/88; Control: n=35/46

Ethnicity: Māori

Socio-economic status: Not provided

Recruitment means: Self-recruited from advertising in local media and actively recruited from Māori health networks


InterventionsTheoretical basis: Cultural safety, reducing barriers and encouraging access through community based clinics with key involvement of Māori health providers

Intervention description/s: Bupropion (Zyban) 150mg once daily for 3 days, then 150 mg twice daily for 7 weeks; oral course; Participants received motivational telephone calls 1 day before and 3-days after the target quit date; Follow-up visits for counselling and data collection scheduled for 3 weeks, 7 weeks, 3 months, 6 months and 12 months after the target quit date; Counselling topics tailored to individual participants and included support and advice on motivation to quit, identification of smoking triggers, diet, exercise and role of family, friends, and work colleagues

Control description/s: Matching placebo control plus identical counselling and follow-up schedule as the intervention

Duration of intervention: 7 week course of bupropion/placebo and eight scheduled counselling sessions

Intervention delivered by: A Māori research nurse was employed to undertake this study


OutcomesMethod of outcome collection: Telephone calls 1 day before and 3 days after target quit date and scheduled clinic visits for 3 weeks, 7 weeks, 3 months, 6 months, 9 months and 12 months

Pre-specified outcome data: Continued abstinence from smoking at 3 and 12 months; continued abstinence from smoking at other time points and adverse events

Validation: Exhaled carbon monoxide (Smoke Check, Micro Medical)

Follow-up period: Twelve months

Number of follow-up periods reported: Six: primary: 3- and 12 months; secondary: 3 weeks, 7 weeks, 6 months and 9 months

Process measures: n= 32 subjects lost to follow up by 12 months in the intervention arm and n=24 subjects in the control arm; n=3 subjects in the intervention arm stopped taking the medication due to a rash; No further information provided


NotesDefinition of continuous abstinence: No cigarettes from the quit data and confirmed with a negative exhaled carbon monoxide measure at each of the clinic visits


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated code

Allocation concealment (selection bias)Unclear riskAuthors state a “…blinded medication pack was dispensed…” no other information provided

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding occurred; authors state participants were not aware which treatment had been allocated

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAuthors state trial was double-blinded; study team were not aware which treatment had been allocated

Incomplete outcome data (attrition bias)
All outcomes
Low riskSubjects lost to follow up were assumed smoking

Selective reporting (reporting bias)Low riskNo selective reporting identified

Imbalance of outcome measures at baselineLow riskNo baseline imbalances were identified

Comparanility of intervention and control group characteristics at baselineLow riskBaseline characteristics for all groups were similar and reported

Protection against contaminationLow riskUnlikely that the control group received the intervention

Selective recruitment of participantsLow riskMethods of recruitment similar however recruitment occurred on a 2:1 ratio for intervention and control respectively

Other biasHigh riskTarget pre-specified population n-value of n=141 participants were not collected due to lack of eligible subjects; Concerns over generalisability of results – population self-selected so were also highly motivated

Ivers 2003

MethodsCountry: Australia

Design: Controlled clinical trial; pre/post design; cluster

Objective/s: The first aim of this study was to assess the patterns of use of free nicotine patches when offered to Indigenous people with a brief intervention for smoking cessation. The second aim was to assess changes in smoking behaviour and attitudes six months after access to free nicotine patches and/or a brief intervention for smoking cessation

Study Site: Participating health clinics

Programme name: Not specified

Methods of analysis: Not described; However author’s state that ‘As a results of self-selection, the treatment groups differed on many baseline parameters… and this precludes any direct comparison of the impact of NRT and brief intervention on smoking behaviour and attitudes.”

Cluster adjustment made: No


ParticipantsEligible for study (n-value): n=130 interviewed at baseline

Recruited: Intervention n=40; Control n=71

Completed: Intervention n=34; Control n=59

Age: 30 years or under: Intervention n=13, Control n=43; Over 30 years of age: Intervention n=27, Control n=28

Gender: Intervention: female n=24, male n=16; Control: female n=27, male n=44

Ethnicity: Indigenous Australian Aboriginals

Socio-economic status: Not specified

Recruitment means: Participants were recruited from a consecutive sample of self-identified Indigenous smokers presenting to participating health centres. The sample included some smokers nominated by a health professional


InterventionsTheoretical basis: Brief intervention and advice on cessation plus nicotine patches to assist smoking cessation; no other information provided; Transtheoretical model (stages of change) discussed

Intervention description/s: Brief intervention for smoking cessation plus six weeks of 21mg nicotine patches, two weeks of 14 mg patches and two weeks of 7 mg patches (total 10 weeks of treatment; patches were to be worn for 24 hours); The brief intervention consisted of: advice on quitting, counselling on cessation, shown a flip-chart about tobacco and provided a pamphlet

Control description/s: Brief intervention only as described above (no patches)

Duration of intervention: 10 weeks in total for course of nicotine patches; approximately five minutes in total for brief intervention

Intervention delivered by: The researcher and a local research assistant explained the study, administered the questionnaire and provided brief interventions for smoking cessation


OutcomesMethod of outcome collection: Verbal questionnaire administered by researcher and local research assistant

Pre-specified outcome data: Number of patches used, changes in smoking behaviour (point prevalence), carbon monoxide breath test, attitudes to smoking, side effects experienced and barriers to using nicotine patches

Validation: Carbon monoxide (CO) breath test

Follow-up period: Six months

Number of follow-up periods reported: One

Process measures: No participant completed a full course of patches; the mean number of patches used, as reported by participants was five patches (range 0-49 patches); Only six people said that they had used more than seven patches, that is, 10% of the suggested course of treatment


NotesDefinition of smoking abstinence: Author did not define

Other notes: Two of the subjects claiming abstinence in the intervention arm had elevated CO levels (10ppm) and as such were removed from analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskSubjects self-selected

Allocation concealment (selection bias)High riskNo allocation concealment occurred

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding of subjects occurred

 

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo mention of blinding for outcome assessors

Incomplete outcome data (attrition bias)
All outcomes
Low riskIncomplete outcome data accounted for within text; all subjects lost to follow-up were assumed smoking

Selective reporting (reporting bias)Low riskNo selective outcome reporting identified

Imbalance of outcome measures at baselineHigh riskStatistically significant differences between intervention and control participants identified at baseline; Statistical analysis not described

Comparanility of intervention and control group characteristics at baselineHigh riskStatistically significant differences between intervention and control participants identified at baseline; Statistical analysis not described

Protection against contaminationLow riskAuthor’s state only “One participant in the brief intervention only group had used patches…”

Selective recruitment of participantsHigh riskSubjects self-selected to intervention and control groups

Other biasHigh riskNo adjustments made for potential clustering effects for the three communities; No subjects completed a full course of patches with the mean number used being five (out of a potential 70 for a full course); Validation of smoking not possible in 18% of intervention subjects and 20% of control subjects

Johnson 1997

MethodsCountry: United States of America

Design: Controlled clinical trial; nested; cluster

Objective/s: Assessment of feasibility and effectiveness in the delivery of a smoking cessation intervention through health clinics, serving to urban American Indians. A primary study goal was the implementation of a culturally appropriate adaptation to the Doctors Helping Smokers (DHS) model

Study Site: Four urban Indian health clinics; Seattle Indian Board and Indian Health Board of Minneapolis were the intervention sites and Spokane Urban Indian and Community Health Services and the Milwaukee Indian Health Centres were the comparison sites

Programme name: GAINS (Give American Indians No-smoking Strategies)

Methods of analysis: Pearson's chi-square test used to compare proportions of variations between conditions; Student's t-test used to compare group means of continuous variables; baseline differences adjusted for using ANCOVA; Adjusted least-square means reported for comparison of smoking outcomes at follow-up

Cluster adjustment made: No


ParticipantsEligible for study (n-value): All subjects presenting for medical appointments were screened for eligibility; No n-values were provided

Recruited: n=601 total

Completed: n=476 total; Retention rates at follow-up ? Intervention Seattle 69.3%, Minneapolis 83.6%; Control Milwaukee 78.3%, Spokane 85.7%

Age: Mean: Intervention 35 years, Control 36.3 years

Gender: Percent female: Intervention 67.9%, Control 59.5% (p=0.030)

Ethnicity: American Indian

Socio-economic status: Education (Intervention % vs. Control %): Junior high school or less 6% vs. 7.7%, Some high school 28.4% vs. 29.2%, High school graduate 30.1% vs. 31.2%, Some tech school/tech school graduate 12% vs. 8.4%, Some college 21.4% vs. 20.8%, College graduate 2% vs. 2.7%; Current employment status (Intervention % vs. Control %): Working full-time 19.6% vs. 31.2%, Working part-time 15.4% vs. 12%, Self-employed 1.5% vs. 3.8%, Unemployed for over 1 year 11.3% vs. 10.9%, Unemployed for under 1 year 22.2% vs. 20.7%, Homemaker 22.2% vs. 12%, Student 6% vs. 5.3%, Retired 1.9% vs. 4.1%

Recruitment means: Urban Indian health clinics


InterventionsTheoretical basis: Not specified

Intervention description/s: Training provided on the Doctors Helping Smokers (DHS) protocol. Two day training sessions were conducted with medical and laboratory staff in each intervention site prior to enrolment; Key personnel were provided with additional instructions on intervention techniques and enrolment procedures; The five major principles of DHS included: screening patient smoking status and labelling charts, use of a smoke card as a reminder to providers, clinical message-giving to discuss smoking cessation, supportive reinforcement by clinic staff, monitoring of quit progress; In addition clinic outreach workers provided counselling in-clinic and supportive telephone calls for smokers attempting cessation

Control description/s: Training in control sites were focused on instructions for screening techniques of patients and record keeping; No smoking cessation training was offered in the comparison sites however they did receive smoking cessation material for distribution to patients

Duration of intervention: Not specifically stated though intervention delivered during doctor consult

Intervention delivered by: Doctors of the health clinics and supportive reinforcement of clinic staff


OutcomesMethod of outcome collection: 20-minute interview administered by trained clinic personnel

Pre-specified outcome data: Smoking history, smoking-related knowledge and behaviours, quit intentions, alcohol use, demographics, height, weight, blood pressure, waist and hip circumference, total cholesterol and fibrinogen

Validation: Saliva cotinine analysis

Follow-up period: Twelve months

Number of follow-up periods reported: One

Process measures: Higher proportion of intervention subjects reported attending zero clinic visits during the study period (Seattle 24% and Minneapolis 18.9% vs. Milwaukee 27.5% and Spokane 23.2%); Receipt of study material higher in the intervention sites with more seeing study posters in the clinic (94.5% vs. 85.6%), received study brochures (80.7% vs. 49.7%), received self-help guide (52.8% vs. 23.9%), received phone calls from staff regarding cessation (47.1% vs. 9.4%)


NotesDefinition of smoking abstinence: Smoked even a puff of a cigarette in the past 7-days

Other notes: $25 cash incentive provided following completion of the questionnaire


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskNo randomisation occurred, sites were selected

Allocation concealment (selection bias)High riskAllocation was not concealed they were “selected according to geographic location, tribal diversity of the patient population, availability of in-house primary care providers, and patient utilisation rates.”

Blinding of participants and personnel (performance bias)
All outcomes
High riskDue to the nature of the intervention it is not possible to blind participants

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo mention of attempted blinding of outcome assessors

Incomplete outcome data (attrition bias)
All outcomes
High riskResponse rates were significantly lower in Seattle (p=0.002) resulting in a higher proportion of assumed-to-be-smokers as a result

Selective reporting (reporting bias)Low riskNo selective reporting identified

Imbalance of outcome measures at baselineLow riskSignificant baseline differences were controlled as covariates in ANCOVA models including number of cigarettes smoked per day

Comparanility of intervention and control group characteristics at baselineLow riskSignificant baseline differences were controlled as covariates in ANCOVA models including gender, employment status and number of clinic visits

Protection against contaminationLow riskUnlikely that the control group received the intervention

Selective recruitment of participantsUnclear riskInsufficient information to permit judgement of yes or no

Other biasHigh riskPre-specified study design was not possible due to limitations in funding (from 14 sites to 4 sites in total); some concerns over comparability of sites due to tribal variations attending each site

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Boles 2009Control group not an Indigenous population; Follow-up period <6 months (3 months in total)

Boyle 2010No baseline data or smoking related outcomes reported

DiGiacomo 2007No control group

Eichner 2010Intervention not specifically aimed at smoking cessation; No smoking cessation related intervention occurred

Fu 2010No control group

Geishirt 2005No baseline data reported

Glasgow 1995Unit of analysis is tribe whilst survey is conducted on tribal leaders only; No smoking related outcomes reported

Glover 2005No control group; Follow-up period <6 months (4 months in total)

Gould 2009No control group

Graham 2008Not specifically targeted at Indigenous communities; Insufficient numbers of Indigenous participants for inclusion

Grigg 2008No control group

GrothMarnat 1996No control group

Hayward 2007No control group

Hensel 1995No control group

Hiscock 2009No control group; No baseline data reported

Hodge 1995No control group

Horn 2005Follow-up period <6 months (3 months in total)

Ivers 2005No control group

Ivers 2006No control group for comparison of survey data, only comparison through tobacco vendors

Laugesen 2000No baseline data collected

Lichtenstein 1995No smoking related outcome data reported

Panaretto 2009No control group

Panaretto 2010No control group

Patten 2010Follow-up period <6 months (108 days in total)

Whittaker 2011Results not reported separately for the Indigenous population

 
Characteristics of ongoing studies [ordered by study ID]
Atkinson 2008

Trial name or titleBOABS Study (Be Our Ally Beat Smoking)

MethodsCountry: Australia

Design: Randomised Controlled Trial; Block stratification by study site

Objective/Aim: Prevention

Study site: Patients visiting primary health care services

Other: Sequence generation through Computer-generated randomization table created by computer software; Allocation concealment through research assistant at the trial site required to contact the central administration site, which holds the allocation schedule. They will then allocate subjects to intervention or control group based on the computer-generated randomization schedule

ParticipantsTarget sample size: n=360

Age: 16 years minimum

Gender: Both males and females

Ethnicity: Aboriginal and/or Torres Strait Islander

Inclusion/exclusion criteria: Inclusion criteria: Current smoker, Aboriginal/Torres Strait Islander, regular client of the health service, considering quitting smoking soon (within the next 30 days); Exclusion criteria: Unable to provide informed consent, health condition that would prohibit completion of trial, unlikely to be available for follow up at 12 months

InterventionsIntervention description: Multi-dimensional smoking cessation intervention; Individualised smoking cessation plan including regular personal contact and counselling (approximately 12-14 individual sessions per subject); In addition, monthly group sessions and support to assist access to existing smoking cessation, health and other services will also be offered

Control description: Best practice regional clinic based smoking cessation program based on the Kimberley Smoking Cessation Protocol

Duration of intervention: 12 months

OutcomesPre-specified outcomes in protocol: 12 month smoking abstinence by urine cotinine levels and self-report; self-report for proportion of subjects reporting reductions in number of cigarettes smoked each week; self-report using health questionnaire of subject health status

Validation: Urinary cotinine levels

Follow-up period: 12 months

Number of intended follow-up periods: Two, 6- and 12 months

Other: Blinding of outcome assessors to occur

Starting date08/12/2008

Contact informationPrimary contact: Dr David Atkinson; PO BOX 1377, Broome, WA 6725, Australia; TEL: +61 8 91936043; FAX: +61 8 91922500; david.atkinson@uwa.edu.au

Secondary contact: Dr Julia Marley; PO BOX 1377, Broome, WA 6725, Australia; TEL: +61 8 91936043; FAX: +61 8 91922500; julia.marley@uwa.edu.au

Notes

Choi 2010

Trial name or titleANBL (All Nations Breath of Life)

MethodsCountry: United States of America

Design: Randomized controlled trial

Objective/Aim: To examine the efficacy of a culturally-tailored smoking cessation program for American Indian/Native Alaskan

Study site: Two sites in the Midwest (Kansas and Oklahoma)

ParticipantsTarget sample size: n=448 smokers with n=28 groups per site, containing n=8 smokers per group

Age: 18-years and older

Gender: Both

Ethnicity: American Indian and Native Alaskan

Inclusion/exclusion criteria: Inclusion criteria: Age 18 years and older, have a home address and telephone number, willing to participate in all study components, willing to be followed for 6 months, smoked at least 100 cigarettes in their lifetime, current smoker, American Indian or Native Alaskan; Exclusion criteria: Planning to leave the state within next 24 months, pregnant or breast feeding or planning to become pregnant in the next 4 months, medically ineligible after screening

InterventionsIntervention description: All subjects will be offered pharmacotherapy (e.g. varenicline, bupropion or nicotine replacement therapy) plus the culturally-tailored ANBL program; The ANBL program consists of in-person group sessions and individual telephone calls

Control description: All subjects will be offered pharmacotherapy (e.g. varenicline, bupropion or nicotine replacement therapy) plus a non-tailored accompanying program with targeted counselling delivered by non-American Indian counsellors

Duration of intervention: Not specified

OutcomesPre-specified outcomes in protocol: Smoking status and continuous abstinence, number of quit attempts, utilisation of smoking cessation pharmacotherapy, number of cigarettes smoked

Validation: None reported

Follow-up period: 12 months

Number of intended follow-up periods: Two, 6- and 12 months

Starting dateSeptember 2010

Contact informationDr Won Choi, wchoi@kumc.edu , University of Kansas Medical Centre, Kansas City, Kansas, United States, 66160, TEL: 913-588-4742

Notes

Eades 2009

Trial name or titleNot specified

MethodsCountry: Australia

Design: Randomized controlled trial

Objective/Aim: To test the effect of a multifaceted high intensity intervention that is culturally specific and incorporates advice, support and nicotine replacement therapy for smoking cessation in pregnant Indigenous women; This intervention is designed to improve the extent to which staff in Indigenous primary health care clinics are able to support pregnant women who are smokers to quit during their pregnancy

Study site: Clinics for pregnant women, actual setting not described; Controls seen in usual general practitioner clinical health care setting

Other: No blinding intended

ParticipantsTarget sample size: n=270

Age: 16-50 years

Gender: Females only

Ethnicity: Aboriginal Australians

Inclusion/exclusion criteria: Inclusion criteria: Pregnant women attending antenatal care before 20 weeks' gestation; Exclusion criteria: Major mental illness or chemical dependency other than tobacco or alcohol

InterventionsIntervention description: Multifaceted tailored intervention which includes culturally specific advice and support for Indigenous women; Evidence based communication and nicotine replacement therapy will be used after 2 failed quit attempts (smokers < 25 cigarettes per day can use 2mg gum up to 24 times per day; smokers >25 cigarettes per day can use 4mg gum up to 24 times per day); The gum is prescribed as needed for up to 12 weeks

Control description: Usual clinical care with brief general practitioner as well as clinic health care provider quit advice

Duration of intervention: Minimum of 2 visits at the clinic, within 5- and 14 days following the visit at which the subject agrees to quit smoking; Specific duration of advice and support services not described; nicotine replacement therapy prescribed for up to 12 weeks

OutcomesPre-specified outcomes in protocol: Self-reported and cotinine validated smoking cessation

Validation: Cotinine validation

Follow-up period: Baseline recruit must be before 20 weeks gestation; Follow-up between 36 to 40 weeks gestation and 6 months post-partum

Number of intended follow-up periods: Two, 36 to 40 weeks gestation and 6 months post-partum

Starting date01/11/2005; Follow up completed

Contact informationProfessor Sandra Eades; Baker IDI Heart and Diabetes Institute, 75 Commercial Road, Melbourne, Victoria 2004, Australia; TEL: +61 3 8532 1535; FAX: +61 3 8532 1100; sandra.eades@bakeridi.edu.au

Notes

Johnston 2010a

Trial name or titleNot specified

MethodsCountry: Australia and New Zealand

Design: Randomized controlled trial; Stratification using permuted blocks by country and infant age

Objective/Aim: To reduce respiratory illness in Indigenous infants

Study site: Darwin City and the Greater Darwin area in the Northern Territory, Australia and within the Counties Manukau District Health Board region, Manukau City, New Zealand; Indigenous families residing in these two geographical areas were recruited with Indigenous newborn infants as the sampling units

Other: Allocation concealment will occur using central randomization through a computer with potential participants assigned a unique registration number allocated by a central computer following details submitted on a web-based form; The number will be used to identify each randomized participant once consent is obtained thus permitting blinding of people assessing the outcomes and analysing the results/data; Sequence generation will occur by computer, stratified for country

ParticipantsTarget sample size: n=420

Age: For mothers/caregivers 16 years or older

Gender: Mothers/caregivers of infants

Ethnicity: Aboriginal Australians, Māori

Inclusion/exclusion criteria: Inclusion criteria for mother/caregiver: Indigenous (defined by maternal self-identification), 16 years or older, currently smokes or infant lives in a household with at least one other person smokes (defined as smoking at least weekly), plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, New Zealand, signed written consent to participate received, English or Māori speaking

InterventionsIntervention description: Family-centred tobacco control program aimed at providing education about the health effects of Environmental Tobacco Smoke (ETS) and behavioural ‘coaching’ techniques to help mothers reduce the infant’s exposure to ETS and identify mothers and other household members motivation to quit smoking and deliver culturally appropriate smoking cessation counselling and treatment options (e.g. nicotine replacement therapy) as required

Control description: Usual care through community health providers including routine visits to maternal and child health providers; checking of developmental progress and well being of the infant; mothers receive messages about smoking cessation and ETS exposure in their homes during visits as part of general health promotion

Duration of intervention: Three face-to-face home visits conducted over the first three months of the infant’s life

OutcomesPre-specified outcomes in protocol: Mother/caregiver’s self-report of smoking cessation: defined as not smoking a single cigarette (not even a puff) in the preceding seven days by the mother/caregiver; Prolonged abstinence (e.g. quit for 3 months at 4 months follow up; quit for 9 months and 12 month follow up); Other outcomes relating to infant ETS exposure and health are also included

Validation: None reported

Follow-up period: 12 months

Number of intended follow-up periods: Two; 4 months, and 12 months; Baseline is when infant aged 5 weeks

Starting date09/11/2009

Contact informationDr Vanessa Johnston; Menzies School of Health Research; PO BOX 41096, Casuarina, Northern Territory 0811, Australia; TEL: +61 (0)8 8922 7968, FAX: +61 (0)8 8927 5187; vanessa.johnston@menzies.edu.au

NotesSmoking cessation outcomes as assessed for this review are a secondary outcome of this investigation

Maddison 2010

Trial name or titleFit2Quit Study

MethodsCountry: New Zealand

Design: Randomized controlled trial; Stratified by study centre, sex and ethnicity

Objective/Aim: To determine the effects of a home and community-based exercise intervention (Fit2Quit) on smoking abstinence at six months follow up when used as an adjunct to usual care, being telephone smoking cessation counselling and nicotine replacement therapy

Study site: Callers to Quitline in the greater Auckland and Waikato areas

Other: Sequence generation through a computer central randomization service

ParticipantsTarget sample size: n=1400 (n=700 per arm)

Age: 18-years or older

Gender: Both

Ethnicity:

At least 25% will be Māori

Inclusion/exclusion criteria: Inclusion criteria: 18 years or older, resident in greater Auckland or Waikato areas of New Zealand interested in quitting, want to be physically active, smoke their first cigarette within 30-minutes of waking, contact via telephone possible, able to provide written informed consent; Exclusion criteria Stroke or heart related condition or severe angina in the last two weeks, enrolled in competing smoking cessation programs, have a medical condition which limits their ability to exercise safely, currently participating in an exercise program or participating in greater than 150 minutes of physical activity per week

InterventionsIntervention description: Exercise intervention (prescription and behavioural support) in addition to usual care of telephone support through Quitline and subsidised nicotine replacement therapy prescribed free of charge by the national Quitline

Control description: Usual care alone (i.e. combination of telephone support and subsidised nicotine replacement therapy prescribed free of charge)

Duration of intervention: Minimum of 10 contacts (face-to-face) over 6 months for home-based exercise program plus counselling and referral to community-based activities and programs; Goal for individuals to participate in a minimum of 30 minutes of moderate-vigorous aerobic-based exercise

OutcomesPre-specified outcomes in protocol: Seven-day point prevalence of smoking abstinence validated using salivary cotinine, 6-month continuous abstinence, BMI (body mass index), cardio-respiratory fitness, physical activity levels, cost effectiveness

Validation: Salivary cotinine

Follow-up period: 6 months

Number of intended follow-up periods: Three; 2-, 3- and 6 months

Starting date01/02/2010

Contact informationPrimary contact: Dr Ralph Madison, Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; TEL: +64 9 373 7599 (extension 84718); FAX: +64 9 373 1710; r.maddison@ctru.auckland.ac.nz

Secondary contact: Dr Vaughan Roberts, Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand; v.roberts@ctru.auckland.ac.nz

NotesMāori population approximately 25% of overall sample

Smith 2010

Trial name or titleMenominee Smoking Cessation Clinical Trial

MethodsCountry: United States of America

Design: Randomized controlled trial

Objective/Aim: To evaluate the effectiveness of a culturally-tailored smoking cessation treatment for American Indian smokers, compared to a standardised (non-culturally-tailored) evidence-based cessation treatment

Study site: Menominee Tribal Clinic serving Menominee and other American Indian patients

ParticipantsTarget sample size: n=150

Age: 18 years and older

Gender: Both

Ethnicity: American Indians, specifically the Menominee

Inclusion/exclusion criteria: Inclusion criteria: At least 18 years of age, smoking cigarettes, eligible to receive health care services at the Menominee Tribal Clinic (i.e. must be an enrolled member of a federally-recognised American Indian Tribe), primary care provider is at the Menominee Tribal Clinic, must be medically able and willing to take varenicline; Exclusion criteria: End-stage renal disease with haemodialysis, any prior suicide attempts, current or recent (past 12-month) suicidal ideation, currently pregnant or breastfeeding, unwilling to use appropriate methods of birth control while taking study medication for 1-month after discontinuing study medication, primary care provider determines that the individual should not take varenicline

InterventionsIntervention description: 12 weeks open-label varenicline tartrate use plus smoking cessation counselling consisting of four sessions (1 via phone and 3 in person); Counselling consists of standard treatment counselling plus culturally-appropriate treatments such as discussion of the history of sacred/traditional use of tobacco (honouring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health), custom booklet on smoking and smoking cessation tailored to Menominee and other American Indian smokers, participants are encouraged to make their own traditional tobacco pouch (symbol of long life)

Control description: Same as above for varenicline and number of counselling sessions, however standard treatment counselling is used based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence); Topics include preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support and relapse prevention

Duration of intervention: 12 weeks open label varenicline tartrate use, counselling consists of four sessions, one in-person pre-quit counselling, one via a phone call and the remaining two in-person counselling sessions

OutcomesPre-specified outcomes in protocol: 7-day point prevalence of smoking abstinence, self-reported abstinence and carbon monoxide validated abstinence at 3- and 6-months

Validation: Exhaled carbon monoxide

Follow-up period: 6 months

Number of intended follow-up periods: Two, 3- and 6months

Starting dateFebruary 2010

Contact informationPrimary contact: Dr Steven Smith, University of Wisconsin, Madison, USA

Secondary contact: Jodi Fossum, jodif@mtclinic.net , TEL: 715-799-5754

Notes

Walker 2011

Trial name or titleRELIQ – Reduced Levels of nicotine in cigarettes to Increase Quitting

MethodsCountry: New Zealand

Design: Randomised controlled trial; Stratified by gender, ethnicity and level of nicotine dependence

Objective/Aim: Determine the combined effect of nicotine-free cigarettes with nicotine replacement therapy (immediately post quitting) on long-term quit rates (6-months). Secondary aim is to determine if such an intervention is cost effective and acceptable

Study site: Recruitment through the national telephone-based Quitline service in New Zealand

Other: Sequence generation will occur via a computer, with stratification

ParticipantsTarget sample size: n=1410

Age: 18 years or older

Gender: Both

Ethnicity: 25% Māori

Inclusion/exclusion criteria: Inclusion criteria: Smokers from throughout New Zealand who want to stop smoking, at least 18-years of age, have their first cigarette within 30-minutes of waking, able to provide verbal consent and have a telephone; Exclusion criteria: Pregnant women and women breastfeeding, current users of nicotine replacement therapy, current client of another smoking cessation program (e.g. Txt2Quit and NRT Online), current user of other pharmacotherapy for smoking cessation, use only non-cigarette tobacco (e.g. pipes, cigars), have had a myocardial infarction within the last two weeks, have had angina, severe cardiac arrhythmia or strike in acute phase within the last two weeks

InterventionsIntervention description: Subjects in the intervention will be asked to stop smoking nicotine-containing cigarettes on a chosen quit day and smoke ad libitum nicotine-free cigarettes for six-weeks; Subjects will also receive nicotine replacement therapy in the form of patches, gum and/or lozenges (as recommended by Quitline) for eight weeks; Plus Quitline counselling

Control description: Subjects will receive nicotine replacement therapy in the form of patches, gum and/or lozenges (as recommended by Quitline) for eight weeks; Plus Quitline counselling

Duration of intervention: Intervention and control arms will receive eight weeks of nicotine replacement therapy, whilst the intervention only arm will receive an additional six weeks of nicotine-free cigarettes (Quest 3)

OutcomesPre-specified outcomes in protocol: Proportion of subjects who stopped smoking in the proceeding 7-days (7-day point prevalence) at the 6 month follow up; continuous abstinence, number of cigarettes currently smoked per day; physical signs and symptoms associated with withdrawal, self-rated chances of quitting, reduced smoking, cost information, use of NRT and non-NRT, adverse events, concomitant medication and alcohol use and abuse

Validation: None reported

Follow-up period: 6-months

Number of intended follow-up periods: Four: 3- and 6 weeks and 3- and 6 months

Other: Blinding of trial steering committee, management committee and other team members from the Clinical Trials Research Unit (with the exception of the project co-ordinator and Quitline research manager) will remain blinded to treatment allocation

Starting date01/04/2009

Contact informationDr Natalie K Walker; Clinical Trials Research Unit, School of Population Health, The University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand; n.walker@ctru.auckland.ac.nz

NotesMāori population approximately 25% of overall sample

 
Comparison 1. Intervention versus control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Smoking cessation41081Risk Ratio (M-H, Fixed, 95% CI)1.43 [1.03, 1.98]

    1.1 Point prevalence
3947Risk Ratio (M-H, Fixed, 95% CI)1.35 [0.95, 1.91]

    1.2 Continuous abstinence
1134Risk Ratio (M-H, Fixed, 95% CI)1.99 [0.79, 4.98]

 2 Attitudes - readiness to quit192Risk Ratio (M-H, Fixed, 95% CI)1.64 [0.82, 3.30]

 3 Smoking cessation - Sensitivity analysis3989Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.95, 1.85]

    3.1 Point prevalence
2855Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.86, 1.76]

    3.2 Continuous abstinence
1134Risk Ratio (M-H, Fixed, 95% CI)1.99 [0.79, 4.98]

 
Summary of findings for the main comparison. interventions for smoking cessation for Indigenous populations

interventions for smoking cessation for Indigenous populations

Patient or population: Indigenous populations
Settings:
Intervention: interventions for smoking cessation

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlInterventions for smoking cessation

Smoking abstinence
Follow-up: 6 to 12 months
Study populationRR 1.43
(1.03 to 1.98)
1081
(4 studies)
⊕⊝⊝⊝
very low1,2

97 per 1000139 per 1000
(100 to 193)

Low

100 per 1000143 per 1000
(103 to 198)

Attitudes - readiness to quit
Follow-up: 6 months
Study populationRR 1.64
(0.82 to 3.3)
92
(1 study)
⊕⊝⊝⊝
very low1,2

203 per 1000334 per 1000
(167 to 671)

Low

200 per 1000328 per 1000
(164 to 660)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 There was insufficient sequence generation, allocation concealment and blinding across some studies
2 It is possible that due to the nature of these studies some publication bias is occurring with a failure to publish studies that produce no effect
 
Table 1. Narrative synthesis of intervention effectiveness

Study ID/sub-headings:Detailed synthesis of intervention effectiveness:

Bramley 2005a

Smoking behaviour
Point prevalence: Māori participants in the treatment group were more likely to report having stopped smoking at 6 weeks than those in the control group with 26.1% quit compared to 11.2% (RR: 2.34, 95% CI: 1.44 – 3.79); Smoking cessation rates at 12 and 26 weeks reported rates remaining high in the intervention group (21.6%) but increased in the control group (18.4%).

Intermediate outcome dataNone reported

Holt 2005

Smoking behaviour
The rates of continued abstinence in the bupropion vs. placebo groups were 44.3% and 17.4% (risk ratio 2.54 (95%CI 1.30 to 5.00)) at 3 months, and 21.6% and 10.9% (risk ratio 1.99 (95% CI 0.79 to 5.00)) at 12 months for intervention and control groups respectively. Reported risk ratios (95% confidence intervals) for the remaining follow-up periods were: 1.00 (0.84 to 1.20) at 3 days; 1.47 (1.06 to 2.05) at 3 weeks; 1.39 (0.93 to 2.10) at 7 weeks; 2.72 (1.12 to 6.61) at 26 weeks; 2.51 (1.03 to 6.14) at 39 weeks. The model based approach with a break point in the abstinence-time slope at 26 weeks favoured the intervention, with a risk ratio of 2.44 (95%CI 1.22 to 4.88). 

Intermediate outcome dataAdverse events: Authors report most side effects as mild and self-limiting; Subjects taking bupropion were more likely to have insomnia (26% vs. 9%; risk ratio 3.0 (95% CI 1.1 to 8.2) over the placebo arm. Three subjects taking bupropion discontinued use due to a rash.

Ivers 2003

Smoking behaviour
Point prevalence: six of those in the nicotine patch group reported they had quit whilst one member of the brief intervention only group had quit. However two participants in the nicotine patch group recorded an elevated CO level (10ppm) and as such there data were not used.

Intermediate outcome dataAdverse events: Twenty-nine per cent of subjects using patches experienced bad dreams, 21% pruritis, 4% nausea, 7% palpitations or shakiness and 7% tiredness. 93% said that the patches stayed stuck on all or most of the time; mortality: One subject in the intervention arm died of causes unrelated to the use of patches; Attitudes - readiness to quit: no significant changes in readiness to quit for intervention or control groups (Fishers’ Exact p=1.0 and 0.21 respectively). 38% of smokers in the intervention group and 29% in the control group were less ready to quit after trying patches than they had been at the baseline visit; costs of interventions: nicotine patches costs approximately $32-35 in addition to freight costs for a week’s supply, in comparison a week’s supply of cigarettes for a pack a day smoker is $46-74. It appears that there were other factors apart from the costs of nicotine patches that prevented smokers from using NRT as an aid to quitting, which might have included a widespread perception that smoking was normal behaviour.

Johnson 1997

Smoking behaviour
At 1 year follow up 7.1% of intervention subjects reported being abstinent compared to control subjects with 4.9%. However when only the validated quits are included the percentages drop to 6.7% and 6.8% for intervention and control groups respectively. Furthermore when subjects missing from follow up are counted as smokers the point prevalence for validated quits is reduced to 5.3%.

Intermediate outcome dataNone reported