Intervention Review

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Relapse prevention interventions for smoking cessation

  1. Peter Hajek1,
  2. Lindsay F Stead2,*,
  3. Robert West3,
  4. Martin Jarvis4,
  5. Jamie Hartmann-Boyce2,
  6. Tim Lancaster2

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 20 AUG 2013

Assessed as up-to-date: 5 JUN 2013

DOI: 10.1002/14651858.CD003999.pub4


How to Cite

Hajek P, Stead LF, West R, Jarvis M, Hartmann-Boyce J, Lancaster T. Relapse prevention interventions for smoking cessation. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD003999. DOI: 10.1002/14651858.CD003999.pub4.

Author Information

  1. 1

    Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Wolfson Institute of Preventive Medicine, London, UK

  2. 2

    University of Oxford, Department of Primary Care Health Sciences, Oxford, UK

  3. 3

    University College London, Department of Epidemiology and Public Health, London, UK

  4. 4

    University College London, Health Behavior Research Centre of Cancer Research UK, Department of Epidemiology and Public Health, London, UK

*Lindsay F Stead, Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. lindsay.stead@phc.ox.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 AUG 2013

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Characteristics of included studies [ordered by study ID]
Becona 1997

MethodsSetting: Cessation clinic, Spain
Recruitment: community volunteers
Group size: 36 to 40


Participants76 smokers, ≥ 10 cigs/day (excludes an untreated control group of 40, not randomly selected). 51% F, av age 34, av cigs/day 28


InterventionsBoth conditions received 8 weekly sessions in groups of 36 to 40, duration NS, TQD week 4. 2 experienced therapists

1. Standard programme: motivational contract, nicotine fading, stimulus control

2. RP. As 1 + problem solving


OutcomesAbstinence at 12 m (definition NS)
Validation: CO < 8 ppm during therapy, informants during follow-up


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo information given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated abstinence

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll randomly assigned participants included in ITT analysis

Borland 2004

MethodsSetting: Quitline, Australia
Recruitment: volunteers calling a quitline to request S-H materials


Participants215 smokers who had quit at time of recruitment (other participants not included in this review)
Demographics for all participants: 54% F, approx 47% < 30 y, av cigs/day 21
63% had quit in previous week


InterventionsAll participants received a quit pack at the time of first contact with the quitline, 1 to 2 days before recruitment

1. Series of tailored advice letters based on standardised telephone assessment. 2 to 3 pages, tailored in part by stage of change, timing varied

2. No further intervention


OutcomesAbstinence at 12 m, sustained for 6 m
Validation: none


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated numbers with even numbers allocated to intervention

Allocation concealment (selection bias)Low riskID number generated after agreement to participate

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinding not possible because of nature of the intervention, but "participants in each condition [did] not know about the other condition unless they specifically asked ... (none did)"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo blinding or validation of smoking status, but because of low-contact nature of intervention, differential misreport of smoking unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow-up 23% in each group; all included in ITT analysis

Brandon 1987

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers


Participants39 abstainers at the end of cessation treatment
Sex NS, av age 31, av cigs/day 27
Treatment: groups of 3 to 7 (probably)
Therapists: 3, counterbalanced across treatments


InterventionsAll-included cessation programme 6 × 2 h over 2 w

1. RP 4 × 1.5 h sessions, 2, 4, 8, 12 w post-cessation: self-monitoring, advice, assignment of exposure and coping exercises

2. No maintenance, one assessment session at 12 w


OutcomesAbstinence at 12 m (assume PP) (phone assessment, non-therapist).
Validation: CO only during treatment, phoning 2 collaterals-no results given


NotesA treatment arm that included rapid puffing not included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomly by treatment group before cessation programme, method not described

Allocation concealment (selection bias)Unclear riskNo information given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemically validated abstinence but no results provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk8 randomly assigned participants did not achieve initial cessation and are not included in analysis as their allocation is not given

Brandon 2000

MethodsSetting: Community, USA
Recruitment: advertisements for ex-smokers wanting to avoid relapse


Participants584 ex-smokers (abstinent > 7 days at baseline).
Av age 49, median abstinence 6.5 m, mean 16 m


Interventions2 × 2 factorial design testing mail and phone intervention
Mailings condition: 8 Stay Quit booklets mailed at 1, 2, 3, 5, 7, 9, 12 m
Hotline condition: information about Stay Quit hotline. Asked to call to register. Participants were called if they did not register within 2 w and at 3 m if they had not called
Minimal contact condition received; first Stay Quit booklet.


OutcomesAbstinence at 12 m (no smoking in past 7 days)
All participants were abstinent at baseline, and relapse rates were low.
Validation: CO < 10 ppm for participants living within 75 miles of laboratory


NotesNo true control
Of 804 randomly assigned, results were based on 584 who met inclusion criteria and were sent materials. (Until 2009 update, denominator of 446 was used. Author provided additional data)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Low risk"The CO results from the subsample suggest that participants' self-reported smoking status had satisfactory validity"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskSome post randomization dropouts not included but equally distributed

Brandon 2004

MethodsSetting: Community, USA
Recruitment: advertisements for ex-smokers wanting to avoid relapse


Participants481 ex-smokers (abstinent > 7 days at baseline)
66% F, av. age 52, av cigs/day 25. Median 75 days of abstinence


Interventions2 × 2 factorial design testing effects of contact versus content

1. Repeated mailings. High contact-high content. 8 "Forever Free" booklet mailings at enrolment and 1, 2, 3, 5, 7, 8, 12 m

2. Massed mailings. Low contact-high content. Same 8 booklets at enrolment

3. Repeated letters. High contact-low content. Single "Forever Free" booklet, 7 supportive letters, same schedule as 1. Provided extended contact and social support without skills training

4. Control. Low contact-low content. Single booklet, no further contact


OutcomesAbstinence at 24 m (no smoking in past 7 days)
Validation: CO for 21 local quitters, no misreporting identified


NotesNew for 2009 update
No true control. Other 3 arms compared with single booklet condition in main analysis. Of 895 randomly assigned, results based on 431 who met inclusion criteria and returned follow-up questionnaire. Non-responders excluded rather than assumed to have relapsed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBecause of the nature of the intervention, blinding not possible, but no additional phone or face contact between personnel and participants; lack of blinding unlikely to affect performance

Blinding of outcome assessment (detection bias)
All outcomes
Low riskMinimal contact, misreport unlikely to be differential and validation of subgroup did not identify any misreporting

Incomplete outcome data (attrition bias)
All outcomes
Low risk85% reached at 24 m, no differential dropout

Buchkremer 1991 1

MethodsSetting: Cessation clinic, Germany
Recruitment: community volunteers


Participants256 smokers, no demographic details


Interventions5 conditions, partly factorial. All received nicotine patch, dose individualised for conditions 1 to 4, +9 weekly sessions, incl reduction, self-monitoring, contract management, risk avoidance. TQD after 6 w

1. Additional training in relapse-coping strategies (during cessation phase)

2. Additional 3 booster sessions, 6 m after end of main therapy

3. Relapse-coping and boosters

4. Control

5. Control (fixed-dose nicotine patch)


OutcomesAbstinence 12 m post-EOT (PP). Rates estimated from graphs
Validation: random urine nicotine, 'almost 100% conformity', no correction


Notes3 versus 4 in contact matched comparison, 1 + 2 versus 4 in extended contact comparison
Inclusion of control group 5 (fixed dose) would marginally increase intervention benefit


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Randomly assigned to experimental groups after previously being matched for age, sex and cigarette consumption"

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo blinding reported but biochemical confirmation taken at random, with 'almost 100% conformity'

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk15/256 (5.9%) dropouts excluded, assignment not given, so not included in analysis

Buchkremer 1991 2

MethodsSetting: Cessation clinic, Germany
Recruitment: community volunteers


Participants185 smokers, no demographic details


Interventions4 conditions, partly factorial. All received nicotine patch (dose individualised for conditions 1 to 3) + 9 weekly sessions, incl reduction, self-monitoring, contract management, risk avoidance. TQD after 6 w

1. Relapse coping training using role play, TQD at 6 w

2. Modified relapse coping. Rapid abstinence, TQD session 4, covert sensitisation, thought-stopping

3. Control, individualised patch dose

4. Control, fixed patch dose


OutcomesAbstinence 12 m post-EOT (PP). Rates estimated from graphs
Validation: random urine, 'almost 100% conformity', no correction


Notes1 + 2 versus 3 in contact matched comparison. Inclusion of control group 4 (fixed dose) would marginally increase intervention benefit


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Randomly assigned to experimental groups after previously being matched for age, sex and cigarette consumption'

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo blinding reported but biochemical confirmation taken at random, with 'almost 100% conformity'

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk23/185 (12.4%) dropouts excluded, assignment not given, so not included in analysis

Conway 2004

MethodsSetting: Naval training, USA
Recruitment: smokers who had enforced abstinence during naval training, unselected, not volunteers


Participants1682 female navy recruits with a history of smoking (661 reached at follow-up). All should have been abstinent for 2 m during training
av age 19, no details of cigs/day


Interventions1. 6 mail contacts over 12 m, at 1, 2, 4, 5, 7, 10 m (2 after follow-up), 1-page flyers, cognitive-behavioural RP; stress management, weight, fitness, tailored for naval women

2. Access to toll-free telephone helpline for support and counselling on RP and quitting if relapse occurred, cognitive-behavioural approach. Once participant called, sessions scheduled in line with risk of relapse

3. No intervention control


OutcomesAbstinence at 12 m (30 day) (Edwards 1999 reports 6 m outcomes)
Validation: none


NotesResults not displayed graphically because denominators not explicit. No evidence of intervention effect. Impact of clustering was negligible


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster randomization by division (80 people)

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-reported smoking status, interventions of varying intensities, but no face-to-face contact, so judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskHigh loss to follow-up (52% at 12 m); participants lost to follow-up not broken down by group; unclear whether included in final denominators

Covey 2007

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers quit after 8 w bupropion & nicotine patch


Participants289 abstainers (excludes 5 withdrawing consent before starting meds)
45% F, av age 43, av cigs/day 21
Therapists: counsellors, 1 m training


InterventionsAll participants received 8 w open-label bupropion and nicotine patch (21 mg with weaning) for 7 w from TQD. Transition procedures preserved blinding for RP phase but allowed weaning from bupropion. Individual counselling, including CBT techniques, 15 min × 6 during open-label, ×4 during RP, ×2 during follow-up

1. Bupropion (300 mg) and nicotine gum (2 mg, use as needed to manage craving) for 16 w

2. Bupropion and placebo gum

3. Nicotine gum and placebo pill (150 mg bupropion for first week)

4. Double placebo (150 mg bupropion for first week)


OutcomesAbstinence (no relapse to 7 days of smoking) for 12 m (10 m after randomization, 6 m after EOT) (Primary outcome for study was time to relapse)
Validation: CO ≤ 8ppm at each visit


NotesNew for 2009 update
Contributes to NRT, bupropion and combination therapy analyses
Quit rate after open-label treatment was 52%, so the final quit rate of 30% for combination therapy is equivalent to ˜16% of people starting treatment


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"A statistician who did not participate in the clinical phases of the study provided computer-generated randomization lists that were not accessible to the clinical staff", stratified by gender and depression history

Allocation concealment (selection bias)Low riskA research nurse who did not have direct contact with participants prepared individual medication kits based on the randomization schedule

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Participants and clinical researchers with direct participant contact were blinded to the randomization". Identical placebos used

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used at each visit

Incomplete outcome data (attrition bias)
All outcomes
Low risk5 randomly assigned participants withdrew before double-blind phase. Greater loss to follow-up in double placebo, losses included in ITT analysis

Croghan 2007

MethodsSetting: Clinic, USA
Recruitment: community volunteers for pharmacotherapy cessation and RP trial


Participants405 abstainers after 3 m pharmacotherapy, 74 from inhaler, 141 bupropion, 190 combination
Participant characteristics not presented at start of RP phase


InterventionsIn cessation phase, participants had been randomly assigned to bupropion (300 mg), nicotine inhaler (up to 16 cartridges/day) or combination. Physician advice at entry, brief (<10 min) counselling at monthly study visits (total 12 to 18, including RP phase) and S-H. Abstainers (7 day PP after 3 m therapy) eligible for RP phase
RP intervention randomly assigned single-therapy abstainers to continue cessation therapy or placebo for 9 m
Combined therapy abstainers randomly assigned to 4 groups: combination, placebo and single therapy, or double placebo


OutcomesAbstinence at 15 m (from TQD, 12 m from RP start, 3 m from EOT) (PP)
Validation: CO ≤ 8ppm


NotesNew for 2009 update
Arms contribute to NRT, bupropion and combination therapy analyses, ignoring differences in cessation induction therapy
Cessation rates at end of induction phase were 14% for inhaler, 26% for bupropion and 34% for combination


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization using a dynamic allocation procedure and balancing stratification factors

Allocation concealment (selection bias)Low riskRandomization procedure makes prior knowledge of allocation unlikely

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskPlacebo used, but insufficient information provided re: blinding to permit judgement

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow up post-medication were high and were not enumerated by group, but all were included in ITT analysis

Curry 1988

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers


Participants139 smokers, 48 in group arms, 91 in S-H arms
Therapists for groups: 2 teams of 2 PhD psychologists. Each team led one group in each programme


InterventionsCompared 2 approaches, in both group and S-H formats

Groups met 8 × 2 h weekly, incl relaxation training, enlisting social support and practising alternative behaviours. S-H intervention provided same components in 8 workbooks

1. RP: focused on smoking as learned behaviour. Quit day (for group format) at 3rd session. Additional elements included identifying high-risk situations, cognitive restructuring and role playing

2. 'Absolute Abstinence' (AA) group. Focused on addictive component of smoking. Quit day (for group format) at 5th session. Additional elements included focused smoking, health education and contingency contract


OutcomesAbstinence from m 9 to m 12 of follow-up
Validation: saliva thiocyanate and two collateral verifiers


NotesGroup and S-H arms used in different comparisons within the matched contact time section


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPart by coin toss and part random number table. Friends co-randomly assigned to same programme but not necessarily same format. More assigned to S-H than group by design

Allocation concealment (selection bias)High riskNo details given, but randomization procedure makes it likely that it was not concealed

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information reported

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAbstinence validated

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly 69% began treatment. Losses to follow-up included an ITT analysis

Davis 1986

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers
Group size 3 to 8


Participants45 smokers who completed treatment
Therapists: 9 advanced clinical psychology graduate students with no previous experience. Each conducted one group


InterventionsAll conditions received 6 × 1½ to 2 h weekly meetings based on Pomerleau and Pomerleau broad-spectrum cessation package. TQD w 5

1. 'Experimental' condition added active cognitive behavioral skills training focusing on 11 problem situations

2. 'Enhanced control' added discussion of same problems

3. 'Control' using Pomerleau and Pomerleau alone


OutcomesAbstinence at 12 m (PP)
Validation: CO


Notes1 and 2 treated as RP
Condition 2 not displayed. 3/14 quit


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinding not possible because of nature of the intervention, but all participants received same amount of contact, and no therapists had previous experience with stop-smoking groups, hence performance bias unlikely

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk5 pretreatment and 6 dropouts during treatment excluded, assignment not specified

Emmons 1988

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers


Participants49 smokers; 71% F, av age 41, av cigs/day 31 (significant difference between groups, 35 vs 27)


Interventions1. Cessation programme with RP focus. 8 × 1½ h weekly, TQD between 3 and 4. pre-quit self-monitoring. Choice of 'cold turkey' or gradual reduction. Relaxation, role-play, cognitive coping

2. Broad-spectrum (BS) programme. 12 × 1 h over 8 w. TQD between 3 and 4. Included nicotine fading


OutcomesAbstinence at 6 m (PP) (EOT and 3 m also reported)
Validation: saliva thiocyanate ≤ 85 microg/ml


NotesIncluded in contact matched section, although different number of sessions
Inclusion of 4 non-completers would increase apparent benefit of BS


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization in blocks, method not described

Allocation concealment (selection bias)Unclear riskNo details given. Friends and relatives assigned to same condition, and significant baseline differences between groups; BS smoked more

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Although facilitators knew that different treatments were being conducted, they were unaware of the components of the alternate treatments". Same duration of contact in both groups. Performance bias unlikely

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated outcome

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskResults exclude 4 pretreatment dropouts, 4 non-completers (3RP, 1BS), 1 medical problem

Ershoff 1995

MethodsSetting: HMO health centre, USA
Recruitment: pregnant women who had quit smoking since becoming pregnant


Participants171 pregnant recent quitters, av length of prior abstinence 31 days, 58% had >7 days of total abstinence
Av age 25, av cigs/day 10


Interventions1. RP. S-H booklets; 4 on cessation given at baseline visit, 4 RP-oriented mailed at weekly intervals

2. Control. 1-page tip sheet on behavioural techniques for avoiding relapse

Both groups had a 2 min discussion on smoking & pregnancy with health educator, were given 2-page pamphlet, congratulated on quitting


OutcomesPP (7 day), late in 3rd trimester (also w 26 and w 34 of pregnancy)
Validation: cotinine, at least 1 ≤ 10 ng/mL and none ≥ 80 ng/mL


Notes11% of women misreported abstinence


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Low riskAllocation before participant contact, blind until end of baseline data collection

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"The health educator was blind to group assignment until the end of data collection... The program was presented as a standard part of prenatal care... Patients had no further contact with the prenatal intake health educator. Prenatal care providers were blind to group assignment, and no effort was made to modify their usual counselling practices"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low risk37 (22%) exclusions due to abortion, miscarriage, move from HMO

Fortmann 1995

MethodsSetting: Community, USA
Recruitment: smokers identified via a random telephone survey (volunteers)


Participants1044 smokers able to quit for 24 h; 42% F, av age 40, av cigs/day 20


InterventionsFactorial trial of nicotine gum and S-H for RP. All participants also offered an incentive of $100 for quitting for 6 m

1. Nicotine gum 2 mg

2. S-H materials

3. Nicotine gum and S-H materials

4. Monetary incentive only


OutcomesPP abstinence at 12 m
Validation: CO < 9 ppm, salivary cotinine < 20 ng/mL


Notes1 and 3 compared with 2 and 4 to assess effect of nicotine gum
2 and 3 compared with 1 and 4 to assess effect of behavioural component


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation

Incomplete outcome data (attrition bias)
All outcomes
Low risk94% followed up at 12 m, all participants included in ITT analysis

Hajek 2001

MethodsSetting: Antenatal clinics, UK
Recruitment: pregnant smokers and recent quitters


Participants249 pregnant recent (within 6 m) quitters, average abstinence 7 w (smokers also in trial, not included for this review)
Av age 28, av cigs/day approx 12


Interventions1. Advice from midwife with explanation of CO reading, pamphlet, prompt placed in notes for reinforcement
2. Usual midwife care


OutcomesAbstinence at 12 m (prolonged for last 12 w of pregnancy and 6 m since birth), also at birth
Validation: CO ≤ 10ppm


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCluster randomized by midwife. "The allocation schedule was generated by drawing of folded tags with Intervention or control designations and assigning them to consecutive names on the list of midwives"

Allocation concealment (selection bias)High riskRandomized midwives were responsible for recruiting participants, fewer control midwives recruited any, so possible recruitment bias

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low riskWomen who were untraceable or unsuitable for follow-up were excluded, other losses included as smokers

Hajek 2002

MethodsSetting: 17 hospitals, UK
Recruitment: inpatients with MI or for CABG


Participants540 smokers or recent quitters (26%) who had not smoked since admission to hospital and motivated to quit


Interventions1. As control + CO reading, booklet on smoking and cardiac recovery, written quiz, offer to find support 'buddy', commitment, reminder in notes. Implemented by cardiac nurses during routine work, est time 20 m
2. Verbal advice, 'Smoking and Your Heart' booklet


OutcomesAbstinence at 12 m, sustained (no more than 5 cigs since enrolment and 7 day PP)
Validation: saliva cotinine < 20 ng/mL (CO used at 6 w follow-up and for visits at 12 m)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Low riskNurses opened a "serially numbered, opaque, sealed envelope designating the patient's allocation"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported, some contamination possible

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk26 deaths and 9 moved. address excluded from denominator in analysis; all others lost to follow-up counted as smokers

Hall 1984

MethodsSetting: Clinic, USA
Recruitment: media adverts and referral


Participants135 smokers; 59% F, av age approx 36, av cigs/day 29
Therapists: 2 psychologists, randomly assigned to groups


Interventions2 × 2 factorial trial, aversive smoking conditions collapsed
1. Skills training, 14 × 75 min sessions. 8 sessions over 3 w involved 6 s or 30 s aversive smoking. 6 sessions over w 1 to 6 covered relaxation, commitment and cost benefits, and RP skills with role-play of risk situations
2. Discussion control. Same aversive smoking. Other 6 sessions used self-scoring tests and group discussion. Discussion of specific skills discouraged


OutcomesAbstinence at 12 m (PP)
Validation: CO < 10 ppm, plasma thiocyanate < 85 ng/mg and confirmation from significant other


NotesMatched for contact time
Author tested for therapist and cohort main effects. None significant


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk8 dropouts from grp 1 and 4 from grp 2 before start of RP sessions reincluded in this analysis

Hall 1985

MethodsSetting: Clinic, USA
Recruitment: referred by physicians, friends or self


Participants84 smokers in relevant arms; 53% M, av age 38, av cigs/day 30.5
Therapists: 2 psychologists


Interventions1. Intensive behavioural treatment (incl RP skill training, relaxation, 30 s aversive smoking of 3 cigs). 14 × 75 min sessions over 8 w
2. Same as 1. + 2 mg nicotine gum available for 6 m
3. Low-contact + nicotine gum. Met 4 × in 3 w, educational materials, written exercises, group discussion


OutcomesAbstinence at 52 w (assume PP)
Validation: CO < 10 ppm, thiocyanate < 85 mg/mL, reports of significant others (biochemical measures failed to confirm self-report in 3 instances)


Notes2 versus 3, not matched for contact time, controlled for gum. 1 not included in meta-analysis; 10/36 quit


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomly assigned within time constraints, method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo placebo NRT; no blinding.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk3 dropouts in conditions 1 and 2 are assumed to be included in denominator for reported % abstinent used to derive numbers quit

Hall 1987

MethodsSetting: Clinic, USA
Recruitment: community volunteers or referrals


Participants139 smokers; 53% M, av age 39, av cigs/day 30
Therapists: advanced graduates in clinical psychology or health psychology


Interventions2 × 2 factorial trial. Nicotine gum/placebo arms collapsed
1. Intensive behavioural treatment incl 6 s aversive smoking, RP skills training, written exercises. 14 × 75 min sessions (period not stated)
2. 'Low contact', incl written exercises, educational materials, group discussions, quitting techniques. 5 × 60 min


OutcomesAbstinence at 52 w (assume PP)
Validation: thiocyanate < 95 mm/L (unless marijuana use reported), CO < 8 ppm, significant other


NotesNot matched for contact time
No reported interaction between behaviour therapy condition and gum condition so gum/no gum collapsed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskPlacebo gum used but gum/no-gum conditions collapsed in meta-analysis. No information provided re behavioural sessions in this domain

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk6 dropouts in 1 and 5 in 2 included in ITT analyses. "Differences between conditions were not statistically significant"

Hannöver 2009

MethodsSetting: Maternity services, Germany
Recruitment: postpartum women in maternity wards


Participants304 women who had not smoked for 4 w at baseline assessment


Interventions1. Counselling using motivational interviewing. Face-to-face session ˜40 days postpartum, telephone boosters 4 & 12 w later
2. Usual care from health system, S-H materials on postpartum smoking and partner smoking


OutcomesSustained abstinence since birth of baby at 24 m (at 6 m, 12 m, PP also reported)
Validation: none


NotesBaseline assessment was conducted a median of 35 days after birth


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskAlternation of screening forms

Allocation concealment (selection bias)High riskAlternate allocation done at study centre so not known to screener in advance, reducing likelihood of selection bias

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"The nature of the intervention made blinding impossible", but assessors "were blind to the women's group membership"

Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported cessation only, intervention face-to-face and intensive compared with control, differential misreport possible

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskParticipants who revoked participation before baseline assessment are not included in denominators

Hasuo 2004

MethodsSetting: Hospital, Japan
Recruitment: Hospitalised volunteers, recently quit or expecting to quit in hospital.


Participants106 smokers, quit on day of hospital discharge 87% M, av age 60. 83% quit before admission


Interventions1. In-hospital counselling from public health nurse, 3 × 20 min sessions, + 3 × 5 min calls, 7, 21, 42 days postdischarge
2. Control: in-hospital counselling only


OutcomesAbstinence at 12 m (assume PP)
Validation: Urine cotinine


NotesNew for 2009 update


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization by computer stratified by smoking status, FTND and self-efficacy

Allocation concealment (selection bias)Low riskTherapists notified of assignment after allocation

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPublic health nurse and participant did not know allocation until the day before discharge, so common treatment component unlikely to be affected by performance bias

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot clear whether results are self-report or cotinine-validated

Incomplete outcome data (attrition bias)
All outcomes
Low risk106 excludes 6 deaths within 12 m and 8 who were smoking on day of discharge, includes all other losses

Hays 2001

MethodsSetting: Clinics, USA, 5 sites
Recruitment: 784 community volunteers for cessation and RP trial


Participants429 abstainers (previously ≥ 15 cigs/day) quit after 7 w open-label bupropion; 51% F, av age 46, av cigs/day 26


InterventionsAll participants first received 7 w bupropion, physician advice, S-H materials and brief individual counselling at follow-up visits to assist cessation
1. Bupropion 300 mg/day, 45 w
2. Placebo


OutcomesContinuous abstinence at 2y (1 y after EOT)
Validation: CO ≤ 10 ppm


NotesQuit rate after open-label phase was 59%, so the final quit rate of 29% in the bupropion group is equivalent to 17% of people starting treatment


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomization to the placebo or bupropion groups was computer generated at a central location..."

Allocation concealment (selection bias)Low riskCode held centrally, investigators blind

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"...the investigators did not know the patient assignments. All bupropion and placebo pills were identical in shape, size, and color"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinding reported, and abstinence biochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low risk74% completed study, 2 deaths excluded, all other withdrawals included in ITT analysis

Hays 2009

MethodsSetting: Clinic, USA

Recruitment: 195 community volunteers for cessation and RP trial (110 included in RP trial)


Participants110 recovering alcoholic abstainers with at least 1 y continuous abstinence from alcohol and drugs, 18+ years old, smoking at least 20 cpd for previous year. Quit for at least last week of 8 w patch therapy

78% M; av age 44; av cpd 29.9 (in initial population of 195 volunteers)


InterventionsAll participants first received brief weekly counselling sessions and nicotine patch for 8 w. Patch tailored on the basis of baseline serum cotinine concentration

1. Bupropion: 150 mg/day first 3 d, then 300 mg/d until w 52

2. Placebo on same schedule

Brief individual counselling (≤ 10 min) at each clinic visit (weekly for w 9-12, monthly for w 13-24, then at 52, 53, 64 and 76 w)


OutcomesAbstinence at 76 w (continuous and 7 d PP)

Validation: CO < 8 ppm


NotesNew for 2013 update

Study does not report number of participants allocated to each group or number of successful abstainers in each group; numbers obtained through extrapolation

Authors contacted to clarify re discrepancy in 76 w data, but no response


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Randomized", method not stated

Allocation concealment (selection bias)Unclear riskMethod not described

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDescribed as "double-blind", placebo used, but no further information given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSmoking status biochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low riskAt w 76, similar rate of dropout in both groups (34% intervention; 37% control). Participants lost to follow-up counted as relapsed smokers

Other biasUnclear riskDiscrepancy in data: at 76 w, 7 d PP less than continuous abstinence

Hurt 2003

MethodsSetting: Clinics, USA, 14 sites
Recruitment: 578 community volunteers for cessation and RP trial


Participants176 abstainers (previously ≥ 15 cigs/day) quit after 8 w of nicotine patch; baseline group: 57% F, av age 42, av cigs/day 26


InterventionsAll participants first received nicotine patch for 8 w at a dose of 22, 33 or 44 mg/day, matched to baseline cigs/day. Brief advice to quit and S-H materials but no formal counselling
1. Bupropion 300 mg/day for 6 m
2. Placebo
No additional counselling during maintenance phase


OutcomesAbstinence at 12 m (PP) (6 m after EOT).
Validation: CO < 8 ppm


NotesQuit rate after open-label phase was 31%, so the final quit rate of 22% in the bupropion group is equivalent to 7% of people starting treatment


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized by 'dynamic allocation', stratified on sex, cigs/day and years of smoking

Allocation concealment (selection bias)Unclear riskNot explicit, although randomization procedure makes concealment probable

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDescribed as "double-blind", placebo used, but no further information given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll participants lost to follow-up counted as smokers, but numbers not provided

Japuntich 2006

MethodsSetting: Clinic/internet, USA
Recruitment: community volunteers


Participants284 smokers (≥ 10 cigs/day); 55% F, av age 41, av cigs/day 22


InterventionsAll participants received bupropion (300 mg) for 9 w, 3 brief (20 min) individual counselling sessions, 5 clinic visits for assessment, monthly assessment calls
1. Access to Comprehensive Health Enhancement Support System for Smoking Cessation and Relapse Prevention (CHESS SCRP) for 12 w, computer and access provided, daily use recommended, reminders to log on up to 3 times a week
2. No additional support


OutcomesAbstinence at 6 m (PP)
Validation: CO ≤ 10ppm


NotesNew for 2009 update
12 m follow-up results not published


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo details given, but as support provided to both groups pre-intervention, and not during intervention period, performance bias unlikely

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk20% losses to follow-up and intervention participants who didn't get computer included in ITT analysis

Joseph 2011

MethodsSetting: Minnesota, USA

Recruitment: community volunteers (via local labor unions)


Participants443 adult smokers of at least 5 cpd interested in quitting in next 14 d

60.2% F, av age 42, av cpd 17.7


InterventionsAll participants received 5 telephone calls and NRT (patch; gum; lozenge, provision modelled on common clinical practice) by mail for 4 w. Randomly assigned to:

1. Longitudinal care modelled on chronic disease mgmt approach. Telephone counselling and NRT by mail for additional 48 w. Counsellors aimed to call every 2 w but adjustment based on participants’ progress/receptivity; if participants chose not to make a quit attempt or reduce, calls made monthly

2. Usual care. 1 additional call at 8 w


Outcomes6 m prolonged abstinence at 18 m follow-up

Validation: none


NotesNew for 2013 update

Number abstinent not provided, extrapolated from percentages given


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Participants were randomly assigned... by a computer-generated scheme, blocked in masked groups of 20"

Allocation concealment (selection bias)Low risk"The randomization schedule was maintained by personnel independent from the study"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified, allocation occurred before end of common treatment component

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSelf-reported outcome only, but no face-to-face contact, hence differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskLow and similar rates of loss to follow-up in both groups (8.6% intervention, 8.1% control); dropouts counted as smokers in ITT analysis

Juliano 2006

MethodsSetting: Clinic, USA
Recruitment: community volunteers


Participants34 early lapsers (within 14 days) out of 67 smokers (≥15 cigs/day) enrolling in cessation phase; initial sample 61% F, av age 40


InterventionsMost participants received bupropion, all received counselling (before quitting, 30 min on quit day) and S-H materials. Participants reported smoking status daily. Lapsers were randomly assigned:
1. Rapid smoking. Puff every 6 s, 6 trials of up to 3 cigs, 5 min break between. Counselling in 30 to 45 min break between 3rd and 4th trials. Intention to provide 3 sessions, preferably on consecutive days, as soon as possible after lapse
2. Usual care-structured interview about lapse via telephone


OutcomesAbstinence at 6 m (PP)
Validation: CO ≤ 6 ppm


NotesNew for 2009 update. Included in behavioural interventions for assisted abstainers but not pooled; both conditions had RP content. 16/20 attended a rapid smoking session, 11 completed 3 sessions


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding, control participants aware of intervention provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll losses to follow-up included in ITT analysis

Killen 1984

MethodsSetting: Clinic, USA
Recruitment: community volunteers


Participants64 smokers (44 in relevant arms); 72% F, av age 44, av cigs/day 32
Behaviour therapy provided by 2 psychologists, 1 medical social worker, assigned randomly to treatment conditions, group size 10 to 12


InterventionsAll participated in cessation training (incl cognitive-behavioural skills training and an aversive smoke-holding procedure), 4 × 1½ h sessions over 4 days, in groups of 10 to 12
1. Nicotine gum (2 mg) for 7 w
2. Skills training for RP. 2 sessions in 2 w, then 4 weekly drop-in sessions. Included identification of high-risk situations and coping strategies, homework
3. Combined 1 and 2


OutcomesAbstinence for 4 w at 10½ m after quit date
Validation: CO < 8 ppm (2 people unable to attend assessment, based on self-report), Serum thiocyanate measured at 6 w only


Notes3 versus 1 for effect of RP component over NRT alone3 versus 2 tests for effect of NRT for initial cessation, not included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described (married couples allocated to same condition)

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding reported. "Interpretation of this data is hampered by the lack of a placebo control condition". Unclear whether therapists aware of gum allocation

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow-up not reported, all participants included

Killen 1990

MethodsSetting: Community, USA (Stanford Stop Smoking Project)
Recruitment: media advertisements for volunteers for S-H RP research programme. To be eligible for randomization, had to have quit for 48 h unaided. (Quit validated by CO < 9 ppm)


Participants1218 smokers who had quit for 48 h; 52% F, av age 43, av cigs/day 25


Interventions4 × 3 factorial design crossing gum and S-H conditions:

Nicotine gum (2 mg) conditions:

1. Ad lib schedule, whenever strong need to smoke

2. Fixed schedule (1 piece/h for at least 12 h/day)

3. Placebo gum

4. No gum

S-H intervention was based on 16 specially written modules. All participants were given the first 'How to cope with the urge to smoke without smoking' booklet. Then randomly assigned to:

  • Self-selected-chose 7 more to receive in weekly mailings
  • Random-sent 7 modules at random
  • No modules-no further contact


OutcomesAbstinence at 12 m (7 day PP)
Validation: saliva cotinine < 20 ng/mL, except for participants who had moved away


NotesQuit rates for module/no-module conditions provided by authors. Gum conditions collapsed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not stated

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"Assignment to gum condition was double-blind" but further information not provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskTreatment condition blinded, biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow-up not reported, all participants included except 8 deaths

Killen 2006

MethodsSetting: Clinic, USA
Recruitment: community volunteers


Participants362 smokers ≥ 10 cigs/day, no current major depression
46% F, av age 45, av cigs/day 20, 25% previous bupropion use


InterventionsAll participants received open-label combination pharmacotherapy of bupropion 300 mg for 11 w, nicotine patch for 10 w. TQD day 7, 30 min individual RP skills training at 6 clinic visits
1. Bupropion 150 mg for 14 w
2. 2 w tapering bupropion, then placebo
Both arms had 4 further clinic visits during extended therapy


OutcomesAbstinence at 12 m (6 m post-EOT) (continuous). PP and 7-day relapse-free outcomes also reported
Validation: CO (10 people not required to provide samples)


NotesNew for 2009 update
PP outcomes favour placebo, but no outcomes showed significant effects
Approximately 52% were quit at the end of baseline therapy


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPre-assigned random sequence stratified by gender, before open-label phase

Allocation concealment (selection bias)Low riskNot explicitly concealed but judged probable that it was

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinded drugs provided to investigator; " ... [the pharmaceutical company]... packaged the treatment and then shipped the blinded drug to the investigator"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskTreatment condition blinded, biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk10% lost to follow-up, included in ITT analysis

Klesges 1999

MethodsSetting: Air Force, USA
Recruitment: recruits undergoing basic military training (BMT)


Participants18010 recruits, 29% regular smokers before enforced abstinence during training. 28% F, av age 20


Interventions1. Single 50-min intervention during final week of training, 50/group, incl non-smokers. Discussed health effects, costs, social impact, role-play
2. Control: general health video
All participants exposed to 6 w smoking ban and shown 2 videos to preview primary intervention


OutcomesAbstinence at 12 m (not defined)
Validation: none
Relapse amongst baseline ex-smokers and initiation amongst non-smokers also reported


NotesResults not displayed graphically because denominators not explicit. No significant overall benefit. ICC small (0.004 for smokers)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized by training flight. 75% assigned to intervention, method of sequence generation not specified

Allocation concealment (selection bias)Low riskNot specified, but training flight allocation was independent of this trial, so potential for bias small

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding reported, control knowledge of intervention unclear, personnel knowledge of participant assignment not reported

Blinding of outcome assessment (detection bias)
All outcomes
Low riskAlthough no biochemical validation used, intervention was of low intensity with limited face-to-face contact, sample size was large, follow-up rate was high and self-report was via survey. Risk of differential misreport is low

Incomplete outcome data (attrition bias)
All outcomes
Low risk96% of available smokers reached

Klesges 2006

MethodsSetting: Air Force, USA
Recruitment: recruits undergoing basic military training (BMT)


ParticipantsSubgroup of ˜7525 regular smokers in intervention and ˜2639 in control


Interventions1. Two 1 h sessions during w 6 of BMT, emphasis on discrepancy between Air Force ideals and smoking. Barriers, role-playing. One sheet of NRT gum available for use at end of training
2. Same schedule, health-related and first aid videos


OutcomesAbstinence at 1 y (sustained from end of BMT)
Validation: none


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized by training flight. 75% assigned to intervention, method of sequence generation not specified

Allocation concealment (selection bias)Low riskNot specified, but training flight allocation was independent of this trial, so potential for bias small

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who conducted follow-ups were not blinded to treatment assignment at follow-up; differential follow-up possible for participants who did not respond to survey and were contacted by telephone.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskRandom subgroup targeted for follow-up, 86% reached. People lost to follow-up excluded because likely to be missing completely at random

Lando 1996

MethodsSetting: Community, USA
Recruitment: community volunteers


Participants1083 smokers who attended a smoking cessation clinic; 60% F, av age 45, av cigs/day 27


InterventionsAll participated in 15-session 8 w group cessation programme
1. Telephone counselling at 3, 9, 21 m. At each point, up to 3 calls could be made if requested
2. Control. No additional contact


OutcomesAbstinence at 34 m (12 m after EOT (7 day PP)). Also assessed at 6, 12 and 24 m
Validation: random half of quitters validated by saliva cotinine < 20 ng/mL at 12 m. 91% confirmed


NotesNot pooled with other studies. Analysis 9.1.1


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskUnclear whether counsellors for group sessions were aware of participant allocation. Unclear if control group was aware of additional support offered to intervention group

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used in subsample with low level of discrepancies indicated, "difference between the intervention and comparison conditions in disconfirmation was not significant"

Incomplete outcome data (attrition bias)
All outcomes
Low risk> 95% reached at each follow-up, all participants included in analysis

Lifrak 1997

MethodsSetting: Substance abuse outpatient facility, USA
Recruitment: community volunteers


Participants69 smokers (≥1 pack/day); 62% F, av age 39, av cigs/day 25


InterventionsAll received nicotine patch (24 h, 10 w tapered dose)
1. Moderate intensity-4 meetings with nurse practitioner who reviewed S-H materials and instructed in patch use
2. High intensity. As 1 plus 16 weekly 45-min cognitive-behavioural RP therapy from clinical social worker or psychiatrist


OutcomesAbstinence at 12 m (1 w PP)
Validation: urine cotinine for some participants, but no corrections made for misreporting


NotesHigh-intensity participants attended median of 8¼ sessions


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided

Blinding of outcome assessment (detection bias)
All outcomes
High riskIncomplete urinary cotinine samples collected, so not used to validate abstinence. Intervention group received significantly more intensive face-to-face contact, differential misreport possible.

Incomplete outcome data (attrition bias)
All outcomes
Low risk12 administrative dropouts/exclusions not included, treatment group not specified

Lowe 1997

MethodsSetting: Prenatal clinic, USA
Recruitment: volunteer recent quitters


Participants78 pregnant women who had quit within previous 3 m (9 exclusions and 19 lost to follow-up not included)
Age/smoking history not described
Therapists: health educator. Reinforcement provided by doctors and nurse trained at workshops


Interventions1. 10 min counselling with health educator. RP materials at 5th grade reading level, enhance social support with materials, chose 'buddy'. Reinforcement at routine visits by clinic staff
2. Usual care, incl nurse advice


OutcomesContinued abstinence at end of pregnancy (exact period NS)
Validation: saliva thiocyanate


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinding not relevant because of nature of the intervention (all relevant personnel involved in delivering intervention); any potential causes of performance bias could be considered deliberate elements of the intervention

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskGreater loss to follow-up in control, so losses to follow-up not included in denominators to give conservative RR

Other biasUnclear riskPotential contamination, "the issue of contamination, while monitored, is one that remains a concern"

Mayer 2010

MethodsSetting: Workplaces, Belgium

Recruitment: participants achieving abstinence in workplace-based smoking cessation programme, randomly assigned by workplace


Participants275 adult attendees of workplace-based cessation programme who achieved 4 weeks continuous abstinence at 3 m after quit date (42 companies)

74% M, av age 40.6, more than 50% smoked 12 to 25 cpd, av FTND 6.5


InterventionsSmokers wishing to quit invited to join cessation program through companies (13 group sessions, nicotine patches provided). Then randomly assigned to RP interventions:

1. Workplace Group Counselling (WGC), conducted at work (company decided if during or after work hours), 90 min each. Groups of 5 to 10 participants

2. Proactive Phone Counselling (PPC), each session minimum of 10 min

Both programmes: 10 sessions (2 in month 1, monthly thereafter); participants have to pay 50 euros to participate (some companies decided to cover fees); content focused on participants' difficulties and provided psychological support where relevant


Outcomes4 w continuous abstinence at 12 m post quit date (immediately after end of RP intervention)

Validation: CO < 10 ppm, urinary cotinine ≤ 317 ng/mL


NotesNew for 2013 update

Higher participation rate in PPC arm (81% to 95%) vs WGC arm (49% to 70%). Not included in an7 meta-analyses: 87/141 quit WGC, 77/134 PPC


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCluster randomized by worksite. “Workplace randomization was based on using a single sequence of random assignments produced by a computer program”

Allocation concealment (selection bias)Unclear riskCompanies randomly assigned at end of cessation program, allocation concealment not described

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemically validated abstinence

Incomplete outcome data (attrition bias)
All outcomes
Low risk5 participants lost to follow-up and counted as smokers

Other biasHigh riskHigher rates of abstinence detected in those with biochemically validated abstinence at enrolment (≤ 317 ng/mL). WGC arm had significantly more of these participants than PPC arm (96.4% vs 89.4%). Adjusted figures not provided

McBride 1999

MethodsSetting: Two managed care organisations, USA
Recruitment: pregnant smokers and recent quitters


Participants897 pregnant women (excludes miscarriages), 44% already quit, no minimum consumption
Av age 28, av cigs/day: 15 before pregnancy, 5 if still smoking


Interventions1. Prepartum intervention: letter tailored to baseline stage of change, health concerns and motivation, S-H book. After 28 w follow-up, sent RP kit
2. Telephone counselling calls, approx 2 w after S-H mailing, and 1 and 2 m later. Motivational interviewing approach. Av 8½ min
3. Pre/postpartum intervention: as 1, plus 3 calls within first 4 m postpartum, av 7.7 min, 3 newsletters
4. Control: S-H booklet only


OutcomesAbstinence at w 28 of pregnancy (analysis 1.1) and 12 m postpartum (7 day PP) (analysis 2.1). Also assessed at 8 w, 6 m postpartum
Validation: saliva cotinine requested by mail, < 20 ng/mL. Only self-reported rates, no difference in confirmation rates


NotesAbstinence at w 28 reported separately for baseline quitters
Relapse rate in 28 w quitters also reported. 1 versus 2 in analysis 1.2.1 and 1 versus 3 in 1.2.2, control group split to avoid double counting in pooled total. No significant benefit of postpartum intervention


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"The intervention was delivered via mail and telephone without involvement of prenatal health care providers". "Couselors were not involved in any follow-up survey activities"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used, not reported: "Since there were no between-group differences in the proportion of saliva samples returned or the proportion confirmed, the primary trial outcomes were based on self-reported smoking status"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNonresponders assumed to have relapsed

McBride 2004

MethodsSetting: Army Medical Center, USA
Recruitment: pregnant smokers and recent quitters with partners


Participants316 pregnant recent quitters, 267 continuing smokers (excludes miscarriages); av age 24, av cigs/day prepregnancy 13


InterventionsBoth interventions included prepartum and postpartum components, in addition to usual care
1. Women only (WO); 3 counselling calls in pregnancy, 3 postpartum, monthly. Motivational interviewing. Late pregnancy relapse prevention kit
2. Partner-assisted (PA); as WO, plus advice on using partner as coach, and 6 calls to partner. Cessation support for smoking partners
3. Usual care; provider advice and mailed pregnancy-specific S-H


OutcomesAbstinence at w 28 of pregnancy and 12 m postpartum (7-day PP). Also assessed at 8 w, 6 m postpartum
Validation: saliva cotinine requested by mail, no difference in return rates, disconfimation rates not given, only self-reported rates reported


NotesNew for 2009 update
End of pregnancy abstinence amongst baseline quitters, combining interventions 1 and 2 versus control in analysis 1.1. No significant effect of either intervention on end of pregnancy abstinence amongst baseline smokers. 12 m postpartum abstinence for those quit at end of pregnancy in analysis 1.2. Abstinence rates not given separately for those quit at randomization, but ⅔ of end-of-pregnancy quitters came from this category, and the prepartum interventions did not increase cessation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not stated

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding reported

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemical validation conducted but not used in outcome data. "Saliva return rates did not differ by condition at either follow-up", but rates of return low and level of misreport not specified

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskExcludes miscarriages, no other information on losses

Mermelstein 2003

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers for cessation programme


Participants341 quitters at the end of 7 w group cessation programme (non-abstinent subgroup not relevant to this review)
Demographics for all 771: 66% F, av age 43, av cigs/day 23


Interventions1. Tailored proactive telephone counselling calls from counsellor who provided cessation course. 3 weekly then 3 to 6 alternate w, 15 min each
2. Supportive but non-specific proactive counselling calls from counsellor, same schedule


OutcomesAbstinence at 15 m, 7-day PP
Validation: none


NotesAnalysis 4.1 but borderline to pool with other studies because both groups could constitute RP; primarily a test of content. Exclusion does not change finding


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized by cessation group

Allocation concealment (selection bias)Unclear riskNot specified

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Counselors were kept blind to condition until the last group meeting"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation not used, but same intensity of contact in both groups, differential misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk96% of entire study provided data at all follow-ups

Morasco 2006

MethodsSetting: Prenatal clinic, USA
Recruitment: recent quitters


Participants33 pregnant recent quitters (subgroup of trial); av age 22, av cigs/day before quit 13


InterventionsAll participants received prompted provider advice and S-H
1. Individual counselling; 90-min psychotherapy session and bimonthly phone calls from mental health counsellors
2. Usual care


OutcomesAbstinence at end of pregnancy and 6 m postpartum (7-day PP)
Validation: CO ≤ 8 ppm


NotesNew for 2009 update. Baseline smoker results reported separately, not used in this review


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskParticipants lost to follow-up counted as smokers, but numbers lost to follow-up not broken down by group

Niaura 1999

MethodsSetting: Cessation clinic, USA
Recruitment: community volunteers


Participants120 smokers; 50% F, av age 44, av cigs/day 28


InterventionsAll participants received single brief individual counselling session 1 w before TQD and instructed to use ALA S-H manual 'Freedom from smoking for you and your family', CO measured. All interventions used 5 sessions over 2 w post TQD, led by PhD level therapists
1. Cognitive-behavioural with cue exposure (75-min sessions) imagined high-risk settings
2. Cognitive-behavioural with cue exposure and nicotine gum (90 min)
3. Brief cognitive-behavioural. Reviewed progress and reinforced use of S-H manual. (15-min sessions). Control for 1
4. Cognitive-behavioural and nicotine gum (60 min). Control for 2


OutcomesSustained abstinence, 12 m and all previous follow-ups (1, 3, 6 m)
Validation: CO < 8 ppm


NotesTest of imaginary cue exposure for RP. 1 and 2 vs 3 and 4 in analysis 7.1


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not stated

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"Counselors were kept blind to the relapse prevention condition to which subjects were assigned". Pts not blinded, and no placebo

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk80% completed follow-up, no group differences, all included in ITT analysis

Pbert 2004

MethodsSetting: Five community health clinics, USA
Recruitment: Low-income women receiving prenatal care and participating in Special Supplemental Nutrition Programme


Participants168 pregnant recent quitters (subgroup of trial); av age 26, av cigs/day 15 to 18 for whole sample


InterventionsSystem-level intervention
1. Training to implement guideline-based 4 A's approach for obstetric, paediatric and nutrition programme providers in the Community Health Centres, practice management system for screening and prompts, interclinic communication
2. No training, usual care from clinic providers


OutcomesAbstinence at delivery (30-day PP) assessed retrospectively at 1 m postpartum assessment, 6 m postpartum
Validation: saliva cotinine ≤ 20 ppm


NotesNew for 2009 update
Saliva collection was incomplete, and lesser agreement was noted between self-report and cotinine values in intervention group, although difference significant only at final follow-up. Not pooled with other studies. When non-responders were treated as smokers, the OR for not smoking at end of pregnancy was 0.95 (P = 0.95)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized by clinic, method not stated

Allocation concealment (selection bias)High riskClinics recruited participants after randomization, 1 control clinic dropped out because of poor recruitment, 2 clinics enrolled > 50% of participants

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskHigher loss to follow-up in intervention (46/81, 57%) than control (37/77, 48%). ITT analysis reported

Powell 1981

MethodsSetting: Clinic, USA
Recruitment: community volunteers
Therapist: senior author


Participants51 quitters (2 treatment dropouts excluded); 57% F, av age 36, av cigs/day 29


InterventionsAll participants received the same cessation programme in a single group. Introductory meeting and 4 consecutive treatment meetings a week later, 1½ h. Systematic focus on skill development. Also used a novel aversive smoking exercise conducted at each session
Maintenance/RP conditions:
1. 4 w support group (number of meetings not specified)
2. Telephone contact system allowing participants to phone each other
3. No contact control


OutcomesAbstinence at 1 y, not defined
Validation: none


NotesArm 2 not shown in graphs, all arms had similar quit rates


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Randomly assigned' with deviations for scheduling conflict and to separate families and friends

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Low riskSubjects randomly assigned to maintenance condition "at the end of the treatment phase", performance bias during treatment phase not likely

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo biochemical validation used, intensity of contact different between conditions with some in person, differential self-report possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll but one participant contacted at follow-up

Ratner 2000

MethodsSetting: Obstetric wards in 5 hospitals, Canada
Recruitment: postpartum women


Participants251 women who had given up smoking for at least 6 w before delivery; av age 28, av cigs/day 10, 74% first child


Interventions1. Counselling session in hospital + 8 telephone (weekly for 1 m, biweekly for 2 m). Skills training. S-H pamphlets, no-smoking materials. Therapists: trained nurse counsellors
2. Usual care


OutcomesContinuous abstinence 12 m postdelivery
Validation: CO < 10 ppm for participants interviewed in person. Data collectors blind


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'Identification numbers randomly assigned to 2 groups, in blocks of 50, via a computer software package'

Allocation concealment (selection bias)Unclear riskNo details about sequence concealment

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskResearch assistants responsible for outcome assessment were blinded, further details not reported

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used at in-person follow-ups (89% of participants)

Incomplete outcome data (attrition bias)
All outcomes
Low riskDenominator excludes 13 not reached at follow-up. No differential dropout

Razavi 1999

MethodsSetting: Workplaces, Belgium
Recruitment: employee volunteers


Participants993 began cessation programme, 349 abstinent at 3 m, 344 entered RP phase. 38% F, av age 39


InterventionsInitial cessation programme of 7 fortnightly visits. Nicotine patch provided if FTQ score ≥ 5. Only quitters abstinent for 1 m enrolled in RP
1. 10 monthly sessions, incl group discussion and role-play led by professional counsellor
2. 10 sessions of group discussion led by former smokers
3. No RP


OutcomesAbstinence for 9 m from start of RP programme
Validation: CO < 10 ppm and urine cotinine≥ 317 ng/mL required
(Rates for CO and self-report alone also reported; higher than for doubly validated rates)


NotesInterventions 1 and 2 combined in analysis 4.1. Separate quit rates: Intervention 1. 59/135 (44%); Intervention 2. 33/88 (37.5%), difference not statistically significant


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCluster-randomized by company, using random number and blinded list

Allocation concealment (selection bias)Low riskCompany allocation blinded and participants recruited before randomization

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo blinding reported but randomization once achieved cessation and cluster randomization by worksite, performance bias unlikely

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow-up not reported, all randomly assigned participants included in analyses

Reitzel 2010

MethodsSetting: Texas, USA

Recruitment: pregnant women recruited through local health system or community advertisements


Participants251 low-income women who quit smoking during pregnancy

Av age 24.6, av cpd 10.2 pre-quit, 92.4% quit smoking approx 8 w after pregnancy


InterventionsAll participants received self-help materials and 5 to 10 min of US guideline-based brief relapse prevention advice

1. MAPS: 6 telephone-based counselling sessions at w 34 and 36 prepartum and at w 2, 4, 7 and 16 postpartum, using combined motivational enhancement and social cognitive approach

2. MAPS+: As per 1, plus 2 additional in-person counselling sessions at baseline and at w 8 postpartum

3. Control: usual care


OutcomesContinuous abstinence at 8 and 26 w postpartum (defined as no smoking since delivery date)

Validation: CO < 10 ppm and/or cotinine < 20 ng/mL


NotesNew for 2013 update

80% of intervention participants received at least 4 calls

MAPS and MAPS+ combined for analysis in trial report; groups did not differ on baseline characteristics, completed calls, session length or percentage of participants abstinent

Number abstinent not provided, extrapolated from percentages given in trial report


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Following baseline data collection, participants were randomized by computer… using minimization"

Allocation concealment (selection bias)Low riskCentralised, see above

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding: "Neither participants nor research personnel was blind to treatment condition assignment following randomization"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSmoking status biochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow-up counted as smokers in ITT analysis. Similar rates of dropout across groups (UC 23%; MAPS 32%; MAPS+ 24%)

Ruger 2008

MethodsSetting: Obstetric clinics, USA
Recruitment: pregnant women who smoked or had quit within 3 months of baseline


Participants57 pregnant recent quitters (subgroup of trial), av age of whole sample 26


Interventions1. Motivational interviewing at home visits (average 3). Tailored to stage of change, S-H materials
2. Usual care


OutcomesQuit at 6 months postpartum
Validation: salivary cotinine, but cutoff and percentage validated not specified


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod not described

Allocation concealment (selection bias)High riskNo details given, but higher proportion of recent quitters in control (23%) than intervention (15%) suggests possible selection bias

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk"Smoking status was verified biochemically by collecting saliva samples for saliva cotinine analysis", unclear whether validation completed, confirmation rates not reported

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts not included in reported denominators, included as smokers in meta-analysis

Schmitz 1999

MethodsSetting: Hospital, USA
Recruitment: women with or at risk of coronary artery disease (CAD)


ParticipantsTwo separate samples recruited:
1. 53 inpatients with CAD who stopped smoking during hospitalisation and wanted to stay quit
2. 107 women volunteering for cessation treatment who had > 1 CAD risk factor
Therapists: 2 smoking counsellors and 2 clinical psychology interns


Interventions1. Coping skills RP, 6 × 1 h, incl stress management, homework
2. Health Belief model, 6 × 1 h smoking-related health information related to disease state or CAD profile. Focus on benefits of stopping


OutcomesPP abstinence at 6 m
Validation: CO < 9 ppm, urine cotinine < 10 ng/mL
Not all quitters tested, confirmation rates not reported


NotesInpatient subgroup in quitters section, analysis 2.1; CAD risk group in trials in smokers, matched control section, analysis 7.1
Quit rates were lower in the CAD sample than in the at-risk group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemical validation used, but not all quitters tested and confirmation rates not reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskPostrandomization dropouts who did not complete baseline and begin treatment were not included in any data, other losses to follow-up counted as smokers

Schroter 2006

MethodsSetting: Four workplaces, Germany
Recruitment: volunteer employees


Participants79 smokers (≥ 10 cigs/day); 42% F, av age 40, av cigs/day 24


InterventionsBoth conditions provided 6 × 90 min sessions over 8 w in groups of 8 to 12 led by qualified providers
1. RP; skills training, planning and practising coping strategies
2. Standard behavioural cessation course with focus on positive changes obtained through abstinence. Included self-monitoring, environmental cue control, problem-solving skills


OutcomesContinuous abstinence at 12 m, not defined further
Validation: none


NotesNew for 2009 update
Compares RP with matched standard programme


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized, 2 groups in each workplace, researchers randomly assigned 1 to each condition, no further details

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot specified

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo validation used, but similar amount of interaction in both groups suggests differential misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk47% attrition reported, but all participants included in analyses

Secker-Walker 1995

MethodsSetting: Private and public prenatal clinics, USA
Recruitment: women at 1st prenatal visit


Participants165 women previously smoking 1+ cigs/day who had quit since start of pregnancy (excludes 10 adverse pregnancy outcomes)
Av age 25


Interventions1. Individual counselling focusing on pros and cons, problem solving, skills rehearsal. 10 to 15 min at 1st, 2nd and 3rd prenatal visit, 36 w and 6 w postpartum. (93% received postpartum session)
2. Usual care control


OutcomesAbstinence at 36 w pregnancy (analysis 1.1) and at 8 to 54 m postpartum (analysis 1.2). Follow-up point varied
Validation: at 36 w, cotinine/creatinine ratio > 80 ng/mg, but some missing data, no validation postpartum


NotesSensitivity analysis excluding losses to follow up does not alter results


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomization method not stated

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given, possible care providers were aware of participants' assignment

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskSelf-report used postpartum and for some women at 36 w ("We included the 40 women who reported not smoking, but were missing 36-week cotinine/creatinine ratios, in the non-smoking group, rather than count them as having relapsed".) Reason for missing validation data at 36 w not reported, group assignment of participants missing data not clear, differential misreport possible

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo significant differences in loss to follow-up at 1 y (35%). Numbers randomly assigned used in analyses, but restricting to numbers available for follow-up does not alter findings

Secker-Walker 1998

MethodsSetting: Prenatal clinic, USA
Recruitment: women at 1st prenatal visit


Participants116 women previously smoking 1+ cigs/day who self-reported quitting since start of pregnancy (excludes 9 adverse pregnancy outcomes). 19 of the women showed evidence of smoking at 1st prenatal visit


Interventions1. Structured intervention from physician, individual counselling by nurse counsellor, 1st, 2nd, 3rd, 5th, 36 w prenatal visits
2. Usual care from physician, prompted at 1st visit


OutcomesSustained abstinence at 36 w pregnancy (analysis 1.1), 1 y postpartum (analysis 1.2)
Validation: CO ≤ 6 ppm at 36 w, also urine cotinine ≤ 500 ng/mL but some missing data


NotesProcess analysis showed counselling to have been received fairly consistently but fell to 66% at 5th visit


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used at 36 w and differential misreport not identified. Similar rates abstinent at 1 y postpartum, differential misreport not likely at final follow-up

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo significant differences in loss to follow up at 1 y (33%). Numbers randomly assigned, excl adverse pregnancy outcomes used in denominators

Segan 2011

MethodsSetting: Victoria, Australia Quitline

Recruitment: callers to Quitline


Participants698 smokers or recent ex-smokers calling Victoria, Australia, Quitline and abstinent for at least 1 w (1444 randomly assigned, but study conducted only in those achieving abstinence)

54% F, av age 37, av cpd 21


InterventionsParticipants received same callback service before quitting and same service in first month postquit (revised version of standard Quitline service: 4 calls in first m postquit to help deal with daily cravings and withdrawal). Service based on 3 Tasks of Quitting Framework. Both groups receive counselling for first 2 tasks

1. 4 to 6 additional calls 1 to 3 m post quitting to actively assist with learning to enjoy and value a smoke-free lifestyle (task 3), initiated when participant reported less than daily cravings or completed 4 standard calls (whichever came first)

2. No additional calls


Outcomes12 m continuous abstinence

Validation: none


NotesNew for 2013 update

n not provided, data extrapolated from percentages given. Only those participants abstinent for 1 w or longer included in final analyses

74% of intervention grp received extra calls, on av 1.7 more calls postquit than control group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomization was controlled by an automated function in the Quitline client management database"

Allocation concealment (selection bias)Low riskCentralised, see above

Blinding of participants and personnel (performance bias)
All outcomes
High risk"Follow-up interviewers were blinded to participant treatment condition, although for the four-month follow-up blinding was lost…" Participant and provider unblinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo biochemical validation, but no face-to-face contact, so differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskSimilar rate lost to follow-up in both groups (28% control; 30% intervention), participants lost to follow-up counted as smokers. Analysis excluding participants lost to follow-up did not affect final comparisons

Other biasHigh riskProbable lack of differentiation between the two conditions and risk of contamination: “In practice, the first couple of integration callbacks typically replaced the last call or two of the standard service (rather than adding on to it)…. Usual care participants received on average 2.2. calls after reaching the point of less than daily cravings, which provided ample opportunity for contamination...”

Severson 1997

MethodsSetting: 49 private paediatric practices, USA
Recruitment: mothers attending for well baby visits


Participants1026 ex-smoking mothers (intervention also given to smoking mothers, not relevant to this review)
Therapists: paediatricians.
25 intervention practices, 23 control


Interventions1. Information pack, including a letter from paediatrician on risks of passive smoking, provided by birth hospital, and extended support (counselling plus follow-up at 2, 4 and 5 m visits) and materials (incl video tape, written materials, signs, magnets, bib)
2. Information pack only


OutcomesSustained abstinence at 12 m (7-day PP at 6 and 12 m)
Validation: none


NotesStudy design allowed for clustering in calculating sample size. ICC proved to be low. Use of a corrected odds ratio, which did not show a significant benefit, did not change conclusions (sensitivity analysis using inverse variance)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster-randomized by practice, method not described

Allocation concealment (selection bias)Unclear riskMethod of allocating practices not described. All eligible patients enrolled in study, "because the survey information was anonymous, and because smoking counselling was considered to be standard medical practice, the study was exempted from the requirements for obtaining informed consent"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants not aware enrolled in study, so blinding not applicable. Unclear whether study personnel (administering surveys) were blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo biochemical validation but cluster-randomized by practice, followed up anonymously via survey, differential misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow-up (31% in each group) assumed to have relapsed, attrition analyses performed

Sheffer 2010

MethodsSetting: Quitline for Arkansas, USA

Recruitment: all participants calling the Quitline within a set amount of time were included


ParticipantsAll Arkansas Quitline callers whose primary form of tobacco use was smoking who ended treatment (completing treatment or ending prematurely) within the set period and did not re-enter counselling within 2 years of index episode (n = 892)

35% M, av age 43, av cpd not specified, mean FTND 7


Interventions1. Intervention: 8 "Forever Free" booklets (aimed at relapse prevention) mailed to all Quitline callers who ended treatment (within given 6 w period)

2. Nothing mailed to callers (all participants who consecutively ended treatment 1 month before or 1 month after intervention group)

All participants received standard Quitline service (av 6 weekly structured CBT sessions 20 to 30 min each); nicotine patches provided free of charge


Outcomes7 d PP at 6 m after discontinuation of treatment

Validation: none


NotesNew for 2013 update

Quasi-randomized; baseline imbalances between groups, adjusted OR available

Intervention did not improve quit rates for participants receiving at least 1 session of counselling and nicotine patches but doubled abstinence rate for those unwilling/unable to receive nicotine patches at 6 m

n not provided, extrapolated from percentages reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuasi-randomized. "The 'Forever Free' booklets were mailed to all quitline callers who ended treatment during a six-week period. For comparison, we included quitline callers whose treatment ended during the months immediately prior and succeeding the 6-week intervention period"

Allocation concealment (selection bias)High riskSee above

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Quitline staff including tobacco treatment specialists and follow-up interviewers were unaware that some participants had received additional materials"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskNo biochemical validation but no additional personalised contact received by intervention group, so differential levels of misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskSimilar rates of dropout in both groups (34.7% intervention, 40.0% control); participants lost to follow-up counted as smokers

Shoptaw 2002

MethodsSetting: Three narcotics treatment centres, USA
Recruitment: volunteers on methadone maintenance


Participants175 smokers (≥ 10/day); 33% F av age 43 to 45, av cigs/day approx 22


InterventionsAll participants received 21-mg nicotine patch for 12 w. Factorial design crossing contingency management, arms collapsed
1. Group counselling: 12 × 1 h weekly sessions, incl mood management
2. Control: NRT alone


OutcomesPP abstinence at 12 m
Validation: CO ≤ 8 ppm, urine cotinine < 30 ng/mL


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization using urn technique

Allocation concealment (selection bias)Low riskNot described but use of urn technique makes it probable that allocation concealed

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskNumber lost to follow-up not reported, but all missing included as smokers, and study reports, "no statistically significant differences across the four treatment conditions for breath samples and urine samples"

Smith 2001

MethodsSetting: Clinic, USA
Recruitment: community volunteers


Participants677 smokers (> 10/day) attempted quit for 1 w; 57% F, av age 42; av cigs/day approx 25


InterventionsAll participants had attended 3 brief (5 to 10 min) individual counselling sessions pre-quit, quit day and 8 days post TQD, + nicotine patches (8 w) + NCI booklet, 'Clearing The Air'
1. Cognitive-behavioural skills training, × 6 from 1 w post TQD, incl managing negative affect, homework, manual
2. Motivational interviewing, supportive group counselling, × 6 from 1 w post TQD. No homework or manual
3. No further intervention


OutcomesAbstinence at 12 m (7-day PP)
Validation: CO < 10 ppm


Notes1 versus 3 in analysis 4.1, including 2, does not alter findings; 17.6% quit in 1, 18.8% in 2. No evidence found for hypothesised differences in relative efficacy for smokers at high or low risk of relapse. High-risk smokers expected to do better with motivational intervention


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomly assigned 1 w after TQD, stratified by ± any smoking post TQD. Method not stated

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants randomly assigned after receiving pre-quit interventions. No further details provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBiochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow-up not reported, all missing included as smokers

Stevens 1989

MethodsSetting: HMO, USA
Recruitment: HMO member volunteers


Participants587 smokers who successfully abstained from smoking for 4 days after a 4-day intensive cessation programme


InterventionsBoth group conditions met for 3 × 2 h weekly meetings
1. Skills condition. Development and active rehearsal of coping strategies
2. Discussion condition. Social support meetings without rehearsal of strategies
3. No further treatment control


OutcomesAbstinence at 1 y, no tobacco use in previous 6 m
Validation: saliva thiocyanate < 0.8 mg/mL or cotinine < 5 ng/mL


NotesStudy hypothesis that discussion control would not increase rates, so in main analysis 1 versus 2 + 3


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskPredetermined random number list

Allocation concealment (selection bias)Unclear riskNot explicit that list concealed, although likelihood of selection bias judged to be small

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskSubjects randomly assigned after initial treatment phase, no further information provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical validation used. Staff following up non-attenders at 1 y meeting blind to treatment assignment

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up 6.6% overall, non-significantly higher in control. Dropouts included in analysis

STRATUS-WW 2006

MethodsSetting: Australia, Canada, USA, setting type not reported but presumably clinic
Recruitment: not stated


Participants5055 adult smokers (> +18) motivated to quit. Randomly assigned to rimonabant 5 mg (N = 2026) or rimonabant 20 mg (N = 3029)
50% M, 88.8% W, mean age 44.1, av CPD 23.6, mean y smoking 24.1, mean quit attempts 4.1, mean FTND score 5.4, 31.7% with FTND score > 7. Mean BMI 27.8


InterventionsPhase 1: cessation trial: participants randomly assigned to rimonabant 5 mg [R5] (N = 2026) or rimonabant 20 mg [R20] (N = 3029) for 10 w, with TQD at day 15. Cessation rates at EoT: R5: 644/2026 (31.8%); R20 1017/3029 (33.6%), difference non-significant; Quitters eligible for phase 2 if: (a) self-reported abstinence for 7+ days, (b) CO ≤ 10 ppm, and (c) compliance level of 80%+ in last 4 w of phase 1
Phase 2: Relapse prevention: re-randomly assigned 644 quitters in R5 group to (i) R5 (N = 322) or (ii) placebo (N = 322), and 1017 quitters in R20 group to (i) R5 (N = 335) or (ii) R20 (N = 340) or (iii) placebo (N = 342). All groups received treatment for a further 42 w.
Behavioural support: not reported


OutcomesPrimary outcome: time to relapse for quitters from w 10 to 32. Relapse defined as ≥ 7 consecutive days of smoking (even a puff), or ≥ 2 consecutive days with ≥ 5 cigs (even a puff) smoked per day
Long-term follow up: 52 w, 104 w
Secondary outcome: time to relapse for quitters from w 10 to 52
Other outcomes: weight change; fasting HDL-cholesterol, triglycerides; safety, adverse events
Validation: phase 1: expired CO < 10 ppm; phase 2: not reported


NotesNew for 2013

Two-year follow-up data were not reported. Results not published and hence are limited, data not available on phase 1 R5 group
Trial was funded by the manufacturer, Sanofi Aventis

Percentage abstinent at 12 m very similar in R5 and R20 phase II groups (41.8 vs 41.5), combined in meta-analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"Double-blind", no further information provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information reported

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot reported

Tonstad 2006

MethodsSetting: Cessation clinics in 7 countries. 6 sites in United States
Recruitment: smokers of ≥10/day for cessation phase


Participants1210 adults previously smoking ≥ 10/day, quit for at least 1 w after 12 w open-label varenicline


Interventions1. Varenicline 1 mg × 2 daily for 12 w with 5 clinic visits
2. Placebo


OutcomesSustained abstinence for 9 m at 1 y
Validation: CO ≥ 10ppm


NotesThe quit rate after the open-label phase was 64%


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentralised computer-generated randomization

Allocation concealment (selection bias)Low riskBased on use of centralised allocation

Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Double-blind treatment phase"; "participant blinding was maintained during this [non-treatment follow-up] phase"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDouble-blind and biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskHigher loss to follow-up in controls due to relapse, dropouts counted as smokers

van Osch 2008

MethodsSetting: participants in national Quit and Win contest, Netherlands

Recruitment: e-mail to Quit and Win participants


Participants1566 participants in national Quit & Win contest (daily smokers, smoking for at least 1 year, 18 years or older)

60.8% F, av age 36.2, av cpd 18.5, average length of smoking 19.1 years


InterventionsQuit and Win contest includes 1 m cessation period, incl computer-tailored cessation advice and telephone counselling

Intervention: participants asked to formulate three coping plans when completing baseline survey

Control: baseline survey only (not prompted to formulate coping strategies)


OutcomesContinuous abstinence and 7 days PP at 7 m

Validation: none, although participants had buddies and were informed that biochemical abstinence would be performed for contest winners


NotesNew for 2013 update

Unclear how abstinence data were obtained

Including only respondents increases evidence of effect


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk"Based on odd or even registration numbers"

Allocation concealment (selection bias)Unclear riskCentralised, but unclear whether participants aware of their registration numbers

Blinding of participants and personnel (performance bias)
All outcomes
Low riskNo blinding reported, but because of the nature of the intervention, performance bias unlikely

Blinding of outcome assessment (detection bias)
All outcomes
Low risk'Buddy' validation and knowledge of biochemical validation would be used for any contest winners, nature of intervention makes differential misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
High riskVery high rates of dropout at 7 m (64% control, 63% intervention). "The relatively high attrition suffered across the two follow-up measurements may restrict validity of the results and may have caused biases in reported abstinence rates"

Van't Hof 2000

MethodsSetting: Six hospitals, USA
Recruitment: women at time of delivery


Participants277 women who had quit during pregnancy, cotinine verified as not smoking at recruitment (excludes 10 not followed up for a variety of reasons). Av age 25, previous cigs/day not reported. 65% were very confident of remaining quit


Interventions1. 15 to 30 min of RP counselling from Visiting Nurse after baseline interview. Reinforcement by paediatric care provider at 2 w, 2 m, 4 m well baby clinics, written materials. Chart sticker used to prompt intervention
2. Usual care, baseline assessment from Visiting Nurse


OutcomesAbstinence at 6 m (assume PP)
Validation: none (assessment by phone, no details of blinding of assessor)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details given

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo biochemical validation, intervention participants received more face-to-face contact than control group, no details of blinding of assessor, differential misreport possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskA sensitivity analysis including losses to follow-up does not change direction or significance of effect

Wetter 2011

MethodsSetting: Seattle, WA, USA

Recruitment: community volunteers


Participants302 female smokers, 18 to 70 years old, smoking at least 10 cpd

Av age 43, av cpd 20.6, av FTND 5.2


InterventionsAll participants received 6 w nicotine patch (21 mg/d); 2 group counselling sessions pre-quit and three postquit (through day 7); ecological momentary assessment (EMA) procedures for week immediately following quit date

1. 1 m computer-delivered treatment (CDT) on palmtop computers (3 modules: managing urge, treatment info and motivational messages) and EMA

2. EMA only for 1 m postquit date


OutcomesRepeated 7 days PP (day 35, month 6, month 12)

Validation: CO < 10 ppm


NotesNew for 2013 update

Trial report provides only OR and adjusted OR (no raw data), n provided by authors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"the study biostatistician generated the randomization sequence"

Allocation concealment (selection bias)Unclear riskMethod not specified

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding not specified, unclear whether participants aware of additional element offered to intervention group

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSmoking status biochemically validated

Incomplete outcome data (attrition bias)
All outcomes
Low riskDropouts counted as smokers in ITT analysis, similar number lost to follow-up in each group at 12 m (21 dropouts control, 19 dropouts treatment)

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Adams 2011Only 2 months follow-up

Allen 2007Only 12 w follow-up

Alterman 2001Considered for inclusion because comparison of different intensity interventions. No mention of RP

Bottausci 1995Small trial, < 10 participants per condition

Brown 2001Considered for inclusion because comparison of different intensity interventions. Intervention focus was on use of CBT for treatment of depression. Relapse mentioned only in text

Carmody 1988Only 3 m follow-up reported. No significant differences at this point

Cinciripini 2000Not possible to distinguish RP from cessation components

Copeland 2006Evaluated a weight management programme for preventing relapse; see separate Cochrane review

Davis 1995Short follow-up, only 12 participants

DiSantis 2010Pilot study with only 1 m follow-up

Dooley 1992Only 3 m follow-up reported. No significant differences at this point

Dubren 1977Only 1 m follow-up reported

Dunphy 2000Only 4 to 8 w follow-up after delivery and intervention

Elfeddali 2012Participants randomly assigned before quitting, no cessation intervention provided to controls, so test of an Internet cessation programme. Not RP

Evins 2011Only 60-day follow-up

Feeney 2001Not explicitly described as an RP intervention, and the control condition has low implementation of the basic cessation programme

French 2007Not randomized

Froelicher 2000Describes a trial in progress, no intervention results

Garvey 2012Considered for inclusion because of frontloading of counselling sessions in one group. No mention of RP

George 2000Tested a specialised group therapy intervention for people with schizophrenia compared with a standard programme. Included other components in addition to RP

Goldstein 1989Considered for inclusion because comparison of different intensity interventions. No mention of RP

Gruder 1993Not possible to distinguish between RP and cessation components

Hall 1994Considered for inclusion because comparison of different intensity interventions. Primary focus was on CBT for depression as adjunct to cessation intervention. No mention of RP

Hall 1996Considered for inclusion because comparison of different intensity interventions. Primary focus was on mood management as adjunct to cessation intervention. No mention of RP

Hall 1998Considered for inclusion because comparison of different intensity interventions. No mention of RP

Hall 2011Considered for inclusion because study evaluates extended therapy. Not RP

Klesges 1987Randomization and analysis by worksite, number of individuals in each treatment condition not given. A non-significant difference favoured RP

Lando 1997Considered for inclusion because comparison of different intensity interventions. No mention of RP

Macleod 2003Considered for inclusion because comparison of different intensity interventions. No mention of RP

Miller 1997Hospital intervention included RP components but excluded because no information on smoking status of participants, and intervention similar in other respects to other inpatient trials. Also compared 2 intensities of telephone follow-up but these were not described as RP

Phillips 2012Only 8 w follow-up

Reid 1999Considered for inclusion because comparison of different intensity interventions. No mention of RP

Solomon 2000Considered for inclusion because comparison of different intensity interventions. No mention of RP

Storro 2008Controlled cohort study of postpartum intervention, not randomized

Tonstad 2013Test of vaccine versus placebo. Effect of pharmacotherapy postquit confounded with pharmacotherapy before quitting

Yoon 2009Only 2 w follow-up

Zelman 1992Considered for inclusion because comparison of different intensity interventions. No mention of RP

 
Characteristics of ongoing studies [ordered by study ID]
Jung 2010

Trial name or titleGetting Physical on Cigarettes - Smoking Cessation & Relapse Prevention

MethodsRCT

Participants420 adult female smokers smoking more than 10 cpd for past 2 years

InterventionsFollowing a 14-week supervised exercise programme, randomly assigned to one of four 'home-based' conditions: (a) exercise maintenance, (b) exercise maintenance plus relapse prevention booklet, (c) relapse prevention booklets plus contact, (d) contact only

OutcomesPrimary outcome is continuous abstinence at 3 and 12 months after the initial 14-week treatment programme

Starting dateOctober 2009

Contact informationDr Harry Prapavessis, hprapave@uwo.ca

NotesNCT01305447

NCT00621777

Trial name or titleA study of varenicline for prevention of relapse to smoking in patients with schizophrenia

MethodsRandomized double-blind placebo-controlled trial

Participants274 smokers with schizophrenia or schizoaffective disorder

Interventions12 weeks open-label varenicline, + 40 weeks randomly assigned to varenicline or placebo

Outcomes7-Day PPA at w 53 (12 w cessation treatment + 40 w relapse prevention treatment), safety/efficacy

Starting dateFebruary 2008

Contact informationAE Evins

Notes

Williams 2011

Trial name or titleThe Smoker's Health Project

MethodsPragmatic comparative effectiveness trial of three self-determination theory (SDT)-based intensive tobacco dependence interventions

Participants818 smokers 18 or older who have smoked at least 100 cigs in lifetime and 5+ cpd over past 4 w

Interventions1. Community care (6 m SDT-based intervention)

2. Extended need support (SDT intervention extended to 12 m, important other trained)

3. Harm reduction (as per 2 + recommends medication use for participants who do not want to stop smoking completely
within 30 d but who are willing to reduce their cigarette use by half)

OutcomesPrimary outcome is prolonged tobacco abstinence at 1 year posttreatment (2 years post randomization)

Starting dateNot specified

Contact informationGeoffrey Williams, Geoffrey_Williams@URMC.Rochester.edu

NotesNCT00178685

 
Comparison 1. Behavioural interventions for abstinent pregnant/postpartum women

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

 1 Not smoking at delivery/ last follow-up prior to delivery81523Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.98, 1.11]

    1.1 Self-help intervention
1171Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.91, 1.21]

    1.2 Individual counselling
5641Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.89, 1.15]

    1.3 Telephone counselling
2711Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.99, 1.15]

 2 Not smoking at longest follow-up after delivery123524Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.99, 1.19]

    2.1 Intervention during pregnancy
5690Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.82, 1.23]

    2.2 Intervention initiated during pregnancy and continued post partum
4989Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.94, 1.33]

    2.3 Intervention initiated after birth
41845Risk Ratio (M-H, Fixed, 95% CI)1.10 [0.96, 1.25]

 
Comparison 2. Behavioural interventions for abstinent hospitalised smokers

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

 1 Cessation at longest follow-up3667Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.78, 1.13]

 
Comparison 3. Behavioural interventions for unaided abstainers

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

 1 Cessation at longest follow-up53561Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.98, 1.19]

 
Comparison 4. Behavioural interventions for assisted abstainers

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

 1 Cessation at longest follow-up51462Risk Ratio (M-H, Fixed, 95% CI)1.00 [0.87, 1.15]

 
Comparison 5. Pharmacotherapy for unaided abstainers

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

 1 Cessation 12m after quit date22261Risk Ratio (M-H, Fixed, 95% CI)1.24 [1.04, 1.47]

    1.1 Nicotine gum vs placebo after brief unassisted abstinence
22261Risk Ratio (M-H, Fixed, 95% CI)1.24 [1.04, 1.47]

 
Comparison 6. Pharmacotherapy for assisted abstainers

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

 1 Nicotine replacement therapy versus placebo. Cessation 12 m+ after quit date2553Risk Ratio (M-H, Fixed, 95% CI)1.04 [0.77, 1.40]

    1.1 16 w nicotine gum vs. placebo
1143Risk Ratio (M-H, Fixed, 95% CI)1.44 [0.77, 2.69]

    1.2 16 w nicotine gum + bupropion vs. placebo gum + bupropion
1146Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.59, 1.56]

    1.3 9 m nicotine inhaler vs. placebo
1168Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.54, 1.72]

    1.4 9 m nicotine inhaler + bupropion vs. placebo inhaler + bupropion
196Risk Ratio (M-H, Fixed, 95% CI)0.86 [0.39, 1.93]

 2 Bupropion vs. placebo. Cessation 12 m+ after quit date61697Risk Ratio (M-H, Fixed, 95% CI)1.15 [0.98, 1.35]

    2.1 52w bupropion vs placebo
1110Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.60, 1.55]

    2.2 45w bupropion vs placebo
1429Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.82, 1.51]

    2.3 24w bupropion vs placebo
1176Risk Ratio (M-H, Fixed, 95% CI)1.46 [0.77, 2.77]

    2.4 16w bupropion vs placebo
1144Risk Ratio (M-H, Fixed, 95% CI)1.72 [0.95, 3.12]

    2.5 16w bupropion + nicotine gum vs placebo + nicotine gum
1145Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.68, 1.92]

    2.6 9m bupropion vs placebo
1141Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.64, 1.84]

    2.7 9m bupropion + placebo inhaler vs double placebo
197Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.40, 1.68]

    2.8 9m bupropion + nicotine inhaler vs placebo + nicotine inhaler
193Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.43, 2.39]

    2.9 14w bupropion vs placebo
1362Risk Ratio (M-H, Fixed, 95% CI)1.19 [0.84, 1.68]

 3 Combination NRT & bupropion vs placebo. Cessation at longest follow-up2243Risk Ratio (M-H, Fixed, 95% CI)1.18 [0.75, 1.87]

 4 Varenicline vs placebo. Cessation 12 m+ after quit date1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Rimonabant vs placebo. Cessation 12 m+ after quit date1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 7. Behavioural interventions for smokers. RP vs. cessation, matched for programme length

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

 1 Group or individual format therapy (+/- adjunct pharmacotherapy), cessation at longest follow-up10872Risk Ratio (M-H, Fixed, 95% CI)0.91 [0.73, 1.13]

 2 Self-help format, cessation at longest follow-up191Risk Ratio (M-H, Fixed, 95% CI)1.52 [0.67, 3.46]

 
Comparison 8. Behavioural interventions for smokers. RP vs. cessation, different intensity programmes

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

 1 Cessation at longest follow-up7699Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.80, 1.27]

    1.1 More than four sessions for control group
5546Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.70, 1.23]

    1.2 Four sessions or less for control group
2153Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.81, 1.86]

 
Comparison 9. Interventions for smokers, tests of adjuncts to cessation programmes

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

 1 Behavioural interventions, cessation at longest follow-up5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Additional proactive telephone contact
22527Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.90, 1.23]

    1.2 Additional web-based support
1284Risk Ratio (M-H, Fixed, 95% CI)1.27 [0.70, 2.31]

    1.3 Additional computer-delivered intervention
1302Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.64, 1.35]

    1.4 Formulation of coping strategies
11566Risk Ratio (M-H, Fixed, 95% CI)1.27 [0.97, 1.67]

 2 Combined behavioural and pharma interventions, cessation at longest follow-up1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Additional proactive telephone counselling + NRT
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Summary of findings for the main comparison. Behavioural interventions for assisted abstainers

Behavioural interventions for relapse prevention for people who have quit smoking using a cessation intervention

Patient or population: people who have quit smoking using a cessation intervention
Intervention: behavioural interventions for relapse prevention

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

Assumed riskCorresponding risk

ControlBehavioural interventions for relapse prevention

Smoking cessation
Follow-up: 9 to 15 months
Study population (average)1 RR 1
(0.87 to 1.15)
1462
(5 studies)
⊕⊝⊝⊝
very low2,3,4

300 per 1000300 per 1000
(261 to 345)

*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.

 1Control group cessation rate calculated as crude average of quitters in control groups across all studies that randomly assigned abstainers.
2Majority of included studies judged to be at unclear or high risk of bias in two or more domains.
3Moderate unexplained statistical heterogeneity (I2 = 56%).
4Total number of events < 300.
 
Summary of findings 2. Pharmacotherapy for assisted abstainers

Pharmacotherapy for relapse prevention for people who have quit smoking using a cessation intervention

Patient or population: people who have quit smoking using a cessation intervention
Intervention: pharmacotherapy for relapse prevention

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

Assumed riskCorresponding risk

ControlPharmacotherapy for relapse prevention

NRT versus placebo. Smoking cessation
Follow-up: 12 to 15 months
Study population (average)2 RR 1.04
(0.77 to 1.4)
553
(2 studies)
⊕⊕⊝⊝
low1

300 per 1000312 per 1000
(231 to 420)

Bupropion versus placebo. Smoking cessation
Follow-up: 12 to 24 months
Study population (average)2 RR 1.15
(0.98 to 1.35)
1697
(6 studies)
⊕⊕⊕⊝
moderate3

300 per 1000345 per 1000
(294 to 405)

Combination NRT & bupropion versus placebo. Smoking cessation
Follow-up: 12 to 15 months
Study population (average)2 RR 1.18
(0.75 to 1.87)
243
(2 studies)
⊕⊕⊝⊝
low1

300 per 1000354 per 1000
(225 to 561)

*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.

 1Total number of events < 100.
2 Control group cessation rate calculated as crude average of quitters in control groups across all studies that randomly assigned abstainers.
3Total number of events < 300.