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Individual behavioural counselling for smoking cessation

  1. Tim Lancaster*,
  2. Lindsay F Stead

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 20 APR 2005

Assessed as up-to-date: 14 JUL 2008

DOI: 10.1002/14651858.CD001292.pub2


How to Cite

Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD001292. DOI: 10.1002/14651858.CD001292.pub2.

Author Information

  1. University of Oxford, Department of Primary Health Care, Oxford, UK

*Tim Lancaster, Department of Primary Health Care, University of Oxford, Rosemary Rue Building, Old Road Campus, Oxford, OX3 7LF, UK. tim.lancaster@dphpc.ox.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 APR 2005

SEARCH

 
Characteristics of included studies [ordered by study ID]
Ahluwalia 2006

MethodsSetting: Community health centre, USA
Recruitment: community volunteers interested in quitting


Participants755 African American light smokers (<= 10 cpd)
67% female, av. age 45, av. cpd 8
Therapists: trained counsellors


InterventionsFactorial trial, 2mg nicotine gum/placebo arms collapsed for this review
1. Counselling using Motivational Interviewing (MI) approach. 3 in-person visits at randomization, wk1, wk8, and phone contact at wk3, wk6, wk16, S-H materials.
2. Counselling using Health education (HE) approach. Same schedule & materials as 1.


OutcomesPP abstinence at 6m (7 day PP)
Validation: cotinine <=20 ng/ml


NotesNew for 2008. Not in main analysis; compares two counselling styles. No significant effect of gum, no evidence of interaction.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskCentrally generated blocked scheme, block size 36

Allocation concealment?Low riskSealed envelopes opened sequentially

Blinding?
All outcomes
Unclear riskStaff & participants blind to pharmacotherapy but not to type of counselling

Incomplete outcome data addressed?
All outcomes
Low risk118 (15.6%) lost to follow-up included in ITT analysis. HE participants less likely to be lost. Alternative assumptions about losses did not alter conclusions. Low level of cotinine validation.

Aleixandre 1998

MethodsSetting: Primary care clinic, Spain
Recruitment: clinic & community volunteers


Participants48 smokers (excludes 6 dropouts)
65% female, av. age 36, av. cpd 24-27
Therapist: unclear, primary care clinic staff


Interventions1. 'Advanced', 4 x30 min over 4 wks, video, cognitive therapy, social influences, relapse prevention
2. 'Minimal' 3 min advice immediately after randomization


OutcomesAbstinence at 12m
Validation: no biochemical validation


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskStratified on cigarette consumption & age, block size 4.

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskStaff not blind, unclear for participants

Incomplete outcome data addressed?
All outcomes
Low risk6 post-randomization dropouts excluded from ITT analyses. Their inclusion would marginally increase effect size.

Alterman 2001

MethodsSetting: cessation clinic, USA
Recruitment: community volunteers


Participants240 smokers of > 1 pack/day
45-54% female, av. age 40, av. cpd 27
Therapists: Nurse practitioners (NP) and trained counsellors


InterventionsAll interventions included 8 wks nicotine patch (21 mg with weaning)
1. Low intensity. Single session with NP.
2. Moderate intensity. as 1 plus additional 3 sessions at wks 3,6,9 with NP.
3. High intensity. As 2. + 12 sessions cognitive behavioural therapy with trained therapist within 15 wks.


OutcomesAbstinence at 1 yr
Validation: urine cotinine < 50ng/ml, CO <= 9ppm


Notes3 vs 2+1 in intensive versus minimal intervention, but sensitivity analysis.
Quit rates significantly lower in 2 than 1 or 3


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'Urn technique'

Allocation concealment?Unclear riskNo details given. Allocation took place after baseline session common to all conditions

Blinding?
All outcomes
Unclear riskStaff not blind, unclear for participants

Incomplete outcome data addressed?
All outcomes
Low risk30 (12.5%) lost to follow up included in ITT analysis

Aveyard 2007

MethodsSetting: 26 general practices (primary care clinics), UK
Recruitment: 92% volunteers in response to mailings


Participants925 smokers
51% female, av. age 43, 50% smoked 11-20 cpd
Therapists: Practice nurses trained to provide cessation support & manage NRT


InterventionsBoth interventions included 8 wks 16mg nicotine patch
1. Basic support; 1 visit (20-40 mins) before quit attempt, phone call on TQD, visits/phone calls at 7-14 days & at 21-28 days (10-20 mins)
2. Weekly support; as 1. plus additional call at 10 days & visits at 14 & 21 days


OutcomesAbstinence at 12m (sustained at 1, 4, 12, 26 wks)
Validation: CO <10ppm at treatment visits, saliva cotinine <15ng/ml at follow ups


NotesNew for 2008 update. Not in main analysis; compares higher and lower intensity counselling. Therapists were not full time specialist counsellors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskRandom number generator

Allocation concealment?Low riskNumbered sealed envelopes

Blinding?
All outcomes
Unclear riskStaff making follow-up calls were blind

Incomplete outcome data addressed?
All outcomes
Low risk288 (31%) lost to follow up, similar across groups, included in ITT analysis

Bobo 1998

MethodsSetting: 12 residential centres for alcohol/drug treatment, USA
Recruitment: inpatient volunteers


Participants(50 participants in each of 12 sites)
67% male, av. age 33
50% smoked >1 pack/day
Therapists: centre staff for 1st session, trained counsellors for telephone sessions


Interventions1. 4 x10-15min sessions. 1st during inpatient stay. 3 by telephone, 8, 12, 16 wks post-discharge.
2. No intervention 


OutcomesAbstinence at 12m post discharge (7 day PP)
Validation: saliva cotinine, but validated quit rates not reported
(A primary outcome for the study was alcohol abstinence) 


NotesCluster-randomized, so individual data not used in primary meta-analysis. Entered into a secondary analysis using inverse variance method, using adjusted OR 1.02 (CI 0.50 to 2.49) 


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?High riskMatched pairs of centres allocated by coin toss, 2 centres declined participation after allocation

Allocation concealment?High riskCluster randomized with participant recruitment (by research team) after centre allocation so potential for selection bias

Blinding?
All outcomes
Unclear riskStaff not blind, unclear for participants

Incomplete outcome data addressed?
All outcomes
Low risk22% lost to follow up. Including them as smokers made little difference to estimates

Bronson 1989

MethodsSetting: internal medicine practice, USA
Recruitment: attenders for periodic health examinations


Participants155 smokers
38%m , av. age 42, av. cpd 25
Therapist: smoking cessation counsellor


Interventions1. Two 20 min counselling sessions during a periodic health examination (benefits of quitting, assessment of motivation, quit plan, high risk/problem solving)
2. Control (completed smoking behaviour questionnaire)
Physicians carrying out health examinations were blind to group assignment and would have given similar advice to all participants.


OutcomesAbstinence at 18m (sustained from 6-18m)
Validation: no biochemical validation at 18m, limited sample for saliva cotinine at 6m


Notes18m data reported in Secker-Walker 1990


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not described

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskPhysicians blind, counsellor not blind, participants probably blind,

Incomplete outcome data addressed?
All outcomes
Low risk20 (13%) not contacted at 6 & 18m, included in ITT analysis.

Burling 1991

MethodsSetting: Inpatient substance abuse treatment centre, USA
Recruitment: inpatient volunteers


Participants39 male veteran inpatients
Therapist: paraprofessional counsellor (Social Work Master's candidate)


Interventions1. Smoking cessation programme; daily 15 min counselling session and computer-guided nicotine fading with contingency contract
2. Wait list control.


OutcomesAbstinence 6m after discharge
Validation - none - no self-reported quitters at 6m


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not described

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskStaff not blind, participants unclear

Incomplete outcome data addressed?
All outcomes
Unclear riskLoss to follow up not reported

Burling 2001

MethodsSetting: Inpatient Veterans rehabilitation centre, USA
Recruitment: inpatient volunteers


Participants150 veteran drug- & alcohol-dependent smokers.
95%m, av. age 40, av. cpd 17
Therapists: Masters/Doctoral level counsellors


InterventionsAll participants were receiving standard substance abuse treatment, smoking banned in building.
1. Multicomponent. 9 wk programme; 7 wk daily counselling, 2 wk biweekly. Target quit wk 5. Nicotine fading, contingency contracting, relapse prevention, coping skills practice. Nicotine patch (14 mg) 4 wks.
2. As 1, but skills generalized to drug & alcohol relapse prevention.
3. Usual care. Other programmes & NRT available


OutcomesAbstinence at 12m (sustained at 1, 3, 6m follow ups)
Continuous abstinence rates taken from graph & abstract. PP rates also reported
Validation: CO & cotinine


Notes1+2 vs 3
Using PP rates would give lower estimate of treatment effect.
No significant difference between 1 &2, but favoured 1.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not described

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskStaff not blind, participants unclear

Incomplete outcome data addressed?
All outcomes
Low risk12 (8%) lost to follow up included in ITT analysis

Dornelas 2000

MethodsSetting: Hospital inpatients, USA
Recruitment: Acute MI patients (not selected for motivation to quit)


Participants100 MI patients (98% smoked in previous wk)
23% female, aged 27-83, av cpd 29
Therapist: Psychologist


Interventions1. 8 x20 min sessions, 1st during hospitalisation, 7 by phone (<1, 4, 8, 12, 20 & 26 wks post-discharge). Stage of change model, motivational interviewing, relapse prevention.
2. Minimal care. Recommended to watch online patient education video, referral to local resources.


OutcomesSustained abstinence at 1 yr (no smoking since discharge)
Validation: household member confirmation for 70%. 1 discrepancy found


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear risk'drawing random numbers from an envelope'

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo information on blinding

Incomplete outcome data addressed?
All outcomes
Low risk20 (20%) lost to follow up included in ITT analysis

Fiore 2004

MethodsSetting: Primary care patients, 16 clinics, USA
Recruitment: Clinic attenders willing to accept treatment


Participants961 smokers of >=10 cpd. (A further 908 were allowed to select treatment. Demographic details based on 1869)
58% female, av. age 40, av. cpd 22
Therapists: Trained cessation counsellors


Interventions(Self-selected group of factorial trial not included in meta-analysis)
1. Nicotine patch, 22mg, 8 wks incl tapering.
2. As 1 plus Committed Quitters programme, single telephone session and tailored S-H.
3. As 2 plus individual counselling, 4 x 15-25 min sessions, pre-quit, ˜TQD, next 2 wks


OutcomesContinuous abstinence at 1 yr (no relapse lasting 7 days), also PP.
Validation: CO, cut-off not specified. 2 discordant


Notes3 versus 1&2 used in meta-analysis. More conservative than 3 versus 2.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not described

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo information on blinding

Incomplete outcome data addressed?
All outcomes
Low riskDenominators in meta-analysis based on numbers who collected patches (85%, similar across arms).

Glasgow 2000

MethodsSetting: 4 Planned Parenthood clinics, USA
Recruitment: Clinic attenders, unselected for motivation


Participants1154 female smokers
Av. age 24, av. cpd 12
Therapists: 4 hours training


InterventionsBoth groups received 20 sec provider advice.
1. Video (9 min) targeted at young women. 12-15 min counselling session, personalized strategies, stage-targeted S-H materials. Offered telephone support call
2. Generic S-H materials


OutcomesAbstinence at 6m (for 30 days)
Validation: saliva cotinine <= 10ng/ml


Notes26% did not want telephone component, 31% of remainder not reached.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskRandomized, block size 4, fixed schedule

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low risk10% loss to follow up included in ITT analysis

Hennrikus 2005

MethodsSetting: 4 hospitals, USA
Recruitment: Newly admitted inpatients invited to participate, not selected by motivation


Participants2095 current smokers
53% female, av. age 47, cpd NS, 15-20% precontemplators
Therapists: research nurses with 12 hours training


Interventions1. Control: modified usual care: smoking cessation booklet in hospital (not used in meta-analysis).
2. Brief advice (A): as control, plus labels in records to prompt advice from nurses and physicians.
3. Brief advice and counselling (A+C): As 2. plus 1 bedside (or phone) session using motivational interviewing and relapse prevention approaches and 3 to 6 calls (2-3 days, 1 wk, 2-3 wk, 1m, 6m)


OutcomesAbstinence at 12m (7-day PP).
Validation: saliva cotinine<15 ng/ml


NotesNew for 2008.
Brief advice & counselling compared to Brief advice. Including Usual Care in control as well would marginally increase relative effect but not change conclusion of no effect.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'randomly ordered within blocks of 30 assignments'

Allocation concealment?Unclear riskAllocation by research assistant, concealment not described

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low risk78 (3.7%) excluded from ITT analysis due to death or too ill for follow up. 426 (20%) lost to follow up included in ITT analysis; higher loss in treatment than control.

Jorenby 1995

MethodsSetting: clinical research centres, USA (2 sites)
Recruitment: community volunteers


Participants504 smokers >= 15 cpd
av. age 44, av. cpd 26-29
Therapists: Trained smoking cessation counsellors


InterventionsFactorial trial; compared 22 mg/day vs 44 mg/day nicotine patch and 3 types of adjuvant treatment. All participants had 8 weekly assessments by research staff
1. Minimal - S-H materials from physician at screening visit for trial entry, instructed not to smoke whilst wearing patch. No further contact with counsellors.
2. Individual - S-H at screening visit + motivational message. Met nurse counsellor x3 after TQD. Counsellor helped generate problem-solving strategies and provided praise and encouragement.
3. Group - S-H + motivational message. 8x 1hr weekly group sessions. Skills training, problem-solving skills.


Outcomes7 day PP abstinence at 26 wks
Validation; CO < 10ppm.


NotesNo significant difference in dose-related outcome and no dose-counselling interaction at 26 wks reported, so patch arm collapsed in analysis. 2 vs 1, counselling vs NRT alone, Comparison with group counselling covered in Cochrane group therapy review.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not stated

Allocation concealment?Unclear risk'In a double blind manner' for NRT, but not specified for counselling

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low risk16.3% lost to follow up included in ITT analysis, no difference across conditions

Kim 2005

MethodsSetting: Outpatient clinic, South Korea
Recruitment: outpatients, not selected on motivation


Participants401 daily smokers, 65% willing to quit within 1m
92% m, av. age 52
Therapists: Retired nurses trained in cessation


InterventionsTest of 5As approach. All participants had first been Asked about smoking status & Advised to quit by physicians and told to go to onsite counsellors, who Assessed willingness to quit, and enrolled & randomized patients.
1. Intervention: Counsellors provided Assist and Arrange components to participants willing to quit within 1m; set quit date, provided Self-help materials, supplied cigarette substitute (˜11 min average). Culturally specific for Koreans. Other participants given 4Rs. Follow-up calls at 1 wk & m (˜7min).
2. Control: Counsellors told participants to quit without further assistance.


OutcomesAbstinence at 5m
Validation: CO<=7ppm


NotesNew for 2008
Marginal to include because 5m follow up and counselling was very brief


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskRandom list with block size of 6 and 12 allocation strata

Allocation concealment?Low riskAssignments in sealed opaque envelopes

Blinding?
All outcomes
Unclear riskOutcome assessors were unaware of participants' group

Incomplete outcome data addressed?
All outcomes
Low risk7 lost to follow up included in ITT analysis

Lifrak 1997

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


Participants69 smokers
av. age 39, av. cpd 25
Therapists: nurse practitioner for 1. and 2, clinical social worker or psychiatrist experienced in addiction treatment for 2.


InterventionsBoth interventions included use of nicotine patch (24 hr, 10 wks tapered dose)
1. Moderate intensity - 4 meetings with nurse who reviewed S-H materials and instructed in patch use.
2. High intensity. As 1 plus 16 weekly 45 min cognitive behavioural relapse-prevention therapy


OutcomesAbstinence at 12m, 1 wk PP
Validation: urine cotinine for some participants, but no corrections made for misreporting.


NotesBoth interventions regarded as counselling, used in comparison of intensity.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskBlock randomization (block size 10)

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low risk12 administrative drop-outs/exclusions not included, treatment group not specified. All others included.

McCarthy 2008

MethodsSetting: clinic, USA
Recruitment: community volunteers


Participants463 smokers
50% female, av. age 36-41 across arms, av.cpd 22
Therapists: trained college-aged or bachelor's level staff, supervised by experienced counsellor


InterventionsFactorial trial. Bupropion/placebo pharmacotherapy arms collapsed.
1. Counselling; 8 x10min session, 2 prequit, TQD, 5 over 4 wks
2. Psychoeducation about medication, support & encouragement. Same no. of sessions, 80mins less contact time


Outcomes7 day PP abstinence at 12m
Validation: CO ≤10ppm


NotesNew for 2008


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskRandom number table

Allocation concealment?Low riskStaff who screened and enrolled participants were unaware of the experimental condition to be assigned

Blinding?
All outcomes
Unclear riskStaff and participants blind to medication but not counselling

Incomplete outcome data addressed?
All outcomes
Low risk171 (37%) failed to attend quit date visit or lost to follow up, included in ITT analysis

Molyneux 2003

MethodsSetting: hospital, UK
Recruitment: hospital inpatients


Participants274 smokers (183 in relevant arms) admitted to medical and surgical wards, smoked in last 28 days
60% m, av age 60, median cpd 17, 81% had previous quit attempt
Therapists: research doctor or nurse trained in cessation counselling


Interventions1. Usual Care, no smoking advice
2. Brief (20 min) bedside counselling + advice leaflet + advice on NRT
3. As 2 plus choice of NRT product (not relevant to this review)


OutcomesContinuous abstinence at 12m
Validation: CO < 10ppm


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'List generated for each centre allocating equally in random permuted blocks of nine.'

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low risk72 (39%) lost to follow up included in ITT analysis

Nakamura 2004

MethodsSetting: communities & worksites, Japan
Recruitment: Smokers with hypertension and/or hypercholesterolemia having health check-ups


Participants977 smokers
98% m, av. age 45, av. cpd 25, ˜20% in preparation/ contemplation
Therapists: mostly public health nurses


InterventionsIntervention: Stage-base counselling, 1 x40 min, 4 x20-30 min at 1,2,4,6m. + Phone call if TQD set
Control: Matched contact intervention for hypertension (161) or hypercholesterolemia (318)


OutcomesAbstinence at 6m, sustained 4 point prevalence at 1,2,4,6m
Validation: CO≤8ppm


NotesNew for 2008. Recruited a largely unmotivated population


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskMethod not stated

Allocation concealment?Unclear riskNo information given

Blinding?
All outcomes
Unclear riskNo information given

Incomplete outcome data addressed?
All outcomes
Low risk54 (5.5%) lost to follow up included in ITT analysis

Ockene 1992

MethodsSetting: cardiac catheterization labs at 3 hospitals, USA
Recruitment: inpatient smokers or recent quitters with coronary artery stenosis, following arteriography


Participants267 smokers (256 surviving at 12m follow up)
av. age 53, av. cpd 25
Therapists: Masters level health educators


Interventions1. Minimal intervention - 10 min advice and review of an information sheet
2. Inpatient counselling session, 30 min, outpatient visits and telephone calls. Opportunity to attend group programme


OutcomesAbstinence at 12m (sustained for 6m)
Validation: saliva cotinine < 20ng/ml


NotesAverage length of contact for intervention was 1.22 hr (20min to > 5hr)


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskMethod not stated

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskPhysicians unaware of intervention condition, therapists blinded, participants unclear

Incomplete outcome data addressed?
All outcomes
Low riskNo mention of losses to follow up and all survivors included in denominators.

Pedersen 2005

MethodsSetting: hospital, Denmark
Recruitment: Inpatients with cardiac disease


Participants105 smokers
36% female, ˜70% aged >50
Therapists: counsellors


Interventions1. Usual care control: in hospital advice to quit + information about NRT + NRT available.
2. Intervention: As 1. plus 5 x30 min post discharge contacts


OutcomesAbstinence at 12 months (point prevalence)
Validation: none


NotesNew for 2008


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskRandomized, method not described

Allocation concealment?Unclear riskSealed envelopes, but not stated to be numbered

Blinding?
All outcomes
Unclear riskNo information

Incomplete outcome data addressed?
All outcomes
Low risk10 (9.5%) lost to follow up, included in ITT analysis

Pederson 1991

MethodsSetting: Chest unit, USA
Recruitment: Inpatients with COPD


Participants74 cigarette smokers
av. age 53, 75% smoked 20+ cpd
Therapist: Non-specialist trained in counselling


Interventions1. Advice to quit
2. Individual counselling; between 3 & 8 15-20 min sessions on alternate days during hospitalisations. S-H manual, support & encouragement.


OutcomesAbstinence at 6m
Sample validated by COHb


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskMethod not described

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskPhysicians blinded, therapist not blinded, participants unclear

Incomplete outcome data addressed?
All outcomes
Low risk8 lost to follow up were reincluded in ITT analysis by reviewers. 8 deaths excluded

Rigotti 1997

MethodsSetting: hospital, USA
Recruitment: Inpatients in medical or surgical services, smoking > 1 cig in month before admission


Participants615 smokers or recent quitters (excluding 35 deaths). 37% of intervention and 32% of controls had a current smoking-related health problem.
Therapist: research assistant supervised by a nurse


Interventions1. Usual care
2. Single bedside counselling session (motivational interviewing, cognitive behavioural and relapse prevention techniques), av 15 min, S-H materials, chart prompts, 1-3 telephone calls post-discharge


OutcomesAbstinence at 6m (PP, sustained abstinence reported based on self report)
Validation: saliva cotinine for people living in Mass (85% of quitters)


NotesUse of validated PP rather than sustained abstinence gives more conservative treatment effect


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Unclear riskEach day's list of eligible smokers put in random order and patients recruited consecutively in this order. Randomized by research assistant

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskOutcome was assessed by blinded interviewer.

Incomplete outcome data addressed?
All outcomes
Low risk73 (22.4%) lost to follow up included in ITT analysis, no evidence of differential loss. 35 (5.4%) deaths excluded.

Schmitz 1999

MethodsSetting: hospital, USA
Recruitment: women with or at risk of Coronary Artery disease (CAD)


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


Interventions1. Coping skills, relapse prevention, 6 x1 hr including stress management, homework.
2. Health Belief model, 6 x1 hr. smoking-related health information about disease state or CAD profile. Focus on benefits of stopping


OutcomesAbstinence at 6m (PP)
Validation: CO < 9ppm, urine cotinine < 10ng/ml
Not all quitters tested, confirmation rates not reported


NotesPost-randomization drop-outs who did not complete baseline and begin treatment were not included in any data.
Quit rates were lower in the CAD sample than in the at-risk group


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'Randomly assigned', stratified on smoking rate and myocardial infarction status

Allocation concealment?Unclear riskNo details given

Blinding?
All outcomes
Unclear riskNo details given

Incomplete outcome data addressed?
All outcomes
Low riskPretreatment drop outs were excluded, all others included in ITT analysis

Simon 1997

MethodsSetting: Veterans Administration hospital, USA
Recruitment: smokers undergoing non-cardiac surgery


Participants299 smokers (smoked within 2 wks of admission) (excl 25 deaths)
98% m, av. age 54, av. cpd 20
Therapist: public health educator


Interventions1. Multicomponent: single counselling session (30-60 min) prior to discharge (based on social learning theory and stages of change). Video, prescription for nicotine gum if no contraindications. 5 follow-up counselling calls over 3m
2. Brief counselling (10 min) and S-H materials.


OutcomesAbstinence at 12m
Validation: serum or saliva cotinine < 15ng/ml. 6 self reports confirmed only by 'significant other'.


Notes65% of Group 1 and 17% of Group 2 reported using NRT, but use of NRT was not significantly associated with quitting in either group


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'Random list of assignments'

Allocation concealment?Low risk'Sealed opaque envelopes opened on formal enrollment'

Blinding?
All outcomes
Unclear riskTherapists could not have been blind. No information on patients

Incomplete outcome data addressed?
All outcomes
Low risk25 (8%) lost to follow up included in ITT analysis, 25 (8%) died, excluded from denominator

Simon 2003

MethodsSetting: Veterans Affairs hospital, USA
Recruitment: hospitalised smokers in contemplation or preparation stage of change


Participants209 smokers, >= 20 cigs in total in week before hospitalisation, excludes 14 deaths during follow up
97% m, av. age 55, av cpd 23
Therapists: trained nurse or public health educator


Interventions1. Intensive counselling: single counselling session (30-60 min) prior to discharge (based on social learning theory and stages of change), 5 telephone counselling calls < 30 min, 1 & 3 wks, monthly for 3m + S-H. Recycling encouraged. Nicotine patches begun in hospital, dose based on pre-hospitalisation smoking rates. 2m supply at discharge.
2. Nicotine patches as 1. ˜10 min session on risks & benefits, S-H.


OutcomesAbstinence at 12m (7 day PP)
Validation: saliva cotinine < 15ng/ml


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'Randomly assigned using computerized algorithm'

Allocation concealment?Unclear riskNo details provided

Blinding?
All outcomes
Unclear riskNo details provided; there was an active control

Incomplete outcome data addressed?
All outcomes
Low risk7 (3%) lost to follow up included in ITT analysis, 14 (6%) died & excluded from denominator

Stevens 1993

MethodsSetting: 2 Health Maintenance Organization hospitals, USA
Recruitment: All hospitalised smokers or recent ex-smokers with stay > 36hrs


Participants1119 smokers or recent quitters (5%)
av. age 44, av. cpd 20
Therapists: Masters level cessation counsellors


Interventions1. 20 min counselling session, 12 min video, quit kit, choice of S-H materials, 1-2 follow-up telephone calls, access to hotline, bimonthly newsletter mailings.
2. Usual care


OutcomesAbstinence at 12m (2 PP, 3 & 12m)
Validation: due to low success in obtaining samples for cotinine analysis, data are based on self report only.


NotesA sensitivity analysis on the effect of exclusion of this non-random study is reported.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?High riskNot random, intervention alternated between hospitals on a monthly basis in order to avoid contamination

Allocation concealment?High riskIntervention or control status of hospital known when patients recruited

Blinding?
All outcomes
Unclear riskPatients in control arm were not identified to hospital staff, and were probably unaware of study design. Telephone assessments were by blinded assessors

Incomplete outcome data addressed?
All outcomes
Low risk6% loss to follow up, no difference by group, included in ITT analysis

Tonnesen 2006

MethodsSetting: 7 chest clinics, Denmark
Recruitment: outpatient attender


Participants370 smokers of >1 cpd with COPD
52% female, av. age 61, av. cpd 20
Therapists: 20 nurses with cessation experience, trained to support medication use and provide standardised counselling


InterventionsFactorial trial. Nicotine sublingual tablet and placebo arms collapsed in meta-analysis
1. High support: 7 x 20-30min clinic visits (0, 2, 4, 8, 12 wks, 6m, 12m) & 5 x 10min phone calls (1, 6, 10 wks , 4½m. 9m), total contact time 4½ hrs.
2. Low support: 4 clinic visits (0, 2 wks, 6m, 12m) & 6 phone calls (1, 4, 6, 9, 12 wks, 9m), total time 2½ hrs


OutcomesSustained abstinence at 12m (validated at all visits from wk 2, PP also reported)
Validation: CO<10ppm


NotesNew for 2008 update. Compares higher and lower intensity counselling. Therapists were not full time specialist counsellors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskBlock randomization list at each centre

Allocation concealment?Unclear riskAllocation process not described

Blinding?
All outcomes
Unclear riskDescribed as double blind, but unclear that this applied to behavioural components

Incomplete outcome data addressed?
All outcomes
Low risk82 (22%) lost to follow up, included in ITT analysis

Weissfeld 1991

MethodsSetting: Veterans Administration outpatient clinics, USA
Recruitment: veterans attending walk-in and general medicine clinics invited to attend quit smoking programme
Randomization: Two stages; initially in 1:2 to control or intervention, then 1:1 to high or low intensity occurred after delivery of low intensity session.


Participants466 male smokers
av. age 55 years, av. cpd 26
Therapists: smoking cessation counsellors


Interventions1. Control - pamphlet on hazards of smoking
2. Low Intensity counselling - single session 20-30 min and S-H booklet
3. High intensity counselling - same initial session, with sustained contact of 3m. One further face-to-face session, telephone calls and mailings, behavioural S-H manual. Prescription and sample of nicotine gum and instructions for use.


OutcomesAbstinence for 1m at 6m (9m for high intensity group, 6m after last contact)
Validation: nicotine metabolites in urine


NotesUsing validated quit rates there was no difference between 2 and 3, although self-reported quitting was greater in 3.
Main analysis uses 2&3 vs 1 with sensitivity analysis of 2 vs 1. Comparison of intensity uses 3 vs 2
39% of group 3 used nicotine gum vs 8% and 7% in 2 and 1


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskRandom number table

Allocation concealment?Low riskConsecutively numbered envelopes containing treatment assignment.

Blinding?
All outcomes
Unclear riskTherapists not blind, unclear whether participants were

Incomplete outcome data addressed?
All outcomes
Low risk34 (7.3%) died or lost to follow up included in ITT analysis. More lost in high intensity group.

Wiggers 2006

MethodsSetting: Cardiovascular outpatient department, Netherlands
Recruitment: patients attending regular consultation; consenting patients referred to nurse practitioner.


Participants385 smokers (8 deaths excluded from outcomes)
37% female, av. age 59, av.cpd 21
Therapist: nurse practitioner


InterventionsIn both groups, patients planning to quit received 8 wks nicotine patch with instruction from nurse.
1. 'Minimal Intervention Strategy for cardiology patients (C-MIS). 15-30 mins at baseline, 1 phone call at 2 wks, additional session on request. Assessment of dependency & motivation, barriers; TQD set for motivated patients
2. Usual care without motivational counselling.


OutcomesAbstinence for 7 days at 12m
Validation: Urine or saliva nicotine/cotinine/thiocyanate. Self-reported smokers also tested; validated rates include smokers with negative biochemical results, so self-reported non-smoking used in MA


NotesNew for 2008. Included on grounds that participants were referred to nurse practitioner for counselling; not part of usual care.


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low risk'A computerized balanced randomization programme taking prognostic factors (e.g. clinic attendance, age and gender) into account.'

Allocation concealment?Low risk'While patients completed their baseline questionnaire (and signed a written informed consent) nurses randomly assigned ...'

Blinding?
All outcomes
Unclear risk'Patients were not informed about the behavioural intervention [before enrollment] in order to avoid a Hawthorne effect'.
Follow up was blind to allocation.

Incomplete outcome data addressed?
All outcomes
Low riskOne withdrawal due to cognitive problems and 8 deaths during follow up not included in analyses. At 12m 45 not reached by mail or phone, included in ITT. More unmarried patients lost.

Windsor 1988

MethodsSetting: University worksite, USA
Recruitment: Employees volunteering for a quit smoking programme


Participants378 smokers
av. age 37, av. cpd 23-27
Therapist: health educator


InterventionsAll groups received a 10 min session of brief advice
1. + S-H manuals
2. + S-H and another session of counselling (20-30 min) with skills training, buddy selection and a contract.
3. as 1. with monetary rewards for cessation
4. as 2. with monetary rewards for cessation


OutcomesAbstinence at 1 yr (sustained at 6 wks, 6m, 1yr, no more than 2 cigs in period)
Validation: saliva thiocyanate < 100μg/ml at all follow ups.


NotesThere was no apparent effect of monetary incentives so this arm is collapsed. 4&2 vs 3&1. Number of quitters estimated from graphs


Risk of bias

BiasAuthors' judgementSupport for judgement

Adequate sequence generation?Low riskComputer-generated assignment

Allocation concealment?Low riskSealed numbered envelopes opened after informed consent & baseline questionnaire

Blinding?
All outcomes
Unclear riskTherapists could not be blind, unlikely that participants were

Incomplete outcome data addressed?
All outcomes
Low risk37 lost to f-up, included in ITT analysis

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Alonso-Pérez 2007Allocation to behavioural treatment was by clinic attended; each of 3 primary care clinics provided different treatment.

Bolman 2002Intervention provided by a nurse as part of usual care, included in Cochrane review of nursing interventions (Rice 2008).

Borrelli 2005Intervention provided by a nurse during normal duties, included in Cochrane review of nursing interventions (Rice 2008).

Camarelles 2002Compares Individual to group counselling, see Cochrane review of group based interventions (Stead 2005).

Canga 2000Intervention provided by a nurse, included in Cochrane review of nursing interventions (Rice 2008).

Colby 1998Short follow up (three months).

Emmons 2001Data not available for intervention and control groups separately. No significant difference reported. Cessation was a secondary outcome in this trial using motivational interviewing to reduce passive smoke exposure. Participants were not selected by motivation to quit.

Froelicher 2004Intervention provided by a nurse; included in Cochrane review of nursing interventions (Rice 2008)

Gifford 2004Trial of an acceptance & commitment-based treatment intervention that included multiple group sessions in addition to individual counselling. Comparator was nicotine patch therapy.

Hilberink 2005Intervention provided by physicians & nurses in usual care setting, not specialist counselling.

Hyman 2007Multiple risk factor intervention.

Kadowaki 2000Intervention was multicomponent and included advice/counselling from a physician, nurse and a group programme. Follow up only 5 months.

Lando 1992There was no face-to-face contact with counsellors. Contact was by pro-active telephone calls.

Lopez 2007Multiple risk factor intervention enrolling smokers and nonsmokers.

Malchodi 2003Intervention specifically for pregnant women, see Cochrane review of smoking cessation interventions in pregnancy (Lumley 2004)

Marks 2002Intervention was provided in a self-help format.

Mildestvedt 2007Multiple risk lifestyle intervention.

Mooney 2007Short follow up (6 wks). Study added a pharmacotherapy compliance enhancing component to individual counselling using CBT.

Niaura 1999All participants received individual counselling; Included in Cochrane NRT review (Stead 2008b).

Okuyemi 2006Intervention combined group and individual counselling with pharmacotherapy.

Rabkin 1984The health education arm of the trial included a group meeting with didactic lecture, film and discussion, followed by a single individual session with a therapist. We decided that this did not meet the criteria for individual counselling.

Rodriguez 2003Intervention combined the systematic use of NRT with counselling; covered in Cochrane review of worksite interventions (Cahill 2008)

Sanz-Pozo 2006Intervention provided by nurses in a primary care clinic, included in Cochrane review of nursing interventions (Rice 2008)

Schnoll 2005Short follow up (three months). Compared 2 counselling approaches, no difference detected.

Schwartz 1967Success was defined as reduction in smoking of over 85%, not complete abstinence.

Sherman 2007Primary outcome was not cessation; assessed rates of receiving counselling, referral and treatment.

Soria 2006Motivational interviewing intervention by primary care physician during routine care

Stein 2006Test of motivational interviewing; not all partipants attempted to quit

Stevens 2000Intervention providers were respiratory therapists not counsellors. Included in Cochrane review of interventions in hospital inpatients, (Rigotti 2007).

Williams 2006Study targeted multiple risk factors.

Woodruff 2002Short follow up (three months).

 
Characteristics of ongoing studies [ordered by study ID]
Niaura 2004

Trial name or titlePositive Paths

MethodsRCT

ParticipantsHIV+ smokers

InterventionsBrief intervention modeled on PHS guidelines versus a more intensive motivational counselling intervention, with both interventions providing 8 weeks of NRT to those setting a quit date.

OutcomesSmoking cessation

Starting dateCompleted

Contact informationRay Niaura

NotesNCT00551720

 
Comparison 1. Individual counselling compared to minimal contact control

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

 1 Smoking cessation at longest follow-up229587Risk Ratio (M-H, Fixed, 95% CI)1.39 [1.24, 1.57]

    1.1 Counselling versus control (no systematic pharmacotherapy)
187855Risk Ratio (M-H, Fixed, 95% CI)1.44 [1.25, 1.65]

    1.2 Counselling plus NRT versus NRT alone
41732Risk Ratio (M-H, Fixed, 95% CI)1.27 [1.02, 1.59]

 
Comparison 2. More intensive versus less intensive counselling

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

 1 Smoking cessation at longest follow-up51897Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.74, 1.25]

    1.1 No pharmacotherapy
2478Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.53, 2.22]

    1.2 Adjunct to pharmacotherapy
41419Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.71, 1.25]

 2 Sensitivity analyses for Alterman 2001 in intensive versus brief counselling comparison5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Using Alterman high versus low
51817Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.81, 1.37]

    2.2 Using Alterman high versus moderate
51817Risk Ratio (M-H, Fixed, 95% CI)1.20 [0.91, 1.58]

 
Comparison 3. Comparisons between counselling approaches of similar intensity

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

 1 Smoking cessation at longest follow-up3Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Relapse Prevention versus Health Belief model
1160Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.45, 1.98]

    1.2 Motivational Interviewing versus Health Education
1755Risk Ratio (M-H, Fixed, 95% CI)0.51 [0.34, 0.76]

    1.3 Counselling versus equal sessions of psychoeducation
1463Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.62, 1.39]