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Behavioural interventions as adjuncts to pharmacotherapy for smoking cessation

  1. Lindsay F Stead*,
  2. Tim Lancaster

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 12 DEC 2012

Assessed as up-to-date: 6 JUL 2012

DOI: 10.1002/14651858.CD009670.pub2


How to Cite

Stead LF, Lancaster T. Behavioural interventions as adjuncts to pharmacotherapy for smoking cessation. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD009670. DOI: 10.1002/14651858.CD009670.pub2.

Author Information

  1. University of Oxford, Department of Primary Care Health Sciences, Oxford, 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: Edited (no change to conclusions)
  2. Published Online: 12 DEC 2012

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This is not the most recent version of the article. View current version (12 OCT 2015)

 
Characteristics of included studies [ordered by study ID]
Alterman 2001

MethodsSetting: cessation clinic, USA
Recruitment: community volunteers


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


InterventionsPharmacotherapy: NRT; 21 mg patch for 8 wks (including weaning period)
1. Low intensity. Single 30 min session with NP.
2. Moderate intensity. as 1 plus additional 3 x 15-20 min 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 versus 1 in main analysis. Quit rates significantly lower in 2 than 1 or 3. 35/160 quit when 2 & 3 combined


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'Urn technique'

Allocation concealment (selection bias)Unclear riskNo details given. Allocation took place after baseline session common to all conditions.

Incomplete outcome data (attrition bias)
All outcomes
Low riskSmall and similar rate lost to follow-up in each group (approx 7%). ‘Intent to treat’ analyses reported in the paper exclude 2 deaths and 2 missing cotinine.

Aveyard 2007

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


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


InterventionsPharmacotherapy: NRT; 16 mg patch for 8 wks
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); 4 contacts, ˜80 mins
2. Weekly support; as 1. plus additional call at 10 days & visits at 14 & 21 days; 7 contacts, ˜140 mins


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


NotesTherapists were not full-time specialist counsellors. Difference between support conditions relatively small.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number generator

Allocation concealment (selection bias)Low riskNumbered sealed envelopes

Incomplete outcome data (attrition bias)
All outcomes
Low riskOver 30% lost to follow-up but similar percentage followed up in both groups (69% intervention vs 68% control, no evidence of differential attrition).

Boyle 2007

MethodsSetting: Health Maintenance Organization, USA
Recruitment: proactive recruitment of members filling a prescription for cessation medications (motivated)


Participants1329 HMO members; 58% F, av. age 47, 66% smoked >pack/day


InterventionsPharmacotherapy: All participants had filled a prescription. Almost 95% used; ˜51% only bupropion, 26% only NRT, remainder both
1. No further intervention
2. Proactive call to offer counselling, up to 9 calls, given choice of structured course or unstructured format


OutcomesAbstinence at 12m (repeated 7-day PP at 3m & 12m)
Validation: none


Notes49% of intervention group reached, 36% of those declined, 31% of total accepted counselling. Average no of calls 5. There was no evidence of a greater relative effect in those reached or those accepting counselling.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, stratified by presence of chronic disease. Method not described.

Allocation concealment (selection bias)Unclear riskNo details given

Incomplete outcome data (attrition bias)
All outcomes
Low riskOver 30% lost to follow-up but similar percentage followed up in both groups (66% intervention vs 65% control, no evidence of differential attrition).

Bushnell 1997

MethodsSetting: Community with large military population, USA
Recruitment: Community volunteers
Group size: max 50 American Cancer Society (ACS) or 15 Vanderbilt University Medical Center (VUMC)


Participants314 military and civilian smokers, excludes 198 people, assignment NS, who did not attend any sessions after randomization. 44% F, age and smoking not described
Therapists: ACS- trained volunteers, VUMC- healthcare professionals


InterventionsAll participants offered free NRT (in group 2 conditional on attending 75% classes)
1. ACS: 4 x 1 hr large group sessions (max 50), no TQD
2. VUMC: 8 x 1 hr group sessions (max 15), relapse prevention model including stress management, diet, exercise


OutcomesAbstinence at 6m (PP)
Validation: CO < 8 ppm, salivary cotinine ≤ 10 mg/ml


NotesEarly benefit of VUMC lost at 6 months. No observed effect in active duty participants at any time.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'randomly assigned', method not stated, stratified by military or civilian

Allocation concealment (selection bias)Unclear riskNo details given

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk198 (out of 512 randomized) did not participate, group not stated, not clear if subjects knew what group they were assigned to before attending first session

Ellerbeck 2009

MethodsSettng: Primary care patients, 50 rural practices, Kansas, USA
Recruitment: smoking patients not selected for motivation, but 67% of those eligible enrolled, only 8.7% in precontemplation stage of change


Participants750 smokers of >10 cpd, 59% F, av. age 47, av. cpd 24, 61% contemplation, 30% preparation


InterventionsAll participants mailed an offer of free pharmacotherapy every 6 months, 4 times in total. Nicotine patch 21 mg for 6 wks or bupropion SR (150 mg twice daily) for 7 wks

1. Control. No other contact.

2. Moderate intensity disease management: up to 2 calls from counsellor in each cycle encouraging uptake of pharmacotherapy, newsletter mailings & periodic progress reports with counselling suggestions faxed to physician.

3. High intensity disease management, up to 6 calls at approx 1, 3, 6, 9, 12 wks from start of each

cycle.


OutcomesAbstinence at 24m (PP). Study also reported analysis based on combination of effects at all follow-up points. Sustained abstinence not a suitable outcome since no quit date and repeated intervention.

Validation: attempted saliva cotinine (< 15 ng/ml) by mail at 12 & 24m. Proxy report used at 24m for non returners. Rate of validation similar across groups.


NotesParticipants could have multiple courses of pharmacotherapy; 23%, 33%, 23%, 12%, and 9% of participants requested 0, 1, 2, 3, or 4 courses, Disease management conditions increased use in first cycle and reduced it later. 41% of cycles used bupropion & 59% patch. Over 24 months average number of calls 3.6 in 2. and 8.2 in 3. Fewer calls in later cycles.

No evidence of effect based on PP, but some evidence of benefit when all follow-ups taken into account

High intensity vs control in main comparison. Moderate intensity quit almost identical (35/238 14.7%).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'computer generated random numbers table was utilized to generate allocation cards in blocks of 24 with allocation equally distributed across treatment groups'

Allocation concealment (selection bias)Low risk'cards were placed in sequentially numbered, opaque, sealed envelopes'

Incomplete outcome data (attrition bias)
All outcomes
Low riskLess than 20% lost to follow-up, similar distribution amongst groups (11% control, 16% in both moderate and high intensity intervention arms)

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, not included in review. Demographic details based on 1869.) 58% F, av. age 40, av. cpd 22
Therapists: Trained cessation counsellors


InterventionsPharmacotherapy: NRT (patch, 22mg, 8 wks incl tapering)

1. NRT alone
2. As 1 plus Committed Quitters programme, single telephone session and tailored S-H.
3. As 2 plus face-to-face 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 used in primary analysis. 3 & 2 versus 1 is more conservative since 2 had lower quit rates than 1. Use of PP outcome does not alter findings.


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

Incomplete outcome data (attrition bias)
All outcomes
Low riskPeople who did not pick up patches were excluded from analyses, similar distribution amongst groups (17% control, 16% in intervention arm 1, 14% intervention arm 2). No reported loss to follow-up for remaining participants.

Gariti 2009

MethodsSetting: academic research centre, USA
Recruitment: community volunteers, interested in quitting


Participants260 light smokers (6-15 cpd), 57% F, av. age ˜43, av. cpd 11, approx 1/3 smoked <10 cpd, approx 50% had history of smoking 20 cod

Therapists: Cessation counsellors


Interventions2x2 double-blind double-dummy. Participants randomized to either nicotine patch (21 mg/day or 14 mg/day (< 10 cpd) for 8 wks incl weaning) or bupropion (9 wks).

1. Pharmacotherapy & medication management, 4 x 5-10 min visits over 6 wks

2. Pharmacotherapy & counselling, 10 weekly individual 10-15 mi sessions


OutcomesAbstinence at 1yr, sustained with no relapse of over 7 days smoking. (Study primary outcome is PP abstinence)

Validation: CO ≤ 9 ppm & cotinine (NicAlert) ≤ 200 ng/ml or cotinine <50 ng/ml


NotesNRT & bupropion conditions not reported separately by counselling condition, so 2 vs 1 entered in NRT or bupropion section. Favoured NRT but no significant difference at any follow-up. More evidence of effect on sustained than PP rates at 1yr, but substituting PP in MA does not affect findings.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated 'urn' randomization by independent data analyst

Allocation concealment (selection bias)Low riskRandomization after enrolment, not predictable

Incomplete outcome data (attrition bias)
All outcomes
Low risk108 (84%) intervention and 108 (82%) control reached at 1 year.

Ginsberg 1992

MethodsSetting: academic research centre, USA
Recruitment: Community volunteers


Participants99 smokers with an acquaintance willing to participate as a support partner; 54% F, av. age 38, av. cpd 26


InterventionsPharmacotherapy: Nicotine gum, 2 mg, duration not specified

1. Instruction for gum use & educational materials, 2 brief sessions over 2 wks
2. Instructions as 1. included with a group based behavioural programme including skill training, 5 sessions over 4 wks. Duration not specified, assumed to be 91 to 300 min.
3. As 1. plus behavioural programme and partner support programme, 8 sessions over 5 wks. Not included in this review


OutcomesAbstinence at 52 wks (not clear if abstinence required at prior assessment at wks 4,12, 26)
Validation: CO < 10ppm, urine cotinine < 50ng/mL. Paper states that cotinine levels failed to confirm self report in 7 people, 3 of whom were still coded as abstinent on the balance of evidence.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'randomly assigned to 3-6 member groups in order of entrance into treatment within time constraints. Treatment for each group was randomly selected ...'

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low risk9 participants lost to follow-up counted as smokers. 1 participant who died excluded from analyses.

Hall 1985

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


Participants84 smokers in relevant arms; 53% male, av. age 38, av. cpd 30.5
Therapists: 2 psychologists


InterventionsPharmacotherapy: NRT; gum (2 mg, available for 6 m)

1. Intensive behavioural treatment (incl relapse prevention skill training, relaxation, 30 seconds aversive smoking of 3 cigs). 14 x 75 min sessions over 8 wks
2. Low-contact . Met x4 in 3w, educational materials, written exercises, group discussion

3. Intensive behavioural, no gum. Not included in this review


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


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'Randomly assigned within time constraints.' Author clarification: 'There were two or more treatment conditions available within any time block, and participants were randomly assigned to conditions within that time block'.

Allocation concealment (selection bias)Unclear riskNo details given

Incomplete outcome data (attrition bias)
All outcomes
Low risk3 dropouts from group 2 and 3 from group 3. 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% male, av. age 39, av. cpd 30 (71 in relevant arms)
Therapists: Advanced graduates in clinical psychology or health psychology


InterventionsPharmacotherapy: NRT (gum). Placebo arms of factorial trial not used in review
1. Intensive behavioural treatment,14 x 75 min sessions (period not stated) (incl 6 seconds aversive smoking, RP skills training, written exercises)
2. 'Low contact' 5 x 60 min sessions (incl written exercises, educational materials, group discussions, quitting techniques)


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


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 reported

Incomplete outcome data (attrition bias)
All outcomes
Low risk2 dropouts in 1 & 2 in 2 included in ITT analyses. "Differences between conditions were not statistically significant."

Hall 1994

MethodsCountry: USA
Recruitment: Community volunteers or referrals


Participants149 smokers ( > 10 cpd)
52% F, av. age 41, av. cpd 25, 31% had history of MDD
Therapists: physician, psychologist. Both received training


InterventionsPharmacotherapy: NRT (gum, 2 mg for up to 12 wks, tapering from wk 4)
1. Mood Management. 10 x 2 hr sessions over 8 wks. Similar to control, plus specific cognitive-behavioural components for developing skills for coping with situations leading to poor mood. Thought stopping, rational-emotive techniques, relaxation etc.

2. Standard group therapy. 5 x 90 min sessions over 8 wks. Information and group support for planning and implementing individual strategies.


OutcomesContinuous abstinence at 52w. (Confirmed quit at all prior assessments and no smoking in previous wk)
Validation: CO ≤10 ppm and urine cotinine ≤60 ng/ml


NotesBoth behavioural interventions were relatively intensive. Positive effect reported for subgroup with history of major depression.


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

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts included as smokers, but numbers not specified

Hall 1998

MethodsSetting: Cessation clinic, USA
Recruitment: Community volunteers. Exclusion criteria included MDD within 3m of baseline


Participants199 smokers of ≥ 10 cpd; 55% F, av. age 40, av. cpd 21-25; 33% had history of MDD
Therapists: 3 doctoral level clinical psychologists


InterventionsPharmacotherapy: Nortriptyline (titrated to therapeutic levels - usually 75-100 mg/day for 12 wks). Placebo arms of factorial trial not used in review
1. Mood Management. 10 x 2 hr sessions over 8 wks.

2. Standard group therapy control. 5 x 90 min sessions over 8 wks. (See Hall 1994 for description of each intervention)


OutcomesAbstinence at 64 wks (1 yr post-treatment). Continuous abstinence rates not reported by psychological treatment group.
Validation: CO < 10ppm and cotinine < 341 nmol/L


NotesBoth behavioural interventions were relatively intensive.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized by computer, after stratification on history of MDD and number of cigs smoked

Allocation concealment (selection bias)Low riskComputer randomization after data collection

Incomplete outcome data (attrition bias)
All outcomes
Low risk16% lost to follow-up at 1 yr, no difference by group, included in denominators for MA

Hall 2002

MethodsCountry: USA
Recruitment: Community volunteers. Exclusion criteria included current MDD


Participants220 smokers (146 in relevant arms); ≥ 10 cpd; 40-47% F, av. age 37-43, av. cpd 20-23; 33% had history of MDD


InterventionsPharmacotherapy: Bupropion (300 mg for 12 wks) or Nortriptyline (titrated to therapeutic levels, typically 75 or 100 mg/d). Factorial 3x2 design, placebo arms not used in this review
1. Medical Management (MM) control: physician advice, S-H, 10-20 min 1st visit, 5 min at 2, 6, 11 wks)
2. Psychological Intervention (PI) as MM plus 5x 90 min group sessions in wks 4, 5, 5, 7 & 11)


OutcomesPP abstinence at 1 yr (47 wks post-quit date). Continuous abstinence not reported by subgroup
Validation: CO ≤10 ppm, urine cotinine ≤ 60 ng/mL


NotesBupropion PI vs MM & nortriptyline PI vs MM used in relevant subgroups. Trial also contributes to review of combined interventions Stead 2012a, using different combination of arms


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, method not specified, 'double blind'

Allocation concealment (selection bias)Unclear riskNo details given

Incomplete outcome data (attrition bias)
All outcomes
Low risk19% lost to follow-up at 12m, similar numbers across groups

Hall 2009

MethodsSetting: Cessation clinic, USA

Recruitment: Community volunteers


Participants402 smokers (≥ 10 cpd) aged ≥ 50; 40% F, av. age 57, av. cpd 21


InterventionsPharmacotherapy: NRT (gum, 10 wks, 2 or 4 mg) & bupropion (12 wks). 2 arms had extended access to gum.

1. 'Standard treatment'; 5 group sessions over 8 wks, 'Clear Horizons' manual

2. Extended CBT; 11 individual 20-40 min sessions from wk 10 – wk 52, schedule front loaded. Incl motivation, mood management, weight control, social support, coping with withdrawal.

3. Extended NRT. Nicotine gum available until wk 52, no additional behavioural support

4. Extended Combined, CBT & NRT; 3 & 4


OutcomesAbstinence at 104 wks (one year after end of all treatment) (PP)

Validation: CO ≤ 10 ppm and urine anatabine/anabasine ≤ 2 mg/ml


NotesMeta-analysis comparison is 2 & 4 vs 1 & 3


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized at end of initial treatment, computerized allocation list by statistician who had no contact with participants. Stratified on gender, history of MDD, current cigarette abstinence status.

Allocation concealment (selection bias)Low risk'The assignment of individual participants by subject number was then transmitted electronically to clinical staff.'

Incomplete outcome data (attrition bias)
All outcomes
Low riskLess than 20% lost to follow-up in each group, denominator excludes participants who died during the study but counts all others lost to follow-up as smokers.

Hollis 2007

MethodsSetting: Community-based telephone quitline programme, Oregon, USA
Recruitment: Callers invited to participate; assumed to be fully or partly motivated to quit


Participants4614 smokers randomized to: brief counselling (872, no NRT; 868, with NRT); moderate counselling (718, no NRT; 715, with NRT); intensive counselling (720, no NRT; 721, with NRT).

40% male, av. age 41, 90% white, av. cpd 21.


InterventionsFactorial design; Arms that were offered free NRT (patches, initial 5 wk supply, 3 more wks available) contribute to this review
Intervention 1. Brief counselling (usual care), 15 min call + referral material + tailored S-H materials.
Intervention 2. Moderate counselling: 40 mins counselling based on MI + 1 brief call to encourage use of community services, tailored S-H materials.
Intervention 3. Intensive counselling: As 2, plus offer of up to 4 additional telephone calls. Each call incorporated MI techniques, stage assessment, relapse prevention as needed.


Outcomes30-day PPA at 6 and 12m
Validation: none


Notes3 vs 1 in main comparison. Actual contact in 3; mean 2.9 sessions, 60.6 min contact

Also contributes to review of combined interventions Stead 2012a.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"a computer algorithm randomly assigned participants"

Allocation concealment (selection bias)Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskModerate level of attrition but balanced between groups, and participants lost to follow-up counted as smokers (72% followed up in groups 1 and 2, 68% followed up in group 3)

Huber 2003

MethodsSetting: Academic research centre, Germany
Recruitment: Community volunteers


Participants225 smokers (102 in relevant arms); 55% F, av. age 38, av. cpd 28


InterventionsPharmacotherapy: nicotine gum, 2 or 4 mg

1. 5 x 90 min weekly meetings. Included contracting, reinforcement, relaxation, skills training.
2. Same schedule of meetings, 45 min only, focus on sharing experiences.
3. As 1, no nicotine gum. Not included in this review

4. Wait-list control for 6 months. Not included in this review


OutcomesPP abstinence at 12m
Validation: CO ≤ 4ppm


NotesControl and intervention fall into same categories for number and duration of sessions


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

Incomplete outcome data (attrition bias)
All outcomes
Low risk31 people attending 2 or fewer meetings not included in analysis. Said to be evenly distributed. Later drop-outs included as smokers; 90% of those receiving therapy (excludes wait list group 4, who are also excluded from this review) followed up at 12m.

Jorenby 1995

MethodsCountry: 2 academic research sites, USA
Recruitment: Community volunteers


Participants504 smokers (≥ 15 cpd); ˜53% F, av. age 44, av. cpd 26-29
Therapists: Trained smoking cessation counsellors


InterventionsCompared 22 mg vs 44 mg nicotine patch and 3 types of adjuvant treatment. Patch groups collapsed. All participants had 8 weekly assessments by research staff
1. Minimal: Given S-H pamphlet by physician during screening visit for trial entry, and instructed not to smoke whilst wearing patch. No further contact with counsellors.
2. Individual: Given S-H pamphlet at screening visit along with motivational message. Also met nurse counsellor x3 following quit date. Nurse helped generate problem-solving strategies and provided praise and encouragement.
3. Group: Given S-H pamphlet at screening visit along with motivational message. Received 8x 1hr weekly group sessions. Skills training, problem-solving skills.


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


NotesNo significant difference in dose-related outcome and no dose-counselling interaction at 26 wks reported. Patch arms collapsed in analysis. 3 vs 1 used in primary comparison, RR 0.99 [0.69, 1.42]. RRs for other comparisons: 2&3 vs 1 = 1.10 [0.81, 1.49], 2 vs 1 = 1.21 [0.86, 1.70], 3 vs 2 = 0.82 [0.58, 1.15]


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized, method not stated

Allocation concealment (selection bias)Unclear risk'In a double blind manner' for NRT, but not specified for counselling

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses not specified by group, relatively low rate lost to follow-up overall (16.3%), Counted as smokers in report & MA.

Killen 2008

MethodsSetting: Community cessation clinic, USA

Recruitment: Community volunteers


Participants301 smokers (≥ 10 cpd or 3.5 packs/wk) (excludes 3 participants who received wrong treatment); 40% F, av. age ˜46, av. cpd ˜20


InterventionsPharmacotherapy: Bupropion (300 mg, 9 wks) & NRT (21 mg patch, 8 wks incl tapering) 

Common behavioural therapy: 6 x 30 min individual CBT sessions at baseline, TQD, 1, 2, 4, 6 wks

1. Extended therapy: 4 x 30 min sessions at 8, 12, 16, 20 wk, & weekly check in calls to automated system; report of relapse or craving prompted proactive calls

2. Control: 5 min general support calls at 8, 12, 16, 20 wks


OutcomesAbstinence at 52 wks (7 day abstinence at both 20 & 52 wks) (Continuous abstinence also reported but not used in MA as could underestimate any effect on recycling)

Validation: CO < 10 ppm (11 self reported quitters no longer living in study area accepted as quitters without validation)


NotesTested of extended duration therapy.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized using a permuted block method (block size = 4), stratified on gender

Allocation concealment (selection bias)Low riskParticipants assigned to next available ID number in corresponding gender. Researchers & participants were blinded to extended treatment assignment to the end of the open-label phase.

Incomplete outcome data (attrition bias)
All outcomes
Low risk89% followed up in standard care group, 90% followed up intervention group

Lando 1997

MethodsSetting: Health Maintenance Organization, USA
Recruitment: Physician referral and HMO clinic newsletters


Participants509 smokers of > 20 cpd, motivated to quit; 56% F, av. age 42, av. cpd 28


InterventionsAll participants received prescriptions for free nicotine patch (Prostep), 22 mg for a maximum of 6 wks plus 11mg for 2 wks. All attended 90 mins group orientation session describing study, use of patch, behavioural information, set quit date. Standard written materials with patch included description of a toll-free telephone help line.
1. No further support
2. Orientation session included encouragement to call toll-free number and a registration card
3. Additional proactive telephone counselling, 4 10-15 min calls (approx 1, 4, 7-9, 12 wks from quit date). Reinforced success or negotiated a new quit date.


OutcomesAbstinence at 12m (from quit date)
Validation: CO at 6m. 96% of quitters were confirmed.


NotesAlso contributes to Cochrane review of telephone counselling (Stead 2006).

Effect of counselling compared to contact & quitline alone. (1& 2 combined since fewer than 1% called quitline and no difference between quit rates.) Participants who did not return questionnaires at 2, 5, 8, 12 wks were called by telephone.
Average number of calls completed 3.76.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskAllocation by orientation session attended; participants did not know condition in advance so risk of selection bias probably low

Incomplete outcome data (attrition bias)
All outcomes
Low risk82% response rate at 12m, no difference between groups, missing treated as smoking

Lifrak 1997

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


Participants69 smokers; 61% F, av. age 39, av. cpd 25


InterventionsPharmacotherapy: nicotine patch (24 hr, 10 wks 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 relapse prevention therapy from clinical social worker or psychiatrist experienced in addiction treatment.


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


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomization (block size 10)

Allocation concealment (selection bias)Unclear riskNo details given

Incomplete outcome data (attrition bias)
All outcomes
Low riskLow rate of attrition (though breakdown by group not provided): 12 administrative dropouts/exclusions not included in analyses

Lloyd-Richardson 2009

MethodsSetting: 6 outpatient HIV clinics & 2 primary care clinics, USA
Recruitment: Eligible patients identified by physicians, motivation to quit not required


Participants444 HIV+ smokers; 37% F, av. age 42, av. cpd 18


InterventionsPharmacotherapy: Nicotine patch for up to 8 wks if willing to set quit date.

1. 2 brief counselling sessions, biweekly patch collection without counselling contact

2. 4 x 30 min sessions + quit day call, using motivational interviewing approach


OutcomesAbstinence at 6m (PP)

Validation: CO < 10 ppm


Notes72% used patch at some point during study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomized, stratified by gender & motivation to quit

Allocation concealment (selection bias)Unclear riskNo details provided

Incomplete outcome data (attrition bias)
All outcomes
Low risk75% intervention, 71% control followed up at 6m. ITT and available case analyses reported.

MacLeod 2003

MethodsSetting: Community, Australia
Recruitment: Community volunteers


Participants854 smokers interested in quitting; 51% F, av. age 42, av. cpd 24


InterventionsAll participants received a free 2 wk supply of nicotine patch by mail, instructed to purchase further supply. 14 or 21 mg depending on body weight.

1. No further intervention
2. As 1. + 5 proactive telephone counselling calls 1, 2, 3, 6 & 10 wks. 20 min session 1, 10 min others. Toll-free hotline, S-H materials.


OutcomesAbstinence at 6m (90-day continuous)
Validation: none, warning of CO test only.


NotesAlso contributes to Cochrane review of telephone counselling (Stead 2006). No face-to-face contact.
Average number of calls 4.7. 9% of participants called hotline.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'Randomized' by shuffling folders each day after participants to be included were listed. Since there was no personal contact with participants risk of bias judged to b low

Allocation concealment (selection bias)Low riskPotential for bias since allocation sequence not fixed in advance, however baseline characteristics similar across groups so no evidence of selection bias.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo significant difference in loss to follow-up, 17% in NRT only, 15% in NRT+ at 6m

McCarthy 2008

MethodsSetting: Clinic, USA
Recruitment: Community volunteers


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


InterventionsFactorial trial of bupropion or placebo pharmacotherapy and counselling versus support
1. Bupropion & counselling; 13 office visits, 8 included additional 10 min counselling, 2 prequit, TQD, 5 over 4 wks (classified as > 300 mins contact)
2. Bupropion & psychoeducation about medication, support & encouragement. 13 office visits, 80 mins less contact time than 1. (classified as 91 to 300 mins contact)
3. Placebo & counselling. Not included in this review
4. Placebo & psychoeducation. Not included in this review


Outcomes7 day PP abstinence at 12m (Prolonged abstinence reported but not verified so PP used in MA)
Validation: CO ≤ 10ppm


Notes1 vs 2 used as test of adjunct behavioural support.
Also contributes to Cochrane reviews of combined interventions (1 vs 4) (Stead 2012a), antidepressants (collapsing behavioural conditions) (Hughes 2007) and individual behavioural counselling (collapsing pharmacotherapy) (Lancaster 2005b).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table

Allocation concealment (selection bias)Low riskStaff who screened and enrolled participants were unaware of the experimental condition to be assigned

Incomplete outcome data (attrition bias)
All outcomes
Low risk63% reached at 12m, but attrition rates did not differ by condition at any point

Ockene 1991

MethodsSetting: Primary care clinics, USA
Recruitment: Clinic attenders, not selected for interest in quitting


Participants380 smokers in relevant arms (excludes deaths and some who did not receive intervention); of 1223 smokers in study; 57% F, av. age 35, av. cpd 23


InterventionsPharmacotherapy: Nicotine gum; offer of free gum

2x3 factorial design, physician intervention +/- follow-up.
1. Physician counselling (initial session and 1 follow- up) and offer of NRT. Follow-up telephone counselling by psychologist or health educator, 3 calls (1, 2, 3m) approx 10 mins, behavioural recommendations. Letters.
2. Physician counselling as 1. No additional follow-up.


OutcomesAbstinence at 6m (7-day); (3m sustained abstinence rates not given by condition)
Validation: none


NotesMarginal to include since relatively low use of pharmacotherapy; in intervention condition, of those reached, 33% refused use and 18% tried for 2 days or less.

12m abstinence rates reported in Ockene 1994 but not given by follow-up condition. Also contributes to review of combined interventions (Stead 2012a).


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskAllocated prior to physician encounter

Incomplete outcome data (attrition bias)
All outcomes
Low risk19% lost to follow-up, higher in telephone follow-up group. All included as smokers in analysis.

Otero 2006

MethodsSetting: Brazil
Recruitment: Community volunteers


Participants1199 smokers (includes 254 non-attenders); 63% F, av. age 42, 46% smoked > 20 cpd
Therapists: trained doctors, nurses or psychologists


InterventionsFactorial design with NRT (21mg or 14mg patch for 8 wks incl tapering) or no NRT and 5 levels of behavioural support collapsed into 3 for analysis. Arms without NRT do not contribute to this review.
1. Single 20 min session - classified as brief intervention control in meta-analysis
2. Cognitive behavioural, 1 or 2 weekly x1 hr sessions
3. As 2, with 3 or 4 weekly sessions.
Maintenance or recycling sessions provided to all groups at 3, 6, 12m.


OutcomesAbstinence at 12m (7 day PP)
Validation: none


Notes3 vs 1 in patch condition only in primary analysis. Also contributes to review of combined interventions (Stead 2012a).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized, stratified by age & sex, by independent specialist

Allocation concealment (selection bias)Low riskTrial administrators blind

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow-up not provided. Non-participants and losses to follow-up included as smokers.

Reid 1999

MethodsSetting: Community, Canada
Recruitment: Volunteers


Participants396 smokers interested in quitting within 30 days, smoking ≥15 cpd; 48% F, av. age 38, av. cpd 23-24


InterventionsPharmacotherapy: NRT; patch (15mg x 8 wks, 10mg x 2 wks, 5mg x 2 wks) free

1. Physician advice (3x 15 min, 2 wks before, 4 wks, 12 wks after quit date)
2. As 1, plus telephone calls from nurse counsellors, x 3 at 2, 6, 13 wks.


OutcomesAbstinence at 12m (PP)
Validation: CO, but self-reported rates reported. Only 1 disconfirmation.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized using table of random numbers, stratified by sex and nicotine dependence

Allocation concealment (selection bias)Unclear riskConcealment unclear but physician blind to allocation

Incomplete outcome data (attrition bias)
All outcomes
Low risk84% intervention 86% control followed-up at 12m

Rovina 2009

MethodsSetting: Smoking cessation clinic, Greece
Recruitments: Clinic attenders invited to participate


Participants205 smokers


InterventionsPharmacotherapy: Bupropion 300mg/day for 19 wks

1. Control: 15 mins physician counselling

2. Nonspecific group therapy (NSGT), 1 hour weekly for 1 m, then every 3 wks until 19 wks

3. Cognitive behavioral group therapy (CBGT), same schedule

4. CBGT without bupropion - not used in review


OutcomesAbstinence at 12m after end of treatment (continuous)

Validation: CO ≤ 10 ppm


Notes2 & 3 vs 1 in primary analysis, same intensity


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomised, method not stated, 3:1:1:1 ratio

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low risk90% followed up at 12m

Simon 2003

MethodsSetting: Hospital for military veterans, USA
Recruitment: Inpatients (all diagnoses) invited to participate


Participants223 smokers, ≥ 20 cigarettes in wk before admission, contemplation or action stage of change, able to use NRT. Av. age 55, av. cpd 23.


InterventionsPharmacotherapy: NRT; patches (tailored dose) in hospital and for 8 wks post discharge

1. Intervention: Nurse or health educator counselling; 30-60 mins initial session. 5 calls at 1, 3 wks, 1m, 2m, 3m, < 30 min/call & S-H materials
2. Control: brief counselling (10 mins) + S-H only


OutcomesAbstinence: 7-day PP at 12m
Validation: Saliva cotinine <15 ng/ml (alternative analysis allowed spousal corroboration)


NotesRelative effect similar if spousal corroboration allowed


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized using computer algorithm

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow-up (3 intervention, 4 control) included as smokers. Deaths (5 intervention, 9 control) excluded from denominator.

Smith 2001

MethodsSetting: Clinic, USA
Recruitment: community volunteers


Participants677 smokers (> 10/day) attempted quit for 1 wk; 57% F, av. age 42; av. cpd 25


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


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


NotesMarginal to include as the counselling was intended for relapse prevention.

1 vs 3 in primary analysis. Including 2 does not alter findings; 17.6% quit in 1, 18.8% in 2. No evidence found for hypothesized 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 riskRandomized 1 wk after TQD, stratified by +/- any smoking post-TQD. Method not stated

Allocation concealment (selection bias)Unclear riskNo details given

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

Solomon 2000

MethodsSetting: Community, USA
Recruitment: Volunteers for free nicotine patch trial


Participants214 female smokers, > 4 cpd, intending to quit in next 2 wks; av. age 33, av. cpd 24


InterventionsPharmacotherapy: NRT; Free nicotine patch (dose based on smoking level) for up to 10 wks, After 1 month contingent on abstinence

1. Access to Nicoderm support line
2. As 1. and Proactive telephone counselling from female ex smoker, 7 hrs training. Up to 12 calls for up to 3m, starting pre quit, quit day, day 4, average 7.


OutcomesAbstinence at 6m (Multiple PP; 7 days at 3m & 6m)
Validation: CO ≤ 8ppm. 7-12% disconfirmation rate. Participants who did not provide samples remained classified as quitters.


NotesIntervention participants received on average 7 calls of 9 mins. Classified in 4-8 subgroup analysis. 95% received at least 1 call. Participants could call Nicoderm support line, 21% of control vs 8% of intervention did so.


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

Incomplete outcome data (attrition bias)
All outcomes
Low riskApproximately 73% followed up in each group

Solomon 2005

MethodsSetting: Community, USA
Recruitment: Volunteers for free nicotine patch trial


Participants330 female smokers > 4 cpd, intending to quit in next 2 wks; av. age 34, av. cpd 24


InterventionsPharmacotherapy: NRT; Free nicotine patch (dose based on smoking level) for up to 10 wks, 2nd & 3rd prescriptions dependent on reporting abstinence

1. No additional support
2. Proactive telephone counselling from female ex smoker, 8 hrs training. Calls for up to 4m, starting pre quit, quit day, day 4


OutcomesAbstinence at 6m (30 days at 3m & 6m)
Validation: none


NotesSimilar to Solomon 2000 with more extended telephone contact.
Average number of calls 8.2, average duration 10 min. Classified in 4-8 subgroup analysis.


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

Incomplete outcome data (attrition bias)
All outcomes
Low risk87% response in both conditions at 6m

Stein 2006

MethodsSetting: 5 methadone maintenance treatment programme centres, USA
Recruitment: Smokers routinely attending maintenance clinic. Willingness to quit not required.


Participants383 methadone-maintained adult smokers. 53% M, av. age 40, av. cpd 27


InterventionsPharmacotherapy: NRT; all participants willing to make quit attempt offered patches (8-12 wks, dose and duration tailored to smoking rate)
1. Motivational interview based tailored Intervention: Up to 3 visits from study counsellor, i.e. 1 x 30-min + 15-30 min quit date session, + follow-up relapse prevention session. Those not ready to quit only received 2 sessions.
2. Control: Brief advice using NCI's 4 As model (<3 minutes), + S-H materials. Up to 2 visits, i.e. baseline and quit date (if set).


OutcomesAbstinence at 6m (PP)
Validation: CO < 8ppm


NotesIncluded since most participants in both conditions did make quit attempts and receive NRT; 81% intervention and 80% control.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, methods not stated

Allocation concealment (selection bias)Unclear riskNo details reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskApprox 82% followed-up in both groups at 6m

Swan 2003

MethodsSetting: HMO, USA
Recruitment: Volunteers from Group Health Co-op membership


Participants1524 smokers ≥ 10 cpd; 57% F, av. age 45, av. cpd 23, 44% history of depression


InterventionsPharmacotherapy: Randomized to bupropion 300 mg/day or 150 mg/day
1. Free & Clear proactive telephone counselling (4 brief calls), access to quitline and S-H materials
2. Zyban Advantage Program (ZAP); tailored S-H materials, single telephone call after TQD, access to Zyban support line


OutcomesAbstinence at 12m (7-day PP)
Validation: none


NotesPrescription was mailed. No face-to-face contact during enrolment or prescription. Estimated as 31-90 minutes contact.

No dose/behavioural treatment interaction at 12m, bupropion arms collapsed.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Open-label randomized trial...The computer code for the procedure calculated probabilities of group assignment that were dynamically modified based on the number of members in each group so that final group sizes were equal. No restrictions such as stratification or blocking were used as part of the randomization process."

Allocation concealment (selection bias)Low riskProcedure built into study database

Incomplete outcome data (attrition bias)
All outcomes
Low risk83% intervention, 88% control followed up at 12m

Swan 2010

MethodsSetting: HMO (Group Health), Seattle, WA, USA

Recruitment: Group Health members contacted by phone & mail from Free & Clear


Participants1202 smokers (≥ 10 cpd); 67% F, av. age 47, av. cpd 22


InterventionsPharmacotherapy: varenicline for 12 wks (1 mg x 2/day, titrated 1st wk). All received 5-10 min orientation call, printed Quit Guides and access to a free support line for ad hoc calls.
1. Web-based counselling: Access to online programme, including quit plan, online library, quit calendar, cost calculator, progress tracker, email links to friends and family and discussion forums.
2. Proactive telephone-based counselling: Free & Clear Quit for Life program. Up to 5 'brief' one-to-one phone sessions initiated by F&C counsellor. Timed for convenience and at relapse-sensitive stages. Used MI techniques.
3. Combination: Proactive calls + web access; counsellor could view info entered online. Participants encouraged to use website for additional info and social support, and to track CPD. Counsellors could view quit status, last log-in and last use of discussion forum.


OutcomesAbstinence at 6m (PP)
Validation: none


Notes3 vs 1 in main analysis, 2&3 vs 1 has little effect on result. 60 min contact on average for 3.

64% were no longer taking varenicline at 3m, but no between-group differences in non-compliance or reasons for stopping.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Group assignment was randomly allocated using an automated algorithm built into the study database"

Allocation concealment (selection bias)Unclear riskNot stated

Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow-up counted as smokers in ITT analysis; equal losses between groups (103 Web, 107 Phone, 100 Web + Phone)

Tonnesen 2006

MethodsSetting: 7 chest clinics, Denmark
Recruitment: Outpatient attender


Participants370 smokers of > 1 cpd with COPD (185 in relevant arms); 52% F, av. age 61, av. cpd 20

Therapists: 20 nurses with cessation experience, trained to support medication use and provide standardised counselling


InterventionsPharmacotherapy: NRT; sublingual. Factorial trial included placebo tablets, only active treatment groups used in this review
1. High support: 7 x 20-30 min 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


NotesAlso contributes to review of combined therapy review (Stead 2012a), using Placebo low support arm as control. Therapists were not full-time specialist counsellors. Using PP outcome does not alter effect. Only contacts before 12 weeks counted for classification of intensity.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomization list at each centre

Allocation concealment (selection bias)Unclear riskAllocation process not described

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk42/185 (23%) of active NRT participants not followed-up at 12m and counted as smokers. Not reported by support condition. Of those who were followed up at 12m, 52% had withdrawn from study treatment. Authors state: "One potential bias may have been the large early dropout of failures from the study. Consequently, these patients were not exposed to the possible effect of more intensive support."

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% F, av. age 59, av.cpd 21
Therapist: nurse practitioner


InterventionsPharmacotherapy: NRT; patch (8 wks, dose based on smoking rate) for smokers making a quit attempt. In 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 at 12m (7 day PP)
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.


NotesParticipants were referred to nurse practitioner for counselling; not part of usual care. Unclear how many patients used NRT; in a subgroup who responded to a questionnaire (Wiggers Int J Behav Med 2006), 16% did not start patch therapy).


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Low risk'While patients completed their baseline questionnaire (and signed a written informed consent) nurses randomly assigned ...' Judged low risk as patient data had to be entered.

Incomplete outcome data (attrition bias)
All outcomes
Low risk89% intervention and 85% control followed up at 12m. 8 deaths excluded from final denominators.

Williams 2010

MethodsSetting: Mental health outpatient clinics, USA

Recruitment: Patients with schizophrenia or schizoaffective disorder, willing to use NRT


Participants100 smokers (> 10 cpd) using an atypical antipsychotic; 16% F, av. age ˜46, av. cpd 23

Therapists: trained mental health clinicians provided both conditions


InterventionsPharmacotherapy: Nicotine patch (21 mg for 16 wks incl tapering)

1. Treatment of Addiction to Nicotine in Schizophrenia (TANS); 24 x 45 min individual counselling sessions over 26 wks

2. Medical Management (MM); 9 x 20 mins over 26 wks


OutcomesContinuous abstinence at 12m

Validation: CO < 10 ppm


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'adaptive urn randomization procedure that accounts for motivation, gender, ethnicity, and heavy versus light smoking status'

Allocation concealment (selection bias)Low riskJudged that process for randomization prevented prior knowledge of condition

Incomplete outcome data (attrition bias)
All outcomes
Low risk75% followed up at 12m, authors report "not different between groups"

Wu 2009

MethodsSetting: Research unit for Asian health, NYC, USA
Recruitment: Via Asian Community Health Coalition member organisations


ParticipantsChinese smokers (any smoking in previous wk); 12% F, av. age 44, av. cpd NS, 25% smoked less than 10 cpd, 49% had never attempted to quit


InterventionsPharmacotherapy: NRT. Patch for 8 wks (could start at any time in 6m period)

1. Culturally tailored counselling in Chinese, 4 x 60 min & S-H

2. Health education in Chinese: 4 x 60 min, including general health, nutrition, exercise & tobacco


OutcomesAbstinence at 6m (PP)

Validation: CO < 6 ppm


NotesConditions had same contact time, but control did not focus on smoking


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskrandomized, method not stated

Allocation concealment (selection bias)Unclear riskdetails not reported

Incomplete outcome data (attrition bias)
All outcomes
Low risk10% intervention and 14% control lost to follow-up at 6m and counted as smokers in ITT analysis

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ahluwalia 2006Conselling conditions had same number of contacts and duration. Compared Motivational Interviewing and Health Education in a factorial trial with nicotine gum or placebo. (Results favoured HE (control) condition.)

Batra 2010Behavioural conditions were matched for number of sessions. Experimental intervention was tailored for at-risk subgroups, and included recommendation to use combination NRT. Standard treatment control recommended single type of NRT.

Bock 2008Only participants interested in quitting (17% at baseline) were offered NRT. Main intervention was motivational interviewing.

Borland 2008Pharmacotherapy was only offered to participants interested in quitting; 24% reported use.

Brown 2007Factorial trial of bupropion/placebo and mood management CBT or standard cessation CBT. Both behavioural interventions were intensive, and experimental treatment was specifically devised for people with depression

Buchanan 2004Only 3 months follow-up (42 participants).

Carlin-Menter 2011Only 3 months follow-up. Compared 2 versus 4 counselling callbacks for smokers calling a quitline who received up to 6 weeks of free NRT.

Chouinard 2005Pharmacotherapy was only offered to participants interested in quitting; 24% used.

Christenhusz 2007Pharmacotherapy differed by arm: control arm advised to use pharmacotherapy but had to pay for it, intervention arm provided with bupropion free of charge.

Cooney 2007Both pharmacotherapy and behavioural components varied by trial arm.

Cooper 2004Main study results have not been published.

Costello 2011Only 5 weeks follow-up. Compared two intensities of pharmacist led behavioural support for participants using NRT.

Fang 2006Only 3 months follow-up.

Ferguson 2012Use of pharmacotherapy was low; only 42.9% of those offered NRT reported receiving any and of those only 51.3% used every day. There was also little difference between number of calls completed between proactive and standard telephone counselling conditions.

Garvey 2012Both behavioural interventions were intensive and matched for contact time, differed only in scheduling of sessions.

Hall 1996Both behavioural interventions were intensive and matched for contact time.

Hall 2004Factorial trial crossing extended behavioural support (CBT) with medical management only, and nortriptyline or placebo, for one year, as adjuncts to nicotine patch and 5 group counselling sessions. Placebo arms could have been compared, but no other trials confounded behavioural support with placebo, and the support common to all conditions was also much more intensive than in other trials.

Hall 2011Similar design to Hall 2004: Factorial trial crossing extended behavioural support (CBT) with medical management only, and bupropion or placebo, as adjunct to nicotine patch and 5 group support sessions over 11 weeks. As with Hall 2004, placebo arms could have been compared, but no other trials confounded behavioural support with placebo, and the support common to all conditions was also much more intensive than in other trials.

Hegaard 2003Study population pregnant smokers, not eligible.

Ingersoll 2009Only 3 months follow-up. Test of motivational interviewing as adjunct to nicotine patch therapy for HIV+ smokers.

Japuntich 2006Intervention was access to an internet site; no person-to-person behavioural support.

Joseph 2004Intervention and control did not differ on use of pharmacotherapy or intensity of behavioural support. Test of timing in relation to alcohol dependence treatment.

Joyce 2008Test of reimbursement for pharmacotherapy and counselling.

Kim 2012Pilot study with only 30 participants.

Kinnunen 2008Main intervention was exercise, not eligible for this review. The matched contact control was not intended to include tangible cessation help, and recruitment to the standard care control was halted early.

Kotz 2009Tested a specific behavioural intervention; feedback of biomedical information.

Levine 2010Behavioural interventions were matched for intensity, specifically tested a weight related intervention.

Marshall 1985Only offer of nicotine gum.

Mochizuki 2004Only 3 months follow-up. Small study of pharmacist advice as adjunct to NRT.

Nilsson 1996Only 4 months follow-up. Intervention was offer of group support and free NRT.

Nollen 2011Only 3 months follow-up. Study of an intervention to increase adherence to varenicline.

Okuyemi 2006All participants received same intensity of motivational interviewing, group sessions and offer of NRT. Tested different targets for motivational interviewing.

Reid 2007Intervention participants did not automatically receive additional behavioural support; intervention consisted of automated telephone calls to identify participants at risk of relapse. Only this subgroup then received further counselling.

Schmitz 2007All participants received same intensity of group based therapy, compared cognitive behavioural to supportive approaches.

Schnoll 2005Only 3 months follow-up, behavioural interventions similar in intensity as adjuncts to nicotine patch.

Shiffman 2000Only 12 weeks follow-up from start of treatment. Study of computer tailored materials as adjunct to nicotine gum.

Shiffman 2001Only 12 weeks follow-up from start of treatment. Study of computer tailored materials as adjunct to nicotine patch.

Sorensen 2003Short follow-up (pre-operative period).

Strecher 2005Only 12 weeks follow-up from start of treatment. No personal behavioural support, study of web-based tailored materials as adjunct to nicotine patch.

Velicer 2006Intervention was automated telephone counselling messages, no personal contact.

Vial 2002Compared intervention from two different types of pharmacist, not between different intensities of support.

Ward 2001Compared two group based behavioural interventions similar in intensity as adjuncts to nicotine patch, See Stead 2005.

Wilson 1988Use of nicotine gum was substantially different between the relevant arms of the trial, and the intervention condition was also a test of the impact of training.

Wolfenden 2005Only 3 month follow-up. Test of multifaceted intervention including offer of NRT at preoperative clinics.

Yu 2006Only 12 weeks follow-up from start of treatment.

 
Characteristics of ongoing studies [ordered by study ID]
Humfleet 2011

Trial name or titleSmoking cessation in HIV+ clinical care settings

MethodsClinical trial evaluating smoking treatment provided in HIV clinical care settings

Participants207 HIV+ smokers, mean age 45

InterventionsParticipants randomly assigned to one of 3 treatments:

(a) 6 session individual counselling treatment

(b) computer/ internet based treatment

(c) minimal contact control condition

All participants had access to 10-weeks of nicotine replacement therapy; treatment duration was 12 weeks.

Outcomes7 day PP abstinence at weeks 12, 24, 36 and 52. Biochemically confirmed with CO < 10 ppm.

Starting dateNot specified

Contact informationgaryh@lppi.ucsf.edu

NotesStudy completed but full results not yet published

 
Comparison 1. Effect of increasing behavioural support. Abstinence at longest follow-up

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

 1 Subgroups by type of pharmacotherapy3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    1.1 NRT
279772Risk Ratio (M-H, Fixed, 95% CI)1.15 [1.06, 1.25]

    1.2 Bupropion
41995Risk Ratio (M-H, Fixed, 95% CI)1.25 [1.08, 1.44]

    1.3 Nortriptyline
2172Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.59, 1.63]

    1.4 Varenicline
1800Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.89, 1.37]

    1.5 NRT & bupropion
2690Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.98, 1.52]

    1.6 Choice of pharmacotherapy
32077Risk Ratio (M-H, Fixed, 95% CI)1.15 [0.92, 1.45]

 2 Subgroups by contrast in number of contacts between intervention & control3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    2.1 4 to 8 or > 8 contacts versus no contact
63762Risk Ratio (M-H, Fixed, 95% CI)1.25 [1.08, 1.45]

    2.2 More than 8 contacts versus 1 to 3 contacts
2609Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.66, 1.18]

    2.3 4 to 8 contacts versus 1 to 3 contacts
126817Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.07, 1.27]

    2.4 More than 8 contacts versus 4-8 contacts
91568Risk Ratio (M-H, Fixed, 95% CI)1.15 [0.98, 1.35]

    2.5 Intervention & control in same contact category
92750Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.97, 1.41]

 3 Subgroups by duration of contact in control condition (not prespecified)3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    3.1 'Brief intervention' for control
2011042Risk Ratio (M-H, Fixed, 95% CI)1.18 [1.10, 1.27]

    3.2 'Dose response', over 30 minutes contact for control
184464Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.99, 1.25]

 4 Subgroup by modality of contact (not prespecified)3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    4.1 All contact by telephone
65311Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.17, 1.41]

    4.2 No contact for control group, face-to-face intervention
32364Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.88, 1.35]

    4.3 Face-to-face contact for both intervention & control conditions
297831Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.99, 1.19]

 5 Subgroups by setting3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    5.1 Recruited and treatment initiated in health care setting
125422Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.94, 1.26]

    5.2 Members of health care organisation
32833Risk Ratio (M-H, Fixed, 95% CI)1.21 [1.07, 1.37]

    5.3 Community volunteers
237251Risk Ratio (M-H, Fixed, 95% CI)1.17 [1.08, 1.27]

 
Comparison 2. Sensitivity analyses

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

 1 Sensitivity analysis including intermediate intensity conditions. Adjunct behavioural support versus pharmacotherapy alone3817804Risk Ratio (M-H, Fixed, 95% CI)1.15 [1.08, 1.22]

    1.1 NRT
2711430Risk Ratio (M-H, Fixed, 95% CI)1.13 [1.04, 1.22]

    1.2 Bupropion
41995Risk Ratio (M-H, Fixed, 95% CI)1.25 [1.08, 1.44]

    1.3 Nortriptyline
2172Risk Ratio (M-H, Fixed, 95% CI)0.98 [0.59, 1.63]

    1.4 Varenicline
11202Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.92, 1.34]

    1.5 NRT & bupropion
2690Risk Ratio (M-H, Fixed, 95% CI)1.22 [0.98, 1.52]

    1.6 Choice of pharmacotherapy
32315Risk Ratio (M-H, Fixed, 95% CI)1.15 [0.92, 1.43]

 2 By outcome definition3815506Risk Ratio (M-H, Fixed, 95% CI)1.16 [1.09, 1.24]

    2.1 12m validation PP outcomes only
143202Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.88, 1.15]

    2.2 12m validated sustained outcomes
72322Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.87, 1.36]

    2.3 Not 12m
92783Risk Ratio (M-H, Fixed, 95% CI)1.21 [1.04, 1.40]

    2.4 No validation at all
87199Risk Ratio (M-H, Fixed, 95% CI)1.24 [1.14, 1.35]

 
Summary of findings for the main comparison. Behavioural interventions as adjuncts to pharmacotherapy for smoking cessation

Behavioural interventions as adjuncts to pharmacotherapy for smoking cessation

Patient or population: People using smoking cessation pharmacotherapy
Settings: Health care and community settings
Intervention: Behavioural interventions as adjuncts to pharmacotherapy

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

Assumed riskCorresponding risk

ControlBehavioural interventions as adjuncts to pharmacotherapy

Smoking cessation at longest follow-up
Follow-up: 6 - 24 months
Study populationRR 1.16
(1.09 to 1.24)
15506
(38 studies)
⊕⊕⊕⊕
high1,2

183 per 1000213 per 1000
(200 to 227)

Median quit rate

210 per 1000244 per 1000
(229 to 260)

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

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

 1 All studies rated at low or unclear risk of bias
2 No overall evidence of statistical heterogeneity (I² = 3%), or of differences between the subgroups defined by pharmacotherapy