Intervention Review

You have free access to this content

Print-based self-help interventions for smoking cessation

  1. Jamie Hartmann-Boyce,
  2. Tim Lancaster*,
  3. Lindsay F Stead

Editorial Group: Cochrane Tobacco Addiction Group

Published Online: 3 JUN 2014

Assessed as up-to-date: 10 APR 2014

DOI: 10.1002/14651858.CD001118.pub3


How to Cite

Hartmann-Boyce J, Lancaster T, Stead LF. Print-based self-help interventions for smoking cessation. Cochrane Database of Systematic Reviews 2014, Issue 6. Art. No.: CD001118. DOI: 10.1002/14651858.CD001118.pub3.

Author Information

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

*Tim Lancaster, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. tim.lancaster@phc.ox.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 3 JUN 2014

SEARCH

 
Characteristics of included studies [ordered by study ID]
Aveyard 2003

MethodsSetting: 65 general practices, UK
Recruitment: volunteers from random selection of smoking patients, not selected for motivation


Participants2471 smokers, 1373 in relevant arms, >80% in precontemplation or contemplation, 10-14% in preparation.
54% F, av. age 41, av. cpd 20


InterventionsNo face-to-face contact.
1. Standard S-H materials, single mailing
2. S-H manual based on Transtheoretical (SoC) model, expert system letter tailored on baseline questionnaire. Further questionnaires at 3m & 6m for additional letters (approx 50% received 3 letters).


OutcomesAbstinence at 12m, sustained for 6m
Validation: saliva cotinine < 14.2 ng/ml


Notes2 vs 1, tailored S-H vs standard S-H


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization using minimization to balance SoC, addiction and socio-economic status.

Allocation concealment (selection bias)Low riskBaseline questionnaires were read optically and data transferred automatically to the Access database that performed the minimization.

Blinding (performance bias and detection bias)
All outcomes
Low riskInterventions of similar intensity. 12m PP "was confirmed with salivary cotinine, so that we had unconfirmed and confirmed prevalence of quitting." Confirmed figures used in analysis.

Incomplete outcome data (attrition bias)
All outcomes
Low risk24% of S-H and 24% control lost to follow up. Included in ITT analysis here, sensitivity analyses allowing for differential drop-out did not change findings

Becona 2001a

MethodsSetting: community, Spain
Recruitment: community volunteers, mainly in contemplation or preparation SoC


Participants300 smokers;
48% F, Av. age 37, av. cpd 26


Interventions1. No intervention. Treatment offered after 6m follow up
2. Standard S-H pamphlets, 6 mailed weekly with personalized letter
3. As 2 with individual feedback based on weekly reports + 2 additional 1 page reports.


OutcomesAbstinence at 6m or 12m, sustained since initial quit.
Validation: CO < 9ppm


Notes2 vs 1 , S-H vs control, excluded from MA comparison 2 due to heterogeneity. Quit rates 16% vs 0% at 6m
3 vs 2, 12m outcome, tailored materials


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskWait list control (control group participants told treatment would be delayed)

Incomplete outcome data (attrition bias)
All outcomes
Low risk<10% lost to follow-up, included in ITT analyses

Becona 2001b

MethodsSetting: community, Spain
Recruitment: smokers interested in quitting within 6m


Participants724 smokers; 42% F, av. age 37, av. cpd 26


Interventions1. Waiting List control (only followed for 6m)
2. S-H Manual
3. S-H brochures sent weekly


OutcomesAbstinence at 12m (30 day PP) or 6m (7 day PP)
Validation: CO at 12 m


Notes3+2 vs 1, S-H vs control, 6m follow up. Excluded from MA comparison 2 due to heterogeneity.
2 vs 3 comparison between materials, not included in MA


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskWaiting list control

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll randomized participants included in ITT analysis, but number followed up not reported

Berman 1995

MethodsSetting: multi-ethnic community, USA
Recruitment: via schools, smokers interested in health screening and cessation


Participants348 smokers; 51% F, av.age 37


InterventionsAll participants received cardiovascular health screening and educational materials.
1. Freedom from Smoking for you and Your Family or Spanish equivalent. Minimally tailored message at completion of 3m telephone follow up and tailored letter (Group class offered after 6m follow up)
2. How to Double your Quitting Power and Spanish equivalent.


OutcomesAbstinence at 6m, continuous (other outcomes also reported, no differences in findings)
Validation: attempted unsuccessfully at 12m


NotesNo non-S-H control so does not contribute to main analysis. No differences at any time point or definition of abstinence.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized by school using coin toss

Allocation concealment (selection bias)High riskParticipants were enrolled proactively after randomization so potential for selection bias. Fewer participants in control (179) than experimental (267) conditions

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation attempted but very few participants provided samples; however, interventions of similar intensity and differed only by content so differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk218 (62.6%) reached at 12m follow up

Betson 1998

MethodsSetting: government outpatient clinic, Hong Kong
Recruitment: smokers aged < 65


Participants865 smokers; 92%M, 49% smoking >10 cpd


Interventions1. No intervention
2. S-H materials (Chinese translation of American Cancer Society booklet)
3. Physician advice (1min, based on 4As)
4. Physician advice and S-H booklet


OutcomesAbstinence at 1 yr (sustained from 3m)
Validation: poor response to request for urine specimen so data based on self report


Notes2 vs 1, S-H with face-to-face contact
4 vs 3, S-H as adjunct to advice
Full paper provided by Professor Lam.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskTable of random numbers used to allocate questionnaires to four groups placed in sealed numbered envelopes

Allocation concealment (selection bias)Unclear risk'Every doctor was given a set of sealed envelopes'. There was considerable imbalance in numbers in each group, unclear whether this was due to randomization procedure or selection bias.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskAbstract only, unclear if participants aware of what other arm received but within comparisons in this review, interventions varied by intensity

Incomplete outcome data (attrition bias)
All outcomes
Low risk36% lost to follow up, included in ITT analysis

Borland 2003

MethodsSetting: Quitline, Australia
Recruitment: smokers seeking materials or counselling


Participants1578 smokers, 1050 in relevant arms; 54% F, modal age 30-49, av. cpd 23


Interventions1. Standard S-H Quit pack based around SoC
2. Additional tailored letters at baseline, and at 3m and 6m based on mailed assessments
3. Additional proactive TC (not incl in this review)
Some participants in all groups received brief reactive counselling before enrolment


OutcomesAbstinence at 1 yr (sustained for 9m)
Validation: none


Notes2 vs 1, tailored S-H vs standard S-H.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk'Shuffling questionnaires'

Allocation concealment (selection bias)Unclear risk'no opportunity for interviewers to influence choice of condition' so bias judged unlikely

Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but as no personal contact and similar levels of intensity, considered low risk for differential misreport

Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 78.9% for 1. 76.9% for 2. Losses included in ITT analysis. Excluding losses would marginally lower effect size

Borland 2004

MethodsSetting: Quitline, Australia
Recruitment: Callers wanting written S-H materials


Participants772 baseline smokers (baseline quitters not included in this review); 54% F (all participants), approx 47% aged < 30, av.cpd 19


Interventions1. Standard S-H quit pack
2. Additional tailored letters, based on assessment phone calls. Av number 5.7 (SD 4.6)


OutcomesAbstinence at 12m (sustained for 6m)
Validation: none


Notes2 vs 1, tailored S-H vs standard S-H. No control for effect of multiple contact


Risk of bias

BiasAuthors' judgementSupport for judgement

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

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

Blinding (performance bias and detection bias)
All outcomes
Low riskBlinding not possible because of nature of the intervention, but "participants in each condition [did] not know about the other condition unless they specifically asked ... (none did)". No blinding or validation of smoking status, but because of low-contact nature of intervention, differential misreport of smoking unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 71.3%% for 1. 63.8% for 2. Losses included in ITT analysis. Excluding losses would lower effect size

BTS 1983

MethodsSetting: Hospital chest clinics and inpatient wards, UK
Recruitment: Patients with smoking-related conditions


Participants748 smokers (in relevant arms); av age 49, av cpd 24


Interventions1. Brief advice to quit from a physician
2. Advice and S-H booklet containing information and advice
3. Same as 2. plus placebo chewing gum (not included in this review)
4. Same as 2. plus nicotine gum (not included in this review)


OutcomesSustained abstinence 6-12m (2m PP)
Validation: venous carboxyhaemoglobin and thiocyanate


Notes2 vs 1, S-H vs control.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentrally generated, 'each physician initially received a balanced block of 12 treatments'

Allocation concealment (selection bias)Low riskNumbered envelopes, opened after eligibility assessed

Blinding (performance bias and detection bias)
All outcomes
Unclear riskBiochemical validation, but possible performance bias in that physicians handing out leaflets were not blind to treatment condition and this may have impacted advice, insufficient detail reported with which to judge

Incomplete outcome data (attrition bias)
All outcomes
Low risk48 withdrawals reincluded in this analysis but has no impact on effect size

Burling 1989

MethodsSetting: Veterans Administration Medical Centre, USA
Recruitment: VA employees


Participants58 smokers; av age 44, av cpd 27


Interventions1. American Cancer Society and ALA pamphlets about smoking, a telephone hotline, and a stop-smoking contest which gave vouchers for a draw, for each day when expired CO < 8ppm.
2. As 1 + use of a computer to enter data on smoking behaviour and smoke a cigarette through a filter attached to the computer; this produced an individualized nicotine fading programme, explained in an accompanying manual.


OutcomesAbstinence at 6m
Validation: CO < 8ppm


Notes2 vs 1, tailored S-H vs standard S-H.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskInterventions of similar intensity, biochemical validation

Incomplete outcome data (attrition bias)
All outcomes
Low risk4 drop-outs reincluded in denominators for this review

Campbell 1986

MethodsSetting: Two chest clinics in Scotland, UK
Recruitment: Smokers attending outpatient clinic (unselected)


Participants1206 smokers referred for chest radiography; 44% aged > 50


Interventions1. S-H. 13 page booklet.
2. No treatment control


OutcomesAbstinence at 1 yr (self report of no smoking for 6m)
Validation: expired CO < 10ppm, non-attenders classified as smokers.


NotesFace-to-face contact but no advice


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuasi-random (interventions alternated fortnightly)

Allocation concealment (selection bias)High riskAll smoking patients attending were eligible so potential for selection bias probably low, but there was an imbalance in age distribution between groups

Blinding (performance bias and detection bias)
All outcomes
Low riskControl group unlikely to know what intervention group was receiving, same amount of personal contact, biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow up 74.5% intervention, 74.1% control, losses included in ITT analysis

Clark 2004

MethodsSetting: Lung cancer screening centre, USA
Recruitment: smokers enrolled in a screening study 1 yr previously


Participants171 smokers; 21% in precontemplation, 29% F, av age 57, 46% smoked 11-20 cpd


Interventions1. List of internet cessation resources, 10 sites with brief descriptions.
2. S-H manuals Clearing the Air and Quit Smoking Action Plan


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


NotesComparison between S-H interventions. Not in MA. Authors' hypothesis was that 1. would be superior. OR 0.44, 95% CI 0.12 to 1.43


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, interventions of similar intensity so bias judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not reported but all included in ITT analysis

Cuckle 1984

MethodsSetting: Community exposed to a 15min tv programme with offer of a smoking quit kit, UK
Recruitment: Random sample of individuals requesting a kit


Participants4492 smokers randomized. Results based on 2117 (47%) who replied to a baseline and follow-up questionnaire.


Interventions1. Control - letter apologising for shortage of kits
2. Quit Kit
3. Quit Kit and additional material 6m later.


OutcomesAbstinence at 12m
Saliva cotinine from 66% of quitters. Quit rates corrected by the disconfirmation rate found for each group


Notes2 vs 1, S-H vs control. 3 vs 2, additional materials


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'One-third were chosen at random as controls and did not receive a kit'

Allocation concealment (selection bias)Unclear riskNo details given, but no personal contact so selection bias unlikely

Blinding (performance bias and detection bias)
All outcomes
High riskControl group would have expected to receive quit kit and then told there was a shortage so did not get them, could introduce performance bias

Incomplete outcome data (attrition bias)
All outcomes
High riskLow response rate in a population-based study so only participants who replied to baseline questionnaire and follow-up questionnaire were included. Response rate to baseline questionnaire was 70% in control group compared to 39% for those receiving a kit.

Cummings 1988

MethodsSetting; Stop smoking hotline, USA
Recruitment: Callers who accepted offer of a stop smoking booklet and who agreed to follow up


Participants1895 smokers; 65% F, av age 42, av cpd 28, 89% had made at least 1 prior quit attempt


InterventionsFirst 4 groups received similar length (+/- 50 pages) and format booklets, differing in precise instructions
1. High structure (day by day plan) recommending 'cold turkey' quitting
2. High structure recommending gradual reduction
3. Low structure (menu of exercises), gradual reduction
4. Low structure, 'cold turkey'
5. Control booklet, 15 pages stressing health effects of smoking


OutcomesAbstinence from 1m-6m, self report by telephone interview with blinded assessors.
No biochemical validation, confirmation by a significant other used


Notes1-4 vs 5 in main 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

Blinding (performance bias and detection bias)
All outcomes
Low riskConfirmation by significant other, booklets similar length so differential misreport unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskAnalyses based on participants reached at 1m and 6m follow up, 89% of those randomized. Drop-out rates similar in all groups.

Curry 1991

MethodsSetting: HMO, USA
Recruitment: Advertisement for study in HMO magazine


Participants1217 smokers; av age 44, av cpd 25


InterventionsFactorial design
1. S-H programme, Breaking Away
2. S-H and up to 3 sets of personalized feedback based on baseline questionnaire and progress reports (intrinsic motivation)
3. S-H and incentives including a prize draw for returning progress reports (extrinsic motivation)
4. S-H and intrinsic and extrinsic motivation


OutcomesSustained abstinence at 12m (7-day at 3m and 12m)
Validation: Saliva cotinine <= 10 ng/ml at 12m for abstainers in locality. Correcting for disconfirmation rates did not affect sustained abstinence numbers.


Notes4&2 vs 3&1 for effect of personalized feedback (tailoring). Extrinsic motivation did not increase quit rates. Aim was to increase use of materials.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, stratified by gender and cpd, no other information

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control group participants knew nature of intervention conditions. Biochemical validation

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on number lost, all randomized participants included in ITT analysis

Curry 1995

MethodsSetting: HMO, USA
Recruitment: Smokers identified via a telephone survey of health behaviour in a random sample of HMO members (unselected)


Participants1137 smokers; 53% F, av age 41, av cpd 17


InterventionsNo face-to-face contact
1. Control - no materials
2. S-H booklet (Breaking Away) with units to complete, relevant to all stages of readiness to quit.
3. As 2 plus feedback based on computer analysis of initial survey. Included a hand-written form, and a list of relevant parts of booklet.
4. As 3 plus up to 3 counsellor-initiated phone calls (not included in this review)


OutcomesSustained abstinence 3m-12m
Validation: saliva cotinine requested but not obtained for all participants. Disconfirmation rates not significantly different between groups.


Notes12m rather than 21m follow up used for comparability with other studies. Author confirmed numbers quit
2 vs 1 in S-H vs control, 3 vs 2 in effect of tailoring


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskControl group aware that they may be receiving materials or phone calls, which they did not - could introduce performance bias. "Collecting saliva cotinine...was challenging because participants had neither explicitly volunteered for a study of smoking behavior nor requested treatment for smoking cessation... nearly one fourth of those contacted refused to provide a sample." Higher disconfirmation in control group but difference was not significant.

Incomplete outcome data (attrition bias)
All outcomes
Low risk88% provided data at all 3 &12m. No difference in response rates across groups. Missing counted as smoking in MA

Davies 1992

MethodsSetting: Community, Ottawa, Canada
Recruitment: Each of 156 nursing students recruited 2 non-hospitalized smokers (selected)


Participants307 smokers; Av age 36, av cpd 20


Interventions1. List of community resources, delivered during a home visit by a nursing student
2. Time to Quit (TTQ) S-H booklet + list of community resources, delivered by a nursing student following training in the TTQ programme.


OutcomesAbstinence at 9m
Validation: saliva cotinine <100ng/ml


NotesIt is unclear what advice was given to the control group. Marginal to include since S-H confounded by student training, but does not affect MA


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskNurses knew would receive more training after delivering control condition and before meeting with intervention participants, introducing likelihood of performance bias

Incomplete outcome data (attrition bias)
All outcomes
Low riskParticipants lost to follow up reincluded as smokers for MA, 28% lost to follow-up, similar across groups

Davis 1984

MethodsSetting: Local communities with Lung Associations, USA
Recruitment: Media advertisements for American Lung Association (ALA) S-H materials


Participants1237 smokers who completed a questionnaire and paid a refundable deposit.


InterventionsNo face-to-face contact
1. ALA leaflets (8 leaflets including 2 brief cessation brochures Me Quit Smoking? Why? and Me Quit Smoking? How?
2. Leaflets and maintenance manual A Lifetime of Freedom from Smoking
3. Cessation manual Freedom from Smoking in 20 days.
4. Cessation and maintenance manuals


OutcomesSustained abstinence at 12m (PP at all 5 follow-up points), self report in telephone interview
Validation: none


Notes2+3+4 vs 1, S-H vs leaflet only


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation used but no personal contact, interventions all similar intensity so differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information on number lost, all randomized participants included in ITT analysis.

Davis 1992

MethodsSetting: Community, USA
Recruitment: Advertisements for the Cancer Information Service hotline


ParticipantsWomen smokers with children under 6 calling hotline. Results based on 630/873 (72%) of those recruited who were followed up at 6m.


Interventions1. Quitting Times, a S-H guide developed to meet the special needs of women smokers with young children. 65 pages in magazine format
2. ALA Freedom from Smoking for You and Your Family
3. National Cancer Institute Clearing the Air


OutcomesAbstinence at 6m (7-day PP)
Validation: no biochemical validation. Confirmation by surrogate. Those refusing to give a surrogate were classified as smokers


NotesDoes not contribute to main analysis, 1 vs 2&3, impact of targeting to population
All 3 guides covered similar topics, no significant differences were found between any of them.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk'Preassigned list randomized by day of week'

Allocation concealment (selection bias)Low riskCounsellors who recruited participants during calls were blinded to the S-H guide that would be received

Blinding (performance bias and detection bias)
All outcomes
Low riskAll groups received S-H so similar levels of intensity. "Follow-up interviews were conducted by trained interviewers who were blinded regarding subject assignment.... Surrogate interviews were conducted to verify the smoking status of those who reported that they had quit smoking..."

Incomplete outcome data (attrition bias)
All outcomes
Low risk72% of participants reached at follow up, similar for all three groups. Analyses based on those reached.

de Vries 2008

MethodsSetting: Community, Netherlands
Recruitment: Telephone recruitment for a multiple risk factor health promotion intervention


Participants156 smokers amongst 2827 participants of whom 1331 (47%) responded at T4. Baseline all participants; 55% F, av age 49


Interventions1. Printed tailored letters on smoking as an identified risk factor (other targets were physical activity, nutrition) (Half group had action planning component in 3rd letter)
2. Printed generic letters


OutcomesAbstinence at 9m (not defined)
Validation: none


NotesEffect of tailoring. Numbers of smokers at baseline and quitters provided by author


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskDetails not given

Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but interventions of similar intensity, differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly baseline smokers who responded to follow-up survey included in analysis

Dijkstra 1998a

MethodsSetting: Community, Netherlands
Recruitment: Newspaper adverts, not selected by level of motivation to quit


Participants1546 smokers; 59% F, av age 40, av cpd 20.3


InterventionsNo face-to-face contact
1. Letter with information on positive outcomes of quitting (OC)
2. Letter with information on skills for quitting (SE)
3. Letter with outcomes and skills information (BO)
All letters were computer-generated, 4-7 page reports, personalized and tailored from baseline questionnaire
4. No information (CO)


Outcomes12m sustained abstinence at 14m, self report by postal questionnaire
Validation: None, participants were told that a sample would be tested for CO levels


Notes1&2&3 vs 4 in tailored materials since 2014. Previously in main comparison.
Results are sensitive to the outcome used, PP do not differ


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskNo biochemical validation used, control group knew other participants receiving an intervention

Incomplete outcome data (attrition bias)
All outcomes
Low risk64% responded at 14m, no difference across groups. Attrition predicted by perceived pros of quitting and intention to quit but did not differ between groups. Denominator in meta-analysis based on all randomized.

Dijkstra 1999

MethodsSetting: Community, Netherlands
Recruitment: Newspaper adverts for smokers not planning to quit in next 6m (unmotivated volunteers)


Participants843 smokers not planning to quit; 63% F, av age 42, av cpd 22


InterventionsNo face-to-face contact
1. Three tailored letters (MT)
2. Single tailored letter (ST)
3. S-H manual, 48 page colour (SHG)
4. No intervention (CO)


OutcomesAbstinence at 6m (7-day PP), self report by postal questionnaire
Validation: none
Primary outcome for trial was SoC and intention to quit


Notes3 vs 4 in S-H vs control. 1&2 vs 3 in effect of tailoring


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control group knew intervention arms receiving additional information, no biochemical validation

Incomplete outcome data (attrition bias)
All outcomes
Low risk89% responded at 6m. Attrition predicted by yrs smoking and group. Denominator used in MA includes all randomized

Etter 2004

MethodsSetting: Community, Switzerland
Recruitment: Mailing to population registers (not selected)


Participants2934 smokers aged 15+; 74% precontemplators, 40% tried to quit in previous yr, 51% F, av age 36, av cpd 20


Interventions1. Tailored 8 page letter + SoC-matched booklets. At 2m, 4m, 12m repeat questionnaire to initiate further letter.
2. No intervention


OutcomesAbstinence at 24m (in maintenance stage, quit for > 6m). 4w and 7-day abstinence also reported.
Validation: none


NotesTailored S-H vs nothing. Approx half of group 1. recvd 1 letter only.
Effect at 6m (Etter Arch Int Med 2001) not sustained at 24m. Relative difference smaller if shorter term abstinence used.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization: 'list of random numbers'

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High risk"...members of the control group received a letter indicating that they had been attributed to that group...", no validation, intervention intensity higher than control group

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up 14.0% in 1 and 10.7% in 2. All non-responders included in ITT analysis.

Fortmann 1995

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


Participants1044 smokers able to quit for 24 hours; av age 40, av cpd 20


InterventionsAll participants were offered an incentive of US$100 for quitting for 6m
1. Nicotine gum 2mg (NG)
2. S-H materials
3. NG and S-H materials
4. Monetary incentive only


OutcomesAbstinence at 12m (PP)
Validation: CO < 9ppm, salivary cotinine < 20ng/ml


Notes2&3 vs 1&4 in S-H vs control. 3 vs 2 for effect of S-H materials added to gum


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized in a 2X2 factorial design, method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation. 12% of self-reported nonsmokers refused confirmation. Follow up and confirmation rates did not differ by conditions. Does not appear that control participants were aware of the nature of the intervention.

Incomplete outcome data (attrition bias)
All outcomes
Low risk6.2% failed to complete telephone interviews.

Gilbert 2013

MethodsSetting: General practices, UK

Recruitment: Identified via GP records, mailed proactively


Participants6697 current smokers aged 18-65, 56% F, av. age 45, av. cpd 18 (excl. 5.4% non-daily smokers). 47% not planning to quit within 6 months


Interventions1. Standard, non-tailored NHS 'Stop smoking start living' booklet and computer tailored

advice report based on information obtained through baseline assessment questionnaire; letter from GP; follow-up assessment via mail at 1 month; additional tailored mailing

2. Standard, non-tailored NHS 'Stop smoking start living' booklet


Outcomes3 month sustained abstinence at 6 months

Validation: none


Notes214 participants excluded post randomization for valid reasons


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"blocked randomisation codes were generated externally and given to an independent administrator in sealed envelopes upon receipt of completed questionnaires"

Allocation concealment (selection bias)Low risk"Participants were accepted into the study before knowledge of the next assignment in the sequence in order to minimise selection bias. Each study participant randomised received the treatment corresponding to the next free study number in the randomised sequence."

Blinding (performance bias and detection bias)
All outcomes
High riskNo biochemical validation, participants aware of what other condition was receiving. "Participants were told that they would be sent some information about quitting, and could be randomly selected to receive additional information based on their answers in the questionnaire."

Incomplete outcome data (attrition bias)
All outcomes
Low risk27% lost intervention, 24% lost control, no significant differences in predictors of drop-outs between groups, authors conducted sensitivity analysis with alternative assumptions about dropouts

Glasgow 1981

MethodsSetting: Community, USA
Recruitment: media advertisements


Participants88 smokers (40 in S-H conditions)


InterventionsFactorial trial of 3 different S-H materials, with or without additional group support
1. Danaher & Lichtenstein manual
2. Pomerleau & Pomerleau manual
3. I Quit Kit


OutcomesAbstinence at 6m
Validation: CO < 15ppm


Notes3 different S-H conditions and no strong hypothesis about direction of treatment difference between D&L and P&P so not used in the MA of different programmes. No statistical difference between quit rates. Also included in group therapy review.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Randomly assigned', method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, all groups received material (difference in content only)

Incomplete outcome data (attrition bias)
All outcomes
Low risk3/88 lost to follow up, group not specified so not included as smokers.

Gritz 1992

MethodsSetting: HMO, USA
Recruitment: Members of HMO agreeing to participate in a Preventive Health Behavior Study and completing a baseline survey (unselected - not informed that focus of study was on smoking)


Participants1396 F smokers; av age 38, 42% smoked 15-24 cpd


InterventionsNo face-to-face contact, 5 follow-up interviews in 2 yrs
1. S-H programme mailed in 6 weekly instalments. Manuals were tailored to the concerns of female smokers and addressed weight gain, social support, stress and coping mechanisms.
2. Control - no materials - same schedule of follow-up phone calls


OutcomesSustained abstinence at 1m, 6m, 12m & 18m.
Validation: saliva cotinine < 15ng/ml, but due to low success in obtaining samples, unadjusted rates used. No difference in disconfirmation rates between intervention and control groups.


NotesThe strictest measure of abstinence extracted gives the lowest P value for the difference between the groups; all other measures give a smaller difference in quit rates.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskControl group participants not aware of nature of intervention, participants did not know study was aimed at smoking cessation. Biochemical validation conducted, not used due to low success in obtaining samples, but no difference in disconfirmation between groups suggesting differential misreport unlikely.

Incomplete outcome data (attrition bias)
All outcomes
Low risk12.7% lost to follow up at 18m. Number in each group at baseline not stated so losses not included as smokers in MA. Similar losses across groups so no effect on estimate

Harackiewicz 1988

MethodsSetting: University campus health centre/medical centre, USA
Recruitment: Smokers applying for free cessation programme.


Participants98 smokers in relevant arms; 61% F, av age 35, av cpd 27 for all trial participants


InterventionsAll received advice from a doctor or nurse to quit by using the written materials, which were different for each group
1. S-H manual employing intrinsic motivation approach (Stopping smoking on your own with Nicorette), and nicotine gum
2. S-H manual employing extrinsic motivation approach (The Doctor's program for stopping smoking with Nicorette), and nicotine gum
3. Intrinsic motivation S-H manual only
4. Control - short booklet only, with no motivational element


OutcomesSustained abstinence at 12m, (3m-12m)
Validation CO < 8ppm at each visit, saliva thiocyanate < 10mg/dl at 3m & 6m. 2 subjects reclassified as smokers.


Notes3 vs 4 for S-H compared to control. 1 & 2 not used.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Randomly assigned', method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, groups differed in intervention contact but not in intensity

Incomplete outcome data (attrition bias)
All outcomes
Low risk22/197 trial participants who did not attend any follow up & excluded from analyses; 'drop-out rates did not differ according to condition'. Other losses assumed to be smoking

Hollis 1993

MethodsSetting - HMO, USA
Recruitment - Smokers visiting primary care physicians (unselected)


Participants2707 smokers (1383 in relevant arms) who received provider advice; av age 40, av cpd 18


InterventionsAll received 30-second quit smoking advice from physician.
1. Self-quit training from a nurse or health counsellor who showed a video, gave a choice of S-H manuals + quit kit. One follow-up phone call.
2. Group referral
3. Choice of group referral or a S-H kit.
4. Control - provider advice and 2-page pamphlet from nurse.


OutcomesAbstinence at 12m (3m & 12m PP)
Validation: Saliva cotinine. Subjects not providing samples counted as smokers.


Notes1 vs 4, comparison of S-H with control


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskPseudo-randomization (two random digits in health record number) of smokers receiving provider advice. More allocated to control than each other condition

Allocation concealment (selection bias)High riskAllocation was not concealed but no evidence of selection bias; baseline characteristics similar.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnlcear if participants knew nature of what other groups were receiving. Biochemical validation. 55% of reported quitters provided saliva sample, no difference by group.

Incomplete outcome data (attrition bias)
All outcomes
Low risk14% lost to follow up at 12m; response rates did not differ significantly across treatment groups, all participants included in analysis.

Hoving 2010

MethodsSetting: Community, Netherlands

Recruitment: 75 general practices (passive recruitment via questionnaire in waiting room), 65 pharmacies (15 passive, 50 active recruitment)


Participants1019 (545 pharmacy, 474 GP), motivated to quit within 6m, smoked in last 7 days before baseline assessment

56% F, av age 45, av cpd 22


InterventionsAll participants completed baseline questionnaire.

1. Mailed 5-7 page tailored letter, using same tailoring as Dijkstra 1998a, based on I-Change model

2. Thank you letter only


OutcomesContinuous abstinence from baseline at 3 and 12 months in pharmacy group, 6 months in GP group

Validation: none


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk‘Randomised based on the colour coding on their questionnaire (blue for experimental group, yellow for control group)’

Allocation concealment (selection bias)High riskAllocation would not be concealed if anyone was aware of the significance of colour

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot specified

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOnly experimental losses to follow-up reported (63/256 pharmacy, 42/220 GP), unclear how many participants were lost in the control group

Humerfelt 1998

MethodsSetting: Community, Norway
Recruitment: From participants in a community survey of men aged 30-45 who had increased risk of obstructive lung disease or lung cancer


Participants2610 M with reduced FEV1 and/or occupational asbestos exposure; av age 37, av cpd 16


Interventions1. Mailed S-H pamphlet, 15 pages, emphasizing behavioural modification techniques in smoking cessation and recommending an early quit date, accompanied by a letter from a respiratory physician advising of the high risk status established by the survey.
2. No intervention


OutcomesAbstinence at 15m (PP)
Validation: subjects in 1 geographical area invited for CO measurement (CO < 10ppm)


NotesFor the MA number of quitters has been adjusted for the validated rate found in the sample who were tested (63% in expt/67% in control). Subjects who stopped smoking prior to receiving materials were included. The authors give 12m sustained abstinence rates of 5.6% vs 3.5% but these rates are based on self report by responders.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskControl group not aware of intervention received by intervention group, biochemical validation conducted in subset of participants and no significant difference in misreport detected (1 intervention; 2 control)

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up higher in the intervention group (17%) than control (8%). The probability of responding to the follow-up questionnaire was inversely related to the baseline cpd consumption in the intervention but not in the control group. Losses included as smokers.

ICRF 1994

MethodsSetting: Primary care, UK
Recruitment: Patients registered with practice invited to join


Participants1686 smokers (over 15 cpd)


Interventions2x2 factorial design:
1. Nicotine patch and 16 page Health Education Authority (HEA) pamphlet
2. Placebo patch and HEA pamphlet
3. Nicotine patch and 46 page booklet with more detailed information on cessation with the use of patches
All participants seen once by a doctor and x4 by a nurse.


OutcomesSustained abstinence at 12m
Validation: salivary cotinine or expired CO


NotesComparison between different S-H materials. Not used in a MA. No clinical or statistically significant difference between the materials in either patch condition.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom allocation of study numbers to intervention groups

Allocation concealment (selection bias)Low riskSequential allocation of study numbers and precoded packages

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, similar levels of intensity across interventions

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly early abstainers were followed up at at 6 & 12m. 9.2% lost to follow-up at 12 weeks. All losses included as smokers.

Janz 1987

MethodsSetting: Two outpatient medical clinics, USA
Recruitment: All smokers attending and giving informed consent for a study of health practices (unselected)


Participants250 smokers; av age 46, av cpd 24


Interventions1. Control - no intervention - clinic physicians not aware of study (not included in review)
2. Advice from physician and brief consultation from a nurse
3. As 2 and the Step-by-Step Quit Kit.


OutcomesAbstinence at 6m (ascertainment by telephone by independent interviewer)
Validation: none


Notes3 vs 2 for effect of S-H as adjunct to advice. The graphed percentages are based on numbers followed up. It has not been possible to obtain data from the authors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskPseudo-random assignment of half-day clinic sessions to expt or control (control does not contribute to this review). Within expt clinics participants randomized to manual or no manual condition, method not described.

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but interventions tested in this review included same amount of face to face contact and self-report collection procedures designed to minimize misreport (research personnel made clear that they had no relationship to healthcare team and responses were confidential)

Incomplete outcome data (attrition bias)
All outcomes
Low risk39 (16%) lost to follow up at 6m. 'Drop-out rates did not vary significantly across study groups'. Losses not given by group so not included in MA

Killen 1990

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


Participants1218 smokers who had quit for 48 hours; av age 43, av cpd 25


Interventions4x3 factorial design crossing gum and S-H conditions:
Nicotine gum (2mg) conditions: Adlib schedule, whenever strong need to smoke/ Fixed schedule (1 piece per hour for at least 12h/day)/ Placebo gum/ No gum
S-H intervention was based on 16 specially written modules. All participants were given the first How to cope with the urge to smoke without smoking booklet. Then randomized to: Self selected - chose 7 more to receive in weekly mailings/ Random - sent 7 modules at random/ No modules - no further contact


OutcomesAbstinence at 12m (no smoking in 7 days prior to follow up)
Validation: By saliva cotinine, except for participants who had moved away.


Notes'No module' condition received booklet judged to be S-H, so only used for effect of additional materials.
Uncollapsed data sought. Reported that no difference by module condition.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, fully crossed factorial design, method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskTreatment condition blinded, biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not described. All surviving participants included in MA

Killen 1997

MethodsSetting: community, USA
Recruitment: advertisements


Participants424 smokers; 50% F, av age 42-47, av cpd 24


Interventions2x2 factorial design. All participants received S-H materials designed to help develop self-control skills
1. S-H and placebo patch
2. S-H and nicotine patch (21mg)
3. As 1. and video, watched during initial office visit, and for use at home
3. As 2. and video


OutcomesSustained abstinence (6m and 12m)
Validation: Saliva cotinine < 20ng/ml


NotesTest of additional materials. Since there was evidence of an interaction between nicotine and video conditions, the nicotine arms are entered separately using a dummy study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized in a 2X2 fully crossed factorial design, method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants not receiving video knew other participants were (and viewing it in a group), biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber lost to follow up not specified, but all participants included in denominators

Killen 1997 +NP

MethodsDummy study to enter results of Killen 1997 arms with nicotine patch


Participants


Interventions


Outcomes


Notes

Kottke 1989

MethodsSetting: Family practices, USA
Recruitment: Physicians recruited for trial. Target population all patients seen during month (unselected)


Participants66 physicians, 1653 smoking patients; '2/3rds female, av age slightly over 40 yrs, just under one pack/day'


Interventions1. Physicians attended 6 hour workshop
2. Physicians attended workshop and given copies of 'Quit and Win' for their patients
3. Physicians received no support, but were asked to advise patients during the study period


OutcomesAbstinence at 1 yr
Validation: Serum cotinine


Notes2 vs 1, effect of self-help in addition to advice from a trained physician. Including 3. in control group does not affect results. (RR for trial becomes 1.02 rather than 0.99).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskCluster randomized by physician not smoker, method not described, potential for imbalance in patient characteristics but number patients per physican low

Allocation concealment (selection bias)High riskResearchers attempted to contact all patients seen by physicians during one month

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, as cluster randomized by physician seems unlikely control group participants would know what other participants were offered

Incomplete outcome data (attrition bias)
All outcomes
Low riskOver 87% of smokers identified at baseline were reach at 1 yr, similar across groups.

Lando 1988

MethodsSetting: Family practice or pulmonary specialists, USA
Recruitment: Physicians' patients wishing to use nicotine gum as a cessation aid


Participants304 smokers; 62% F, av age 42, av cpd 31


Interventions1. Nicotine gum (NG) and expt S-H materials emphasizing behavioural strategies, as well as correct use of gum
2. NG and control pamphlet Danger: the facts about smoking (American Cancer Society).


OutcomesAbstinence at 12m
Validation: proportion asked to provide saliva for thiocyanate, 5 discrepant, 2 in S-H, 3 in control, but not clear if these were at 6 or 12m so self-reported outcome used


NotesIn main comparison with advice and leaflet for control, and comparison of NG+SH vs NG alone


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation conducted but not used, but similar levels of intensity and physicians blind to pamphlet condition so differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo mention of number lost to follow up

Lando 1991

MethodsSetting: Community cardiovascular risk factor screening programme, USA
Recruitment: Smokers identified from screening programme who agreed to take part


Participants570 smokers; approx 50% F, av age 42, av cpd 20


InterventionsNo face-to-face contact.
1. S-H Quit for Good materials (NCI)
2. S-H Quit and Win materials - a more extensive and structured programme
3. Wait-list control


OutcomesAbstinence 7m after randomization (but only 3-4m after receipt of materials)
Validation: none


NotesBoth 1 and 2 treated as S-H programmes. There was no difference in results between them. Both expt and control subjects likely to have been exposed to simultaneous community Quit and Win contests. Author notes that a number of participants quit between randomization and receipt of materials. This study is also included in the Quit and Win review (Cahill 2008).


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; there were significant differences between intervention & control for sex and education, and higher confidence in quitting among controls

Blinding (performance bias and detection bias)
All outcomes
High riskWait list control

Incomplete outcome data (attrition bias)
All outcomes
Low risk25 lost to follow up, of which 13 were in control groups. Denominators are those followed up.

Ledwith 1984

MethodsSetting: Community, Scotland UK
Recruitment: Newspaper advertisements for a smoker's advice centre


Participants1839 smokers responding to offers of advice on stopping smoking


InterventionsNo face-to-face contact.
1. No advice control
2. S-H leaflet with standard letter
3. S-H leaflet and offer of individual advice by returning a questionnaire


OutcomesAbstinence at 12m (for 10m or more - based on self report)
Validation: attempt to obtain saliva for thiocyanate but not complete, data based on self report only.


Notes2 vs 1, S-H. 3 vs 2, effect of tailored advice. Only 34% returned baseline questionnaire to initiate tailored component.
No information about contents of leaflet. Borderline whether this counts as a structured S-H programme.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'Assigned at random', method not described

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskThough attempts to get biochemical validation were unsuccessful, control group was unaware of other treatment assignments and no face-to-face contact was given, hence differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk16% lost to follow up. Non-respondents included as smokers.

Lennox 2001

MethodsSetting: General practice, Scotland UK
Recruitment: smokers in general practices who returned questionnaires


Participants2610 smokers; no demographic details


InterventionsNo face-to-face contact.
1. Tailored letter from physician. 4 pages, based on SoC, decisional balance and other indicators from questionnaire.
2. Untailored letter from physician. Same format, included specific behavioural advice on quitting
3. Control, letter acknowledging questionnaire


OutcomesAbstinence at 12m. (24m data reported but PP so does not represent a more conservative measure)
Validation: saliva cotinine


Notes2 vs 3 , S-H no contact. 1 vs 2, tailoring


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random numbers

Allocation concealment (selection bias)Low risk'After the questionnaires were returned, we randomised the participants to the groups'. No participant contact, low risk of selection bias.

Blinding (performance bias and detection bias)
All outcomes
Low riskSimilar intervention intensities, no face-to-face contact, and biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low risk22% loss to follow up, similar across groups, non-responders counted as smokers.

Lichtenstein 2000

MethodsSetting: Community, USA
Recruitment: via electric utility mailing to identify households with smokers and low radon concentrations


Participants1006 smokers in 714 households; av cpd 20


InterventionsNo face-to-face contact.
1. Standard Environmental Protection Agency leaflet on risks of radon
2. Pamphlet highlighting risk of smoking in low concentrations of radon, with tips for quitting, or not smoking indoors
3. as 2. + up to 2 brief proactive telephone calls.
All groups got standard letter with radon results.


OutcomesAbstinence at 12m, sustained at 3 & 12m
Validation: none


Notes2 vs 1, S-H vs other control. 3 contributes to telephone counselling review (Stead 2013b).
Cluster randomization, 54% of smokers lived with another smoker. Intraclass correlation for sustained abstinence was .010. Analyses did not correct for this.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but the arms included in this analysis were similar levels of intensity with no personal contact, so differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk80% of households reached at 3 & 12m, no difference across conditions. Missing treated as smoking

Lichtenstein 2008

MethodsSetting: Community, USA
Recruitment: via electric utility mailing with offer of radon test kit to identify households with smokers


Participants1364 households with 1821 smokers, ˜18 cpd


InterventionsFactorial design crossing +/- brief phone counselling with video S-H materials. All households given A Citizens Guide to Radon and letter tailored to results of radon level test
1. Video, 15min, explaining risk of smoking & radon combination, encouraging quitting and/or household smoking bans.
2. No video


OutcomesAbstinence at 12m, sustained at 3 & 12m
Validation: none


NotesResults of analyses accounting for clustering of multiple smokers in households reported to yield results generally consistent with simple analyses. We were unable to get data for arms with and without phone counselling so the collapsed data contributes to comparisons 1.1.2 & 2.1.2


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskResponding households sequentially randomized to 4 conditions subject to stratification on radon test status; no true randomization sequence used

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but all received phone counselling and some S-H, so performance and detection bias judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk83% of households completed 12m assessment, 76% completed both 3 & 12m

Lipkus 1999

MethodsSetting: Health centre, USA
Recruitment: from telephone survey of patients


Participants266 randomized, 160 followed up; Low income African-American smokers, unselected by motivation, 52% F, 49% aged > 50


Interventions1. Physician prompts attached to chart (included other screening tests). Providers trained to use 4As model
2. As 1 +mailing of tailored print communication around birthday
3. As 2, + TC


OutcomesAbstinence 16m after last intervention, 30 day quit
Validation: none


Notes2 vs 1, tailored S-H adjunct to advice. (3 vs 2 in telephone counselling review)
Reported rates based on numbers followed up, not randomized.
Provider compliance reported to be 48%


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants aware what other participants were receiving, no biochemical validation, self-help group has more communication than control

Incomplete outcome data (attrition bias)
All outcomes
Low risk40% loss to follow up, largely due to disconnected phone numbers, 'loss to follow-up did not appear to be a function of any demographic, psychosocial of smoking pattern, nor was it a function of the intervention smokers received'. Losses not included as smokers.

McFall 1993

MethodsSetting: community, USA
Recruitment: during a TV cessation programme


ParticipantsSmokers who registered and received the manual or reported viewing at least 1 part of programme


Interventions1. TV programme and ALA FfS
2. Maintenance; as 1. and 10 newsletters over following 6m


OutcomesAbstinence at 12m. (24m data reported but PP with increase over time so does not represent a more conservative measure. RR similar)
Validation: none


Notes2 vs 1. effect of additional materials


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if participants aware what other participants were receiving, no biochemical validation, maintenance group has more communication than control

Incomplete outcome data (attrition bias)
All outcomes
Low risk24% lost in maintenance condition, 27% in control. MA includes responders; Including losses would give less conservative effect.

Meyer 2008

MethodsSetting: Primary health care centres, Germany
Recruitment: smoking patients attending practices during 3 study weeks


ParticipantsSmokers, unselected for motivation; 48% F, av age 34, av cpd 16


Interventions1. Assessment only control
2. Up to 3 letters individually tailored to SoC. First used baseline assessment, 3m & 6m depended on further assessment. Stage-matched S-H manuals
3. Brief physician advice & S-H manuals


OutcomesAbstinence at 24m (sustained for 6m)
Validation: none


NotesAnalyses in paper allowing for clustering give slightly larger estimates than use of crude numbers quit. Different assumptions about losses to follow up did not substantially alter any results. Abstinence rates increased over time in all groups. Prolonged abstinence at all follow ups is very low, not used here. 63% got 3 letters, 21% got 2 and 17% only 1.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuasi-random & clustered based on time of attendance. Fixed sequence of assessment-only, tailored letters, advice. At least 2 weeks between each study week.

Allocation concealment (selection bias)High riskCondition known at time of recruitment. All patients screened so recruitment bias should have been avoided, no evidence of difference in baseline characteristics

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo validation but practice team, practitioner and follow-up interviewers all blinded, however unclear if control participants were aware what intervention participants were receiving

Incomplete outcome data (attrition bias)
All outcomes
Low risk56% of letters & 64% of control reached at 24m. Different approaches to missing data did not alter conclusions.

Meyer 2012

MethodsSetting: 151 general practices, Germany

Recruitment: smoking patients attending practice


Participants3215 patients (113 excluded) age 18+ who reported any tobacco smoking within last six months.

44% F, av. cpd not stated, av. age 41, 38% precontemplators


Interventions1. Brief advice from practitioner (10 mins) + stage of change specific S-H manuals

2. Two individually tailored computer-generated letters based on stage of change, plus S-H manuals as per 1

3. 1+2


OutcomesAbstinence at 12m, self-reported as prolonged for previous 6m

Validation: None


Notes3 vs 1 used as test of individually tailored S-H as adjunct to advice. 2 vs 1 in analysis 4.1, direct comparison of tailored materials and advice


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskCluster-randomized by practice. Practices randomly assigned prior to recruitment. Authors note, "randomization was seriously undermined by obviously different mechanisms of patient selection for each study condition."

Allocation concealment (selection bias)High riskPractices not blind to condition when patients recruited, and differential recruitment rates by condition.

Blinding (performance bias and detection bias)
All outcomes
High riskSee above.

Incomplete outcome data (attrition bias)
All outcomes
Low risk30% drop-out in group 1, 21% group 2, 29% group 3. Authors report sensitivity analyses regarding assumptions about participants lost to follow-up showed "same patterns of results."

Nollen 2007

MethodsSetting: hospital, USA
Recruitment: smokers visiting hospital, interested in quitting in next 6m


Participants500 African-American smokers; 60% F, av age 43, av cpd 20


InterventionsAll participants received 8w nicotine patch and 2 phone calls
1. Standard materials; ALA FfS + How to Quit video
2. Culturally sensitive guide Pathways to Freedom: Winning the Fight against Tobacco and Harlem Health Connection's Kick-It video (40 min) targeted for African-Americans


OutcomesAbstinence at 6m (30 day PP)
Validation: CO < 10ppm


NotesStudy ID was Ahluwalia 1999 until publication of full report. Minor change to results. Comparison between targeted and untargeted materials. Significantly more participants used the targeted materials (68.8% vs 59.6%) but no difference detected in salience or perceived materials


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomization codes computer-generated by study statistician in blocks of 20

Allocation concealment (selection bias)Unclear riskDescribed as investigator blind but no explicit statement

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used, interventions of similar intensity

Incomplete outcome data (attrition bias)
All outcomes
High risk66% lost to follow up at 6m, included in ITT analysis, no evidence of differential loss by group.

Omenn 1988

MethodsSetting: Single worksite (13,000 workers, 9 employers), USA
Recruitment: worksite volunteers


Participants243 with preference for a S-H programme


Interventions(Only S-H format conditions considered in this review)
1. Multiple component programme
2. Relapse prevention programme
3. Minimal treatment programme (American Cancer Society's Quitter's Guide, 7-day plan)


OutcomesAbstinence at 12m
Validation: saliva cotinine ≦ 35 ng/ml


NotesComparison between S-H materials; not in MA. No clinical or statistically significant differences between quit rates in the 3 groups.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk'nurses at aid stations using randomized assignment lists generated by research centre, within preference for format'

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation, interventions of similar intensities

Incomplete outcome data (attrition bias)
All outcomes
Low riskAt least 89% followed up in each arm, non-respondents counted as smokers

Orleans 1991

MethodsSetting: HMO, USA
Recruitment: Largely through publicity in HMO magazine


Participants2021 smokers; 63% F, av age 44, av cpd 26


Interventions1. Free & Clear, 28 page guide incorporating nicotine fading and standard behavioural abstinence and relapse prevention techniques. Also a Quit Kit and ALA A Lifetime a Freedom from Smoking
2. Same materials as 1. plus 2 copies of a social support guide to be given to 'allies'.
3. As 2. + TC +quitline
4. Control - Referral guide describing available S-H guides and local resources, plus NCI Clearing the Air


OutcomesAbstinence at 16m for over 6m, by blinded telephone interview.
Validation: Saliva cotinine < 10ng/ml, or thiocyanate < 2,400 umol/l for gum users.


Notes1+2 vs 4, effect of S-H alone. (3 assessed in TC review)
By 16m, 59% of participants in the control group reported that they had used an additional treatment method.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, method not stated, stratified by living alone/not, advice to quit in last 12m/not and nicotine content of cig brand

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskAll arms included in this review received written material of similar levels of intensity. Biochemical validation in sample at 16m; "to improve the veracity of smoking self-report, all follow-up questionnaires and interviews began with a reminder that the subjects might be asked for a saliva specimen for nicotine assessment, creating a sort of “bogus pipeline”"

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up 6% at 16m, did not differ across treatment groups. Analyses based on respondents; including losses would marginally increase estimated effect

Orleans 1998

MethodsSetting: Community, USA
Recruitment: African-American smokers calling a Cancer Information Service telephone counselling line in response to targeted campaign


Participants1422 African-American smokers; av age not stated, 62% in 20-39 age group, median cpd 20


Interventions1. 36 page Pathways to Freedom guide and tailored TC. Guide used African-American models and addressed specific obstacles
2. Standard guide Clearing the Air and standard NCI TC


OutcomesAbstinence at 6m, 7-day PP, telephone questionnaire (12m abstinence also assessed in sample of 445 smokers)
Validation: none


NotesTest of population targeting. Counselling was also different for the 2 groups.
At 12m there were significant differences (15.0% vs 8.8% for sample selected for follow up)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized by last digit of caller's contact phone number; risk of bias probably low

Allocation concealment (selection bias)Low riskPresumably recruited before phone number and thus allocation known, so risk of bias probably low

Blinding (performance bias and detection bias)
All outcomes
High riskSelf-reported outcomes from participants not blinded to treatment condition, intervention includes personal contact with tailoring in one group

Incomplete outcome data (attrition bias)
All outcomes
Low risk37% lost to follow up at 6m. No differential drop out, MA includes non-responders as smokers.

Orleans 2000

MethodsSetting: community, USA
Recruitment: smokers aged > 65 using nicotine patch


Participants720 smokers; 'mostly F', av age 72, av cpd 22


InterventionsAll participant had filled a prescription for nicotine patch
1. Clear Horizons guide for older smokers + 7 personalized tailored computer-generated mailings over 6m.
2. Fact sheet on patch-assisted quitting


OutcomesAbstinence at 12m, ?7-day PP
Validation: ?none (Limited information in abstract)


NotesFollow-up rates supplied by N Boyd. Considered with other studies testing S-H adjuncts to pharmacotherapy, not with other tailored studies. 'Tailored messages were based on past research identifying the factors associated with general quitting success and with patch assisted quitting among older smokers'. Not based on individual characteristics.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskLimited information in abstract, unclear if biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up 21% expt, 23% control, not significantly different. Non-responders included as smokers.

Owen 1989

MethodsSetting: community, Australia
Recruitment: advertisements for smokers wishing to quit


Participants208 smokers; av age 42, av cpd 28


Interventions1. 'Quit Kit' along with apology that course full. Kit included a 5-day cessation plan
2. S-H programme in 4 mailed parts
3. As 2. but personalized with additional text, based on registration form. Option to send for additional materials


OutcomesAbstinence at 9m (PP)
Validation: some cotinine assays, but no correction for a possible 15% misreport level.


NotesIntervention 1 meets criteria for basic S-H, so 2 vs 1 for effect of additional materials and 3 vs 2 for effect of personalized materials.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskControl group (1) received notice course was full, could introduce performance bias by artificially decreasing control group quit rates

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk12% lost to follow up at 9m, similar between groups. Non-respondents included as smokers

Pallonen 1994

MethodsSetting: Community cardiovascular risk factor study, Finland
Recruitment: Male smokers identified via survey


Participants165 M smokers who were classified as precontemplators or contemplators according to the SoC model; av age 52, av cpd 19


Interventions1. SH. Five 10-20 page S-H manuals matched to SoC, mailed after each 6m assessment.
2. Usual care and annual telephone assessment


OutcomesSustained abstinence at 2 yrs (2 PP)
Validation: none


NotesIncluded in main analysis although targeted materials. Ns are smokers for whom complete follow-up data were available


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized in 2:1 ratio, but prepared smokers in treatment condition then offered clinic so groups were not balanced by SoC

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskUnclear if control participants knew nature of intervention, no biochemical validation, different intensities of intervention

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk37% lost to follow up by 2 yrs and not reincluded in MA as group not given. Authors report sensitivity analysis of effect of excluding people with incomplete follow up and state that bias is not introduced

Parekh 2014

MethodsSetting: 21 general practices, Australia

Recruitment: Letters to patients identified via practice records


ParticipantsApproximately 400 people who completed a baseline health behaviour questionnaire and were not non smokers (˜14% of participants). Aged 18-70, had consulted in previous 6 months. 69% F av.age 46.9 (all participants)


Interventions1. Single Intervention: Feedback on combined health score and personalised computer tailored advice (addressing smoking, diet, physical activity, and BMI), plus one page health promotion information sheets for each behaviour that did not meet national guidelines

2. Dual intervention: As per 1, plus additional assessment and computerised feedback at 3 months

3. Dual control: As per 1 but without combined health score, and addressing other health behaviours (immunization, protection behaviour, non smoking policies in home, screening; none of the items in 1.)

4. As per 3, plus additional assessment and computerised feedback at 3 months


OutcomesAbstinence at 12m, self reported


NotesMultiple risk factor intervention, only a minority of participants were smokers. Intervention tailored to health risks, smoking materials not individually tailored. Numbers of smokers at baseline and follow-up estimated from percentages. Dual and single arms combined in comparison 1.1.2/2.1.2.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“permuted block procedure stratified by GP”

Allocation concealment (selection bias)Unclear riskNot reported

Blinding (performance bias and detection bias)
All outcomes
Low risk“participants were blinded to the group to which they were randomized”

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts only reported for all participants, not for smokers

Pederson 1983

MethodsSetting: Respiratory specialist outpatient clinic, USA
Recruitment: All smokers attending (unselected)


Participants75 smokers; av age 52, av cpd 25


Interventions1. Advice to quit, and effects of smoking on present health, from respiratory specialist
2. Advice and S-H manual, Break the Smoking Habit: A behavioral program for giving up cigarettes (Pomerleau & Pomerleau)


OutcomesAbstinence at 6m, (self report of no smoking for 3m via telephone interview)
Validation: none


NotesDue to quasi-random allocation a sensitivity analysis of the effect of excluding this study is reported in the discussion.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuasi-random assignment by week of attendance, possibility of baseline differences

Allocation concealment (selection bias)High riskNot concealed so risk of bias although all eligible patients at a clinic supposed to be recruited thus avoiding selection bias

Blinding (performance bias and detection bias)
All outcomes
Low riskNo biochemical validation but self-report not given to physician, control group not aware of intervention content, and equal amounts of physician contact in both groups, so differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk5 lost in expt, 1 in control, included as non-responders in MA

Prochaska 1993

MethodsSetting: Community, USA
Recruitment: Advertisements for volunteers to test S-H materials


Participants756 smokers (93 precontemplation, 435 contemplation, 228 preparation) (569 in relevant arms); av age 43, av cpd 27


Interventions1. Standard S-H. ALA FfS, A Lifetime of Freedom from Smoking, 50 most often asked questions ...
2. Targeted manuals - 5 covering precontemplation, contemplation, action, maintenance, relapse. Participants sent manual for their SoC and subsequent ones, except for relapse which was sent following an assessment at which relapse occurred.
3. Tailored Interactive - in addition to manuals, sent personalized reports in response to questionnaires
4. Counsellor telephone calls - same as 3. with short calls at 0,1,3,6m (not included in this review)


OutcomesSustained abstinence at 18m (12m and 18m)
Validation: none. Participants asked for names of significant others but these not contacted


Notes2 vs 1 targeting, 3 vs 2 tailoring
Ns randomized and quit rates as shown in graphs obtained from authors.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, method not stated, stratified by SoC

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low risk"Bogus pipeline" approach; names of significant others asked for but not contacted. Similar intensities across interventions (all received manuals)

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition at each assessment averaged 5.5%, not significantly different across conditions. Non-respondents included as smokers in MA

Prochaska 2001a

MethodsSetting: Managed care organisation, USA
Recruitment: Smokers identified by survey of members. 85% recruited to a study


Participants1447 smokers (967 at 18m follow up); 56% F, av age 38, av cpd 20


Interventions1. Assessment only (completed questionnaires on 4 occasions)
2. Expert System. Tailored 2-3 page report at 0,3,6m, and SoC-matched manual
3. As 2+ TC
4. As 3 + computer for scheduled cig reduction.


OutcomesAbstinence at 18m, sustained for 6m (Other measures of abstinence also reported)
Validation: None


Notes2 vs 1, tailoring. 3 contributes to telephone counselling review. 4 not included
Arm 2 is also evaluated in Velicer 1999 results


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskSelf-reported outcomes from participants not blinded to treatment condition, treatment more intensive than control and no information on blinding reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskMA includes losses to follow up and refusals. Author analysis suggests ITT analysis is biased. A sensitivity analysis (comparison 99) tests impact on outcome

Prochaska 2001b

MethodsSetting: Community, USA
Recruitment: random digit dialling. 80% of smokers reached recruited


Participants4144 smokers (2571 at 24m follow up); 55% F, av age 41, av cpd 20


Interventions1. Assessment only (questioned at 6m intervals)
2. Expert System. See Prochaska 2001a


OutcomesAbstinence at 24m, sustained for 6m (Other measures of abstinence also reported)
Validation: none


Notes2 vs 1, tailoring


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information on blinding provided, no validation, interventions different levels of intensity so differential misreport judged possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskSimilar rates of loss to follow up but slightly higher refusal in expt. Non-respondents included as smokers in MA. A sensitivity analysis (comparison 99) tests impact on outcome

Prochaska 2004

MethodsSetting: Community, USA
Recruitment: Parents of 9th grade students in a separate study, at risk for one of the targeted health behaviours


Participants711 smokers from total of 2460 participants; 75% F (full sample), av age 43 (full), av CPD 18, 41% precontemp, 41% contemplators, 18% preparation


Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-5 page report at 0,6 & 12m and manual


OutcomesAbstinence at 24m, sustained for 6m (Other measures of abstinence also reported)
Validation: none


Notes2 vs 1, tailoring


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo information on blinding provided, no validation, interventions different levels of intensity so differential misreport judged possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskSlightly higher loss to follow up in Intervention (45% than control (40%). All participants included in this MA

Prochaska 2005

MethodsSetting: Community, USA
Recruitment: primary care patients proactively recruited by phone, at risk for one of the targeted health behaviours


Participants1211 smokers from total of 5407 participants; 70% F (full sample), av age 45 (full), av cpd 17, 31% precontemp, 46% contemplators, 23.5% preparation


Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-5 page report at 0,6 & 12m and manual


OutcomesAbstinence at 24m, PP
Validation: none


Notes2 vs 1, tailoring. Sustained abstinence also an outcome; 'same pattern of results' but details not reported. Number of smokers by group at baseline not reported. Data requested.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskTelephone assessors blinded but unclear if participants knew nature of other arm, no validation, interventions different levels of intensity so differential misreport judged possible

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk35% loss to follow up at 24m. Insufficient data to include non-respondents in MA but no interaction between missing data and intervention.

Prue 1983

MethodsSetting: Veterans Administration Medical Centre outpatients clinic, USA
Recruitment: Smokers referred to smoking treatment programme who could not attend clinic sessions (selected)


Participants40 smokers (likely to be predominantly M); av age 45, av cpd 32


Interventions1. S-H programme (Pomerleau & Pomerleau) preceded by brand fading schedule. There were also telephone calls from psychologists.
2. Wait list control


OutcomesPP abstinence at 6m follow up (wait list treated after 6m)
Validation: significant other only


NotesThis is a minimal contact programme rather than a strict S-H one, marginal for inclusion; very small impact on MA effects


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskWait list control, performance bias possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants included in analyses, but number lost to follow-up not reported

Resnicow 1997

MethodsSetting: Predominantly African-American community in USA
Recruitment: In healthcare, church and public housing settings. Presented as 'health promotion' not smoking cessation.


Participants650 smokers recruited in treatment channels and 504 in control channels who completed follow-up interviews. (Attrition similar between groups)
av age 45, av cpd 16


Interventions1. S-H kit including Kick It guide, video and aids. Bi-monthly mailings and single booster telephone call
2. Health education materials not exclusively addressing smoking, and a cholesterol education video


OutcomesPP at 6m
Validation: none


NotesLess than a third of intervention group received telephone call. A post hoc analysis reported significantly higher quit rates amongst call than no call group.
Multivariate analysis controlling for intracluster correlation gives OR of quitting in treatment group as 1.36, 95% CI 0.87 to 2.11, compared to OR 1.42 95% CI 0.98 to 2.04 from figures used in MA


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster randomized stratified by type of site, prior to recruitment of smokers. Method of sequence generation not reported

Allocation concealment (selection bias)High riskAllocation known at time of recruitment, unclear that this introduced high risk of bias; all participants received smoking cessation materials

Blinding (performance bias and detection bias)
All outcomes
High riskNo biochemical validation and differential levels of contact between groups (including additional phone call), differential misreport judged possible

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition similar between treatment (7.5%) and control (6.8%) conditions. Non-respondents did not differ on baseline characteristics; not included in MA denominators.

Rice 1994

MethodsSetting: hospital clinic, USA
Recruitment: By health professional and self referral


Participants406 smokers with a cardiovascular health problem


Interventions1. S-H materials Smokeless 6 booklet programme and individual nurse counselling
2. S-H materials and group meetings
3. S-H alone. Prompted to open envelope containing booklets on same schedule as other groups met
4. Advice to quit from nurse only


OutcomesAbstinence at 12m
Validation; saliva thiocyanate tested but rates not corrected for misreport


Notes3 vs 4, S-H vs control. 1&2 not used in this review


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomized, method not stated. Stratified by sex, smoking history and history of cardiovascular incident.

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Unclear riskBiochemical validation conducted but not reported; unclear if participants knew what other arms were receiving; arms involved differing levels of intensity

Incomplete outcome data (attrition bias)
All outcomes
Low risk8% did not provide data at final follow-up and counted as smokers in final analysis; 12 died before follow-up and were not included in final outcome figures

Other biasUnclear riskDifferential non-participation by experimental group assignments

Schofield 1999

MethodsSetting: hospital, Australia
Recruitment: Smokers discharged from hospital, (unselected)


Participants2465 smokers or recent quitters. Excludes 1693 randomized but lost at 12m follow up. No differential drop out, 59% followed up in each arm. No demographic data


Interventions1. S-H 31 page SoC-based booklet + personally addressed letter from consultant stating health risks and urging to quit
2. Usual care


OutcomesAbstinence at 12m, and at 6m
Validation: urine cotinine ≦ 50ng/ml or CO ≦ 8ppm for sample. Refusers (22% in each group) classified as smokers.


NotesS-H, no contact. Authors report a benefit for subgroup for whom quitting highly relevant for diagnosis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomized: 'alternately allocated to intervention or control conditions by computer'

Allocation concealment (selection bias)Low riskSmokers were identified at time of admission and allocation was determined at that time. Mailing of materials done by medical records office.

Blinding (performance bias and detection bias)
All outcomes
Low riskControl group does not appear to have been aware of intervention condition, and biochemical validation used

Incomplete outcome data (attrition bias)
All outcomes
Low riskSome people discovered to be ineligible at follow up and excluded. Loss to follow up 41% identical in each group. MA based on eligible respondents.

Schumann 2008

MethodsSetting: Community, Germany
Recruitment: from participants in a general population health examination survey


Participants847 smokers (exsmokers in study not included here); 46% F (full sample), av age 44 (full), av cpd 15. Controls more likely to be in preparation (32 % vs 20%) & with past yr quit attempt


Interventions1. Assessment only (completed questionnaires on 3 occasions)
2. Expert System. Tailored 3-4 page letter and 8-26 page SoC matched booklet at 0,3 & 6m


OutcomesAbstinence at 24m, sustained 18m follow up (other measures of abstinence also reported)
Validation: none


NotesTailoring. 67% got 3 letters, 21% 2, 13% only 1. 72% reported reading some of materials.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskEach participant was assigned a unique computer-generated random number between 0 and 1, the data file was sorted by ascending random numbers, and participants were then consecutively assigned to the 3 study conditions.’

Allocation concealment (selection bias)Low riskNo opportunity to alter allocation or exclude

Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, written contact only, participants in control group do not appear to have known of intervention, and all participants engaged in long term questionnaires re: smoking status, so differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskSomewhat greater loss in intervention (34%) than control (27%). MA includes lost as smokers. Authors report GEE gave similar results.

Smith 2004

MethodsSetting: 10 communities, Canada
Recruitment: Volunteers intending to quit


Participants632 smokers (423 in relevant arms); 61% F, av age 42, 61% had prior use of NRT


InterventionsFactorial design comparing 2 intensities of TC and 2 types of print materials:
1. Booklet (Canadian Cancer Society [CCS] One step at a Time, 44 pages)
2. Pamphlet (CCS How to Quit Smoking, single page)
TC conditions collapsed, booklet-only control group not used in review


OutcomesAbstinence at 12m, sustained at 3m & 6m follow ups
Validation: none


NotesNo non-S-H control, comparison between materials. Results not reported by group; 'no significant interactions or main effects'.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Low riskCentralized, sequential envelopes

Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but no difference in personal contact between intervention arms so differential misreport judged unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk'Collapsing across telephone counseling groups, significantly more participants receiving print only were available for follow-up at 12 months (73%) than those receiving telephone counselling (62%). Those not available for follow-up were considered smokers for the intention-to-treat analyses.'

Strecher 2005

MethodsSetting: community, USA
Recruitment: telephone callers to NCI Cancer Information Service, interested in quitting


Participants1978 smokers; 70% F, av age 41, 46% smoked > pack/day, FTND 5.9


InterventionsAll participants received approx 15min of telecounselling.
Control: Single untailored 24 page booklet (Clearing the Air)
Intervention 1: Single 8 page tailored booklet, addressing motives and barriers cited by smoker
Intervention 2: Single untailored 24 page booklet (Clearing the Air) 2: Multiple tailored materials (booklet, 2 newsletters, letter), 5m, 8m, 12m. Tailored on baseline data
Intervention 3: Single untailored 24 page booklet (Clearing the Air) 3: Multiple retailored materials (same components and schedule as 2, used data from 5m follow up for retailoring)


OutcomesAbstinence at 12m (7day PP, but had also reported abstinence at 5m follow up)
Validation: none


NotesTo derive numbers quit, assumed equal numbers in each condition. 2+3+4 vs 1 in tailored vs untailored. Slightly more evidence of effect when comparing multiple to single (3+4 vs 1+2), and also for retailored materials amongst subgroup who were quit at 5m


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, all participants received same telecounselling and were unaware of other treatment conditions, so risk judged to be low

Incomplete outcome data (attrition bias)
All outcomes
Low riskOnly respondents at 5m eligible for 12m follow up. 56% loss at 12m (but includes those smoking at 5m), no difference by condition. Losses included as smokers.

Sutton 2007

MethodsSetting: Community, UK
Recruitment: Callers to UK Quitline (smokers planning to quit in next 30 days or quit in last  14 days)


Participants1506 including 344 (23%) recent quitters; 66% F, av age 38, av cpd 21


InterventionsAll participants received telephone counselling and QUIT information pack
1. Standard letter
2. Tailored 3 page letter (based on social cognitive theory and perspectives on change model. Aimed to encourage & support smokers. Medium or high dependence smokers advised to talk to their GP about cessation products)


OutcomesAbstinence at 6m, self-reported as sustained for 3m
Validation: none


NotesTailoring. Subgroup of baseline smokers showed larger effect of intervention, but still not significant


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk‘Randomization was effected by dividing days randomly within each of a series of consecutive 56-day blocks into two equal sets, with allocation to group depending on which day the participant called the Quitline.’

Allocation concealment (selection bias)Low risk‘Randomization was carried out by a member of the research team who had no direct contact with the counsellors or the participants. Counsellors were unaware of which condition the participant was allocated to and would have remained blind unless the participant had happened to mention during a subsequent telephone conversation that they had or had not received a tailored letter.’

Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, participants received same telephone counselling and both received one off written material, so risk of differential misreport judged to be low

Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow up nonsignificantly higher in control (24.4%) than intervention (20.8%). Losses treated as smoking

Sykes 2001

MethodsSetting: cessation clinic, UK
Recruitment: community volunteers interested in quitting


Participants260 smokers, high proportion low SES; 64% F, av age not stated; av cpd 25


Interventions1. Quit for Life. Cognitive behavioural manual, audiotape. Gradual reduction pre-quit day, stresses psychological addiction.
2. Stopping Smoking Made Easier. leaflet, SoC-based, abrupt quit


OutcomesAbstinence at 12m (Sykes 2001 reports 6m)
Validation: CO < 9ppm


NotesComparison between S-H materials. Does not contribute to MA. 1 yr data from Marks 2002.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskCluster randomized by orientation group attended, method not described

Allocation concealment (selection bias)Unclear riskAlthough potential for selection bias 'the receptionist was unaware of which intervention each group of participants would receive'.

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation and similar intensity of interventions

Incomplete outcome data (attrition bias)
All outcomes
Low risk15% loss to follow up at 1 yr, similar across groups

Thompson 1988

MethodsSetting: HMO, USA
Recruitment: consecutive attenders (unselected)


Participants379 smokers (in relevant arms); av cpd not stated, 68% smoked > 15 cpd


InterventionsComplete factorial design of 3 interventions:
A - Physician advice - structured and interactive, 3-5 mins
B - S-H materials (NCI Calling it Quits and Why do you Smoke, and a personalized follow-up letter.
C - referral to group cessation classes
Control - brief advice only


OutcomesAbstinence at 8-9m by telephone survey
Validation: none


NotesA+B & B vs A & Control in S-H + advice vs advice only


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk'physician used a randomized folder placed in the patient chart', unclear when and how randomization schedule generated

Allocation concealment (selection bias)Unclear riskParticipants enrolled before visiting physician so selection bias by physician avoided

Blinding (performance bias and detection bias)
All outcomes
Low riskThough no biochemical validation, participants never aware that smoking cessation was study target so risk of performance bias and differential misreport judged to be low

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk8% lost of follow up, but not clear by what arm and not included in final analyses

van der Aalst 2012

MethodsSetting: Community, Belgium and the Netherlands

Recruitment: Subgroup of participants enrolled in lung cancer screening trial, identified via population registry


Participants1284 current smoking male participants of lung cancer screening trial, 50-75 years old, smokers of > 15 cpd for > 25 years or > 10 cpd for > 30 years

100% M, av. age 57, av. cpd 18, 55% not planning to quit within 6 months


Interventions1. Computer-tailored smoking cessation advice via mail (one-off), only sent to participants who completed questionnaire after randomization

2. Standard brochure (35 page "Smoking cessation, why and how")


OutcomesContinuous abstinence at 2 years (prolonged and PP also reported)

Validation: none


NotesParticipants had to return questionnaire before receiving tailored brochure – only 23% did so (147/642). In that subset, quit rates were slightly higher (14.3% prolonged as compared to 12.5% in total intervention group), but still less than control group and no sig. difference.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot specified

Allocation concealment (selection bias)Unclear riskNot specified

Blinding (performance bias and detection bias)
All outcomes
Low riskNot blinded but at assessment, majority of participants unaware of which are they had been assigned to; differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk84% intervention and 85% control followed up at 2 years

Velicer 1999

MethodsSetting: Managed care organisation, USA
Recruitment: Smokers identified by survey of members. 85% recruited to study


Participants2882 smokers in a managed care organisation; av age 38, av cpd 20


Interventions1. Interactive expert system, generated 2-4 page reports based on SoC model, and stage-based manuals. 4 different levels of contact - 1,2,3 or 4 occasions at 3m intervals
2. Stage-based manuals only, same 4 levels of contact


OutcomesAbstinence at 18m, sustained for 6m (Other measures of abstinence also reported)
Validation: None


Notes1 vs 2, tailoring. There was no evidence of a dose response to the number of contacts in either condition, and expert system conditions were better than stage-based at each contact level so these are collapsed in MA.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
Low riskNot blinded or biochemically validated, but given similar intensity of both conditions, performance bias and differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low riskAuthors report numbers refusing follow up and numbers not reached. The size and significance of the results is sensitive to whether or not those lost to follow up or refusing to respond are included in the denominator as continued smokers, see sensitivity analysis 99. Including all non-responders in denominator gives a more conservative estimate and is used in the MA

Velicer 2006

MethodsSetting: Community, USA
Recruitment: Proactive approach to smokers at Veterans Administration Medical Centre


Participants2054 smokers (1031 in relevant arms); 23% F, av age 51, 40% precontemplators, 40% contemplators, 20% preparers


Interventions1. Stage-based S-H manuals; participants sent manual for current stage and next stage on
2. As 1. plus 6w nicotine patch if in appropriate stage, reassessed fro NRT eligibility at 6 & 10M
3. As 2. plus one expert system feedback report (see Prochaska trials)
4. As 3. plus regular automated telephone counselling


OutcomesAbstinence at 30m, sustained for 6m
Validation: none


Notes3 vs 2 for tailored adjunct to targeted S-H. In NRT groups 350 (67%) received NRT at baseline and 448 (86%) received NRT at some point


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-based random number generator

Allocation concealment (selection bias)Low riskAllocation done after completion of survey. Randomized participants who did not return consent form are excluded from further analyses

Blinding (performance bias and detection bias)
All outcomes
Low riskSelf-reported outcomes from participants not blinded to treatment condition, but intensity did not differ substantially by condition so differential misreport judged to be unlikely

Incomplete outcome data (attrition bias)
All outcomes
Low risk39% lost incl 8% refused by 30m, no significant differences between groups. Different treatments of missing data reported not to have altered pattern of results. Sensitivity analyses in comparison 999

Webb 2013

MethodsSetting: Community, USA

Recruitment: Community volunteers


Participants424 current smokers of ≥ 5 cpd, 57% F, av. age 42, av. cpd 19.7


InterventionsBoth groups received two priming phone calls explaining benefits of intervention and encouraging use of materials. In intervention, priming call explicitly stated materials were tailored.

1. 4 self-help booklets with placebo tailoring, covering cigarette smoking, cessation and relapse prevention, based on cognitive behavioural techniques

2. 4 standard self-help booklets covering same materials


Outcomes1 month sustained abstinence at 6m

Validation: CO ≤ 8 ppm for locals


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot specified

Allocation concealment (selection bias)Unclear riskNot specified

Blinding (performance bias and detection bias)
All outcomes
Low riskBiochemical validation used and interventions of similar intensities

Incomplete outcome data (attrition bias)
All outcomes
Low risk29% lost intervention group, 25% lost control

Willemsen 2006

MethodsSetting: Community, Netherlands
Recruitment: Smokers identified from a market research database, willing to participate in the evaluation of an ‘information aid’


Participants1014 smokers 'intending to quit'; 46% F, modal age 35-44, modal cpd 18-22, 86% daily smokers


Interventions1. Mailed Decision Aid; Starter’s kit including information about all major available treatment methods, classified into known effective & unknown. Samples of materials, and information on how to obtain them. Video with descriptions of quitting experiences.
2. No intervention


OutcomesSustained abstinence at 6m (quit for more than ˜4m)
Validation: none


NotesS-H vs control. Aid had no effect on prolonged abstinence outcome used in MA but there was an effect on PP abstinence. Aim of intervention was to increase use of efficacious aids, but it had no effect. Authors note aid 'did not contain any concrete self-help information that the smokers might have put into practice'.


Risk of bias

BiasAuthors' judgementSupport for judgement

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

Allocation concealment (selection bias)Unclear riskNo details given

Blinding (performance bias and detection bias)
All outcomes
High riskParticipants in control group aware it was a trial of self-help materials, and never received materials, which could have artificially lowered control group quit rate

Incomplete outcome data (attrition bias)
All outcomes
Low risk11.8% lost at 6m, intervention participants more likely to be missing at 2w but not 6m follow up. Losses included as smokers.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Armitage 2008aFollow-up only 2m.

Armitage 2008bFollow up only 1m. Intervention borderline for inclusion.

Arnold 2009Follow-up only 1m.

Balanda 1999Follow up only 1m after provision of one of two S-H guides to quitline callers. No differences between groups found.

Bansal-Travers 2010Only 1 month follow-up; all participants received NRT and counselling

Brandon 2000Only recent quitters recruited. Included in Cochrane review of relapse prevention.

Brandon 2004Only recent quitters recruited. Included in Cochrane review of relapse prevention (Hajek 2009).

Brandon 2012Relapse prevention intervention

Brown 1992Both arms received S-H materials. Test of telephone counselling, included in Cochrane review of telephone counselling (Stead 2013b).

Burling 2000Evaluated an internet-based intervention. Previously included in review but not in a meta-analysis. Falls within scope of separate Cochrane protocol (Koshy 2008)

Carré 2008Short follow-up; not primarily directed at cessation.

Conway 2004Intervention targeted at relapse prevention. See Edwards 1999

Curry 1988Compares S-H materials with a relapse prevention approach to abstinence-based approach. Now included in relapse prevention review (Hajek 2009)

Dijkstra 1998bFollow up only 4m (6w from last contact for multiple tailored letters condition).
The study compared combinations of tailored letters and a S-H guide for a population of smokers not planning to quit.

Dijkstra 2001Follow up only 3m. Compares different types of information in S-H materials.

Dijkstra 2005Not a structured S-H intervention, outcome is 'quitting activity' at 4m. Participants were students recruited to evaluate smoking cessation messages.

Dijkstra 2006Outcome is change in stage, not abstinence.

Dijkstra 2009Field study testing function of disengagement beliefs. Numbers abstinent not reported.

Edwards 1999The intervention was directed at relapse prevention in female naval recruits required to quit smoking during basic training. Included in review of relapse prevention interventions (Hajek 2009).

Emmons 2013Doesn't test S-H; S-H served as control for more intensive intervention

Etter 2007Intervention provided information about additives in cigarettes, focus on motivating rather than assisting quitting.

Garcia 2000Trial of group therapy-based interventions. S-H manuals provided in addition to group therapy in order to test effect of therapist contact. Included in Cochrane Group therapy review (Stead 2005).

Gritz 1988No control group.

Hall 2003Smoking cessation was not an outcome.

Jeffery 1982No long-term follow up. The control was a group programme.

Jeffery 1990Compared the offer of a S-H programme at a nominal cost with the same programme for a US$60 payment, refundable if successful. There was a very low recruitment rate to the incentive programme (9 participants, 0.09% of households randomly assigned to receive the incentive option).

Johs 2003No long- term follow up.

Jordan 1999Only 3m follow up planned. Compared an internet-based programme with an ALA printed manuals, 54 participants.

Kreuter 1996Intervention provided single page of cessation information for participants who were smokers (22%) and interested in quitting. Not a S-H intervention by the criteria for this review. (Neither standard nor enhanced feedback increased quit rates over control)

Kreuter 2012Print materials not designed as S-H; intention to increase number of people taking up referrals to specialist service

Lenert 2004Not randomized; used consecutive series of participants.

Lipkus 2004S-H was the control condition.

McBride 1999The intervention included 3 proactive telephone calls in addition to provision of S-H materials.
No effect of the intervention was found.

McDonald 2003Unpublished study, insufficient data to include

McDonnell 2011Doesn't test S-H; S-H served as control for more intensive intervention

McMahon 2000Tested incentives and social support as adjuncts to self-help. Included in Cochrane review of support (Park 2004)

Meade 1989Compared smokers' ability to understand materials written at different grade levels. Cessation was not an outcome.

Moore 2002Participants were pregnant women.

Murphy 2005Only 3m follow up, and marginal to classify as S-H intervention; provided information on access to pharmacotherapy and cessation support

Naughton 2012Doesn't test S-H; S-H served as control for more intensive intervention

O'Hara 1993Follow up only 3w after receipt of materials

Ossip-Klein 1991Both arms received S-H materials. Test of hotline availability, included in Cochrane review of Telephone Counselling (Stead 2013b).

Ossip-Klein 1997Both arms received S-H materials. Test of telephone counselling, included in Cochrane review of Telephone Counselling (Stead 2013b).

Pallonen 1998Intervention targeted for adolescents. Two S-H computer-based interventions were compared. Included in a Cochrane review of cessation interventions for adolescents and young people (Grimshaw 2006).

Pederson 1981Although this is described as a trial of behavioural S-H manuals, the treatment conditions included an introductory and 2 further group meetings.

Rimer 1994No long-term follow up data reported in full.

Russell 1979The leaflet used as an adjunct to physician advice did not meet study criteria for a structured S-H intervention. Smokers given the leaflet were also warned that they would be followed up. The study found a non-significant increase in the quit rate amongst patients who were given the leaflet in addition to advice, but including it would not alter the results of the MA, which found no effect of materials as an adjunct to advice.

Sallis 1986Only 2m follow up then wait list control offered treatment.

Senesael 2013Multiple risk factor intervention recruiting only 7 smokers. Unclear if smoking intervention met inclusion criteria.

Shi 2013Doesn't test S-H; S-H served as control for more intensive intervention

Shiffman 2000Only 6w follow up. Tested materials tailored to individual smokers, in addition to nicotine gum, compared to gum and standard written materials.

Shiffman 2001Only 6w follow up. Tested materials tailored to individual smokers, in addition to nicotine patches, compared to patches and standard written materials.

Sims 2013Doesn't test S-H; S-H served as control for more intensive intervention

Song 2012Relapse prevention intervention

Stanczyk 2013Web-based intervention

Strecher 1994Did not meet review criteria for S-H materials. Compared health letters tailored to individual recipient's smoking behaviour with no intervention (Study 2) or a standardized health letter from a physician (an adaptation of NCI Quit for Good pamphlet addressing general benefits of and barriers to quitting smoking) (Study 1). Study 1 had less than 6m follow up.

Strecher 2000Participants were pregnant women.

Strecher 2005bShort follow up

Strecher 2008Did not meet review criteria for S-H materials; Web-based programme.

Te Poel 2009Web-based intervention

Travis 2004Short follow up; S-H was an adjunct to telephone counselling.

Travis 2009Only 3 months follow-up

Ussher 2011Uncontrolled evaluation

Webb 2005Smoking status was not a measured outcome.

Webb 2007Smoking status was not a measured outcome.

Webb 2008Only 3 months follow-up

Webb 2009Only 3 months follow-up.

Webb 2010Outcomes included risk perceptions, readiness to quit smoking, and smoking-related knowledge, not smoking cessation.

Weissfeld 1991'Self-help' condition received several individual counselling sessions.

Wetter 2011All groups received multiple group counselling sessions

Willemsen 1995Not a randomized trial.

Windsor 1989All groups received the same S-H intervention, differed on additional support or incentives.

Zhu 1996All arms received S-H materials. Test of telephone counselling, included in Cochrane review of Telephone Counselling (Stead 2013b).

 
Comparison 1. Non-tailored self help vs no self help, pooled by amount of contact

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

 1 Neither group had face-to-face contact (long term abstinence)1720264Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.95, 1.18]

    1.1 Control group given no materials
1113241Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.04, 1.37]

    1.2 Control group given leaflet/pamphlet
67023Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.74, 1.04]

 2 Neither group had face-to-face contact (Becona studies only)2924Risk Ratio (M-H, Fixed, 95% CI)11.32 [5.27, 24.31]

    2.1 Control group given no materials
2924Risk Ratio (M-H, Fixed, 95% CI)11.32 [5.27, 24.31]

 3 Both groups had face-to-face contact (long-term abstinence)53866Risk Ratio (M-H, Fixed, 95% CI)1.17 [0.96, 1.42]

    3.1 Control group given no materials
42712Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.35]

    3.2 Control group given leaflet/pamphlet
11154Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.98, 2.04]

 4 Both groups had face-to-face contact with advice (long term abstinence)115365Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.80, 1.18]

    4.1 Control group given no materials
83581Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.73, 1.16]

    4.2 Control group given leaflet/pamphlet
31784Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.79, 1.60]

 
Comparison 2. Non-tailored self help vs no self help, pooling all studies

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

 1 Long-term abstinence3229495Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.98, 1.16]

    1.1 No contact/No materials for control
1113241Risk Ratio (M-H, Fixed, 95% CI)1.19 [1.04, 1.37]

    1.2 No contact/Leaflet for control
67023Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.74, 1.04]

    1.3 Face-to-face contact/No materials for control
42712Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.86, 1.35]

    1.4 Face-to-face contact/Leaflet for control
11154Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.98, 2.04]

    1.5 Advice/No materials for control
83581Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.73, 1.16]

    1.6 Advice/Leaflet for control
31784Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.79, 1.60]

 
Comparison 3. Tailored self-help materials

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

 1 Long-term abstinence3140890Risk Ratio (M-H, Fixed, 95% CI)1.28 [1.18, 1.37]

    1.1 Individually tailored materials versus no materials
913437Risk Ratio (M-H, Fixed, 95% CI)1.35 [1.19, 1.53]

    1.2 Individually tailored versus standard or stage-matched materials (matched for number of contacts)
1011024Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.94, 1.20]

    1.3 Individually tailored initial and additional materials versus standard or stage-matched single mailing
611379Risk Ratio (M-H, Fixed, 95% CI)1.32 [1.09, 1.61]

    1.4 Individually tailored additional materials versus standard or stage-matched single mailing
32787Risk Ratio (M-H, Fixed, 95% CI)1.72 [1.25, 2.37]

    1.5 Individually tailored materials as an adjunct to advice
21839Risk Ratio (M-H, Fixed, 95% CI)1.68 [1.19, 2.37]

    1.6 Placebo tailoring versus standard
1424Risk Ratio (M-H, Fixed, 95% CI)1.98 [1.18, 3.31]

 
Comparison 4. Tailored materials versus brief advice

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

 1 Long-term abstinence22992Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.86, 1.49]

 
Comparison 5. Self help plus NRT vs NRT alone

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

 1 Long-term abstinence42291Risk Ratio (M-H, Fixed, 95% CI)1.05 [0.88, 1.25]

    1.1 Non-tailored materials
2825Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.73, 1.24]

    1.2 Tailored materials
21466Risk Ratio (M-H, Fixed, 95% CI)1.13 [0.89, 1.43]

 
Comparison 6. Other enhancements/adjuncts to self-help materials

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

 1 Long-term abstinence11Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Additional written materials
44085Risk Ratio (M-H, Fixed, 95% CI)1.01 [0.87, 1.17]

    1.2 Additional video
2424Risk Ratio (M-H, Fixed, 95% CI)0.72 [0.41, 1.28]

    1.3 Targeted materials versus standard materials
53101Risk Ratio (M-H, Fixed, 95% CI)1.11 [0.90, 1.37]

 
Summary of findings for the main comparison. Print-based self help compared to no materials for smoking cessation

Print-based self help compared to no materials for smoking cessation

Patient or population: People who smoke, not selected for interest in quitting smoking
Settings: Community - materials provided without personal contact
Intervention: Print-based self help materials
Comparison: No materials

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

Assumed riskCorresponding risk

No materialsPrint-based self help materials

Abstinence - non-tailored self-help
Follow-up: 6+ months
Moderate risk population1 RR 1.19
(1.04 to 1.37)
13241
(11 studies)
⊕⊕⊕⊝
moderate2.3
No evidence of effect detected in other studies where the controls received other materials (n = 6), or where all participants had personal contact (n = 5) or brief advice (n = 11).

50 per 100060 per 1000
(52 to 69)

Abstinence - individually tailored self-help
Follow-up: 6+ months
Moderate risk population1 RR 1.35
(1.19 to 1.53)
13437
(9 studies)
⊕⊕⊕⊝
moderate4
Similar effect also detected in 22 other studies where the controls received non-tailored materials, but effect may be partially due to additional contacts.

50 per 100068 per 1000
(60 to 76)

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 Control group success rate based on average across studies. Low rate reflects intervention in participants not selected on basis of motivation to quit. All studies conducted in high income countries.
2 Majority of studies at high or unclear risk of bias but no evidence of differential effect based on risk of bias
3 Lower confidence interval close to no effect
4 All but one study at high or unclear risk of bias. One study at low risk of bias was small with wide confidence intervals